Sec. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS
230 words·~1 min read·
/statute-compilations/comps-15494/sec-503A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## 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)”.
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 503
AVAILABILITY OF REGULATORY MANAGEMENT PLANS
Cites 1Cited by 0 across 0 sources