Part A—National All-Hazards Preparedness and Response Planning, Coordinating, and Reporting
Editorial Notes
Codification
§300hh. Public health and medical preparedness and response functions
(a) In general
The Secretary of Health and Human Services shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Plan developed pursuant to section 314(6) 1 of title 6, or any successor plan.
(b) Interagency agreement
The Secretary, in collaboration with the Secretary of Veterans Affairs, the Secretary of Transportation, the Secretary of Defense, the Secretary of Homeland Security, and the head of any other relevant Federal agency, shall establish an interagency agreement, consistent with the National Response Plan or any successor plan, under which agreement the Secretary of Health and Human Services shall assume operational control of emergency public health and medical response assets, as necessary, in the event of a public health emergency, except that members of the armed forces under the authority of the Secretary of Defense shall remain under the command and control of the Secretary of Defense, as shall any associated assets of the Department of Defense.
(c) Coordination with Federal agencies
In leading the Federal public health and medical response to a declared or potential public health emergency, consistent with this section, the Secretary shall coordinate with, and may request support from, other Federal departments and agencies, as appropriate in order to carry out necessary activities and leverage the expertise of such departments and agencies, which may include the provision of assistance at the direction of the Secretary related to supporting the public health and medical response for States, localities, and Tribes.
(d) Annual report on emergency response and preparedness
The Secretary shall submit a written report each fiscal year 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, containing—
(1) updated information related to an assessment of the response to any public health emergency declared, or otherwise in effect, during the previous fiscal year;
(2) findings related to drills and operational exercises completed in the previous fiscal year pursuant to
(3) the state of public health preparedness and response capabilities for chemical, biological, radiological, and nuclear threats, including emerging infectious diseases; and
(4) any challenges in preparing for or responding to such threats, as appropriate.
(July 1, 1944, ch. 373, title XXVIII, §2801, as added
Editorial Notes
References in Text
Amendments
2022—Subsec. (c).
Subsec. (d).
2006—
Statutory Notes and Related Subsidiaries
Data Use Agreements
"(1)
"(A)
"(B)
"(i) ensure that the agreements and memoranda of understanding described in such subparagraph—
"(I) address the methods of granting access to data held by one agency or office with another to support the respective missions of such agencies or offices;
"(II) consider minimum necessary principles of data sharing for appropriate use;
"(III) include appropriate privacy and cybersecurity protections; and
"(IV) are subject to regular updates, as appropriate;
"(ii) collaborate with the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Preparedness and Response, the Office of the Chief Information Officer, and, as appropriate, the Office of the National Coordinator for Health Information Technology, and other entities within the Department of Health and Human Services; and
"(iii) consider the terms and conditions of any existing data use agreements with other public or private entities and any need for updates to such existing agreements, consistent with paragraph (2).
"(2)
"(3)
Guidance for Participation in Exercises and Drills
Government Accountability Office Report
"(a)
"(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population;
"(2) the coordination of the activities described in paragraph (1);
"(3) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population;
"(4) the activities and costs of the Civil Support Teams of the National Guard in responding to biological threats or attacks against the civilian population;
"(5) the activities of the working group under subsection (a) and the efforts made by such group to carry out the activities described in such subsection; and
"(6) the ability of private sector contractors to enhance governmental responses to biological threats or attacks."
1 See References in Text note below.
§300hh–1. National Health Security Strategy
(a) In general
(1) Preparedness and response regarding public health emergencies
Beginning in 2018 and every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a coordinated strategy (to be known as the National Health Security Strategy) and any revisions thereof, and an accompanying implementation plan for public health emergency preparedness and response. Such National Health Security Strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal (as described in
(2) Evaluation of progress
The National Health Security Strategy shall include an evaluation of the progress made by Federal, State, local, and tribal entities, based on the evidence-based benchmarks and objective standards that measure levels of preparedness established pursuant to
(3) Public health workforce
In 2022, the National Health Security Strategy shall include a national strategy for establishing an effective and prepared public health workforce, including defining the functions, capabilities, and gaps in such workforce (including gaps in the environmental health and animal health workforces, as applicable), describing the status of such workforce, identifying strategies to recruit, retain, and protect such workforce from workplace exposures during public health emergencies, and identifying current capabilities to meet the requirements of
(b) Preparedness goals
The National Health Security Strategy shall include provisions in furtherance of the following:
(1) Integration
Integrating public health and public and private medical capabilities with other first responder systems, including through—
(A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities through drills and exercises, including drills and exercises to ensure medical surge capacity for events without notice; and
(B) integrating public and private sector public health and medical donations and volunteers.
