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

[CITE: 42USC300aa-1]

 
TITLE 42 - THE PUBLIC HEALTH AND WELFARE
    CHAPTER 6A - PUBLIC HEALTH SERVICE
    SUBCHAPTER XIX - VACCINES
    Part 1 - National Vaccine Program
 
-HEAD-
    Sec. 300aa-1. Establishment
 
-STATUTE-
      The Secretary shall establish in the Department of Health and
    Human Services a National Vaccine Program to achieve optimal
    prevention of human infectious diseases through immunization and to
    achieve optimal prevention against adverse reactions to vaccines.
    The Program shall be administered by a Director selected by the
    Secretary.
 
-SOURCE-
    (July 1, 1944, ch. 373, title XXI, Sec. 2101, as added Pub. L.
    99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3756.)
 
-MISC1-
                              PRIOR PROVISIONS
      A prior section 300aa-1, act July 1, 1944, Sec. 2102, was
    successively renumbered by subsequent acts and transferred, see
    section 238a of this title.
      A prior section 2101 of act July 1, 1944, was successively
    renumbered by subsequent acts and transferred, see section 238 of
    this title.
                               EFFECTIVE DATE
      Section 323 of title III of Pub. L. 99-660, as amended by Pub. L.
    100-203, title IV, Sec. 4302(a), Dec. 22, 1987, 101 Stat. 1330-221;
    Pub. L. 102-168, title II, Sec. 201(a), Nov. 26, 1991, 105 Stat.
    1102, provided that: ''Subtitle 1 of title XXI of the Public Health
    Service Act (part 1 of this subchapter (42 U.S.C. 300aa-1 to
    300aa-6)) shall take effect on the date of the enactment of this
    Act (Nov. 14, 1986) and parts A and B of subtitle 2 of such title
    (subparts A and B of part 2 of this subchapter (42 U.S.C. 300aa-10
    to 300aa-23)) shall take effect on October 1, 1988 and parts C and
    D of such title (subparts C and D of part 2 of this subchapter (42
    U.S.C. 300aa-25 to 300aa-33)) and this title (probably means
    provisions of title III of Pub. L. 99-660 other than those that
    enacted this subchapter and redesignated former sections 300aa to
    300aa-15 of this title as sections 300cc to 300cc-15 of this title;
    these other provisions amended sections 218, 242c, 262, 286, and
    289f of this title and enacted provisions set out as notes under
    sections 201, 300aa-1, and 300aa-4 of this title) shall take effect
    on the date of the enactment of the Vaccine Compensation Amendments
    of 1987 (Dec. 22, 1987).''
                                SEVERABILITY
      Section 322 of title III of Pub. L. 99-660, as amended by Pub. L.
    101-239, title VI, Sec. 6602, Dec. 19, 1989, 103 Stat. 2293; Pub.
    L. 101-502, Sec. 5(g)(1), Nov. 3, 1990, 104 Stat. 1288, provided
    that:
      ''(a) In General. - Except as provided in subsection (b), if any
    provision (of) part A or B of subtitle 2 of title XXI of the Public
    Health Service Act (subparts A and B of part 2 of this subchapter),
    as added by section 311(a), or the application of such a provision
    to any person or circumstance is held invalid by reason of a
    violation of the Constitution, both such parts shall be considered
    invalid.
      ''(b) Special Rule. - If any amendment made by section 6601 of
    the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239,
    amending sections 300aa-10 to 300aa-17, 300aa-21, 300aa-23,
    300aa-26, and 300aa-27 of this title) to title XXI of the Public
    Health Service Act (this subchapter) or the application of such a
    provision to any person or circumstance is held invalid by reason
    of the Constitution, subsection (a) shall not apply and such title
    XXI of the Public Health Service Act without such amendment shall
    continue in effect.''
      (Amendment by section 5(g)(1) of Pub. L. 101-502 to section
    322(a) of Pub. L. 99-660, set out above, effective Nov. 14, 1986,
    see section 5(h) of Pub. L. 101-502, set out as an Effective Date
    of 1990 Amendment note under section 300aa-11 of this title.)
            EVALUATION OF PROGRAM; STUDY AND REPORT TO CONGRESS
      Pub. L. 101-239, title VI, Sec. 6601(t), Dec. 19, 1989, 103 Stat.
    2293, as amended by Pub. L. 102-168, title II, Sec. 201(b), Nov.
    26, 1991, 105 Stat. 1103, directed the Secretary of Health and
    Human Services to evaluate the National Vaccine Injury Compensation
    Program under this subchapter and report results of such study to
    Committee on Energy and Commerce of House of Representatives and
    Committee on Labor and Human Resources of Senate not later than
    Jan. 1, 1993.
                              RELATED STUDIES
      Section 312 of title III of Pub. L. 99-660 directed Secretary of
    Health and Human Services, not later than 3 years after the
    effective date of this title (see Effective Date note above), to
    conduct, through studies by the Institute of Medicine of the
    National Academy of Sciences or other appropriate nonprofit private
    groups or associations, a review of pertussis vaccines and related
    illnesses and conditions and MMR vaccines, vaccines containing
    material intended to prevent or confer immunity against measles,
    mumps, and rubella disease, and related illnesses and conditions,
    make specific findings and report these findings in the Federal
    Register not later than 3 years after the effective date of this
    title, and at the same time these findings are published in the
    Federal Register, propose regulations as a result of such findings,
    and not later than 42 months after the effective date of this
    title, promulgate such proposed regulations with such modifications
    as may be necessary after opportunity for public hearing.
                        STUDY OF OTHER VACCINE RISKS
      Section 313 of title III of Pub. L. 99-660 provided that:
      ''(a) Study. -
        ''(1) Not later than 3 years after the effective date of this
      title (see Effective Date note above), the Secretary shall, after
      consultation with the Advisory Commission on Childhood Vaccines
      established under section 2119 of the Public Health Service Act
      (section 300aa-19 of this title) -
