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

[CITE: 42USC300aa-2]

 
TITLE 42 - THE PUBLIC HEALTH AND WELFARE
    CHAPTER 6A - PUBLIC HEALTH SERVICE
    SUBCHAPTER XIX - VACCINES
    Part 1 - National Vaccine Program
 
-HEAD-
    Sec. 300aa-2. Program responsibilities
 
-STATUTE-
      (a) The Director of the Program shall have the following
    responsibilities:
      (1) Vaccine research
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, coordinate and provide
      direction for research carried out in or through the National
      Institutes of Health, the Centers for Disease Control and
      Prevention, the Office of Biologics Research and Review of the
      Food and Drug Administration, the Department of Defense, and the
      Agency for International Development on means to induce human
      immunity against naturally occurring infectious diseases and to
      prevent adverse reactions to vaccines.
      (2) Vaccine development
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, coordinate and provide
      direction for activities carried out in or through the National
      Institutes of Health, the Office of Biologics Research and Review
      of the Food and Drug Administration, the Department of Defense,
      and the Agency for International Development to develop the
      techniques needed to produce safe and effective vaccines.
      (3) Safety and efficacy testing of vaccines
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, coordinate and provide
      direction for safety and efficacy testing of vaccines carried out
      in or through the National Institutes of Health, the Centers for
      Disease Control and Prevention, the Office of Biologics Research
      and Review of the Food and Drug Administration, the Department of
      Defense, and the Agency for International Development.
      (4) Licensing of vaccine manufacturers and vaccines
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, coordinate and provide
      direction for the allocation of resources in the implementation
      of the licensing program under section 263a of this title.
      (5) Production and procurement of vaccines
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, ensure that the governmental
      and non-governmental production and procurement of safe and
      effective vaccines by the Public Health Service, the Department
      of Defense, and the Agency for International Development meet the
      needs of the United States population and fulfill commitments of
      the United States to prevent human infectious diseases in other
      countries.
      (6) Distribution and use of vaccines
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, coordinate and provide
      direction to the Centers for Disease Control and Prevention and
      assistance to States, localities, and health practitioners in the
      distribution and use of vaccines, including efforts to encourage
      public acceptance of immunizations and to make health
      practitioners and the public aware of potential adverse reactions
      and contraindications to vaccines.
      (7) Evaluating the need for and the effectiveness and adverse
          effects of vaccines and immunization activities
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, coordinate and provide
      direction to the National Institutes of Health, the Centers for
      Disease Control and Prevention, the Office of Biologics Research
      and Review of the Food and Drug Administration, the National
      Center for Health Statistics, the National Center for Health
      Services Research and Health Care Technology Assessment, and the
      Health Care Financing Administration in monitoring the need for
      and the effectiveness and adverse effects of vaccines and
      immunization activities.
      (8) Coordinating governmental and non-governmental activities
        The Director of the Program shall, through the plan issued
      under section 300aa-3 of this title, provide for the exchange of
      information between Federal agencies involved in the
      implementation of the Program and non-governmental entities
      engaged in the development and production of vaccines and in
      vaccine research and encourage the investment of non-governmental
      resources complementary to the governmental activities under the
      Program.
      (9) Funding of Federal agencies
        The Director of the Program shall make available to Federal
      agencies involved in the implementation of the plan issued under
      section 300aa-3 of this title funds appropriated under section
      300aa-6 of this title to supplement the funds otherwise available
      to such agencies for activities under the plan.
      (b) In carrying out subsection (a) of this section and in
    preparing the plan under section 300aa-3 of this title, the
    Director shall consult with all Federal agencies involved in
    research on and development, testing, licensing, production,
    procurement, distribution, and use of vaccines.
 
-SOURCE-
    (July 1, 1944, ch. 373, title XXI, Sec. 2102, as added Pub. L.
    99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3756;
    amended Pub. L. 102-531, title III, Sec. 312(d)(13), Oct. 27, 1992,
    106 Stat. 3505.)
 
-MISC1-
                              PRIOR PROVISIONS
      A prior section 300aa-2, act July 1, 1944, Sec. 2103, was
    successively renumbered by subsequent acts and transferred, see
    section 238b of this title.
      A prior section 2102 of act July 1, 1944, was successively
    renumbered by subsequent acts and transferred, see section 238a of
    this title.
                                 AMENDMENTS
      1992 - Subsec. (a)(1), (3), (6), (7). Pub. L. 102-531 substituted
    ''Centers for Disease Control and Prevention'' for ''Centers for
    Disease Control''.
                DEMONSTRATION PROJECTS FOR OUTREACH PROGRAMS
      Pub. L. 101-502, Sec. 2(b), Nov. 3, 1990, 104 Stat. 1285,
    provided that:
      ''(1) In general. - The Secretary of Health and Human Services,
    acting through the Director of the Centers for Disease Control, may
    make grants to public and nonprofit private entities for the
    purpose of carrying out demonstration projects -
        ''(A) to provide, without charge, immunizations against
      vaccine-preventable diseases to children not more than 2 years of
      age who reside in communities whose population includes a
      significant number of low-income individuals; and
        ''(B) to provide outreach services to identify such children
      and to inform the parents (or other guardians) of the children of
      the availability from the entities of the immunizations specified
      in subparagraph (A).
      ''(2) Authorization of appropriations. - For the purpose of
    carrying out paragraph (1), there are authorized to be appropriated
    such sums as may be necessary for each of the fiscal years 1991
    through 1993.''
      (Centers for Disease Control changed to Centers for Disease
    Control and Prevention by Pub. L. 102-531, title III, Sec. 312,
    Oct. 27, 1992, 106 Stat. 3504.)
                             SUPPLY OF VACCINES
      Pub. L. 101-502, Sec. 3, Nov. 3, 1990, 104 Stat. 1285, provided
    that:
      ''(a) In General. - The Secretary of Health and Human Services,
    acting through the Director of the Centers for Disease Control,
    shall acquire and maintain a supply of vaccines sufficient to
    provide vaccinations throughout a 6-month period.  Any proceeds
    received by the Secretary from the sale of vaccines from such
    supply shall be available to the Secretary for the purpose of
    purchasing vaccines for the supply.  Such proceeds shall remain
    available for such purpose until expended.
      ''(b) Authorization of Appropriations. - For the purpose of
    carrying out subsection (a), there are authorized to be
    appropriated $5,000,000 for fiscal year 1991, and such sums as may
    be necessary for each of the fiscal years 1992 through 1995.''
      (Centers for Disease Control changed to Centers for Disease
    Control and Prevention by Pub. L. 102-531, title III, Sec. 312,
    Oct. 27, 1992, 106 Stat. 3504.)
      Pub. L. 100-177, title I, Sec. 110(b), Dec. 1, 1987, 101 Stat.
    991, provided that:
      ''(1) In general. - The Secretary of Health and Human Services,
    acting through the Director of the Centers for Disease Control,
    shall acquire and maintain a supply of vaccines sufficient to
    provide vaccinations throughout a 6-month period.
      ''(2) Authorization of Appropriations. - There are authorized to
    be appropriated to carry out paragraph (1) $5,000,000 for fiscal
    year 1988, and such sums as may be necessary for each of the fiscal
    years 1989 and 1990.''
      (Centers for Disease Control changed to Centers for Disease
    Control and Prevention by Pub. L. 102-531, title III, Sec. 312,
    Oct. 27, 1992, 106 Stat. 3504.)
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in sections 300aa-3, 300aa-5, 300aa-6
    of this title.