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U.S. Code as of:
01/19/04
Section 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
Centers for Medicare & Medicaid Services 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.
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