21 U.S.C. § 360fff–4: Guidance; other provisions

Summary

The Secretary must publish draft guidance within 1 year after November 26, 2014, and final guidance within 2 years. The guidance will explain how to follow the sunscreen rules, including what to submit, what data is needed to show a sunscreen ingredient is safe and effective, how a request can be withdrawn, and how the agency will handle the number of requests and any backlog. Collections of information for this guidance are not subject to the Paperwork Reduction Act. People could start sending submissions on November 26, 2014, and the Secretary must review them even if final guidance is not yet issued. These rules do not change the marketing of sunscreens sold in interstate commerce on or before November 26, 2014, unless this part says otherwise. The Secretary still has the power to stop or limit the sale of sunscreens that are unsafe, ineffective, or misbranded. The part does not change the Secretary’s authority over other drugs except where another section says so, and it does not affect drugs already approved under section 355 or section 351 of the Public Health Service Act. Timelines in certain parts of the process stop applying to requests submitted after the date that is 6 years after November 26, 2014.

Title 21, §360fff–4

Food and Drugs, Source: USLM XML via OLRC

(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(A)Draft guidance

Not later than 1 year after November 26, 2014, the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to sunscreen under this part, including guidance on—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 content 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(iii)the process by which a request under section 360fff–1 of this title or a pending request is withdrawn; and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

The Secretary shall finalize the guidance described in subparagraph (A) not later than 2 years after November 26, 2014.

(C)Inapplicability of Paperwork Reduction Act

Chapter 35 of title 44 shall not apply to collections of information made for purposes of guidance under this subsection.

(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

Nothing in this part shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before November 26, 2014, except as otherwise provided in this part.

(2)Ensuring safety and effectiveness

Nothing in this part shall be construed to alter the authority of the Secretary with respect to prohibiting the marketing of a sunscreen that is not safe and effective or is misbranded, or with respect to imposing restrictions on the marketing of a sunscreen to ensure safety and effectiveness, except as otherwise provided in this part, including section 360fff–3(e) of this title.

(3)Other drugs

Except as otherwise provided in section 360fff–6 of this title, nothing in this part shall be construed to affect the authority of the Secretary under this chapter or the Public Health Service Act (42 U.S.C. 201 et seq.) with respect to a drug other than a nonprescription sunscreen.

(4)Effect on drugs otherwise approved

Nothing in this part shall affect the marketing of a drug approved under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(c)Timelines

The timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of section 360fff–3(a) of this title shall not apply to any requests submitted to the Secretary under section 360fff–1 of this title after the date that is 6 years after November 26, 2014.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see

Short Title

note set out under section 201 of Title 42 and Tables.

§360fff–4 Guidance; Other Provisions