(2) Public health
Developing and sustaining Federal, State, local, and tribal essential public health security capabilities, including the following:
(A) Disease situational awareness domestically and abroad, including detection, identification, investigation, and related information technology activities.
(B) Disease containment including capabilities for isolation, quarantine, social distancing, decontamination, relevant health care services and supplies, and transportation and disposal of medical waste.
(C) Risk communication and public preparedness.
(D) Rapid distribution and administration of medical countermeasures.
(E) Response to environmental hazards.
(3) Medical
Increasing the preparedness, response capabilities, and surge capacity of hospitals, other health care facilities (including pharmacies, mental health facilities, and ambulatory care facilities and which may include dental health facilities), and trauma care, critical care, and emergency medical service systems, with respect to public health emergencies (including related availability, accessibility, and coordination), which shall include developing plans for the following:
(A) Strengthening public health emergency medical and trauma management and treatment capabilities.
(B) Fatality management.
(C) Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.
(D) Rapid distribution and administration of medical countermeasures.
(E) Effective utilization of any available public and private mobile medical assets (which may include such dental health assets) and integration of other Federal assets.
(F) Protecting health care workers and health care first responders from workplace exposures during a public health emergency or exposures to agents that could cause a public health emergency.
(G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems.
(4) At-risk individuals
(A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs and considerations of individuals with disabilities, in the event of a public health emergency.
(B) For the purpose of this chapter, the term "at-risk individuals" means children, pregnant women, senior citizens and other individuals who have access or functional needs in the event of a public health emergency, as determined by the Secretary.
(5) Coordination
Minimizing duplication of, and ensuring coordination between, Federal, State, local, and tribal planning, preparedness, and response activities (including the State Emergency Management Assistance Compact and other applicable compacts). Such planning shall be consistent with the National Response Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
(6) Continuity of operations
Maintaining vital public health and medical services to allow for optimal Federal, State, local, and tribal operations in the event of a public health emergency.
(7) Countermeasures
(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.
(B) For purposes of this paragraph, the term "countermeasures" has the same meaning as the terms "qualified countermeasures" under
(8) Medical and public health community resiliency
Strengthening the ability of States, local communities, and tribal communities to prepare for, respond to, and be resilient in the event of public health emergencies, whether naturally occurring, unintentional, or deliberate by—
(A) optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities; and
(B) promoting familiarity with local medical and public health systems.
(9) Zoonotic disease, food, and agriculture
Improving coordination among Federal, State, local, Tribal, and territorial entities (including through consultation with the Secretary of Agriculture) to prevent, detect, and respond to outbreaks of plant or animal disease (including zoonotic disease) that could compromise national security resulting from a deliberate attack, a naturally occurring threat, the intentional adulteration of food, or other public health threats, taking into account interactions between animal health, human health, and animals' and humans' shared environment as directly related to public health emergency preparedness and response capabilities, as applicable.
(10) Global health security
Assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities.
(July 1, 1944, ch. 373, title XXVIII, §2802, as added
Editorial Notes
Amendments
2019—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (b)(2)(E).
Subsec. (b)(3).
Subsec. (b)(3)(F).
Subsec. (b)(3)(G).
Subsec. (b)(4)(B).
Subsec. (b)(5).
Subsec. (b)(9), (10).
2013—Subsec. (a)(1).
Subsec. (b)(1)(A).
Subsec. (b)(3).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B).
Subsec. (b)(3)(C), (D).
Subsec. (b)(3)(E).
Subsec. (b)(3)(F).
Subsec. (b)(3)(G).
Subsec. (b)(4)(A).
