GUIDANCE; OTHER PROVISIONS.

SEC. 586D. [21 U.S.C. 360fff-4] GUIDANCE; OTHER PROVISIONS. (a) Guidance.— (1) In general.— (A) Draft guidance.—Not later than 1 year after the date of enactment of the Sunscreen Innovation Act, the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to sunscreen under this subchapter, including guidance on— (i) the format and content of information submitted by a sponsor in support of a request under section 586A 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is GRASE and is not misbranded; (iii) the process by which a request under section 586A or a pending request is withdrawn; and (iv) the process by which the Secretary will carry out section 586C(c), including with respect to how the Secretary will address the total number of requests received under section 586A and pending requests. (B) Final guidance.—The Secretary shall finalize the guidance described in subparagraph (A) not later than 2 years after the date of enactment of the Sunscreen Innovation Act. (C) Inapplicability of paperwork reduction act.—Chapter 35 of title 44, United States Code 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 the date of enactment of the Sunscreen Innovation Act, make submissions under this subchapter; and (B) the Secretary shall review and act upon such submissions in accordance with this subchapter. (b) Rules of Construction.— (1) Currently marketed sunscreens.—Nothing in this subchapter shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before the date of enactment of this subchapter, except as otherwise provided in this subchapter. (2) Ensuring safety and effectiveness.—Nothing in this subchapter 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 subchapter, including section 586C(e). (3) Other drugs.—Except as otherwise provided in section 586F, nothing in this subchapter shall be construed to affect the authority of the Secretary under this Act 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 subchapter shall affect the marketing of a drug approved under section 505 of this Act or section 351 of the Public Health Service Act. (c) Timelines.—The timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of section 586C(a) shall not apply to any requests submitted to the Secretary under section 586A after the date that is 6 years after the date of enactment of the Sunscreen Innovation Act.[Section 586E was repealed by section 3854(b)(5) of division A of Public Law 116–136.]