Public Law 119-102 (07/12/2026)

42 U.S.C. § 300aa–2

Program responsibilities

Section text and notes

(a)
The Director of the Program shall have the following responsibilities:
(1)

Vaccine research

section 300aa–3 of this titleThe Director of the Program shall, through the plan issued under , 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

section 300aa–3 of this titleThe Director of the Program shall, through the plan issued under , 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

section 300aa–3 of this titleThe Director of the Program shall, through the plan issued under , 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

section 300aa–3 of this titlesection 263a of this titleThe Director of the Program shall, through the plan issued under , coordinate and provide direction for the allocation of resources in the implementation of the licensing program under .

(5)

Production and procurement of vaccines

section 300aa–3 of this titleThe Director of the Program shall, through the plan issued under , 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

section 300aa–3 of this titleThe Director of the Program shall, through the plan issued under , 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

section 300aa–3 of this titleThe Director of the Program shall, through the plan issued under , 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

section 300aa–3 of this titleThe Director of the Program shall, through the plan issued under , 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

section 300aa–3 of this titlesection 300aa–6 of this titleThe Director of the Program shall make available to Federal agencies involved in the implementation of the plan issued under funds appropriated under to supplement the funds otherwise available to such agencies for activities under the plan.

(b)
section 300aa–3 of this title In carrying out subsection (a) and in preparing the plan under , 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 Pub. L. 99–660, title III, § 311(a)100 Stat. 3756 Pub. L. 102–531, title III, § 312(d)(13)106 Stat. 3505 Pub. L. 108–173, title IX, § 900(e)(2)(F)117 Stat. 2372 (, title XXI, § 2102, as added , , ; amended , , ; , , .)

Editorial Notes

Prior Provisions

section 238b of this titleA prior section 300aa–2, act , § 2103, was successively renumbered by subsequent acts and transferred, see .

section 238a of this titleA prior section 2102 of act , was successively renumbered by subsequent acts and transferred, see .

Amendments

Pub. L. 108–1732003—Subsec. (a)(7). substituted “Centers for Medicare & Medicaid Services” for “Health Care Financing Administration”.

Pub. L. 102–5311992—Subsec. (a)(1), (3), (6), (7). substituted “Centers for Disease Control and Prevention” for “Centers for Disease Control”.

Statutory Notes and Related Subsidiaries

Encouraging Vaccine Innovation; Meetings

Pub. L. 114–255, div. A, title III, § 3093(a)130 Stat. 1151

“The Director of the Centers for Disease Control and Prevention shall ensure that appropriate staff within the relevant centers and divisions of the Office of Infectious Diseases, and others, as appropriate, coordinate with respect to the public health needs, epidemiology, and program planning and implementation considerations related to immunization, including with regard to meetings with stakeholders related to such topics.”
, , , provided that:

Grants for Research on Vaccine Against Valley Fever

Pub. L. 109–432, div. B, title IV, § 402120 Stat. 2994 , , , authorized the Secretary of Health and Human Services to make grants for research on the development of a vaccine against coccidioidomycosis (commonly known as Valley Fever) before .

Demonstration Projects for Outreach Programs

Pub. L. 101–502, § 2(b)104 Stat. 1285

“(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.”
, , , provided that:

Pub. L. 102–531, title III, § 312106 Stat. 3504 [Centers for Disease Control changed to Centers for Disease Control and Prevention by , , .]

Supply of Vaccines

Pub. L. 101–502, § 3104 Stat. 1285

“(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.”
, , , provided that:

Pub. L. 102–531, title III, § 312106 Stat. 3504 [Centers for Disease Control changed to Centers for Disease Control and Prevention by , , .]

Pub. L. 100–177, title I, § 110(b)101 Stat. 991

“(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.”
, , , provided that:

Pub. L. 102–531, title III, § 312106 Stat. 3504 [Centers for Disease Control changed to Centers for Disease Control and Prevention by , , .]