Subsec. (b)(4)(B).
Subsec. (b)(7), (8).
Executive Documents
Ex. Ord. No. 13527. Establishing Federal Capability for the Timely Provision of Medical Countermeasures Following a Biological Attack
Ex. Ord. No. 13527, Dec. 30, 2009, 75 F.R. 737, 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:
This policy would seek to: (1) mitigate illness and prevent death; (2) sustain critical infrastructure; and (3) complement and supplement State, local, territorial, and tribal government medical countermeasure distribution capacity.
(b) The Secretaries of Health and Human Services and Homeland Security, in coordination with the U.S. Postal Service, within 180 days of the date of this order, shall establish a national U.S. Postal Service medical countermeasures dispensing model for U.S. cities to respond to a large-scale biological attack, with anthrax as the primary threat consideration.
(c) In support of the national U.S. Postal Service model, the Secretaries of Homeland Security, Health and Human Services, and Defense, and the Attorney General, in coordination with the U.S. Postal Service, and in consultation with State and local public health, emergency management, and law enforcement officials, within 180 days of the date of this order, shall develop an accompanying plan for supplementing local law enforcement personnel, as necessary and appropriate, with local Federal law enforcement, as well as other appropriate personnel, to escort U.S. Postal workers delivering medical countermeasures.
(b) The Secretaries of Homeland Security and Health and Human Services, in coordination with the Secretary of Defense, within 90 days of the date of this order, shall develop a concept of operations and establish requirements for a Federal rapid response to dispense medical countermeasures to an affected population following a large-scale biological attack.
(b) The Secretaries of Health and Human Services and Homeland Security, within 180 days of the date of this order, shall develop a plan for the provision of medical countermeasures to ensure that mission-essential functions of executive branch departments and agencies continue to be performed following a large-scale biological attack.
(a) Nothing in this order shall be construed to impair or otherwise affect:
(i) authority granted by law to a department or agency, or the head thereof; or
(ii) 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.
Barack Obama.
§300hh–2. Enhancing medical surge capacity
(a) Study of enhancing medical surge capacity
As part of the joint review described in
(1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on a contingency basis, to a community in the event of a public health emergency;
(2) integrating the practice of telemedicine within the National Disaster Medical System; and
(3) other strategies to improve such capacity as determined appropriate by the Secretary.
(b) Authority to acquire and operate mobile medical assets
In addition to any other authority to acquire, deploy, and operate mobile medical assets, the Secretary may acquire, deploy, and operate mobile medical assets if, taking into consideration the evaluation conducted under subsection (a), such acquisition, deployment, and operation is determined to be beneficial and feasible in improving the capacity of the Department of Health and Human Services to provide additional medical surge capacity to local communities in the event of a public health emergency.
(c) Using Federal facilities to enhance medical surge capacity
(1) Analysis
The Secretary shall conduct an analysis of whether there are Federal facilities which, in the event of a public health emergency, could practicably be used as facilities in which to provide health care.
(2) Memoranda of understanding
If, based on the analysis conducted under paragraph (1), the Secretary determines that there are Federal facilities which, in the event of a public health emergency, could be used as facilities in which to provide health care, the Secretary shall, with respect to each such facility, seek to conclude a memorandum of understanding with the head of the Department or agency that operates such facility that permits the use of such facility to provide health care in the event of a public health emergency.
