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42 U.S.C. § 300cc–12 — Use of investigational new drugs with respect to acquired immune deficiency syndrome
Federal law — U.S. Code and appendices · legal_authorities
**(a) Encouragement of applications with respect to clinical trials**
(1) If, in the determination of the Secretary, there is preliminary evidence that a new drug has effectiveness in humans with respect to the prevention or treatment of acquired immune deficiency syndrome, the Secretary shall, through statements published in the Federal Register—
(A) announce the fact of such determination; and
(B) with respect to the new drug involved, encourage an application for an exemption for investigational use of the new drug under regulations issued under [section 355(i) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim).
(2)
(A) The AIDS Research Advisory Committee established pursuant to [section 300cc–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300cc-3&num=0&edition=prelim) shall make recommendations to the Secretary with respect to new drugs appropriate for determinations described in paragraph (1).
(B) The Secretary shall, as soon as is practicable, determine the merits of recommendations received by the Secretary pursuant to subparagraph (A).
**(b) Encouragement of applications with respect to treatment use in circumstances other than clinical trials**
(1) In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a) and with respect to which an exemption is in effect for purposes of [section 355(i) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim), the Secretary shall—
(A) as appropriate, encourage the sponsor of the investigation of the new drug to submit to the Secretary, in accordance with regulations issued under suc
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 300cc–12
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Source file: Laws/federal/codes/united-states-code/title-42/section-300cc12-use-of-investigational-new-drugs-with-respect-to-acquired-immune-deficie--962db57380.md
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Source location: Title 42, Chapter 6A, § 300cc–12; chapter-6a-public-health-service.md
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**(a) Encouragement of applications with respect to clinical trials**
(1) If, in the determination of the Secretary, there is preliminary evidence that a new drug has effectiveness in humans with respect to the prevention or treatment of acquired immune deficiency syndrome, the Secretary shall, through statements published in the Federal Register—
(A) announce the fact of such determination; and
(B) with respect to the new drug involved, encourage an application for an exemption for investigational use of the new drug under regulations issued under [section 355(i) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim).
(2)
(A) The AIDS Research Advisory Committee established pursuant to [section 300cc–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300cc-3&num=0&edition=prelim) shall make recommendations to the Secretary with respect to new drugs appropriate for determinations described in paragraph (1).
(B) The Secretary shall, as soon as is practicable, determine the merits of recommendations received by the Secretary pursuant to subparagraph (A).
**(b) Encouragement of applications with respect to treatment use in circumstances other than clinical trials**
(1) In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a) and with respect to which an exemption is in effect for purposes of [section 355(i) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim), the Secretary shall—
(A) as appropriate, encourage the sponsor of the investigation of the new drug to submit to the Secretary, in accordance with regulations issued under such section, an application to use the drug in the treatment of individuals—
(i) who are infected with the etiologic agent for acquired immune deficiency syndrome; and
(ii) who are not participating in the clinical trials conducted pursuant to such exemption; and
(B) if such an application is approved, encourage, as appropriate, licensed medical practitioners to obtain, in accordance with such regulations, the new drug from such sponsor for the purpose of treating such individuals.
(2) If the sponsor of the investigation of a new drug described in paragraph (1) does not submit to the Secretary an application described in such paragraph (relating to treatment use), the Secretary shall, through statements published in the Federal Register, encourage, as appropriate, licensed medical practitioners to submit to the Secretary such applications in accordance with regulations described in such paragraph.
**(c) Technical assistance with respect to treatment use** In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a), the Secretary may, directly or through grants or contracts, provide technical assistance with respect to the process of—
(1) submitting to the Secretary applications for exemptions described in paragraph (1)(B) of such subsection;
(2) submitting to the Secretary applications described in subsection (b); and
(3) with respect to sponsors of investigations of new drugs, facilitating the transfer of new drugs from such sponsors to licensed medical practitioners.
**(d) “New drug” defined** For purposes of this section, the term “new drug” has the meaning given such term in [section 321 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim).
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Federal law — U.S. Code and appendices · legal_authorities
The Secretary may provide for suitably acknowledging, within the Department (whether by memorials, designations, or other suitable acknowledgments), (1) efforts of persons who have contributed substantially to the health of the Nation and (2) gifts for use in activities of the Department related to health.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 238j
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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