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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Source file: Laws/federal/codes/united-states-code/title-21/section-301-short-title--03e47b1661.md
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Source location: Title 21, Chapter 9, § 301; chapter-009-federal-food-drug-and-cosmetic-act.md
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Director of NIH may conduct or support research to examine the long-term health implications of silicone breast implants, both gel and saline filled. Such research studies may include the following: (1) Developing and examining techniques to measure concentrations of silicone in body fluids and tissues. (2) Surveillance of recipients of silicone breast implants, including long-term outcomes and local complications. **(b) Definition** For purposes of this section, the term “breast implant” means a breast prosthesis that is implanted to augment or reconstruct the female breast.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 289g–3
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Federal law — U.S. Code and appendices · legal_authorities
### Statutory Notes Section, Pub. L. 110–85, title XI, § 1111, Sept. 27, 2007, 121 Stat. 975, related to identification of clinically susceptible concentrations of antimicrobials. See [section 360a–2 of Title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360a–2&num=0&edition=prelim), Food and Drugs.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–5a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) New drugs and biological products** (1) **In general** (A) *General requirements* — Except with respect to an application for which subparagraph (B) applies, a person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug— (i) under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or (ii) under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration, shall submit with the application the assessments described in paragraph (2). (B) *Certain molecularly targeted cancer indications* — A person that submits, on or after the date that is 3 years after August 18, 2017, an original application for a new active ingredient under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is— (i) intended for the treatment of an adult cancer; and (ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer. (2) **Assessments** (A) *In general* — The assessments referred to in
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355c
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Request by sponsor; response by Secretary** The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before— (1) it may be approved for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or (2) if the drug is a biological product, it may be licensed for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or licensing of such drug for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). **(b) Regulations** The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360aa
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General rule** For purposes of section 38, the credit determined under this section for the taxable year is an amount equal to 25 percent of the qualified clinical testing expenses for the taxable year. **(b) Qualified clinical testing expenses** For purposes of this section— (1) **Qualified clinical testing expenses** (A) *In general* — Except as otherwise provided in this paragraph, the term “qualified clinical testing expenses” means the amounts which are paid or incurred by the taxpayer during the taxable year which would be described in subsection (b) of section 41 if such subsection were applied with the modifications set forth in subparagraph (B). (B) *Modifications* — For purposes of subparagraph (A), subsection (b) of section 41 shall be applied— (i) by substituting “clinical testing” for “qualified research” each place it appears in paragraphs (2) and (3) of such subsection, and (ii) by substituting “100 percent” for “65 percent” in paragraph (3)(A) of such subsection. (C) *Exclusion for amounts funded by grants, etc.* — The term “qualified clinical testing expenses” shall not include any amount to the extent such amount is funded by any grant, contract, or otherwise by another person (or any governmental entity). (2) **Clinical testing** (A) *In general* — The term “clinical testing” means any human clinical testing— (i) which is carried out under an exemption for a drug being tested for a rare disease or condition under section 505(i) of the Federal Food, Drug, and Cosmetic Act (or regulations issued under such section), (ii) which occurs— (I) after the date such drug is designated under section 526 of such Act, and (II) before the date on which an application with respect to such drug is approved under
Source: Supplied U.S. Code snapshot — release unconfirmed · 26 U.S.C. § 45C
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
In this part— (1) the term “Advisory Committee” means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee; (2) the term “final sunscreen order” means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients— (A) is GRASE and is not misbranded if marketed in accordance with such order; or (B) is not GRASE and is misbranded; (3) the term “GRASE” means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in [section 321(p) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/p&num=0&edition=prelim); (4) the term “GRASE determination” means, with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such ingredient or combination of ingredients is GRASE; (5) the term “nonprescription” means not subject to [section 353(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/1&num=0&edition=prelim); (6) the term “pending request” means each request with respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) for consideration for inclusion in the over-the-counter drug monograph system— (A) that was determined to be eligible for such review by publication of a notice of eligibilit
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360fff
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary shall, acting through the Director of NIH, establish a nonprofit corporation to be known as the Foundation for the National Institutes of Health (hereafter in this section referred to as the “Foundation”). The Foundation shall not be an agency or instrumentality of the United States Government. **(b) Purpose of Foundation** The purpose of the Foundation shall be to support the National Institutes of Health in its mission (including collection of funds for pediatric pharmacologic research), and to advance collaboration with biomedical researchers from universities, industry, and nonprofit organizations. **(c) Certain activities of Foundation** (1) **In general** — In carrying out subsection (b), the Foundation may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of the following activities with respect to the purpose described in such subsection: (A) A program to provide and administer endowed positions that are associated with the research program of the National Institutes of Health. Such endowments may be expended for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the endowed positions. (B) A program to provide and administer fellowships and grants to research personnel in order to work and study in association with the National Institutes of Health. Such fellowships and grants may include stipends, travel, health insurance benefits and other appropriate expenses. The recipients of fellowships shall be selected by the donors and the Foundation upon the recommendation of the National Institutes of Health employees in the laboratory where the fellow would serve
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 290b
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Federal law — U.S. Code and appendices · legal_authorities
### Statutory Notes Section, Pub. L. 95–203, § 4(c), (d), Nov. 23, 1977, 91 Stat. 1453, 1454, related to distribution of information on health risks of saccharin.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 343a
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Federal law — U.S. Code and appendices · legal_authorities
The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the Secretary.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355d
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