(July 1, 1944, ch. 373, title XXVIII, §2803, as added
§300hh–3. Office of Pandemic Preparedness and Response Policy
(a) In general
There is established in the Executive Office of the President an Office of Pandemic Preparedness and Response Policy (referred to in this section as the "Office"), which shall be headed by a Director (referred to in this section as the "Director") appointed by the President and who shall be compensated at the rate provided for level II of the Executive Schedule in
(b) Functions of the Director
The primary function of the Director is to provide advice, within the Executive Office of the President, on policy related to preparedness for, and response to, pandemic and other biological threats that may impact national security, and support strategic coordination and communication with respect to relevant activities across the Federal Government. In addition to such other functions and activities as the President may assign, the Director, consistent with applicable laws and the National Response Framework, shall—
(1) serve as the principal advisor to the President on all matters related to pandemic preparedness and response policy and make recommendations to the President regarding pandemic and other biological threats that may impact national security;
(2) coordinate Federal activities to prepare for, and respond to, pandemic and other biological threats, by—
(A) providing strategic direction to the heads of applicable Federal departments, agencies, and offices, including—
(i) the establishment, implementation, prioritization, and assessment of policy goals and objectives across the Executive Office of the President and such departments, agencies, and offices;
(ii) supporting the assessment and clarification of roles and responsibilities related to such Federal activities; and
(iii) supporting the development and implementation of metrics and performance measures to evaluate the extent to which applicable activities meet such goals and objectives;
(B) providing, in consultation with the Secretary of Health and Human Services and the heads of other relevant Federal departments, agencies, and offices, leadership with respect to the National Biodefense Strategy and related activities pursuant to
(C) facilitating coordination and communication between such Federal departments, agencies, and offices to improve preparedness for, and response to, such threats;
(D) ensuring that the authorities, capabilities, and expertise of each such department, agency, and office are appropriately leveraged to facilitate the whole-of-Government response to such threats;
(E) overseeing coordination of Federal efforts to prepare for and support the production, supply, and distribution of relevant medical products and supplies during a response to a pandemic or other biological threat, as applicable and appropriate, including supporting Federal efforts to assess any relevant vulnerabilities in the supply chain of such products and supplies, and identify opportunities for private entities to engage with the Federal Government to address medical product and medical supply needs during such a response;
(F) overseeing coordination of Federal efforts for the basic and advanced research, development, manufacture, and procurement of medical countermeasures for such threats, including by—
(i) serving, with the Secretary of Health and Human Services, as co-Chair of the Public Health Emergency Medical Countermeasures Enterprise established pursuant to
(ii) promoting coordination between the medical countermeasure research, development, and procurement activities of respective Federal departments and agencies, including to advance the discovery and development of new medical products and technologies;
(G) convening heads of Federal departments and agencies, as appropriate, on topics related to capabilities to prepare for, and respond to, such threats;
(H) assessing and advising on international cooperation in preparing for, and responding to, such threats to advance the national security objectives of the United States; and
(I) overseeing other Federal activities to assess preparedness for, and responses to, such threats, including—
(i) drills and operational exercises conducted pursuant to applicable provisions of law; and
(ii) Federal after-action reports developed following such drills and exercises or a response to a pandemic or other biological threat;
(3) promote and support the development of relevant expertise and capabilities within the Federal Government to ensure that the United States can quickly detect, identify, and respond to such threats, and provide recommendations, as appropriate, to the President;
(4) consult with the Director of the Office of Management and Budget and other relevant officials within the Executive Office of the President, including the Assistant to the President for National Security Affairs and the Director of the Office of Science and Technology Policy, regarding activities related to preparing for, and responding to, such threats and relevant research and emerging technologies that may advance the biosecurity and preparedness and response goals of the Federal Government;
(5) identify opportunities to leverage current and emerging technologies, including through public-private partnerships, as appropriate, to address such threats and advance the preparedness and response goals of the Federal Government; and
(6) ensure that findings of Federal after-action reports conducted pursuant to paragraph (2)(I)(ii) are implemented to the maximum extent feasible within the Federal Government.
(c) Support from other agencies
Each department, agency, and instrumentality of the executive branch of the Federal Government, including any independent agency, is authorized to support the Director by providing the Director such information as the Director determines necessary to carry out the functions of the Director under this section.
(d) Preparedness outlook report
(1) In general
Within its first year of operation, the Director, in consultation with the heads of relevant Federal departments and agencies and other officials within the Executive Office of the President, shall through a report submitted to the President and made available to the public, to the extent practicable, identify and describe situations and conditions which warrant special attention within the next 5 years, involving current and emerging problems of national significance related to pandemic or other biological threats, and opportunities for, and the barriers to, the research, development, and procurement of medical countermeasures to adequately respond to such threats.
(2) Revisions
The Office shall revise the report under paragraph (1) not less than once every 5 years and work with relevant Federal officials to address the problems, barriers, opportunities, and actions identified under this report through the development of the President's Budgets and programs.
