21 U.S.C. § 360fff — Definitions

Page 472 TITLE 21—FOOD AND DRUGS § 360fff PART I—NONPRESCRIPTION SUNSCREEN AND OTHER ACTIVE INGREDIENTS TERMINATION OF PART This part ceased to be effective at the end of fiscal year 2022, see section 360fff–8 of this title. § 360fff. Definitions 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 stat- ing that a nonprescription sunscreen active in- gredient 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 rec- ognized, 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, rec- ommended, or suggested in the labeling of a drug as described in section 321(p) of this title; (4) the term ‘‘GRASE determination’’ means, with respect to a nonprescription active ingre- dient or a combination of nonprescription ac- tive 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; (6) the term ‘‘pending request’’ means each request with respect to a nonprescription sun- screen active ingredient submitted under sec- tion 330.14 of title 21, Code of Federal Regula- tions (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 eli- gibility in the Federal Register prior to No- vember 26, 2014; and (B) for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014; (7) the term ‘‘proposed sunscreen order’’ means an order containing a tentative deter- mination published by the Secretary in the Federal Register containing information pro- posing 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; (B) is not GRASE and is misbranded; or (C) is not GRASE and is misbranded be- cause the data are insufficient to classify such ingredient or combination of ingredi- ents as GRASE and not misbranded and ad- ditional information is necessary to allow the Secretary to determine otherwise; (8) the term ‘‘sponsor’’ means the person that submitted— (A) a request under section 360fff–1 of this title; (B) a pending request; or (C) any other application subject to this part; (9) the term ‘‘sunscreen’’ means a drug con- taining one or more sunscreen active ingredi- ents; and (10) the term ‘‘sunscreen active ingredient’’ means an active ingredient that is intended for application to the skin of humans for pur- poses of absorbing, reflecting, or scattering ul- traviolet radiation. (June 25, 1938, ch. 675, § 586, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2035.) Statutory Notes and Related Subsidiaries CONSTRUCTION Pub. L. 113–195, § 2(b), Nov. 26, 2014, 128 Stat. 2045, pro- vided that: ‘‘Nothing in the amendment made by this section [enacting this section and sections 360fff–1 to [former] 360fff–5 of this title] shall be construed to— ‘‘(1) limit the right of a sponsor (as defined in sec- tion 586(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360fff(8)], as added by subsection (a)) to request that the Secretary of Health and Human Services convene an advisory committee; or ‘‘(2) limit the authority of the Secretary of Health and Human Services to meet with a sponsor (as de- fined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)).’’ § 360fff–1. Submission of requests Any person may submit a request to the Sec- retary for a determination of whether a non- prescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dos- age strength, and route of administration) is GRASE and should be included in part 352 of title 21, Code of Federal Regulations (or any suc- cessor regulations) concerning nonprescription sunscreen. (June 25, 1938, ch. 675, § 586A, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2036.) § 360fff–2. Eligibility determinations; data sub- mission; filing (a) Eligibility determinations (1) In general Not later than 60 calendar days after the date of receipt of a request under section 360fff–1 of this title, the Secretary shall— (A) determine, in accordance with para- graph (2), whether the request is eligible for further review under subsection (b) and sec- tion 360fff–3 of this title; (B) notify the sponsor of the determina- tion of the Secretary; and (C) make such determination publicly available in accordance with paragraph (3) and subsection (b)(1). (2) Criteria for eligibility (A) In general To be eligible for review under subsection (b) and section 360fff–3 of this title, a request