
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-2]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                        SUBCHAPTER XIX--VACCINES
 
                    Part 1--National Vaccine Program
 
Sec. 300aa-2. Program responsibilities

    (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.

(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.)


                            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.]

                  Section Referred to in Other Sections

    This section is referred to in sections 300aa-3, 300aa-5, 300aa-6 of 
this title.
