subpart c—assuring a safer childhood vaccination program in united states
§300aa–25. Recording and reporting of information
(a) General rule
Each health care provider who administers a vaccine set forth in the Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person's permanent medical record (or in a permanent office log or file to which a legal representative shall have access upon request) with respect to each such vaccine—
(1) the date of administration of the vaccine,
(2) the vaccine manufacturer and lot number of the vaccine,
(3) the name and address and, if appropriate, the title of the health care provider administering the vaccine, and
(4) any other identifying information on the vaccine required pursuant to regulations promulgated by the Secretary.
(b) Reporting
(1) Each health care provider and vaccine manufacturer shall report to the Secretary—
(A) the occurrence of any event set forth in the Vaccine Injury Table, including the events set forth in
(B) the occurrence of any contraindicating reaction to a vaccine which is specified in the manufacturer's package insert, and
(C) such other matters as the Secretary may by regulation require.
Reports of the matters referred to in subparagraphs (A) and (B) shall be made beginning 90 days after December 22, 1987. The Secretary shall publish in the Federal Register as soon as practicable after such date a notice of the reporting requirement.
(2) A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of such vaccine within which vaccine-related illnesses, disabilities, injuries, or conditions, the symptoms and manifestations of such illnesses, disabilities, injuries, or conditions, or deaths occur, and the manufacturer and lot number of the vaccine.
(3) The Secretary shall issue the regulations referred to in paragraph (1)(C) within 180 days of December 22, 1987.
(c) Release of information
(1) Information which is in the possession of the Federal Government and State and local governments under this section and which may identify an individual shall not be made available under
(A) the person who received the vaccine, or
(B) the legal representative of such person.
(2) For purposes of paragraph (1), the term "information which may identify an individual" shall be limited to the name, street address, and telephone number of the person who received the vaccine and of that person's legal representative and the medical records of such person relating to the administration of the vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider who administered the vaccine, the date of the vaccination, or information concerning any reported illness, disability, injury, or condition resulting from the administration of the vaccine, any symptom or manifestation of such illness, disability, injury, or condition, or death resulting from the administration of the vaccine.
(3) Except as provided in paragraph (1), all information reported under this section shall be available to the public.
(July 1, 1944, ch. 373, title XXI, §2125, as added
Editorial Notes
Codification
In subsec. (b)(1), (3), "December 22, 1987" was substituted for "the effective date of this subpart" on authority of section 323 of
Amendments
1987—Subsec. (b)(1), (3).
Statutory Notes and Related Subsidiaries
Effective Date
Subpart effective Dec. 22, 1987, see section 323 of
§300aa–26. Vaccine information
(a) General rule
Not later than 1 year after December 22, 1987, the Secretary shall develop and disseminate vaccine information materials for distribution by health care providers to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury Table. Such materials shall be published in the Federal Register and may be revised.
(b) Development and revision of materials
Such materials shall be developed or revised—
(1) after notice to the public and 60 days of comment thereon, and
(2) in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers and parent organizations, the Centers for Disease Control and Prevention, and the Food and Drug Administration.
(c) Information requirements
The information in such materials shall be based on available data and information, shall be presented in understandable terms and shall include—
(1) a concise description of the benefits of the vaccine,
(2) a concise description of the risks associated with the vaccine,
(3) a statement of the availability of the National Vaccine Injury Compensation Program, and
(4) such other relevant information as may be determined by the Secretary.
(d) Health care provider duties
On and after a date determined by the Secretary which is—
(1) after the Secretary develops the information materials required by subsection (a), and
(2) not later than 6 months after the date such materials are published in the Federal Register,
each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to the legal representatives of any child or to any other individual to whom such provider intends to administer such vaccine a copy of the information materials developed pursuant to subsection (a), supplemented with visual presentations or oral explanations, in appropriate cases. Such materials shall be provided prior to the administration of such vaccine.
(July 1, 1944, ch. 373, title XXI, §2126, as added
Editorial Notes
Codification
In subsec. (a), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of
Amendments
1993—Subsec. (a).
Subsec. (b).
Subsec. (c).
