Part B—Federal-State Cooperation
§243. General grant of authority for cooperation
(a) Enforcement of quarantine regulations; prevention of communicable diseases
The Secretary is authorized to accept from State and local authorities any assistance in the enforcement of quarantine regulations made pursuant to this chapter which such authorities may be able and willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and suppression of communicable diseases and with respect to other public health matters, shall cooperate with and aid State and local authorities in the enforcement of their quarantine and other health regulations, and shall advise the several States on matters relating to the preservation and improvement of the public health.
(b) Comprehensive and continuing planning; training of personnel for State and local health work; fees
The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing planning as to their current and future health needs, the establishment and maintenance of adequate public health services, and otherwise carrying out public health activities. The Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private entities reasonable fees for the training of their personnel under the preceding sentence.
(c) Development of plan to control epidemics and meet emergencies or problems resulting from disasters; cooperative planning; temporary assistance; reimbursement of United States
(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems. The Secretary may enter into agreements providing for the cooperative planning between the Service and public and private community health programs and agencies to cope with health problems (including epidemics and health emergencies).
(2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance provided under this paragraph as he may determine to be reasonable under the circumstances. Any reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such reimbursement is received.
(July 1, 1944, ch. 373, title III, §311,
Editorial Notes
Amendments
1985—Subsec. (c)(1).
1983—Subsec. (c)(2).
1981—Subsec. (a).
Subsec. (b).
1976—Subsec. (b).
Subsec. (c).
1970—Subsecs. (a), (b).
1967—Subsec. (c).
1966—
Statutory Notes and Related Subsidiaries
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1966 Amendment
Food Allergens in the Food Code
Training of Private Persons Subject to Reimbursement or Advances to Appropriations
§244. Public access defibrillation programs
(a) In general
The Secretary shall award grants to States, political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation programs—
(1) by training and equipping local emergency medical services personnel, including firefighters, police officers, paramedics, emergency medical technicians, and other first responders, to administer immediate care, including cardiopulmonary resuscitation and automated external defibrillation, to cardiac arrest victims;
(2) by purchasing automated external defibrillators, placing the defibrillators in public places where cardiac arrests are likely to occur, and training personnel in such places to administer cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims;
(3) by setting procedures for proper maintenance and testing of such devices, according to the guidelines of the manufacturers of the devices;
(4) by providing training to members of the public in cardiopulmonary resuscitation and automated external defibrillation;
(5) by integrating the emergency medical services system with the public access defibrillation programs so that emergency medical services personnel, including dispatchers, are informed about the location of automated external defibrillators in their community; and
(6) by encouraging private companies, including small businesses, to purchase automated external defibrillators and provide training for their employees to administer cardiopulmonary resuscitation and external automated defibrillation to cardiac arrest victims in their community.
(b) Preference
In awarding grants under subsection (a), the Secretary shall give a preference to a State, political subdivision of a State, Indian tribe, or tribal organization that—
(1) has a particularly low local survival rate for cardiac arrests, or a particularly low local response rate for cardiac arrest victims; or
(2) demonstrates in its application the greatest commitment to establishing and maintaining a public access defibrillation program.
(c) Use of funds
A State, political subdivision of a State, Indian tribe, or tribal organization that receives a grant under subsection (a) may use funds received through such grant to—
(1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration;
(2) provide automated external defibrillation and basic life support training in automated external defibrillator usage through nationally recognized courses;
(3) provide information to community members about the public access defibrillation program to be funded with the grant;
(4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in public places;
(5) produce materials to encourage private companies, including small businesses, to purchase automated external defibrillators;
(6) establish an information clearinghouse, that shall be administered by an organization that has substantial expertise in pediatric education, pediatric medicine, and electrophysiology and sudden death, that provides information to increase public access to defibrillation in schools; and
(7) further develop strategies to improve access to automated external defibrillators in public places.
(d) Application
(1) In general
To be eligible to receive a grant under subsection (a), a State, political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
(2) Contents
An application submitted under paragraph (1) shall—
(A) describe the comprehensive public access defibrillation program to be funded with the grant and demonstrate how such program would make automated external defibrillation accessible and available to cardiac arrest victims in the community;
(B) contain procedures for implementing appropriate nationally recognized training courses in performing cardiopulmonary resuscitation and the use of automated external defibrillators;
(C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with the local emergency medical services system in the oversight of training and notification of incidents of the use of the automated external defibrillators;
(D) contain procedures for proper maintenance and testing of the automated external defibrillators, according to the labeling of the manufacturer;
(E) contain procedures for ensuring notification of local emergency medical services system personnel, including dispatchers, of the location and type of devices used in the public access defibrillation program; and
(F) provide for the collection of data regarding the effectiveness of the public access defibrillation program to be funded with the grant in affecting the out-of-hospital cardiac arrest survival rate.
(e) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $25,000,000 for for 1 each of fiscal years 2003 through 2014. Not more than 10 percent of amounts received under a grant awarded under this section may be used for administrative expenses.
(July 1, 1944, ch. 373, title III, §312, as added
Editorial Notes
Prior Provisions
A prior section 244, acts July 1, 1944, ch. 373, title III, §312,
A prior section 312 of act July 1, 1944, was classified to
Amendments
2010—Subsec. (c)(6).
Subsec. (e).
2003—Subsec. (c)(6), (7).
Statutory Notes and Related Subsidiaries
Findings
"(1) Over 220,000 Americans die each year from cardiac arrest. Every 2 minutes, an individual goes into cardiac arrest in the United States.
"(2) The chance of successfully returning to a normal heart rhythm diminishes by 10 percent each minute following sudden cardiac arrest.
"(3) Eighty percent of cardiac arrests are caused by ventricular fibrillation, for which defibrillation is the only effective treatment.
"(4) Sixty percent of all cardiac arrests occur outside the hospital. The average national survival rate for out-of-hospital cardiac arrest is only 5 percent.
"(5) Communities that have established and implemented public access defibrillation programs have achieved average survival rates for out-of-hospital cardiac arrest as high as 50 percent.
"(6) According to the American Heart Association, wide use of defibrillators could save as many as 50,000 lives nationally each year.
"(7) Successful public access defibrillation programs ensure that cardiac arrest victims have access to early 911 notification, early cardiopulmonary resuscitation, early defibrillation, and early advanced care."
§244–1. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, §312, formerly §306, as added Aug. 2, 1956, ch. 871, title I, §101,
Statutory Notes and Related Subsidiaries
Effective Date of Repeal
§244a. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362
Section, act July 1, 1944, ch. 373, title III, §312a, as added Aug. 31, 1954, ch. 1158, §2,
§245. Public awareness campaign on the importance of vaccinations
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other offices and agencies, as appropriate, shall award competitive grants or contracts to one or more public or private entities to carry out a national, evidence-based campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for the prevention and control of diseases, combat misinformation about vaccines, and disseminate scientific and evidence-based vaccine-related information, with the goal of increasing rates of vaccination across all ages, as applicable, particularly in communities with low rates of vaccination, to reduce and eliminate vaccine-preventable diseases.
(b) Consultation
In carrying out the campaign under this section, the Secretary shall consult with appropriate public health and medical experts, including the National Academy of Medicine and medical and public health associations and nonprofit organizations, in the development, implementation, and evaluation of the evidence-based public awareness campaign.
(c) Requirements
The campaign under this section shall—
(1) be a nationwide, evidence-based media and public engagement initiative;
(2) include the development of resources for communities with low rates of vaccination, including culturally and linguistically appropriate resources, as applicable;
(3) include the dissemination of vaccine information and communication resources to public health departments, health care providers, and health care facilities, including such providers and facilities that provide prenatal and pediatric care;
(4) be complementary to, and coordinated with, any other Federal, State, local, or Tribal efforts, as appropriate; and
(5) assess the effectiveness of communication strategies to increase rates of vaccination.
(d) Additional activities
The campaign under this section may—
(1) include the use of television, radio, the internet, and other media and telecommunications technologies;
(2) include the use of in-person activities;
(3) be focused to address specific needs of communities and populations with low rates of vaccination; and
(4) include the dissemination of scientific and evidence-based vaccine-related information, such as—
(A) advancements in evidence-based research related to diseases that may be prevented by vaccines and vaccine development;
(B) information on vaccinations for individuals and communities, including individuals for whom vaccines are not recommended by the Advisory Committee for Immunization Practices, and the effects of low vaccination rates within a community on such individuals;
(C) information on diseases that may be prevented by vaccines; and
(D) information on vaccine safety and the systems in place to monitor vaccine safety.
(e) Evaluation
The Secretary shall—
(1) establish benchmarks and metrics to quantitatively measure and evaluate the awareness campaign under this section;
(2) conduct qualitative assessments regarding the awareness campaign under this section; and
(3) prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives an evaluation of the awareness campaign under this section.
(f) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities described in this section.
(g) Authorization of appropriations
There are authorized to be appropriated to carry out this section and subsections (k) and (n) of
(July 1, 1944, ch. 373, title III, §313, as added
Editorial Notes
Prior Provisions
A prior section 245, act July 1, 1944, ch. 373, title III, §313, as added
Another prior section 245, acts July 1, 1944, ch. 373, title III, §313,
A prior section 313 of act July 1, 1944, was classified to
Statutory Notes and Related Subsidiaries
Maternal Vaccination Awareness
§245a. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, §313, formerly §309, as added Sept. 8, 1960,
Statutory Notes and Related Subsidiaries
Effective Date of Repeal
Repeal effective Oct. 1, 1977, see section 503(c) of
§246. Grants and services to States
(a) Comprehensive health planning and services
(1) In order to assist the States in comprehensive and continuing planning for their current and future health needs, the Secretary is authorized during the period beginning July 1, 1966, and ending June 30, 1973, to make grants to States which have submitted, and had approved by the Secretary, State plans for comprehensive State health planning. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $15,000,000 for the fiscal year ending June 30, 1971, $17,000,000 for the fiscal year ending June 30, 1972, $20,000,000 for the fiscal year ending June 30, 1973, and $10,000,000 for the fiscal year ending June 30, 1974.
(2) In order to be approved for purposes of this subsection, a State plan for comprehensive State health planning must—
(A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental agency, as the sole agency for administering or supervising the administration of the State's health planning functions under the plan;
(B) provide for the establishment of a State health planning council, which shall include representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the representative of the hospitals or other health care facilities of such Department which are located in such State) and nongovernmental organizations and groups concerned with health (including representation of the regional medical program or programs included in whole or in part within the State), and of consumers of health services, to advise such State agency in carrying out its functions under the plan, and a majority of the membership of such council shall consist of representatives of consumers of health services;
(C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the Secretary, are designed to provide for comprehensive State planning for health services (both public and private and including home health care), including the facilities and persons required for the provision of such services, to meet the health needs of the people of the State and including environmental considerations as they relate to public health;
(D) provide for encouraging cooperative efforts among governmental or nongovernmental agencies, organizations and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such agencies, organizations, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and rehabilitation;
(E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this subsection will be used to supplement and, to the extent practicable, to increase the level of funds that would otherwise be made available by the State for the purpose of comprehensive health planning and not to supplant such non-Federal funds;
(F) provide such methods of administration (including methods relating to the establishment and maintenance of personnel standards on a merit basis, except that the Secretary shall exercise no authority with respect to the selection, tenure of office, and compensation of any individual employed in accordance with such methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;
(G) provide that the State agency will make such reports, in such form and containing such information, as the Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of such reports;
(H) provide that the State agency will from time to time, but not less often than annually, review its State plan approved under this subsection and submit to the Secretary appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan developed in accordance with criteria established by the Secretary after consultation with the State which will meet the needs of the State for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State agency furnishing such assistance will periodically review the program (developed pursuant to clause (i)) of each health care facility in the State and recommend appropriate modification thereof;
(J) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for funds paid to the State under this subsection; and
(K) contain such additional information and assurances as the Secretary may find necessary to carry out the purposes of this subsection.
(3)(A) From the sums appropriated for such purpose for each fiscal year, the several States shall be entitled to allotments determined, in accordance with regulations, on the basis of the population and the per capita income of the respective States; except that no such allotment to any State for any fiscal year shall be less than 1 per centum of the sum appropriated for such fiscal year pursuant to paragraph (1). Any such allotment to a State for a fiscal year shall remain available for obligation by the State, in accordance with the provisions of this subsection and the State's plan approved thereunder, until the close of the succeeding fiscal year.
(B) The amount of any allotment to a State under subparagraph (A) for any fiscal year which the Secretary determines will not be required by the State, during the period for which it is available, for the purposes for which allotted shall be available for reallotment by the Secretary from time to time, on such date or dates as he may fix, to other States with respect to which such a determination has not been made, in proportion to the original allotments to such States under subparagraph (A) for such fiscal year, but with such proportionate amount for any of such other States being reduced to the extent it exceeds the sum the Secretary estimates such State needs and will be able to use during such period; and the total of such reductions shall be similarly reallotted among the States whose proportionate amounts were not so reduced. Any amount so reallotted to a State from funds appropriated pursuant to this subsection for a fiscal year shall be deemed part of its allotment under subparagraph (A) for such fiscal year.
(4) From each State's allotment for a fiscal year under this subsection, the State shall from time to time be paid the Federal share of the expenditures incurred during that year or the succeeding year pursuant to its State plan approved under this subsection. Such payments shall be made on the basis of estimates by the Secretary of the sums the State will need in order to perform the planning under its approved State plan under this subsection, but with such adjustments as may be necessary to take account of previously made underpayments or overpayments. The "Federal share" for any State for purposes of this subsection shall be all, or such part as the Secretary may determine, of the cost of such planning, except that in the case of the allotments for the fiscal year ending June 30, 1970, it shall not exceed 75 per centum of such cost.
(b) Project grants for areawide health planning; authorization of appropriations; prerequisites for grants; application; contents
(1)(A) The Secretary is authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make, with the approval of the State agency administering or supervising the administration of the State plan approved under subsection (a), project grants to any other public or nonprofit private agency or organization (but with appropriate representation of the interests of local government where the recipient of the grant is not a local government or combination thereof or an agency of such government or combination) to cover not to exceed 75 per centum of the costs of projects for developing (and from time to time revising) comprehensive regional, metropolitan area, or other local area plans for coordination of existing and planned health services, including the facilities and persons required for provision of such services; and including the provision of such services through home health care; except that in the case of project grants made in any State prior to July 1, 1968, approval of such State agency shall be required only if such State has such a State plan in effect at the time of such grants. No grant may be made under this subsection after June 30, 1970, to any agency or organization to develop or revise health plans for an area unless the Secretary determines that such agency or organization provides means for appropriate representation of the interests of the hospitals, other health care facilities, and practicing physicians serving such area, and the general public. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $5,000,000 for the fiscal year ending June 30, 1967, $7,500,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $20,000,000 for the fiscal year ending June 30, 1971, $30,000,000 for the fiscal year ending June 30, 1972, $40,000,000 for the fiscal year ending June 30, 1973, and $25,100,000 for the fiscal year ending June 30, 1974.
(B) Project grants may be made by the Secretary under subparagraph (A) to the State agency administering or supervising the administration of the State plan approved under subsection (a) with respect to a particular region or area, but only if (i) no application for such a grant with respect to such region or area has been filed by any other agency or organization qualified to receive such a grant, and (ii) such State agency certifies, and the Secretary finds, that ample opportunity has been afforded to qualified agencies and organizations to file application for such a grant with respect to such region or area and that it is improbable that, in the foreseeable future, any agency or organization which is qualified for such a grant will file application therefor.
(2)(A) In order to be approved under this subsection, an application for a grant under this subsection must contain or be supported by reasonable assurances that there has been or will be established, in or for the area with respect to which such grant is sought, an areawide health planning council. The membership of such council shall include representatives of public, voluntary, and nonprofit private agencies, institutions, and organizations concerned with health (including representatives of the interests of local government of the regional medical program for such area, and of consumers of health services). A majority of the members of such council shall consist of representatives of consumers of health services.
(B) In addition, an application for a grant under this subsection must contain or be supported by reasonable assurances that the areawide health planning agency has made provision for assisting health care facilities in its area to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan which will meet the needs of the State and the area for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner.
(c) Project grants for training, studies, and demonstrations; authorization of appropriations
The Secretary is also authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make grants to any public or nonprofit private agency, institution, or other organization to cover all or any part of the cost of projects for training, studies, or demonstrations looking toward the development of improved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30, 1969, $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000 for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and $4,700,000 for the fiscal year ending June 30, 1974.
(July 1, 1944, ch. 373, title III, §314,
Editorial Notes
Amendments
1991—Subsec. (a)(2)(B).
1985—Subsec. (g).
1981—Subsec. (d).
1980—Subsec. (g).
1979—Subsec. (d)(2)(C)(ii).
Subsec. (d)(4)(A).
Subsec. (g)(2)(D)(iv).
1978—Subsec. (d).
Subsec. (d)(7)(A).
Subsec. (d)(7)(B).
Subsec. (f).
Subsec. (g).
1977—Subsec. (d)(7)(A).
Subsec. (d)(7)(B).
1976—Subsec. (g)(4)(B).
1975—Subsec. (d).
Subsec. (e).
1973—Subsec. (a)(1).
Subsec. (b)(1)(A).
Subsec. (c).
Subsec. (d)(1).
Subsec. (e).
1972—Subsec. (d)(2)(K).
1971—Subsec. (f).
1970—
Subsec. (a)(1).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(2)(C).
Subsec. (d)(2)(K).
Subsec. (d)(2)(L).
Subsec. (e).
1967—Subsec. (a)(1).
Subsec. (a)(2)(I) to (K).
Subsec. (a)(4).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(5).
Subsec. (d)(7).
Subsec. (e).
Subsec. (f)(5).
Subsec. (f)(6), (8).
Subsec. (g)(4)(B).
1966—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsecs. (h) to (m).
1965—Subsec. (c).
1962—Subsec. (l).
1961—Subsec. (c).
Subsec. (m).
1958—Subsec. (c).
1956—Subsec. (l). Act Aug. 1, 1956, added subsec. (l).
1948—Subsec. (e). Act June 16, 1948, §5(a), added subsec. (e) to provide for community programs of heart disease control. Former subsec. (e) redesignated (f).
Subsec. (f). Act June 16, 1948, §5(a), (b), redesignated former subsec. (e) as (f) and inserted proviso relating to determination and certification of amounts to be paid under subsec. (e). Former subsec. (f) redesignated (g).
Subsec. (g). Act June 16, 1948, §5(a), (c), redesignated former subsec. (f) as (g) and brought subsecs. (e) and (f)(1) within the provisions of this subsection. Former subsec. (g) redesignated (h).
Subsec. (h). Act June 16, 1948, §5(a), (d), redesignated former subsec. (g) as (h) and made subsection applicable to agencies, institutions or other organizations specified in subsec. (f)(1). Former subsec. (h) redesignated (i).
Subsec. (i). Act June 16, 1948, §5(a), (e), redesignated former subsec. (h) as (i), made subsection applicable to subsec. (e), and made technical changes as a result of the renumbering of subsections. Former subsec. (i) redesignated (j).
Subsecs. (j), (k). Act June 16, 1948, §5(a), redesignated former subsecs. (i) and (j) as (j) and (k), respectively.
1946—Subsec. (c). Act July 3, 1946, increased annual appropriation from $20,000,000 to $30,000,000, and increased annual amount available to provide demonstrations and to train personnel for State and local health work from $2,000,000 to $3,000,000.
Subsec. (d). Act July 3, 1946, provided that Surgeon General shall give special consideration to the extent of the mental health problem as well as other special problems.
Subsecs. (f), (h), (i). Act July 3, 1946, provided that in matters relating to work in field of mental health Surgeon General shall deal with State mental health authorities where they differ from general health authorities.
Statutory Notes and Related Subsidiaries
Change of Name
"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1980 Amendment
Section 107(d) of
Effective Date of 1979 Amendment
Amendment by
Effective Date of 1978 Amendments
Effective Date of 1975 Amendment
Amendment by section 501(b) of
Effective Date of 1971 Amendment
Repeal of subsec. (f) of this section (less applicability to commissioned officers of the Public Health Service) by section 403(a) of
Effective Date of 1970 Amendments
Effective Date of 1967 Amendment
Effective Date of 1966 Amendment
Effective Date of 1962 Amendment
Effective and Termination Date of 1958 Amendment
Effective Date of 1956 Amendment
Act Aug. 1, 1956, ch. 852, §18,
Repeals
The directory language of, but not the amendment made by,
Transfer of Functions
Functions, powers, and duties of Secretary of Health and Human Services under subsecs. (a)(2)(F) and (d)(2)(F) of this section, insofar as relates to the prescription of personnel standards on a merit basis, transferred to Office of Personnel Management, see
Year 2000 Health Objectives Planning
Congressional Findings and Declaration
"(A) individual health status can be effectively and economically improved through an adequate investment in community public health programs and services;
"(B) the Federal Government and the States and their communities share in the financial responsibility for funding public health programs;
"(C) the Federal contribution to funds for public health programs should serve as an incentive to an additional investment by State and local governments;
"(D) existing categorical programs of Federal financial assistance to combat specific public health problems should be supplemented by a national program of stable generic support for such public health activities as the prevention and control of environmental health hazards, prevention and control of diseases, prevention and control of health problems of particularly vulnerable population groups, and development and regulation of health care facilities and health services delivery systems; and
"(E) the States and their communities, not the Federal Government, should have primary responsibility for identifying and measuring the impact of public health problems and the allocation of resources for their amelioration."
"(a) The Congress declares that fulfillment of our national purpose depends on promoting and assuring the highest level of health attainable for every person, in an environment which contributes positively to healthful individual and family living; that attainment of this goal depends on an effective partnership, involving close intergovernmental collaboration, official and voluntary efforts, and participation of individuals and organizations; that Federal financial assistance must be directed to support the marshaling of all health resources—national, State, and local—to assure comprehensive health services of high quality for every person, but without interference with existing patterns of private professional practice of medicine, dentistry, and related healing arts.
"(b) To carry out such purpose, and recognizing the changing character of health problems, the Congress finds that comprehensive planning for health services, health manpower, and health facilities is essential at every level of government; that desirable administration requires strengthening the leadership and capacities of State health agencies; and that support of health services provided people in their communities should be broadened and made more flexible."
Act July 3, 1956, ch. 852, §2,
"(a) The Congress hereby finds and declares—
"(1) that the latest information on the number and relevant characteristics of persons in the country suffering from heart disease, cancer, diabetes, arthritis and rheumatism, and other diseases, injuries, and handicapping conditions is now seriously out of date; and
"(2) that periodic inventories providing reasonably current information on these matters are urgently needed for purposes such as (A) appraisal of the true state of health of our population (including both adults and children), (B) adequate planning of any programs to improve their health, (C) research in the field of chronic diseases, and (D) measurement of the numbers of persons in the working ages so disabled as to be unable to perform gainful work.
"(b) It is, therefore, the purpose of this Act [see Short Title of 1956 Amendment note set out under
Limitation on Grants-in-Aid to Schools of Public Health
Grants to States To Provide for Vaccination Against Poliomyelitis
The Poliomyelitis Vaccination Assistance Act of 1955, act Aug. 12, 1955, ch. 863,
Applicability of Reorganization Plan No. 3 of 1966
Executive Documents
Transfer of Functions
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§246a. Bureau of State Services management fund; establishment; advancements; availability
For the purpose of facilitating the economical and efficient conduct of operations in the Bureau of State Services which are financed by two or more appropriations where the costs of operation are not readily susceptible of distribution as charges to such appropriations, there is established the Bureau of State Services management fund. Such amounts as the Secretary may determine to represent a reasonable distribution of estimated costs among the various appropriations involved may be advanced each year to this fund and shall be available for expenditure for such costs under such regulations as may be prescribed by the Secretary: Provided, That funds advanced to this fund shall be available only in the fiscal year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected wherever practicable with the appropriations from which such funds are advanced.
(
Editorial Notes
Codification
Section was not enacted as part of the Public Health Service Act which comprises this chapter.
Amendments
1970—
§247. Assisting veterans with military emergency medical training to meet requirements for becoming civilian health care professionals
(a) Program
(1) In general
The Secretary may establish a program, in consultation with the Secretary of Labor, consisting of awarding demonstration grants to States to streamline State requirements and procedures in order to assist veterans who held certain military occupational specialties related to medical care or who have completed certain medical training while serving in the Armed Forces of the United States to meet certification, licensure, and other requirements applicable to civilian health care professions (such as emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State.
(2) Consultation and collaboration
In determining the eligible military occupational specialties or training courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of Defense, the Secretary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans' Employment and Training, and shall collaborate with the initiatives carried out under
(b) Use of funds
Amounts received as a demonstration grant under this section shall be used to—
(1) prepare and implement a plan to streamline State requirements and procedures as described in subsection (a), including by—
(A) determining the extent to which the requirements for the education, training, and skill level of civilian health care professions (such as emergency medical technicians, paramedics, licensed practical nurses, registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to requirements for the education, training, and skill level of veterans who served in medical related fields while a member of the Armed Forces of the United States; and
(B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed Forces of the United States to forgo or meet any such equivalent State requirements; and
(2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to meet certification, licensure or other requirements applicable to becoming a civilian health care professional (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician assistant professions) in the State, develop or expand career pathways at institutions of higher education to support veterans in meeting such requirements.
(c) Report
Upon the completion of the demonstration program under this section, the Secretary shall submit to Congress a report on the program.
(d) Funding
No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section shall be carried out using amounts otherwise available for such purpose.
(e) Sunset
The demonstration program under this section shall not exceed 5 years.
(July 1, 1944, ch. 373, title III, §315, as added
Editorial Notes
Prior Provisions
A prior section 247, act July 1, 1944, ch. 373, title III, §315, as added Oct. 4, 1988,
Another prior section 247, act July 1, 1944, ch. 373, title III, §315, as added Nov. 10, 1978,
Another prior section 247, acts July 1, 1944, ch. 373, title III, §315,
§247a. Family support groups for Alzheimer's disease patients
(a) Establishment; priorities
Subject to available appropriations, the Secretary, acting through the National Institute of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the establishment of family support groups to provide, without charge, educational, emotional, and practical support to assist individuals with Alzheimer's disease or a related memory disorder and members of the families of such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
(1) university medical centers and other appropriate health care facilities which receive Federal funds from the Secretary and which conduct research on Alzheimer's disease or provide services to individuals with such disease; and
(2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
(b) National network to coordinate groups
The Secretary shall promote the establishment of a national network to coordinate the family support groups described in subsection (a).
(July 1, 1944, ch. 373, title III, §316, as added
Editorial Notes
Prior Provisions
A prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Nov. 10, 1978,
Another prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Oct. 30, 1970,
Amendments
1993—Subsec. (c).
§247b. Project grants for preventive health services
(a) Grant authority
The Secretary may make grants to States, and in consultation with State health authorities, to political subdivisions of States and to other public entities to assist them in meeting the costs of establishing and maintaining preventive health service programs.
(b) Application
No grant may be made under section (a) 1 unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and be submitted in such manner as the Secretary shall by regulation prescribe and shall provide—
(1) a complete description of the type and extent of the program for which the applicant is seeking a grant under subsection (a);
(2) with respect to each such program (A) the amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program, (B) a description of the services provided by the applicant in such program in such period, (C) the amount of Federal funds needed by the applicant to continue providing such services in such program, and (D) if the applicant proposes changes in the provision of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of Federal funds needed by the applicant to make such changes;
(3) assurances satisfactory to the Secretary that the program which will be provided with funds under a grant under subsection (a) will be provided in a manner consistent with the State health plan in effect under section 300m–3(c) 2 of this title and in those cases where the applicant is a State, that such program will be provided, where appropriate, in a manner consistent with any plans in effect under an application approved under section 247 2 of this title;
(4) assurances satisfactory to the Secretary that the applicant will provide for such fiscal control and fund accounting procedures as the Secretary by regulation prescribes to assure the proper disbursement of and accounting for funds received under grants under subsection (a);
(5) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or programs;
(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such information as the Secretary may by regulation prescribe) as the Secretary may reasonably require and keep such records and afford such access thereto as the Secretary may find necessary to assure the correctness of, and to verify, such reports;
(7) assurances satisfactory to the Secretary that the applicant will comply with any other conditions imposed by this section with respect to grants; and
(8) such other information as the Secretary may by regulation prescribe.
(c) Approval; annual project review
(1) The Secretary shall not approve an application submitted under subsection (b) for a grant for a program for which a grant was previously made under subsection (a) unless the Secretary determines—
(A) the program for which the application was submitted is operating effectively to achieve its stated purpose,
(B) the applicant complied with the assurances provided the Secretary when applying for such previous grant, and
(C) the applicant will comply with the assurances provided with the application.
(2) The Secretary shall review annually the activities undertaken by each recipient of a grant under subsection (a) to determine if the program assisted by such grant is operating effectively to achieve its stated purposes and if the recipient is in compliance with the assurances provided the Secretary when applying for such grant.
(d) Amount of grant; payment
The amount of a grant under subsection (a) shall be determined by the Secretary. Payments under such grants may be made in advance on the basis of estimates or by the way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(e) Reduction
The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—
(1) the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished the grant recipient, and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee,
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(f) Recordkeeping; audit authority
(1) Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall by regulation prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of grants under subsection (a) that are pertinent to such grants.
(g) Use of grant funds; mandatory treatment prohibited
(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to a State or to an agency or a political subdivision of a State under provisions of Federal law (other than this section) and which are available for the conduct of preventive health service programs from being used in connection with programs assisted through grants under subsection (a).
(2) Nothing in this section shall be construed to require any State or any agency or political subdivision of a State to have a preventive health service program which would require any person, who objects to any treatment provided under such a program, to be treated or to have any child or ward treated under such program.
(h) Reports
The Secretary shall include, as part of the report required by
(i) Technical assistance
The Secretary may provide technical assistance to States, State health authorities, and other public entities in connection with the operation of their preventive health service programs.
(j) Authorization of appropriations
(1) Except for grants for immunization programs the authorization of appropriations for which are established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are authorized to be appropriated such sums as may be necessary. Not more than 10 percent of the total amount appropriated under the preceding sentence for any fiscal year shall be available for grants under subsection (k)(1) for such fiscal year.
(2) For grants under subsection (a) for preventive health service programs for the provision without charge of immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be appropriated such sums as may be necessary.
(k) Additional grants to States, political subdivisions, and other public and nonprofit private entities
(1) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases that may be prevented through vaccination;
(B) demonstration projects for the prevention and control of such diseases;
(C) public information and education programs for the prevention and control of such diseases;
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel);
(E) planning, implementation, and evaluation of activities to address vaccine-preventable diseases, including activities to—
(i) identify communities at high risk of outbreaks related to vaccine-preventable diseases, including through improved data collection and analysis;
(ii) pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination;
(iii) reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines;
(iv) partner with community organizations and health care providers to develop and deliver evidence-based interventions, including culturally and linguistically appropriate interventions, to increase vaccination rates;
(v) improve delivery of evidence-based vaccine-related information to parents and others; and
(vi) improve the ability of State, local, Tribal, and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases, including, as appropriate, with local educational agencies, as defined in
(F) research related to strategies for improving awareness of scientific and evidence-based vaccine-related information, including for communities with low rates of vaccination, in order to understand barriers to vaccination, improve vaccination rates, and assess the public health outcomes of such strategies.
(2) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases and conditions;
(B) demonstration projects for the prevention and control of such diseases and conditions;
(C) public information and education programs for the prevention and control of such diseases and conditions; and
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases and conditions for health professionals (including allied health personnel).
(3) No grant may be made under this subsection unless an application therefor is submitted to the Secretary in such form, at such time, and containing such information as the Secretary may by regulation prescribe.
(4) Subsections (d), (e), and (f) of this section shall apply to grants under this subsection in the same manner as such subsections apply to grants under subsection (a) of this section.
(l) Authority to purchase recommended vaccines for adults
(1) In general
The Secretary may negotiate and enter into contracts with manufacturers of vaccines for the purchase and delivery of vaccines for adults as provided for under subsection (e).
(2) State purchase
A State may obtain additional quantities of such adult vaccines (subject to amounts specified to the Secretary by the State in advance of negotiations) through the purchase of vaccines from manufacturers at the applicable price negotiated by the Secretary under this subsection.
(m) Demonstration program to improve immunization coverage
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a demonstration program to award grants to States to improve the provision of recommended immunizations for children, adolescents, and adults through the use of evidence-based, population-based interventions for high-risk populations.
(2) State plan
To be eligible for a grant under paragraph (1), a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a State plan that describes the interventions to be implemented under the grant and how such interventions match with local needs and capabilities, as determined through consultation with local authorities.
(3) Use of funds
Funds received under a grant under this subsection shall be used to implement interventions that are recommended by the Task Force on Community Preventive Services (as established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention) or other evidence-based interventions, including—
(A) providing immunization reminders or recalls for target populations of clients, patients, and consumers;
(B) educating targeted populations and health care providers concerning immunizations in combination with one or more other interventions;
(C) reducing out-of-pocket costs for families for vaccines and their administration;
(D) carrying out immunization-promoting strategies for participants or clients of public programs, including assessments of immunization status, referrals to health care providers, education, provision of on-site immunizations, or incentives for immunization;
(E) providing for home visits that promote immunization through education, assessments of need, referrals, provision of immunizations, or other services;
(F) providing reminders or recalls for immunization providers;
(G) conducting assessments of, and providing feedback to, immunization providers;
(H) any combination of one or more interventions described in this paragraph; or
(I) immunization information systems to allow all States to have electronic databases for immunization records.
(4) Consideration
In awarding grants under this subsection, the Secretary shall consider any reviews or recommendations of the Task Force on Community Preventive Services.
(5) Evaluation
Not later than 3 years after the date on which a State receives a grant under this subsection, the State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage rates among high-risk populations within the State.
(6) Report to Congress
Not later than 4 years after March 23, 2010,2 the Secretary shall submit to Congress a report concerning the effectiveness of the demonstration program established under this subsection together with recommendations on whether to continue and expand such program.
(7) Authorization of appropriations
There is authorized to be appropriated to carry out this subsection, such sums as may be necessary for each of fiscal years 2010 through 2014.
(n) Vaccination data
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and enhance, and, as appropriate, establish and improve, programs and conduct activities to collect, monitor, and analyze vaccination coverage data to assess levels of protection from vaccine-preventable diseases, including by assessing factors contributing to underutilization of vaccines and variations of such factors, and identifying communities at high risk of outbreaks associated with vaccine-preventable diseases.
(July 1, 1944, ch. 373, title III, §317, as added
Editorial Notes
References in Text
March 23, 2010, referred to in subsec. (m)(6), was in the original "the date of enactment of the Affordable Health Choices Act", and was translated as meaning the date of enactment of the Patient Protection and Affordable Care Act,
Amendments
2020—Subsec. (k)(1)(E), (F).
Subsec. (n).
2010—Subsec. (j)(1).
Subsec. (j)(2).
Subsecs. (l), (m).
2000—Subsec. (j)(1).
1998—Subsec. (j)(1).
Subsec. (j)(2).
1993—Subsec. (j).
Subsec. (k)(2).
"(A) research into the prevention, control, and elimination of tuberculosis, especially research concerning strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect certain populations;
"(B) demonstration projects for the prevention, control, and elimination of tuberculosis;
"(C) public information and education programs for prevention, control, and elimination of tuberculosis; and
"(D) education, training, and clinical skills improvement activities in the prevention, control, and elimination of tuberculosis for health professionals, including allied health personnel."
Subsec. (k)(3).
Subsec. (k)(4), (5).
Subsec. (l).
1990—Subsec. (j)(1)(A).
Subsec. (j)(1)(B).
Subsec. (j)(1)(C).
Subsec. (j)(2).
Subsec. (k)(2)(A) to (D).
Subsec. (l).
1987—Subsec. (j).
Subsec. (k).
1985—Subsec. (j).
1984—Subsec. (j)(1).
Subsec. (j)(2).
1981—Subsec. (a).
Subsec. (j).
1979—Subsec. (j)(4), (5).
1978—
Subsec. (g)(2).
1976—
Subsecs. (j) to (l).
1975—Subsec. (d)(3).
Subsec. (h)(1).
1974—Subsec. (a).
Subsec. (b)(2)(C).
Subsecs. (b)(3), (d)(1), (2), (3), (f)(1).
Subsec. (h)(1).
Subsec. (i).
1972—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
1970—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsecs. (f), (g).
1965—Subsec. (a).
Subsec. (b).
Subsec. (c).
Statutory Notes and Related Subsidiaries
Effective Date of 1978 Amendment
Effective Date of 1976 Amendment
Effective Date of 1975 Amendment
Effective Date of 1972 Amendment
Rule of Construction Regarding Access to Immunizations
Assistance of Administrator of Veterans' Affairs in Administration of National Swine Flu Immunization Program of 1976; Claims for Damages
Study by Secretary of Scope and Extent of Liability Arising Out of Immunization Program; Alternative Protective Approaches; Report to Congress
1 So in original. Probably should be "subsection (a)".
2 See References in Text note below.
§247b–1. Screenings, referrals, and education regarding lead poisoning
(a) Authority for grants
(1) In general
Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and political subdivisions of States for the initiation and expansion of community programs designed—
(A) to provide, for infants and children—
(i) screening for elevated blood lead levels;
(ii) referral for treatment of such levels; and
(iii) referral for environmental intervention associated with such levels; and
(B) to provide education about childhood lead poisoning.
(2) Authority regarding certain entities
With respect to a geographic area with a need for activities authorized in paragraph (1), in any case in which neither the State nor the political subdivision in which such area is located has applied for a grant under paragraph (1), the Secretary may make a grant under such paragraph to any grantee under
(3) Provision of all services and activities through each grantee
In making grants under paragraph (1), the Secretary shall ensure that each of the activities described in such paragraph is provided through each grantee under such paragraph. The Secretary may authorize such a grantee to provide the services and activities directly, or through arrangements with other providers.
(b) Status as medicaid provider
(1) In general
Subject to paragraph (2), the Secretary may not make a grant under subsection (a) unless, in the case of any service described in such subsection that is made available pursuant to the State plan approved under title XIX of the Social Security Act [
(A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(B) the applicant will enter into an agreement with a provider under which the provider will provide the service, and the provider has entered into such a participation agreement and is qualified to receive such payments.
(2) Waiver regarding certain secondary agreements
(A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the provider does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits plan.
(B) A determination by the Secretary of whether a provider referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary donations regarding the provision of services to the public.
(c) Priority in making grants
In making grants under subsection (a), the Secretary shall give priority to applications for programs that will serve areas with a high incidence of elevated blood lead levels in infants and children.
(d) Grant application
No grant may be made under subsection (a), unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Secretary shall prescribe and shall include each of the following:
(1) A complete description of the program which is to be provided by or through the applicant.
(2) Assurances satisfactory to the Secretary that the program to be provided under the grant applied for will include educational programs designed to—
(A) communicate to parents, educators, and local health officials the significance and prevalence of lead poisoning in infants and children (including the sources of lead exposure, the importance of screening young children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which the program is designed to detect and prevent; and
(B) communicate to health professionals and paraprofessionals updated knowledge concerning lead poisoning and research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning among all socioeconomic groupings; the benefits of expanded lead screening; and the therapeutic and other interventions available to prevent and combat lead poisoning in affected children and families).
(3) Assurances satisfactory to the Secretary that the applicant will report on a quarterly basis the number of infants and children screened for elevated blood lead levels, the number of infants and children who were found to have elevated blood lead levels, the number and type of medical referrals made for such infants and children, the outcome of such referrals, and other information to measure program effectiveness.
(4) Assurances satisfactory to the Secretary that the applicant will make such reports respecting the program involved as the Secretary may require.
(5) Assurances satisfactory to the Secretary that the applicant will coordinate the activities carried out pursuant to subsection (a) with related activities and services carried out in the State by grantees under title V or XIX of the Social Security Act [
(6) Assurances satisfactory to the Secretary that Federal funds made available under such a grant for any period will be so used as to supplement and, to the extent practical, increase the level of State, local, and other non-Federal funds that would, in the absence of such Federal funds, be made available for the program for which the grant is to be made and will in no event supplant such State, local, and other non-Federal funds.
(7) Assurances satisfactory to the Secretary that the applicant will ensure complete and consistent reporting of all blood lead test results from laboratories and health care providers to State and local health departments in accordance with guidelines of the Centers for Disease Control and Prevention for standardized reporting as described in subsection (m).
(8) Such other information as the Secretary may prescribe.
(e) Relationship to services and activities under other programs
(1) In general
A recipient of a grant under subsection (a) may not make payments from the grant for any service or activity to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service or activity—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(2) Applicability to certain secondary agreements for provision of services
Paragraph (1) shall not apply in the case of a provider through which a grantee under subsection (a) provides services under such subsection if the Secretary has provided a waiver under subsection (b)(2) regarding the provider.
(f) Method and amount of payment
The Secretary shall determine the amount of a grant made under subsection (a). Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants. Not more than 10 percent of any grant may be obligated for administrative costs.
(g) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—
(1) the fair market value of any supplies or equipment furnished the grant recipient; and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(h) Records
Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(i) Audit and examination of records
The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of a grant under subsection (a), that are pertinent to such grant.
(j) Annual report
(1) In general
Not later than May 1 of each year, the Secretary shall submit to the Congress a report on the effectiveness during the preceding fiscal year of programs carried out with grants under subsection (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2).
(2) Certain requirements
Each report under paragraph (1) shall include, in addition to any other information that the Secretary may require, the following information:
(A) The number of infants and children screened.
(B) Demographic information on the population of infants and children screened, including the age and racial or ethnic status of such population.
(C) The number of screening sites.
(D) A description of the severity of the extent of the blood lead levels of the infants and children screened, expressed in categories of severity.
(E) The sources of payment for the screenings.
(F) The number of grantees that have established systems to ensure mandatory reporting of all blood lead tests from laboratories and health care providers to State and local health departments.
(G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if any, provided in the report under paragraph (1) preceding the report involved.
(k) Indian tribes
For purposes of this section, the term "political subdivision" includes Indian tribes.
(l) Funding
(1) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2005.
(2) Allocation for other programs
Of the amounts appropriated under paragraph (1) for any fiscal year, the Secretary may reserve not more than 20 percent for carrying out programs regarding the activities described in subsection (a) in addition to the program of grants established in such subsection.
(m) Guidelines for standardized reporting
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop national guidelines for the uniform reporting of all blood lead test results to State and local health departments.
(July 1, 1944, ch. 373, title III, §317A, as added
Editorial Notes
References in Text
The reference to
The Social Security Act, referred to in subsecs. (b)(1) and (d)(5), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 247b–1,
Amendments
2003—Subsec. (a)(2).
2002—Subsec. (a)(2).
2000—Subsec. (d)(7), (8).
Subsec. (j)(2)(F), (G).
Subsec. (l)(1).
Subsec. (m).
1998—Subsec. (l)(1).
1993—Subsec. (l)(1).
1992—
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Amendment by
Development and Implementation of Effective Data Management by the Centers for Disease Control and Prevention
"(1)
"(A) assist with the improvement of data linkages between State and local health departments and between State health departments and the Centers for Disease Control and Prevention;
"(B) assist States with the development of flexible, comprehensive State-based data management systems for the surveillance of children with lead poisoning that have the capacity to contribute to a national data set;
"(C) assist with the improvement of the ability of State-based data management systems and federally-funded means-tested public benefit programs (including the special supplemental food program for women, infants and children (WIC) under section 17 of the Child Nutrition Act of 1966 (
"(D) assist States with the establishment of a capacity for assessing how many children enrolled in the Medicaid, WIC, early head start, and other federally-funded means-tested public benefit programs are being screened for lead poisoning at age-appropriate intervals;
"(E) use data obtained as result of activities under this section to formulate or revise existing lead blood screening and case management policies; and
"(F) establish performance measures for evaluating State and local implementation of the requirements and improvements described in subparagraphs (A) through (E).
"(2)
"(3)
1 See References in Text notes below.
§247b–2. Repealed. Pub. L. 97–35, title IX, §902(a), Aug. 13, 1981, 95 Stat. 559
Section,
Statutory Notes and Related Subsidiaries
Effective Date of Repeal
Repeal effective Oct. 1, 1981, see section 902(h) of
§247b–3. Education, technology assessment, and epidemiology regarding lead poisoning
(a) Prevention
(1) Public education
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out a program to educate health professionals and paraprofessionals and the general public on the prevention of lead poisoning in infants and children. In carrying out the program, the Secretary shall make available information concerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and secondary preventive measures that may be taken to prevent such poisoning.
(2) Interagency Task Force
(A) Not later than 6 months after October 27, 1992, the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of Lead Poisoning (in this paragraph referred to as the "Task Force"). The Task Force shall coordinate the efforts of Federal agencies to prevent lead poisoning.
(B) The Task Force shall be composed of—
(i) the Secretary, who shall serve as the chair of the Task Force;
(ii) the Secretary of Housing and Urban Development;
(iii) the Administrator of the Environmental Protection Agency; and
(iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials respectively.
(C) The Task Force shall—
(i) review, evaluate, and coordinate current strategies and plans formulated by the officials serving as members of the Task Force, including—
(I) the plan of the Secretary of Health and Human Services entitled "Strategic Plan for the Elimination of Lead Poisoning", dated February 21, 1991;
(II) the plan of the Secretary of Housing and Urban Development entitled "Comprehensive and Workable Plan for the Abatement of Lead-Based Paint in Privately Owned Housing", dated December 7, 1990; and
(III) the strategy of the Administrator of the Environmental Protection Agency entitled "Strategy for Reducing Lead Exposures", dated February 21, 1991;
(ii) develop a unified implementation plan for programs that receive Federal financial assistance for activities related to the prevention of lead poisoning;
(iii) establish a mechanism for sharing and disseminating information among the agencies represented on the Task Force;
(iv) identify the most promising areas of research and education concerning lead poisoning;
(v) identify the practical and technological constraints to expanding lead poisoning prevention;
(vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and not later than May 1 of each year, submit to the Committee on Labor and Human Resources of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and Commerce of the House of Representatives, a report that summarizes the findings made as a result of such review and that contains the recommendations of the Task Force on the programs and policies with respect to which the Task Force is established, including related budgetary recommendations; and
(vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning prevention activities of the Federal Government.
(b) Technology assessment and epidemiology
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, directly or through grants or contracts—
(1) provide for the development of improved, more cost-effective testing measures for detecting lead toxicity in children;
(2) provide for the development of improved methods of assessing the prevalence of lead poisoning, including such methods as may be necessary to conduct individual assessments for each State;
(3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and children, on the demographic characteristics of infants and children with such poisoning (including racial and ethnic status), and on the source of payment for treatment for such poisoning (including the extent to which insurance has paid for such treatment); and
(4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poisoning in infants and children.
(July 1, 1944, ch. 373, title III, §317B, as added
Editorial Notes
Amendments
1993—
Statutory Notes and Related Subsidiaries
Change of Name
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
§247b–3a. Training and reports by the Health Resources and Services Administration
(a) Training
The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration and in collaboration with the Administrator of the Centers for Medicare & Medicaid Services and the Director of the Centers for Disease Control and Prevention, shall conduct education and training programs for physicians and other health care providers regarding childhood lead poisoning, current screening and treatment recommendations and requirements, and the scientific, medical, and public health basis for those policies.
(b) Report
The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, annually shall report to Congress on the number of children who received services through health centers established under
(c) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each 1 the fiscal years 2001 through 2005.
(
Editorial Notes
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
2003—Subsec. (a).
1 So in original. Probably should be followed by "of".
§247b–4. National Center on Birth Defects and Developmental Disabilities
(a) In general
(1) National Center
There is established within the Centers for Disease Control and Prevention a center to be known as the National Center on Birth Defects and Developmental Disabilities (referred to in this section as the "Center"), which shall be headed by a director appointed by the Director of the Centers for Disease Control and Prevention.
(2) General duties
The Secretary shall carry out programs—
(A) to collect, analyze, and make available data on birth defects, developmental disabilities, and disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the causes of such defects and disabilities and on the incidence and prevalence of such defects and disabilities;
(B) to operate regional centers for the conduct of applied epidemiological research on the prevention of such defects and disabilities;
(C) to provide information and education to the public on the prevention of such defects and disabilities;
(D) to conduct research on and to promote the prevention of such defects and disabilities, and secondary health conditions among individuals with disabilities; and
(E) to support a National Spina Bifida Program to prevent and reduce suffering from the Nation's most common permanently disabling birth defect.
(3) Folic acid
The Secretary shall carry out
(4) Certain programs
(A) Transfers
All programs and functions described in subparagraph (B) are transferred to the Center, effective upon the expiration of the 180-day period beginning on October 17, 2000.
(B) Relevant programs
The programs and functions described in this subparagraph are all programs and functions that—
(i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability prevention; or other relevant diseases, disorders, or conditions as determined 1 the Secretary; and
(ii) were carried out through the National Center for Environmental Health as of the day before October 17, 2000.
(C) Related transfers
Personnel employed in connection with the programs and functions specified in subparagraph (B), and amounts available for carrying out the programs and functions, are transferred to the Center, effective upon the expiration of the 180-day period beginning on October 17, 2000. Such transfer of amounts does not affect the period of availability of the amounts, or the availability of the amounts with respect to the purposes for which the amounts may be expended.
(b) Grants and contracts
(1) In general
In carrying out subsection (a), the Secretary may make grants to and enter into contracts with public and nonprofit private entities.
(2) Supplies and services in lieu of award funds
(A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Department of Health and Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(3) Application for award
The Secretary may make an award of a grant or contract under paragraph (1) only if an application for the award is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the purposes for which the award is to be made.
(c) Biennial report
Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—
(1) contains information regarding the incidence and prevalence of birth defects, developmental disabilities, and the health status of individuals with disabilities and the extent to which these conditions have contributed to the incidence and prevalence of infant mortality and affected quality of life;
(2) contains information under paragraph (1) that is specific to various racial and ethnic groups (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);
(3) contains an assessment of the extent to which various approaches of preventing birth defects, developmental disabilities, and secondary health conditions among individuals with disabilities have been effective;
(4) describes the activities carried out under this section;
(5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or developmental disabilities, information on the health status of individuals with disabilities, information on any health disparities experienced by such individuals, and recommendations for improving the health and wellness and quality of life of such individuals;
(6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Disease Control and Prevention, including conferences related to spina bifida; and
(7) contains any recommendations of the Secretary regarding this section.
(d) Applicability of privacy laws
The provisions of this section shall be subject to the requirements of
(e) Advisory committee
Notwithstanding any other provision of law, the members of the advisory committee appointed by the Director of the National Center for Environmental Health that have expertise in birth defects, developmental disabilities, and disabilities and health shall be transferred to and shall advise the National Center on Birth Defects and Developmental Disabilities effective on December 3, 2003.
(f) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2003 through 2007.
(July 1, 1944, ch. 373, title III, §317C, as added
Editorial Notes
Amendments
2010—Subsec. (a)(4)(B)(i).
2003—Subsec. (a)(2)(A).
Subsec. (a)(2)(D), (E).
Subsecs. (b), (c).
Subsec. (d).
Subsec. (d)(1).
Subsec. (d)(3).
Subsec. (d)(5) to (7).
Subsec. (e).
Subsec. (f).
2000—
Subsec. (a).
Subsec. (b)(1).
