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

(a)

General rule

December 22, 1987Not later than 1 year after , 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 Pub. L. 99–660, title III, § 311(a)Nov. 14, 1986100 Stat. 3775 Pub. L. 100–203, title IV, § 4302(b)(1)Dec. 22, 1987101 Stat. 1330–221 Pub. L. 101–239, title VI, § 6601(p)Dec. 19, 1989103 Stat. 2292 Pub. L. 102–531, title III, § 312(d)(15)Oct. 27, 1992106 Stat. 3505 Pub. L. 103–183, title VII, § 708Dec. 14, 1993107 Stat. 2242 (, title XXI, § 2126, as added , , ; amended , , ; , , ; , , ; , , .)

Editorial Notes

Codification

December 22, 1987section 323 of Pub. L. 99–660 section 300aa–1 of this titleIn subsec. (a), “” substituted for “the effective date of this subpart” on authority of , as amended, set out as an Effective Date note under .

Amendments

Pub. L. 103–183, § 708(a)Subsec. (b). , struck out “by rule” after “revised” in introductory provisions and substituted “and 60” for “, opportunity for a public hearing, and 90” in par. (1).

Pub. L. 103–183, § 708(b)Subsec. (c). , 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.”

Pub. L. 103–183, § 708(c)Subsec. (d). , (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”.

Pub. L. 102–5311992—Subsec. (b)(2). substituted “Centers for Disease Control and Prevention” for “Centers for Disease Control”.

Pub. L. 101–2391989—Subsec. (c)(9). 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”.

Pub. L. 100–2031987—Subsec. (a). substituted “effective date of this subpart” for “effective date of this part”.

Statutory Notes and Related Subsidiaries

Effective Date of 1989 Amendment

Pub. L. 101–239Dec. 19, 1989section 6601(s)(1) of Pub. L. 101–239 section 300aa–10 of this titleFor applicability of amendments by to petitions filed after , 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 , set out as a note under .

Section text and notes