21 USC 360 - Guidance; other provisions

View all text of Part I [§ 360fff - § 360fff-8]

§ 360fff–4. Guidance; other provisions

(a) Guidance

(1) In general

(A) Draft guidance

Not later than 1 year after November 26, 2014, the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to sunscreen under this part, including guidance on—

(i) the format and span of information submitted by a sponsor in support of a request under section 360fff–1 of this title or a pending request;

(ii) the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;

(iii) the process by which a request under section 360fff–1 of this title or a pending request is withdrawn; and

(iv) the process by which the Secretary will carry out section 360fff–3(c) of this title, including with respect to how the Secretary will address the total number of requests received under section 360fff–1 of this title and pending requests.

(B) Final guidance

(2) Submissions pending issuance of final guidance

Irrespective of whether final guidance under paragraph (1) has been issued—

(A) persons may, beginning on November 26, 2014, make submissions under this part; and

(B) the Secretary shall review and act upon such submissions in accordance with this part.

(b) Rules of construction

(1) Currently marketed sunscreens

(2) Ensuring safety and effectiveness

(3) Other drugs

(4) Effect on drugs otherwise approved

(June 25, 1938, ch. 675, § 586D, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2044.)