1998—
1993—
Statutory Notes and Related Subsidiaries
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Congressional Findings
"(1) Birth defects are the leading cause of infant mortality, directly responsible for one out of every five infant deaths.
"(2) Thousands of the 150,000 infants born with a serious birth defect annually face a lifetime of chronic disability and illness.
"(3) Birth defects threaten the lives of infants of all racial and ethnic backgrounds. However, some conditions pose excess risks for certain populations. For example, compared to all infants born in the United States, Hispanic-American infants are more likely to be born with anencephaly spina bifida and other neural tube defects and African-American infants are more likely to be born with sickle-cell anemia.
"(4) Birth defects can be caused by exposure to environmental hazards, adverse health conditions during pregnancy, or genetic mutations. Prevention efforts are slowed by lack of information about the number and causes of birth defects. Outbreaks of birth defects may go undetected because surveillance and research efforts are underdeveloped and poorly coordinated.
"(5) Public awareness strategies, such as programs using folic acid vitamin supplements to prevent spina bifida and alcohol avoidance programs to prevent Fetal Alcohol Syndrome, are essential to prevent the heartache and costs associated with birth defects."
Definitions
For meaning of references to an intellectual disability and to individuals with intellectual disabilities in provisions amended by section 2 of
1 So in original. Probably should be followed by the word "by".
§247b–4a. Early detection, diagnosis, and interventions for newborns and infants with hearing loss
(a) Definitions
For the purposes of this section only, the following terms in this section are defined as follows:
(1) Hearing screening
Newborn and infant hearing screening consists of objective physiologic procedures to detect possible hearing loss and to identify newborns and infants who, after rescreening, require further audiologic and medical evaluations.
(2) Audiologic evaluation
Audiologic evaluation consists of procedures to assess the status of the auditory system; to establish the site of the auditory disorder; the type and degree of hearing loss, and the potential effects of hearing loss on communication; and to identify appropriate treatment and referral options. Referral options should include linkage to State IDEA part C coordinating agencies or other appropriate agencies, medical evaluation, hearing aid/sensory aid assessment, audiologic rehabilitation treatment, national and local consumer, self-help, parent, and education organizations, and other family-centered services.
(3) Medical evaluation
Medical evaluation by a physician consists of key components including history, examination, and medical decision making focused on symptomatic and related body systems for the purpose of diagnosing the etiology of hearing loss and related physical conditions, and for identifying appropriate treatment and referral options.
(4) Medical intervention
Medical intervention is the process by which a physician provides medical diagnosis and direction for medical and/or surgical treatment options of hearing loss and/or related medical disorder associated with hearing loss.
(5) Audiologic rehabilitation
Audiologic rehabilitation (intervention) consists of procedures, techniques, and technologies to facilitate the receptive and expressive communication abilities of a child with hearing loss.
(6) Early intervention
Early intervention (e.g., nonmedical) means providing appropriate services for the child with hearing loss and ensuring that families of the child are provided comprehensive, consumer-oriented information about the full range of family support, training, information services, communication options and are given the opportunity to consider the full range of educational and program placements and options for their child.
(b) Purposes
The purposes of this section are to clarify the authority within the Public Health Service Act [
(1) All babies born in hospitals in the United States and its territories should have a hearing screening before leaving the birthing facility. Babies born in other countries and residing in the United States via immigration or adoption should have a hearing screening as early as possible.
(2) All babies who are not born in hospitals in the United States and its territories should have a hearing screening within the first 3 months of life.
(3) Appropriate audiologic and medical evaluations should be conducted by 3 months for all newborns and infants suspected of having hearing loss to allow appropriate referral and provisions for audiologic rehabilitation, medical and early intervention before the age of 6 months.
(4) All newborn and infant hearing screening programs and systems should include a component for audiologic rehabilitation, medical and early intervention options that ensures linkage to any new and existing statewide systems of intervention and rehabilitative services for newborns and infants with hearing loss.
(5) Public policy in regard to newborn and infant hearing screening and intervention should be based on applied research and the recognition that newborns, infants, toddlers, and children who are deaf or hard-of-hearing have unique language, learning, and communication needs, and should be the result of consultation with pertinent public and private sectors.
(c) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
Under the existing authority of the Public Health Service Act [
(1) To develop and monitor the efficacy of statewide newborn and infant hearing screening, evaluation and intervention programs and systems. Early intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act [
(2) To collect data on statewide newborn and infant hearing screening, evaluation and intervention programs and systems that can be used for applied research, program evaluation and policy development.
(d) Technical assistance, data management, and applied research
(1) Centers for Disease Control and Prevention
Under the existing authority of the Public Health Service Act [
(A) to ensure quality monitoring of newborn and infant hearing loss screening, evaluation, and intervention programs and systems;
(B) to provide technical assistance on data collection and management;
(C) to study the costs and effectiveness of newborn and infant hearing screening, evaluation and intervention programs and systems conducted by State-based programs in order to answer issues of importance to State and national policymakers;
(D) to identify the causes and risk factors for congenital hearing loss;
(E) to study the effectiveness of newborn and infant hearing screening, audiologic and medical evaluations and intervention programs and systems by assessing the health, intellectual and social developmental, cognitive, and language status of these children at school age; and
(F) to promote the sharing of data regarding early hearing loss with State-based birth defects and developmental disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing loss.
(2) National Institutes of Health
Under the existing authority of the Public Health Service Act, the Director of the National Institutes of Health, acting through the Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of this section, continue a program of research and development on the efficacy of new screening techniques and technology, including clinical studies of screening methods, studies on efficacy of intervention, and related research.
(e) Coordination and collaboration
(1) In general
Under the existing authority of the Public Health Service Act [
(2) Policy development
Under the existing authority of the Public Health Service Act, the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and collaborate on recommendations for policy development at the Federal and State levels and with the private sector, including consumer, medical and other health and education professional-based organizations, with respect to newborn and infant hearing screening, evaluation and intervention programs and systems.
(3) State early detection, diagnosis, and intervention programs and systems; data collection
Under the existing authority of the Public Health Service Act, the Administrator of the Health Resources and Services Administration and the Director of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States to establish newborn and infant hearing screening, evaluation and intervention programs and systems under subsection (c) and to develop a data collection system under subsection (d).
(f) Rule of construction
Nothing in this section shall be construed to preempt any State law.
(g) Authorization of appropriations
(1) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems
For the purpose of carrying out subsection (c) under the existing authority of the Public Health Service Act [
(2) Technical assistance, data management, and applied research; Centers for Disease Control and Prevention
For the purpose of carrying out subsection (d)(1) under the existing authority of the Public Health Service Act, there are authorized to the Centers for Disease Control and Prevention, appropriations in the amount of $5,000,000 for fiscal year 2000, $7,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal year 2002.
(3) Technical assistance, data management, and applied research; National Institute on Deafness and Other Communication Disorders
For the purpose of carrying out subsection (d)(2) under the existing authority of the Public Health Service Act, there are authorized to the National Institute on Deafness and Other Communication Disorders appropriations for such sums as may be necessary for each of the fiscal years 2000 through 2002.
(
Editorial Notes
References in Text
The Public Health Service Act, referred to in subsecs. (b) to (e) and (g), is act July 1, 1944, ch. 373,
The Individuals with Disabilities Education Act, referred to in subsecs. (c)(1) and (e)(1), is title VI of
The Social Security Act, referred to in subsec. (e)(1), is act Aug. 14, 1935, ch. 531,
Codification
Section was enacted as part of the Departments of Labor, Health, and Human Services, and Education, and Related Agencies Appropriations Act, 2000, and not as part of the Public Health Service Act which comprises this chapter.
§§247b–4b to 247b–4d. Repealed. Pub. L. 109–416, §3(b)(1)–(3), Dec. 19, 2006, 120 Stat. 2829
Section 247b–4b,
Section 247b–4c,
Section 247b–4d,
§247b–4e. Repealed. Pub. L. 109–416, §3(b)(4), Dec. 19, 2006, 120 Stat. 2829 ; Pub. L. 109–482, title I, §104(b)(3)(D), Jan. 15, 2007, 120 Stat. 3694
Section,
Statutory Notes and Related Subsidiaries
Effective Date of Repeal
Repeal by
§247b–4f. Research relating to preterm labor and delivery and the care, treatment, and outcomes of preterm and low birthweight infants
(a) Omitted
(b) Studies and activities on preterm birth
(1) In general
The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, may, subject to the availability of appropriations—
(A) conduct epidemiological studies on the factors relating to prematurity, such as clinical, biological, social, environmental, genetic, and behavioral factors, and other determinants that contribute to health disparities and are related to prematurity, as appropriate;
(B) conduct activities to improve national data to facilitate tracking the burden of preterm birth; and
(C) continue efforts to prevent preterm birth, including late preterm birth, through the identification of opportunities for prevention and the assessment of the impact of such efforts.
(2) Report
Not later than 2 years after November 27, 2013, and every 2 years thereafter, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the appropriate committees of Congress reports regarding activities and studies conducted under paragraph (1), including any applicable analyses of preterm birth. Such report shall be posted on the Internet website of the Department of Health and Human Services..1
(c) Pregnancy risk assessment monitoring survey
The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall—
(1) continue systems for the collection of maternal-infant clinical and biomedical information, including electronic health records, electronic databases, and biobanks, to link with the Pregnancy Risk Assessment Monitoring System (PRAMS) and other epidemiological studies of prematurity in order to track, to the extent practicable, all pregnancy outcomes and prevent preterm birth; and
(2) provide technical assistance, as appropriate, to support States in improving the collection of information pursuant to this subsection.
(d) Evaluation of existing tools and measures
The Secretary of Health and Human Services shall review existing tools and measures to ensure that such tools and measures include information related to the known risk factors of low birth weight and preterm birth.
(e) Authorization of appropriations
There is authorized to be appropriated to carry out this section, $2,000,000 for each of fiscal years 2019 through 2023.
(
Editorial Notes
Codification
Section 2 of
Section is comprised of section 3 of
Section was enacted as part of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act or the PREEMIE Act, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
2018—Subsec. (b)(1)(A).
Subsec. (b)(2).
Subsec. (c).
Subsec. (e).
2013—Subsec. (b).
Subsec. (e).
Statutory Notes and Related Subsidiaries
Advisory Committee on Infant Mortality
"(1)
"(2)
"(A) Programs of the Department of Health and Human Services that are directed at reducing infant mortality, preterm birth, and improving the health status of pregnant women and infants, and information on cost-effectiveness and outcomes of such programs.
"(B) Strategies to coordinate the various Federal programs and activities with State, local, and private programs and efforts that address factors that affect infant mortality.
"(C) The Healthy Start program under section 330H of the Public Health Service Act (
"(D) Implementation of Healthy People objectives related to maternal and infant health.
"(E) Strategies to reduce racial, ethnic, geographic, and other health disparities in birth outcomes, including by increasing awareness of Federal programs related to appropriate access to, or information regarding, prenatal care to address risk factors for preterm labor and delivery.
"(F) Strategies, including the implementation of such strategies, to address gaps in Federal research, programs, and education efforts related to the prevention of severe maternal morbidity, maternal mortality, infant mortality, and other adverse birth outcomes.
"(3)
"(A) Representatives provided for in the original charter of the Advisory Committee.
"(B) A representative of the National Center for Health Statistics.
"(4)
"(A) publish a report summarizing activities and recommendations of the Advisory Committee since the publication of the previous report;
"(B) submit such report to the Secretary and the appropriate Committees of Congress; and
"(C) post such report on the Internet website of the Department of Health and Human Services."
Purpose
"(1) reduce rates of preterm labor and delivery;
"(2) work toward an evidence-based standard of care for pregnant women at risk of preterm labor or other serious complications, and for infants born preterm and at a low birthweight; and
"(3) reduce infant mortality and disabilities caused by prematurity."
§247b–4g. Repealed. Pub. L. 113–55, title I, §104(a), Nov. 27, 2013, 127 Stat. 643
Section,
§247b–5. Preventive health measures with respect to prostate cancer
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and local health departments for the purpose of enabling such States and departments to carry out programs that may include the following:
(1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners regarding screening for prostate cancer.
(2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National Institutes of Health, the effectiveness of screening strategies for prostate cancer.
(3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the quality of life for men after prostrate 1 cancer screening and followup.
(4) To develop and disseminate public information and education programs for prostate cancer, including appropriate messages about the risks and benefits of prostate cancer screening for the general public, health care providers, policy makers and other appropriate individuals.
(5) To improve surveillance for prostate cancer.
(6) To address the needs of underserved and minority populations regarding prostate cancer.
(7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Preventive Services Task Force and shall seek input, where appropriate, from professional societies and other private and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening—
(A) to screen men for prostate cancer as a preventive health measure;
(B) to provide appropriate referrals for the medical treatment of men who have been screened under subparagraph (A) and to ensure, to the extent practicable, the provision of appropriate followup services and support services such as case management;
(C) to establish mechanisms through which State and local health departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and
(D) to improve, in consultation with the Health Resources and Services Administration, the education, training, and skills of health practitioners (including appropriate allied health professionals) in the detection and control of prostate cancer.
(8) To evaluate activities conducted under paragraphs (1) through (7) through appropriate surveillance or program monitoring activities.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such section, to make available non-Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such contributions may be made directly or through donations from public or private entities.
(2) Determination of amount of non-Federal contribution
(A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary may include only non-Federal contributions in excess of the average amount of non-Federal contributions made by the applicant involved toward the purpose described in subsection (a) for the 2-year period preceding the fiscal year for which the applicant involved is applying to receive a grant under such subsection.
(C) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary shall, subject to subparagraphs (A) and (B) of this paragraph, include any non-Federal amounts expended pursuant to title XIX of the Social Security Act [
(c) Education on significance of early detection
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that, in carrying out subsection (a)(3), the applicant will carry out education programs to communicate to men, and to local health officials, the significance of the early detection of prostate cancer.
(d) Requirement of provision of all services by date certain
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees—
(1) to ensure that, initially and throughout the period during which amounts are received pursuant to the grant, not less than 60 percent of the grant is expended to provide each of the services or activities described in paragraphs (1) and (2) of such subsection;
(2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the services or activities described in such subsection is provided; and
(3) to ensure that not more than 40 percent of the grant is expended to provide the services or activities described in paragraphs (3) through (6) of such section.2
(e) Additional required agreements
(1) Priority for low-income men
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that low-income men, and men at risk of prostate cancer, will be given priority in the provision of services and activities pursuant to paragraphs (1) and (2) of such subsection.
(2) Limitation on imposition of fees for services
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(A) will be made according to a schedule of charges that is made available to the public;
(B) will be adjusted to reflect the income of the man involved; and
(C) will not be imposed on any man with an income of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with
(3) Relationship to items and services under other programs
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the grant will not be expended to make payment for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(4) Coordination with other prostate cancer programs
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the services and activities funded through the grant will be coordinated with other Federal, State, and local prostate cancer programs.
(5) Limitation on administrative expenses
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that not more than 10 percent of the grant will be expended for administrative expenses with respect to the grant.
(6) Restrictions on use of grant
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that the grant will not be expended to provide inpatient hospital services for any individual.
(7) Records and audits
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees that—
(A) the applicant will establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the applicant under such section; 3 and
(B) upon request, the applicant will provide records maintained pursuant to paragraph (1) to the Secretary or the Comptroller of the United States for purposes of auditing the expenditures by the applicant of the grant.
(f) Reports to Secretary
The Secretary may not make a grant under subsection (a) unless the applicant involved agrees to submit to the Secretary such reports as the Secretary may require with respect to the grant.
(g) Description of intended uses of grant
The Secretary may not make a grant under subsection (a) unless—
(1) the applicant involved submits to the Secretary a description of the purposes for which the applicant intends to expend the grant;
(2) the description identifies the populations, areas, and localities in the applicant 4 with a need for the services or activities described in subsection (a);
(3) the description provides information relating to the services and activities to be provided, including a description of the manner in which the services and activities will be coordinated with any similar services or activities of public or nonprivate entities; and
(4) the description provides assurances that the grant funds will be used in the most cost-effective manner.
(h) Requirement of submission of application
The Secretary may not make a grant under subsection (a) unless an application for the grant is submitted to the Secretary, the application contains the description of intended uses required in subsection (g), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(i) Method and amount of payment
The Secretary shall determine the amount of a grant made under subsection (a). Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of the underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(j) Technical assistance and provision of supplies and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to subsection (a). The Secretary may provide such technical assistance directly or through grants to, or contracts with, public and private entities.
(2) Provision of supplies and services in lieu of grant funds
(A) Upon the request of an applicant receiving a grant under subsection (a), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the applicant in carrying out such section and, for such purpose, may detail to the applicant any officer or employee of the Department of Health and Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the grant under subsection (a) to the applicant involved by an amount equal to the costs of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(k) "Units of local government" defined
For purposes of this section, the term "units of local government" includes Indian tribes.
(l) Authorization of appropriations
(1) In general
For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004.
(2) Allocation for technical assistance
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall reserve not more than 20 percent for carrying out subsection (j)(1).
(July 1, 1944, ch. 373, title III, §317D, as added
Editorial Notes
References in Text
The Social Security Act, referred to in subsec. (b)(2)(C), is act Aug. 14, 1935, ch. 531,
Amendments
2000—Subsec. (a).
"(1) to screen men for prostate cancer as a preventive health measure;
"(2) to provide appropriate referrals for medical treatment of men screened pursuant to paragraph (1) and to ensure, to the extent practicable, the provision of appropriate follow-up services;
"(3) to develop and disseminate public information and education programs for the detection and control of prostate cancer;
"(4) to improve the education, training, and skills of health professionals (including appropriate allied health professionals) in the detection and control of prostate cancer;
"(5) to establish mechanisms through which the States and such departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and
"(6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or program monitoring activities."
Subsec. (l)(1).
1998—Subsec. (l)(1).
1993—
Subsec. (l)(1).
Statutory Notes and Related Subsidiaries
Effective Date of 1998 Amendment
Amendment by
1 So in original. Probably should be "prostate".
2 So in original. Probably should be "subsection."
3 So in original. Probably should be "subsection;".
4 So in original. Probably should be "application".
§247b–6. National strategy for combating and eliminating tuberculosis
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions, and other public entities for preventive health service programs for the prevention, control, and elimination of tuberculosis.
(b) Research and development; demonstration projects; education and training
With respect to the prevention, treatment, control, and elimination of tuberculosis, the Secretary may, directly or through grants to public or nonprofit private entities, carry out the following:
(1) Research, with priority given to research and development concerning latent tuberculosis infection, strains of tuberculosis resistant to drugs, and research concerning cases of tuberculosis that affect certain populations at risk for tuberculosis.
(2) Research and development and related activities to develop new tools for the elimination of tuberculosis, including drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis. The Secretary is encouraged to give priority to programmatically relevant research so that new tools can be utilized in public health practice.
(3) Demonstration projects for—
(A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent multidrug resistant and extensively drug resistant strains of tuberculosis;
(B) the intensification of efforts to reduce health disparities in the incidence of tuberculosis;
(C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among United States-Mexico binational populations, including through expansion of the scope and number of programs that—
(i) detect and treat binational cases of tuberculosis; and
(ii) treat high-risk cases of tuberculosis referred from Mexican health departments;
(D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are in the United States;
(E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings documented as having a high risk for tuberculosis; and
(F) tuberculosis detection, control, and prevention.
(4) Public information and education activities.
(5) Education, training, clinical skills improvement activities, and workplace exposure prevention for health professionals, including allied health personnel and emergency response employees.
(6) Support of Centers to carry out activities under paragraphs (1) through (4).
(7) Collaboration with international organizations and foreign countries in carrying out such activities.
(8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance and database management systems with cross-jurisdictional capabilities, which shall conform to the standards and implementation specifications for such information technologies as recommended by the Secretary.
(c) Cooperation with providers of primary health services
The Secretary may make a grant under subsection (a) or (b) only if the applicant for the grant agrees that, in carrying out activities under the grant, the applicant will cooperate with public and nonprofit private providers of primary health services or substance abuse services, including entities receiving assistance under
(d) Application for grant
(1) In general
The Secretary may make a grant under subsection (a) or (b) only if an application for the grant is submitted to the Secretary and the application, subject to paragraph (2), is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the subsection involved.
(2) Plan for prevention, control, and elimination
The Secretary may make a grant under subsection (a) only if the application under paragraph (1) contains a plan regarding the prevention, control, and elimination of tuberculosis in the geographic area with respect to which the grant is sought.
(3) Determination of amount of nonfederal contributions
(A) Priority
In awarding grants under subsection (a) or (b), the Secretary shall give highest priority to an applicant that provides assurances that the applicant will contribute non-Federal funds to carry out activities under this section, which may be provided directly or through donations from public or private entities and may be in cash or in kind, including equipment or services.
(B) Federal amounts not to be included as contributions
Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of non-Federal contributions as described in subparagraph (A).
(e) Supplies and services in lieu of grant funds
(1) In general
Upon the request of a grantee under subsection (a) or (b), the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the grantee in carrying out the subsection involved and, for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services.
(2) Corresponding reduction in payments
With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(f) Advisory Council
(1) In general
The Secretary shall establish an advisory council to be known as the Advisory Council for the Elimination of Tuberculosis (in this subsection referred to as the "Council").
(2) Duties
The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the Secretary. In addition, the Council shall, with respect to eliminating such disease, provide to the Secretary and other appropriate Federal officials advice on—
(A) coordinating the activities of the Department of Health and Human Services and other Federal agencies that relate to the disease, including activities under subsection (b);
(B) responding rapidly and effectively to emerging issues in tuberculosis; and
(C) efficiently utilizing the Federal resources involved.
(3) Comprehensive plan
(A) In general
In carrying out paragraph (2), the Council shall make or update recommendations on the development, revision, and implementation of a comprehensive plan to eliminate tuberculosis in the United States.
(B) Consultation
In carrying out subparagraph (A), the Council may consult with appropriate public and private entities, which may, subject to the direction or discretion of the Secretary, include—
(i) individuals who are scientists, physicians, laboratorians, and other health professionals, who are not officers or employees of the Federal Government and who represent the disciplines relevant to tuberculosis elimination;
(ii) members of public-private partnerships or private entities established to address the elimination of tuberculosis;
(iii) members of national and international nongovernmental organizations whose purpose is to eliminate tuberculosis;
(iv) members from the general public who are knowledgeable with respect to tuberculosis elimination including individuals who have or have had tuberculosis; and
(v) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.
(C) Certain components of plan
In carrying out subparagraph (A), the Council shall, subject to the direction or discretion of the Secretary—
(i) consider recommendations for the involvement of the United States in continuing global and cross-border tuberculosis control activities in countries where a high incidence of tuberculosis directly affects the United States; and
(ii) review the extent to which progress has been made toward eliminating tuberculosis.
(4) Biennial report
(A) In general
The Council shall submit a biennial report to the Secretary, as determined necessary by the Secretary, on the activities carried under this section. Each such report shall include the opinion of the Council on the extent to which its recommendations regarding the elimination of tuberculosis have been implemented, including with respect to—
(i) activities under subsection (b); and
(ii) the national plan referred to in paragraph (3).
(B) Public
The Secretary shall make a report submitted under subparagraph (A) public.
(5) Composition
The Council shall be composed of—
(A) ex officio representatives from the Centers for Disease Control and Prevention, the National Institutes of Health, the United States Agency for International Development, the Agency for Healthcare Research and Quality, the Health Resources and Services Administration, the United States-Mexico Border Health Commission, and other Federal departments and agencies that carry out significant activities related to tuberculosis;
(B) State and local tuberculosis control and public health officials;
(C) individuals who are scientists, physicians, laboratorians, and other health professionals who represent disciplines relevant to tuberculosis elimination; and
(D) members of national and international nongovernmental organizations established to address the elimination of tuberculosis.
(6) Staff, information, and other assistance
The Secretary shall provide to the Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council.
(g) Federal Tuberculosis Task Force
(1) Duties
The Federal Tuberculosis Task Force (in this subsection referred to as the "Task Force") shall provide to the Secretary and other appropriate Federal officials advice on research into new tools under subsection (b)(2), including advice regarding the efficient utilization of the Federal resources involved.
(2) Comprehensive plan for new tools development
In carrying out paragraph (1), the Task Force shall make recommendations on the development of a comprehensive plan for the creation of new tools for the elimination of tuberculosis, including drugs, diagnostics, and vaccines.
(3) Consultation
In developing the comprehensive plan under paragraph (1),2 the Task Force shall consult with external parties including representatives from groups such as—
(A) scientists, physicians, laboratorians, and other health professionals who represent the specialties and disciplines relevant to the research under consideration;
(B) members from public-private partnerships, private entities, or foundations (or both) engaged in activities relevant to research under consideration;
(C) members of national and international nongovernmental organizations established to address tuberculosis elimination;
(D) members from the general public who are knowledgeable with respect to tuberculosis including individuals who have or have had tuberculosis; and
(E) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and disciplines relevant to the research under consideration.
(h) Authorization of appropriations
(1) General program
(A) In general
For the purpose of carrying out this section, there are authorized to be appropriated $200,000,000 for fiscal year 2009, $210,000,000 for fiscal year 2010, $220,500,000 for fiscal year 2011, $231,525,000 for fiscal year 2012, and $243,101,250 for fiscal year 2013.
(B) Reservation for emergency grants
Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve not more than 25 percent for emergency grants under subsection (a) for any geographic area, State, political subdivision of a State, or other public entity in which there is, relative to other areas, a substantial number of cases of tuberculosis, multidrug resistant tuberculosis, or extensively drug resistant tuberculosis or a substantial rate of increase in such cases.
(C) Priority
In allocating amounts appropriated under subparagraph (A), the Secretary shall give priority to allocating such amounts for grants under subsection (a).
(D) Allocation of funds
(i) Requirement of formula
Of the amounts appropriated under subparagraph (A), not reserved under subparagraph (B), and allocated by the Secretary for grants under subsection (a), the Secretary shall distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.
(ii) Relevant factors
The formula developed by the Secretary under clause (i) shall take into account the level of tuberculosis morbidity and case complexity in the respective geographic area and may consider other factors relevant to tuberculosis in such area.
(iii) No change to formula required
This subparagraph does not require the Secretary to modify the formula that was used by the Secretary to distribute funds to grantees under subsection (a) for fiscal year 2009.
(2) Limitation
The authorization of appropriations established in paragraph (1) for a fiscal year is effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount appropriated to carry out this section for fiscal year 2009.
(July 1, 1944, ch. 373, title III, §317E, as added
Editorial Notes
References in Text
The reference to
Amendments
2008—
Subsec. (b).
Subsec. (d)(3).
Subsec. (f)(2) to (6).
Subsec. (g).
Subsec. (h).
2003—Subsec. (c).
2002—Subsec. (c).
1998—Subsec. (g)(1)(A).
Subsec. (g)(1)(B).
Subsec. (g)(2).
Statutory Notes and Related Subsidiaries
Effective Date of 2003 Amendment
Amendment by
Effective Date of 1998 Amendment
Amendment by section 401(b)(1) of
Construction of 2008 Amendment
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See
1 See References in Text notes below.
2 So in original. Probably should be "paragraph (2),".
§247b–7. Loan repayment program
(a) In general
(1) Authority
Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct prevention activities or preparedness and response activities, including rapid response to public health emergencies and significant public health threats, as employees of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $50,000 of the principal and interest of the educational loans of such health professionals.
(2) Limitation
The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for Toxic Substances and Disease Registry for purposes of paragraph (1) for a period of not less than 2 years.
(b) Applicability of certain provisions
With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of this subchapter, the provisions of such subpart shall, except as inconsistent with subsection (a), apply to the program established in this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.
(c) Authorization of appropriations
(1) In general
For the purpose of carrying out this section, except as described in paragraph (2), there are authorized to be appropriated $500,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2002.
(2) Epidemic Intelligence Service program
For purposes of carrying out this section with respect to qualified health professionals serving in the Epidemic Intelligence Service, as authorized under
(d) Availability of appropriations
Amounts appropriated for a fiscal year for contracts under subsection (a) shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated.
(July 1, 1944, ch. 373, title III, §317F, as added
Editorial Notes
Amendments
2019—Subsec. (a)(1).
Subsec. (a)(2)(B).
Subsec. (c).
1998—Subsec. (a)(1).
Subsec. (c).
Subsec. (d).
§247b–8. Fellowship and training programs
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by such Centers to train individuals to develop skills in epidemiology, surveillance, laboratory analysis, and other disease detection and prevention methods. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after receiving such training, in local, State, national, and international efforts toward the prevention and control of diseases, injuries, and disabilities. Such fellowships and training may be administered through the use of either appointment or nonappointment procedures.
(July 1, 1944, ch. 373, title III, §317G, as added
Statutory Notes and Related Subsidiaries
Effective Date
§247b–9. Diabetes in children and youth
(a) Surveillance on juvenile diabetes
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a sentinel system to collect data on juvenile diabetes, including with respect to incidence and prevalence, and shall establish a national database for such data.
(b) Type 2 diabetes in youth
The Secretary shall implement a national public health effort to address type 2 diabetes in youth, including—
(1) enhancing surveillance systems and expanding research to better assess the prevalence and incidence of type 2 diabetes in youth and determine the extent to which type 2 diabetes is incorrectly diagnosed as type 1 diabetes among children; and
(2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia and improving existing glucometers that measure blood glucose.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317H, as added
§247b–9a. Better diabetes care
(a) Short title
This section may be cited as the "Catalyst to Better Diabetes Care Act of 2009".
(b) National diabetes report card
(1) In general
The Secretary, in collaboration with the Director of the Centers for Disease Control and Prevention (referred to in this section as the "Director"), shall prepare on a biennial basis a national diabetes report card (referred to in this section as a "Report Card") and, to the extent possible, for each State.1
(2) Contents
(A) In general
Each Report Card shall include aggregate health outcomes related to individuals diagnosed with diabetes and prediabetes including—
(i) preventative care practices and quality of care;
(ii) risk factors; and
(iii) outcomes.
(B) Updated reports
Each Report Card that is prepared after the initial Report Card shall include trend analysis for the Nation and, to the extent possible, for each State, for the purpose of—
(i) tracking progress in meeting established national goals and objectives for improving diabetes care, costs, and prevalence (including Healthy People 2010); and
(ii) informing policy and program development.
(3) Availability
The Secretary, in collaboration with the Director, shall make each Report Card publicly available, including by posting the Report Card on the Internet.
(c) Improvement of vital statistics collection
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with appropriate agencies and States, shall—
(A) promote the education and training of physicians on the importance of birth and death certificate data and how to properly complete these documents, including the collection of such data for diabetes and other chronic diseases;
(B) encourage State adoption of the latest standard revisions of birth and death certificates; and
(C) work with States to re-engineer their vital statistics systems in order to provide cost-effective, timely, and accurate vital systems data.
(2) Death certificate additional language
In carrying out this subsection, the Secretary may promote improvements to the collection of diabetes mortality data, including the addition of a question for the individual certifying the cause of death regarding whether the deceased had diabetes.
(d) Study on appropriate level of diabetes medical education
(1) In general
The Secretary shall, in collaboration with the Institute of Medicine and appropriate associations and councils, conduct a study of the impact of diabetes on the practice of medicine in the United States and the appropriateness of the level of diabetes medical education that should be required prior to licensure, board certification, and board recertification.
(2) Report
Not later than 2 years after March 23, 2010, the Secretary shall submit a report on the study under paragraph (1) to the Committees on Ways and Means and Energy and Commerce of the House of Representatives and the Committees on Finance and Health, Education, Labor, and Pensions of the Senate.
(e) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary.
(
Editorial Notes
Codification
Section was enacted as part of the Patient Protection and Affordable Care Act, and not as part of the Public Health Service Act which comprises this chapter.
§247b–10. Compilation of data on asthma
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and the quality of asthma management;
(2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and
(3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma nationally.
(b) Surveillance activities
The Director of the Centers for Disease Control and Prevention, acting through the representative of the Director on the National Asthma Education Prevention Program Coordinating Committee, shall, in carrying out subsection (a), provide an update on surveillance activities at each Committee meeting.
(c) Collaborative efforts
The activities described in subsection (a)(1) may be conducted in collaboration with eligible entities awarded a grant under
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317I, as added
§247b–11. Effects of folic acid in prevention of birth defects
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and intensify programs (directly or through grants or contracts) for the following purposes:
(1) To provide education and training for health professionals and the general public for purposes of explaining the effects of folic acid in preventing birth defects and for purposes of encouraging each woman of reproductive capacity (whether or not planning a pregnancy) to consume on a daily basis a dietary supplement that provides an appropriate level of folic acid.
(2) To conduct research with respect to such education and training, including identifying effective strategies for increasing the rate of consumption of folic acid by women of reproductive capacity.
(3) To conduct research to increase the understanding of the effects of folic acid in preventing birth defects, including understanding with respect to cleft lip, cleft palate, and heart defects.
(4) To provide for appropriate epidemiological activities regarding folic acid and birth defects, including epidemiological activities regarding neural tube defects.
(b) Consultations with States and private entities
In carrying out subsection (a), the Secretary shall consult with the States and with other appropriate public or private entities, including national nonprofit private organizations, health professionals, and providers of health insurance and health plans.
(c) Technical assistance
The Secretary may (directly or through grants or contracts) provide technical assistance to public and nonprofit private entities in carrying out the activities described in subsection (a).
(d) Evaluations
The Secretary shall (directly or through grants or contracts) provide for the evaluation of activities under subsection (a) in order to determine the extent to which such activities have been effective in carrying out the purposes of the program under such subsection, including the effects on various demographic populations. Methods of evaluation under the preceding sentence may include surveys of knowledge and attitudes on the consumption of folic acid and on blood folate levels. Such methods may include complete and timely monitoring of infants who are born with neural tube defects.
(e) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317J, as added
§247b–12. Safe motherhood
(a) Surveillance
(1) Purpose
The purposes of this subsection are to establish or continue a Federal initiative to support State and tribal maternal mortality review committees, to improve data collection and reporting around maternal mortality, and to develop or support surveillance systems at the local, State, and national level to better understand the burden of maternal complications and mortality and to decrease the disparities among populations at risk of death and severe complications from pregnancy.
(2) Activities
For the purpose described in paragraph (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may carry out the following activities:
(A) The Secretary may continue and improve activities related to a national maternal mortality data collection and surveillance program to identify and support the review of pregnancy-associated deaths and pregnancy-related deaths that occur during, or within 1 year following, pregnancy, including improving disaggregation of data (in a manner consistent with applicable State and Federal privacy laws).
(B) The Secretary may expand the Pregnancy Risk Assessment Monitoring System to provide surveillance and collect data in each State.
(C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical support, financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health programs in each State.
(D) The Secretary may, in cooperation with States, Indian tribes, and tribal organizations, develop a program to support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality review committees, in accordance with subsection (d).
(b) Prevention research
(1) Purpose
The purpose of this subsection is to provide the Secretary with the authority to further expand research concerning risk factors, prevention strategies, and the roles of the family, health care providers and the community in safe motherhood.
(2) Research
The Secretary may carry out activities to expand research relating to—
(A) prepregnancy counseling, especially for at risk populations such as women with diabetes and women with substance use disorder;
(B) the identification of critical components of prenatal delivery and postpartum care;
(C) the identification of outreach and support services, such as folic acid education, that are available for pregnant women;
(D) the identification of women who are at high risk for complications;
(E) preventing preterm delivery;
(F) preventing urinary tract infections;
(G) preventing unnecessary caesarean sections;
(H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes, including an examination of the higher rates of maternal mortality among African American women and other groups of women with disproportionately high rates of maternal mortality;
(I) activities to reduce disparities in maternity services and outcomes;
(J) an examination of the relationship between interpersonal violence and maternal complications and mortality;
(K) preventing and reducing adverse health consequences that may result from smoking and substance abuse and misuse before, during and after pregnancy;
(L) preventing infections that cause maternal and infant complications;
(M) an examination of the relationship between maternal health and obstetric services in rural areas and outcomes in delivery and postpartum care; and
(N) other areas determined appropriate by the Secretary.
(c) Prevention programs
The Secretary may carry out activities to promote safe motherhood, including—
(1) public education campaigns on healthy pregnancies;
(2) education programs for physicians, nurses and other health care providers;
(3) activities to promote community support services for pregnant women; and
(4) activities to promote physical, mental, and behavioral health during, and up to 1 year following, pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use disorder.
(d) Maternal mortality review committees
(1) In general
In order to participate in the program under subsection (a)(2)(D), the applicable maternal mortality review committee of the State, Indian tribe, or tribal organization shall—
(A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State, tribal, or local public health officials, epidemiologists, statisticians, community organizations, geographic regions within the area covered by such committee, and individuals or organizations that represent the populations in the area covered by such committee that are most affected by pregnancy-related deaths or pregnancy-associated deaths and lack of access to maternal health care services; and
(B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review committee's methods and processes for data collection and review, as required under paragraph (3), use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths, regardless of the outcome of the pregnancy.
(2) Process for confidential reporting
States, Indian tribes, and tribal organizations that participate in the program described in this subsection shall, through the State maternal mortality review committee, develop a process that—
(A) provides for confidential case reporting of pregnancy-associated and pregnancy-related deaths to the appropriate State or tribal health agency, including such reporting by—
(i) health care professionals;
(ii) health care facilities;
(iii) any individual responsible for completing death records, including medical examiners and medical coroners; and
(iv) other appropriate individuals or entities; and
(B) provides for voluntary and confidential case reporting of pregnancy-associated deaths and pregnancy-related deaths to the appropriate State or tribal health agency by family members of the deceased, and other appropriate individuals, for purposes of review by the applicable maternal mortality review committee; and
(C) shall include—
(i) making publicly available contact information of the committee for use in such reporting; and
(ii) conducting outreach to local professional organizations, community organizations, and social services agencies regarding the availability of the review committee.
(3) Data collection and review
States, Indian tribes, and tribal organizations that participate in the program described in this subsection shall—
(A) annually identify pregnancy-associated deaths and pregnancy-related deaths—
(i) through the appropriate vital statistics unit by—
(I) matching each death record related to a pregnancy-associated death or pregnancy-related death in the State or tribal area in the applicable year to a birth certificate of an infant or fetal death record, as applicable;
(II) to the extent practicable, identifying an underlying or contributing cause of each pregnancy-associated death and each pregnancy-related death in the State or tribal area in the applicable year; and
(III) collecting data from medical examiner and coroner reports, as appropriate;
(ii) using other appropriate methods or information to identify pregnancy-associated deaths and pregnancy-related deaths, including deaths from pregnancy outcomes not identified through clause (i)(I);
(B) through the maternal mortality review committee, review data and information to identify adverse outcomes that may contribute to pregnancy-associated death and pregnancy-related death, and to identify trends, patterns, and disparities in such adverse outcomes to allow the State, Indian tribe, or tribal organization to make recommendations to individuals and entities described in paragraph (2)(A), as appropriate, to improve maternal care and reduce pregnancy-associated death and pregnancy-related death;
(C) identify training available to the individuals and entities described in paragraph (2)(A) for accurate identification and reporting of pregnancy-associated and pregnancy-related deaths;
(D) ensure that, to the extent practicable, the data collected and reported under this paragraph is in a format that allows for analysis by the Centers for Disease Control and Prevention; and
(E) publicly identify the methods used to identify pregnancy-associated deaths and pregnancy-related deaths in accordance with this section.
(4) Confidentiality
States, Indian tribes, and tribal organizations participating in the program described in this subsection shall establish confidentiality protections to ensure, at a minimum, that—
(A) there is no disclosure by the maternal mortality review committee, including any individual members of the committee, to any person, including any government official, of any identifying information about any specific maternal mortality case; and
(B) no information from committee proceedings, including deliberation or records, is made public unless specifically authorized under State and Federal law.
(5) Reports to CDC
For fiscal year 2019, and each subsequent fiscal year, each maternal mortality review committee participating in the program described in this subsection shall submit to the Director of the Centers for Disease Control and Prevention a report that includes—
(A) data, findings, and any recommendations of such committee; and
(B) as applicable, information on the implementation during such year of any recommendations submitted by the committee in a previous year.
(6) State partnerships
States may partner with one or more neighboring States to carry out the activities under this subparagraph. With respect to the States in such a partnership, any requirement under this subparagraph relating to the reporting of information related to such activities shall be deemed to be fulfilled by each such State if a single such report is submitted for the partnership.
(7) Appropriate mechanisms for Indian tribes and tribal organizations
The Secretary, in consultation with Indian tribes, shall identify and establish appropriate mechanisms for Indian tribes and tribal organizations to demonstrate, report data, and conduct the activities as required for participation in the program described in this subsection. Such mechanisms may include technical assistance with respect to grant application and submission procedures, and award management activities.
(8) Research availability
The Secretary shall develop a process to ensure that data collected under paragraph (5) is made available, as appropriate and practicable, for research purposes, in a manner that protects individually identifiable or potentially identifiable information and that is consistent with State and Federal privacy law.
(e) Definitions
In this section—
(1) the terms "Indian tribe" and "tribal organization" have the meanings given such terms in
(2) the term "pregnancy-associated death" means a death of a woman, by any cause, that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
(3) the term "pregnancy-related death" means a death of a woman that occurs during, or within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
(A) from any cause related to, or aggravated by, the pregnancy or its management; and
(B) not from accidental or incidental causes.
(f) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $58,000,000 for each of fiscal years 2019 through 2023.
(July 1, 1944, ch. 373, title III, §317K, as added
Editorial Notes
Amendments
2022—Subsec. (a)(2)(A).
Subsec. (b)(2)(M), (N).
2018—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(D).
Subsec. (b)(2)(A).
Subsec. (b)(2)(H).
Subsec. (b)(2)(I).
Subsec. (b)(2)(J).
Subsec. (b)(2)(K).
Subsec. (b)(2)(L), (M).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(4).
Subsecs. (d), (e).
Subsec. (f).
§247b–13. Prenatal and postnatal health
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out programs—
(1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and misuse, including—
(A) data on—
(i) the incidence, prevalence, and implications of such activities; and
(ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other maternal and child health outcomes associated with such activities; and
(B) additional information or data, as appropriate, on family health history, medication exposures during pregnancy, demographic information, such as race, ethnicity, geographic location, and family history, and other relevant information, to inform such analysis;
(2) to conduct applied epidemiological research on the prevention and long-term outcomes associated with prenatal and postnatal smoking, alcohol and other substance abuse and misuse;
(3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
(4) to provide information and education to the public on the prevention and implications of prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
(5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
(A) long-term outcomes of children affected by neonatal abstinence syndrome;
(B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
(C) relevant studies, evaluations, or information the Secretary determines to be appropriate.
(b) Grants
In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States, local governments, tribal entities, scientific and academic institutions, federally qualified health centers, and other public and nonprofit entities, and may provide technical and consultative assistance to such entities.
(c) Coordinating activities
To carry out this section, the Secretary may—
(1) provide technical and consultative assistance to entities receiving grants under subsection (b);
(2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease Control and Prevention;
(3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy laws; and
(4) coordinate with the National Coordinator for Health Information Technology, as appropriate, to assist States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such recognized standards are available, in order to facilitate interoperability between such systems and health information technology systems, including certified health information technology.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023.
(July 1, 1944, ch. 373, title III, §317L, as added
Editorial Notes
Amendments
2018—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (a)(5).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Statutory Notes and Related Subsidiaries
Improving Data and the Public Health Response
"(1) providing technical assistance to support States and Federally recognized Indian Tribes in collecting information on neonatal abstinence syndrome through the utilization of existing surveillance systems and collaborating with States and Federally recognized Indian Tribes to improve the quality, consistency, and collection of such data; and
"(2) providing technical assistance to support States in implementing effective public health measures, such as disseminating information to educate the public, health care providers, and other stakeholders on prenatal opioid use and neonatal abstinence syndrome."
§247b–13a. Screening and treatment for maternal mental health and substance use disorders
(a) Grants
The Secretary shall make grants to States, Indian Tribes and Tribal organizations (as such terms are defined in
(b) Application
To seek a grant under this section, an entity listed in subsection (a) shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. At a minimum, any such application shall include explanations of—
(1) how a program, or programs, will increase the percentage of women screened and treated, as appropriate, for maternal mental health and substance use disorders in 1 or more communities; and
(2) how a program, or programs, if expanded, would increase access to screening and treatment services for maternal mental health and substance use disorders.
(c) Priority
In awarding grants under this section, the Secretary shall, as appropriate, give priority to entities listed in subsection (a) that—
(1) are proposing to create, improve, or enhance screening, prevention, and treatment services for maternal mental health and substance use disorders in primary care settings;
(2) are currently partnered with, or will partner with, one or more community-based organizations to address maternal mental health and substance use disorders;
(3) are located in, or provide services under this section in, an area with disproportionately high rates of maternal mental health or substance use disorders or other related disparities; and
(4) operate in a health professional shortage area designated under
(d) Use of funds
The activities eligible for funding through a grant under subsection (a)—
(1) shall include—
(A) providing appropriate training on maternal mental health and substance use disorder screening, brief intervention, treatment (as applicable for health care providers), and referrals for treatment to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals;
(B) providing information on maternal mental health and substance use disorder screening, brief intervention, treatment (as applicable for health care providers) and referrals for treatment, follow-up support services, and linkages to community-based resources to health care providers in the primary care setting and, as applicable, relevant health paraprofessionals; and
(C) to the extent practicable and appropriate, enabling health care providers (such as obstetrician-gynecologists, nurse practitioners, nurse midwives, pediatricians, psychiatrists, mental and other behavioral health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric consultation (in-person or remotely), including through the use of technology-enabled collaborative learning and capacity building models (as defined in
(2) may include—
(A) establishing linkages with and among community-based resources, including mental health resources, primary care resources, and support groups;
(B) utilizing telehealth services, including for rural areas and medically underserved areas (as defined in
(C) providing assistance to pregnant and postpartum women to receive maternal mental health and substance use disorder treatment, including patient consultation, care coordination, and navigation for such treatment;
(D) coordinating, as appropriate, with maternal and child health programs of State, local, and Tribal governments, including child psychiatric access programs;
(E) conducting public outreach and awareness regarding grants under subsection (a);
(F) creating multistate consortia to carry out the activities required or authorized under this subsection; and
(G) training health care providers in the primary care setting and relevant health paraprofessionals on trauma-informed care, culturally and linguistically appropriate services, and best practices related to training to improve the provision of maternal mental health and substance use disorder care for racial and ethnic minority populations and reduce related disparities in the delivery of such care.
(e) Technical assistance
The Secretary shall provide technical assistance to grantees and entities listed in subsection (a) for carrying out activities pursuant to this section.
(f) Dissemination of best practices
The Secretary, based on evaluation of the activities funded pursuant to this section, shall identify and disseminate evidence-based or evidence-informed practices for screening, assessment, treatment, and referral to treatment services for maternal mental health and substance use disorders, including culturally and linguistically appropriate services, for women during pregnancy and 12 months following pregnancy.
(g) Matching requirement
The Federal share of the cost of the activities for which a grant is made to an entity under subsection (a) shall not exceed 90 percent of the total cost of such activities.
(h) Authorization of appropriations
To carry out this section, there are authorized to be appropriated $24,000,000 for each of fiscal years 2023 through 2027.
(July 1, 1944, ch. 373, title III, §317L–1, as added
Editorial Notes
Amendments
2022—
Subsec. (a).
Subsec. (b).
Subsec. (b)(1), (2).
Subsec. (c).
Subsec. (d)(1)(A).
Subsec. (d)(1)(B).
Subsec. (d)(1)(C).
Subsec. (d)(2)(A).
Subsec. (d)(2)(B).
Subsec. (d)(2)(C) to (G).
Subsecs. (e) to (g).
Subsec. (h).
§247b–14. Oral health promotion and disease prevention
(a) Grants to increase resources for community water fluoridation
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and Indian tribes for the purpose of increasing the resources available for community water fluoridation.
(2) Use of funds
A State shall use amounts provided under a grant under paragraph (1)—
(A) to purchase fluoridation equipment;
(B) to train fluoridation engineers;
(C) to develop educational materials on the benefits of fluoridation; or
(D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation.
(b) Community water fluoridation
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with the Director of the Indian Health Service, shall establish a demonstration project that is designed to assist rural water systems in successfully implementing the water fluoridation guidelines of the Centers for Disease Control and Prevention that are entitled "Engineering and Administrative Recommendations for Water Fluoridation, 1995" (referred to in this subsection as the "EARWF").
(2) Requirements
(A) Collaboration
In collaborating under paragraph (1), the Directors referred to in such paragraph shall ensure that technical assistance and training are provided to tribal programs located in each of the 12 areas of the Indian Health Service. The Director of the Indian Health Service shall provide coordination and administrative support to tribes under this section.
(B) General use of funds
Amounts made available under paragraph (1) shall be used to assist small water systems in improving the effectiveness of water fluoridation and to meet the recommendations of the EARWF.
(C) Fluoridation specialists
(i) In general
In carrying out this subsection, the Secretary shall provide for the establishment of fluoridation specialist engineering positions in each of the Dental Clinical and Preventive Support Centers through which technical assistance and training will be provided to tribal water operators, tribal utility operators and other Indian Health Service personnel working directly with fluoridation projects.
(ii) Liaison
A fluoridation specialist shall serve as the principal technical liaison between the Indian Health Service and the Centers for Disease Control and Prevention with respect to engineering and fluoridation issues.
(iii) CDC
The Director of the Centers for Disease Control and Prevention shall appoint individuals to serve as the fluoridation specialists.
(D) Implementation
The project established under this subsection shall be planned, implemented and evaluated over the 5-year period beginning on the date on which funds are appropriated under this section and shall be designed to serve as a model for improving the effectiveness of water fluoridation systems of small rural communities.
(3) Evaluation
In conducting the ongoing evaluation as provided for in paragraph (2)(D), the Secretary shall ensure that such evaluation includes—
(A) the measurement of changes in water fluoridation compliance levels resulting from assistance provided under this section;
(B) the identification of the administrative, technical and operational challenges that are unique to the fluoridation of small water systems;
(C) the development of a practical model that may be easily utilized by other tribal, State, county or local governments in improving the quality of water fluoridation with emphasis on small water systems; and
(D) the measurement of any increased percentage of Native Americans or Alaskan Natives who receive the benefits of optimally fluoridated water.
(c) School-based dental sealant program
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with the Administrator of the Health Resources and Services Administration, shall award a grant to each of the 50 States and territories and to Indians, Indian tribes, tribal organizations and urban Indian organizations (as such terms are defined in
(2) Use of funds
A State shall use amounts received under a grant under paragraph (1) to provide funds to eligible school-based entities or to public elementary or secondary schools to enable such entities or schools to provide children with access to dental care and dental sealant services. Such services shall be provided by licensed dental health professionals in accordance with State practice licensing laws.
(3) Eligibility
To be eligible to receive funds under paragraph (1), an entity shall—
(A) prepare and submit to the State an application at such time, in such manner and containing such information as the State may require; and
(B) be a public elementary or secondary school—
(i) that is located in an urban area in which and 1 more than 50 percent of the student population is participating in Federal or State free or reduced meal programs; or
(ii) that is located in a rural area and, with respect to the school district in which the school is located, the district involved has a median income that is at or below 235 percent of the poverty line, as defined in
(d) Oral health infrastructure
(1) Cooperative agreements
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or tribal organizations (as those terms are defined in
(2) Authorization of appropriations
There is authorized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through 2014.
