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)”.