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21 U.S.C. § 360fff — Definitions
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
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Source file: Laws/federal/codes/united-states-code/title-21/section-360fff-definitions--b243c61603.md
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Source location: Title 21, Chapter 9, § 360fff; chapter-009-federal-food-drug-and-cosmetic-act.md
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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 eligibility in the Federal Register prior to November 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 determination published by the Secretary in the Federal Register containing information proposing 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 because the data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and additional 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360fff-1&num=0&edition=prelim);
(B) a pending request; or
(C) any other application subject to this part;
(9) the term “sunscreen” means a drug containing one or more sunscreen active ingredients; and
(10) the term “sunscreen active ingredient” means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation.
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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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Federal law — U.S. Code and appendices · legal_authorities
**(a) Review of new request**
(1) **Proposed sunscreen order** — In the case of a request under [section 360fff–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360fff-1&num=0&edition=prelim), not later than 300 calendar days after the date on which such request is filed under subsection (b)(2)(A) or (b)(3)(B)(ii)(III) of [section 360fff–2 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360fff-2&num=0&edition=prelim), the Secretary—
(A) may convene a meeting of the Advisory Committee to review such request; and
(B) shall complete the review of such request and issue a proposed sunscreen order with respect to such request.
(2) **Proposed sunscreen order by Commissioner** — If the Secretary does not issue a proposed sunscreen order under paragraph (1)(B) within such 300-day period, the sponsor of such request may notify the Office of the Commissioner of such request and request review by the Office of the Commissioner. If such sponsor so notifies the Office of the Commissioner, the Commissioner shall, not later than 60 calendar days after the date of notification under this paragraph, issue a proposed sunscreen order with respect to such request.
(3) **Public comment period** — A proposed sunscreen order issued under paragraph (1)(B) or (2) with respect to a request shall provide for a period of 45 calendar days for public comment.
(4) **Meeting** — A sponsor may request, in writing, a meeting with respect to a proposed sunscreen order issued under this subsection and described in subparagraph (B) or (C) of [section 360fff(7) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360fff/7&num=0&edition=prelim), not later than 30 calendar day
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360fff–3
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Federal law — U.S. Code and appendices · legal_authorities
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 dete
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360fff
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