(e) Definitions
For purposes of this section, the term "Indian tribe" means an Indian tribe or tribal organization as defined in section 5304(b) and section 5304(c) 3 of title 25.
(f) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317M, as added
Editorial Notes
References in Text
Amendments
2010—Subsec. (c)(1).
Subsecs. (d) to (f).
1 So in original. The word "and" probably should not appear.
2 So in original. The comma probably should not appear.
3 See References in Text note below.
§247b–14a. Identification of interventions that reduce the burden and transmission of oral, dental, and craniofacial diseases in high risk populations; development of approaches for pediatric oral and craniofacial assessment
(a) In general
The Secretary of Health and Human Services, through the Maternal and Child Health Bureau, the Indian Health Service, and in consultation with the National Institutes of Health and the Centers for Disease Control and Prevention, shall—
(1) support community-based research that is designed to improve understanding of the etiology, pathogenesis, diagnosis, prevention, and treatment of pediatric oral, dental, craniofacial diseases and conditions and their sequelae in high risk populations;
(2) support demonstrations of preventive interventions in high risk populations including nutrition, parenting, and feeding techniques; and
(3) develop clinical approaches to assess individual patients for the risk of pediatric dental disease.
(b) Compliance with State practice laws
Treatment and other services shall be provided pursuant to this section by licensed dental health professionals in accordance with State practice and licensing laws.
(c) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this section for each 1 the fiscal years 2001 through 2005.
(
Editorial Notes
Codification
Section was enacted as part of the Children's Health Act of 2000, and not as part of the Public Health Service Act which comprises this chapter.
1 So in original. Probably should be followed by "of".
§247b–15. Surveillance and education regarding infections associated with illicit drug use and other risk factors
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may (directly or through grants to public and nonprofit private entities) provide for programs for the following:
(1) To cooperate with States and Indian tribes in implementing or maintaining a national system to determine the incidence of infections commonly associated with illicit drug use, such as viral hepatitis, human immunodeficiency virus, and infective endocarditis, and to assist the States in determining the prevalence of such infections, which may include the reporting of cases of such infections.
(2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph (1) resulting from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.
(3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified under paragraph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.
(4) To develop and disseminate public information and education programs for the detection and control of infections described in paragraph (1), with priority given to high-risk populations as determined by the Secretary.
(5) To improve the education, training, and skills of health professionals in the detection and control of infections described in paragraph (1), including to improve coordination of treatment of substance use disorders and infectious diseases, with priority given to substance use disorder treatment providers, pediatricians and other primary care providers, obstetrician-gynecologists, and infectious disease clinicians, including HIV clinicians.
(b) Laboratory procedures
The Secretary may (directly or through grants to public and nonprofit private entities) carry out programs to provide for improvements in the quality of clinical-laboratory procedures regarding infections described in subsection (a)(1).
(c) Definition
In this section, the term "Indian tribe" has the meaning given that term in
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for each of the fiscal years 2019 through 2023.
(July 1, 1944, ch. 373, title III, §317N, as added
Editorial Notes
Amendments
2018—
Statutory Notes and Related Subsidiaries
Study and Demonstration Projects Regarding Cases of Hepatitis C Among Certain Emergency Response Employees
"(a)
"(1)
"(A) an estimate of the prevalence of hepatitis C among designated emergency response employees in the United States; and
"(B) the likely means through which such employees become infected with such disease in the course of performing their duties as such employees.
"(2)
"(3)
"(b)
"(1)
"(A) Training designated emergency response employees in minimizing the risk of infection with hepatitis C in performing their duties as such employees.
"(B) Testing such employees for infection with the disease.
"(C) Treating the employees for the disease.
"(2)
"(3)
"(4)
"(5)
"(A) a summary of evaluations under paragraph (4); and
"(B) the recommendations of the Secretary for administrative or legislative initiatives regarding the activities described in paragraph (1).
"(c)
§247b–16. Grants for lead poisoning related activities
(a) Authority to make grants
(1) In general
The Secretary shall make grants to States to support public health activities in States and localities where data suggests that at least 5 percent of preschool-age children have an elevated blood lead level through—
(A) effective, ongoing outreach and community education targeted to families most likely to be at risk for lead poisoning;
(B) individual family education activities that are designed to reduce ongoing exposures to lead for children with elevated blood lead levels, including through home visits and coordination with other programs designed to identify and treat children at risk for lead poisoning; and
(C) the development, coordination and implementation of community-based approaches for comprehensive lead poisoning prevention from surveillance to lead hazard control.
(2) State match
A State is not eligible for a grant under this section unless the State agrees to expend (through State or local funds) $1 for every $2 provided under the grant to carry out the activities described in paragraph (1).
(3) Application
To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may require.
(b) Coordination with other children's programs
A State shall identify in the application for a grant under this section how the State will coordinate operations and activities under the grant with—
(1) other programs operated in the State that serve children with elevated blood lead levels, including any such programs operated under title V, XIX, or XXI of the Social Security Act [
(2) one or more of the following—
(A) the child welfare and foster care and adoption assistance programs under parts B and E of title IV of such Act [
(B) the head start program established under the Head Start Act (
(C) the program of assistance under the special supplemental nutrition program for women, infants and children (WIC) under
(D) local public and private elementary or secondary schools; or
(E) public housing agencies, as defined in
(c) Performance measures
The Secretary shall establish needs indicators and performance measures to evaluate the activities carried out under grants awarded under this section. Such indicators shall be commensurate with national measures of maternal and child health programs and shall be developed in consultation with the Director of the Centers for Disease Control and Prevention.
(d) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §317O, as added
Editorial Notes
References in Text
The Social Security Act, referred to in subsec. (b)(1), (2)(A), is act Aug. 14, 1935, ch. 531,
The Head Start Act, referred to in subsec. (b)(2)(B), is subchapter B (§§635–657) of
§247b–17. Human papillomavirus (Johanna's Law)
(a) Surveillance
(1) In general
The Secretary, acting through the Centers for Disease Control and Prevention, shall—
(A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other special studies that would determine the prevalence in various age groups and populations of specific types of human papillomavirus (referred to in this section as "HPV") in different sites in various regions of the United States, through collection of special specimens for HPV using a variety of laboratory-based testing and diagnostic tools; and
(B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).
(2) Report
The Secretary shall make a progress report to the Congress with respect to paragraph (1) no later than 1 year after the effective date of this section.
(b) Prevention activities; education program
(1) In general
The Secretary, acting through the Centers for Disease Control and Prevention, shall conduct prevention research on HPV, including—
(A) behavioral and other research on the impact of HPV-related diagnosis on individuals;
(B) formative research to assist with the development of educational messages and information for the public, for patients, and for their partners about HPV;
(C) surveys of physician and public knowledge, attitudes, and practices about genital HPV infection; and
(D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and disseminate educational materials for the public and health care providers regarding HPV and its impact and prevention.
(2) Report; final proposal
The Secretary shall make a progress report to the Congress with respect to paragraph (1) not later than 1 year after the effective date of this section, and shall develop a final report not later than 3 years after such effective date, including a detailed summary of the significant findings and problems and the best strategies to prevent future infections, based on available science.
(c) HPV education and prevention
(1) In general
The Secretary shall prepare and distribute educational materials for health care providers and the public that include information on HPV. Such materials shall address—
(A) modes of transmission;
(B) consequences of infection, including the link between HPV and cervical cancer;
(C) the available scientific evidence on the effectiveness or lack of effectiveness of condoms in preventing infection with HPV; and
(D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of cervical cancer purposes in preventing cervical cancer.
(2) Medically accurate information
Educational material under paragraph (1), and all other relevant educational and prevention materials prepared and printed from this date forward for the public and health care providers by the Secretary (including materials prepared through the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration), or by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV shall contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD the materials are designed to address. Such requirement only applies to materials mass produced for the public and health care providers, and not to routine communications.
(d) Johanna's Law
(1) National public awareness campaign
(A) In general
The Secretary shall carry out a national campaign to increase the awareness and knowledge of health care providers and women with respect to gynecologic cancers.
(B) Written materials
Activities under the national campaign under subparagraph (A) shall include—
(i) maintaining a supply of written materials that provide information to the public on gynecologic cancers; and
(ii) distributing the materials to members of the public upon request.
(C) Public service announcements
Activities under the national campaign under subparagraph (A) shall, in accordance with applicable law and regulations, include developing and placing, in telecommunications media, public service announcements intended to encourage women to discuss with their physicians their risks of gynecologic cancers. Such announcements shall inform the public on the manner in which the written materials referred to in subparagraph (B) can be obtained upon request, and shall call attention to early warning signs and risk factors based on the best available medical information.
(2) Report and strategy
(A) Report
Not later than 6 months after January 12, 2007, the Secretary shall submit to the Congress a report including the following:
(i) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of the public with respect to different types of cancer, including gynecologic cancers.
(ii) A description of the past and present activities of the Department of Health and Human Services to increase awareness and knowledge of health care providers with respect to different types of cancer, including gynecologic cancers.
(iii) For each activity described pursuant to clause (i) or (ii), a description of the following:
(I) The funding for such activity for fiscal year 2006 and the cumulative funding for such activity for previous fiscal years.
(II) The background and history of such activity, including—
(aa) the goals of such activity;
(bb) the communications objectives of such activity;
(cc) the identity of each agency within the Department of Health and Human Services responsible for any aspect of the activity; and
(dd) how such activity is or was expected to result in change.
(III) How long the activity lasted or is expected to last.
(IV) The outcomes observed and the evaluation methods, if any, that have been, are being, or will be used with respect to such activity.
(V) For each such outcome or evaluation method, a description of the associated results, analyses, and conclusions.
(B) Strategy
(i) Development; submission to Congress
Not later than 3 months after submitting the report required by subparagraph (A), the Secretary shall develop and submit to the Congress a strategy for improving efforts to increase awareness and knowledge of the public and health care providers with respect to different types of cancer, including gynecological cancers.
(ii) Consultation
In developing the strategy under clause (i), the Secretary should consult with qualified private sector groups, including nonprofit organizations.
(3) Full compliance
(A)
(B) If the Secretary fails to submit the certification as provided for under subparagraph (A), the Secretary shall, not later than 3 months after the date on which the report is to be submitted under subparagraph (A), and every 3 months thereafter, submit to Congress an explanation as to why the Secretary has not yet complied with the first sentence of subparagraph (A), a detailed description of all actions undertaken within the month for which the report is being submitted to bring the Secretary into compliance with such sentence, and the anticipated date the Secretary expects to be in full compliance with such sentence.
(4) Consultation with nonprofit gynecologic cancer organizations
In carrying out the national campaign under this subsection, the Secretary shall consult with nonprofit gynecologic cancer organizations, with a mission both to conquer ovarian or other gynecologic cancer and to provide outreach to State and local governments and communities, for the purpose of determining the best practices for providing gynecologic cancer information and outreach services to varied populations.
(6) 1 Authorization of appropriations
For the purpose of carrying out this subsection, there is authorized to be appropriated $16,500,000 for the period of fiscal years 2007 through 2009 and $18,000,000 for the period of fiscal years 2012 through 2014.
(July 1, 1944, ch. 373, title III, §317P, as added
Editorial Notes
References in Text
Johanna's Law, referred to in section catchline and subsec. (d), is
The effective date of this section, referred to in subsecs. (a)(2) and (b)(2), is the date of enactment of
Amendments
2010—Subsec. (d)(4).
Subsec. (d)(6).
2007—
Subsec. (d).
1 So in original. No par. (5) has been enacted.
§247b–18. Surveillance and research regarding muscular dystrophy
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants and cooperative agreements to public or nonprofit private entities (including health departments of States and political subdivisions of States, and including universities and other educational entities) for the collection, analysis, and reporting of data on Duchenne and other forms of muscular dystrophy. In making such awards, the Secretary may provide direct technical assistance in lieu of cash.
(b) National muscular dystrophy epidemiology program
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to public or nonprofit private entities (including health departments of States and political subdivisions of States, and including universities and other educational entities) for the purpose of carrying out epidemiological activities regarding Duchenne and other forms of muscular dystrophies, including collecting and analyzing information on the number, incidence, correlates, and symptoms of cases. In carrying out the preceding sentence, the Secretary shall provide for a national surveillance program and, to the extent possible, ensure that data be representative of all affected populations and shared in a timely manner. In making awards under this subsection, the Secretary may provide direct technical assistance in lieu of cash.
(c) Coordination with centers of excellence
The Secretary shall ensure that epidemiological information under subsections (a) and (b) is made available to centers of excellence supported under
(d) Data
In carrying out this section, the Secretary may ensure that any data on patients that is collected as part of the Muscular Dystrophy STARnet (under a grant under this section) is regularly updated to reflect changes in patient condition over time.
(e) Reports and study
(1) Annual report
Not later than 18 months after October 8, 2008, and annually thereafter, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress a report—
(A) concerning the activities carried out by MD STARnet site 1 funded under this section during the year for which the report is prepared;
(B) containing the data collected and findings derived from the MD STARnet sites each fiscal year (as funded under a grant under this section during fiscal years 2008 through 2012); and
(C) that every 2 years outlines prospective data collection objectives and strategies.
(2) Tracking health outcomes
The Secretary may provide health outcome data on the health and survival of people with muscular dystrophy.
(f) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this section.
(July 1, 1944, ch. 373, title III, §317Q, as added
Editorial Notes
Amendments
2014—Subsec. (b).
2008—Subsecs. (d) to (f).
Statutory Notes and Related Subsidiaries
Findings
"(1) Of the childhood muscular dystrophies, Duchenne Muscular Dystrophy (DMD) is the world's most common and catastrophic form of genetic childhood disease, and is characterized by a rapidly progressive muscle weakness that almost always results in death, usually by 20 years of age.
"(2) Duchenne muscular dystrophy is genetically inherited, and mothers are the carriers in approximately 70 percent of all cases.
"(3) If a female is a carrier of the dystrophin gene, there is a 50 percent chance per birth that her male offspring will have Duchenne muscular dystrophy, and a 50 percent chance per birth that her female offspring will be carriers.
"(4) Duchenne is the most common lethal genetic disorder of childhood worldwide, affecting approximately 1 in every 3,500 boys worldwide.
"(5) Children with muscular dystrophy exhibit extreme symptoms of weakness, delay in walking, waddling gait, difficulty in climbing stairs, and progressive mobility problems often in combination with muscle hypertrophy.
"(6) Other forms of muscular dystrophy affecting children and adults include Becker, limb girdle, congenital, facioscapulohumeral, myotonic, oculopharyngeal, distal, and Emery-Dreifuss muscular dystrophies.
"(7) Myotonic muscular dystrophy (also known as Steinert's disease and dystrophia myotonica) is the second most prominent form of muscular dystrophy and the type most commonly found in adults. Unlike any of the other muscular dystrophies, the muscle weakness is accompanied by myotonia (delayed relaxation of muscles after contraction) and by a variety of abnormalities in addition to those of muscle.
"(8) Facioscapulohumeral muscular dystrophy (referred to in this section as 'FSHD') is a neuromuscular disorder that is inherited genetically and has an estimated frequency of 1 in 20,000. FSHD, affecting between 15,000 to 40,000 persons, causes a progressive and sever [sic] loss of skeletal muscle gradually bringing weakness and reduced mobility. Many persons with FSHD become severely physically disabled and spend many decades in a wheelchair.
"(9) FSHD is regarded as a novel genetic phenomenon resulting from a crossover of subtelomeric DNA and may be the only human disease caused by a deletion-mutation.
"(10) Each of the muscular dystrophies, though distinct in progressivity and severity of symptoms, have a devastating impact on tens of thousands of children and adults throughout the United States and worldwide and impose severe physical and economic burdens on those affected.
"(11) Muscular dystrophies have a significant impact on quality of life—not only for the individual who experiences its painful symptoms and resulting disability, but also for family members and caregivers.
"(12) Development of therapies for these disorders, while realistic with recent advances in research, is likely to require costly investments and infrastructure to support gene and other therapies.
"(13) There is a shortage of qualified researchers in the field of neuromuscular research.
"(14) Many family physicians and health care professionals lack the knowledge and resources to detect and properly diagnose the disease as early as possible, thus exacerbating the progressiveness of symptoms in cases that go undetected or misdiagnosed.
"(15) There is a need for efficient mechanisms to translate clinically relevant findings in muscular dystrophy research from basic science to applied work.
"(16) Educating the public and health care community throughout the country about this devastating disease is of paramount importance and is in every respect in the public interest and to the benefit of all communities."
Report to Congress
1 So in original. Probably should be plural.
§247b–19. Information and education
(a) In general
The Secretary of Health and Human Services (referred to in this Act as the "Secretary") shall establish and implement a program to provide information and education on muscular dystrophy to health professionals and the general public, including information and education on advances in the diagnosis and treatment of muscular dystrophy and training and continuing education through programs for scientists, physicians, medical students, and other health professionals who provide care for patients with muscular dystrophy.
(b) Stipends
The Secretary may use amounts made available under this section provides 1 stipends for health professionals who are enrolled in training programs under this section.
(c) Requirements
In carrying out this section, the Secretary may—
(1) partner with leaders in the muscular dystrophy patient community;
(2) cooperate with professional organizations and the patient community in the development and issuance of care considerations for pediatric and adult patients, including acute care considerations, for Duchenne-Becker muscular dystrophy, and various other forms of muscular dystrophy, and in periodic review and updates, as appropriate;
(3) in developing and updating care considerations under paragraph (2), incorporate strategies specifically responding to the findings of the national transitions survey of minority, young adult, and adult communities of muscular dystrophy patients; and
(4) widely disseminate the Duchenne-Becker muscular dystrophy and various other forms of muscular dystrophy care considerations as broadly as possible, including through partnership opportunities with the muscular dystrophy patient community.
(d) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary to carry out this section.
(
Editorial Notes
References in Text
This Act, referred to in subsec. (a), is
Codification
Section was enacted as part of the Muscular Dystrophy Community Assistance, Research and Education Amendments of 2001, also known as the MD–CARE Act, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
2014—Subsec. (c)(2).
Subsec. (c)(3), (4).
2008—Subsecs. (c), (d).
1 So in original. Probably should be "to provide".
§247b–20. Food safety grants
(a) In general
The Secretary may award grants to States and Indian tribes (as defined in
(b) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $19,500,000 for fiscal year 2010, and such sums as may be necessary for each of the fiscal years 2011 through 2015.
(July 1, 1944, ch. 373, title III, §317R, as added
Editorial Notes
Amendments
2011—Subsec. (b).
2003—
§247b–21. Mosquito-borne diseases; coordination grants to States; assessment and control grants to political subdivisions
(a) Coordination grants to States; assessment grants to political subdivisions
(1) In general
With respect to mosquito control programs to prevent and control mosquito-borne diseases (referred to in this section as "control programs"), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States for the purpose of—
(A) coordinating control programs in the State involved; and
(B) assisting such State in making grants to political subdivisions of the State to conduct assessments to determine the immediate needs in such subdivisions for control programs, including programs to address emerging infectious mosquito-borne diseases, and to develop, on the basis of such assessments, plans for carrying out control programs in the subdivisions or improving existing control programs.
(2) Preference in making grants
In making grants under paragraph (1), the Secretary shall give preference to States that have one or more political subdivisions with an incidence, prevalence, or high risk of mosquito-borne disease, or a population of infected mosquitoes, that is substantial relative to political subdivisions in other States.
(3) Certain requirements
A grant may be made under paragraph (1) only if—
(A) the State involved has developed, or agrees to develop, a plan for coordinating control programs in the State, and the plan takes into account any assessments or plans described in subsection (b)(3) that have been conducted or developed, respectively, by political subdivisions in the State;
(B) in developing such plan, the State consulted or will consult (as the case may be under subparagraph (A)) with political subdivisions in the State that are carrying out or planning to carry out control programs;
(C) the State agrees to monitor control programs in the State in order to ensure that the programs are carried out in accordance with such plan, with priority given to coordination of control programs in political subdivisions described in paragraph (2) that are contiguous;
(D) the State agrees that the State will make grants to political subdivisions as described in paragraph (1)(B), and that such a grant will not exceed $10,000; and
(E) the State agrees that the grant will be used to supplement, and not supplant, State and local funds available for the purpose described in paragraph (1).
(4) Reports to Secretary
A grant may be made under paragraph (1) only if the State involved agrees that, promptly after the end of the fiscal year for which the grant is made, the State will submit to the Secretary a report that—
(A) describes the activities of the State under the grant; and
(B) contains an evaluation of whether the control programs of political subdivisions in the State were effectively coordinated with each other, which evaluation takes into account any reports that the State received under subsection (b)(5) from such subdivisions.
(5) Number of grants
A State may not receive more than one grant under paragraph (1).
(b) Prevention and control grants to political subdivisions
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to political subdivisions of States or consortia of political subdivisions of States, for the operation, including improvement, of control programs.
(2) Preference in making grants
In making grants under paragraph (1), the Secretary shall give preference to a political subdivision or consortium of political subdivisions that—
(A) has—
(i) a history of elevated incidence or prevalence of mosquito-borne disease;
(ii) a population of infected mosquitoes;
(iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence or prevalence of mosquito-borne disease in the pending fiscal year, including an emerging infectious mosquito-borne disease that presents a serious public health threat; or
(iv) a public health emergency due to the incidence or prevalence of a mosquito-borne disease that presents a serious public health threat;
(B) demonstrates to the Secretary that such political subdivision or consortium of political subdivisions will, if appropriate to the mosquito circumstances involved, effectively coordinate the activities of the control programs with contiguous political subdivisions;
(C) demonstrates to the Secretary (directly or through State officials) that the State in which such a political subdivision or consortium of political subdivisions is located has identified or will identify geographic areas in such State that have a significant need for control programs and will effectively coordinate such programs in such areas; and
(D)(i) is located in a State that has received a grant under subsection (a); or
(ii) that 1 demonstrates to the Secretary that the control program is consistent with existing State mosquito control plans or policies, or other applicable State preparedness plans.
(3) Requirement of assessment and plan
A grant may be made under paragraph (1) only if the political subdivision or consortium of political subdivisions involved—
(A) has conducted an assessment to determine the immediate needs in such subdivision or consortium for a control program, including an entomological survey of potential mosquito breeding areas; and
(B) has, on the basis of such assessment, developed a plan for carrying out such a program.
(4) Requirement of matching funds
(A) In general
With respect to the costs of a control program to be carried out under paragraph (1) by a political subdivision or consortium of political subdivisions, a grant under such paragraph may be made only if the subdivision or consortium agrees to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 1/3 of such costs ($1 for each $2 of Federal funds provided in the grant).
(B) Determination of amount contributed
Non-Federal contributions required in subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(C) Waiver
The Secretary may waive the requirement established in subparagraph (A) if the Secretary determines that—
(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver; or
(ii) the geographical area covered by a political subdivision or consortium for a grant under paragraph (1) has an extreme mosquito control need due to—
(I) the size or density of the potentially impacted human population;
(II) the size or density of a mosquito population that requires heightened control; or
(III) the severity of the mosquito-borne disease, such that expected serious adverse health outcomes for the human population justify the waiver.
(5) Reports to Secretary
A grant may be made under paragraph (1) only if the political subdivision or consortium of political subdivisions involved agrees that, promptly after the end of the fiscal year for which the grant is made, the subdivision or consortium will submit to the Secretary, and to the State within which the subdivision or consortium is located, a report that describes the control program and contains an evaluation of whether the program was effective.
(6) Number of grants
A political subdivision or a consortium of political subdivisions may not receive more than one grant under paragraph (1).
(c) Applications for grants
A grant may be made under subsection (a) or (b) only if an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(d) Technical assistance
Amounts appropriated under subsection (f) may be used by the Secretary to provide training and technical assistance with respect to the planning, development, and operation of assessments and plans under subsection (a) and control programs under subsection (b). The Secretary may provide such technical assistance directly or through awards of grants or contracts to public and private entities.
(e) Definition of political subdivision
In this section, the term "political subdivision" means the local political jurisdiction immediately below the level of State government, including counties, parishes, and boroughs. If State law recognizes an entity of general government that functions in lieu of, and is not within, a county, parish, or borough, the Secretary may recognize an area under the jurisdiction of such other entities of general government as a political subdivision for purposes of this section.
(f) Authorization of appropriations
(1) In general
For the purpose of carrying out this section, there are authorized to be appropriated $100,000,000 for each of fiscal years 2019 through 2023.
(2) Public health emergencies
In the case of control programs carried out in response to a mosquito-borne disease that constitutes a public health emergency, the authorization of appropriations under paragraph (1) is in addition to applicable authorizations of appropriations under this chapter and other medical and public health preparedness and response laws.
(3) Fiscal year 2019 appropriations
For fiscal year 2019, 50 percent or more of the funds appropriated under paragraph (1) shall be used to award grants to political subdivisions or consortia of political subdivisions under subsection (b).
(July 1, 1944, ch. 373, title III, §317S, as added
Editorial Notes
Amendments
2019—Subsec. (a)(1)(B).
Subsec. (b)(1).
Subsec. (b)(2)(A)(iii).
Subsec. (b)(2)(A)(iv).
Subsec. (b)(2)(D).
Subsec. (b)(4)(C).
Subsec. (b)(6).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(3).
§247b–22. Microbicide research
(a) In general
The Director of the Centers for Disease Control and Prevention is strongly encouraged to fully implement the Centers' microbicide agenda to support research and development of microbicides for use to prevent the transmission of the human immunodeficiency virus.
(b) Authorization of appropriations
There are authorized to be appropriated such sums as may be necessary for each of fiscal years 2009 through 2013 to carry out this section.
(July 1, 1944, ch. 373, title III, §317T, as added
§247b–23. National strategy and regional centers of excellence in vector-borne diseases
(a) In general
The Secretary shall—
(1)(A) ensure the development and implementation of a national strategy to address vector-borne diseases, including tick-borne diseases, that—
(i) identifies and assesses gaps and any unnecessary duplication in federally-funded programs; and
(ii) identifies strategic goals to address such diseases and appropriate benchmarks to measure progress toward achieving such goals; and
(B) update such strategy, as appropriate; and
(2) coordinate programs and activities, including related to data collection, research, and the development of diagnostics, treatments, vaccines, and other related activities, to address vector-borne diseases, including tick-borne diseases, across the Department of Health and Human Services and with other Federal agencies or departments, as appropriate.
(b) Consultation
In carrying out subsection (a)(1), the Secretary shall consult with the Tick-Borne Disease Working Group established under
(1) epidemiologists with experience in vector-borne diseases;
(2) representatives of patient advocacy and research organizations that focus on vector-borne diseases, including such organizations that have demonstrated experience in related research, public health, data collection, or patient access to care;
(3) health information technology experts or other information management specialists;
(4) clinicians, entomologists, vector management professionals, public health professionals, and others with expertise in vector-borne diseases; and
(5) researchers, including researchers with experience conducting translational research.
(c) Centers of excellence
The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention, shall award grants, contracts, or cooperative agreements to institutions of higher education for the establishment or continued support of regional centers of excellence in vector-borne diseases to address vector-borne diseases, including tick-borne diseases, by—
(1) facilitating collaboration between academia and public health organizations for public health surveillance, prevention, and response activities related to vector-borne diseases, including tick-borne diseases;
(2) providing training for public health entomologists and other health care professionals, as appropriate, to address vector-borne diseases, including tick-borne diseases;
(3) conducting research to develop and validate prevention and control tools and methods, including evidence-based and innovative, evidence-informed tools and methods to anticipate and respond to disease outbreaks; or
(4) preparing for and responding to outbreaks of vector-borne diseases, including tick-borne diseases.
(d) Eligibility
To be eligible to receive a grant, contract, or cooperative agreement under subsection (c), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a description of how the entity will conduct the activities described in such subsection.
(e) Reports
(1) Program summary
An entity receiving an award under subsection (c) shall, not later than one year after receiving such award, and annually thereafter, submit to the Secretary a summary of programs and activities funded under the award.
(2) Progress report
Not later than 4 years after December 20, 2019, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the progress made in addressing vector-borne diseases, including tick-borne diseases, through activities carried out under this section.
(f) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2021 through 2025.
(July 1, 1944, ch. 373, title III, §317U, as added
§247b–24. Addressing factors related to improving health outcomes
(a) In general
The Secretary may, as appropriate, award grants, contracts, or cooperative agreements to eligible entities for the conduct of evidence-based or evidence-informed projects, which may include the development of networks to improve health outcomes by improving the capacity of such entities to address factors that contribute to negative health outcomes in communities.
(b) Eligible entities
To be eligible to receive an award under this section, an entity shall—
(1)(A) be a State, local, or Tribal health department, community-based organization, Indian Tribe or Tribal organization (as such terms are defined in
(B) be a consortia of entities described in subparagraph (A) or a public-private partnership, including a community partnership;
(2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary shall require;
(3) in the case of an entity other than a community-based organization, demonstrate a history of successfully working with an established community-based organization to address health outcomes; and
(4) submit a plan to conduct activities described in subsection (a) based on a community needs assessment that takes into account community input.
(c) Use of funds
An entity described in subsection (b) shall use funds received under subsection (a), in consultation with State, local, and Tribal health departments, community-based organizations, entities serving medically underserved communities, and other entities, as applicable, for one or more of the following purposes:
(1) Supporting the implementation, evaluation, and dissemination of strategies, through evidence-informed or evidence-based programs and through the support and use of public health and health care professionals to address factors related to health outcomes.
(2) Establishing, maintaining, or improving, in consultation with State, local, or Tribal health departments, technology platforms or networks to support, in a manner that is consistent with applicable Federal and State privacy law—
(A) coordination among appropriate entities, and, as applicable and appropriate, activities to improve such coordination;
(B) information sharing on health and related social services; and
(C) technical assistance and related support for entities participating in the platforms or networks.
(3) Implementing best practices for improving health outcomes and reducing disease among underserved populations.
(4) Supporting consideration of factors related to health outcomes in preparing for, and responding to, public health emergencies, through outreach, education, research, and other relevant activities.
(d) Best practices and technical assistance
The Secretary, in consultation with the Director of the Office of Minority Health, the National Coordinator for Health Information Technology, and the Administrator of the Administration for Community Living, may award grants, contracts, and cooperative agreements to public or nonprofit private entities, including minority serving institutions (defined, for purposes of this subsection, as institutions and programs described in
(1) identify or facilitate the development of best practices to support improved health outcomes for underserved populations;
(2) provide technical assistance, training, and evaluation assistance to award recipients under subsection (a);
(3) disseminate best practices, including to award recipients under subsection (a); and
(4) leverage, establish, or operate regional centers to develop, evaluate, and disseminate effective strategies on factors related to health outcomes, including supporting research and training related to such strategies.
(e) Award periods
The Secretary shall issue awards under this section for periods of not more than 5 years and may issue extensions of such award periods for an additional period of up to 3 years.
(f) Report
Not later than September 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes information on activities funded under this section. Such report shall include a description of—
(1) changes in the capacity of public health entities to address factors related to health outcomes in communities, including any applicable platforms or networks developed or utilized to coordinate health and related social services and any changes in workforce capacity or capabilities;
(2) improvements in health outcomes and in reducing health disparities in medically underserved communities;
(3) activities conducted to support consideration of factors related to health outcomes in preparing for, and responding to, public health emergencies, through outreach, education, and other relevant activities;
(4) communities and populations served by recipients of awards under subsection (a);
(5) activities supported under subsection (e); and
(6) other relevant activities and outcomes, as determined by the Secretary.
(g) Authorization of appropriations
To carry out this section, there are authorized to be appropriated $35,000,000 for each of fiscal years 2023 through 2027. Of the amounts appropriated under this subsection for a fiscal year, 5 percent shall be reserved for awards under subsection (a) to Indian Tribes and Tribal organizations (as such terms are defined in
(July 1, 1944, ch. 373, title III, §317V, as added
§247c. Sexually transmitted diseases; prevention and control projects and programs
(a) Technical assistance to public and nonprofit private entities and scientific institutions
The Secretary may provide technical assistance to appropriate public and nonprofit private entities and to scientific institutions for their research in, and training and public health programs for, the prevention and control of sexually transmitted diseases.
(b) Research, demonstration, and public information and education projects
The Secretary may make grants to States, political subdivisions of States, and any other public and nonprofit private entity for—
(1) research into the prevention and control of sexually transmitted diseases;
(2) demonstration projects for the prevention and control of sexually transmitted diseases;
(3) public information and education programs for the prevention and control of such diseases; and
(4) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).
(c) Project grants to States
The Secretary is also authorized to make project grants to States and, in consultation with the State health authority, to political subdivisions of States, for—
(1) sexually transmitted diseases surveillance activities, including the reporting, screening, and followup of diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
(2) casefinding and case followup activities respecting sexually transmitted diseases, including contact tracing of infectious cases of sexually transmitted diseases and routine testing, including laboratory tests and followup systems;
(3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
(4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and control strategies and activities as may be prescribed by the Secretary.
(d) Grants for innovative, interdisciplinary approaches
The Secretary may make grants to States and political subdivisions of States for the development, implementation, and evaluation of innovative, interdisciplinary approaches to the prevention and control of sexually transmitted diseases.
(e) Authorization of appropriations; terms and conditions; payments; recordkeeping; audit; grant reduction; information disclosure
(1) For the purpose of making grants under subsections (b) through (d), there are authorized to be appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.
(2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(3) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients of grants under this section that are pertinent to such grants.
(4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances, travel expenses, and any other costs in connection with the detail of an officer or employee of the United States to the recipient when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such recipient and for the purpose of carrying out the program with respect to which the grant under this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
(5) All information obtained in connection with the examination, care, or treatment of any individual under any program which is being carried out with a grant made under this section shall not, without such individual's consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a state or political subdivision of a State. Information derived from any such program may be disclosed—
(A) in summary, statistical, or other form; or
(B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or provided care or treatment under such program is not disclosed.
(f) Consent of individuals
Nothing in this section shall be construed to require any State or any political subdivision of a State to have a sexually transmitted diseases program which would require any person, who objects to any treatment provided under such a program, to be treated under such a program.
(July 1, 1944, ch. 373, title III, §318, as added
Editorial Notes
Prior Provisions
A prior section 247c, act July 1, 1944, ch. 373 title III, §318, as added Aug. 18, 1964,
Amendments
1998—Subsec. (e).
Subsec. (e)(5).
Subsec. (f).
1993—Subsec. (b)(3).
Subsec. (c)(3).
Subsec. (d).
Subsec. (e).
Subsec. (e)(1).
Subsec. (e)(5).
1988—
Subsec. (d).
Subsec. (d)(1).
Subsecs. (e) to (g).
1984—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsecs. (f), (g).
1981—Subsec. (d)(1).
1979—Subsec. (b).
1978—Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (f).
Subsec. (g).
1976—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Statutory Notes and Related Subsidiaries
Effective Date of 1998 Amendment
Amendment by
Distribution of Information on Acquired Immune Deficiency Syndrome by Director of Centers for Disease Control to Every American Household
Congressional Findings and Declarations
"(1) the number of reported cases of venereal disease persists in epidemic proportions in the United States;
"(2) the number of persons affected by venereal disease and reported to public health authorities is only a fraction of those actually affected;
"(3) the incidence of venereal disease continues to be particularly high among American youth, ages fifteen to twenty-nine, and among populations in metropolitan areas;
"(4) venereal disease accounts for severe permanent disabilities and sometimes death in newborns and causes reproductive dysfunction in women of childbearing age;
"(5) it is conservatively estimated that the public cost of health care for persons suffering from complications of venereal disease exceeds one-half billion dollars annually;
"(6) the number of trained Federal venereal disease prevention and control personnel has fallen to a dangerously inadequate level;
"(7) no vaccine for syphilis, gonorrhea, or any other venereal disease has yet been developed, nor does a blood test for the detection of asymptomatic gonorrhea in women exist, nor are safe and effective therapeutic agents available for some other venereal diseases;
"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup have all been found to be effective venereal disease prevention and control methodologies;
"(9) skilled and knowledgeable health care providers, informed and concerned individuals and active, well-coordinated voluntary groups are fundamental to venereal disease prevention and control;
"(10) biomedical research toward improved diagnostic and therapeutic tools is of singular importance to the elimination of venereal disease; and
"(11) an increasing number of sexually transmissible diseases besides syphilis and gonorrhea have become a public health hazard."
"(1) the number of reported cases of venereal disease continues in epidemic proportions in the United States;
"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those actually infected;
"(3) the incidence of venereal disease is particularly high in the 15–29-year age group, and in metropolitan areas;
"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
"(5) the number of cases of congenital syphilis, a preventable disease, tends to parallel the incidence of syphilis in adults;
"(6) it is conservatively estimated that the public cost of care for persons suffering the complications of venereal disease exceed $80,000,000 annually;
"(7) medical researchers have no successful vaccine for syphilis or gonorrhea, and have no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females;
"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup activities have all been found to be effective disease intervention methodologies;
"(9) knowledgeable health providers and concerned individuals and groups are fundamental to venereal disease prevention and control;
"(10) biomedical research leading to the development of vaccines for syphilis and gonorrhea is of singular importance for the eventual eradication of these dreaded diseases; and
"(11) a variety of other sexually transmitted diseases, in addition to syphilis and gonorrhea, have become of public health significance."
"(a) The Congress finds and declares that—
"(1) the number or reported cases of venereal disease has reached epidemic proportions in the United States;
"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those treated by physicians;
"(3) the incidence of venereal disease is particularly high among individuals in the 20–24 age group, and in metropolitan areas;
"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
"(5) the number of cases of congenital syphilis, a preventable disease, in infants under one year of age increased by 331/3 per centum between 1970 and 1971;
"(6) health education programs in schools and through the mass media may prevent a substantial portion of the venereal disease problem; and
"(7) medical authorities have no successful vaccine for syphilis or gonorrhea and no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females.
"(b) In order to preserve and protect the health and welfare of all citizens, it is the purpose of this Act [enacting this section, amending
§247c–1. Infertility and sexually transmitted diseases
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions of States, and other public or nonprofit private entities for the purpose of carrying out the activities described in subsection (c) regarding any treatable sexually transmitted disease that can cause infertility in women if treatment is not received for the disease.
(b) Authority regarding individual diseases
With respect to diseases described in subsection (a), the Secretary shall, in making a grant under such subsection, specify the particular disease or diseases with respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved agrees to carry out this section only with respect to the disease or diseases so specified.
(c) Authorized activities
With respect to any sexually transmitted disease described in subsection (a), the activities referred to in such subsection are—
(1) screening women for the disease and for secondary conditions resulting from the disease, subject to compliance with criteria issued under subsection (f);
(2) providing treatment to women for the disease;
(3) providing counseling to women on the prevention and control of the disease (including, in the case of a woman with the disease, counseling on the benefits of locating and providing such counseling to any individual from whom the woman may have contracted the disease and any individual whom the woman may have exposed to the disease);
(4) providing follow-up services;
(5) referrals for necessary medical services for women screened pursuant to paragraph (1), including referrals for evaluation and treatment with respect to acquired immune deficiency syndrome and other sexually transmitted diseases;
(6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5), providing to the partner of the woman the services described in such paragraphs, as appropriate;
(7) providing outreach services to inform women of the availability of the services described in paragraphs (1) through (6);
(8) providing to the public information and education on the prevention and control of the disease, including disseminating such information; and
(9) providing training to health care providers in carrying out the screenings and counseling described in paragraphs (1) and (3).
(d) Requirement of availability of all services through each grantee
The Secretary may make a grant under subsection (a) only if the applicant involved agrees that each activity authorized in subsection (c) will be available through the applicant. With respect to compliance with such agreement, the applicant may expend the grant to carry out any of the activities directly, and may expend the grant to enter into agreements with other public or nonprofit private entities under which the entities carry out the activities.
(e) Required providers regarding certain services
The Secretary may make a grant under subsection (a) only if the applicant involved agrees that, in expending the grant to carry out activities authorized in subsection (c), the services described in paragraphs (1) through (7) of such subsection will be provided only through entities that are State or local health departments, grantees under
(f) Quality assurance regarding screening for diseases
For purposes of this section, the Secretary shall establish criteria for ensuring the quality of screening procedures for diseases described in subsection (a).
(g) Confidentiality
The Secretary may make a grant under subsection (a) only if the applicant involved agrees, subject to applicable law, to maintain the confidentiality of information on individuals with respect to activities carried out under subsection (c).
(h) Limitation on imposition of fees for services
The Secretary may make a grant under subsection (a) only if the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(1) will be made according to a schedule of charges that is made available to the public;
(2) will be adjusted to reflect the income of the individual involved; and
(3) will not be imposed on any individual with an income of less than 150 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with
(i) Limitations on certain expenditures
The Secretary may make a grant under subsection (a) only if the applicant involved agrees that not less than 80 percent of the grant will be expended for the purpose of carrying out paragraphs (1) through (7) of subsection (c).
(j) Reports to Secretary
(1) Collection of data
The Secretary may make a grant under subsection (a) only if the applicant involved agrees, with respect to any disease selected under subsection (b) for the applicant, to submit to the Secretary, for each fiscal year for which the applicant receives such a grant, a report providing—
(A) the incidence of the disease among the population of individuals served by the applicant;
(B) the number and demographic characteristics of individuals in such population;
(C) the types of interventions and treatments provided by the applicant, and the health conditions with respect to which referrals have been made pursuant to subsection (c)(5);
(D) an assessment of the extent to which the activities carried pursuant to subsection (a) have reduced the incidence of infertility in the geographic area involved; and
(E) such other information as the Secretary may require with respect to the project carried out with the grant.
(2) Utility and comparability of data
The Secretary shall carry out activities for the purpose of ensuring the utility and comparability of data collected pursuant to paragraph (1).
(k) Maintenance of effort
With respect to activities for which a grant under subsection (a) is authorized to be expended, the Secretary may make such a grant only if the applicant involved agrees to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the average level of such expenditures maintained by the applicant for the 2-year period preceding the fiscal year for which the applicant is applying to receive such a grant.
(l) Requirement of application
(1) In general
The Secretary may make a grant under subsection (a) only if an application for the grant is submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(2) Submission of plan for program of grantee
(A) In general
The Secretary may make a grant under subsection (a) only if the applicant involved submits to the Secretary a plan describing the manner in which the applicant will comply with the agreements required as a condition of receiving such a grant, including a specification of the entities through which activities authorized in subsection (c) will be provided.
(B) Participation of certain entities
The Secretary may make a grant under subsection (a) only if the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has been prepared in consultation with an appropriate number and variety of—
(i) representatives of entities in the geographic area involved that provide services for the prevention and control of sexually transmitted diseases, including programs to provide to the public information and education regarding such diseases; and
(ii) representatives of entities in such area that provide family planning services.
(m) Duration of grant
The period during which payments are made to an entity from a grant under subsection (a) may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the payments in such year. The preceding sentence may not be construed to establish a limitation on the number of grants under such subsection that may be made to an entity.
(n) Technical assistance, and supplies and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and technical assistance to grantees under subsection (a) with respect to the planning, development, and operation of any program or service carried out under such subsection. The Secretary may provide such technical assistance directly or through grants or contracts.
(2) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant by—
(A) the fair market value of any supplies or equipment furnished the grant recipient; and
(B) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(o) Evaluations and reports by Secretary
(1) Evaluations
The Secretary shall, directly or through contracts with public or private entities, provide for annual evaluations of programs carried out pursuant to subsection (a) in order to determine the quality and effectiveness of the programs.
(2) Report to Congress
Not later than 1 year after the date on which amounts are first appropriated pursuant to subsection (q), and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report—
(A) summarizing the information provided to the Secretary in reports made pursuant to subsection (j)(1), including information on the incidence of sexually transmitted diseases described in subsection (a); and
(B) summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year.
(p) Coordination of Federal programs
The Secretary shall coordinate the program carried out under this section with any similar programs administered by the Secretary (including coordination between the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health).
(q) Authorization of appropriations
For the purpose of carrying out this section, other than subsections (o) and (r), there are authorized to be appropriated $25,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998.
(r) Separate grants for research on delivery of services
(1) In general
The Secretary may make grants for the purpose of conducting research on the manner in which the delivery of services under subsection (a) may be improved. The Secretary may make such grants only to grantees under such subsection and to public and nonprofit private entities that are carrying out programs substantially similar to programs carried out under such subsection.
(2) Authorization of appropriations
For the purpose of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 through 1998.
(July 1, 1944, ch. 373, title III, §318A, as added
Editorial Notes
References in Text
The reference to
Amendments
2003—Subsec. (e).
2002—Subsec. (e).
1993—
Subsec. (o)(2).
Subsec. (q).
Subsec. (r)(2).
Statutory Notes and Related Subsidiaries
Change of Name
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
Effective Date of 2003 Amendment
Amendment by
1 See References in Text notes below.
§247c–2. Data collection regarding programs under subchapter XXIV
For the purpose of collecting and providing data for program planning and evaluation activities under subchapter XXIV, there are authorized to be appropriated to the Secretary (acting through the Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of appropriations that are available for such purpose.
(July 1, 1944, ch. 373, title III, §318B, as added
§247d. Public health emergencies
(a) Emergencies
If the Secretary determines, after consultation with such public health officials as may be necessary, that—
(1) a disease or disorder presents a public health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.
(b) Public Health Emergency Fund
(1) In general
There is established in the Treasury a fund to be designated as the "Public Health Emergency Fund" to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities. There is authorized to be appropriated to the Fund such sums as may be necessary.
(2) Uses
The Secretary may use amounts in the Fund established under paragraph (1), to—
(A) facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);
(B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under
(C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in
(D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under
(E) support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under
(F) support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and
(G) carry out other activities, as the Secretary determines applicable and appropriate.
(3) Report
Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—
(A) the expenditures made from the Public Health Emergency Fund in such fiscal year, including—
(i) the amount obligated;
(ii) the recipient or recipients of such obligated funds;
(iii) the specific response activities such obligated funds will support; and
(iv) the declared or potential public health emergency for which such funds were obligated; and
(B) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the Fund.
(4) Review
Not later than 2 years after June 24, 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2).
(5) GAO report
Not later than 4 years after June 24, 2019, the Comptroller General of the United States shall—
(A) conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and
(B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.
(c) Supplement not supplant
Funds appropriated under this section shall be used to rapidly respond to public health emergencies or potential public health emergencies and supplement and not supplant other Federal, State, and local public funds provided for activities under this chapter or funds otherwise provided for emergency response.
(d) Data submittal and reporting deadlines
In any case in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are unable to comply with deadlines for the submission to the Secretary of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly after granting such an extension or waiver, the Secretary shall notify the Congress of such action and publish in the Federal Register a notice of the extension or waiver.
(e) Temporary reassignment of State and local personnel during a public health emergency
(1) Emergency reassignment of federally funded personnel
Notwithstanding any other provision of law, and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such Governor or tribal organization's designee, the Secretary may authorize the requesting State or Indian tribe to temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian tribe, State and local public health department or agency personnel funded in whole or in part through programs authorized under this chapter, as appropriate.
(2) Activation of emergency reassignment
(A) Public health emergency
The Secretary may authorize a temporary reassignment of personnel under paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).
(B) Contents of request
To seek authority for a temporary reassignment of personnel under paragraph (1), the Governor of a State or a tribal organization shall submit to the Secretary a request for such reassignment flexibility and shall include in the request each of the following:
(i) An assurance that the public health emergency in the geographic area of the requesting State or Indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available.
(ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of State and local personnel described in paragraph (1).
(iii) An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-Hazards Public Health Emergency Preparedness and Response Plan under
(iv) An identification of—
(I) each Federal program from which personnel would be temporarily reassigned pursuant to the requested authority; and
(II) the number of personnel who would be so reassigned from each such program.
(v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization agree.
(C) Consideration
In reviewing a request for temporary reassignment under paragraph (1), the Secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this chapter would be adversely affected by the reassignment.
(D) Termination and extension
(i) Termination
A State or Indian tribe's temporary reassignment of personnel under paragraph (1) shall terminate upon the earlier of the following:
(I) The Secretary's determination that the public health emergency no longer exists.
(II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Secretary approved the State or Indian tribe's request for such reassignment flexibility.
(ii) Extension of reassignment flexibility
The Secretary may extend reassignment flexibility of personnel under paragraph (1) beyond the date otherwise applicable under clause (i)(II) if the public health emergency still exists as of such date, but only if—
(I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and
(II) the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph (B).
(3) Voluntary nature of temporary reassignment of State and local personnel
(A) In general
Unless otherwise provided under the law or regulation of the State or Indian tribe that receives authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for reassignment pursuant to such authorization—
(i) shall have the opportunity to volunteer for temporary reassignment; and
(ii) shall not be required to agree to a temporary reassignment.
(B) Prohibition on conditioning Federal awards
The Secretary may not condition the award of a grant, contract, or cooperative agreement under this chapter on the requirement that a State or Indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph (1) agree to such reassignment.
(4) Notice to Congress
The Secretary shall give notice to the Congress in conjunction with the approval under this subsection of—
(A) any initial request for temporary reassignment of personnel; and
(B) any request for an extension of such temporary reassignment.
(5) Guidance
The Secretary shall—
(A) not later than 6 months after March 13, 2013, issue proposed guidance on the temporary reassignment of personnel under this subsection; and
(B) after providing notice and a 60-day period for public comment, finalize such guidance.
(6) Report to Congress
Not later than 4 years after March 13, 2013, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—
(A) a description of how, and under what circumstances, such temporary reassignment has been used by States and Indian tribes;
(B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to public health emergencies;
(C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;
(D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and
(E) recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.
(7) Definitions
In this subsection—
(A) the terms "Indian tribe" and "tribal organization" have the meanings given such terms in
(B) the term "State" includes, in addition to the entities listed in the definition of such term in
(8) Sunset
This subsection shall terminate on December 31, 2024.
(f) Determination with respect to Paperwork Reduction Act waiver during a public health emergency
(1) Determination
If the Secretary determines, after consultation with such public health officials as may be necessary, that—
(A)(i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or
(ii) a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and
(B) the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of
then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time.
(2) Transparency
If the Secretary determines that a waiver is necessary under paragraph (1), the Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief justification for such waiver, the anticipated period of time such waiver will be in effect, and the agencies and offices within the Department of Health and Human Services to which such waiver shall apply, and update such information posted on the Internet website of the Department of Health and Human Services, as applicable.
(3) Effectiveness of waiver
Any waiver under this subsection shall take effect on the date on which the Secretary posts information on the Internet website as provided for in this subsection.
(4) Termination of waiver
Upon determining that the circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly update the Internet website of the Department of Health and Human Services to reflect the termination of such waiver.
(5) Limitations
(A) Period of waiver
The period of a waiver under paragraph (1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to subsection (a), and any immediate postresponse review regarding the public health emergency consistent with the requirements of this subsection.
(B) Subsequent compliance
An initiative subject to a waiver under paragraph (1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of
(g) Certain appointments to support public health emergency responses
(1) In general
In order to support the initial response to a public health emergency declared by the Secretary under this section, the Secretary may, subject to paragraph (2) and without regard to
(A) address a critical hiring need directly related to responding to a public health emergency declared by the Secretary under this section; or
(B) address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human Services to respond in the event of a public health emergency declared by the Secretary under this section.
(2) Number of appointments
Each fiscal year in which the Secretary makes a determination of a public health emergency under subsection (a) (not including a renewal), the Secretary may directly appoint not more than—
(A) 400 individuals under paragraph (1)(A); and
(B) 100 individuals under paragraph (1)(B).
