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42 U.S.C. § 300aa–2 — Program responsibilities
Federal law — U.S. Code and appendices · legal_authorities
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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 Revie
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Stable record: federal_law:legal_authorities:record_usc_8602edd375e71bd39e3dd69f
Source file: Laws/federal/codes/united-states-code/title-42/section-300aa2-program-responsibilities--c30c3feaff.md
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Source location: Title 42, Chapter 6A, § 300aa–2; chapter-6a-public-health-service.md
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**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), coordinate and provide direction for the allocation of resources in the implementation of the licensing program under [section 263a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section263a&num=0&edition=prelim).
(5) **Production and procurement of vaccines** — The Director of the Program shall, through the plan issued under [section 300aa–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim) funds appropriated under [section 300aa–6 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-6&num=0&edition=prelim) to supplement the funds otherwise available to such agencies for activities under the plan.
**(b)** In carrying out subsection (a) and in preparing the plan under [section 300aa–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300aa-3&num=0&edition=prelim), 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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Federal law — U.S. Code and appendices · legal_authorities
The Immigration and Naturalization Service may, by agreement of the heads of the departments concerned, permit the Public Health Service to use hospitals at immigration stations for the care of Public Health Service patients. The Surgeon General shall reimburse the Immigration and Naturalization Service for the actual cost of furnishing fuel, light, water, telephone, and similar supplies and services, which reimbursement shall be covered into the proper Immigration and Naturalization Service appropriation, or such costs may be paid from working funds established as provided by law, but no charge shall be made for the expense of physical upkeep of the hospitals. The Immigration and Naturalization Service shall reimburse the Surgeon General for the care and treatment of persons detained in hospitals of the Public Health Service at the request of the Immigration and Naturalization Service unless such persons are entitled to care and treatment under section 249(a) 11 See References in Text note below. of this title.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 238b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Acceptance by Secretary** The Secretary of Health and Human Services is authorized to accept on behalf of the United States gifts made unconditionally by will or otherwise for the benefit of the Service or for the carrying out of any of its functions. Conditional gifts may be so accepted if recommended by the Surgeon General, and the principal of and income from any such conditional gift shall be held, invested, reinvested, and used in accordance with its conditions, but no gift shall be accepted which is conditioned upon any expenditure not to be met therefrom or from the income thereof unless such expenditure has been approved by Act of Congress.
**(b) Depository of funds; availability for expenditure** Any unconditional gift of money accepted pursuant to the authority granted in subsection (a) of this section, the net proceeds from the liquidation (pursuant to subsection (c) or subsection (d) of this section) of any other property so accepted, and the proceeds of insurance on any such gift property not used for its restoration, shall be deposited in the Treasury of the United States and are hereby appropriated and shall be held in trust by the Secretary of the Treasury for the benefit of the Service, and he may invest and reinvest such funds in interest-bearing obligations of the United States or in obligations guaranteed as to both principal and interest by the United States. Such gifts and the income from such investments shall be available for expenditure in the operation of the Service and the performance of its functions, subject to the same examination and audit as is provided for appropriations made for the Service by Congress.
**(c) Evidences of unconditional gifts of intangible property** The evidences of any unconditional gift of intangible personal
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 238a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) “Laboratory” or “clinical laboratory” defined** As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
**(b) Certificate requirement** No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.
**(c) Issuance and renewal of certificates**
(1) **In general** — The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d).
(2) **Term** — A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish.
**(d) Requirements for certificates**
(1) **In general** — A laboratory may be issued a certificate or have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application—
(i) in such form and manner as the Secretary shall prescribe,
(ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including—
(I) the number and types of laboratory examinations and other procedures
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 263a
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