Sec. 503. Availability of regulatory management plans

172 words·~1 min read·/bill/115/hr/6378/eh/section-503

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Section 565(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4(f) ) is amended— by redesignating paragraphs

(3)through

(6)as paragraphs

(4)through (7), respectively; by inserting after paragraph

(2)the following: The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including— the process by which an applicant may submit a request for a regulatory management plan; the timeframe by which the Secretary is required to respond to such request; the information required for the submission of such request; a description of the types of development milestones and performance targets that could be discussed and included in such plans; and contact information for beginning the regulatory management plan process. ; in paragraph (6), as so redesignated, in the matter preceding subparagraph (A)— by striking paragraph (4)(A) and inserting paragraph (5)(A) ; and by striking paragraph (4)(B) and inserting paragraph (5)(B) ; and in paragraph (7)(A), as so redesignated, by striking paragraph (3)(A) and inserting paragraph (4)(A) .

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21 USC 360bbb–4(f)

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Sec. 503

Availability of regulatory management plans

Cite21 USC 360bbb–4(f)

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