EFFECTIVE DATE AND APPLICABILITY.

SEC. 909. EFFECTIVE DATE AND APPLICABILITY.(a) Effective Date.—This subtitle takes effect 180 days after the date of the enactment of this Act.(b) Drugs Deemed to Have Risk Evaluation and Mitigation Strategies.—(1) In general.—A drug that was approved before the effective date of this Act is, in accordance with paragraph (2), deemed to have in effect an approved risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (as added by section 901) (referred to in this section as the “Act”) if there are in effect on the effective date of this Act elements to assure safe use—(A) required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; or121 STAT. 951(B) otherwise agreed to by the applicant and the Secretary for such drug.(2) Elements of strategy; enforcement.—The approved risk evaluation and mitigation strategy in effect for a drug under paragraph (1)—(A) is deemed to consist of the timetable required under section 505–1(d) and any additional elements under subsections (e) and (f) of such section in effect for such drug on the effective date of this Act; and(B) is subject to enforcement by the Secretary to the same extent as any other risk evaluation and mitigation strategy under section 505–1 of the Act, except that sections 303(f)(4) and 502(y) and (z) of the Act (as added by section 902) shall not apply to such strategy before the Secretary has completed review of, and acted on, the first assessment of such strategy under such section 505–1.(3) Submission.—Not later than 180 days after the effective date of this Act, the holder of an approved application for which a risk evaluation and mitigation strategy is deemed to be in effect under paragraph (1) shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such proposed strategy is subject to section 505–1 of the Act as if included in such application at the time of submission of the application to the Secretary.