From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]

[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
 
-HEAD-
    Sec. 300aa-26. Vaccine information
 
-STATUTE-
    (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.
 
-SOURCE-
    (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.)
 
-COD-
                                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.
 
-MISC3-
                                 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.