(3) Compensation
The annual rate of basic pay of an individual appointed under this subsection shall be determined in accordance with
(4) Reporting
The Secretary shall establish and maintain records regarding the use of the authority under this subsection, including—
(A) the number of positions filled through such authority;
(B) the types of appointments of such positions;
(C) the titles, occupational series, and grades of such positions;
(D) the number of positions publicly noticed to be filled under such authority;
(E) the number of qualified applicants who apply for such positions;
(F) the qualification criteria for such positions; and
(G) the demographic information of individuals appointed to such positions.
(5) Notification to Congress
In the event the Secretary, within a single fiscal year, directly appoints more than 50 percent of the individuals allowable under either subparagraph (A) or (B) of paragraph (2), the Secretary shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum, include—
(A) information on each such appointment within such fiscal year;
(B) a description of how each such position relates to the requirements of subparagraph (A) or (B) of paragraph (1); and
(C) the additional number of personnel, if any, the Secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph (1) within such fiscal year.
(6) Reports to Congress
Not later than September 30, 2023, and annually thereafter for each fiscal year in which the authority under this subsection is used, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the total number of appointments filled under this subsection within the fiscal year and a description of how the positions relate to the requirements of subparagraph (A) or (B) of paragraph (1).
(7) Sunset
The authority under this subsection shall expire on September 30, 2028.
(h) Stockpile depletion reporting
The Secretary shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under
(1) the deployment of the contents of the stockpile in response to State, local, and Tribal requests;
(2) the amount of such products that remain within the stockpile following such deployment; and
(3) plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.
(July 1, 1944, ch. 373, title III, §319, as added
Editorial Notes
References in Text
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (h), is
Prior Provisions
A prior section 247d, act July 1, 1944, ch. 373, title III, §319, as added
Another prior section 247d, act July 1, 1944, ch. 373, title III, §319, formerly §310, as added Sept. 25, 1962,
Amendments
2024—Subsec. (e)(8).
2023—Subsec. (e)(8).
2022—Subsec. (b)(2)(F), (G).
Subsec. (b)(3)(A).
Subsec. (g).
Subsec. (h).
2019—Subsec. (b)(1).
Subsec. (b)(2), (3).
Subsec. (b)(4), (5).
Subsec. (c).
Subsec. (e)(8).
2016—Subsec. (f).
2013—Subsec. (e).
2002—Subsec. (a).
Subsec. (d).
Statutory Notes and Related Subsidiaries
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
Effective Date of 2002 Amendment
Consideration of Unique Challenges in Noncontiguous States and Territories
Funding for COVID–19 Vaccine Activities at the Centers for Disease Control and Prevention
"(a)
"(b)
"(1) conduct activities to enhance, expand, and improve nationwide COVID–19 vaccine distribution and administration, including activities related to distribution of ancillary medical products and supplies related to vaccines; and
"(2) provide technical assistance, guidance, and support to, and award grants or cooperative agreements to, State, local, Tribal, and territorial public health departments for enhancement of COVID–19 vaccine distribution and administration capabilities, including—
"(A) the distribution and administration of vaccines licensed under section 351 of the Public Health Service Act (
"(B) the establishment and expansion, including staffing support, of community vaccination centers, particularly in underserved areas;
"(C) the deployment of mobile vaccination units, particularly in underserved areas;
"(D) information technology, standards-based data, and reporting enhancements, including improvements necessary to support standards-based sharing of data related to vaccine distribution and vaccinations and systems that enhance vaccine safety, effectiveness, and uptake, particularly among underserved populations;
"(E) facilities enhancements;
"(F) communication with the public regarding when, where, and how to receive COVID–19 vaccines; and
"(G) transportation of individuals to facilitate vaccinations, including at community vaccination centers and mobile vaccination units, particularly for underserved populations.
"(c)
"(1)
"(A)
"(B)
"(2)
"(A)
"(B)
"(i) the amount the State, locality, or territory received, or would receive, under the base formula; and
"(ii) the amount the State, locality, or territory would receive under the alternative allocation."
Funding for COVID–19 Testing, Contact Tracing, and Mitigation Activities
"(a)
"(b)
"(1) implement a national, evidence-based strategy for testing, contact tracing, surveillance, and mitigation with respect to SARS–CoV–2 and COVID–19, including through activities authorized under section 319(a) of the Public Health Service Act [
"(2) provide technical assistance, guidance, and support, and award grants or cooperative agreements to State, local, and territorial public health departments for activities to detect, diagnose, trace, and monitor SARS–CoV–2 and COVID–19 infections and related strategies and activities to mitigate the spread of COVID–19;
"(3) support the development, manufacturing, procurement, distribution, and administration of tests to detect or diagnose SARS–CoV–2 and COVID–19, including through—
"(A) support for the development, manufacture, procurement, and distribution of supplies necessary for administering tests, such as personal protective equipment; and
"(B) support for the acquisition, construction, alteration, or renovation of non-federally owned facilities for the production of diagnostics and ancillary medical products and supplies where the Secretary determines that such an investment is necessary to ensure the production of sufficient amounts of such supplies;
"(4) establish and expand Federal, State, local, and territorial testing and contact tracing capabilities, including—
"(A) through investments in laboratory capacity, such as—
"(i) academic and research laboratories, or other laboratories that could be used for processing of COVID–19 testing;
"(ii) community-based testing sites and community-based organizations; or
"(iii) mobile health units, particularly in medically underserved areas; and
"(B) with respect to quarantine and isolation of contacts;
"(5) enhance information technology, data modernization, and reporting, including improvements necessary to support sharing of data related to public health capabilities;
"(6) award grants to, or enter into cooperative agreements or contracts with, State, local, and territorial public health departments to establish, expand, and sustain a public health workforce; and
"(7) to cover administrative and program support costs necessary to conduct activities related to subparagraph (a)."
Importance of the Blood Supply
"(a)
"(b)
"(c)
"(d)
"(1) a description of the activities carried out under subsection (a);
"(2) a description of trends in blood supply donations; and
"(3) an evaluation of the impact of the public awareness campaign, including any geographic or population variations."
Reporting by Laboratories of Results of Tests To Detect SARS–CoV–2 or To Diagnose COVID–19
"(a)
"(b)
"(c)
Executive Documents
Ex. Ord. No. 13987. Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID–19 and To Provide United States Leadership on Global Health and Security
Ex. Ord. No. 13987, Jan. 20, 2021, 86 F.R. 7019, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
(i) coordinating a Government-wide effort to reduce disparities in the response, care, and treatment of COVID–19, including racial and ethnic disparities;
(ii) coordinating the Federal Government's efforts to produce, supply, and distribute personal protective equipment, vaccines, tests, and other supplies for the Nation's COVID–19 response, including through the use of the Defense Production Act, as amended (
(iii) coordinating the Federal Government's efforts to expand COVID–19 testing and the use of testing as an effective public health response;
(iv) coordinating the Federal Government's efforts to support the timely, safe, and effective delivery of COVID–19 vaccines to the United States population;
(v) coordinating the Federal Government's efforts to support the safe reopening and operation of schools, child care providers, and Head Start programs, and to help ensure the continuity of educational and other services for young children and elementary and secondary students during the COVID–19 pandemic; and
(vi) coordinating, as appropriate, with State, local, Tribal, and territorial authorities.
(b) The COVID–19 Response Coordinator shall have the authority to convene principals from relevant agencies, in consultation with the Assistant to the President for Domestic Policy (APDP) on matters involving the domestic COVID–19 response, and in consultation with the Assistant to the President for National Security Affairs (APNSA) on matters involving the global COVID–19 response. The COVID–19 Response Coordinator shall also coordinate any corresponding deputies and interagency processes.
(c) The COVID–19 Response Coordinator may act through designees in performing these or any other duties.
(a) Preparing to Respond to Biological Threats and Pandemics. To identify, monitor, prepare for, and, if necessary, respond to emerging biological and pandemic threats:
(i) The APNSA shall convene the National Security Council (NSC) Principals Committee as necessary to coordinate the Federal Government's efforts to address such threats and to advise the President on the global response to and recovery from COVID–19, including matters regarding: the intersection of the COVID–19 response and other national security equities; global health security; engaging with and strengthening the World Health Organization; public health, access to healthcare, and the secondary impacts of COVID–19; and emerging biological risks and threats, whether naturally occurring, deliberate, or accidental.
(ii) Within 180 days of the date of this order [Jan. 20, 2021], the APNSA shall, in coordination with relevant agencies, the COVID–19 Response Coordinator, and the APDP, complete a review of and recommend actions to the President concerning emerging domestic and global biological risks and national biopreparedness policies. The review and recommended actions shall incorporate lessons from the COVID–19 pandemic and, among other things, address: the readiness of the pandemic supply chain, healthcare workforce, and hospitals; the development of a framework of pandemic readiness with specific triggers for when agencies should take action in response to large-scale biological events; pandemic border readiness; the development and distribution of medical countermeasures; epidemic forecasting and modeling; public health data modernization; bio-related intelligence; bioeconomic investments; biotechnology risks; the development of a framework for coordinating with and distributing responsibilities as between the Federal Government and State, local, Tribal, and territorial authorities; and State, local, Tribal, and territorial preparedness for biological events.
(b) NSC Directorate on Global Health Security and Biodefense. There shall be an NSC Directorate on Global Health Security and Biodefense, which shall be headed by a Senior Director for Global Health Security and Biodefense. The Senior Director shall be responsible for monitoring current and emerging biological threats, and shall report concurrently to the APNSA and to the COVID–19 Response Coordinator on matters relating to COVID–19. The Senior Director shall oversee the Global Health Security Agenda Interagency Review Council, which was established pursuant to Executive Order 13747 of November 4, 2016 (Advancing the Global Health Security Agenda To Achieve a World Safe and Secure From Infectious Disease Threats) [
(c) Responsibility for National Biodefense Preparedness. Notwithstanding any statements in the National Security Presidential Memorandum–14 of September 18, 2018 (Support for National Biodefense), the APNSA shall be responsible for coordinating the Nation's biodefense preparedness efforts, and, as stated in sections 1 and 2 of this order, the COVID–19 Response Coordinator shall be responsible for coordinating the Federal Government's response to the COVID–19 pandemic.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 13991. Protecting the Federal Workforce and Requiring Mask-Wearing
Ex. Ord. No. 13991, Jan. 20, 2021, 86 F.R. 7045, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, including
Accordingly, to protect the Federal workforce and individuals interacting with the Federal workforce, and to ensure the continuity of Government services and activities, on-duty or on-site Federal employees, on-site Federal contractors, and other individuals in Federal buildings and on Federal lands should all wear masks, maintain physical distance, and adhere to other public health measures, as provided in CDC guidelines.
(b) The Director of the Office of Management and Budget (OMB), the Director of the Office of Personnel Management (OPM), and the Administrator of General Services, in coordination with the President's Management Council and the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), shall promptly issue guidance to assist heads of agencies with implementation of this section.
(c) Heads of agencies shall promptly consult, as appropriate, with State, local, Tribal, and territorial government officials, Federal employees, Federal employee unions, Federal contractors, and any other interested parties concerning the implementation of this section.
(d) Heads of agencies may make categorical or case-by-case exceptions in implementing subsection (a) of this section to the extent that doing so is necessary or required by law, and consistent with applicable law. If heads of agencies make such exceptions, they shall require appropriate alternative safeguards, such as additional physical distancing measures, additional testing, or reconfiguration of workspace, consistent with applicable law. Heads of agencies shall document all exceptions in writing.
(e) Heads of agencies shall review their existing authorities and, to the extent permitted by law and subject to the availability of appropriations and resources, seek to provide masks to individuals in Federal buildings when needed.
(f) The COVID–19 Response Coordinator shall coordinate the implementation of this section. Heads of the agencies listed in
(b) The COVID–19 Response Coordinator, in coordination with the Secretary of HHS, the Secretary of Homeland Security, and the heads of other relevant agencies, shall promptly identify and inform agencies of options to incentivize, support, and encourage widespread mask-wearing consistent with CDC guidelines and applicable law.
(a) Establishment. There is hereby established the Safer Federal Workforce Task Force (Task Force).
(b) Membership. The Task Force shall consist of the following members:
(i) the Director of OPM, who shall serve as Co-Chair;
(ii) the Administrator of General Services, who shall serve as Co-Chair;
(iii) the COVID–19 Response Coordinator, who shall serve as Co-Chair;
(iv) the Director of OMB;
(v) the Director of the Federal Protective Service;
(vi) the Director of the United States Secret Service;
(vii) the Administrator of the Federal Emergency Management Agency;
(viii) the Director of CDC; and
(ix) the heads of such other agencies as the Co-Chairs may individually or jointly invite to participate.
(c) Organization. A member of the Task Force may designate, to perform the Task Force functions of the member, a senior-level official who is a full-time officer or employee of the member's agency. At the direction of the Co-Chairs, the Task Force may establish subgroups consisting exclusively of Task Force members or their designees, as appropriate.
(d) Administration. The General Services Administration shall provide funding and administrative support for the Task Force to the extent permitted by law and within existing appropriations. The Co-Chairs shall convene regular meetings of the Task Force, determine its agenda, and direct its work.
(e) Mission. The Task Force shall provide ongoing guidance to heads of agencies on the operation of the Federal Government, the safety of its employees, and the continuity of Government functions during the COVID–19 pandemic. Such guidance shall be based on public health best practices as determined by CDC and other public health experts, and shall address, at a minimum, the following subjects as they relate to the Federal workforce:
(i) testing methodologies and protocols;
(ii) case investigation and contact tracing;
(iii) requirements of and limitations on physical distancing, including recommended occupancy and density standards;
(iv) equipment needs and requirements, including personal protective equipment;
(v) air filtration;
(vi) enhanced environmental disinfection and cleaning;
(vii) safe commuting and telework options;
(viii) enhanced technological infrastructure to support telework;
(ix) vaccine prioritization, distribution, and administration;
(x) approaches for coordinating with State, local, Tribal, and territorial health officials, as well as business, union, academic, and other community leaders;
(xi) any management infrastructure needed by agencies to implement public health guidance; and
(xii) circumstances under which exemptions might appropriately be made to agency policies in accordance with CDC guidelines, such as for mission-critical purposes.
(f) Agency Cooperation. The head of each agency listed in
(i) "Federal employees" and "Federal contractors" mean employees (including members of the Armed Forces and members of the National Guard in Federal service) and contractors (including such contractors' employees) working for the executive branch;
(ii) "Federal buildings" means buildings, or office space within buildings, owned, rented, or leased by the executive branch of which a substantial portion of occupants are Federal employees or Federal contractors; and
(iii) "Federal lands" means lands under executive branch control.
(b) The Director of OPM and the Administrator of General Services shall seek to consult, in coordination with the heads of any other relevant agencies and the COVID–19 Response Coordinator, with the Sergeants at Arms of the Senate and the House of Representatives and the Director of the Administrative Office of the United States Courts (or such other persons designated by the Majority and Minority Leaders of the Senate, the Speaker and Minority Leader of the House, or the Chief Justice of the United States, respectively), to promote mask-wearing, physical distancing, and adherence to other public health measures within the legislative and judicial branches, and shall provide requested technical assistance as needed to facilitate compliance with CDC guidelines.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) Independent agencies are strongly encouraged to comply with the requirements of this order.
(d) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 13994. Ensuring a Data-Driven Response to COVID–19 and Future High-Consequence Public Health Threats
Ex. Ord. No. 13994, Jan. 21, 2021, 86 F.R. 7189, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Consistent with this policy, the heads of all executive departments and agencies (agencies) shall facilitate the gathering, sharing, and publication of COVID–19-related data, in coordination with the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), to the extent permitted by law, and with appropriate protections for confidentiality, privacy, law enforcement, and national security. These efforts shall assist Federal, State, local, Tribal, and territorial authorities in developing and implementing policies to facilitate informed community decision-making, to further public understanding of the pandemic and the response, and to deter the spread of misinformation and disinformation.
(b) The COVID–19 Response Coordinator shall, as necessary, convene appropriate representatives from relevant agencies to coordinate the agencies' collection, provision, and analysis of data, including key equity indicators, regarding the COVID–19 response, as well as their sharing of such data with State, local, Tribal, and territorial authorities.
(c) The Director of OMB, in consultation with the Director of OSTP, the United States Chief Technology Officer, and the COVID–19 Response Coordinator, shall promptly review the Federal Government's existing approaches to open data, and shall issue supplemental guidance, as appropriate and consistent with applicable law, concerning how to de-identify COVID–19-related data; how to make data open to the public in human- and machine-readable formats as rapidly as possible; and any other topic the Director of OMB concludes would appropriately advance the policy of this order. Any guidance shall include appropriate protections for the information described in section 5 of this order.
(d) The Director of the Office of Personnel Management, in consultation with the Director of OMB, shall promptly:
(i) review the ability of agencies to hire personnel expeditiously into roles related to information technology and the collection, provision, analysis, or other use of data to address high-consequence public health threats, such as the COVID–19 pandemic; and
(ii) take action, as appropriate and consistent with applicable law, to support agencies in such efforts.
(a) review the effectiveness, interoperability, and connectivity of public health data systems supporting the detection of and response to high-consequence public health threats, such as the COVID–19 pandemic;
(b) review the collection of morbidity and mortality data by State, local, Tribal, and territorial governments during high-consequence public health threats, such as the COVID–19 pandemic; and
(c) issue a report summarizing the findings of the reviews detailed in subsections (a) and (b) of this section and any recommendations for addressing areas for improvement identified in the reviews.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 13995. Ensuring an Equitable Pandemic Response and Recovery
Ex. Ord. No. 13995, Jan. 21, 2021, 86 F.R. 7193, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to address the disproportionate and severe impact of coronavirus disease 2019 (COVID–19) on communities of color and other underserved populations, it is hereby ordered as follows:
Addressing this devastating toll is both a moral imperative and pragmatic policy. It is impossible to change the course of the pandemic without tackling it in the hardest-hit communities. In order to identify and eliminate health and social inequities resulting in disproportionately higher rates of exposure, illness, and death, I am directing a Government-wide effort to address health equity. The Federal Government must take swift action to prevent and remedy differences in COVID–19 care and outcomes within communities of color and other underserved populations.
(a) Membership. The Task Force shall consist of the Secretary of HHS; an individual designated by the Secretary of HHS to Chair the Task Force (COVID–19 Health Equity Task Force Chair); the heads of such other executive departments, agencies, or offices (agencies) as the Chair may invite; and up to 20 members from sectors outside of the Federal Government appointed by the President.
(i) Federal members may designate, to perform the Task Force functions of the member, a senior-level official who is a part of the member's agency and a full-time officer or employee of the Federal Government.
(ii) Nonfederal members shall include individuals with expertise and lived experience relevant to groups suffering disproportionate rates of illness and death in the United States; individuals with expertise and lived experience relevant to equity in public health, health care, education, housing, and community-based services; and any other individuals with expertise the President deems relevant. Appointments shall be made without regard to political affiliation and shall reflect a diverse set of perspectives.
(iii) Members of the Task Force shall serve without compensation for their work on the Task Force, but members shall be allowed travel expenses, including per diem in lieu of subsistence, as authorized by law for persons serving intermittently in the Government service (
(iv) At the direction of the Chair, the Task Force may establish subgroups consisting exclusively of Task Force members or their designees under this section, as appropriate.
(b) Mission and Work.
(i) Consistent with applicable law and as soon as practicable, the Task Force shall provide specific recommendations to the President, through the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), for mitigating the health inequities caused or exacerbated by the COVID–19 pandemic and for preventing such inequities in the future. The recommendations shall include:
(A) recommendations for how agencies and State, local, Tribal, and territorial officials can best allocate COVID–19 resources, in light of disproportionately high rates of COVID–19 infection, hospitalization, and mortality in certain communities and disparities in COVID–19 outcomes by race, ethnicity, and other factors, to the extent permitted by law;
(B) recommendations for agencies with responsibility for disbursing COVID–19 relief funding regarding how to disburse funds in a manner that advances equity; and
(C) recommendations for agencies regarding effective, culturally aligned communication, messaging, and outreach to communities of color and other underserved populations.
(ii) The Task Force shall submit a final report to the COVID–19 Response Coordinator addressing any ongoing health inequities faced by COVID–19 survivors that may merit a public health response, describing the factors that contributed to disparities in COVID–19 outcomes, and recommending actions to combat such disparities in future pandemic responses.
(c) Data Collection. To address the data shortfalls identified in section 1 of this order, and consistent with applicable law, the Task Force shall:
(i) collaborate with the heads of relevant agencies, consistent with the Executive Order entitled "Ensuring a Data-Driven Response to COVID–19 and Future High-Consequence Public Health Threats," [Ex. Ord. No. 13994, set out above] to develop recommendations for expediting data collection for communities of color and other underserved populations and identifying data sources, proxies, or indices that would enable development of short-term targets for pandemic-related actions for such communities and populations;
(ii) develop, in collaboration with the heads of relevant agencies, a set of longer-term recommendations to address these data shortfalls and other foundational data challenges, including those relating to data intersectionality, that must be tackled in order to better prepare and respond to future pandemics; and
(iii) submit the recommendations described in this subsection to the President, through the COVID–19 Response Coordinator.
(d) External Engagement. Consistent with the objectives set out in this order and with applicable law, the Task Force may seek the views of health professionals; policy experts; State, local, Tribal, and territorial health officials; faith-based leaders; businesses; health providers; community organizations; those with lived experience with homelessness, incarceration, discrimination, and other relevant issues; and other stakeholders.
(e) Administration. Insofar as the Federal Advisory Committee Act, as amended ([former] 5 U.S.C. App.) [see
(f) Termination. Unless extended by the President, the Task Force shall terminate within 30 days of accomplishing the objectives set forth in this order, including the delivery of the report and recommendations specified in this section, or 2 years from the date of this order [Jan. 21, 2021], whichever comes first.
(a) The Secretary of Agriculture, the Secretary of Labor, the Secretary of HHS, the Secretary of Housing and Urban Development, the Secretary of Education, the Administrator of the Environmental Protection Agency, and the heads of all other agencies with authorities or responsibilities relating to the pandemic response and recovery shall, as appropriate and consistent with applicable law:
(i) consult with the Task Force to strengthen equity data collection, reporting, and use related to COVID–19;
(ii) assess pandemic response plans and policies to determine whether personal protective equipment, tests, vaccines, therapeutics, and other resources have been or will be allocated equitably, including by considering:
(A) the disproportionately high rates of COVID–19 infection, hospitalization, and mortality in certain communities; and
(B) any barriers that have restricted access to preventive measures, treatment, and other health services for high-risk populations;
(iii) based on the assessments described in subsection (a)(ii) of this section, modify pandemic response plans and policies to advance equity, with consideration to:
(A) the effect of proposed policy changes on the distribution of resources to, and access to health care by, communities of color and other underserved populations;
(B) the effect of proposed policy changes on agencies' ability to collect, analyze, and report data necessary to monitor and evaluate the impact of pandemic response plans and policies on communities of color and other underserved populations; and
(C) policy priorities expressed by communities that have suffered disproportionate rates of illness and death as a result of the pandemic;
(iv) strengthen enforcement of anti-discrimination requirements pertaining to the availability of, and access to, COVID–19 care and treatment; and
(v) partner with States, localities, Tribes, and territories to explore mechanisms to provide greater assistance to individuals and families experiencing disproportionate economic or health effects from COVID–19, such as by expanding access to food, housing, child care, or income support.
(b) The Secretary of HHS shall:
(i) provide recommendations to State, local, Tribal, and territorial leaders on how to facilitate the placement of contact tracers and other workers in communities that have been hardest hit by the pandemic, recruit such workers from those communities, and connect such workers to existing health workforce training programs and other career advancement programs; and
(ii) conduct an outreach campaign to promote vaccine trust and uptake among communities of color and other underserved populations with higher levels of vaccine mistrust due to discriminatory medical treatment and research, and engage with leaders within those communities.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 13996. Establishing the COVID–19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID–19 and Other Biological Threats
Ex. Ord. No. 13996, Jan. 21, 2021, 86 F.R. 7197, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, including
(a) Establishment and Membership. There is established a COVID–19 Pandemic Testing Board (Testing Board), chaired by the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator) or his designee. The Testing Board shall include representatives from executive departments and agencies (agencies) that are designated by the President. The heads of agencies so designated shall designate officials from their respective agencies to represent them on the Testing Board.
(b) Mission and Functions. To support the implementation and oversight of the policy laid out in section 1 of this order, the Testing Board shall:
(i) coordinate Federal Government efforts to promote COVID–19 diagnostic, screening, and surveillance testing;
(ii) make recommendations to the President with respect to prioritizing the Federal Government's assistance to State, local, Tribal, and territorial authorities, in order to expand testing and reduce disparities in access to testing;
(iii) identify barriers to access and use of testing in, and coordinate Federal Government efforts to increase testing for:
(A) priority populations, including healthcare workers and other essential workers;
(B) communities with major shortages in testing availability and use;
(C) at-risk settings, including long-term care facilities, correctional facilities, immigration custodial settings, detention facilities, schools, child care settings, and food processing and manufacturing facilities; and
(D) high-risk groups, including people experiencing homelessness, migrants, and seasonal workers;
(iv) identify methods to expand State, local, Tribal, and territorial capacity to conduct testing, contact tracing, and isolation and quarantine, in order for schools, businesses, and travel to be conducted safely;
(v) provide guidance on how to enhance the clarity, consistency, and transparency of Federal Government communication with the public about the goals and purposes of testing;
(vi) identify options for the Federal Government to maximize testing capacity of commercial labs and academic labs; and
(vii) propose short- and long-term reforms for the Federal Government to: increase State, local, Tribal, and territorial capacity to conduct testing; expand genomic sequencing; and improve the effectiveness and speed of the Federal Government's response to future pandemics and other biological emergencies.
(d) The Chair of the Testing Board shall coordinate with the Secretary of Health and Human Services (HHS) and the heads of other relevant agencies or their designees, as necessary, to ensure that the Testing Board's work is coordinated with the Public Health Emergency Countermeasures Enterprise within HHS.
(i) facilitate the provision of COVID–19 testing free of charge to those who lack comprehensive health insurance; and
(ii) clarify group health plans' and health insurance issuers' obligations to provide coverage for COVID–19 testing.
(b) The Secretary of HHS, the Secretary of Education, and the Secretary of Homeland Security, through the Administrator of the Federal Emergency Management Agency (FEMA), in coordination with the COVID–19 Response Coordinator, shall promptly, and as appropriate and consistent with applicable law:
(i) provide support for surveillance tests for settings such as schools; and
(ii) expand equitable access to COVID–19 testing.
(b) The Secretary of HHS shall, as appropriate and consistent with applicable law, as soon as practicable:
(i) provide technical support to State, local, Tribal, and territorial public health agencies with respect to testing and contact-tracing efforts; and
(ii) assist such authorities in the training of public health workers. This may include technical assistance to non-Federal public health workforces in connection with testing, contact tracing, and mass vaccinations, as well as other urgent public health workforce needs, such as combating opioid use.
(c) The Secretary of HHS shall submit to the President, through the COVID–19 Response Coordinator, the Assistant to the President for Domestic Policy (APDP), and the Assistant to the President for National Security Affairs (APNSA), a plan detailing:
(i) how the Secretary of HHS would deploy personnel in response to future high-consequence public health threats; and
(ii) five-year targets and budget requirements for achieving a sustainable public health workforce, as well as options for expanding HHS capacity, such as by expanding the U.S. Public Health Service Commissioned Corps and Epidemic Intelligence Service, so that the Department can better respond to future pandemics and other biological threats.
(d) The Secretary of HHS, the Secretary of Homeland Security, the Secretary of Labor, the Secretary of Education, and the Chief Executive Officer of the Corporation for National and Community Service, in coordination with the COVID–19 Response Coordinator, the APDP, and the APNSA, shall submit a plan to the President for establishing a national contact tracing and COVID–19 public health workforce program, to be known as the U.S. Public Health Job Corps, which shall be modeled on or developed as a component of the FEMA Corps program. Such plan shall include means by which the U.S. Public Health Job Corps can be part of the National Civilian Community Corps program, as well as recommendations about whether it would be appropriate for the U.S. Public Health Job Corps to immediately assign personnel from any of the agencies involved in the creation of the plan, including existing AmeriCorps members, to join or aid the U.S. Public Health Job Corps. The U.S. Public Health Job Corps will:
(i) conduct and train individuals in contact tracing related to the COVID–19 pandemic;
(ii) assist in outreach for vaccination efforts, including by administering vaccination clinics;
(iii) assist with training programs for State, local, Tribal, and territorial governments to provide testing, including in schools; and
(iv) provide other necessary services to Americans affected by the COVID–19 pandemic.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 13997. Improving and Expanding Access to Care and Treatments for COVID–19
Ex. Ord. No. 13997, Jan. 21, 2021, 86 F.R. 7201, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
(a) develop a plan for supporting a range of studies, including large-scale randomized trials, for identifying optimal clinical management strategies, and for supporting the most promising treatments for COVID–19 and future high-consequence public health threats, that can be easily manufactured, distributed, and administered, both domestically and internationally;
(b) develop a plan, in consultation with non-governmental partners, as appropriate, to support research:
(i) in rural hospitals and other rural locations; and
(ii) that studies the emerging evidence concerning the long-term impact of COVID–19 on patient health; and
(c) consider steps to ensure that clinical trials include populations that have been historically underrepresented in such trials.
(a) The Secretary of Defense, the Secretary of HHS, the Secretary of Veterans Affairs, and the heads of other relevant executive departments and agencies (agencies), in coordination with the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), shall promptly, as appropriate and consistent with applicable law, provide targeted surge assistance to critical care and long-term care facilities, including nursing homes and skilled nursing facilities, assisted living facilities, intermediate care facilities for individuals with disabilities, and residential treatment centers, in their efforts to combat the spread of COVID–19.
(b) The COVID–19 Response Coordinator, in coordination with the Secretary of Defense, the Secretary of HHS, the Secretary of Veterans Affairs, and the heads of other relevant agencies, shall review the needs of Federal facilities providing care to COVID–19 patients and develop recommendations for further actions such facilities can take to support active military personnel, veterans, and Tribal nations during this crisis.
(c) The Secretary of HHS shall promptly:
(i) issue recommendations on how States and healthcare providers can increase the capacity of their healthcare workforces to address the COVID–19 pandemic; and
(ii) through the Administrator of the Health Resources and Services Administration and the Administrator of the Substance Abuse and Mental Health Services Administration, take appropriate actions, as consistent with applicable law, to expand access to programs and services designed to meet the long-term health needs of patients recovering from COVID–19, including through technical assistance and support to community health centers.
(b) To facilitate the utilization of existing COVID–19 treatments, the Secretary of HHS shall identify barriers to maximizing the effective and equitable use of existing COVID–19 treatments and shall, as appropriate and consistent with applicable law, provide support to State, local, Tribal, and territorial authorities aimed at overcoming those barriers.
(c) To address the affordability of treatments and clinical care, the Secretary of HHS shall, promptly and as appropriate and consistent with applicable law:
(i) evaluate the COVID–19 Uninsured Program, operated by the Health Resources and Services Administration within HHS, and take any available steps to promote access to treatments and clinical care for those without adequate coverage, to support safety-net providers in delivering such treatments and clinical care, and to make the Program easy to use and accessible for patients and providers, with information about the Program widely disseminated; and
(ii) evaluate Medicare, Medicaid, group health plans, and health insurance issuers, and take any available steps to promote insurance coverage for safe and effective COVID–19 treatments and clinical care.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 13998. Promoting COVID–19 Safety in Domestic and International Travel
Ex. Ord. No. 13998, Jan. 21, 2021, 86 F.R. 7205, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
(a) Mask Requirement. The Secretary of Labor, the Secretary of Health and Human Services (HHS), the Secretary of Transportation (including through the Administrator of the Federal Aviation Administration (FAA)), the Secretary of Homeland Security (including through the Administrator of the Transportation Security Administration (TSA) and the Commandant of the United States Coast Guard), and the heads of any other executive departments and agencies (agencies) that have relevant regulatory authority (heads of agencies) shall immediately take action, to the extent appropriate and consistent with applicable law, to require masks to be worn in compliance with CDC guidelines in or on:
(i) airports;
(ii) commercial aircraft;
(iii) trains;
(iv) public maritime vessels, including ferries;
(v) intercity bus services; and
(vi) all forms of public transportation as defined in
(b) Consultation. In implementing this section, the heads of agencies shall consult, as appropriate, with interested parties, including State, local, Tribal, and territorial officials; industry and union representatives from the transportation sector; and consumer representatives.
(c) Exceptions. The heads of agencies may make categorical or case-by-case exceptions to policies developed under this section, consistent with applicable law, to the extent that doing so is necessary or required by law. If the heads of agencies do make exceptions, they shall require alternative and appropriate safeguards, and shall document all exceptions in writing.
(d) Preemption. To the extent permitted by applicable law, the heads of agencies shall ensure that any action taken to implement this section does not preempt State, local, Tribal, and territorial laws or rules imposing public health measures that are more protective of public health than those required by the heads of agencies.
(e) Coordination. The Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator) shall coordinate the implementation of this section. The heads of agencies shall update the COVID–19 Response Coordinator on their progress in implementing this section, including any categorical exceptions established under subsection (c) of this section, within 7 days of the date of this order [Jan. 21, 2021] and regularly thereafter. The heads of agencies are encouraged to bring to the attention of the COVID–19 Response Coordinator any questions regarding the scope or implementation of this section.
(a) Recommendations. The Secretary of Transportation (including through the Administrator of the FAA) and the Secretary of Homeland Security (including through the Administrator of the TSA and the Commandant of the Coast Guard), in consultation with the Director of CDC, shall promptly provide to the COVID–19 Response Coordinator recommendations concerning how their respective agencies may impose additional public health measures for domestic travel.
(b) Consultation. In implementing this section, the Secretary of Transportation and the Secretary of Homeland Security shall engage with interested parties, including State, local, Tribal, and territorial officials; industry and union representatives from the transportation sector; and consumer representatives.
(a) Policy. It is the policy of my Administration that, to the extent feasible, travelers seeking to enter the United States from a foreign country shall be:
(i) required to produce proof of a recent negative COVID–19 test prior to entry; and
(ii) required to comply with other applicable CDC guidelines concerning international travel, including recommended periods of self-quarantine or self-isolation after entry into the United States.
(b) Air Travel.
(i) The Secretary of HHS, including through the Director of CDC, and in coordination with the Secretary of Transportation (including through the Administrator of the FAA) and the Secretary of Homeland Security (including through the Administrator of the TSA), shall, within 14 days of the date of this order [Jan. 21, 2021], assess the CDC order of January 12, 2021, regarding the requirement of a negative COVID–19 test result for airline passengers traveling into the United States, in light of subsection (a) of this section. Based on such assessment, the Secretary of HHS and the Secretary of Homeland Security shall take any further appropriate regulatory action, to the extent feasible and consistent with CDC guidelines and applicable law. Such assessment and regulatory action shall include consideration of:
(A) the timing and types of COVID–19 tests that should satisfy the negative test requirement, including consideration of additional testing immediately prior to departure;
(B) the proof of test results that travelers should be required to provide;
(C) the feasibility of implementing alternative and sufficiently protective public health measures, such as testing, self-quarantine, and self-isolation on arrival, for travelers entering the United States from countries where COVID–19 tests are inaccessible, particularly where such inaccessibility of tests would affect the ability of United States citizens and lawful permanent residents to return to the United States; and
(D) measures to prevent fraud.
(ii) The Secretary of HHS, in coordination with the Secretary of Transportation (including through the Administrator of the FAA) and the Secretary of Homeland Security (including through the Administrator of the TSA), shall promptly provide to the President, through the COVID–19 Response Coordinator, a plan for how the Secretary and other Federal Government actors could implement the policy stated in subsection (a) of this section with respect to CDC-recommended periods of self-quarantine or self-isolation after a flight to the United States from a foreign country, as he deems appropriate and consistent with applicable law. The plan shall identify agencies' tools and mechanisms to assist travelers in complying with such policy.
(iii) The Secretary of State, in consultation with the Secretary of HHS (including through the Director of CDC), the Secretary of Transportation (including through the Administrator of the FAA), and the Secretary of Homeland Security, shall seek to consult with foreign governments, the World Health Organization, the International Civil Aviation Organization, the International Air Transport Association, and any other relevant stakeholders to establish guidelines for public health measures associated with safe international travel, including on aircraft and at ports of entry. Any such guidelines should address quarantine, testing, COVID–19 vaccination, follow-up testing and symptom-monitoring, air filtration requirements, environmental decontamination standards, and contact tracing.
(c) Land Travel. The Secretary of State, in consultation with the Secretary of HHS, the Secretary of Transportation, the Secretary of Homeland Security, and the Director of CDC, shall immediately commence diplomatic outreach to the governments of Canada and Mexico regarding public health protocols for land ports of entry. Based on this diplomatic engagement, within 14 days of the date of this order, the Secretary of HHS (including through the Director of CDC), the Secretary of Transportation, and the Secretary of Homeland Security shall submit to the President a plan to implement appropriate public health measures at land ports of entry. The plan should implement CDC guidelines, consistent with applicable law, and take into account the operational considerations relevant to the different populations who enter the United States by land.
(d) Sea Travel. The Secretary of Homeland Security, through the Commandant of the Coast Guard and in consultation with the Secretary of HHS and the Director of CDC, shall, within 14 days of the date of this order, submit to the President a plan to implement appropriate public health measures at sea ports. The plan should implement CDC guidelines, consistent with applicable law, and take into account operational considerations.
(e) International Certificates of Vaccination or Prophylaxis. Consistent with applicable law, the Secretary of State, the Secretary of HHS, and the Secretary of Homeland Security (including through the Administrator of the TSA), in coordination with any relevant international organizations, shall assess the feasibility of linking COVID–19 vaccination to International Certificates of Vaccination or Prophylaxis (ICVP) and producing electronic versions of ICVPs.
(f) Coordination. The COVID–19 Response Coordinator, in consultation with the Assistant to the President for National Security Affairs and the Assistant to the President for Domestic Policy, shall coordinate the implementation of this section. The Secretary of State, the Secretary of HHS, the Secretary of Transportation, and the Secretary of Homeland Security shall update the COVID–19 Response Coordinator on their progress in implementing this section within 7 days of the date of this order and regularly thereafter. The heads of all agencies are encouraged to bring to the attention of the COVID–19 Response Coordinator any questions regarding the scope or implementation of this section.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 13999. Protecting Worker Health and Safety
Ex. Ord. No. 13999, Jan. 21, 2021, 86 F.R. 7211, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
The Federal Government must take swift action to reduce the risk that workers may contract COVID–19 in the workplace. That will require issuing science-based guidance to help keep workers safe from COVID–19 exposure, including with respect to mask-wearing; partnering with State and local governments to better protect public employees; enforcing worker health and safety requirements; and pushing for additional resources to help employers protect employees.
(a) issue, within 2 weeks of the date of this order [Jan. 21, 2021] and in conjunction or consultation with the heads of any other appropriate executive departments and agencies (agencies), revised guidance to employers on workplace safety during the COVID–19 pandemic;
(b) consider whether any emergency temporary standards on COVID–19, including with respect to masks in the workplace, are necessary, and if such standards are determined to be necessary, issue them by March 15, 2021;
(c) review the enforcement efforts of the Occupational Safety and Health Administration (OSHA) related to COVID–19 and identify any short-, medium-, and long-term changes that could be made to better protect workers and ensure equity in enforcement;
(d) launch a national program to focus OSHA enforcement efforts related to COVID–19 on violations that put the largest number of workers at serious risk or are contrary to anti-retaliation principles; and
(e) coordinate with the Department of Labor's Office of Public Affairs and Office of Public Engagement and all regional OSHA offices to conduct, consistent with applicable law, a multilingual outreach campaign to inform workers and their representatives of their rights under applicable law. This campaign shall include engagement with labor unions, community organizations, and industries, and place a special emphasis on communities hit hardest by the pandemic.
(i) coordinate with States that have occupational safety and health plans approved under section 18 of the Occupational Safety and Health Act (Act) (
(ii) in States that do not have such plans, consult with State and local government entities with responsibility for public employee safety and health and with public employee unions to bolster protection from COVID–19 for public sector workers.
(b) The Secretary of Agriculture, the Secretary of Labor, the Secretary of Health and Human Services, the Secretary of Transportation, and the Secretary of Energy, in consultation with the heads of any other appropriate agencies, shall, consistent with applicable law, explore mechanisms to protect workers not protected under the Act [
(c) The Secretary of Labor, acting through the Assistant Secretary of Labor for Mine Safety and Health, shall consider whether any emergency temporary standards on COVID–19 applicable to coal and metal or non-metal mines are necessary, and if such standards are determined to be necessary and consistent with applicable law, issue them as soon as practicable.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Ex. Ord. No. 14000. Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers
Ex. Ord. No. 14000, Jan. 21, 2021, 86 F.R. 7215, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, to ensure that students receive a high-quality education during the coronavirus disease 2019 (COVID–19) pandemic, and to support the safe reopening and continued operation of schools, child care providers, Head Start programs, and institutions of higher education, it is hereby ordered as follows:
Accordingly, it is the policy of my Administration to provide support to help create the conditions for safe, in-person learning as quickly as possible; ensure high-quality instruction and the delivery of essential services often received by students and young children at school, institutions of higher education, child care providers, and Head Start programs; mitigate learning loss caused by the pandemic; and address educational disparities and inequities that the pandemic has created and exacerbated.
(a) The Secretary of Education shall, consistent with applicable law:
(i) provide, in consultation with the Secretary of Health and Human Services, evidence-based guidance to assist States and elementary and secondary schools in deciding whether and how to reopen, and how to remain open, for in-person learning; and in safely conducting in-person learning, including by implementing mitigation measures such as cleaning, masking, proper ventilation, and testing;
(ii) provide, in consultation with the Secretary of Health and Human Services, evidence-based guidance to institutions of higher education on safely reopening for in-person learning, which shall take into account considerations such as the institution's setting, resources, and the population it serves;
(iii) provide advice to State, local, Tribal, and territorial educational authorities, institutions of higher education, local education agencies, and elementary and secondary schools regarding distance and online learning, blended learning, and in-person learning; and the promotion of mental health, social-emotional well-being, and communication with parents and families;
(iv) develop a Safer Schools and Campuses Best Practices Clearinghouse to enable schools and institutions of higher education to share lessons learned and best practices for operating safely during the pandemic;
(v) provide technical assistance to schools and institutions of higher education so that they can ensure high-quality learning during the pandemic;
(vi) direct the Department of Education's Assistant Secretary for Civil Rights to deliver a report as soon as practicable on the disparate impacts of COVID–19 on students in elementary, secondary, and higher education, including those attending historically black colleges and universities, Tribal colleges and universities, Hispanic-serving institutions, and other minority-serving institutions;
(vii) coordinate with the Director of the Institute of Education Sciences to facilitate, consistent with applicable law, the collection of data necessary to fully understand the impact of the COVID–19 pandemic on students and educators, including data on the status of in-person learning. These data shall be disaggregated by student demographics, including race, ethnicity, disability, English-language-learner status, and free or reduced lunch status or other appropriate indicators of family income; and
(viii) consult with those who have been struggling for months with the enormous challenges the COVID–19 pandemic poses for education, including students; educators; unions; families; State, local, Tribal, and territorial officials; and members of civil rights and disability rights organizations, in carrying out the directives in this order.
(b) The Secretary of Health and Human Services shall, consistent with applicable law:
(i) facilitate the collection of data needed to inform the safe reopening and continued operation of elementary and secondary schools, child care providers, and Head Start programs, and ensure that such data are readily available to State, local, Tribal, and territorial leaders and the public, consistent with privacy interests, and that such data are disaggregated by race, ethnicity, and other factors as appropriate;
(ii) ensure, in coordination with the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator) and other relevant agencies, that COVID–19-related supplies the Secretary administers, including testing materials, are equitably allocated to elementary and secondary schools, child care providers, and Head Start programs to support in-person care and learning;
(iii) to the maximum extent possible, support the development and operation of contact tracing programs at the State, local, Tribal, and territorial level, by providing guidance and technical support to ensure that contact tracing is available to facilitate the reopening and safe operation of elementary and secondary schools, child care providers, Head Start programs, and institutions of higher education;
(iv) provide guidance needed for child care providers and Head Start programs for safely reopening and operating, including procedures for mitigation measures such as cleaning, masking, proper ventilation, and testing, as well as guidance related to meeting the needs of children, families, and staff who have been affected by the COVID–19 pandemic, including trauma-informed care, behavioral and mental health support, and family support, as appropriate; and
(v) provide technical assistance to States, localities, Tribes, and territories to support the accelerated distribution of Federal COVID–19 relief funds to child care providers, and identify strategies to help child care providers safely remain open during the pandemic and beyond while the sector experiences widespread financial disruption due to increased costs and less revenue.
(c) The Secretary of Education and the Secretary of Health and Human Services shall submit a report to the Assistant to the President for Domestic Policy and the COVID–19 Response Coordinator identifying strategies to address the impact of COVID–19 on educational outcomes, especially along racial and socioeconomic lines, and shall share those strategies with State, local, Tribal, and territorial officials. In developing these strategies, the Secretaries shall, as appropriate and consistent with applicable law, consult with such officials, as well as with education experts; educators; unions; civil rights advocates; Tribal education experts; public health experts; child development experts; early educators, including child care providers; Head Start staff; school technology practitioners; foundations; families; students; community advocates; and others.
(d) The Federal Communications Commission is encouraged, consistent with applicable law, to increase connectivity options for students lacking reliable home broadband, so that they can continue to learn if their schools are operating remotely.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Addressing the Long-Term Effects of COVID–19
Memorandum of President of the United States, Apr. 5, 2022, 87 F.R. 20995, provided:
Memorandum for the Heads of Executive Departments and Agencies
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
As we chart the path forward, we remember the more than 950,000 people in the United States lost to COVID–19. They were beloved parents, grandparents, children, siblings, spouses, neighbors, and friends. More than 200,000 children in the United States have lost a parent or caregiver to the disease. Each soul is irreplaceable, and the families and communities left behind are still reeling from profound loss. Many families and communities have already received support from Federal programs that help with the loss they have experienced. As we move forward, we commit to ensuring that families and communities can access these support programs and connect to resources they may need to help with their healing, health, and well-being.
At the same time, many of our family members, neighbors, and friends continue to experience negative long-term effects of COVID–19. Many individuals report debilitating, long-lasting effects of having been infected with COVID–19, often called "long COVID." These symptoms can happen to anyone who has had COVID–19—including individuals across ages, races, genders, and ethnicities; individuals with or without disabilities; individuals with or without underlying health conditions; and individuals whether or not they had initial symptoms. Individuals experiencing long COVID report experiencing new or recurrent symptoms, which can include anxiety and depression, fatigue, shortness of breath, difficulty concentrating, heart palpitations, disordered sleep, chest and joint pain, headaches, and other symptoms. These symptoms can persist long after the acute COVID–19 infection has resolved. Even young people and otherwise healthy people have reported long COVID symptoms that last for many months. These symptoms may be affecting individuals' ability to work, conduct daily activities, engage in educational activities, and participate in their communities. Our world-class research and public health organizations have begun the difficult work of understanding these new conditions, their causes, and potential prevention and treatment options. Our health care and support programs are working to help meet the needs of individuals experiencing the lasting effects of COVID–19. To organize the Federal Government's response, executive departments and agencies (agencies) must work together to use the expertise, resources, and benefit programs of the Federal Government to ensure that we are accelerating scientific progress and providing individuals with the support and services they need.
In addition, the American public is grappling with a mental health crisis exacerbated by the pandemic. Too many have felt the effects of social isolation, sickness, economic insecurity, increased caregiver burdens, and grief. My Administration has made significant investments in mental health as well as substance use disorder prevention, treatment, and recovery support for the American public, including by expanding access to community-based behavioral health services. We are committed to advancing these behavioral health efforts in order to better identify the effects of the pandemic on mental health, substance use, and well-being, and to take steps to address these effects for the people we serve.
Our Nation can continue to protect the public—and spare countless families from the deepest pain imaginable—if everybody does their part. Today, we have numerous tools to protect ourselves and our loved ones from COVID–19—from vaccines to tests, treatments, masks, and more. My Administration recognizes the toll of this pandemic on the American public and commits to redoubling our efforts to support the American people in addressing the long-term effects of COVID–19 on their lives and on society.
(b) The heads of agencies shall assist and provide information to the Secretary, consistent with applicable law, as may be necessary to carry out the Secretary's duties described in subsection (a) of this section.
(c) In performing the duties described in subsection (a) of this section, the Secretary shall seek information from relevant nongovernmental experts, organizations, and stakeholders, including individuals affected directly by the long-term effects of COVID–19. The Secretary shall consider using all available legal authorities, as appropriate and consistent with applicable law, to assist in gathering relevant information, including a waiver under
(b) The National Research Action Plan shall build upon existing research efforts and include strategies to:
(i) help measure and characterize long COVID in both children and adults, including with respect to its frequency, severity, duration, risk factors, and trends over time;
(ii) support the development of estimates on prevalence and incidence of long COVID disaggregated by demographic groups and symptoms;
(iii) better understand the epidemiology, course of illness, risk factors, and vaccine effectiveness in prevention of long COVID;
(iv) advance our understanding of the health and socioeconomic burdens on individuals affected by long COVID, including among different race and ethnicity groups, pregnant people, and those with underlying disabilities;
(v) foster development of new treatments and care models for long COVID based on a better understanding of the pathophysiological mechanisms of the SARS–CoV–2 virus;
(vi) inform decisions related to high-quality support, services, and interventions for long COVID;
(vii) improve data-sharing between agencies and academic and industry researchers about long COVID, to the extent permitted by law; and
(viii) specifically account for the pandemic's effect on underserved communities and rural populations.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(d) The Secretary is authorized and directed to publish this memorandum in the Federal Register.
J.R. Biden, Jr.
§247d–1. Vaccine tracking and distribution
(a) Tracking
The Secretary, together with relevant manufacturers, wholesalers, and distributors as may agree to cooperate, may track the initial distribution of federally purchased influenza vaccine in an influenza pandemic, or other federally purchased vaccine to address another pandemic. Such tracking information shall be used to inform Federal, State, local, and tribal decision makers during an influenza pandemic or other pandemic.
(b) Distribution
The Secretary shall promote communication between State, local, and tribal public health officials and such manufacturers, wholesalers, and distributors as agree to participate, regarding the effective distribution of seasonal influenza vaccine. Such communication shall include estimates of high priority populations, as determined by the Secretary, in State, local, and tribal jurisdictions in order to inform Federal, State, local, and tribal decision makers during vaccine shortages and supply disruptions.
(c) Confidentiality
The information submitted to the Secretary or its contractors, if any, under this section or under any other section of this chapter related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in
(d) Guidelines
The Secretary, in order to maintain the confidentiality of relevant information and ensure that none of the information contained in the systems involved may be used to provide proprietary advantage within the vaccine market, while allowing State, local, and tribal health officials access to such information to maximize the delivery and availability of vaccines to high priority populations, during times of influenza pandemics or other pandemics, vaccine shortages, and supply disruptions, in consultation with manufacturers, distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a) and (b).
(e) Authorization of appropriations
There are authorized to be appropriated to carry out this section, $30,800,000 for each of fiscal years 2019 through 2023.
