1

 So in original. Probably should be preceded by “section”.

Editorial Notes

Amendments

2020—Subsec. (b)(7). Pub. L. 116–136, § 3854(b)(2), designated existing provisions as subpar. (A), inserted heading, and added subpar. (B).

Subsec. (e)(3). Pub. L. 116–136, § 3854(b)(1), amended par. (3) generally. Prior to amendment, par. (3) related to inclusion of ingredients that are subjects of final orders in the sunscreen monograph.

Subsec. (f). Pub. L. 116–136, § 3854(b)(3), added subsec. (f).

Statutory Notes and Related Subsidiaries

Review of Nonprescription Sunscreen Active Ingredients

Pub. L. 116–136, div. A, title III, § 3854(a), Mar. 27, 2020, 134 Stat. 454, provided that:

“(1)

Applicability of section 505g for pending submissions.—

“(A)

In general.—

A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that, as of the date of enactment of this Act [Mar. 27, 2020], is subject to a proposed sunscreen order under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3) may elect, by means of giving written notification to the Secretary of Health and Human Services within 180 calendar days of the enactment of this Act, to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h], as added by section 3851 of this subtitle.

“(B)

Election exercised.—

Upon receipt by the Secretary of Health and Human Services of a timely notification under subparagraph (A)—

“(i)

the proposed sunscreen order involved is deemed to be a request for an order under subsection (b) of section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle; and

“(ii)

such order is deemed to have been accepted for filing under subsection (b)(6)(A)(i) of such section 505G.

“(C)

Election not exercised.—

If a notification under subparagraph (A) is not received by the Secretary of Health and Human Services within 180 calendar days of the date of enactment of this Act, the review of the proposed sunscreen order described in subparagraph (A)—

“(i)

shall continue under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–3); and

“(ii)

shall not be eligible for review under section 505G, added by section 3851 of this subtitle.

“(2)

Definitions.—

In this subsection, the terms ‘sponsor’, ‘nonprescription’, ‘sunscreen active ingredient’, and ‘proposed sunscreen order’ have the meanings given to those terms in section 586 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).”