42 USC 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.