          ''(A) arrange for a broad study of the risks (other than the
        risks considered under section 102 (21 U.S.C. 382)) to children
        associated with each vaccine set forth in the Vaccine Injury
        Table under section 2114 of such Act (section 300aa-14 of this
        title), and
          ''(B) establish guidelines, after notice and opportunity for
        public hearing and consideration of all relevant medical and
        scientific information, respecting the administration of such
        vaccines which shall include -
            ''(i) the circumstances under which any such vaccine should
          not be administered,
            ''(ii) the circumstances under which administration of any
          such vaccine should be delayed beyond its usual time of
          administration, and
            ''(iii) the groups, categories, or characteristics of
          potential recipients of such vaccine who may be at
          significantly higher risk of major adverse reactions to such
          vaccine than the general population of potential recipients.
        ''(2)(A) The Secretary shall request the Institute of Medicine
      of the National Academy of Sciences to conduct the study required
      by paragraph (1) under an arrangement by which the actual
      expenses incurred by such Academy in conducting such study will
      be paid by the Secretary.
        ''(B) If the Institute of Medicine is unwilling to conduct such
      study under such an arrangement, the Secretary shall enter into a
      similar arrangement with other appropriate nonprofit private
      groups or associations under which such groups or associations
      will conduct such study.
        ''(C) The Institute of Medicine or other group or association
      conducting the study required by paragraph (1) shall conduct such
      studies in consultation with the Advisory Commission on Childhood
      Vaccines established under section 2119 of the Public Health
      Service Act (section 300aa-19 of this title).
      ''(b) Revision of Guidelines. - The Secretary shall periodically,
    but at least every 3 years after establishing guidelines under
    subsection (a), review and revise such guidelines after notice and
    opportunity for public hearing and consideration of all relevant
    medical and scientific information, unless the Secretary finds that
    on the basis of all relevant information no revision of such
    guidelines is warranted and publishes such finding in the Federal
    Register.
      ''(c) Factors Affecting Guidelines. - Guidelines under subsection
    (a) shall take into account -
        ''(1) the risk to potential recipients of the vaccines with
      respect to which the guidelines are established,
        ''(2) the medical and other characteristics of such potential
      recipients, and
        ''(3) the risks to the public of not having such vaccines
      administered.
      ''(d) Dissemination. - The Secretary shall widely disseminate the
    guidelines established under subsection (a) to -
        ''(1) physicians and other health care providers,
        ''(2) professional health associations,
        ''(3) State and local governments and agencies, and
        ''(4) other relevant entities.''
    REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION
      Section 314 of title III of Pub. L. 99-660 directed Secretary of
    Health and Human Services, not later than 1 year after the
    effective date of this title (see Effective Date note above) and
    after consultation with Advisory Commission on Childhood Vaccines
    and with other appropriate entities, to review the warnings, use
    instructions, and precautionary information presently issued by
    manufacturers of vaccines set forth in the Vaccine Injury Table set
    out in section 300aa-14 of this title and by rule determine whether
    such warnings, instructions, and information adequately warn health
    care providers of the nature and extent of dangers posed by such
    vaccines, and, if any such warning, instruction, or information is
    determined to be inadequate for such purpose in any respect,
    require at the same time that the manufacturers revise and reissue
    such warning, instruction, or information as expeditiously as
    practical, but not later than 18 months after the effective date of
    this title.
                   STUDY OF IMPACT ON SUPPLY OF VACCINES
      Section 316 of title III of Pub. L. 99-660 provided that: ''On
    June 30, 1987, and on June 30 of each second year thereafter, the
    Secretary of Health and Human Services shall submit to the
    Committee on Energy and Commerce (now Committee on Commerce) of the
    House of Representatives and the Committee on Labor and Human
    Resources of the Senate -
        ''(1) an assessment of the impact of the amendments made by
      this title (enacting this subchapter, amending sections 218,
      242c, 262, 286, and 289f of this title, redesignating former
      sections 300aa to 300aa-15 of this title as sections 300cc to
      300cc-15 of this title, and enacting provisions set out as notes
      under this section and sections 201 and 300aa-1 of this title) on
      the supply of vaccines listed in the Vaccine Injury Table under
      section 2114 of the Public Health Service Act (section 300aa-14
      of this title), and
        ''(2) an assessment of the ability of the administrators of
      vaccines (including public clinics and private administrators) to
      provide such vaccines to children.''
                       WAIVER OF PAPERWORK REDUCTION
      Section 321 of title III of Pub. L. 99-660 provided that:
    ''Chapter 35 of title 44, United States Code, shall not apply to
    information required for purposes of carrying out this title and
    implementing the amendments made by this title (enacting this
    subchapter, amending sections 218, 242c, 262, 286, and 289f of this
    title, redesignating former sections 300aa to 300aa-15 of this
    title as sections 300cc to 300cc-15 of this title, and enacting
    provisions set out as notes under sections 201, 300aa-1, and
    300aa-4 of this title).''