(f) Report to Congress
As part of the National Health Security Strategy described in
(July 1, 1944, ch. 373, title III, §319A, as added
Editorial Notes
References in Text
Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (c), is section 264(c) of
Amendments
2022—Subsec. (a).
Subsec. (d).
2019—Subsec. (e).
2013—Subsec. (e).
2006—
2002—Subsec. (a)(1).
§247d–2. Earlier development of diagnostic tests
The Secretary may contract with public and private entities, as appropriate, to increase capacity in the rapid development, validation, manufacture, and dissemination of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an emerging infectious disease with respect to which a public health emergency is declared under
(July 1, 1944, ch. 373, title III, §319B, as added
Editorial Notes
Prior Provisions
A prior section 247d–2, act July 1, 1944, ch. 373, title III, §319B, as added
§247d–3. Repealed. Pub. L. 109–417, title II, §204(b)(1), Dec. 19, 2006, 120 Stat. 2851
Section, act July 1, 1944, ch. 373, title III, §319C, as added
§247d–3a. Improving State and local public health security
(a) In general
To enhance the security of the United States with respect to public health emergencies, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award cooperative agreements to eligible entities to enable such entities to conduct the activities described in subsection (d).
(b) Eligible entities
To be eligible to receive an award under subsection (a), an entity shall—
(1)(A) be a State;
(B) be a political subdivision determined by the Secretary to be eligible for an award under this section (based on criteria described in subsection (h)(4)); or
(C) be a consortium of States; and
(2) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including—
(A) an All-Hazards Public Health Emergency Preparedness and Response Plan which shall include—
(i) a description of the activities such entity will carry out under the agreement to meet the goals identified under
(ii) a description of the activities such entity will carry out with respect to pandemic influenza, as a component of the activities carried out under clause (i), and consistent with the requirements of paragraphs (2) and (5) of subsection (g);
(iii) preparedness and response strategies and capabilities that take into account the medical and public health needs of at-risk individuals in the event of a public health emergency;
(iv) a description of the mechanism the entity will implement to utilize the Emergency Management Assistance Compact, or other mutual aid agreement, for medical and public health mutual aid, and, as appropriate, the activities such entity will implement pursuant to
(I) providing a public method of communication for purposes of volunteer coordination (such as a phone number);
(II) providing for optional registration to participate in volunteer services during processes related to State medical licensing, registration, or certification or renewal of such licensing, registration, or certification; or
(III) other mechanisms as the State determines appropriate;
(v) a description of how the entity will include the State Unit on Aging in public health emergency preparedness;
(vi) a description of how, as appropriate, the entity may partner with relevant public and private stakeholders, including public health agencies with specific expertise that may be relevant to public health security, such as environmental health agencies, in public health emergency preparedness and response;
(vii) a description of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs during and following a public health emergency;
(viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency preparedness and response plans in public health emergency preparedness, including State education agencies 1 (as defined in
(ix) in the case of entities that operate on the United States-Mexico border or the United States-Canada border, a description of the activities such entity will carry out under the agreement that are specific to the border area including disease detection, identification, investigation, and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section;
(x) a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance, including any utilization of poison control centers;
(xi) a description of how the entity will partner with health care facilities, including hospitals and nursing homes and other long-term care facilities, to promote and improve public health preparedness and response;
(xii) a description of how the entity will provide technical assistance to improve public health preparedness and response, as appropriate, to agencies or other entities that operate facilities within the entity's jurisdiction in which there is an increased risk of infectious disease outbreaks in the event of a public health emergency declared under
(xiii) a description of how, as appropriate and practicable, the entity will include critical infrastructure partners, such as utility companies within the entity's jurisdiction, in planning pursuant to this subparagraph to help ensure that critical infrastructure will remain functioning during, or return to function as soon as practicable after, a public health emergency;
(B) an assurance that the entity will report to the Secretary on an annual basis (or more frequently as determined by the Secretary) on the evidence-based benchmarks and objective standards established by the Secretary to evaluate the preparedness and response capabilities of such entity under subsection (g);
(C) an assurance that the entity will conduct, on at least an annual basis, an exercise or drill that meets any criteria established by the Secretary to test the preparedness and response capabilities of such entity, including addressing the needs of at-risk individuals, and that the entity will report back to the Secretary within the application of the following year on the strengths and weaknesses identified through such exercise or drill, and corrective actions taken to address material weaknesses;
(D) an assurance that the entity will require relevant staff to complete relevant preparedness and response trainings, including trainings related to efficient and effective operation during an incident or event within an Incident Command System;
(E) an assurance that the entity will provide to the Secretary the data described under
(F) an assurance that the entity will conduct activities to inform and educate the hospitals within the jurisdiction of such entity on the role of such hospitals in the plan required under subparagraph (A);
(G) an assurance that the entity, with respect to the plan described under subparagraph (A), has developed and will implement an accountability system to ensure that such entity makes satisfactory annual improvement and describes such system in the plan under subparagraph (A);
(H) a description of the means by which to obtain public comment and input on the plan described in subparagraph (A) and on the implementation of such plan, that shall include an advisory committee or other similar mechanism for obtaining comment from the public and from other State, local, and tribal stakeholders; and
(I) as relevant, a description of the process used by the entity to consult with local departments of public health to reach consensus, approval, or concurrence on the relative distribution of amounts received under this section.
(c) Limitation
Beginning in fiscal year 2009, the Secretary may not award a cooperative agreement to a State unless such State is a participant in the Emergency System for Advance Registration of Volunteer Health Professionals described in
(d) Use of funds
(1) In general
An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (2), (4), (5), and (6) of
(2) Effect of section
Nothing in this subsection may be construed as establishing new regulatory authority or as modifying any existing regulatory authority.
(e) Coordination with local response capabilities
An entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant Metropolitan Medical Response Systems, local public health departments, the Cities Readiness Initiative, local emergency plans, and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under
(f) Consultation with Homeland Security
In making awards under subsection (a), the Secretary shall consult with the Secretary of Homeland Security to—
(1) ensure maximum coordination of public health and medical preparedness and response activities with the Metropolitan Medical Response System, and other relevant activities;
(2) minimize duplicative funding of programs and activities; and
(3) analyze activities, including exercises and drills, conducted under this section to develop recommendations and guidance on best practices for such activities.
(g) Achievement of measurable evidence-based benchmarks and objective standards
(1) In general
Not later than 180 days after December 19, 2006, the Secretary shall develop or where appropriate adopt, and require the application of, measurable evidence-based benchmarks and objective standards that measure levels of preparedness with respect to the activities described in this section and with respect to activities described in
(A) include outcome goals representing operational achievements of the National Preparedness Goals developed under
(B) at a minimum, require entities to—
(i) measure progress toward achieving the outcome goals; and
(ii) at least annually, test, exercise, and rigorously evaluate the public health and medical emergency preparedness and response capabilities of the entity, and report to the Secretary on such measured and tested capabilities and measured and tested progress toward achieving outcome goals, based on criteria established by the Secretary.
(2) Criteria for pandemic influenza plans
(A) In general
Not later than 180 days after December 19, 2006, the Secretary shall develop and disseminate to the chief executive officer of each State criteria for an effective State plan for responding to pandemic influenza. The Secretary shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and standards described in paragraph (1).
(B) Rule of construction
Nothing in this section shall be construed to require the duplication of Federal efforts with respect to the development of criteria or standards, without regard to whether such efforts were carried out prior to or after December 19, 2006.3
(3) Technical assistance
The Secretary shall, as determined appropriate by the Secretary, provide to a State, upon request, technical assistance in meeting the requirements of this section, including the provision of advice by experts in the development of high-quality assessments, the setting of State objectives and assessment methods, the development of measures of satisfactory annual improvement that are valid and reliable, and other relevant areas.
(4) Notification of failures
The Secretary shall develop and implement a process to notify entities that are determined by the Secretary to have failed to meet the requirements of paragraph (1) or (2). Such process shall provide such entities with the opportunity to correct such noncompliance. An entity that fails to correct such noncompliance shall be subject to paragraph (5).
(5) Withholding of amounts from entities that fail to achieve benchmarks or submit influenza plan
Beginning with fiscal year 2019, and in each succeeding fiscal year, the Secretary shall—
(A) withhold from each entity that has failed substantially to meet the benchmarks and performance measures described in paragraph (1) for either of the 2 immediately preceding fiscal years (beginning with fiscal year 2018), pursuant to the process developed under paragraph (4), the amount described in paragraph (6); and
(B) withhold from each entity that has failed to submit to the Secretary a plan for responding to pandemic influenza that meets the criteria developed under paragraph (2), the amount described in paragraph (6).
(6) Amounts described
(A) In general
The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or
(i) For no more than one of each of the first 2 fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5), an amount equal to 10 percent of the amount the entity was eligible to receive for the respective fiscal year.
(ii) For no more than one of the first 2 fiscal years immediately following the third consecutive fiscal year in which an entity experienced such a failure, in lieu of applying clause (i), an amount equal to 15 percent of the amount the entity was eligible to receive for the respective fiscal year.
(B) Separate accounting
Each failure described in subparagraph (A) or (B) of paragraph (5) shall be treated as a separate failure for purposes of calculating amounts withheld under subparagraph (A).
(7) Reallocation of amounts withheld
(A) In general
The Secretary shall make amounts withheld under paragraph (6) available for making awards under
(B) Preference in reallocation
In making awards under
(8) Waive or reduce withholding
The Secretary may waive or reduce the withholding described in paragraph (6), for a single entity or for all entities in a fiscal year, if the Secretary determines that mitigating conditions exist that justify the waiver or reduction.
(h) Funding
(1) Authorization of appropriations
(A) In general
For the purpose of carrying out this section, there is authorized to be appropriated $685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5)).
(B) Requirement for State matching funds
Beginning in fiscal year 2009, in the case of any State or consortium of two or more States, the Secretary may not award a cooperative agreement under this section unless the State or consortium of States agree that, with respect to the amount of the cooperative agreement awarded by the Secretary, the State or consortium of States will make available (directly or through donations from public or private entities) non-Federal contributions in an amount equal to—
(i) for the first fiscal year of the cooperative agreement, not less than 5 percent of such costs ($1 for each $20 of Federal funds provided in the cooperative agreement); and
(ii) for any second fiscal year of the cooperative agreement, and for any subsequent fiscal year of such cooperative agreement, not less than 10 percent of such costs ($1 for each $10 of Federal funds provided in the cooperative agreement).
(C) Determination of amount of non-Federal contributions
As determined by the Secretary, non-Federal contributions required in subparagraph (B) may be provided directly or through donations from public or private entities and may be in cash or in kind, fairly evaluated, including plant, equipment or services. Amounts provided by the Federal government, or services assisted or subsidized to any significant extent by the Federal government, may not be included in determining the amount of such non-Federal contributions.
(2) Maintaining State funding
(A) In general
An entity that receives an award under this section shall maintain expenditures for public health security at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period.
(B) Rule of construction
Nothing in this section shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by State, local, or tribal public health agencies who are carrying out activities supported by such awards (regardless of whether the primary assignment of such personnel is to carry out such activities).
(3) Determination of amount
(A) In general
The Secretary shall award cooperative agreements under subsection (a) to each State or consortium of 2 or more States that submits to the Secretary an application that meets the criteria of the Secretary for the receipt of such an award and that meets other implementation conditions established by the Secretary for such awards.
(B) Base amount
In determining the amount of an award pursuant to subparagraph (A) for a State, the Secretary shall first determine an amount the Secretary considers appropriate for the State (referred to in this paragraph as the "base amount"), except that such amount may not be greater than the minimum amount determined under subparagraph (D).
(C) Increase on basis of population
After determining the base amount for a State under subparagraph (B), the Secretary shall increase the base amount by an amount equal to the product of—
(i) the amount appropriated under paragraph (1)(A) for the fiscal year, less an amount equal to the sum of all base amounts determined for the States under subparagraph (B), and less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); and
(ii) subject to paragraph (4)(C), the percentage constituted by the ratio of an amount equal to the population of the State over an amount equal to the total population of the States (as indicated by the most recent data collected by the Bureau of the Census).
(D) Minimum amount
Subject to the amount appropriated under paragraph (1)(A), an award pursuant to subparagraph (A) for a State shall be the greater of the base amount as increased under subparagraph (C), or the minimum amount under this subparagraph. The minimum amount under this subparagraph is—
(i) in the case of each of the several States, the District of Columbia, and the Commonwealth of Puerto Rico, an amount equal to the lesser of—
(I) $5,000,000; or
(II) if the amount appropriated under paragraph (1)(A) is less than $667,000,000, an amount equal to 0.75 percent of the amount appropriated under such paragraph, less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); or
(ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Virgin Islands, an amount determined by the Secretary to be appropriate, except that such amount may not exceed the amount determined under clause (i).
(4) Certain political subdivisions
(A) In general
For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph (1) for the year an amount determined necessary by the Secretary to make awards under subsection (a) to political subdivisions that have a substantial number of residents, have a substantial local infrastructure for responding to public health emergencies, and face a high degree of risk from bioterrorist attacks or other public health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph.
(B) Coordination with Statewide plans
An award pursuant to subparagraph (A) may not be made unless the application of the political subdivision involved is in coordination with, and consistent with, applicable Statewide plans described in subsection (b).
(C) Relationship to formula grants
In the case of a State that will receive an award pursuant to paragraph (3), and in which there is located a political subdivision that will receive an award pursuant to subparagraph (A), the Secretary shall, in determining the amount under paragraph (3)(C) for the State, subtract from the population of the State an amount equal to the population of such political subdivision.
(D) Continuity of funding
In determining whether to make an award pursuant to subparagraph (A) to a political subdivision, the Secretary may consider, as a factor indicating that the award should be made, that the political subdivision received public health funding from the Secretary for fiscal year 2006.
(5) Significant unmet needs; degree of risk
(A) In general
For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph (1) for the year an amount determined necessary by the Secretary to make awards under subsection (a) to eligible entities that—
(i) have a significant need for funds to build capacity to identify, detect, monitor, and respond to a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to paragraph (3); and
(ii) face a particularly high degree of risk of such a threat.
(B) Recipients of grants
Awards pursuant to subparagraph (A) may be supplemental awards to States that receive awards pursuant to paragraph (3), or may be awards to eligible entities described in subsection (b)(1)(B) within such States.
(C) Finding with respect to District of Columbia
The Secretary shall consider the District of Columbia to have a significant unmet need for purposes of subparagraph (A), and to face a particularly high degree of risk for such purposes, on the basis of the concentration of entities of national significance located within the District.
(6) Funding of local entities
The Secretary shall, in making awards under this section, ensure that with respect to the cooperative agreement awarded, the entity make available appropriate portions of such award to political subdivisions and local departments of public health through a process involving the consensus, approval or concurrence with such local entities.
(7) Availability of cooperative agreement funds
(A) In general
Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.
(B) Funds contingent on achieving benchmarks
The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as described in subsection (g).
(i) Administrative and fiscal responsibility
(1) Annual reporting requirements
Each entity shall prepare and submit to the Secretary annual reports on its activities under this section and
(A) secure an accurate description of those activities;
(B) secure a complete record of the purposes for which funds were spent, and of the recipients of such funds;
(C) describe the extent to which the entity has met the goals and objectives it set forth under this section or
(D) determine the extent to which funds were expended consistent with the entity's application transmitted under this section or
(E) publish such information on a Federal Internet website consistent with subsection (j).
(2) Audits; implementation
(A) In general
Each entity receiving funds under this section or
(B) Repayment
Each entity shall repay to the United States amounts found by the Secretary, after notice and opportunity for a hearing to the entity, not to have been expended in accordance with this section or
(C) Withholding of payment
The Secretary may, after notice and opportunity for a hearing, withhold payment of funds to any entity which is not using its allotment under this section or
(j) Compilation and availability of data
The Secretary shall compile the data submitted under this section and make such data available in a timely manner on an appropriate Internet website in a format that is useful to the public and to other entities and that provides information on what activities are best contributing to the achievement of the outcome goals described in subsection (g).
(k) Evaluation
(1) In general
Not later than 2 years after June 24, 2019, and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection (g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy under
(2) Content
The evaluation under this paragraph shall include—
(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets;
(B) a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under
(C) a description of amounts received by eligible entities described in subsection (b) and
(D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and
(July 1, 1944, ch. 373, title III, §319C–1, as added
Editorial Notes
Codification
December 19, 2006, referred to in subsec. (g)(2)(B), was in the original "the date of enactment of this section", which was translated as meaning the date of enactment of
Amendments
2022—Subsec. (b)(2)(A)(vii).
Subsec. (b)(2)(A)(viii).
Subsec. (b)(2)(A)(xii), (xiii).
Subsec. (b)(2)(D) to (I).
2019—Subsec. (a).
Subsec. (b)(2)(A)(iv).
Subsec. (b)(2)(A)(vi).
Subsec. (b)(2)(A)(vii) to (x).
Subsec. (b)(2)(A)(xi), (xii).
Subsec. (b)(2)(C).
Subsec. (b)(2)(F).
Subsec. (e).
Subsec. (g)(5).
Subsec. (g)(5)(A).
Subsec. (g)(6)(A).
Subsec. (h)(1)(A).
Subsec. (k).
2015—Subsec. (b)(2)(A)(vii).
2013—Subsec. (b)(1)(B).
Subsec. (b)(1)(C).
Subsec. (b)(2)(A)(i), (ii).
"(i) a description of the activities such entity will carry out under the agreement to meet the goals identified under
"(ii) a pandemic influenza plan consistent with the requirements of paragraphs (2) and (5) of subsection (g);".
Subsec. (b)(2)(A)(vi) to (ix).
Subsec. (b)(2)(C).
Subsec. (b)(2)(D).
Subsec. (f)(2) to (4).
Subsec. (g)(1)(A).
Subsec. (g)(2)(A).
Subsec. (h).
Subsec. (h)(1)(A).
Subsec. (h)(1)(B) to (D).
Subsec. (h)(3)(C), (D).
Subsec. (h)(4)(B).
Subsec. (h)(7).
Subsec. (i).
Subsec. (i)(1)(E).
Subsec. (i)(3).
Subsecs. (j), (k).
2006—
Subsecs. (a) to (h).
Subsec. (i).
Subsec. (i)(1) to (3)(A).
Subsec. (i)(4)(A).
Subsec. (i)(4)(D).
Subsec. (i)(5)(A).
Subsec. (i)(6).
Subsec. (j).
Subsec. (k).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Effective Date of 2019 Amendment
Effective Date of 2015 Amendment
Amendment by
Emergency Medical and Public Health Communications Pilot Projects
"(1)
"(2)
"(3)
"(4)
"(5)
"(6)
1 So in original.
2 So in original. Probably should be followed by a semicolon.
3 See Codification note below.
§247d–3b. Partnerships for State and regional hospital preparedness to improve surge capacity
(a) In general
The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award competitive grants or cooperative agreements to eligible entities to enable such entities to improve surge capacity and enhance community and hospital preparedness for, and response to, public health emergencies in accordance with subsection (c), including, as appropriate, capacity and preparedness to address the needs of children and other at-risk individuals.
(b) Eligibility
To be eligible for an award under subsection (a), an entity shall—
(1)(A) be a coalition that includes—
(i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with
(ii) one or more other local health care facilities, including clinics, health centers, community health centers, primary care facilities, mental health centers, mobile medical assets, or nursing homes;
(iii)(I) one or more political subdivisions;
(II) one or more States; or
(III) one or more States and one or more political subdivisions; and
(iv) one or more emergency medical service organizations or emergency management organizations; and
(B) prepare, in consultation with the Chief Executive Officer and the lead health officials of the State, District, or territory in which the hospital and health care facilities described in subparagraph (A) are located, and submit to the Secretary, an application at such time, in such manner, and containing such information as the Secretary may require; or
(2)(A) be an entity described in
(B) submit an application at such time, in such manner, and containing such information as the Secretary may require, including the information or assurances required under
(c) Use of funds
An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of
(d) Preferences
(1) Regional coordination
In making awards under subsection (a), the Secretary shall give preference to eligible entities that submit applications that, in the determination of the Secretary—
(A) will enhance coordination—
(i) among the entities described in subsection (b)(1)(A)(i);
(ii) among one or more facilities in a regional health care emergency system under
(iii) between such entities and the entities described in subsection (b)(1)(A)(ii); and
(B) include, in the coalition described in subsection (b)(1)(A), a significant percentage of the hospitals and health care facilities within the geographic area served by such coalition.
(2) Other preferences
In making awards under subsection (a), the Secretary shall give preference to eligible entities that, in the determination of the Secretary—
(A) include one or more hospitals that are participants in the National Disaster Medical System;
(B) are located in a geographic area that faces a high degree of risk, as determined by the Secretary in consultation with the Secretary of Homeland Security; or
(C) have a significant need for funds to achieve the preparedness and response goals described in
(e) Consistency of planned activities
The Secretary may not award a cooperative agreement to an eligible entity described in subsection (b)(1) unless the application submitted by the entity is coordinated and consistent with an applicable State All-Hazards Public Health Emergency Preparedness and Response Plan and relevant local plans, as determined by the Secretary in consultation with relevant State health officials.
(f) Limitation on awards
A political subdivision shall not participate in more than one coalition described in subsection (b)(1).
(g) Coordination
(1) Local response capabilities
An eligible entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve Corps, the local Cities Readiness Initiative, and local emergency plans.
(2) National collaboration
Coalitions consisting of one or more eligible entities under this section may, to the extent practicable, collaborate with other coalitions consisting of one or more eligible entities under this section for purposes of national coordination and collaboration with respect to activities to achieve the preparedness and response goals described under paragraphs (1), (3), (4), (5), and (6) of
(h) Maintenance of funding
(1) In general
An entity that receives an award under this section shall maintain expenditures for health care preparedness at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period.
(2) Rule of construction
Nothing in this section shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by State, local, or tribal agencies who are carrying out activities supported by such awards (regardless of whether the primary assignment of such personnel is to carry out such activities).
(i) Performance and accountability
(1) In general
The requirements of section 247d–3a(g), (i), (j), and (k) of this title shall apply to entities receiving awards under this section (regardless of whether such entities are described under subsection (b)(1)(A) or (b)(2)(A)) in the same manner as such requirements apply to entities under
(2) Meeting goals of National Health Security Strategy
The Secretary shall implement objective, evidence-based metrics to ensure that entities receiving awards under this section are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy under
(j) Authorization of appropriations
(1) In general
(A) Authorization of appropriations
For purposes of carrying out this section and
(B) Reservation of amounts for regional systems
(i) In general
Subject to clause (ii), of the amount appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 5 percent for the purpose of carrying out
(ii) Reservation contingent on continued appropriations for this section
If for fiscal year 2019 or a subsequent fiscal year, the amount appropriated under subparagraph (A) is such that, after application of clause (i), the amount remaining for the purpose of carrying out this section would be less than the amount available for such purpose for the previous fiscal year, the amount that may be reserved under clause (i) shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year.
(iii) Sunset
The authority to reserve amounts under clause (i) shall expire on September 30, 2023.
(2) Reservation of amounts for partnerships
Prior to making awards described in paragraph (3), the Secretary may reserve from the amount appropriated under paragraph (1)(A) for a fiscal year and not reserved for the purpose described in paragraph (1)(B)(i), an amount determined appropriate by the Secretary for making awards to entities described in subsection (b)(1)(A).
(3) Awards to States and political subdivisions
(A) In general
From amounts appropriated for a fiscal year under paragraph (1)(A) and not reserved under paragraph (1)(B)(i) or (2), the Secretary shall make awards to entities described in subsection (b)(2)(A) that have completed an application as described in subsection (b)(2)(B).
(B) Amount
The Secretary shall determine the amount of an award to each entity described in subparagraph (A) in the same manner as such amounts are determined under
(4) Availability of cooperative agreement funds
(A) In general
Amounts provided to an eligible entity under a cooperative agreement under subsection (a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided.
(B) Funds contingent on achieving benchmarks
The continued availability of funds under subparagraph (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as required under subsection (i).
(July 1, 1944, ch. 373, title III, §319C–2, as added
Editorial Notes
Amendments
2019—Subsec. (a).
Subsec. (b)(1)(A).
Subsec. (b)(1)(A)(iv).
Subsec. (d)(1)(A)(ii), (iii).
Subsec. (d)(1)(B).
Subsec. (d)(2)(C).
Subsec. (f).
Subsec. (g)(2).
Subsec. (i)(1).
Subsec. (j)(1).
Subsec. (j)(2).
Subsec. (j)(3)(A).
2013—Subsec. (a).
Subsec. (b)(1)(A)(ii).
Subsec. (c).
Subsec. (g).
Subsec. (i).
Subsec. (j)(1).
Subsec. (j)(3)(B).
Subsec. (j)(4).
2007—Subsec. (j)(3)(B).
2006—
§247d–3c. Guidelines for regional health care emergency preparedness and response systems
(a) Purpose
It is the purpose of this section to identify and provide guidelines for regional systems of hospitals, health care facilities, and other public and private sector entities, with varying levels of capability to treat patients and increase medical surge capacity during, in advance of, and immediately following a public health emergency, including threats posed by one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases.
(b) Guidelines
The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Health Resources and Services Administration, the Commissioner of Food and Drugs, the Assistant Secretary for Mental Health and Substance Use, the Assistant Secretary of Labor for Occupational Safety and Health, the Secretary of Veterans Affairs, the heads of such other Federal agencies as the Secretary determines to be appropriate, and State, local, Tribal, and territorial public health officials, shall, not later than 2 years after June 24, 2019—
(1) identify and develop a set of guidelines relating to practices and protocols for all-hazards public health emergency preparedness and response for hospitals and health care facilities to provide appropriate patient care during, in advance of, or immediately following, a public health emergency, resulting from one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may include existing practices, such as trauma care and medical surge capacity and capabilities), with respect to—
(A) a regional approach to identifying hospitals and health care facilities based on varying capabilities and capacity to treat patients affected by such emergency, including—
(i) the manner in which the system will coordinate with and integrate the partnerships and health care coalitions established under
(ii) informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community;
(B) physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply chain needs, taking into account resiliency, geographic considerations, and rural considerations;
(C) protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health, psychological resilience, and training of the workforce, as applicable;
(D) in a manner that allows for disease containment (within the meaning of
(E) the needs of children and other at-risk individuals;
(2) make such guidelines available on the internet website of the Department of Health and Human Services in a manner that does not compromise national security; and
(3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (e) and information resulting from applicable reports required under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (including any amendments made by such Act), to address new and emerging public health threats.
(c) Considerations
In identifying, developing, and updating guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall—
(1) include input from hospitals and health care facilities (including health care coalitions under
(2) consult and engage with appropriate health care providers and professionals, including physicians, nurses, first responders, health care facilities (including hospitals, primary care clinics, community health centers, mental health facilities, ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers, environmental health agencies, public health laboratories, poison control centers, blood banks, tissue banks, and other experts that the Assistant Secretary determines appropriate, to meet the goals under
(3) consider feedback related to financial implications for hospitals, health care facilities, public health agencies, laboratories, blood banks, tissue banks, and other entities engaged in regional preparedness planning to implement and follow such guidelines, as applicable; and
(4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health emergencies as part of the regional health care emergency preparedness and response system.
(d) Technical assistance
The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention and the Assistant Secretary of Labor for Occupational Safety and Health, may provide technical assistance and consultation toward meeting the guidelines described in subsection (b).
(e) Demonstration project for regional health care preparedness and response systems
(1) In general
The Assistant Secretary for Preparedness and Response may establish a demonstration project pursuant to the development and implementation of guidelines under subsection (b) to award grants to improve medical surge capacity for all hazards, build and integrate regional medical response capabilities, improve specialty care expertise for all-hazards response, and coordinate medical preparedness and response across State, local, Tribal, territorial, and regional jurisdictions.
(2) Sunset
The authority under this subsection shall expire on September 30, 2023.
(July 1, 1944, ch. 373, title III, §319C–3, as added
Editorial Notes
References in Text
The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, referred to in subsec. (b)(3), is
§247d–4. Facilities and capacities of the Centers for Disease Control and Prevention
(a) In general
(1) Findings
Congress finds that the Centers for Disease Control and Prevention has an essential role in defending against and combatting public health threats domestically and abroad and requires secure and modern facilities, and expanded, improved, and appropriately maintained capabilities related to bioterrorism and other public health emergencies, sufficient to enable such Centers to conduct this important mission.
(2) Facilities
(A) In general
The Director of the Centers for Disease Control and Prevention may design, construct, and equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings, scientific communication facilities, transshipment complexes, secured and isolated parking structures, office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to better conduct the capacities described in
(B) Multiyear contracting authority
For any project of designing, constructing, equipping, or renovating any facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into a single contract or related contracts that collectively include the full scope of the project, and the solicitation and contract shall contain the clause "availability of funds" found at section 52.232–18 of title 48, Code of Federal Regulations.
(3) Improving the capacities of the Centers for Disease Control and Prevention
The Secretary shall expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Disease Control and Prevention relating to preparedness for and responding effectively to bioterrorism and other public health emergencies, by—
(A) expanding or enhancing the training of personnel;
(B) improving communications facilities and networks, including delivery of necessary information to rural areas;
(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b); and
(D) improving laboratory facilities related to bioterrorism, infectious disease outbreaks, and other public health emergencies, including increasing the security of such facilities.
(4) Study of resources for facilities and capacities
Not later than June 1, 2022, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under this subsection. Such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the construction, renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations and expenditures.
(b) Establishment of systems of public health communications and surveillance networks
(1) In general
The Secretary, directly or through awards of grants, contracts, or cooperative agreements, shall provide for the establishment of an integrated system or systems of public health alert communications and surveillance networks between and among—
(A) Federal, State, local, and Tribal public health officials; and
(B) public and private health-related laboratories, hospitals, poison control centers, immunization information systems, and other health care facilities; 1
(2) Requirements
The Secretary shall develop a plan to, and ensure that networks under paragraph (1) allow for the timely sharing and discussion, in a secure manner and in a form readily usable for analytical approaches, of essential, deidentified information concerning bioterrorism or another public health emergency, or recommended methods for responding to such an attack or emergency, allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort. The Secretary shall ensure that the activities carried out pursuant to the previous sentence are conducted in a manner that protects personal privacy, to the extent required by applicable Federal and State information privacy or security law, at a minimum.
(3) Standards
(A) In general
Not later than 1 year after June 24, 2019, the Secretary, in cooperation with health care providers, State, local, Tribal, and territorial public health officials, and relevant Federal agencies (including the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology), shall, as necessary, adopt technical and reporting standards, including standards for interoperability as defined by
(B) Deference to standards development organizations
In adopting and implementing standards under this subsection and subsection (c), the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards entities.
(c) Modernizing public health situational awareness and biosurveillance
(1) In general
The Secretary, in collaboration with State, local, and Tribal public health officials, shall establish, modernize, and improve as applicable and appropriate, a near real-time electronic nationwide public health situational awareness capability through an interoperable network of systems to share data and information that is deidentified, as applicable, to enhance early detection of, rapid response to, and management of, potentially catastrophic infectious disease outbreaks, novel emerging threats, and other public health emergencies that originate domestically or abroad. Such network shall be built on existing State situational awareness systems or enhanced systems that enable such interoperability, to the extent practicable. The Secretary shall ensure that the activities carried out pursuant to this paragraph are conducted in a manner that protects personal privacy, to the extent required by applicable Federal and State information privacy or security law, at a minimum.
(2) Coordination and consultation
In establishing and improving the network under paragraph (1), the Secretary shall—
(A) facilitate coordination among agencies within the Department of Health and Human Services that provide, or have the potential to provide, information and data to, and analyses for, the situational awareness and biosurveillance network under paragraph (1), including coordination among relevant agencies related to health care services, the facilitation of health information exchange (including the Office of the National Coordinator for Health Information Technology), and public health emergency preparedness and response; and
(B) consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National Institute of Standards and Technology), the Secretary of Defense, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.
(3) Elements
(A) In general
The network described in paragraph (1) shall include data and information transmitted in a standardized format from—
(i) State, local, and Tribal public health entities, including public health laboratories;
(ii) Federal health agencies;
(iii) zoonotic disease monitoring systems; and
(iv) public and private sector health care entities, hospitals, pharmacies, poison control centers or professional organizations in the field of poison control, immunization information systems, community health centers, health centers, clinical laboratories, and public environmental health agencies, to the extent practicable and provided that such data are voluntarily provided simultaneously to the Secretary and appropriate State, local, and Tribal public health agencies.
(B) Review
Not later than 2 years after June 24, 2019, and every 6 years thereafter, the Secretary shall conduct a review of the elements described in subparagraph (A). Such review shall include a discussion of the addition of any elements pursuant to clause (v), including elements added to advancing new technologies, and identify any challenges in the incorporation of elements under subparagraph (A), and make recommendations to improve the quality of data collected pursuant to subparagraph (A) to ensure complete, accurate, and timely sharing of such data, as appropriate, across such elements as described in subparagraph (A). The Secretary shall provide such review to the congressional committees of jurisdiction.
(4) Rule of construction
Paragraph (3) shall not be construed as requiring separate reporting of data and information from each source listed.
(5) Required activities
(A) In general
In establishing, operating, and updating, as appropriate, the network described in paragraph (1), the Secretary shall—
(i) utilize applicable interoperability standards as adopted by the Secretary, and in consultation with the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology, through a joint public and private sector process;
(ii) define minimal data elements for such network;
(iii) in collaboration with State, local, and Tribal public health officials, integrate and build upon existing State, local, and Tribal capabilities, ensuring simultaneous sharing of data, information, and analyses that is deidentified, as applicable, from the network described in paragraph (1) with State, local, and Tribal public health agencies in accordance with applicable Federal and State privacy and security law;
(iv) in collaboration with State, local, and Tribal public health officials, develop procedures and standards for the collection, analysis, and interpretation of data that States, regions, or other entities collect and report to the network described in paragraph (1);
(v) pilot test standards and implementation specifications, consistent with the process described in
(vi) in collaboration with State, local, and Tribal public health officials, integrate and update applicable existing public health data systems and networks of the Department of Health and Human Services to reflect technological advancements, consistent with
(B) Public meeting
(i) In general
Not later than 180 days after June 24, 2019, and 180 days after December 29, 2022, the Secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals, functions, and uses of the network described in paragraph (1) and incorporating the elements described in paragraph (3)(A).
(ii) Experts
The public meeting shall include representatives of relevant Federal agencies (including representatives from the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology); State, local, Tribal, and territorial public health officials; stakeholders with expertise in biosurveillance and situational awareness; stakeholders with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting); experts in State-based public health data systems; experts in standards and implementation specifications, including transaction standards; and experts in privacy and data security.
(iii) Topics
Such public meeting shall include a discussion of—
(I) data elements, including minimal or essential data elements, that are voluntarily provided for such network, which may include elements from public health and public and private health care entities, to the extent practicable;
(II) standards and implementation specifications that may improve the collection, analysis, and interpretation of data during a public health emergency;
(III) strategies to encourage the access, exchange, and use of information;
(IV) considerations for State, local, Tribal, and territorial capabilities and infrastructure related to data exchange and interoperability, including existing public health data systems;
(V) privacy and security protections provided at the Federal, State, local, Tribal, and territorial levels, and by nongovernmental stakeholders;
(VI) opportunities for the incorporation of innovative technologies to improve the network;
(VII) strategies to integrate laboratory and public health data systems and capabilities to support rapid and accurate reporting of laboratory test results and associated relevant data;
(VIII) strategies to improve the collection, reporting, and dissemination of relevant, aggregated, deidentified demographic data to inform responses to public health emergencies, including identification of at-risk populations and to address potential health disparities; and
(IX) strategies to improve the electronic exchange of health information, as appropriate, between State and local health departments and health care providers and facilities to improve the detection of, and responses to, potentially catastrophic infectious disease outbreaks.
(6) Strategy and implementation plan
(A) In general
Not later than 18 months after June 24, 2019, and every 5 years thereafter, the Secretary shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that—
(i) is informed by the public meeting under paragraph (5)(B);
(ii) includes a review and assessment of existing capabilities of the network and related infrastructure, including input provided by the public meeting under paragraph (5)(B);
(iii) identifies and demonstrates the measurable steps the Secretary will carry out to—
(I) develop, implement, and evaluate the network described in paragraph (1), utilizing elements described in paragraph (3)(A);
(II) modernize and enhance biosurveillance activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics and all-hazards) from public and private entities;
(III) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services, including the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies within and across agencies;
(IV) test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;
(V) improve coordination and collaboration, as appropriate, with other Federal departments to improve the capabilities of the network and reduce administrative burden on State, local, and Tribal entities; and
(VI) implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and biosurveillance capabilities;
(iv) includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause (iii);
(v) establishes dates by which each measurable step under clause (iii) will be implemented, including a description of how such steps will further the goals of the network, consistent with paragraph (1); and
(vi) identifies and demonstrates measurable steps the Secretary will take to further develop and integrate infectious disease detection, support rapid, accurate, and secure sharing of laboratory test results, deidentified as appropriate, during a public health emergency, and improve coordination and collaboration with State, local, and Tribal public health officials, clinical laboratories, and other entities with expertise in public health surveillance.
(B) Annual budget plan
Not later than 2 years after June 24, 2019, and on an annual basis thereafter, in accordance with the strategy and implementation plan under this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan under this section. Such budget plan shall include—
(i) a summary of resources previously expended to establish, improve, and utilize the nationwide public health situational awareness and biosurveillance network under paragraph (1);
(ii) estimates of costs and resources needed to establish and improve the network under paragraph (1) according to the strategy and implementation plan under subparagraph (A);
(iii) the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities, resources, and authorities needed to address such gaps; and
(iv) a strategy to minimize and address such gaps and improve inefficiencies.
(7) Consultation with the National Biodefense Science Board
In carrying out this section and consistent with
(A) identify the steps necessary to achieve a national biosurveillance system for human health (taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and environmental health), with international connectivity, where appropriate, that is predicated on State, regional, and community level capabilities and creates a networked system to allow for two-way information flow between and among Federal, State, and local government public health authorities and clinical health care providers;
(B) identify any duplicative surveillance programs and gaps in surveillance programs under the authority of the Secretary, or changes that are necessary to existing programs, in order to enhance and modernize such activities, minimize duplication, strengthen and streamline such activities under the authority of the Secretary, and achieve real-time and appropriate data that relate to disease activity, both human and zoonotic;
(C) coordinate with applicable existing advisory committees of the Director of the Centers for Disease Control and Prevention, including such advisory committees consisting of representatives from State, local, and Tribal public health authorities and appropriate public and private sector health care entities, animal health organizations related to zoonotic disease, and academic institutions, in order to provide guidance on public health surveillance activities; and
(D) provide recommendations to the Secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with
(8) Situational awareness and biosurveillance as a national security priority
The Secretary, on a periodic basis as applicable and appropriate, shall meet with the Director of National Intelligence to inform the development and capabilities of the nationwide public health situational awareness and biosurveillance network.
(9) Rules of construction
(A) Nothing in this subsection shall be construed to supplant, in whole or in part, State, local, or Tribal activities or responsibilities related to public health surveillance.
(B) Nothing in this subsection shall be construed to alter the authority of the Secretary with respect to the types of data the Secretary may receive through systems supported or established under this section.
(d) State and regional systems to enhance situational awareness in public health emergencies
(1) In general
To implement the network described in subsection (c), the Secretary may award grants to States or consortia of States to enhance the ability of such States or consortia of States to establish or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies, in collaboration with appropriate public health agencies, environmental health agencies, sentinel hospitals, clinical laboratories, pharmacies, poison control centers, immunization programs, other health care organizations, and animal health organizations within such States.
(2) Eligibility
To be eligible to receive a grant under paragraph (1), the State or consortium of States shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including an assurance that the State or consortium of States will submit to the Secretary—
(A) reports of such deidentified data, information, and metrics as the Secretary may require, in consultation with such State or consortium of States;
(B) a report on the effectiveness of the systems funded under the grant;
(C) a description of the manner in which grant funds will be used to enhance the timelines and comprehensiveness of efforts to detect, respond to, and manage potentially catastrophic infectious disease outbreaks and public health emergencies, including any public-private partnerships or other partnerships entered into to improve such capacity; and
(D) an implementation plan that may include measurable steps to achieve the purposes described in paragraph (1).
(3) Use of funds
A State or consortium of States that receives an award under this subsection—
(A) shall establish, enhance, or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies;
(B) may award grants or contracts to entities described in paragraph (1) within or serving such State to assist such entities in improving the operation of information technology systems, facilitating the secure exchange of data and information, and training personnel to enhance the operation of the system described in subparagraph (A); and
(C) may conduct a pilot program for the development of multi-State telehealth network test beds that build on, enhance, and securely link existing State and local telehealth programs to prepare for, monitor, respond to, and manage the events of public health emergencies, facilitate coordination and communication among medical, public health, and emergency response agencies, and provide medical services through telehealth initiatives within the States that are involved in such a multi-State telehealth network test bed.
(4) Limitation
Information technology systems acquired or implemented using grants awarded under this section must be compliant with—
(A) interoperability and other technological standards, as determined by the Secretary; and
(B) data collection and reporting requirements for the network described in subsection (c).
(5) Technical assistance
The Secretary may provide technical assistance to States, localities, Tribes, and territories or a consortium of States, localities, Tribes, and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the Secretary.
(6) Non-duplication of effort
The Secretary shall ensure that activities carried out under an award under this subsection do not unnecessarily duplicate efforts of other agencies and offices within the Department of Health and Human Services.
(e) Personnel authorities
(1) Specially qualified personnel
In addition to any other personnel authorities, to carry out subsections (b) and (c), the Secretary may—
(A) appoint highly qualified individuals to scientific or professional positions at the Centers for Disease Control and Prevention, not to exceed 30 such employees at any time (specific to positions authorized by this subsection), with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and
(B) compensate individuals appointed under subparagraph (A) in the same manner and subject to the same terms and conditions in which individuals appointed under 9903 2 of title 5 are compensated, without regard to the provisions of
(2) Limitations
The Secretary shall exercise the authority under paragraph (1) in a manner that is consistent with the limitations described in
(f) Timeline
The Secretary shall accomplish the purposes under subsections (b) and (c) no later than September 30, 2023, and shall provide a justification to the congressional committees of jurisdiction for any missed or delayed implementation of measurable steps identified under subsection (c)(6)(A)(iii).
(g) Independent evaluation
Not later than 3 years after June 24, 2019, the Comptroller General of the United States shall conduct an independent evaluation and submit to the Secretary and the congressional committees of jurisdiction a report concerning the activities conducted under subsections (b) and (c), and provide recommendations, as applicable and appropriate, on necessary improvements to the biosurveillance and situational awareness network.
(h) Authorization of appropriations
There are authorized to be appropriated—
(1) to carry out subsection (a), $25,000,000 for each of fiscal years 2022 and 2023; and
(2) to carry out subsections (b), (c), and (d), $136,800,000 for each of fiscal years 2022 and 2023.
(i) Definition
For purposes of this section the term "biosurveillance" means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.
(July 1, 1944, ch. 373, title III, §319D, as added
Editorial Notes
Amendments
2022—
Subsec. (a)(3).
Subsec. (a)(3)(D).
Subsec. (b)(1)(A).
Subsec. (b)(1)(C).
Subsec. (b)(2).
Subsec. (c)(1).
Subsec. (c)(3)(A)(v).
Subsec. (c)(3)(B).
Subsec. (c)(5)(A).
Subsec. (c)(5)(A)(iii).
Subsec. (c)(5)(A)(vi).
Subsec. (c)(5)(B)(i).
Subsec. (c)(5)(B)(ii).
Subsec. (c)(5)(B)(iii)(IV).
Subsec. (c)(5)(B)(iii)(VII) to (IX).
Subsec. (c)(6)(A).
Subsec. (c)(6)(A)(iii)(V), (VI).
Subsec. (c)(6)(A)(v).
Subsec. (c)(6)(A)(vi).
Subsec. (c)(9).
Subsec. (d)(2)(A).
Subsec. (d)(2)(C).
Subsec. (d)(6).
Subsecs. (e) to (g).
Subsec. (h).
Subsecs. (i), (j).
2019—
Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b).
Subsec. (b)(1)(B).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (c)(5)(A).
Subsec. (c)(5)(A)(i).
Subsec. (c)(5)(A)(v).
Subsec. (c)(5)(B).
Subsec. (c)(6).
Subsec. (c)(7).
Subsec. (c)(7)(A).
Subsec. (c)(7)(B).
Subsec. (c)(7)(C).
Subsec. (c)(7)(D).
Subsec. (c)(8).
Subsec. (d)(1).
Subsec. (d)(2)(D).
Subsec. (d)(5).
Subsecs. (f) to (h).
Subsec. (i).
Subsec. (j).
2013—Subsec. (b)(1)(B).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (c).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3)(D).
Subsec. (c)(5)(A).
Subsec. (c)(6).
Subsec. (d).
Subsec. (d)(1), (4)(B).
Subsec. (d)(5).
Subsec. (e).
Subsec. (f).
Subsec. (g).
2006—Subsec. (a)(1).
Subsec. (a)(3).
Subsecs. (d) to (g).
2002—
Statutory Notes and Related Subsidiaries
Working Capital Fund
Similar provisions were contained in the following prior appropriation act:
2 So in original. Probably should be preceded by "section".
§247d–4a. Infectious Diseases Rapid Response Reserve Fund
There is established in the Treasury a reserve fund to be known as the "Infectious Diseases Rapid Response Reserve Fund" (the "Reserve Fund"): Provided, That of the funds provided under the heading "CDC-Wide Activities and Program Support" [
(
Editorial Notes
References in Text
CDC and NIH, referred to in text, mean the Centers for Disease Control and Prevention and the National Institutes of Health, respectively.
The PHS Act, referred to in text, means the Public Health Service Act, act July 1, 1944, ch. 373,
Codification
Section was enacted as part of the Department of Health and Human Services Appropriations Act, 2019, and also as part of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019, and the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
2024—
Statutory Notes and Related Subsidiaries
Reports Required
§247d–4b. Children's Preparedness Unit
(a) Enhancing emergency preparedness for children
The Secretary, acting through the Director of the Centers for Disease Control and Prevention (referred to in this subsection as the "Director"), shall maintain an internal team of experts, to be known as the Children's Preparedness Unit (referred to in this subsection as the "Unit"), to work collaboratively to provide guidance on the considerations for, and the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the Director regarding emergency preparedness and response efforts pertaining to children at the Centers for Disease Control and Prevention.
(b) Expertise
The team described in subsection (a) shall include one or more pediatricians, which may be a developmental-behavioral pediatrician, and may also include behavioral scientists, child psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as the Secretary determines appropriate.
(c) Duties
The team described in subsection (a) may—
(1) assist State, local, Tribal, and territorial emergency planning and response activities related to children, which may include developing, identifying, and sharing best practices;
(2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public health officials to improve preparedness and response capabilities with respect to the needs of children, including providing such technical assistance, training, and consultation to eligible entities in order to support the achievement of measurable evidence-based benchmarks and objective standards applicable to
(3) improve the utilization of methods to incorporate the needs of children in planning for and responding to a public health emergency, including public awareness of such methods;
(4) coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to
(5) provide expertise and input during the development of guidance and clinical recommendations to address the needs of children when preparing for, and responding to, public health emergencies, including pursuant to
(6) carry out other duties related to preparedness and response activities for children, as the Secretary determines appropriate.
(July 1, 1944, ch. 373, title III, §319D–1, as added
§247d–5. Combating antimicrobial resistance
(a) Task force
(1) In general
The Secretary shall establish an Antimicrobial Resistance Task Force to provide advice and recommendations to the Secretary and coordinate Federal programs relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other organization in existence as of November 13, 2000, to serve as such a task force, if such committee, or other organization meets the requirements of this section.
(2) Members of task force
The task force described in paragraph (1) shall be composed of representatives from such Federal agencies, and shall seek input from public health constituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.
(3) Agenda
(A) In general
The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including—
(i) public health factors contributing to increasing antimicrobial resistance;
(ii) public health needs to detect and monitor antimicrobial resistance;
(iii) detection, prevention, and control strategies for resistant pathogens;
(iv) the need for improved information and data collection;
(v) the assessment of the risk imposed by pathogens presenting a threat to the public health; and
(vi) any other issues which the Secretary determines are relevant to antimicrobial resistance.
(B) Detection and control
The Secretary, in consultation with the task force described in paragraph (1) and State and local public health officials, shall—
(i) develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and
(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and exchange antimicrobial resistance data between public health departments.
(4) Meetings
The task force described under paragraph (1) shall convene not less than twice a year, or more frequently as the Secretary determines to be appropriate.
(b) Research and development of new antimicrobial drugs and diagnostics
The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established under subsection (a), shall directly or through awards of grants or cooperative agreements to public or private entities provide for the conduct of research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—
(1) the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;
(2) the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;
(3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
(4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy; and
(5) other relevant research areas.
(c) Education of medical and public health personnel
The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Resources and Services Administration, the Director of the Agency for Healthcare Research and Quality, members of the task force described in subsection (a), professional organizations and societies, and such other public health officials as may be necessary, shall—
(1) develop and implement educational programs to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics;
(2) develop and implement educational programs to instruct health care professionals in the prudent use of antibiotics; and
(3) develop and implement programs to train laboratory personnel in the recognition or identification of resistance in pathogens.
(d) Grants
(1) In general
The Secretary shall award competitive grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance.
(2) Eligible entities
Eligible entities for grants under paragraph (1) shall be State or local public health agencies, Indian tribes or tribal organizations, or other public or private nonprofit entities.
(3) Use of funds
An eligible entity receiving a grant under paragraph (1) shall use funds from such grant for activities that are consistent with the factors identified by the task force under subsection (a)(3), which may include activities that—
(A) provide training to enable such entity to identify patterns of resistance rapidly and accurately;
(B) develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, State, and local health agencies and health care providers; and
(C) develop and implement policies to control the spread of antimicrobial resistance.
(e) Grants for demonstration programs
(1) In general
The Secretary shall award competitive grants to eligible entities to establish demonstration programs to promote judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens.
(2) Eligible entities
Eligible entities for grants under paragraph (1) may include hospitals, clinics, institutions of long-term care, professional medical societies, schools or programs that train medical laboratory personnel, or other public or private nonprofit entities.
(3) Technical assistance
The Secretary shall provide appropriate technical assistance to eligible entities that receive grants under paragraph (1).
(f) Monitoring at Federal health care facilities
The Secretary shall encourage reporting on aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and the implementation of antimicrobial stewardship programs by health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service and shall provide technical assistance to the Secretary of Defense and the Secretary of Veterans Affairs, as appropriate and upon request.
(g) Report on antimicrobial resistance in humans and use of antimicrobial drugs
Not later than 1 year after December 13, 2016, and annually thereafter, the Secretary shall prepare and make publicly available data and information concerning—
(1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under
(2) antimicrobial stewardship, which may include summaries of State efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship; and
(3) coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs with respect to the monitoring of—
(A) any applicable resistance under paragraph (1); and
(B) drugs approved under
(h) Information related to antimicrobial stewardship programs
The Secretary shall, as appropriate, disseminate guidance, educational materials, or other appropriate materials related to the development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities, such as nursing homes and other long-term care facilities, ambulatory surgical centers, dialysis centers, outpatient clinics, and hospitals, including community and rural hospitals.
