2016 US Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter V - Drugs and Devices
Part I - Nonprescription Sunscreen and Other Active Ingredients
Sec. 360fff - Definitions

(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—

(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;

(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;

(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—

(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—

(8) the term "sponsor" means the person that submitted—

(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.

"(1) limit the right of a sponsor (as defined in section 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 defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a))."