
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300aa-26]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                        SUBCHAPTER XIX--VACCINES
 
          Part 2--National Vaccine Injury Compensation Program
 
  subpart c--assuring a safer childhood vaccination program in united 
                                 states
 
Sec. 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) of this section, 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) of this section, 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, Sec. 2126, as added Pub. L. 99-660, 
title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3775; amended Pub. L. 
100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330-221; 
Pub. L. 101-239, title VI, Sec. 6601(p), Dec. 19, 1989, 103 Stat. 2292; 
Pub. L. 102-531, title III, Sec. 312(d)(15), Oct. 27, 1992, 106 Stat. 
3505; Pub. L. 103-183, title VII, Sec. 708, Dec. 14, 1993, 107 Stat. 
2242.)

                          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, Sec. 708(c), inserted ``or to 
any other individual'' after ``to the legal representatives of any 
child''.
    Subsec. (b). Pub. L. 103-183, Sec. 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, Sec. 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, Sec. 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''.


                    Effective Date of 1989 Amendment

    For 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.