(i) Supporting State-based activities to combat antimicrobial resistance
The Secretary shall continue to work with State and local public health departments on statewide or regional programs related to antimicrobial resistance. Such efforts may include activities to related to—
(1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs;
(2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and
(3) promoting antimicrobial stewardship.
(j) Antimicrobial resistance and stewardship activities
(1) In general
For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of
(A) provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and
(B) evaluate—
(i) antimicrobial resistance data using a standardized approach; and
(ii) trends in the utilization of drugs approved under such
(2) Use of systems
The Secretary shall use available systems, including the National Healthcare Safety Network or other systems identified by the Secretary, to fulfill the requirements or conduct activities under this section.
(k) Network of antibiotic resistance regional laboratories
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as appropriate, maintain a network of antibiotic resistance laboratory sites to ensure the maintenance of appropriate capabilities, within existing laboratory capacity maintained or supported by the Centers for Disease Control and Prevention, to—
(A) identify and monitor the emergence and changes in the patterns of antimicrobial-resistant pathogens;
(B) detect, identify, confirm, and isolate such resistant pathogens, including, as appropriate, performing such activities upon the request of another laboratory and providing related technical assistance, and, as applicable, support efforts to respond to local or regional outbreaks of such resistant pathogens; and
(C) perform activities to support the diagnosis of such resistant pathogens and determine the susceptibility of relevant pathogen samples to applicable treatments.
(2) Geographic distribution
The Secretary shall ensure that such capacity and capabilities are appropriately distributed among the geographical regions of the United States.
(3) Partnerships and nonduplication of current domestic capacity
Activities supported under this subsection may be based in an academic center, a State health department, or other facility operated by a public or private entity that carries out relevant laboratory or public health surveillance activities.
(l) International collaboration
(1) In general
The Secretary, in coordination with heads of other relevant Federal departments and agencies, shall support activities related to addressing antimicrobial resistance internationally, including by—
(A) supporting basic, translational, epidemiological, and clinical research related to antimicrobial-resistant pathogens, including such pathogens that have not yet been detected in the United States, and improving related public health surveillance systems, and laboratory and other response capacity; and
(B) providing technical assistance related to antimicrobial resistant infection and control activities.
(2) Awards
In carrying out paragraph (1), the Secretary may award grants, contracts, or cooperative agreements to public and private entities, including nongovernmental organizations, with applicable expertise, for purposes of supporting new and innovative approaches to the prevention, detection, and mitigation of antimicrobial-resistant pathogens.
(m) Antimicrobial
For purposes of subsections (f) through (j), the term "antimicrobial" includes any antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other microorganisms, as appropriate.
(n) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities under this section.
(o) Authorization of appropriations
There are authorized to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006.
(July 1, 1944, ch. 373, title III, §319E, as added
Editorial Notes
Amendments
2022—Subsecs. (k) to (o).
2016—Subsecs. (f) to (m).
2002—Subsec. (b).
Subsec. (b)(4).
Subsec. (e)(2).
Subsec. (g).
Statutory Notes and Related Subsidiaries
Construction of 2016 Amendment
Nothing in amendment by
Additional Strategies for Combating Antibiotic Resistance
"(a)
"(b)
"(1) the effectiveness of antibiotics;
"(2) research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities;
"(3) surveillance of antibiotic-resistant bacterial infections, including publicly available and up-to-date information on resistance to antibiotics;
"(4) education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals;
"(5) methods to prevent or reduce the transmission of antibiotic-resistant bacterial infections, including stewardship programs; and
"(6) coordination with respect to international efforts in order to inform and advance United States capabilities to combat antibiotic resistance.
"(c)
"(1)
"(2)
"(d)
"(e)
Availability of Data
Executive Documents
Ex. Ord. No. 13676. Combating Antibiotic-Resistant Bacteria
Ex. Ord. No. 13676, Sept. 18, 2014, 79 F.R. 56931, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, I hereby order as follows:
Detecting, preventing, and controlling antibiotic resistance requires a strategic, coordinated, and sustained effort. It also depends on the engagement of governments, academia, industry, healthcare providers, the general public, and the agricultural community, as well as international partners. Success in this effort will require significant efforts to: minimize the emergence of antibiotic-resistant bacteria; preserve the efficacy of new and existing antibacterial drugs; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance efforts in public health and agriculture; develop and promote the use of new, rapid diagnostic technologies; accelerate scientific research and facilitate the development of new antibacterial drugs, vaccines, diagnostics, and other novel therapeutics; maximize the dissemination of the most up-to-date information on the appropriate and proper use of antibiotics to the general public and healthcare providers; work with the pharmaceutical industry to include information on the proper use of over-the-counter and prescription antibiotic medications for humans and animals; and improve international collaboration and capabilities for prevention, surveillance, stewardship, basic research, and drug and diagnostics development.
The Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.
(a) Membership. In addition to the Co-Chairs, the Task Force shall consist of representatives from:
(i) the Department of State;
(ii) the Department of Justice;
(iii) the Department of Veterans Affairs;
(iv) the Department of Homeland Security;
(v) the Environmental Protection Agency;
(vi) the United States Agency for International Development;
(vii) the Office of Management and Budget;
(viii) the Domestic Policy Council;
(ix) the National Security Council staff;
(x) the Office of Science and Technology Policy;
(xi) the National Science Foundation; and
(xii) such executive departments, agencies, or offices as the Co-Chairs may designate.
Each executive department, agency, or office represented on the Task Force (Task Force agency) shall designate an employee of the Federal Government to perform the functions of the Task Force. In performing its functions, the Task Force may make use of existing interagency task forces on antibiotic resistance.
(b) Mission. The Task Force shall identify actions that will provide for the facilitation and monitoring of implementation of this order and the National Strategy for Combating Antibiotic-Resistant Bacteria (Strategy).
(c) Functions.
(i) By February 15, 2015, the Task Force shall submit a 5-year National Action Plan (Action Plan) to the President that outlines specific actions to be taken to implement the Strategy. The Action Plan shall include goals, milestones, and metrics for measuring progress, as well as associated timelines for implementation. The Action Plan shall address recommendations made by the President's Council of Advisors on Science and Technology regarding combating antibiotic resistance.
(ii) Within 180 days of the release of the Action Plan and each year thereafter, the Task Force shall provide the President with an update on Federal Government actions to combat antibiotic resistance consistent with this order, including progress made in implementing the Strategy and Action Plan, plans for addressing any barriers preventing full implementation of the Strategy and Action Plan, and recommendations for new or modified actions. Annual updates shall include specific goals, milestones, and metrics for all proposed actions and recommendations. The Task Force shall take Federal Government resources into consideration when developing these proposed actions and recommendations.
(iii) In performing its functions, the Task Force shall review relevant statutes, regulations, policies, and programs, and shall consult with relevant domestic and international organizations and experts, as necessary.
(iv) The Task Force shall conduct an assessment of progress made towards achieving the milestones and goals outlined in the Strategy in conjunction with the Advisory Council established pursuant to section 4 of this order.
(b) The Secretary shall designate a chairperson from among the members of the Advisory Council.
(c) The Advisory Council shall provide advice, information, and recommendations to the Secretary regarding programs and policies intended to: preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance. The Secretary shall provide the President with all written reports created by the Advisory Council.
(d) Task Force agencies shall, to the extent permitted by law, provide the Advisory Council with such information as it may require for purposes of carrying out its functions.
(e) To the extent permitted by law, and subject to the availability of appropriations, HHS shall provide the Advisory Council with such funds and support as may be necessary for the performance of its functions.
(b) Task Force agencies shall, as appropriate, define, promulgate, and implement stewardship programs in other healthcare settings, including office-based practices, outpatient settings, emergency departments, and institutional and long-term care facilities such as nursing homes, pharmacies, and correctional facilities.
(c) By the end of calendar year 2016, the Department of Defense (DoD) and the Department of Veterans Affairs (VA) shall review their existing regulations and, as appropriate, propose new regulations and other actions that require their hospitals and long-term care facilities to implement robust antibiotic stewardship programs that adhere to best practices, such as those defined by the CDC. DoD and the VA shall also take steps to encourage their other healthcare facilities, such as ambulatory surgery centers and outpatient clinics, to adopt antibiotic stewardship programs.
(d) Task Force agencies shall, as appropriate, monitor improvements in antibiotic use through the National Healthcare Safety Network and other systems.
(e) The Food and Drug Administration (FDA) in HHS, in coordination with the Department of Agriculture (USDA), shall continue taking steps to eliminate the use of medically important classes of antibiotics for growth promotion purposes in food-producing animals.
(f) USDA, the Environmental Protection Agency (EPA), and FDA shall strengthen coordination in common program areas, such as surveillance of antibiotic use and resistance patterns in food-producing animals, inter-species disease transmissibility, and research findings.
(g) DoD, HHS, and the VA shall review existing regulations and propose new regulations and other actions, as appropriate, to standardize the collection and sharing of antibiotic resistance data across all their healthcare settings.
(b) Task Force agencies shall, as appropriate, link data from Federal Government sample isolate repositories for bacteria strains to an integrated surveillance system, and, where feasible, the repositories shall enhance their sample collections and further interoperable data systems with national surveillance efforts.
(c) USDA, EPA, and FDA shall work together with stakeholders to monitor and report on changes in antibiotic use in agriculture and their impact on the environment.
(d) Task Force agencies shall, as appropriate, monitor antibiotic resistance in healthcare settings through the National Healthcare Safety Network and related systems.
(b) Task Force agencies shall take steps to implement the measures and achieve the milestones outlined in the Strategy and Action Plan.
(c) DoD, HHS, and the VA shall review and, as appropriate, update their hospital and long-term care infectious disease protocols for identifying, isolating, and treating antibiotic-resistant bacterial infection cases.
(b) Together with the countermeasures it develops for biodefense threats, the Biomedical Advanced Research Development Authority in HHS shall develop new and next-generation countermeasures that target antibiotic-resistant bacteria that present a serious or urgent threat to public health.
(c) The Public Health Emergency Medical Countermeasures Enterprise in HHS shall, as appropriate, coordinate with Task Force agencies' efforts to promote new and next-generation countermeasures to target antibiotic-resistant bacteria that present a serious or urgent threat to public health.
(b) Nothing in this order shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(d) Insofar as the Federal Advisory Committee Act, as amended ([former] 5 U.S.C. App.) [see
Barack Obama.
Extension of Term of Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Term of Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria extended until Sept. 30, 2019, by Ex. Ord. No. 13811, Sept. 29, 2017, 82 F.R. 46363, formerly set out as a note under
Previous extension of term of Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria was contained in the following prior Executive Order:
Ex. Ord. No. 13708, Sept. 30, 2015, 80 F.R. 60271, extended term until Sept. 30, 2017.
Delegation of Authority to Re-Establish the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Memorandum of President of the United States, Mar. 3, 2020, 85 F.R. 13469, provided:
Memorandum for the Secretary of Health and Human Services
By the authority vested in me as President by the Constitution and the laws of the United States of America, including
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(d) You are hereby authorized and directed to publish this memorandum in the Federal Register.
Donald J. Trump.
§247d–5a. Repealed. Pub. L. 114–255, div. A, title III, §3044(b)(1), Dec. 13, 2016, 130 Stat. 1121
Section,
§247d–6. Public health countermeasures to a bioterrorist attack
(a) All-hazards public health and medical response curricula and training
(1) In general
The Secretary, in collaboration with the Secretary of Defense, and in consultation with relevant public and private entities, shall develop core health and medical response curricula and trainings by adapting applicable existing curricula and training programs to improve responses to public health emergencies.
(2) Curriculum
The public health and medical response training program may include course work related to—
(A) medical management of casualties, taking into account the needs of at-risk individuals;
(B) public health aspects of public health emergencies;
(C) mental health aspects of public health emergencies;
(D) national incident management, including coordination among Federal, State, local, tribal, international agencies, and other entities; and
(E) protecting health care workers and health care first responders from workplace exposures during a public health emergency.
(3) Peer review
On a periodic basis, products prepared as part of the program shall be rigorously tested and peer-reviewed by experts in the relevant fields.
(4) Credit
The Secretary and the Secretary of Defense shall—
(A) take into account continuing professional education requirements of public health and healthcare professions; and
(B) cooperate with State, local, and tribal accrediting agencies and with professional associations in arranging for students enrolled in the program to obtain continuing professional education credit for program courses.
(5) Dissemination and training
(A) In general
The Secretary may provide for the dissemination and teaching of the materials described in paragraphs (1) and (2) by appropriate means, as determined by the Secretary.
(B) Certain entities
The education and training activities described in subparagraph (A) may be carried out by Federal public health, medical, or dental entities, appropriate educational entities, professional organizations and societies, private accrediting organizations, and other nonprofit institutions or entities meeting criteria established by the Secretary.
(C) Grants and contracts
In carrying out this subsection, the Secretary may carry out activities directly or through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies.
(b) Advice to the Federal Government
(1) Required advisory committees
In coordination with the working group under subsection (a), the Secretary shall establish advisory committees in accordance with paragraphs (2) and (3) to provide expert recommendations to assist such working groups in carrying out their respective responsibilities under subsections (a) and (b).
(2) National Advisory Committee on At-Risk Individuals and Public Health Emergencies
(A) In general
For purposes of paragraph (1), the Secretary shall establish an advisory committee to be known as the National Advisory Committee on At-Risk Individuals and Public Health Emergencies (referred to in this paragraph as the "Advisory Committee").
(B) Duties
The Advisory Committee shall provide recommendations regarding—
(i) the preparedness of the health care (including mental health care) system to respond to public health emergencies as they relate to at-risk individuals;
(ii) needed changes to the health care and emergency medical service systems and emergency medical services protocols to meet the special needs of at-risk individuals; and
(iii) changes, if necessary, to the national stockpile under
(C) Composition
The Advisory Committee shall be composed of such Federal officials as may be appropriate to address the special needs of the diverse population groups of at-risk populations.
(D) Termination
The Advisory Committee terminates six years after June 12, 2002.
(3) Emergency Public Information and Communications Advisory Committee
(A) In general
For purposes of paragraph (1), the Secretary shall establish an advisory committee to be known as the Emergency Public Information and Communications Advisory Committee (referred to in this paragraph as the "EPIC Advisory Committee").
(B) Duties
The EPIC Advisory Committee shall make recommendations to the Secretary and report on appropriate ways to communicate public health information regarding bioterrorism and other public health emergencies to the public.
(C) Composition
The EPIC Advisory Committee shall be composed of individuals representing a diverse group of experts in public health, medicine, communications, behavioral psychology, and other areas determined appropriate by the Secretary.
(D) Dissemination
The Secretary shall review the recommendations of the EPIC Advisory Committee and ensure that appropriate information is disseminated to the public.
(E) Termination
The EPIC Advisory Committee terminates one year after June 12, 2002.
(c) Expansion of Epidemic Intelligence Service Program
The Secretary may establish 20 officer positions in the Epidemic Intelligence Service Program, in addition to the number of the officer positions offered under such Program in 2006, for individuals who agree to participate, for a period of not less than 2 years, in the Career Epidemiology Field Officer program in a State, local, or tribal health department that serves a health professional shortage area (as defined under
(d) Centers for Public Health Preparedness and Response
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants, contracts, or cooperative agreements to institutions of higher education, including accredited schools of public health, or other nonprofit private entities to establish or maintain a network of Centers for Public Health Preparedness and Response (referred to in this subsection as "Centers").
(2) Eligibility
To be eligible to receive an award under this subsection, an entity shall submit to the Secretary an application containing such information as the Secretary may require, including a description of how the entity will—
(A) coordinate relevant activities with applicable State, local, and Tribal health departments and officials, health care facilities, and health care coalitions to improve public health preparedness and response, as informed by the public health preparedness and response needs of the community, or communities, involved;
(B) prioritize efforts to implement evidence-informed or evidence-based practices to improve public health preparedness and response, including by helping to reduce the transmission of emerging infectious diseases; and
(C) use funds awarded under this subsection, including by carrying out any activities described in paragraph (3).
(3) Use of funds
The Centers established or maintained under this subsection shall use funds awarded under this subsection to carry out activities to advance public health preparedness and response capabilities, which may include—
(A) identifying, translating, and disseminating promising research findings or strategies into evidence-informed or evidence-based practices to inform preparedness for, and responses to, chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and other public health emergencies, which may include conducting research related to public health preparedness and response systems;
(B) improving awareness of such evidence-informed or evidence-based practices and other relevant scientific or public health information among health care professionals, public health professionals, other stakeholders, and the public, including through the development, evaluation, and dissemination of trainings and training materials, consistent with
(C) utilizing and expanding relevant technological and analytical capabilities to inform public health and medical preparedness and response efforts;
(D) expanding activities, including through public-private partnerships, related to public health preparedness and response, including participation in drills and exercises and training public health experts, as appropriate; and
(E) providing technical assistance and expertise that relies on evidence-based practices, as applicable, related to responses to public health emergencies, as appropriate, to State, local, and Tribal health departments and other entities pursuant to paragraph (2)(A).
(4) Distribution of awards
In awarding grants, contracts, or cooperative agreements under this subsection, the Secretary shall support not fewer than 10 Centers, subject to the availability of appropriations, and ensure that such awards are equitably distributed among the geographical regions of the United States.
(e) Accelerated research and development on priority pathogens and countermeasures
(1) In general
With respect to pathogens of potential use in a bioterrorist attack, and other agents that may cause a public health emergency, the Secretary, taking into consideration any recommendations of the working group under subsection (a), shall conduct, and award grants, contracts, or cooperative agreements for, research, investigations, experiments, demonstrations, and studies in the health sciences relating to—
(A) the epidemiology and pathogenesis of such pathogens;
(B) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the working group established in subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy;
(C) the development of priority countermeasures; and
(D) other relevant areas of research;
with consideration given to the needs of children and other vulnerable populations.
(2) Priority
The Secretary shall give priority under this section to the funding of research and other studies related to priority countermeasures.
(3) Role of Department of Veterans Affairs
In carrying out paragraph (1), the Secretary shall consider using the biomedical research and development capabilities of the Department of Veterans Affairs, in conjunction with that Department's affiliations with health-professions universities. When advantageous to the Government in furtherance of the purposes of such paragraph, the Secretary may enter into cooperative agreements with the Secretary of Veterans Affairs to achieve such purposes.
(4) Priority countermeasures
For purposes of this section, the term "priority countermeasure" means a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the Secretary determines to be—
(A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to
(B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences or death and may be caused by the administering of a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under subparagraph (A).
(f) Authorization of appropriations
(1) Fiscal year 2007
There are authorized to be appropriated to carry out this section for fiscal year 2007—
(A) to carry out subsection (a)—
(i) $5,000,000 to carry out paragraphs (1) through (4); and
(ii) $7,000,000 to carry out paragraph (5);
(B) to carry out subsection (c), $3,000,000; and
(C) to carry out subsection (d), $31,000,000.
(2) Subsequent fiscal years
There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal year 2008 and each subsequent fiscal year.
(July 1, 1944, ch. 373, title III, §319F, as added
Editorial Notes
Amendments
2022—Subsec. (d).
Subsec. (f)(1)(C).
2013—Subsec. (a)(5)(B).
2006—Subsec. (a).
Subsec. (b)(2).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B)(i).
Subsec. (b)(2)(B)(ii), (iii).
Subsec. (b)(2)(C).
Subsec. (b)(2)(D).
Subsec. (b)(3)(B).
Subsecs. (c) to (h).
Subsecs. (i), (j).
2004—Subsec. (a)(1).
Subsec. (h)(4)(B).
2002—Subsec. (a).
"(1) coordinate research on pathogens likely to be used in a bioterrorist attack on the civilian population as well as therapies to treat such pathogens;
"(2) coordinate research and development into equipment to detect pathogens likely to be used in a bioterrorist attack on the civilian population and protect against infection from such pathogens;
"(3) develop shared standards for equipment to detect and to protect against infection from pathogens likely to be used in a bioterrorist attack on the civilian population; and
"(4) coordinate the development, maintenance, and procedures for the release of, strategic reserves of vaccines, drugs, and medical supplies which may be needed rapidly after a bioterrorist attack upon the civilian population."
Subsec. (b).
Subsecs. (c), (d).
Subsec. (e).
Subsec. (e)(2).
Subsec. (f).
Subsec. (g).
"(1) develop and implement educational programs to instruct public health officials, medical professionals, and other personnel working in health care facilities in the recognition and care of victims of a bioterrorist attack; and
"(2) develop and implement programs to train laboratory personnel in the recognition and identification of a potential bioweapon."
Subsec. (h).
"(1) the epidemiology and pathogenesis of potential bioweapons;
"(2) the development of new vaccines or other therapeutics against pathogens likely to be used in a bioterrorist attack;
"(3) the development of medical diagnostics to detect potential bioweapons; and
"(4) other relevant research areas."
Subsec. (i).
Subsec. (j).
Statutory Notes and Related Subsidiaries
Other Reports
"(1)
"(A) the recommendations and findings of the National Advisory Committee on Children and Terrorism under section 319F(c)(2) of the Public Health Service Act [probably means section 319F(b)(2),
"(B) the recommendations and findings of the EPIC Advisory Committee under section 319F(c)(3) of such Act [probably means section 319F(b)(3),
"(C) the characteristics that may render a rural community uniquely vulnerable to a biological attack, including distance, lack of emergency transport, hospital or laboratory capacity, lack of integration of Federal or State public health networks, workforce deficits, or other relevant characteristics;
"(D) the characteristics that may render areas or populations designated as medically underserved populations (as defined in section 330 of such Act [
"(E) the recommendations of the Secretary with respect to additional legislative authority that the Secretary determines is necessary to effectively strengthen rural communities, or medically underserved populations (as defined in section 330 of such Act); and
"(F) the need for and benefits of a National Disaster Response Medical Volunteer Service that would be a private-sector, community-based rapid response corps of medical volunteers."
Study Regarding Communications Abilities of Public Health Agencies
§247d–6a. Authority for use of certain procedures regarding qualified countermeasure research and development activities
(a) In general
(1) Authority
In conducting and supporting research and development activities regarding countermeasures under
(2) Definitions
In this section:
(A) Qualified countermeasure
The term "qualified countermeasure" means a drug (as that term is defined by
(i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;
(ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or
(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).
(B) Infectious disease
The term "infectious disease" means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person.
(3) Interagency cooperation
(A) In general
In carrying out activities under this section, the Secretary is authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government.
(B) Limitation
An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section.
(4) Availability of facilities to the Secretary
In any grant, contract, or cooperative agreement entered into under the authority provided in this section with respect to a biocontainment laboratory or other related or ancillary specialized research facility that the Secretary determines necessary for the purpose of performing, administering, or supporting qualified countermeasure research and development, the Secretary may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be available as needed to the Secretary to respond to public health emergencies affecting national security.
(5) Transfers of qualified countermeasures
Each agreement for an award of a grant, contract, or cooperative agreement under
(b) Expedited procurement authority
(1) Increased simplified acquisition threshold for qualified countermeasure procurements
(A) In general
For any procurement by the Secretary of property or services for use (as determined by the Secretary) in performing, administering, or supporting qualified countermeasure research or development activities under this section that the Secretary determines necessary to respond to pressing research and development needs under this section, the amount specified in
(i)
(ii)
(B) Application of certain provisions
Notwithstanding subparagraph (A) and the provision of law and regulations referred to in such subparagraph, each of the following provisions shall apply to procurements described in this paragraph to the same extent that such provisions would apply to such procurements in the absence of subparagraph (A):
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(C) Internal controls to be instituted
The Secretary shall institute appropriate internal controls for procurements that are under this paragraph, including requirements with regard to documenting the justification for use of the authority in this paragraph with respect to the procurement involved.
(D) Authority to limit competition
In conducting a procurement under this paragraph, the Secretary may not use the authority provided for under subparagraph (A) to conduct a procurement on a basis other than full and open competition unless the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.
(2) Procedures other than full and open competition
(A) In general
In using the authority provided in
(B) Relation to other authorities
The authority under subparagraph (A) is in addition to any other authority to use procedures other than competitive procedures.
(C) Applicable government-wide regulations
The Secretary shall implement this paragraph in accordance with government-wide regulations implementing such section 3304(a)(1) (including requirements that offers be solicited from as many potential sources as is practicable under the circumstances, that required notices be published, and that submitted offers be considered), as such regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency.
(3) Increased micropurchase threshold
(A) In general
For a procurement described by paragraph (1), the amount specified in subsections (a), (d), and (e) of
(B) Internal controls to be instituted
The Secretary shall institute appropriate internal controls for purchases that are under this paragraph and that are greater than $2,500.
(C) Exception to preference for purchase card mechanism
No provision of law establishing a preference for using a Government purchase card method for purchases shall apply to purchases that are under this paragraph and that are greater than $2,500.
(4) Review
(A) Review allowed
Notwithstanding subsection (f),
(i) with a contracting agency; or
(ii) with the Comptroller General under subchapter V of
(B) Override of stay of contract award or performance committed to agency discretion
Notwithstanding
(i) An authorization under
(ii) An authorization under section 3553(d)(3)(C) of such title to perform a contract for a procurement described in paragraph (1) of this subsection.
(c) Authority to expedite peer review
(1) In general
The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of qualified countermeasure research, in place of the peer review and advisory council review procedures that would be required under
(A) that is for performing, administering, or supporting qualified countermeasure research and development activities; and
(B) the amount of which is not greater than $1,500,000.
(2) Subsequent phases of research
The Secretary's determination of whether to employ expedited peer review with respect to any subsequent phases of a research grant, contract, or cooperative agreement under this section shall be determined without regard to the peer review procedures used for any prior peer review of that same grant, contract, or cooperative agreement. Nothing in the preceding sentence may be construed to impose any requirement with respect to peer review not otherwise required under any other law or regulation.
(d) Authority for personal services contracts
(1) In general
For the purpose of performing, administering, or supporting qualified countermeasure research and development activities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, obtain by contract (in accordance with
(2) Federal Tort Claims Act coverage
(A) In general
A person carrying out a contract under paragraph (1), and an officer, employee, or governing board member of such person, shall, subject to a determination by the Secretary, be deemed to be an employee of the Department of Health and Human Services for purposes of claims under
(B) Exclusivity of remedy
The remedy provided by subparagraph (A) shall be exclusive of any other civil action or proceeding by reason of the same subject matter against the entity involved (person, officer, employee, or governing board member) for any act or omission within the scope of the Federal Tort Claims Act.
(C) Recourse in case of gross misconduct or contract violation
(i) In general
Should payment be made by the United States to any claimant bringing a claim under this paragraph, either by way of administrative determination, settlement, or court judgment, the United States shall have, notwithstanding any provision of State law, the right to recover against any entity identified in subparagraph (B) for that portion of the damages so awarded or paid, as well as interest and any costs of litigation, resulting from the failure of any such entity to carry out any obligation or responsibility assumed by such entity under a contract with the United States or from any grossly negligent or reckless conduct or intentional or willful misconduct on the part of such entity.
(ii) Venue
The United States may maintain an action under this subparagraph against such entity in the district court of the United States in which such entity resides or has its principal place of business.
(3) Internal controls to be instituted
(A) In general
The Secretary shall institute appropriate internal controls for contracts under this subsection, including procedures for the Secretary to make a determination of whether a person, or an officer, employee, or governing board member of a person, is deemed to be an employee of the Department of Health and Human Services pursuant to paragraph (2).
(B) Determination of employee status to be final
A determination by the Secretary under subparagraph (A) that a person, or an officer, employee, or governing board member of a person, is or is not deemed to be an employee of the Department of Health and Human Services shall be final and binding on the Secretary and the Attorney General and other parties to any civil action or proceeding.
(4) Number of personal services contracts limited
The number of experts and consultants whose personal services are obtained under paragraph (1) shall not exceed 30 at any time.
(e) Streamlined personnel authority
(1) In general
In addition to any other personnel authorities, the Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, without regard to those provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of
(2) Limitations
The authority provided for under paragraph (1) shall be exercised in a manner that—
(A) recruits and appoints individuals based solely on their abilities, knowledge, and skills;
(B) does not discriminate for or against any applicant for employment on any basis described in
(C) does not allow an official to appoint an individual who is a relative (as defined in section 3110(a)(3) of such title) of such official;
(D) does not discriminate for or against an individual because of the exercise of any activity described in paragraph (9) or (10) of section 2302(b) of such title; and
(E) accords a preference, among equally qualified persons, to persons who are preference eligibles (as defined in section 2108(3) of such title).
(3) Internal controls to be instituted
The Secretary shall institute appropriate internal controls for appointments under this subsection.
(f) Actions committed to agency discretion
Actions by the Secretary under the authority of this section are committed to agency discretion.
(July 1, 1944, ch. 373, title III, §319F–1, as added
Editorial Notes
References in Text
The Project BioShield Act of 2004, referred to in subsec. (b)(1)(D), is
The Federal Tort Claims Act, referred to in subsec. (d)(2), is title IV of act Aug. 2, 1946, ch. 753,
Codification
In subsec. (b)(1)(A), "
In subsec. (b)(1)(A)(i), "
In subsec. (b)(1)(A)(ii), "
In subsec. (b)(1)(B)(ii), "
In subsec. (b)(1)(B)(iii), "
In subsec. (b)(1)(B)(v), "
In subsec. (b)(2)(A), "
In subsec. (b)(2)(C), "such section 3304(a)(1)" substituted for "such section 303(c)(1)" on authority of
In subsec. (b)(3)(A), "subsections (a), (d), and (e) of
Amendments
2019—Subsec. (a)(1), (5).
2013—Subsec. (a)(2)(A).
2006—Subsec. (a)(2).
"(A) treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or
"(B) treat, identify, or prevent harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in subparagraph (A)."
Statutory Notes and Related Subsidiaries
Rule of Construction
Collaboration and Coordination
Outreach
Recommendation for Export Controls on Certain Biomedical Countermeasures
Ensuring Coordination, Cooperation and the Elimination of Unnecessary Duplication in Programs Designed To Protect the Homeland From Biological, Chemical, Radiological, and Nuclear Agents
"(a)
"(b)
§247d–6b. Strategic National Stockpile and security countermeasure procurements
(a) Strategic National Stockpile
(1) In general
The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, and in coordination with the Secretary of Homeland Security (referred to in this section as the "Homeland Security Secretary"), shall maintain a stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile) in such numbers, types, and amounts as are determined consistent with
(2) Threat-based review
(A) In general
The Secretary shall conduct an annual threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under
(B) Additions, modifications, and replenishments
Each annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—
(i) information regarding—
(I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile;
(II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including—
(aa) consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies on the health care system; and
(bb) an assessment of the current supply chain for such products, including information on supply chain redundancies, any known domestic manufacturing capacity for such products, and any related vulnerabilities;
(III) the presence or lack of a commercial market for the countermeasure at the time of procurement;
(IV) the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;
(V) an assessment of whether the emergency health security threat or threats described in subclause (IV) could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats;
(VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile;
(VII) a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under
(VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and
(ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.
(3) Procedures
The Secretary, in managing the stockpile under paragraph (1), shall—
(A) consult with the working group under
(B) ensure that adequate procedures are followed, regularly reviewed, and updated with respect to such stockpile for inventory management and accounting, and for the physical security of the stockpile;
(C) in consultation with Federal, State, local, and Tribal officials, take into consideration the timing and location of special events, and the availability, deployment, dispensing, and administration of countermeasures;
(D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that—
(i) emerging threats, advanced technologies, and new countermeasures are adequately considered;
(ii) the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment; and
(iii) such contents are in working condition or usable, as applicable, and are ready for deployment, which may include conducting maintenance services on such contents of the stockpile and disposing of such contents that are no longer in working condition, or usable, as applicable;
(E) devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, Tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;
(F) deploy the stockpile at the discretion of the Secretary, in consultation with, or at the request of, the Secretary of Homeland Security, to respond to an actual or potential emergency;
(G) deploy the stockpile at the discretion of the Secretary to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety;
(H) ensure the adequate physical security of the stockpile;
(I) ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under
(J) provide assistance, including technical assistance, to maintain and improve State 1 local, and Tribal public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as appropriate; and
(K) convene meetings, not less than once per year, with representatives from State, local, and Tribal health departments or officials, relevant industries, other Federal agencies, and other appropriate stakeholders, in a manner that does not compromise national security, to coordinate and share information related to maintenance and use of the stockpile, including a description of future countermeasure needs and additions, modifications, and replenishments of the contents of the stockpile, and considerations related to the manufacturing and procurement of products consistent with the requirements of the with the requirements of 2
(4) Utilization guidelines
The Secretary shall ensure timely and accurate recommended utilization guidelines for qualified countermeasures (as defined in
(5) Vendor-managed inventory and warm-base surge capacity
(A) In general
For the purposes of maintaining the stockpile under paragraph (1) and carrying out procedures under paragraph (3), the Secretary may enter into contracts or cooperative agreements with vendors, which may include manufacturers or distributors of medical products, with respect to medical products intended to be delivered to the ownership of the Federal Government. Each such contract or cooperative agreement shall be subject to such terms and conditions as the Secretary may specify, including terms and conditions with respect to—
(i) procurement, maintenance, storage, and delivery of products, in alignment with inventory management and other applicable best practices, under such contract or cooperative agreement, which may consider, as appropriate, costs of transporting and handling such products; or
(ii) maintenance of domestic manufacturing capacity and capabilities of such products to ensure additional reserved production capacity and capabilities are available, and that such capacity and capabilities are able to support the rapid manufacture, purchase, storage, and delivery of such products, as required by the Secretary to prepare for, or respond to, an existing or potential public health emergency.
(B) Report
Not later than 2 years after December 29, 2022, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on any contracts or cooperative agreements entered into under subparagraph (A) for purposes of establishing and maintaining vendor-managed inventory or reserve manufacturing capacity and capabilities for products intended for the stockpile, including a description of—
(i) the amount of each award;
(ii) the recipient of each award;
(iii) the product or products covered through each award; and
(iv) how the Secretary works with each recipient to ensure situational awareness related to the manufacturing capacity for, or inventory of, such products and coordinates the distribution and deployment of such products, as appropriate and applicable.
(6) GAO report
(A) In general
Not later than 3 years after June 24, 2019, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015. Such review shall include—
(i) an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;
(ii) an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;
(iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment;
(iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that received advanced research and development funding from the Biomedical Advanced Research and Development Authority;
(v) an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);
(vi) a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of the stockpile to meet emergency health security needs;
(vii) an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller General;
(viii) with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities;
(ix) an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under
(x) with respect to reports issued in 2027 or any subsequent year, an assessment of selected contracts or cooperative agreements entered into pursuant to paragraph (5).
(B) Submission
Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.
(7) Reimbursement for certain supplies
(A) In general
The Secretary may, at appropriate intervals, make available for purchase excess contents procured for, and maintained within, the stockpile under paragraph (1) to any Federal agency or State, local, or Tribal government. The Secretary shall make such contents available for purchase only if—
(i) such contents are in excess of what is required for appropriate maintenance of such stockpile;
(ii) the Secretary determines that the costs for maintaining such excess contents are not appropriate to expend to meet the needs of the stockpile; and
(iii) the Secretary determines that such action does not compromise national security and is in the national interest.
(B) Reimbursement and collection
The Secretary may require reimbursement for contents that are made available under subparagraph (A), in an amount that reflects the cost of acquiring and maintaining such contents and the costs incurred to make available such contents in the time and manner specified by the Secretary. Amounts collected under this subsection shall be credited to the appropriations account or fund that incurred the costs to procure such contents, and shall remain available, without further appropriation, until expended, for the purposes of the appropriation account or fund so credited.
(C) Rule of construction
This paragraph shall not be construed to preclude transfers of contents in the stockpile under other authorities.
(D) Report
Not later than 2 years after December 29, 2022, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on the use of the authority provided under this paragraph, including details of each action taken pursuant to this paragraph, the account or fund to which any collected amounts have been credited, and how the Secretary has used such amounts.
(E) Sunset
The authority under this paragraph shall terminate on September 30, 2028.
(b) Smallpox vaccine development
(1) In general
The Secretary shall award contracts, enter into cooperative agreements, or carry out such other activities as may reasonably be required in order to ensure that the stockpile under subsection (a) includes an amount of vaccine against smallpox as determined by such Secretary to be sufficient to meet the health security needs of the United States.
(2) Rule of construction
Nothing in this section shall be construed to limit the private distribution, purchase, or sale of vaccines from sources other than the stockpile described in subsection (a).
(c) Additional authority regarding procurement of certain countermeasures; availability of special reserve fund
(1) In general
(A) Use of fund
A security countermeasure may, in accordance with this subsection, be procured with amounts in the special reserve fund as defined in subsection (h).
(B) Security countermeasure
For purposes of this subsection, the term "security countermeasure" means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (
(i)(I) the Secretary determines to be a priority (consistent with
(II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and
(III)(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [
(bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under paragraph (5); or
(ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [
(2) Determination of material threats
(A) Material threat
The Homeland Security Secretary, in consultation with the Secretary and the heads of other agencies as appropriate, shall on an ongoing basis—
(i) assess current and emerging threats of chemical, biological, radiological, and nuclear agents; and
(ii) determine which of such agents present a material threat against the United States population sufficient to affect national security.
(B) Public health impact; necessary countermeasures
The Secretary shall on an ongoing basis—
(i) assess the potential public health consequences for the United States population of exposure to agents identified under subparagraph (A)(ii); and
(ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for which countermeasures are necessary to protect the public health.
(C) Notice to Congress
The Secretary and the Secretary of Homeland Security shall send to Congress, not later than March 15 of each year, all current material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives that a determination has been made pursuant to subparagraph (A) or (B).
(D) Assuring access to threat information
In making the assessment and determination required under subparagraph (A), the Homeland Security Secretary shall use all relevant information to which such Secretary is entitled under
(3) Assessment of availability and appropriateness of countermeasures
(A) In general
The Secretary, in consultation with the Homeland Security Secretary, shall assess on an ongoing basis the availability and appropriateness of specific countermeasures to address specific threats identified under paragraph (2).
(B) Information
The Secretary shall institute a process for making publicly available the results of assessments under subparagraph (A) while withholding such information as—
(i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or
(ii) would otherwise be exempt from disclosure under
(4) Call for development of countermeasures; commitment for recommendation for procurement
(A) Proposal to the President
If, pursuant to an assessment under paragraph (3), the Homeland Security Secretary and the Secretary make a determination that a countermeasure would be appropriate but is either currently not developed or unavailable for procurement as a security countermeasure or is approved, licensed, or cleared only for alternative uses, such Secretaries may jointly submit to the President a proposal to—
(i) issue a call for the development of such countermeasure; and
(ii) make a commitment that, upon the first development of such countermeasure that meets the conditions for procurement under paragraph (5), the Secretaries will, based in part on information obtained pursuant to such call, and subject to the availability of appropriations, make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure, as applicable.
(B) Countermeasure specifications
The Homeland Security Secretary and the Secretary shall, to the extent practicable, include in the proposal under subparagraph (A)—
(i) estimated quantity of purchase (in the form of number of doses or number of effective courses of treatments regardless of dosage form);
(ii) necessary measures of minimum safety and effectiveness;
(iii) estimated price for each dose or effective course of treatment regardless of dosage form; and
(iv) other information that may be necessary to encourage and facilitate research, development, and manufacture of the countermeasure or to provide specifications for the countermeasure.
(C) Presidential approval
If the President approves a proposal under subparagraph (A), the Homeland Security Secretary and the Secretary shall make known to persons who may respond to a call for the countermeasure involved—
(i) the call for the countermeasure;
(ii) specifications for the countermeasure under subparagraph (B); and
(iii) the commitment described in subparagraph (A)(ii).
(5) Secretary's determination of countermeasures appropriate for funding from special reserve fund
(A) In general
The Secretary, in accordance with the provisions of this paragraph, shall identify specific security countermeasures that the Secretary determines, in consultation with the Homeland Security Secretary, to be appropriate for inclusion in the stockpile under subsection (a) pursuant to procurements made with amounts in the special reserve fund as defined in subsection (h) (referred to in this subsection individually as a "procurement under this subsection").
(B) Requirements
In making a determination under subparagraph (A) with respect to a security countermeasure, the Secretary shall determine and consider the following:
(i) The quantities of the product that will be needed to meet the stockpile needs.
(ii) The feasibility of production and delivery within 10 years of sufficient quantities of the product.
(iii) Whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure.
(6) Recommendations for procurement
(A) Notice to appropriate congressional committees
The Secretary shall notify the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives of each decision to make available the special reserve fund as defined in subsection (h) for procurement of a security countermeasure, including, where available, the number of, the nature of, and other information concerning potential suppliers of such countermeasure, and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons for each such rejection.
(B) Subsequent specific countermeasures
Procurement under this subsection of a security countermeasure for a particular purpose does not preclude the subsequent procurement under this subsection of any other security countermeasure for such purpose if the Secretary has determined under paragraph (5)(A) that such countermeasure is appropriate for inclusion in the stockpile and if, as determined by the Secretary, such countermeasure provides improved safety or effectiveness, or for other reasons enhances preparedness to respond to threats of use of a biological, chemical, radiological, or nuclear agent. Such a determination by the Secretary is committed to agency discretion.
(7) Procurement
(A) Payments from special reserve fund
The special reserve fund as defined in subsection (h) shall be available for payments made by the Secretary to a vendor for procurement of a security countermeasure in accordance with the provisions of this paragraph.
(B) Procurement
(i) In general
The Secretary shall be responsible for—
(I) arranging for procurement of a security countermeasure, including negotiating terms (including quantity, production schedule, and price) of, and entering into, contracts and cooperative agreements, and for carrying out such other activities as may reasonably be required, including advanced research and development, in accordance with the provisions of this subparagraph; and
(II) promulgating such regulations as the Secretary determines necessary to implement the provisions of this subsection.
(ii) Contract terms
A contract for procurements under this subsection shall (or, as specified below, may) include the following terms:
(I) Payment conditioned on delivery
The contract shall provide that no payment may be made until delivery of a portion, acceptable to the Secretary, of the total number of units contracted for, except that, notwithstanding any other provision of law, the contract may provide that, if the Secretary determines (in the Secretary's discretion) that an advance payment, partial payment for significant milestones, or payment to increase manufacturing capacity is necessary to ensure success of a project, the Secretary shall pay an amount, not to exceed 10 percent of the contract amount, in advance of delivery. The Secretary shall, to the extent practicable, make the determination of advance payment at the same time as the issuance of a solicitation. The contract shall provide that such advance payment is required to be repaid if there is a failure to perform by the vendor under the contract. The contract may also provide for additional advance payments of 5 percent each for meeting the milestones specified in such contract, except that such payments shall not exceed 50 percent of the total contract amount. If the specified milestones are reached, the advanced payments of 5 percent shall not be required to be repaid. Nothing in this subclause shall be construed as affecting the rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.
(II) Discounted payment
The contract may provide for a discounted price per unit of a product that is not licensed, cleared, or approved as described in paragraph (1)(B)(i)(III)(aa) at the time of delivery, and may provide for payment of an additional amount per unit if the product becomes so licensed, cleared, or approved before the expiration date of the contract (including an additional amount per unit of product delivered before the effective date of such licensing, clearance, or approval).
(III) Contract duration
The contract shall be for a period not to exceed five years, except that, in first awarding the contract, the Secretary may provide for a longer duration, not exceeding 10 years, if the Secretary determines that complexities or other difficulties in performance under the contract justify such a period. The contract shall be renewable for additional periods, none of which shall exceed five years. The Secretary shall notify the vendor within 90 days of a determination by the Secretary to renew, extend, or terminate such contract.
(IV) Storage by vendor
The contract may provide that the vendor will provide storage for stocks of a product delivered to the ownership of the Federal Government under the contract, for such period and under such terms and conditions as the Secretary may specify, and in such case amounts from the special reserve fund as defined in subsection (h) shall be available for costs of shipping, handling, storage, and related costs for such product.
(V) Product approval
The contract shall provide that the vendor seek approval, clearance, or licensing of the product from the Secretary; for a timetable for the development of data and other information to support such approval, clearance, or licensing; and that the Secretary may waive part or all of this contract term on request of the vendor or on the initiative of the Secretary.
(VI) Non-stockpile transfers of security countermeasures
The contract shall provide that the vendor will comply with all applicable export-related controls with respect to such countermeasure.
(VII) Sales exclusivity
The contract may provide that the vendor is the exclusive supplier of the product to the Federal Government for a specified period of time, not to exceed the term of the contract, on the condition that the vendor is able to satisfy the needs of the Government. During the agreed period of sales exclusivity, the vendor shall not assign its rights of sales exclusivity to another entity or entities without approval by the Secretary. Such a sales exclusivity provision in such a contract shall constitute a valid basis for a sole source procurement under
(VIII) Warm based surge capacity
The contract may provide that the vendor establish domestic manufacturing capacity of the product to ensure that additional production of the product is available in the event that the Secretary determines that there is a need to quickly purchase additional quantities of the product. Such contract may provide a fee to the vendor for establishing and maintaining such capacity in excess of the initial requirement for the purchase of the product. Additionally, the cost of maintaining the domestic manufacturing capacity shall be an allowable and allocable direct cost of the contract.
(IX) Contract terms
The Secretary, in any contract for procurement under this section—
(aa) may specify—
(AA) the dosing and administration requirements for the countermeasure to be developed and procured;
(BB) the amount of funding that will be dedicated by the Secretary for advanced research, development, and procurement of the countermeasure; and
(CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section; and
(bb) shall provide a clear statement of defined Government purpose limited to uses related to a security countermeasure, as defined in paragraph (1)(B).
(iii) Availability of simplified acquisition procedures
(I) In general
If the Secretary determines that there is a pressing need for a procurement of a specific countermeasure, the amount of the procurement under this subsection shall be deemed to be below the threshold amount specified in
(aa)
(bb)
(II) Application of certain provisions
Notwithstanding subclause (I) and the provision of law and regulations referred to in such clause, each of the following provisions shall apply to procurements described in this clause to the same extent that such provisions would apply to such procurements in the absence of subclause (I):
(aa)
(bb)
(cc)
(dd)
(ee)
(ff)
(gg)
(III) Internal controls to be established
The Secretary shall establish appropriate internal controls for procurements made under this clause, including requirements with respect to documentation of the justification for the use of the authority provided under this paragraph with respect to the procurement involved.
(IV) Authority to limit competition
In conducting a procurement under this subparagraph, the Secretary may not use the authority provided for under subclause (I) to conduct a procurement on a basis other than full and open competition unless the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.
(iv) Procedures other than full and open competition
(I) In general
In using the authority provided in
(II) Relation to other authorities
The authority under subclause (I) is in addition to any other authority to use procedures other than competitive procedures.
(III) Applicable government-wide regulations
The Secretary shall implement this clause in accordance with government-wide regulations implementing such section 3304(a)(1) (including requirements that offers be solicited from as many potential sources as is practicable under the circumstances, that required notices be published, and that submitted offers be considered), as such regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency.
(v) Premium provision in multiple award contracts
(I) In general
If, under this subsection, the Secretary enters into contracts with more than one vendor to procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include in each of such contracts a provision that—
(aa) identifies an increment of the total quantity of security countermeasure required, whether by percentage or by numbers of units; and
(bb) promises to pay one or more specified premiums based on the priority of such vendors' production and delivery of the increment identified under item (aa), in accordance with the terms and conditions of the contract.
(II) Determination of Government's requirement not reviewable
If the Secretary includes in each of a set of contracts a provision as described in subclause (I), such Secretary's determination of the total quantity of security countermeasure required, and any amendment of such determination, is committed to agency discretion.
(vi) Extension of closing date for receipt of proposals not reviewable
A decision by the Secretary to extend the closing date for receipt of proposals for a procurement under this subsection is committed to agency discretion.
(vii) Limiting competition to sources responding to request for information
In conducting a procurement under this subsection, the Secretary may exclude a source that has not responded to a request for information under
(viii) Flexibility
In carrying out this section, the Secretary may, consistent with the applicable provisions of this section, enter into contracts and other agreements that are in the best interest of the Government in meeting identified security countermeasure needs, including with respect to reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.
(8) Interagency cooperation
(A) In general
In carrying out activities under this section, the Homeland Security Secretary and the Secretary are authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government. Such agreements may allow other executive agencies to order qualified and security countermeasures under procurement contracts or other agreements established by the Secretary. Such ordering process (including transfers of appropriated funds between an agency and the Department of Health and Human Services as reimbursements for such orders for countermeasures) may be conducted under the authority of
(B) Limitation
An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section to the Homeland Security Secretary or to the Secretary.
(d) Disclosures
No Federal agency may disclose under
(e) Definition
For purposes of subsection (a), the term "stockpile" includes—
(1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or
(2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or vendors agree to provide to such Secretary supplies described in subsection (a).
(f) Authorization of appropriations
(1) Strategic National Stockpile
For the purpose of carrying out subsection (a), there are authorized to be appropriated $610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023, to remain available until expended. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (h).
(2) Smallpox vaccine development
For the purpose of carrying out subsection (b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006.
(g) Special reserve fund
(1) Authorization of appropriations
In addition to amounts appropriated to the special reserve fund prior to March 13, 2013, there is authorized to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out
(2) Use of special reserve fund for advanced research and development
The Secretary may utilize not more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out
(3) Restrictions on use of funds
Amounts in the special reserve fund shall not be used to pay costs other than payments made by the Secretary to a vendor for advanced development (under
(4) Report on security countermeasure procurement
Not later than March 1 of each year in which the Secretary determines that the amount of funds available for procurement of security countermeasures is less than $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for procurement and the impact such amount of funding will have—
(A) in meeting the security countermeasure needs identified under this section; and
(B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to
(5) Clarification on contracting authority
The Secretary, acting through the Director of the Biomedical Advanced Research and Development Authority, shall carry out the programs funded by the special reserve fund (for the procurement of security countermeasures under subsection (c) and for carrying out
(h) Definitions
In this section:
(1) The term "advanced research and development" has the meaning given such term in
(2) The term "special reserve fund" means the "Biodefense Countermeasures" appropriations account, any appropriation made available pursuant to
(i) Pilot program to support State medical stockpiles
(1) In general
The Secretary, in consultation with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, shall award grants or cooperative agreements to not fewer than 5 States, or consortia of States, with consideration given to distribution among the geographical regions of the United States, to establish, expand, or maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies determined by the State to be necessary to respond to a public health emergency declared by the Governor of a State or by the Secretary under
(2) Requirements
(A) Application
To be eligible to receive an award under paragraph (1), an entity shall prepare, in consultation with appropriate health care entities and health officials within the jurisdiction of such State or States, and submit to the Secretary an application that contains such information as the Secretary may require, including—
(i) a plan for such stockpile, consistent with paragraph (4), including—
(I) a description of the activities such entity will carry out under the agreement;
(II) an assurance that such entity will use funds under such award in alignment with the requirements of
(III) an outline of proposed expenses; and
(ii) a description of how such entity will coordinate with relevant entities in receipt of an award under
(B) Matching funds
(i) Subject to clause (ii), the Secretary may not make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection, to make available non-Federal contributions toward such costs in an amount equal to—
(I) for each of fiscal years 2023 and 2024, not less than $1 for each $20 of Federal funds provided in the award; and
(II) for fiscal year 2025 and each fiscal year thereafter, not less than $1 for each $10 of Federal funds provided in the award.
(ii)
(C) Administrative expenses
Not more than 10 percent of amounts received by an entity pursuant to an award under this subsection may be used for administrative expenses.
