Title 42The Public Health and WelfareRelease 119-73

§300aa–26 Vaccine information

Title 42 › Chapter CHAPTER 6A— - PUBLIC HEALTH SERVICE › Subchapter SUBCHAPTER XIX— - VACCINES › Part Part 2— - National Vaccine Injury Compensation Program › Subpart subpart c— - assuring a safer childhood vaccination program in united states › § 300aa–26

Last updated Apr 6, 2026|Official source

Summary

The Secretary must create and share vaccine information sheets no later than 1 year after December 22, 1987. Health care providers must give these sheets to a child’s legal guardian or to anyone getting a vaccine listed on the Vaccine Injury Table. The sheets must be published in the Federal Register and can be updated. Before making or changing the sheets, the Secretary must tell the public and allow 60 days for comments, and must consult with the Advisory Commission on Childhood Vaccines, relevant health care providers and parent groups, the CDC, and the FDA. The information must use available facts, be easy to understand, and include a short description of benefits, a short description of risks, a notice that the National Vaccine Injury Compensation Program is available, and any other relevant details the Secretary decides. The Secretary will set an effective date that is after the materials are made and no later than 6 months after they are published.

Full Legal Text

Title 42, §300aa–26

The Public Health and Welfare — Source: USLM XML via OLRC

(a)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)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)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)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,

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Codification In subsec. (a), “December 22, 1987” substituted for “the

Effective Date

of this subpart” on authority of section 323 of Pub. L. 99–660, as amended, set out as an

Effective Date

note under section 300aa–1 of this title.

Amendments

1993—Subsec. (a). Pub. L. 103–183, § 708(c), inserted “or to any other individual” after “to the legal representatives of any child”. Subsec. (b). Pub. L. 103–183, § 708(a), struck out “by rule” after “revised” in introductory provisions and substituted “and 60” for “, opportunity for a public hearing, and 90” in par. (1). Subsec. (c). Pub. L. 103–183, § 708(b), inserted in introductory provisions “shall be based on available data and information,” after “such materials”, added pars. (1) to (4), and struck out former pars. (1) to (10) which read as follows: “(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). Pub. L. 103–183, § 708(c), (d), in concluding provisions, inserted “or to any other individual” after “to the legal representatives of any child”, substituted “supplemented with visual presentations or oral explanations, in appropriate cases” for “or other written information which meets the requirements of this section”, and struck out “or other information” after “Such materials”. 1992—Subsec. (b)(2). Pub. L. 102–531 substituted “Centers for Disease Control and Prevention” for “Centers for Disease Control”. 1989—Subsec. (c)(9). Pub. L. 101–239 amended par. (9) generally. Prior to amendment, par. (9) read as follows: “a summary of relevant State and Federal laws concerning the vaccine, including information on— “(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). Pub. L. 100–203 substituted “

Effective Date

of this subpart” for “

Effective Date

of this part”.

Statutory Notes and Related Subsidiaries

Effective Date

of 1989 AmendmentFor applicability of

Amendments

by Pub. L. 101–239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101–239, set out as a note under section 300aa–10 of this title.

Reference

Citations & Metadata

Citation

42 U.S.C. § 300aa–26

Title 42The Public Health and Welfare

Last Updated

Apr 6, 2026

Release point: 119-73