"(1) the frequency, severity, and potential long-term effects of the disease to be prevented by the vaccine,
"(2) the symptoms or reactions to the vaccine which, if they occur, should be brought to the immediate attention of the health care provider,
"(3) precautionary measures legal representatives should take to reduce the risk of any major adverse reactions to the vaccine that may occur,
"(4) early warning signs or symptoms to which legal representatives should be alert as possible precursors to such major adverse reactions,
"(5) a description of the manner in which legal representatives should monitor such major adverse reactions, including a form on which reactions can be recorded to assist legal representatives in reporting information to appropriate authorities,
"(6) a specification of when, how, and to whom legal representatives should report any major adverse reaction,
"(7) the contraindications to (and bases for delay of) the administration of the vaccine,
"(8) an identification of the groups, categories, or characteristics of potential recipients of the vaccine who may be at significantly higher risk of major adverse reaction to the vaccine than the general population,
"(9) a summary of—
"(A) relevant Federal recommendations concerning a complete schedule of childhood immunizations, and
"(B) the availability of the Program, and
"(10) such other relevant information as may be determined by the Secretary."
Subsec. (d).
1992—Subsec. (b)(2).
1989—Subsec. (c)(9).
"(A) the number of vaccinations required for school attendance and the schedule recommended for such vaccinations, and
"(B) the availability of the Program, and".
1987—Subsec. (a).
Statutory Notes and Related Subsidiaries
Effective Date of 1989 Amendment
For applicability of amendments by
§300aa–27. Mandate for safer childhood vaccines
(a) General rule
In the administration of this part and other pertinent laws under the jurisdiction of the Secretary, the Secretary shall—
(1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 22, 1987, and promote the refinement of such vaccines, and
(2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.
(b) Task force
(1) The Secretary shall establish a task force on safer childhood vaccines which shall consist of the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control.
(2) The Director of the National Institutes of Health shall serve as chairman of the task force.
(3) In consultation with the Advisory Commission on Childhood Vaccines, the task force shall prepare recommendations to the Secretary concerning implementation of the requirements of subsection (a).
(c) Report
Within 2 years after December 22, 1987, and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) during the preceding 2-year period.
(July 1, 1944, ch. 373, title XXI, §2127, as added
Editorial Notes
Codification
In subsecs. (a)(1), (c), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of
Amendments
1989—Subsecs. (b), (c).
1987—Subsecs. (a)(1), (b).
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
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date of 1989 Amendment
For applicability of amendments by
§300aa–28. Manufacturer recordkeeping and reporting
(a) General rule
Each vaccine manufacturer of a vaccine set forth in the Vaccine Injury Table or any other vaccine the administration of which is mandated by the law or regulations of any State, shall, with respect to each batch, lot, or other quantity manufactured or licensed after December 22, 1987—
(1) prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and reworking of each batch, lot, or other quantity of such vaccine, including the identification of any significant problems encountered in the production, testing, or handling of such batch, lot, or other quantity,
(2) if a safety test on such batch, lot, or other quantity indicates a potential imminent or substantial public health hazard is presented, report to the Secretary within 24 hours of such safety test which the manufacturer (or manufacturer's representative) conducted, including the date of the test, the type of vaccine tested, the identity of the batch, lot, or other quantity tested, whether the batch, lot, or other quantity tested is the product of repooling or reworking of previous batches, lots, or other quantities (and, if so, the identity of the previous batches, lots, or other quantities which were repooled or reworked), the complete test results, and the name and address of the person responsible for conducting the test,
(3) include with each such report a certification signed by a responsible corporate official that such report is true and complete, and
(4) prepare, maintain, and upon request submit to the Secretary product distribution records for each such vaccine by batch, lot, or other quantity number.
(b) Sanction
Any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required under paragraph (1) or (2) of subsection (a) shall—
(1) be subject to a civil penalty of up to $100,000 per occurrence, or
(2) be fined $50,000 or imprisoned for not more than 1 year, or both.
Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who directed that such record or report be destroyed, altered, falsified, or concealed, and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruction, alteration, falsification, or concealment shall be treated as a separate occurrence.
(July 1, 1944, ch. 373, title XXI, §2128, as added
Editorial Notes
Codification
In subsec. (a), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of
Amendments
1987—Subsec. (a).