(3) Lead entity
An entity in receipt of an award under paragraph (1) may designate a lead entity, which may be a public or private entity, as appropriate, to manage the stockpile at the direction of the State or consortium of States.
(4) Use of funds
An entity in receipt of an award under paragraph (1) shall use such funds to—
(A) purchase, store, and maintain a stockpile of appropriate drugs, vaccines and other biological products, medical devices, and other medical supplies to be used during a public health emergency, major disaster, or emergency described in paragraph (1), in such numbers, types, and amounts as the entity determines necessary, consistent with such entity's stockpile plan established pursuant to paragraph (2)(A)(i);
(B) deploy the stockpile as required by the entity to respond to an actual or potential public health emergency, major disaster, or other emergency described in paragraph (1);
(C) replenish and make necessary additions or modifications to the contents of such stockpile, including to address potential depletion;
(D) in consultation with Federal, State, and local officials, take into consideration the availability, deployment, dispensing, and administration requirements of medical products within the stockpile;
(E) ensure that procedures are followed for inventory management and accounting, and for the physical security of the stockpile, as appropriate;
(F) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that, to the extent practicable, new technologies and medical products are considered;
(G) carry out exercises, drills, and other training for purposes of stockpile deployment, dispensing, and administration of medical products, and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies, major disasters, or other emergencies described in paragraph (1) of varying types and scales, which may be conducted in accordance with requirements related to exercises, drills, and other training for recipients of awards under
(H) carry out other activities related to the State strategic stockpile as the entity determines appropriate, to support State efforts to prepare for, and respond to, public health threats.
(5) Supplement not supplant
Awards under paragraph (1) shall supplement, not supplant, the maintenance and use of the Strategic National Stockpile by the Secretary under subsection (a).
(6) Guidance for States
Not later than 180 days after December 29, 2022, the Secretary, in consultation with States, health officials, and other relevant stakeholders, as appropriate, shall issue guidance, and update such guidance as appropriate, for States related to maintaining and replenishing a stockpile of medical products, which may include strategies and best practices related to—
(A) types of medical products and medical supplies that are critical to respond to public health emergencies, and may be appropriate for inclusion in a stockpile by States, with consideration of threats that require the large-scale and simultaneous deployment of stockpiles, including the stockpile maintained by the Secretary pursuant to subsection (a), and long-term public health and medical response needs;
(B) appropriate management of the contents of a stockpile, including management by vendors of reserve amounts of medical products and supplies intended to be delivered to the ownership of the State and appropriate disposition of excess products, as applicable; and
(C) the procurement of medical products and medical supplies consistent with the requirements of
(7) Technical assistance
The Secretary shall provide assistance to States, including technical assistance, as appropriate, in establishing, maintaining, improving, and utilizing a medical stockpile, including appropriate inventory management and disposition of products.
(8) Reporting
(A) State reports
Each entity receiving an award under paragraph (1) shall update, as appropriate, the plan established pursuant to paragraph (2)(A)(i) and submit to the Secretary an annual report on implementation of such plan, including any changes to the contents of the stockpile supported under such award. The Secretary shall use information obtained from such reports to inform the maintenance and management of the Strategic National Stockpile pursuant to subsection (a).
(B) Reports to Congress
Not later than 1 year after the initial issuance of awards pursuant to paragraph (1), and annually thereafter for the duration of the program established under this subsection, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on such program, including—
(i) Federal and State expenditures to support stockpiles under such program;
(ii) activities conducted pursuant to paragraph (4); and
(iii) any additional information from the States that the Secretary determines relevant.
(9) Authorization of appropriations
To carry out this subsection, there is authorized to be appropriated $3,500,000,000 for each of fiscal years 2023 and 2024, to remain available until expended.
(July 1, 1944, ch. 373, title III, §319F–2, formerly
Editorial Notes
References in Text
Section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, referred to in subsec. (a)(6)(A)(ix), is section 403(b) of
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(1)(B)(i)(III)(aa), is act June 25, 1938, ch. 675,
The Project BioShield Act of 2004, referred to in subsec. (c)(7)(B)(iii)(IV), is
Codification
In subsec. (c)(7)(B)(ii)(VII), "
In subsec. (c)(7)(B)(iii)(I), "
In subsec. (c)(7)(B)(iii)(I)(aa), "
In subsec. (c)(7)(B)(iii)(I)(bb), "
In subsec. (c)(7)(B)(iii)(II)(bb), "
In subsec. (c)(7)(B)(iii)(II)(cc), "
In subsec. (c)(7)(B)(iii)(II)(ee), "
In subsec. (c)(7)(B)(iv)(I), "
In subsec. (c)(7)(B)(iv)(III), "such section 3304(a)(1)" substituted for "such section 303(c)(1)" on authority of
In subsec. (c)(7)(B)(vii), "
Section was formerly classified to
Amendments
2022—Subsec. (a)(2)(B)(i)(II).
Subsec. (a)(3)(B).
Subsec. (a)(3)(C).
Subsec. (a)(3)(D).
Subsec. (a)(3)(F).
Subsec. (a)(3)(J).
Subsec. (a)(3)(K).
Subsec. (a)(5).
Subsec. (a)(6).
Subsec. (a)(6)(A)(x).
Subsec. (a)(7).
"(A) within 1 year of their expiration date; or
"(B) determined by the Secretary to no longer be needed in the stockpile due to advances in medical or technical capabilities."
Subsec. (c)(2)(C).
Subsec. (f)(1).
Subsec. (i).
2021—Subsec. (a)(6).
2020—Subsec. (a)(1).
2019—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(3)(A).
Subsec. (a)(3)(C).
Subsec. (a)(3)(E).
Subsec. (a)(3)(I), (J).
Subsec. (a)(4).
Subsec. (a)(5).
Subsec. (c)(2)(C).
Subsec. (c)(7)(B)(ii)(III).
Subsec. (d).
Subsec. (f)(1).
Subsec. (g)(1).
2016—Subsec. (a)(3).
Subsec. (c)(4)(A)(ii).
Subsec. (c)(6).
Subsec. (c)(6)(A).
Subsec. (c)(6)(B).
Subsec. (c)(6)(C), (D).
Subsec. (c)(6)(E).
Subsec. (c)(7)(A).
Subsec. (c)(7)(B), (C).
Subsec. (g)(4).
"(A) in meeting the security countermeasure needs identified under this section; and
"(B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to
Subsec. (g)(5).
2013—Subsec. (a)(1).
Subsec. (a)(2)(D).
Subsec. (c).
Subsec. (c)(1)(B)(i)(III)(bb).
Subsec. (c)(2)(C).
Subsec. (c)(5)(B)(ii).
Subsec. (c)(6)(C).
Subsec. (c)(7)(C)(i)(I).
Subsec. (c)(7)(C)(ii)(III).
Subsec. (c)(7)(C)(ii)(IX).
"(aa) the dosing and administration requirements for countermeasures to be developed and procured;
"(bb) the amount of funding that will be dedicated by the Secretary for development and acquisition of the countermeasure; and
"(cc) the specifications the countermeasure must meet to qualify for procurement under a contract under this section."
Subsec. (c)(7)(C)(viii).
Subsec. (c)(9), (10).
Subsec. (f)(1).
Subsecs. (g), (h).
2006—
Subsec. (a)(1).
Subsec. (c).
Subsec. (c)(1)(B)(i)(I).
Subsec. (c)(3).
Subsec. (c)(4)(A).
Subsec. (c)(5)(B)(i).
Subsec. (c)(7)(B).
Subsec. (c)(7)(C)(ii)(I).
Subsec. (c)(7)(C)(ii)(VII) to (IX).
Subsec. (c)(8)(A).
2004—
2002—Subsec. (a)(1).
Subsecs. (a)(2), (b)(1).
Statutory Notes and Related Subsidiaries
Effective Date of 2002 Amendment
Improving Transparency and Predictability of Processes of the Strategic National Stockpile
Increased Manufacturing Capacity for Certain Critical Antibiotic Drugs
"(a)
"(1)
"(2)
"(A) be a manufacturer that is in compliance with, or demonstrates capability to comply with, the relevant requirements of the Federal Food, Drug, and Cosmetic Act (
"(B) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including—
"(i) a description of proposed activities to be supported by an award under this subsection to increase manufacturing capacity for such antibiotic drug or drugs;
"(ii) the antibiotic drug or drugs, or related active pharmaceutical ingredients or key starting materials for such drug or drugs, that such entity intends to manufacture with any increased manufacturing capacity supported by an award under this subsection;
"(iii) any additional products such increased manufacturing capacity could be used to manufacture;
"(iv) a description of the current supply chain for such antibiotic drugs, including any existing and applicable manufacturing facilities, known vulnerabilities in the supply chain, known or potential supply limitations, such as foreign export restrictions, or subsidies from foreign governments, as applicable;
"(v) a description of how such entity may use advanced or flexible manufacturing in carrying out the terms of an award under this subsection; and
"(vi) a strategic plan regarding the maintenance, operation, and sustainment of such increased manufacturing capacity following the expiration of a contract under this subsection.
"(3)
"(4)
"(5)
"(A)
"(B)
"(C)
"(i)
"(ii)
"(iii)
"(D)
"(i) may specify—
"(I) the amount of funding that will be dedicated by the Secretary for supporting increased manufacturing capacity under such contract; and
"(II) the amount of manufacturing capacity that such eligible entity must meet; and
"(ii) shall provide a clear statement of defined Federal Government purpose limited to uses related to increasing domestic manufacturing capacity for antibiotic drugs to address identified supply chain vulnerabilities and challenges to establishing and maintaining domestic manufacturing capacity.
"(E)
"(b)
"(1) the antibiotic drugs for which the Secretary prioritized awards under subsection (a), including a description of how the Secretary consulted with stakeholders to inform such prioritization;
"(2) information regarding each contract awarded pursuant to subsection (a), including—
"(A) the recipient of each such contract, including any recipients of a subaward;
"(B) the milestone and performance requirements pursuant to each such contract;
"(C) the duration of each such contract;
"(D) the amount of funding provided by the Secretary pursuant to each such contract, including any advanced or partial payments;
"(E) the antibiotic drugs supported through each such contract, including a description of the medical necessity of each such antibiotic drug and any supply chain vulnerabilities, limitations, and related characteristics identified pursuant to subsection (a)(2)(B)(iv) for each such antibiotic drug; and
"(F) the amount of increased manufacturing capacity for such antibiotic drug that each such contract supports; and
"(3) a description of how such contracts address supply chain vulnerabilities, including increasing manufacturing capacity of antibiotic drugs in the United States; and
"(4) a description of the strategic plan submitted pursuant to subsection (a)(2)(B)(vi) by each recipient of an award under subsection (a).
"(c)
"(1) to limit, directly or indirectly, or otherwise impact the private distribution, purchase, or sale of antibiotic drugs or active pharmaceutical ingredients or key starting materials; or
"(2) to authorize the Secretary to disclose any information that is a trade secret, or other privileged or confidential information subject to
"(d)
"(1)
"(2)
"(3)
"(4)
"(e)
First Responder Anthrax Preparedness
"SECTION 1. SHORT TITLE.
"This Act may be cited as the 'First Responder Anthrax Preparedness Act'.
"SEC. 2. VOLUNTARY PRE-EVENT ANTHRAX VACCINATION PILOT PROGRAM FOR EMERGENCY RESPONSE PROVIDERS.
"(a)
"(1)
"(2)
"(A) a determination that the vaccine is not otherwise allotted for other purposes;
"(B) a determination that the provision of the vaccine will not reduce, or otherwise adversely affect, the capability to meet projected requirements for this product during a public health emergency, including a significant reduction of available quantities of vaccine in the Strategic National Stockpile; and
"(C) such other considerations as determined appropriate by the Secretary of Health and Human Services.
"(3)
"(A) establish a communication platform for the pilot program;
"(B) develop and deliver education and training for the pilot program;
"(C) conduct economic analysis of the pilot program, including a preliminary estimate of total costs and expected benefits;
"(D) create a logistical platform for the anthrax vaccine request process under the pilot program;
"(E) establish goals and desired outcomes for the pilot program; and
"(F) establish a mechanism to reimburse the Secretary of Health and Human Services for—
"(i) the costs of shipment and transportation of such vaccines provided to the Secretary of Homeland Security from the Strategic National Stockpile under such pilot program, including staff time directly supporting such shipment and transportation; and
"(ii) the amount, if any, by which the warehousing costs of the Strategic National Stockpile are increased in order to operate such pilot program.
"(4)
"(A)
"(B)
"(5)
"(6)
"(A) materials regarding the associated benefits and risks of any vaccine provided under the pilot program, and of exposure to anthrax;
"(B) additional material consistent with the Centers for Disease Control and Prevention's clinical guidance; and
"(C) notice that the Federal Government is not obligated to continue providing anthrax vaccine after the date on which the pilot program ends.
"(7)
"(A) define the roles and responsibilities of each Department for the pilot program; and
"(B) establish other performance metrics and policies for the pilot program, as appropriate.
"(8)
"(A)
"(i) a detailed tabulation of the costs to administer the program, including—
"(I) total costs for management and administration;
"(II) total costs to ship vaccines;
"(III) total number of full-time equivalents allocated to the program; and
"(IV) total costs to the Strategic National Stockpile;
"(ii) the number and percentage of eligible emergency response providers, as determined by each pilot location, that volunteer to participate;
"(iii) the degree to which participants complete the vaccine regimen;
"(iv) the total number of doses of vaccine administered; and
"(v) recommendations to improve initial and recurrent participation in the pilot program.
"(B)
"(i) consider whether the pilot program required under this subsection should continue after the date described in subsection (c); and
"(ii) include—
"(I) an analysis of the costs and benefits of continuing the program to provide anthrax vaccines to emergency response providers;
"(II) an explanation of the economic, health, and other risks and benefits of administering vaccines through the pilot program rather than post-event treatment; and
"(III) in the case of a recommendation under clause (i) to continue the pilot program after the date described in subsection (c), a plan under which the pilot program could be continued.
"(b)
"(c)
Stockpile Functions Transferred
"(1)
"(2)
"(A)
"(B)
Potassium Iodide
"(a)
"(b)
"(1)
"(A) Such government submits to the President a plan for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident.
"(B) The plan is accompanied by certifications by such government that the government has not already received sufficient quantities of potassium iodide tablets from the Federal Government.
"(2)
"(A) The State in which the locality involved is located—
"(i) does not have a plan described in paragraph (1)(A); or
"(ii) has a plan described in such paragraph, but the plan does not address populations at a distance greater than 10 miles from the nuclear power plant involved.
"(B) The local government has petitioned the State to modify the State plan to address such populations, not exceeding 20 miles from such plant, and 60 days have elapsed without the State modifying the State plan to address populations at the full distance sought by the local government through the petition.
"(C) The local government has submitted its local plan under paragraph (1)(A) to the State, and the State has approved the plan and certified that the plan is not inconsistent with the State emergency plan.
"(c)
"(d)
"(e)
"(1)
"(A) on whether potassium iodide tablets have been made available under subsection (a) or other Federal, State, or local programs, and the extent to which State and local governments have established stockpiles of such tablets; and
"(B) the measures taken by the President to implement this section.
"(2)
"(A)
"(B)
"(f)
[Memorandum of President of the United States, July 3, 2007, 72 F.R. 37627, provided:
[Memorandum for the Secretary of Health and Human Services[,] the Secretary of Energy[,] the Secretary of Homeland Security[,] the Chairman of the Nuclear Regulatory Commission[, and] the Director of the Office of Science and Technology Policy
[By the authority vested in me as President by the Constitution and the laws of the United States, including
[(1) the function of making a determination under subsection 127(f) of
[(2) the functions of the President under section 127 of
[In the performance of such functions the Chairman and the Director should consult each other and the Secretaries of Health and Human Services, Energy, and Homeland Security, as appropriate.
[The Director is authorized and directed to publish this memorandum in the Federal Register.]
Executive Documents
Ex. Ord. No. 13944. Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States
Ex. Ord. No. 13944, Aug. 6, 2020, 85 F.R. 49929, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
(a) accelerate the development of cost-effective and efficient domestic production of Essential Medicines and Medical Countermeasures and have adequate redundancy built into the domestic supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs;
(b) ensure long-term demand for Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States;
(c) create, maintain, and maximize domestic production capabilities for Critical Inputs, Finished Drug Products, and Finished Devices that are essential to protect public safety and human health and to provide for the national defense; and
(d) combat the trafficking of counterfeit Essential Medicines, Medical Countermeasures, and Critical Inputs over e-commerce platforms and from third-party online sellers involved in the government procurement process.
I am therefore directing each executive department and agency involved in the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs (agency) to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, and to identify vulnerabilities in our Nation's supply chains for these products. Under this order, agencies will have the necessary flexibility to increase their domestic procurement in appropriate and responsible ways, while protecting our Nation's service members, veterans, and their families from increases in drug prices and without interfering with our Nation's ability to respond to the spread of COVID–19.
(i) using procedures to limit competition to only those Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States; and
(ii) dividing procurement requirements among two or more manufacturers located in the United States, as appropriate.
(b) Within 90 days of the date of this order [Aug. 6, 2020], the Director of the Office of Management and Budget (OMB), in consultation with appropriate agency heads, shall:
(i) review the authority of each agency to limit the online procurement of Essential Medicines and Medical Countermeasures to e-commerce platforms that have:
(A) adopted, and certified their compliance with, the applicable best practices published by the Department of Homeland Security in its Report to the President on "Combating Trafficking in Counterfeit and Pirated Goods," dated January 24, 2020; and
(B) agreed to permit the Department of Homeland Security's National Intellectual Property Rights Coordination Center to evaluate and confirm their compliance with such best practices; and
(ii) report its findings to the President.
(c) Within 90 days of the date of this order, the head of each agency shall, in consultation with the FDA Commissioner, develop and implement procurement strategies, including long-term contracts, consistent with law, to strengthen and mobilize the Public Health Industrial Base in order to increase the manufacture of Essential Medicines, Medical Countermeasures, and Critical Inputs in the United States.
(d) No later than 30 days after the FDA Commissioner has identified, pursuant to section 3(c) of this order, the initial list of Essential Medicines, Medical Countermeasures, and Critical Inputs, the United States Trade Representative shall, to the extent permitted by law, take all appropriate action to modify United States Federal procurement product coverage under all relevant Free Trade Agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of Essential Medicines, Medical Countermeasures, and Critical Inputs. The United States Trade Representative shall further modify United States Federal procurement product coverage, as appropriate, to reflect updates by the FDA Commissioner. After the modifications to United States Federal procurement coverage take effect, the United States Trade Representative shall make any necessary, corresponding modifications of existing waivers under section 301 of the Trade Agreements Act of 1979 [
(e) No later than 60 days after the FDA Commissioner has identified, pursuant to section 3(c) of this order, the initial list of Essential Medicines, Medical Countermeasures, and Critical Inputs, and notwithstanding the public interest exception in subsection (f)(i)(1) of this section, the Secretary of Defense shall, to the maximum extent permitted by applicable law, use his authority under section 225.872–1(c) of the Defense Federal Acquisition Regulation Supplement to restrict the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs to domestic sources and to reject otherwise acceptable offers of such products from sources in Qualifying Countries in instances where considered necessary for national defense reasons.
(f) Subsections (a), (d), and (e) of this section shall not apply:
(i) where the head of the agency determines in writing, with respect to a specific contract or order, that (1) their application would be inconsistent with the public interest; (2) the relevant Essential Medicines, Medical Countermeasures, and Critical Inputs are not produced in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality; or (3) their application would cause the cost of the procurement to increase by more than 25 percent, unless applicable law requires a higher percentage, in which case such higher percentage shall apply;
(ii) with respect to the procurement of items that are necessary to respond to any public health emergency declared under section 319 of the Public Health Service Act (
(g) To the maximum extent permitted by law, any public interest determination made pursuant to section 2(f)(i)(1) of this order shall be construed to maximize the procurement and use of Essential Medicines and Medical Countermeasures produced in the United States.
(h) The head of an agency who makes any determination pursuant to section 2(f)(i) of this order shall submit an annual report to the President, through the Director of OMB and the Assistant to the President for Trade and Manufacturing Policy, describing the justification for each such determination.
(i) considering proposing regulations or revising guidance on the collection of the following information from manufacturers of Essential Medicines and Medical Countermeasures as part of the application and regulatory approval process:
(A) the sources of Finished Drug Products, Finished Devices, and Critical Inputs;
(B) the use of any scarce Critical Inputs; and
(C) the date of the last FDA inspection of the manufacturer's regulated facilities and the results of such inspection;
(ii) entering into written agreements, pursuant to section 20.85 of title 21, Code of Federal Regulations, with the National Security Council, Department of State, Department of Defense, Department of Veterans Affairs, and other interested agencies, as appropriate, to disclose records regarding the security and vulnerabilities of the supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs;
(iii) recommending to the President any changes in applicable law that may be necessary to accomplish the objectives of this subsection; and
(iv) reviewing FDA regulations to determine whether any of those regulations may be a barrier to domestic production of Essential Medicines, Medical Countermeasures, and Critical Inputs, and by advising the President whether such regulations should be repealed or amended.
(b) The Secretary of Health and Human Services, through the FDA Commissioner, shall take all appropriate action, consistent with applicable law, to:
(i) accelerate FDA approval or clearance, as appropriate, for domestic producers of Essential Medicines, Medical Countermeasures, and Critical Inputs, including those needed for infectious disease and CBRN threat preparedness and response;
(ii) issue guidance with recommendations regarding the development of Advanced Manufacturing techniques;
(iii) negotiate with countries to increase site inspections and increase the number of unannounced inspections of regulated facilities manufacturing Essential Medicines, Medical Countermeasures, and Critical Inputs; and
(iv) refuse admission, as appropriate, to imports of Essential Medicines, Medical Countermeasures, and Critical Inputs if the facilities in which they are produced refuse or unreasonably delay an inspection.
(c) Within 90 days of the date of this order, and periodically updated as appropriate, the FDA Commissioner, in consultation with the Director of OMB, the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services, the Assistant to the President for Economic Policy, and the Director of the Office of Trade and Manufacturing Policy, shall identify the list of Essential Medicines, Medical Countermeasures, and their Critical Inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.
(d) Within 180 days of the date of this order, the Secretary of Defense, in consultation with the Director of OMB, shall take all necessary and appropriate action, consistent with law, to identify vulnerabilities in the supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs necessary to meet the unique needs of the United States Armed Forces and to mitigate the vulnerabilities identified in subsection (a) of this section. The Secretary of Defense shall provide to the Secretary of Health and Human Services, the FDA Commissioner, the Director of OMB, and the Director of the Office of Trade and Manufacturing Policy a list of defense-specific Essential Medicines, Medical Countermeasures, and Critical Inputs that are medically necessary to have available for defense use in adequate amounts and in appropriate dosage forms. The Secretary of Defense shall, as appropriate, periodically update this list.
(i) the Essential Medicines, Medical Countermeasures, and Critical Inputs procured by the agency;
(ii) the agency's annual itemized and aggregated expenditures for all Essential Medicines, Medical Countermeasures, and Critical Inputs;
(iii) the sources of these products and inputs; and
(iv) the agency's plan to support domestic production of such products and inputs in the next fiscal year.
(b) Within 180 days of the date of this order, the Secretary of Commerce shall submit a report to the Director of OMB, the Assistant to the President for National Security Affairs, the Director of the National Economic Council, and the Director of the Office of Trade and Manufacturing Policy, describing any change in the status of the Public Health Industrial Base and recommending initiatives to strengthen the Public Health Industrial Base.
(c) To the maximum extent permitted by law, and with the redaction of any information protected by law from disclosure, each agency's report shall be published in the Federal Register and on each agency's official website.
(a) "Active Pharmaceutical Ingredient" has the meaning set forth in section 207.1 of title 21, Code of Federal Regulations.
(b) "Advanced Manufacturing" means any new medical product manufacturing technology that can improve drug quality, address shortages of medicines, and speed time to market, including continuous manufacturing and 3D printing.
(c) "API Starting Material" means a raw or intermediate material that is used in the manufacturing of an API, that is incorporated as a significant structural fragment into the structure of the API, and that is determined by the FDA Commissioner to be relevant in assessing the safety and effectiveness of Essential Medicines and Medical Countermeasures.
(d) "Critical Inputs" means API, API Starting Material, and other ingredients of drugs and components of medical devices that the FDA Commissioner determines to be critical in assessing the safety and effectiveness of Essential Medicines and Medical Countermeasures.
(e) "Essential Medicines" are those Essential Medicines deemed necessary for the United States pursuant to section 3(c) of this order.
(f) "Finished Device" has the meaning set forth in section 820.3(l) of title 21, Code of Federal Regulations.
(g) "Finished Drug Product" has the meaning set forth in section 207.1 of title 21, Code of Federal Regulations.
(h) "Healthcare and Public Health Sector" means the critical infrastructure sector identified in Presidential Policy Directive 21 of February 12, 2013 (Critical Infrastructure Security and Resilience), and the National Infrastructure Protection Plan of 2013.
(i) An Essential Medicine or Medical Countermeasure is "produced in the United States" if the Critical Inputs used to produce the Essential Medicine or Medical Countermeasures are produced in the United States and if the Finished Drug Product or Finished Device, are manufactured, prepared, propagated, compounded, or processed, as those terms are defined in
(j) "Medical Countermeasures" means items that meet the definition of "qualified countermeasure" in
(k) "Public Health Industrial Base" means the facilities and associated workforces within the United States, including research and development facilities, that help produce Essential Medicines, Medical Countermeasures, and Critical Inputs for the Healthcare and Public Health Sector.
(l) "Qualifying Countries" has the meaning set forth in section 225.003, Defense Federal Acquisition Regulation Supplement.
(a) the ability of State, local, tribal, or territorial governments to timely procure necessary resources to respond to any public health emergency declared under section 319 of the Public Health Service Act (
(b) the ability or authority of any agency to respond to the spread of COVID–19; or
(c) the authority of the Secretary of Veterans Affairs to take all necessary steps, including those necessary to implement the policy set forth in section 1 of this order, to ensure that service members, veterans, and their families continue to have full access to Essential Medicines at reasonable and affordable prices.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of OMB relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Donald J. Trump.
Ex. Ord. No. 13962. Ensuring Access to United States Government COVID–19 Vaccines
Ex. Ord. No. 13962, Dec. 8, 2020, 85 F.R. 79777, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
(b) The Secretary of Health and Human Services, in consultation with the Secretary of Defense and the heads of other executive departments and agencies (agencies), as appropriate, shall ensure that Americans have priority access to United States Government COVID–19 Vaccines, and shall ensure that the most vulnerable United States populations have first access to such vaccines.
(c) The Secretary of Health and Human Services shall ensure that a sufficient supply of COVID–19 vaccine doses is available for all Americans who choose to be vaccinated in order to safeguard America from COVID–19.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Donald J. Trump.
Ex. Ord. No. 14001. A Sustainable Public Health Supply Chain
Ex. Ord. No. 14001, Jan. 21, 2021, 86 F.R. 7219, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Defense Production Act of 1950, as amended (
(i) immediately review the availability of critical materials, treatments, and supplies needed to combat COVID–19 (pandemic response supplies), including personal protective equipment (PPE) and the resources necessary to effectively produce and distribute tests and vaccines at scale; and
(ii) assess, including by reviewing prior such assessments, whether United States industry can be reasonably expected to provide such supplies in a timely manner.
(b) Where a review and assessment described in section 2(a)(i) of this order identifies shortfalls in the provision of pandemic response supplies, the head of the relevant agency shall:
(i) promptly revise its operational assumptions and planning factors being used to determine the scope and prioritization, acquisition, and distribution of such supplies; and
(ii) take appropriate action using all available legal authorities, including the Defense Production Act, to fill those shortfalls as soon as practicable by acquiring additional stockpiles, improving distribution systems, building market capacity, or expanding the industrial base.
(c) Upon completing the review and assessment described in section 2(a)(i) of this order, the Secretary of Health and Human Services shall provide to the President, through the COVID–19 Response Coordinator, a report on the status and inventory of the Strategic National Stockpile.
(d) The Secretary of State, the Secretary of Defense, the Secretary of Health and Human Services, the Secretary of Homeland Security, and the heads of any other agencies relevant to inventorying pandemic response supplies shall, as soon as practicable, provide to the President, through the COVID–19 Response Coordinator, a report consisting of:
(i) an assessment of the need for, and an inventory of current supplies of, key pandemic response supplies;
(ii) an analysis of their agency's capacity to produce, provide, and distribute pandemic response supplies;
(iii) an assessment of their agency's procurement of pandemic response supplies on the availability of such supplies on the open market;
(iv) an account of all existing or ongoing agency actions, contracts, and investment agreements regarding pandemic response supplies;
(v) a list of any gaps between the needs identified in section 2(a)(i) of this order and supply chain delivery, and recommendations on how to close such gaps; and
(vi) a compilation and summary of their agency's existing distribution and prioritization plans for pandemic response supplies, which shall include any assumptions or planning factors used to determine such needs and any recommendations for changes to such assumptions or factors.
(e) The COVID–19 Response Coordinator, in coordination with the heads of appropriate agencies, shall review the report described in section 2(d) of this order and submit recommendations to the President that address:
(i) whether additional use of the Defense Production Act, by the President or agencies exercising delegated authority under the Act, would be helpful; and
(ii) the extent to which liability risk, regulatory requirements, or other factors impede the development, production, and procurement of pandemic response supplies, and any actions that can be taken, consistent with law, to remove those impediments.
(f) The heads of agencies responsible for completing the requirements of this section, as appropriate and in coordination with the COVID–19 Response Coordinator, shall consult with State, local, Tribal, and territorial authorities, as well as with other entities critical to assessing the availability of and need for pandemic response supplies.
(a) The Secretary of Health and Human Services shall promptly recommend to the President, through the COVID–19 Response Coordinator, whether any changes should be made to the authorities delegated to the Secretary by Executive Order 13910 of March 23, 2020 (Preventing Hoarding of Health and Medical Resources To Respond to the Spread of COVID–19) [
(b) The Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Homeland Security shall promptly review and provide to the President, through the COVID–19 Response Coordinator, recommendations for how to address the pricing of pandemic response supplies, including whether and how to direct the use of reasonable pricing clauses in Federal contracts and investment agreements, or other related vehicles, and whether to use General Services Administration Schedules to facilitate State, local, Tribal, and territorial government buyers and compacts in purchasing pandemic response supplies using Federal supply schedules.
(a) mechanisms to respond to emergency supply needs of State, local, Tribal, and territorial authorities, which should include standards and processes to prioritize requests and delivery and to ensure equitable distribution based on public health criteria;
(b) an analysis of the role of foreign supply chains in America's pandemic supply chain, America's role in the international public health supply chain, and options for strengthening and better coordinating global supply chain systems in future pandemics;
(c) mechanisms to address points of failure in the supply chains and to ensure necessary redundancies;
(d) the roles of the Strategic National Stockpile and other Federal and military stockpiles in providing pandemic supplies on an ongoing or emergency basis, including their roles in allocating supplies across States, localities, tribes, and territories, sustaining supplies during a pandemic, and in contingency planning to ensure adequate preparedness for future pandemics and public health emergencies;
(e) approaches to assess and maximize the value and efficacy of public/private partnerships and the value of Federal investments in latent manufacturing capacity; and
(f) an approach to develop a multi-year implementation plan for domestic production of pandemic supplies.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
J.R. Biden, Jr.
Designation and Authorization To Perform Functions Under Section 319F–2 of the Public Health Service Act
Memorandum of President of the United States, Oct. 21, 2004, 69 F.R. 70349, provided:
Memorandum for the Director of the Office of Management and Budget
By the authority vested in me by the Constitution and the laws of the United States of America, including
Any reference in this memorandum to the provision of any Act shall be deemed to include references to any hereafter-enacted provision of law that is the same or substantially the same as such provision.
You are authorized and directed to publish this memorandum in the Federal Register.
George W. Bush.
1 So in original. Probably should be followed by a comma.
3 So in original. Another closing parenthesis probably should precede the comma.
§247d–6c. Repealed. Pub. L. 113–5, title II, §205, Mar. 13, 2013, 127 Stat. 179
Section,
§247d–6d. Targeted liability protections for pandemic and epidemic products and security countermeasures
(a) Liability protections
(1) In general
Subject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.
(2) Scope of claims for loss
(A) Loss
For purposes of this section, the term "loss" means any type of loss, including—
(i) death;
(ii) physical, mental, or emotional injury, illness, disability, or condition;
(iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
(iv) loss of or damage to property, including business interruption loss.
Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.
(B) Scope
The immunity under paragraph (1) applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.
(3) Certain conditions
Subject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if—
(A) the countermeasure was administered or used during the effective period of the declaration that was issued under subsection (b) with respect to the countermeasure;
(B) the countermeasure was administered or used for the category or categories of diseases, health conditions, or threats to health specified in the declaration; and
(C) in addition, in the case of a covered person who is a program planner or qualified person with respect to the administration or use of the countermeasure, the countermeasure was administered to or used by an individual who—
(i) was in a population specified by the declaration; and
(ii) was at the time of administration physically present in a geographic area specified by the declaration or had a connection to such area specified in the declaration.
(4) Applicability of certain conditions
With respect to immunity under paragraph (1) and subject to the other provisions of this section:
(A) In the case of a covered person who is a manufacturer or distributor of the covered countermeasure involved, the immunity applies without regard to whether such countermeasure was administered to or used by an individual in accordance with the conditions described in paragraph (3)(C).
(B) In the case of a covered person who is a program planner or qualified person with respect to the administration or use of the covered countermeasure, the scope of immunity includes circumstances in which the countermeasure was administered to or used by an individual in circumstances in which the covered person reasonably could have believed that the countermeasure was administered or used in accordance with the conditions described in paragraph (3)(C).
(5) Effect of distribution method
The provisions of this section apply to a covered countermeasure regardless of whether such countermeasure is obtained by donation, commercial sale, or any other means of distribution, except to the extent that, under paragraph (2)(E) of subsection (b), the declaration under such subsection provides that subsection (a) applies only to covered countermeasures obtained through a particular means of distribution.
(6) Rebuttable presumption
For purposes of paragraph (1), there shall be a rebuttable presumption that any administration or use, during the effective period of the emergency declaration by the Secretary under subsection (b), of a covered countermeasure shall have been for the category or categories of diseases, health conditions, or threats to health with respect to which such declaration was issued.
(b) Declaration by Secretary
(1) Authority to issue declaration
Subject to paragraph (2), if the Secretary makes a determination that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency, the Secretary may make a declaration, through publication in the Federal Register, recommending, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, and stating that subsection (a) is in effect with respect to the activities so recommended.
(2) Contents
In issuing a declaration under paragraph (1), the Secretary shall identify, for each covered countermeasure specified in the declaration—
(A) the category or categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure;
(B) the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect, which period or periods may be designated by dates, or by milestones or other description of events, including factors specified in paragraph (6);
(C) the population or populations of individuals for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation to all individuals);
(D) the geographic area or areas for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation), including, with respect to individuals in the populations identified under subparagraph (C), a specification, as determined appropriate by the Secretary, of whether the declaration applies only to individuals physically present in such areas or whether in addition the declaration applies to individuals who have a connection to such areas, which connection is described in the declaration; and
(E) whether subsection (a) is effective only to a particular means of distribution as provided in subsection (a)(5) for obtaining the countermeasure, and if so, the particular means to which such subsection is effective.
(3) Effective period of declaration
(A) Flexibility of period
The Secretary may, in describing periods under paragraph (2)(B), have different periods for different covered persons to address different logistical, practical or other differences in responsibilities.
(B) Additional time to be specified
In each declaration under paragraph (1), the Secretary, after consulting, to the extent the Secretary deems appropriate, with the manufacturer of the covered countermeasure, shall also specify a date that is after the ending date specified under paragraph (2)(B) and that allows what the Secretary determines is—
(i) a reasonable period for the manufacturer to arrange for disposition of the covered countermeasure, including the return of such product to the manufacturer; and
(ii) a reasonable period for covered persons to take such other actions as may be appropriate to limit administration or use of the covered countermeasure.
(C) Additional period for certain strategic national stockpile countermeasures
With respect to a covered countermeasure that is in the stockpile under
(4) Amendments to declaration
The Secretary may through publication in the Federal Register amend any portion of a declaration under paragraph (1). Such an amendment shall not retroactively limit the applicability of subsection (a) with respect to the administration or use of the covered countermeasure involved.
(5) Certain disclosures
In publishing a declaration under paragraph (1) in the Federal Register, the Secretary is not required to disclose any matter described in
(6) Factors to be considered
In deciding whether and under what circumstances or conditions to issue a declaration under paragraph (1) with respect to a covered countermeasure, the Secretary shall consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasure.
(7) Judicial review
No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this subsection.
(8) Preemption of State law
During the effective period of a declaration under subsection (b), or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—
(A) is different from, or is in conflict with, any requirement applicable under this section; and
(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act [
(9) Report to Congress
Within 30 days after making a declaration under paragraph (1), the Secretary shall submit to the appropriate committees of the Congress a report that provides an explanation of the reasons for issuing the declaration and the reasons underlying the determinations of the Secretary with respect to paragraph (2). Within 30 days after making an amendment under paragraph (4), the Secretary shall submit to such committees a report that provides the reasons underlying the determination of the Secretary to make the amendment.
(c) Definition of willful misconduct
(1) Definition
(A) In general
Except as the meaning of such term is further restricted pursuant to paragraph (2), the term "willful misconduct" shall, for purposes of subsection (d), denote an act or omission that is taken—
(i) intentionally to achieve a wrongful purpose;
(ii) knowingly without legal or factual justification; and
(iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
(B) Rule of construction
The criterion stated in subparagraph (A) shall be construed as establishing a standard for liability that is more stringent than a standard of negligence in any form or recklessness.
(2) Authority to promulgate regulatory definition
(A) In general
The Secretary, in consultation with the Attorney General, shall promulgate regulations, which may be promulgated through interim final rules, that further restrict the scope of actions or omissions by a covered person that may qualify as "willful misconduct" for purposes of subsection (d).
(B) Factors to be considered
In promulgating the regulations under this paragraph, the Secretary, in consultation with the Attorney General, shall consider the need to define the scope of permissible civil actions under subsection (d) in a way that will not adversely affect the public health.
(C) Temporal scope of regulations
The regulations under this paragraph may specify the temporal effect that they shall be given for purposes of subsection (d).
(D) Initial rulemaking
Within 180 days after December 30, 2005, the Secretary, in consultation with the Attorney General, shall commence and complete an initial rulemaking process under this paragraph.
(3) Proof of willful misconduct
In an action under subsection (d), the plaintiff shall have the burden of proving by clear and convincing evidence willful misconduct by each covered person sued and that such willful misconduct caused death or serious physical injury.
(4) Defense for acts or omissions taken pursuant to Secretary's declaration
Notwithstanding any other provision of law, a program planner or qualified person shall not have engaged in "willful misconduct" as a matter of law where such program planner or qualified person acted consistent with applicable directions, guidelines, or recommendations by the Secretary regarding the administration or use of a covered countermeasure that is specified in the declaration under subsection (b), provided either the Secretary, or a State or local health authority, was provided with notice of information regarding serious physical injury or death from the administration or use of a covered countermeasure that is material to the plaintiff's alleged loss within 7 days of the actual discovery of such information by such program planner or qualified person.
(5) Exclusion for regulated activity of manufacturer or distributor
(A) In general
If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [
(i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or
(ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.
Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement action.
(B) Definitions
For purposes of this paragraph, the following terms have the following meanings:
(i) Enforcement action
The term "enforcement action" means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [
(ii) Covered remedy
The term "covered remedy" means an outcome—
(I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [
(II) that results from a final determination by a court or from a final agency action.
(iii) Final
The terms "final" and "finally"—
(I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and
(II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal.
(C) Rules of construction
(i) In general
Nothing in this paragraph shall be construed—
(I) to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act [
(II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of the United States, of the Secretary, of the Attorney General, or of any other official with respect to any administrative or court proceeding under this chapter, under the Federal Food, Drug, and Cosmetic Act [
(ii) Mandatory recalls
A mandatory recall called for in the declaration is not a Food and Drug Administration enforcement action.
(d) Exception to immunity of covered persons
(1) In general
Subject to subsection (f), the sole exception to the immunity from suit and liability of covered persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct, as defined pursuant to subsection (c), by such covered person. For purposes of
(2) Persons who can sue
An action under this subsection may be brought for wrongful death or serious physical injury by any person who suffers such injury or by any representative of such a person.
(e) Procedures for suit
(1) Exclusive Federal jurisdiction
Any action under subsection (d) shall be filed and maintained only in the United States District Court for the District of Columbia.
(2) Governing law
The substantive law for decision in an action under subsection (d) shall be derived from the law, including choice of law principles, of the State in which the alleged willful misconduct occurred, unless such law is inconsistent with or preempted by Federal law, including provisions of this section.
(3) Pleading with particularity
In an action under subsection (d), the complaint shall plead with particularity each element of the plaintiff's claim, including—
(A) each act or omission, by each covered person sued, that is alleged to constitute willful misconduct relating to the covered countermeasure administered to or used by the person on whose behalf the complaint was filed;
(B) facts supporting the allegation that such alleged willful misconduct proximately caused the injury claimed; and
(C) facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or serious physical injury.
(4) Verification, certification, and medical records
(A) In general
In an action under subsection (d), the plaintiff shall verify the complaint in the manner stated in subparagraph (B) and shall file with the complaint the materials described in subparagraph (C). A complaint that does not substantially comply with subparagraphs (B) and (C) shall not be accepted for filing and shall not stop the running of the statute of limitations.
(B) Verification requirement
(i) In general
The complaint shall include a verification, made by affidavit of the plaintiff under oath, stating that the pleading is true to the knowledge of the deponent, except as to matters specifically identified as being alleged on information and belief, and that as to those matters the plaintiff believes it to be true.
(ii) Identification of matters alleged upon information and belief
Any matter that is not specifically identified as being alleged upon the information and belief of the plaintiff, shall be regarded for all purposes, including a criminal prosecution, as having been made upon the knowledge of the plaintiff.
(C) Materials required
In an action under subsection (d), the plaintiff shall file with the complaint—
(i) an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed, certifying, and explaining the basis for such physician's belief, that such person suffered the serious physical injury or death alleged in the complaint and that such injury or death was proximately caused by the administration or use of a covered countermeasure; and
(ii) certified medical records documenting such injury or death and such proximate causal connection.
(5) Three-judge court
Any action under subsection (d) shall be assigned initially to a panel of three judges. Such panel shall have jurisdiction over such action for purposes of considering motions to dismiss, motions for summary judgment, and matters related thereto. If such panel has denied such motions, or if the time for filing such motions has expired, such panel shall refer the action to the chief judge for assignment for further proceedings, including any trial.
(6) Civil discovery
(A) Timing
In an action under subsection (d), no discovery shall be allowed—
(i) before each covered person sued has had a reasonable opportunity to file a motion to dismiss;
(ii) in the event such a motion is filed, before the court has ruled on such motion; and
(iii) in the event a covered person files an interlocutory appeal from the denial of such a motion, before the court of appeals has ruled on such appeal.
(B) Standard
Notwithstanding any other provision of law, the court in an action under subsection (d) shall permit discovery only with respect to matters directly related to material issues contested in such action, and the court shall compel a response to a discovery request (including a request for admission, an interrogatory, a request for production of documents, or any other form of discovery request) under Rule 37, Federal Rules of Civil Procedure, only if the court finds that the requesting party needs the information sought to prove or defend as to a material issue contested in such action and that the likely benefits of a response to such request equal or exceed the burden or cost for the responding party of providing such response.
(7) Reduction in award of damages for collateral source benefits
(A) In general
In an action under subsection (d), the amount of an award of damages that would otherwise be made to a plaintiff shall be reduced by the amount of collateral source benefits to such plaintiff.
(B) Provider of collateral source benefits not to have lien or subrogation
No provider of collateral source benefits shall recover any amount against the plaintiff or receive any lien or credit against the plaintiff's recovery or be equitably or legally subrogated to the right of the plaintiff in an action under subsection (d).
(C) Collateral source benefit defined
For purposes of this paragraph, the term "collateral source benefit" means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any service, product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to—
(i) any State or Federal health, sickness, income-disability, accident, or workers' compensation law;
(ii) any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage;
(iii) any contract or agreement of any group, organization, partnership, or corporation to provide, pay for, or reimburse the cost of medical, hospital, dental, or income disability benefits; or
(iv) any other publicly or privately funded program.
(8) Noneconomic damages
In an action under subsection (d), any noneconomic damages may be awarded only in an amount directly proportional to the percentage of responsibility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term "noneconomic damages" means damages for losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.
(9) Rule 11 sanctions
Whenever a district court of the United States determines that there has been a violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are responsible for the violation, an appropriate sanction, which may include an order to pay the other party or parties for the reasonable expenses incurred as a direct result of the filing of the pleading, motion, or other paper that is the subject of the violation, including a reasonable attorney's fee. Such sanction shall be sufficient to deter repetition of such conduct or comparable conduct by others similarly situated, and to compensate the party or parties injured by such conduct.
(10) Interlocutory appeal
The United States Court of Appeals for the District of Columbia Circuit shall have jurisdiction of an interlocutory appeal by a covered person taken within 30 days of an order denying a motion to dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection (a) or based on an assertion of the exclusion under subsection (c)(5).
(f) Actions by and against the United States
Nothing in this section shall be construed to abrogate or limit any right, remedy, or authority that the United States or any agency thereof may possess under any other provision of law or to waive sovereign immunity or to abrogate or limit any defense or protection available to the United States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of
(g) Severability
If any provision of this section, or the application of such provision to any person or circumstance, is held to be unconstitutional, the remainder of this section and the application of such remainder to any person or circumstance shall not be affected thereby.
(h) Rule of construction concerning National Vaccine Injury Compensation Program
Nothing in this section, or any amendment made by the Public Readiness and Emergency Preparedness Act, shall be construed to affect the National Vaccine Injury Compensation Program under subchapter XIX of this chapter.
(i) Definitions
In this section:
(1) Covered countermeasure
The term "covered countermeasure" means—
(A) a qualified pandemic or epidemic product (as defined in paragraph (7));
(B) a security countermeasure (as defined in
(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (
(D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared under
(2) Covered person
The term "covered person", when used with respect to the administration or use of a covered countermeasure, means—
(A) the United States; or
(B) a person or entity that is—
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;
(iii) a program planner of such countermeasure;
(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or
(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
(3) Distributor
The term "distributor" means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
(4) Manufacturer
The term "manufacturer" includes—
(A) a contractor or subcontractor of a manufacturer;
(B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure; and
(C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
(5) Person
The term "person" includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local government agency or department.
(6) Program planner
The term "program planner" means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under subsection (b).
(7) Qualified pandemic or epidemic product
The term "qualified pandemic or epidemic product" means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (
(A)(i) a product manufactured, used, designed, developed, modified, licensed, or procured—
(I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or
(II) to limit the harm such pandemic or epidemic might otherwise cause;
(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or
(iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and
(B)(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [
(ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [
(iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [
(8) Qualified person
The term "qualified person", when used with respect to the administration or use of a covered countermeasure, means—
(A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or
(B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b).
(9) Security countermeasure
The term "security countermeasure" has the meaning given such term in
(10) Serious physical injury
The term "serious physical injury" means an injury that—
(A) is life threatening;
(B) results in permanent impairment of a body function or permanent damage to a body structure; or
(C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
(July 1, 1944, ch. 373, title III, §319F–3, as added
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (b)(8)(B), (c)(5)(A), (B)(i), (ii)(I), (C)(i), and (i)(7)(B)(i), is act June 25, 1938, ch. 675,
The Federal Rules of Civil Procedure, referred to in subsec. (e)(6)(B), (9), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.
The Public Readiness and Emergency Preparedness Act, referred to in subsec. (h), is div. C of
Amendments
2020—Subsec. (i)(1)(D).
"(i) approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or successor regulations);
"(ii) subject to the emergency use authorization issued by the Secretary on March 2, 2020, or subsequent emergency use authorizations, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act [
"(iii) used during the period beginning on January 27, 2020, and ending on October 1, 2024, in response to the public health emergency declared on January 31, 2020, pursuant to
2013—Subsec. (i)(1)(C).
Subsec. (i)(7)(A)(iii).
Subsec. (i)(7)(B)(iii).
1 So in original. Probably should be chapter "V".
2 So in original. A third closing parenthesis probably should appear.
§247d–6e. Covered countermeasure process
(a) Establishment of Fund
Upon the issuance by the Secretary of a declaration under
(b) Payment of compensation
(1) In general
If the Secretary issues a declaration under 247d–6d(b) of this title, the Secretary shall, after amounts have by law been provided for the Fund under subsection (a), provide compensation to an eligible individual for a covered injury directly caused by the administration or use of a covered countermeasure pursuant to such declaration.
(2) Elements of compensation
The compensation that shall be provided pursuant to paragraph (1) shall have the same elements, and be in the same amount, as is prescribed by
(3) Rule of construction
Neither reasonable and necessary medical benefits nor lifetime total benefits for lost employment income due to permanent and total disability shall be limited by
(4) Determination of eligibility and compensation
Except as provided in this section, the procedures for determining, and for reviewing a determination of, whether an individual is an eligible individual, whether such individual has sustained a covered injury, whether compensation may be available under this section, and the amount of such compensation shall be those stated in
(5) Covered countermeasure injury table
(A) In general
The Secretary shall by regulation establish a table identifying covered injuries that shall be presumed to be directly caused by the administration or use of a covered countermeasure and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such presumption to apply. The Secretary may only identify such covered injuries, for purpose of inclusion on the table, where the Secretary determines, based on compelling, reliable, valid, medical and scientific evidence that administration or use of the covered countermeasure directly caused such covered injury.
(B) Amendments
The provisions of
(C) Judicial review
No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this paragraph.
(6) Meanings of terms
In applying
(A) the terms "vaccine" and "smallpox vaccine" shall be deemed to mean a covered countermeasure;
(B) the terms "smallpox vaccine injury table" and "table established under
(C) other terms used in those sections shall have the meanings given to such terms by this section.
(c) Voluntary program
The Secretary shall ensure that a State, local, or Department of Health and Human Services plan to administer or use a covered countermeasure is consistent with any declaration under 247d–6d of this title and any applicable guidelines of the Centers for Disease Control and Prevention and that potential participants are educated with respect to contraindications, the voluntary nature of the program, and the availability of potential benefits and compensation under this part.
(d) Exhaustion; exclusivity; election
(1) Exhaustion
Subject to paragraph (5), a covered individual may not bring a civil action under
(2) Tolling of statute of limitations
The time limit for filing a civil action under
(3) Rule of construction
This section shall not be construed as superseding or otherwise affecting the application of a requirement, under
(4) Exclusivity
The remedy provided by subsection (a) shall be exclusive of any other civil action or proceeding for any claim or suit this section encompasses, except for a proceeding under
(5) Election
If under subsection (a) the Secretary determines that a covered individual qualifies for compensation, the individual has an election to accept the compensation or to bring an action under
(e) Definitions
For purposes of this section, the following terms shall have the following meanings:
(1) Covered countermeasure
The term "covered countermeasure" has the meaning given such term in
(2) Covered individual
The term "covered individual", with respect to administration or use of a covered countermeasure pursuant to a declaration, means an individual—
(A) who is in a population specified in such declaration, and with respect to whom the administration or use of the covered countermeasure satisfies the other specifications of such declaration; or
(B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith belief that the individual is in the category described by subparagraph (A).
