AVAILABILITY OF REGULATORY MANAGEMENT PLANS.

SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS. Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(f)) is amended—(1) by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively;(2) by inserting after paragraph (2) the following:“(3) Publication.—The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including—“(A) the process by which an applicant may submit a request for a regulatory management plan;“(B) the timeframe by which the Secretary is required to respond to such request;“(C) the information required for the submission of such request;“(D) a description of the types of development milestones and performance targets that could be discussed and included in such plans; and“(E) contact information for beginning the regulatory management plan process.”;(3) in paragraph (6), as so redesignated, in the matter preceding subparagraph (A)—(A) by striking “paragraph (4)(A)” and inserting “paragraph (5)(A)”; and(B) by striking “paragraph (4)(B)” and inserting “paragraph (5)(B)”; and(4) in paragraph (7)(A), as so redesignated, by striking “paragraph (3)(A)” and inserting “paragraph (4)(A)”.