(e) Interdepartmental working group
The Director shall lead an interdepartmental working group that will meet on a regular basis to evaluate national biosecurity and pandemic preparedness issues and make recommendations to the heads of applicable Federal departments, agencies and offices. The working group shall consist of representatives from—
(1) the Office of Pandemic Preparedness and Response Policy, to serve as the chair;
(2) the Department of Health and Human Services;
(3) the Department of Homeland Security;
(4) the Department of Defense;
(5) the Office of Management and Budget; and
(6) other Federal Departments and agencies.
(f) Industry Liaison
(1) In general
Not later than 10 days after the initiation of a Federal response to a pandemic or other biological threat that may pose a risk to national security, the Director shall appoint an Industry Liaison within the Office of Pandemic Preparedness and Response Policy to serve until the termination of such response.
(2) Activities
The Industry Liaison shall—
(A) not later than 20 days after the initiation of such response, identify affected industries and develop a plan to regularly communicate with, and receive input from, affected industries;
(B) work with relevant Federal departments and agencies to support information sharing and coordination with industry stakeholders; and
(C) communicate, and support the provision of technical assistance, as applicable, with private entities interested in supporting such response, which may include entities not historically involved in the public health or medical sectors, as applicable and appropriate.
(g) Additional functions of the Director
The Director, in addition to the other duties and functions set forth in this section—
(1) shall—
(A) serve as a member of the Domestic Policy Council and the National Security Council;
(B) serve as a member of the Intergovernmental Science, Engineering, and Technology Advisory Panel under
(C) consult with State, Tribal, local, and territorial governments, industry, academia, professional societies, and other stakeholders, as appropriate;
(D) use for administrative purposes, on a reimbursable basis, the available services, equipment, personnel, and facilities of Federal, State, and local agencies; and
(E) at the President's request, perform such other duties and functions and enter into contracts and other arrangements for studies, analyses, and related services with public or private entities, as applicable and appropriate; and
(2) may hold such hearings in various parts of the United States as necessary to determine the views of the entities and individuals referred to in paragraph (1) and of the general public, concerning national needs and trends in pandemic preparedness and response.
(h) Staffing and detailees
In carrying out functions under this section, the Director may—
(1) appoint not more than 25 individuals to serve as employees of the Office as necessary to carry out this section;
(2) fix the compensation of such personnel at a rate to be determined by the Director, up to the amount of annual compensation (excluding expenses) specified in
(3) utilize the services of consultants, which may include by obtaining services described under
(4) direct, with the concurrence of the Secretary of a department or head of an agency, the temporary reassignment within the Federal Government of personnel employed by such department or agency, in order to carry out the functions of the Office.
(i) Preparedness review and report
The Director, in consultation with the heads of applicable Federal departments, agencies, and offices, shall—
(1) not later than 1 year after December 29, 2022, conduct a review of applicable Federal strategies, policies, procedures, and after-action reports to identify gaps and inefficiencies related to pandemic preparedness and response;
(2) not later than 18 months after December 29, 2022, and every 2 years thereafter, submit to the President and 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—
(A) current and emerging pandemic and other biological threats that pose a significant level of risk to national security;
(B) the roles and responsibilities of the Federal Government in preparing for, and responding to, such threats;
(C) the findings of the review conducted under paragraph (1);
(D) any barriers or limitations related to addressing such findings;
(E) current and planned activities to update Federal strategies, policies, and procedures to address such findings, consistent with applicable laws and the National Response Framework;
(F) current and planned activities to support the development of expertise within the Federal Government pursuant to subsection (b)(3); and
(G) opportunities to improve Federal preparedness and response capacities and capabilities through the use of current and emerging technologies.
(j) Nonduplication of effort
The Director shall ensure that activities carried out under this section do not unnecessarily duplicate the efforts of other Federal departments, agencies, and offices.
(
Editorial Notes
References in Text
Level IV of the Executive Schedule, referred to in subsec. (h)(3), is set out in
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.
Section is comprised of section 2104 of div. FF of