(3) Covered injury
The term "covered injury" means serious physical injury or death.
(4) Declaration
The term "declaration" means a declaration under
(5) Eligible individual
The term "eligible individual" means an individual who is determined, in accordance with subsection (b), to be a covered individual who sustains a covered injury.
(July 1, 1944, ch. 373, title III, §319F–4, as added
Editorial Notes
References in Text
H. Con. Res. 95 of the 109th Congress, referred to in subsec. (a), is H. Con. Res. 95, Apr. 28, 2005,
§247d–6f. Provision of medical countermeasures to Indian programs and facilities
In the event that the Secretary deploys the contents of the Strategic National Stockpile under
(July 1, 1944, ch. 373, title III, §319F–5, as added
§247d–7. Repealed. Pub. L. 117–328, div. FF, title II, §2231(b), Dec. 29, 2022, 136 Stat. 5753
Section, act July 1, 1944, ch. 373, title III, §319G, as added
§247d–7a. Grants regarding training and education of certain health professionals
(a) In general
The Secretary may make awards of grants and cooperative agreements to appropriate public and nonprofit private health or educational entities, including health professions schools and programs as defined in
(b) Authority regarding non-Federal contributions
The Secretary may require as a condition of an award under subsection (a) that a grantee under such subsection provide non-Federal contributions toward the purpose described in such subsection.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.
(July 1, 1944, ch. 373, title III, §319H, as added
§247d–7b. Emergency system for advance registration of volunteer health professional
(a) In general
Not later than 12 months after December 19, 2006, the Secretary shall link existing State verification systems to maintain a single national interoperable network of systems, each system being maintained by a State or group of States, for the purpose of verifying the credentials and licenses of health care professionals who volunteer to provide health services during a public health emergency. Such health care professionals may include members of the National Disaster Medical System, members of the Medical Reserve Corps, and individual health care professionals.
(b) Requirements
The interoperable network of systems established under subsection (a) (referred to in this section as the "verification network") shall include—
(1) with respect to each volunteer health professional included in the verification network—
(A) information necessary for the rapid identification of, and communication with, such professionals; and
(B) the credentials, certifications, licenses, and relevant training of such individuals; and
(2) the name of each member of the Medical Reserve Corps, the National Disaster Medical System, and any other relevant federally-sponsored or administered programs determined necessary by the Secretary.
(c) Other assistance
The Secretary may make grants and provide technical assistance to States and other public or nonprofit private entities for activities relating to the verification network developed under subsection (a).
(d) Accessibility
The Secretary shall ensure that the verification network is electronically accessible by State, local, and tribal health departments and can be linked with the identification cards under
(e) Confidentiality
The Secretary shall establish and require the application of and compliance with measures to ensure the effective security of, integrity of, and access to the data included in the verification network.
(f) Coordination
The Secretary shall coordinate with the Secretary of Veterans Affairs and the Secretary of Homeland Security to assess the feasibility of integrating the verification network under this section with the VetPro system of the Department of Veterans Affairs and the National Emergency Responder Credentialing System of the Department of Homeland Security. The Secretary shall, if feasible, integrate the verification network under this section with such VetPro system and the National Emergency Responder Credentialing System.
(g) Updating of information
The States that are participants in the verification network shall, on at least a quarterly basis, work with the Director to provide for the updating of the information contained in the verification network.
(h) Clarification
Inclusion of a health professional in the verification network shall not constitute appointment of such individual as a Federal employee for any purpose, either under
(i) Health care provider licenses
The Secretary shall encourage States to establish and implement mechanisms to waive the application of licensing requirements applicable to health professionals, who are seeking to provide medical services (within their scope of practice), during a national, State, local, or tribal public health emergency upon verification that such health professionals are licensed and in good standing in another State and have not been disciplined by any State health licensing or disciplinary board. In order to inform the development of such mechanisms by States, the Secretary shall make available information and material provided by States that have developed mechanisms to waive the application of licensing requirements to applicable health professionals seeking to provide medical services during a public health emergency. Such information shall be made publicly available in a manner that does not compromise national security.
(j) Rule of construction
This section may not be construed as authorizing the Secretary to issue requirements regarding the provision by the States of credentials, licenses, accreditations, or hospital privileges.
(k) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023.
(July 1, 1944, ch. 373, title III, §319I, as added
Editorial Notes
Amendments
2019—
Subsec. (a).
Subsec. (i).
Subsec. (k).
2013—Subsec. (k).
2006—Subsecs. (a), (b).
Subsec. (c).
Subsecs. (d) to (k).
§247d–7c. Supplies and services in lieu of award funds
(a) In general
Upon the request of a recipient of an award under any of
(b) Corresponding reduction in payments
With respect to a request described in subsection (a), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(July 1, 1944, ch. 373, title III, §319J, as added
§247d–7d. Security for countermeasure development and production
(a) In general
The Secretary, in consultation with the Attorney General and the Secretary of Defense, may provide technical or other assistance to provide security to persons or facilities that conduct development, production, distribution, or storage of priority countermeasures (as defined in
(b) Guidelines
The Secretary may develop guidelines to enable entities eligible to receive assistance under subsection (a) to secure their facilities against potential terrorist attack.
(July 1, 1944, ch. 373, title III, §319K, as added
Editorial Notes
Amendments
2019—Subsec. (a).
§247d–7e. Biomedical Advanced Research and Development Authority
(a) Definitions
In this section:
(1) BARDA
The term "BARDA" means the Biomedical Advanced Research and Development Authority.
(2) Fund
The term "Fund" means the Biodefense Medical Countermeasure Development Fund established under subsection (d).
(3) Other transactions
The term "other transactions" means transactions, other than procurement contracts, grants, and cooperative agreements.
(4) Qualified countermeasure
The term "qualified countermeasure" has the meaning given such term in
(5) Qualified pandemic or epidemic product
The term "qualified pandemic or epidemic product" has the meaning given the term in
(6) Advanced research and development
(A) In general
The term "advanced research and development" means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—
(i) are conducted after basic research and preclinical development of the product; and
(ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [
(B) Activities included
The term under subparagraph (A) includes—
(i) testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act [
(ii) design and development of tests or models, including animal models, for such testing;
(iii) activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity;
(iv) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products;
(v) activities to improve the shelf-life of the product or technologies for administering the product; and
(vi) such other activities as are part of the advanced stages of testing, refinement, improvement, manufacturing, or preparation of the product for such use and as are specified by the Secretary.
(7) Security countermeasure
The term "security countermeasure" has the meaning given such term in
(8) Research tool
The term "research tool" means a device, technology, biological material (including a cell line or an antibody), reagent, animal model, computer system, computer software, or analytical technique that is developed to assist in the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products.
(9) Program manager
The term "program manager" means an individual appointed to carry out functions under this section and authorized to provide project oversight and management of strategic initiatives.
(10) Person
The term "person" includes an individual, partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government agency or department.
(b) Strategic plan for countermeasure research, development, and procurement
(1) In general
Not later than 6 months after December 19, 2006, the Secretary shall develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, support for domestic manufacturing surge capacity and capabilities, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. The Secretary shall carry out such activities as may be practicable to disseminate the information contained in such plan to persons who may have the capacity to substantially contribute to the activities described in such strategic plan. The Secretary shall update and incorporate such plan as part of the National Health Security Strategy described in
(2) Content
The strategic plan under paragraph (1) shall guide—
(A) research and development, conducted or supported by the Department of Health and Human Services, of qualified countermeasures and qualified pandemic or epidemic products against possible biological, chemical, radiological, and nuclear agents and to emerging infectious diseases;
(B) innovation in technologies that may assist advanced research and development of qualified countermeasures and qualified pandemic or epidemic products (such research and development referred to in this section as "countermeasure and product advanced research and development");
(C) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products; and
(D) procurement of such qualified countermeasures and qualified pandemic or epidemic products by such Department.
(c) Biomedical Advanced Research and Development Authority
(1) Establishment
There is established within the Department of Health and Human Services the Biomedical Advanced Research and Development Authority.
(2) In general
Based upon the strategic plan described in subsection (b), the Secretary shall coordinate the acceleration of countermeasure and product advanced research and development by—
(A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies, relevant industries, academia, and other persons, with respect to such advanced research and development;
(B) promoting countermeasure and product advanced research and development, including through the establishment and maintenance of domestic manufacturing surge capacity and capabilities, consistent with subsection (a)(6)(B)(iv);
(C) facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act [
(D) promoting innovation to reduce the time and cost of countermeasure and product advanced research and development.
(3) Director
The BARDA shall be headed by a Director (referred to in this section as the "Director") who shall be appointed by the Secretary and to whom the Secretary shall delegate such functions and authorities as necessary to implement this section, including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section.
(4) Duties
(A) Collaboration
To carry out the purpose described in paragraph (2)(A), the Secretary shall—
(i) facilitate and increase the expeditious and direct communication between the Department of Health and Human Services and relevant persons with respect to countermeasure and product advanced research and development, including by—
(I) facilitating such communication regarding the processes for procuring such advanced research and development with respect to qualified countermeasures and qualified pandemic or epidemic products of interest;
(II) soliciting information about and data from research on potential qualified countermeasures and qualified pandemic or epidemic products and related technologies;
(III) facilitating such communication, as appropriate, regarding manufacturing surge capacity and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic products to prepare for, or respond to, a public health emergency or potential public health emergency; and
(IV) facilitating such communication, as appropriate and in a manner that does not compromise national security, with respect to potential eligibility for the material threat medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act [
(ii) at least annually—
(I) convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies as appropriate, and other interested persons;
(II) sponsor opportunities to demonstrate the operation and effectiveness of relevant biodefense countermeasure technologies; and
(III) convene such working groups on countermeasure and product advanced research and development as the Secretary may determine are necessary to carry out this section;
(iii) communicate regularly with entities in receipt of an award pursuant to subparagraph (B)(v), and facilitate communication between such entities and other entities in receipt of an award pursuant to subparagraph (B)(iv), as appropriate, for purposes of planning and response regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities, including any planned uses of such capacity and capabilities in the near- and mid-term, and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities; and
(iv) carry out the activities described in
(B) Support advanced research and development
To carry out the purpose described in paragraph (2)(B), the Secretary shall—
(i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products;
(ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services;
(iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act [
(iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development; and
(v) award contracts, grants, and cooperative agreements and enter into other transactions to support, maintain, and improve domestic manufacturing surge capacity and capabilities, including through supporting flexible or advanced manufacturing, to ensure that additional capacity is available to rapidly manufacture products that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency.
(C) Facilitating advice
To carry out the purpose described in paragraph (2)(C) the Secretary shall—
(i) connect interested persons with the offices or employees authorized by the Secretary to advise such persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [
(ii) with respect to persons performing countermeasure and product advanced research and development funded under this section, enable such offices or employees to provide to the extent practicable such advice in a manner that is ongoing and that is otherwise designed to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure; and
(iii) consult with the Commissioner of Food and Drugs, pursuant to section 565(b)(2) of the Federal Food, Drug, and Cosmetic Act [
(D) Supporting innovation
To carry out the purpose described in paragraph (2)(D), the Secretary may award contracts, grants, and cooperative agreements, or enter into other transactions, such as prize payments, to promote—
(i) innovation in technologies that may assist countermeasure and product advanced research and development, including to improve manufacturing capacities and capabilities for medical countermeasures;
(ii) research on and development of research tools and other devices and technologies; and
(iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, platform technologies, technologies to administer countermeasures, and technologies to improve storage and transportation of countermeasures.
(E) Medical countermeasures innovation partner
(i) In general
To support the purposes described in paragraph (2), the Secretary, acting through the Director of BARDA, may enter into an agreement (including through the use of grants, contracts, cooperative agreements, or other transactions as described in paragraph (5)) with an independent, nonprofit entity to—
(I) foster and accelerate the development and innovation of medical countermeasures and technologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products, including through the use of strategic venture capital practices and methods;
(II) promote the development of new and promising technologies that address urgent medical countermeasure needs, as identified by the Secretary;
(III) address unmet public health needs that are directly related to medical countermeasure requirements, such as novel antimicrobials for multidrug resistant organisms and multiuse platform technologies for diagnostics, prophylaxis, vaccines, and therapeutics; and
(IV) provide expert consultation and advice to foster viable medical countermeasure innovators, including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical, biological, radiological, and nuclear countermeasure products.
(ii) Eligibility
(I) In general
To be eligible to enter into an agreement under clause (i) an entity shall—
(aa) be an independent, nonprofit entity;
(bb) have a demonstrated record of being able to create linkages between innovators and investors and leverage such partnerships and resources for the purpose of addressing identified strategic needs of the Federal Government;
(cc) have experience in promoting novel technology innovation;
(dd) be problem-driven and solution-focused based on the needs, requirements, and problems identified by the Secretary under clause (iv);
(ee) demonstrate the ability, or the potential ability, to promote the development of medical countermeasure products;
(ff) demonstrate expertise, or the capacity to develop or acquire expertise, related to technical and regulatory considerations with respect to medical countermeasures; and
(gg) not be within the Department of Health and Human Services.
(II) Partnering experience
In selecting an entity with which to enter into an agreement under clause (i), the Secretary shall place a high value on the demonstrated experience of the entity in partnering with the Federal Government to meet identified strategic needs.
(iii) Not agency
An entity that enters into an agreement under clause (i) shall not be deemed to be a Federal agency for any purpose, including for any purpose under title 5.
(iv) Direction
Pursuant to an agreement entered into under this subparagraph, the Secretary, acting through the Director of BARDA, shall provide direction to the entity that enters into an agreement under clause (i). As part of this agreement the Director of BARDA shall—
(I) communicate the medical countermeasure needs, requirements, and problems to be addressed by the entity under the agreement;
(II) develop a description of work to be performed by the entity under the agreement;
(III) provide technical feedback and appropriate oversight over work carried out by the entity under the agreement, including subsequent development and partnerships consistent with the needs and requirements set forth in this subparagraph;
(IV) ensure fair consideration of products developed under the agreement in order to maintain competition to the maximum practical extent, as applicable and appropriate under applicable provisions of this section; and
(V) ensure, as a condition of the agreement that the entity—
(aa) has in place a comprehensive set of policies that demonstrate a commitment to transparency and accountability;
(bb) protects against conflicts of interest through a comprehensive set of policies that address potential conflicts of interest, ethics, disclosure, and reporting requirements;
(cc) provides monthly accounting on the use of funds provided under such agreement; and
(dd) provides on a quarterly basis, reports regarding the progress made toward meeting the identified needs set forth in the agreement.
(v) Supplement not supplant
Activities carried out under this subparagraph shall supplement, and not supplant, other activities carried out under this section.
(vi) No establishment of entity
To prevent unnecessary duplication and target resources effectively, nothing in this subparagraph shall be construed to authorize the Secretary to establish within the Department of Health and Human Services an entity for the purposes of carrying out this subparagraph.
(vii) Transparency and oversight
Upon request, the Secretary shall provide to Congress the information provided to the Secretary under clause (iv)(V)(dd).
(viii) Independent evaluation
Not later than 4 years after December 13, 2016, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the Secretary and the appropriate committees of Congress a report, concerning the activities conducted under this subparagraph. Such report shall include recommendations with respect to any agreement or activities carried out pursuant to this subparagraph.
(ix) Sunset
This subparagraph shall have no force or effect after September 30, 2028.
(F) Strategic initiatives
The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of countermeasures and products, as applicable, to address areas including—
(i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;
(ii) threats that consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and
(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.
(G) Annual reports by award recipients
As a condition of receiving an award under subparagraph (B)(v), a recipient shall develop and submit to the Secretary annual reports related to the maintenance of such capacity and capabilities, including ensuring that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary.
(5) Transaction authorities
(A) Other transactions
(i) In general
The Secretary shall have the authority to enter into other transactions (as defined in subsection (a)(3)) under this subsection.
(ii) Limitations on authority
(I) In general
To the maximum extent practicable, competitive procedures shall be used when entering into transactions to carry out projects under this subsection.
(II) Written determinations required
The authority of this subparagraph may be exercised for a project that is expected to cost the Department of Health and Human Services in excess of $100,000,000 only upon a written determination by the Assistant Secretary for Financial Resources, that the use of such authority is essential to promoting the success of the project. The authority of the Assistant Secretary for Financial Resources under this subclause may not be delegated.
(iii) Authority during a public health emergency
(I) In general
Notwithstanding clause (ii), the Secretary, shall, to the maximum extent practicable, use competitive procedures when entering into transactions to carry out projects under this subsection for purposes of a public health emergency declared by the Secretary under
(II) Report
After the expiration of the public health emergency declared by the Secretary under
(iv) Guidelines
The Secretary shall establish guidelines regarding the use of the authority under clause (i). Such guidelines shall include auditing requirements.
(B) Expedited authorities
(i) In general
In awarding contracts, grants, and cooperative agreements, and in entering into other transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts, supplied by subsections (b), (c), and (d) of
(ii) Application of provisions
Provisions in such
(iii) Authority to limit competition
For purposes of applying
(iv) Availability of data
The Secretary shall require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction under subparagraph (B) or (D) of paragraph (4), a person make available to the Secretary on an ongoing basis, and submit upon request to the Secretary, all data related to or resulting from countermeasure and product advanced research and development carried out pursuant to this section.
(C) Advance payments; advertising
The Secretary may waive the requirements of
(D) Milestone-based payments allowed
In awarding contracts, grants, and cooperative agreements, and in entering into other transactions, under this section, the Secretary may use milestone-based awards and payments.
(E) Foreign nationals eligible
The Secretary may under this section award contracts, grants, and cooperative agreements to, and may enter into other transactions with, highly qualified foreign national persons outside the United States, alone or in collaboration with American participants, when such transactions may inure to the benefit of the American people.
(F) Establishment of research centers
The Secretary may assess the feasibility and appropriateness of establishing, through contract, grant, cooperative agreement, or other transaction, an arrangement with an existing research center in order to achieve the goals of this section. If such an agreement is not feasible and appropriate, the Secretary may establish one or more federally-funded research and development centers, or university-affiliated research centers, in accordance with
(G) Government purpose
In awarding contracts, grants, and cooperative agreements under this section, the Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.
(H) Supporting warm-base and surge capacity and capabilities
Pursuant to an award under subparagraph (B)(v),1 the Secretary may make payments for activities necessary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary to prepare for, or respond to, an existing or potential public health emergency or otherwise address threats that pose a significant level of risk to national security. The Secretary may support the utilization of such capacity and capabilities under awards for countermeasure and product advanced research and development, as appropriate, to provide for the maintenance of such capacity and capabilities.
(6) At-risk individuals
In carrying out the functions under this section, the Secretary may give priority to the advanced research and development of qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, older adults, and other at-risk individuals with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products.
(7) Personnel authorities
(A) Specially qualified scientific and professional personnel
(i) In general
In addition to any other personnel authorities, the Secretary may—
(I) without regard to those provisions of title 5 governing appointments in the competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such as program managers, to carry out this section; and
(II) compensate them in the same manner and subject to the same terms and conditions in which individuals appointed under section 9903 of such title are compensated, without regard to the provisions of
(ii) Manner of exercise of authority
The authority provided for in this subparagraph shall be exercised subject to the same limitations described in
(iii) Term of appointment
The term limitations described in
(B) Special consultants
In carrying out this section, the Secretary may appoint special consultants pursuant to
(C) Limitation
(i) In general
The Secretary may hire up to 100 highly qualified individuals, or up to 50 percent of the total number of employees, whichever is less, under the authorities provided for in subparagraphs (A) and (B).
(ii) Report
The Secretary shall report to Congress on a biennial basis on the implementation of this subparagraph.
(d) Fund
(1) Establishment
There is established the Biodefense Medical Countermeasure Development Fund, which shall be available to carry out this section in addition to such amounts as are otherwise available for this purpose.
(2) Funding
To carry out the purposes of this section, there is authorized to be appropriated to the Fund $611,700,000 for each of fiscal years 2019 through 2023, such amounts to remain available until expended.
(e) Inapplicability of certain provisions
(1) Disclosure
(A) Nondisclosure of information
(i) In general
Information described in clause (ii) shall be deemed to be information described in
(ii) Information described
The information described in this clause is information relevant to programs of the Department of Health and Human Services that could compromise national security and reveal significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against chemical, biological, radiological, or nuclear threats, and is comprised of—
(I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c);
(II) information pertaining to the location security, personnel, and research materials and methods of high-containment laboratories conducting research with select agents, toxins, or other agents with a material threat determination under
(III) security and vulnerability assessments.
(B) Review
Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or necessity of continued nondisclosure.
(C) Reporting
One year after June 24, 2019, and annually thereafter, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclosure, as well as the nature of any request under
(D) Sunset
This paragraph shall cease to have force or effect after December 31, 2024.
(2) Review
Notwithstanding
(f) Independent evaluation
(1) In general
Not later than 180 days after December 29, 2022, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out to facilitate flexible manufacturing capacity pursuant to this section.
(2) Report
Not later than 1 year after December 29, 2022, the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess—
(A) the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological, radiological, and nuclear threats;
(B) the activities supported by flexible manufacturing initiatives;
(C) the ability of flexible manufacturing activities carried out under this section to—
(i) secure and leverage leading technical expertise with respect to countermeasure advanced research, development, and manufacturing processes; and
(ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents; and
(D) plans for the near-, mid-, and long-term sustainment of manufacturing activities carried out under this section, including such activities pursuant to subsection (c)(5)(H), specific actions to regularly assess the ability of recipients of an award under subsection (c)(4)(B)(v) to rapidly manufacture countermeasures as required by the Secretary, and recommendations to address challenges, if any, related to such activities.
(July 1, 1944, ch. 373, title III, §319L, as added
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(6)(A)(ii), (B)(i) and (c)(2)(C), (4)(B)(iii), (C)(i), (iii), is act June 25, 1938, ch. 675,
The Federal Tort Claims Act, referred to in subsec. (c)(5)(B)(ii), is title IV of act Aug. 2, 1946, ch. 753,
Codification
In subsec. (c)(5)(C), "
In subsec. (c)(5)(F), "
Amendments
2024—Subsec. (e)(1)(D).
2023—Subsec. (e)(1)(D).
2022—Subsec. (a)(6)(B)(iv), (v).
Subsec. (a)(6)(B)(vi).
Subsec. (b)(1).
Subsec. (b)(2)(C), (D).
Subsec. (c)(2)(B).
Subsec. (c)(4)(A)(i)(III), (IV).
Subsec. (c)(4)(A)(iii), (iv).
Subsec. (c)(4)(B)(v).
Subsec. (c)(4)(C)(iii).
Subsec. (c)(4)(D)(i).
Subsec. (c)(4)(E)(ix).
Subsec. (c)(4)(G).
Subsec. (c)(5)(H).
Subsec. (e)(2).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (f)(2)(D).
2020—Subsec. (c)(5)(A)(iii), (iv).
2019—Subsec. (a)(3).
Subsec. (c)(4)(A)(iii).
Subsec. (c)(4)(D)(iii).
Subsec. (c)(4)(E)(ix).
Subsec. (c)(4)(F).
Subsec. (c)(5)(A)(i).
Subsec. (c)(5)(A)(ii)(I).
Subsec. (c)(5)(A)(ii)(II).
Subsec. (c)(6).
Subsec. (d)(2).
Subsec. (e)(1)(A).
Subsec. (e)(1)(C).
Subsec. (e)(1)(D).
2016—Subsec. (c)(3).
Subsec. (c)(4)(E).
2013—Subsec. (c)(4)(B)(iii).
Subsec. (c)(4)(D)(iii).
Subsec. (c)(5)(G).
Subsec. (d)(2).
"(A) $1,070,000,000 for fiscal years 2006 through 2008, the amounts to remain available until expended; and
"(B) such sums as may be necessary for subsequent fiscal years, the amounts to remain available until expended."
Subsec. (e)(1)(C).
Subsec. (f).
Executive Documents
Ex. Ord. No. 13887. Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health
Ex. Ord. No. 13887, Sept. 19, 2019, 84 F.R. 49935, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, including
(b) Vaccination is the most effective defense against influenza. Despite recommendations by the Centers for Disease Control and Prevention (CDC) that nearly every American should receive the influenza vaccine annually, however, seasonal influenza vaccination levels in the United States have currently reached only about 45 percent of CDC goals.
(c) All influenza vaccines presently in use have been developed for circulating or anticipated influenza viruses. These vaccines must be reformulated for each influenza season as well as in the event of a pandemic. Additional research is needed to develop influenza vaccines that provide more effective and longer-lasting protection against many or all influenza viruses.
(d) The current domestic enterprise for manufacturing influenza vaccines has critical shortcomings. Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires months-long production timelines, limiting their utility for pandemic control; rely on a potentially vulnerable supply chain of eggs; require the use of vaccine viruses adapted for growth in eggs, which could introduce mutations of the influenza vaccine virus that may render the final product less effective; and are unsuitable for efficient and scalable continuous manufacturing platforms.
(e) The seasonal influenza vaccine market rewards manufacturers that deliver vaccines in time for the influenza season, without consideration of the speed or scale of these manufacturers' production processes. This approach is insufficient to meet the response needs in the event of a pandemic, which can emerge rapidly and with little warning. Because the market does not sufficiently reward speed, and because a pandemic has the potential to overwhelm or compromise essential government functions, including defense and homeland security, the Government must take action to promote faster and more scalable manufacturing platforms.
(b) In addition to the Co-Chairs, the Task Force shall consist of a senior official from the following executive branch departments, agencies, and offices:
(i) the Department of Defense (DOD);
(ii) the Department of Justice;
(iii) the Department of Agriculture;
(iv) the Department of Veterans Affairs (VA);
(v) the Department of Homeland Security;
(vi) the United States Food and Drug Administration;
(vii) the Centers for Disease Control and Prevention;
(viii) the National Institutes of Health (NIH);
(ix) the Centers for Medicare and Medicaid Services (CMS); and
(x) the Biomedical Advanced Research and Development Authority (BARDA).
(c) The Co-Chairs may jointly invite additional Federal Government representatives, with the consent of the applicable executive department, agency, or office head, to attend meetings of the Task Force or to become members of the Task Force, as appropriate.
(d) The staffs of the Department of State, the Office of Management and Budget (OMB), the National Security Council, the Council of Economic Advisers, the Domestic Policy Council, the National Economic Council, and the Office of Science and Technology Policy (OSTP) may attend and participate in any Task Force meetings or discussions.
(e) The Task Force may consult with State, local, tribal, and territorial government officials and private sector representatives, as appropriate and consistent with applicable law.
(f) Within 120 days of the date of this order [Sept. 19, 2019], the Task Force shall submit a report to the President, through the Assistant to the President for National Security Affairs, the Assistant to the President for Domestic Policy, the Director of the Office of Management and Budget, and the Director of the Office of Science and Technology Policy. The report shall include:
(i) a 5-year national plan (Plan) to promote the use of more agile and scalable vaccine manufacturing technologies and to accelerate development of vaccines that protect against many or all influenza viruses;
(ii) recommendations for encouraging non-profit, academic, and private-sector influenza vaccine innovation; and
(iii) recommendations for increasing influenza vaccination among the populations recommended by the CDC and for improving public understanding of influenza risk and informed influenza vaccine decision-making.
(g) Not later than June 1 of each of the 5 years following submission of the report described in subsection (f) of this section, the Task Force shall submit an update on implementation of the Plan and, as appropriate, new recommendations for achieving the policy objectives set forth in section 2 of this order.
(a) The Secretary of HHS shall:
(i) through the Assistant Secretary for Preparedness and Response and BARDA:
(A) estimate the cost of expanding and diversifying domestic vaccine-manufacturing capacity to use innovative, faster, and more scalable technologies, including cell-based and recombinant vaccine manufacturing, through cost-sharing agreements with the private sector, which shall include an agreed-upon pricing strategy during a pandemic;
(B) estimate the cost of expanding domestic production capacity of adjuvants in order to combine such adjuvants with both seasonal and pandemic influenza vaccines;
(C) estimate the cost of expanding domestic fill-and-finish capacity to rapidly fulfill antigen and adjuvant needs for pandemic response;
(D) estimate the cost of developing, evaluating, and implementing delivery systems to augment limited supplies of needles and syringes and to enable the rapid and large-scale administration of pandemic influenza vaccines;
(E) evaluate incentives for the development and production of vaccines by private manufacturers and public-private partnerships, including, in emergency situations, the transfer of technology to public-private partnerships—such as the HHS Centers for Innovation and Advanced Development and Manufacturing or other domestic manufacturing facilities—in advance of a pandemic, in order to be able to ensure adequate domestic pandemic manufacturing capacity and capability;
(F) support, in coordination with the DOD, NIH, and VA, a suite of clinical studies featuring different adjuvants to support development of improved vaccines and further expand vaccine supply by reducing the dose of antigen required; and
(G) update, in coordination with other relevant public health agencies, the research agenda to dramatically improve the effectiveness, efficiency, and reliability of influenza vaccine production;
(ii) through the Director of NIH, provide to the Task Force estimated timelines for implementing NIH's strategic plan and research agenda for developing influenza vaccines that can protect individuals over many years against multiple types of influenza viruses;
(iii) through the Commissioner of Food and Drugs:
(A) further implement vaccine production process improvements to reduce the time required for vaccine production (e.g., through the use of novel technologies for vaccine seed virus development and through implementation of improved potency and sterility assays);
(B) develop, in conjunction with the CDC, proposed alternatives for the timing of vaccine virus selection to account for potentially shorter timeframes associated with non-egg based manufacturing and to facilitate vaccines optimally matched to the circulating strains;
(C) further support the conduct, in collaboration with the DOD, BARDA, and CDC, of applied scientific research regarding developing cell lines and expression systems that markedly increase the yield of cell-based and recombinant influenza vaccine manufacturing processes; and
(D) assess, in coordination with BARDA and relevant vaccine manufacturers, the use and potential effects of using advanced manufacturing platforms for influenza vaccines;
(iv) through the Director of the CDC:
(A) expand vaccine effectiveness studies to more rapidly evaluate the effectiveness of cell-based and recombinant influenza vaccines relative to egg-based vaccines;
(B) explore options to expand the production capacity of cell-based vaccine candidates used by industry;
(C) develop a plan to expand domestic capacity for whole genome characterization of influenza viruses;
(D) increase influenza vaccine use through enhanced communication and by removing barriers to vaccination; and
(E) enhance communication to healthcare providers about the performance of influenza vaccines, in order to assist them in promoting the most effective vaccines for their patient populations; and
(v) through the Administrator of CMS, examine the current legal, regulatory, and policy framework surrounding payment for influenza vaccines and assess adoption of domestically manufactured vaccines that have positive attributes for pandemic response (such as scalability and speed of manufacturing).
(b) The Secretary of Defense shall:
(i) provide OMB with a cost estimate for transitioning DOD's annual procurement of influenza vaccines to vaccines manufactured both domestically and through faster, more scalable, and innovative technologies;
(ii) direct, in coordination with the VA, CDC, and other components of HHS, the conduct of epidemiological studies of vaccine effectiveness to improve knowledge of the clinical effect of the currently licensed influenza vaccines;
(iii) use DOD's network of clinical research sites to evaluate the effectiveness of licensed influenza vaccines, including methods of boosting their effectiveness;
(iv) identify opportunities to use DOD's vaccine research and development enterprise, in collaboration with HHS, to include both early discovery and design of influenza vaccines as well as later-stage evaluation of candidate influenza vaccines;
(v) investigate, in collaboration with HHS, alternative correlates of immune protection that could facilitate development of next-generation influenza vaccines;
(vi) direct the conduct of a study to assess the feasibility of using DOD's advanced manufacturing facility for manufacturing cell-based or recombinant influenza vaccines during a pandemic; and
(vii) accelerate, in collaboration with HHS, research regarding rapidly scalable prophylactic influenza antibody approaches to complement a universal vaccine initiative and address gaps in current vaccine coverage.
(c) The Secretary of VA shall provide OMB with a cost estimate for transitioning its annual procurement of influenza vaccines to vaccines manufactured both domestically and with faster, more scalable, and innovative technologies.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Donald J. Trump.
1 So in original. Probably should be "paragraph (4)(B)(v),".
§247d–7f. Collaboration and coordination
(a) Limited antitrust exemption
(1) Meetings and consultations to discuss security countermeasures, qualified countermeasures, or qualified pandemic or epidemic product development
(A) Authority to conduct meetings and consultations
The Secretary, in coordination with the Attorney General and the Secretary of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security countermeasure (as defined in
(B) Meeting and consultation conditions
A meeting or consultation conducted under subparagraph (A) shall—
(i) be chaired or, in the case of a consultation, facilitated by the Secretary;
(ii) be open to persons involved in the development, manufacture, distribution, purchase, or storage of a countermeasure or product, as determined by the Secretary;
(iii) be open to the Attorney General, the Secretary of Homeland Security, and the Chairman;
(iv) be limited to discussions involving covered activities; and
(v) be conducted in such manner as to ensure that no national security, confidential commercial, or proprietary information is disclosed outside the meeting or consultation.
(C) Limitation
The Secretary may not require participants to disclose confidential commercial or proprietary information.
(D) Transcript
The Secretary shall maintain a complete verbatim transcript of each meeting or consultation conducted under this subsection. Such transcript (or a portion thereof) shall not be disclosed under
(E) Exemption
(i) In general
Subject to clause (ii), it shall not be a violation of the antitrust laws for any person to participate in a meeting or consultation conducted in accordance with this paragraph.
(ii) Limitation
Clause (i) shall not apply to any agreement or conduct that results from a meeting or consultation and that is not covered by an exemption granted under paragraph (4).
(2) Submission of written agreements
The Secretary shall submit each written agreement regarding covered activities that is made pursuant to meetings or consultations conducted under paragraph (1) to the Attorney General and the Chairman for consideration. In addition to the proposed agreement itself, any submission shall include—
(A) an explanation of the intended purpose of the agreement;
(B) a specific statement of the substance of the agreement;
(C) a description of the methods that will be utilized to achieve the objectives of the agreement;
(D) an explanation of the necessity for a cooperative effort among the particular participating persons to achieve the objectives of the agreement; and
(E) any other relevant information determined necessary by the Attorney General, in consultation with the Chairman and the Secretary.
(3) Exemption for conduct under approved agreement
It shall not be a violation of the antitrust laws for a person to engage in conduct in accordance with a written agreement to the extent that such agreement has been granted an exemption under paragraph (4), during the period for which the exemption is in effect.
(4) Action on written agreements
(A) In general
The Attorney General, in consultation with the Chairman, shall grant, deny, grant in part and deny in part, or propose modifications to an exemption request regarding a written agreement submitted under paragraph (2), in a written statement to the Secretary, within 15 business days of the receipt of such request. An exemption granted under this paragraph shall take effect immediately.
(B) Extension
The Attorney General may extend the 15-day period referred to in subparagraph (A) for an additional period of not to exceed 10 business days.
(C) Determination
An exemption shall be granted regarding a written agreement submitted in accordance with paragraph (2) only to the extent that the Attorney General, in consultation with the Chairman and the Secretary, finds that the conduct that will be exempted will not have any substantial anticompetitive effect that is not reasonably necessary for ensuring the availability of the countermeasure or product involved.
(5) Limitation on and renewal of exemptions
An exemption granted under paragraph (4) shall be limited to covered activities, and such exemption shall be renewed (with modifications, as appropriate, consistent with the finding described in paragraph (4)(C)), on the date that is 3 years after the date on which the exemption is granted unless the Attorney General in consultation with the Chairman determines that the exemption should not be renewed (with modifications, as appropriate) considering the factors described in paragraph (4).
(6) Authority to obtain information
Consideration by the Attorney General for granting or renewing an exemption submitted under this section shall be considered an antitrust investigation for purposes of the Antitrust Civil Process Act (
(7) Limitation on parties
The use of any information acquired under an agreement for which an exemption has been granted under paragraph (4), for any purpose other than specified in the exemption, shall be subject to the antitrust laws and any other applicable laws.
(8) Report
Not later than one year after the date of enactment of this Act 1 and biannually thereafter, the Attorney General and the Chairman shall report to Congress on the use of the exemption from the antitrust laws provided by this subsection.
(b) Sunset
The applicability of this section shall expire after December 31, 2024.
(c) Definitions
In this section:
(1) Antitrust laws
The term "antitrust laws"—
(A) has the meaning given such term in subsection (a) of
(B) includes any State law similar to the laws referred to in subparagraph (A).
(2) Countermeasure or product
The term "countermeasure or product" refers to a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product (as those terms are defined in subsection (a)(1)).
(3) Covered activities
(A) In general
Except as provided in subparagraph (B), the term "covered activities" includes any activity relating to the development, manufacture, distribution, purchase, or storage of a countermeasure or product.
(B) Exception
The term "covered activities" shall not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an agreement for which an exemption has been granted under subsection (a)(4), the following activities involving 2 or more persons:
(i) Exchanging information among competitors relating to costs, profitability, or distribution of any product, process, or service if such information is not reasonably necessary to carry out covered activities—
(I) with respect to a countermeasure or product regarding which such meeting or consultation is being conducted; or
(II) that are described in the agreement as exempted.
(ii) Entering into any agreement or engaging in any other conduct—
(I) to restrict or require the sale, licensing, or sharing of inventions, developments, products, processes, or services not developed through, produced by, or distributed or sold through such covered activities; or
(II) to restrict or require participation, by any person participating in such covered activities, in other research and development activities, except as reasonably necessary to prevent the misappropriation of proprietary information contributed by any person participating in such covered activities or of the results of such covered activities.
(iii) Entering into any agreement or engaging in any other conduct allocating a market with a competitor that is not expressly exempted from the antitrust laws under subsection (a)(4).
(iv) Exchanging information among competitors relating to production (other than production by such covered activities) of a product, process, or service if such information is not reasonably necessary to carry out such covered activities.
(v) Entering into any agreement or engaging in any other conduct restricting, requiring, or otherwise involving the production of a product, process, or service that is not expressly exempted from the antitrust laws under subsection (a)(4).
(vi) Except as otherwise provided in this subsection, entering into any agreement or engaging in any other conduct to restrict or require participation by any person participating in such covered activities, in any unilateral or joint activity that is not reasonably necessary to carry out such covered activities.
(vii) Entering into any agreement or engaging in any other conduct restricting or setting the price at which a countermeasure or product is offered for sale, whether by bid or otherwise.
(July 1, 1944, ch. 373, title III, §319L–1, formerly
Editorial Notes
References in Text
The Antitrust Civil Process Act, referred to in subsec. (a)(6), is
The date of enactment of this Act, referred to in subsec. (a)(8), probably means the date of enactment of
Codification
Section was formerly set out as a note under
Prior Provisions
A prior section 247d–7f, act July 1, 1944, ch. 373, title III, §319M, as added
Amendments
2024—Subsec. (b).
2023—Subsec. (b).
2019—Subsec. (a)(1)(A).
Subsec. (b).
2013—Subsec. (b).
Statutory Notes and Related Subsidiaries
Effective Date of 2013 Amendment
1 See References in Text note below.
§247d–7g. National Biodefense Science Board and working groups
(a) In general
(1) Establishment and function
The Secretary shall establish the National Biodefense Science Board (referred to in this section as the "Board") to provide expert advice and guidance to the Secretary on scientific, technical and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
(2) Membership
The membership of the Board shall be comprised of individuals who represent the Nation's preeminent scientific, public health, and medical experts, as follows—
(A) such Federal officials as the Secretary may determine are necessary to support the functions of the Board;
(B) four individuals representing the pharmaceutical, biotechnology, and device industries;
(C) four individuals representing academia; and
(D) five other members as determined appropriate by the Secretary, of whom—
(i) one such member shall be a practicing healthcare professional;
(ii) one such member shall be an individual from an organization representing healthcare consumers;
(iii) one such member shall be an individual with pediatric subject matter expertise; and
(iv) one such member shall be a State, tribal, territorial, or local public health official.
Nothing in this paragraph shall preclude a member of the Board from satisfying two or more of the requirements described in subparagraph (D).
(3) Term of appointment
A member of the Board described in subparagraph (B), (C), or (D) of paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the initial Board appointees in order to provide for a staggered term of appointment for all members.
(4) Consecutive appointments; maximum terms
A member may be appointed to serve not more than 3 terms on the Board and may serve not more than 2 consecutive terms.
(5) Duties
The Board shall—
(A) advise the Secretary on current and future trends, challenges, and opportunities presented by advances in biological and life sciences, biotechnology, and genetic engineering with respect to threats posed by naturally occurring infectious diseases and chemical, biological, radiological, and nuclear agents;
(B) at the request of the Secretary, review and consider any information and findings received from the working groups established under subsection (b);
(C) at the request of the Secretary, provide recommendations and findings for expanded, intensified, and coordinated biodefense research and development activities; and
(D) provide any recommendation, finding, or report provided to the Secretary under this paragraph to the appropriate committees of Congress.
(6) Meetings
(A) Initial meeting
Not later than one year after December 19, 2006, the Secretary shall hold the first meeting of the Board.
(B) Subsequent meetings
The Board shall meet at the call of the Secretary, but in no case less than twice annually.
(7) Vacancies
Any vacancy in the Board shall not affect its powers, but shall be filled in the same manner as the original appointment.
(8) Chairperson
The Secretary shall appoint a chairperson from among the members of the Board.
(9) Powers
(A) Hearings
The Board may hold such hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Board considers advisable to carry out this subsection.
(B) Postal services
The Board may use the United States mails in the same manner and under the same conditions as other departments and agencies of the Federal Government.
(10) Personnel
(A) Employees of the Federal Government
A member of the Board that is an employee of the Federal Government may not receive additional pay, allowances, or benefits by reason of the member's service on the Board.
(B) Other members
A member of the Board that is not an employee of the Federal Government may be compensated at a rate not to exceed the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under
(C) Travel expenses
Each member of the Board shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under subchapter I of
(D) Detail of Government employees
Any Federal Government employee may be detailed to the Board with the approval for the contributing agency without reimbursement, and such detail shall be without interruption or loss of civil service status or privilege.
(b) Other working groups
The Secretary may establish a working group of experts, or may use an existing working group or advisory committee, to—
(1) identify innovative research with the potential to be developed as a qualified countermeasure or a qualified pandemic or epidemic product;
(2) identify accepted animal models for particular diseases and conditions associated with any biological, chemical, radiological, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify strategies to accelerate animal model and research tool development and validation; and
(3) obtain advice regarding supporting and facilitating advanced research and development related to qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, and other vulnerable populations, and other issues regarding activities under this section that affect such populations.
(c) Definitions
Any term that is defined in
(d) Authorization of appropriations
There are authorized to be appropriated $1,000,000 to carry out this section for fiscal year 2007 and each fiscal year thereafter.
(July 1, 1944, ch. 373, title III, §319M, as added
Editorial Notes
Codification
Section was formerly classified to
Amendments
2013—Subsec. (a)(2).
Subsec. (a)(2)(D)(iii), (iv).
Subsec. (a)(5)(D).
§247d–8. Coordinated program to improve pediatric oral health
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish a program to fund innovative oral health activities that improve the oral health of children under 6 years of age who are eligible for services provided under a Federal health program, to increase the utilization of dental services by such children, and to decrease the incidence of early childhood and baby bottle tooth decay.
(b) Grants
The Secretary shall award grants to or enter into contracts with public or private nonprofit schools of dentistry or accredited dental training institutions or programs, community dental programs, and programs operated by the Indian Health Service (including federally recognized Indian tribes that receive medical services from the Indian Health Service, urban Indian health programs funded under title V of the Indian Health Care Improvement Act [
(c) Distribution
In awarding grants under this section, the Secretary shall, to the extent practicable, ensure an equitable national geographic distribution of the grants, including areas of the United States where the incidence of early childhood caries is highest.
(d) Authorization of appropriations
There is authorized to be appropriated to carry out this section $10,000,000 for each 1 the fiscal years 2001 through 2005.
(July 1, 1944, ch. 373, title III, §320A, as added
Editorial Notes
References in Text
The Indian Health Care Improvement Act, referred to in subsec. (b), is
The Indian Self-Determination and Education Assistance Act, referred to in subsec. (b), is
Codification
Section 1603 of
1 So in original. Probably should be followed by "of".
§247d–9. Dental education for parents of newborns
The Secretary shall develop and implement, through entities that fund or provide perinatal care services to targeted low-income children under a State child health plan under title XXI of the Social Security Act [
(
Editorial Notes
References in Text
The Social Security Act, referred to in text, is act Aug. 14, 1935, ch. 531,
Codification
Section was enacted as part of the Children's Health Insurance Program Reauthorization Act of 2009, and not as part of the Public Health Service Act which comprises this chapter.
Statutory Notes and Related Subsidiaries
Effective Date
Section effective Apr. 1, 2009, and applicable to child health assistance and medical assistance provided on or after that date, with certain exceptions, see section 3 of
Definition of "Secretary"
"Secretary" means the Secretary of Health and Human Services, see section 1(c)(3) of
§247d–10. Pilot program for public health laboratories to detect fentanyl and other synthetic opioids
(a) Grants
The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall award grants to, or enter into cooperative agreements with, Federal, State, and local agencies to improve coordination between public health laboratories and laboratories operated by law enforcement agencies, such as Customs and Border Protection and the Drug Enforcement Administration, to improve detection of synthetic opioids, including fentanyl and its analogues, as described in subsection (b).
(b) Detection activities
The Secretary, in consultation with the Director of the National Institute of Standards and Technology, the Director of the Centers for Disease Control and Prevention, the Attorney General of the United States, and the Administrator of the Drug Enforcement Administration, shall, for purposes of this section, develop or identify—
(1) best practices for safely handling and testing synthetic opioids, including fentanyl and its analogues, including with respect to reference materials, instrument calibration, and quality control protocols;
(2) reference materials and quality control standards related to synthetic opioids, including fentanyl and its analogues, to enhance—
(A) clinical diagnostics;
(B) postmortem data collection; and
(C) portable testing equipment utilized by law enforcement and public health officials; and
(3) procedures for the identification of new and emerging synthetic opioid formulations and procedures for reporting those findings to appropriate law enforcement agencies and Federal, State, and local public health laboratories and health departments, as appropriate.
(c) Laboratories
The Secretary shall require recipients of grants or cooperative agreements under subsection (a) to—
(1) follow the best practices established under subsection (b) and have the appropriate capabilities to provide laboratory testing of controlled substances, such as synthetic fentanyl, and biospecimens for the purposes of aggregating and reporting public health information to Federal, State, and local public health officials, laboratories, and other entities the Secretary deems appropriate;
(2) work with law enforcement agencies and public health authorities, as practicable;
(3) provide early warning information to Federal, State, and local law enforcement agencies and public health authorities regarding trends or other data related to the supply of synthetic opioids, including fentanyl and its analogues;
(4) provide biosurveillance capabilities with respect to identifying trends in adverse health outcomes associated with non-fatal exposures; and
(5) provide diagnostic testing, as appropriate and practicable, for non-fatal exposures of emergency personnel, first responders, and other individuals.
(d) Authorization of appropriations
To carry out this section, there is authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023.
(
Editorial Notes
Codification
Section was enacted as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Public Health Service Act which comprises this chapter.
§247d–11. State All Payer Claims Databases
(a) In general
The Secretary shall make one-time grants to eligible States for the purposes described in subsection (b).
(b) Uses
A State may use a grant received under subsection (a) for one of the following purposes:
(1) To establish a State All Payer Claims Database.
(2) To improve an 1 existing State All Payer Claims Databases.1
(c) Eligibility
To be eligible to receive a grant under subsection (a), a State shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary specifies, including, with respect to a State All Payer Claims Database, at least specifics on how the State will ensure uniform data collection and the privacy and security of such data.
(d) Grant period and amount
Grants awarded under this section shall be for a period of 3-years,2 and in an amount of $2,500,000, of which $1,000,000 shall be made available to the State for each of the first 2 years of the grant period, and $500,000 shall be made available to the State for the third year of the grant period.
(e) Authorized users
(1) Application
An entity desiring authorization for access to a State All Payer Claims Database that has received a grant under this section shall submit to the State All Payer Claims Database an application for such access, which shall include—
(A) in the case of an entity requesting access for research purposes—
(i) a description of the uses and methodologies for evaluating health system performance using such data; and
(ii) documentation of approval of the research by an institutional review board, if applicable for a particular plan of research; or
(B) in the case of an entity such as an employer, health insurance issuer, third-party administrator, or health care provider, requesting access for the purpose of quality improvement or cost-containment, a description of the intended uses for such data.
(2) Requirements
(A) Access for research purposes
Upon approval of an application for research purposes under paragraph (1)(A), the authorized user shall enter into a data use and confidentiality agreement with the State All Payer Claims Database that has received a grant under this subsection, which shall include a prohibition on attempts to reidentify and disclose individually identifiable health information and proprietary financial information.
(B) Customized reports
Employers and employer organizations may request customized reports from a State All Payer Claims Database that has received a grant under this section, at cost, subject to the requirements of this section with respect to privacy, security, and proprietary financial information.
(C) Non-customized reports
A State All Payer Claims Database that has received a grant under this section shall make available to all authorized users aggregate data sets available through the State All Payer Claims Database, free of charge.
(3) Waivers
The Secretary may waive the requirements of this subsection of a State All Payer Claims Database to provide access of entities to such database if such State All Payer Claims Database is substantially in compliance with this subsection.
(f) Expanded access
(1) Multi-State applications
The Secretary may prioritize applications submitted by a State whose application demonstrates that the State will work with other State All Payer Claims Databases to establish a single application for access to data by authorized users across multiple States.
(2) Expansion of data sets
The Secretary may prioritize applications submitted by a State whose application demonstrates that the State will implement the reporting format for self-insured group health plans described in
(g) Definitions
In this section—
(1) the term "individually identifiable health information" has the meaning given such term in
(2) the term "proprietary financial information" means data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan, managed care entity (as defined in
(3) the term "State All Payer Claims Database" means, with respect to a State, a database that may include medical claims, pharmacy claims, dental claims, and eligibility and provider files, which are collected from private and public payers.
(h) Authorization of appropriations
To carry out this section, there is authorized to be appropriated $50,000,000 for each of fiscal years 2022 and 2023, and $25,000,000 for fiscal year 2024, to remain available until expended.
(July 1, 1944, ch. 373, title III, §320B, as added
Editorial Notes
Codification
Section 115(a) of div. BB of
2 So in original. Probably should be "3 years,".
§247d–12. Coordination and collaboration regarding blood supply
The Secretary of Health and Human Services, or the Secretary's designee, shall—
(1) ensure coordination and collaboration between relevant Federal departments and agencies related to the safety and availability of the blood supply, including—
(A) the Department of Health and Human Services, including the Office of the Assistant Secretary for Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health, the Centers for Medicare & Medicaid Services, and the Health Resources and Services Administration;
(B) the Department of Defense; and
(C) the Department of Veterans Affairs; and
(2) consult and communicate with private stakeholders, including blood collection establishments, health care providers, accreditation organizations, researchers, and patients, regarding issues related to the safety and availability of the blood supply.
(
Editorial Notes
Codification
Section was enacted as part of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act, also known as the PREVENT Pandemics Act, and also as part of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, and not as part of the Public Health Service Act which comprises this chapter.