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42 U.S.C. § 300aa–26Vaccine information

submitted 82 years ago by Pub. L. 99-660 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 308 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Secretary must create and share plain-language materials about vaccine benefits, risks, and the compensation program. These materials go through public comment and consultation with experts before being published. Providers must give this information to patients before vaccinating them, once the materials are ready.

(a) General rule: By one year after December 22, 1987, the Secretary had to create and distribute vaccine information materials. Health care providers give these to the legal representatives of children, or to any other person getting a vaccine listed in the Vaccine Injury Table. These materials must be published in the Federal Register and can be updated later. (b) Development and revision of materials: The materials must be created or revised: (1) after the public is notified and given 60 days to comment; and (2) with input from the Advisory Commission on Childhood Vaccines, relevant health care providers and parent groups, the Centers for Disease Control and Prevention, and the FDA. (c) Information requirements: The materials must be based on real data, written in understandable language, and include: (1) a short description of the vaccine's benefits; (2) a short description of the vaccine's risks; (3) a statement that the National Vaccine Injury Compensation Program exists; and (4) any other information the Secretary decides is relevant. (d) Health care provider duties: Starting on a date the Secretary sets — which must come after the materials are ready, and no later than 6 months after they're published in the Federal Register — every provider who gives a listed vaccine must give a copy of these materials to the legal representative of a child, or to any other person about to get the vaccine. Providers can add pictures or verbal explanations when appropriate. Providers must give out these materials before giving the vaccine.
the actual law source: uscode.house.gov ↗public domain
(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.

Source credit: (July 1, 1944, ch. 373, title XXI, § 2126, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3775; amended Pub. L. 100–203, title IV, § 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221; Pub. L. 101–239, title VI, § 6601(p), Dec. 19, 1989, 103 Stat. 2292; Pub. L. 102–531, title III, § 312(d)(15), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103–183, title VII, § 708, Dec. 14, 1993, 107 Stat. 2242.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 99-660 · 100 Stat. 3775
  • 1987Amended · Pub. L. 100-203 · 101 Stat. 1330
  • 1989Amended · Pub. L. 101-239 · 103 Stat. 2292
  • 1992Amended · Pub. L. 102-531 · 106 Stat. 3505
  • 1993Amended · Pub. L. 103-183 · 107 Stat. 2242

A history note hasn’t been published yet. The record shows enactment by Pub. L. 99-660 on 1944-07-01.

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