Sec. 3616. Enhancing coordination and transparency on inspections
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Section 506D of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356d ) is amended— by adding at the end the following: The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program regarding— the reviews of reports shared pursuant to section 704(b)(2); and any feedback or corrective or preventive actions in response to such reports. ; and by amending subsection
(f)to read as follows: Subsection
(a)shall cease to be effective on the date that is 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act. Subsections (b), (c), and
(e)shall not be in effect during the period beginning 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act and ending on the date of enactment of the Food and Drug Omnibus Reform Act of 2022. Subsections (b), (c), and
(e)shall be in effect beginning on the date of enactment of the Food and Drug Omnibus Reform Act of 2022. . Section 506C–1(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1(a) ) is amended— by redesignating paragraphs
(3)through
(7)as paragraphs
(5)through (9), respectively; by inserting after paragraph
(2)the following: describes the coordination and alignment activities undertaken pursuant to section 506D(g); provides the number of reports that were required under section 704(b)(2) to be sent to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages, and the number of such reports that were sent; ; and in paragraph (5)(A), as so redesignated, by striking paragraph
(7)and inserting paragraph
(9). The amendments made by paragraph
(1)shall apply with respect to reports submitted under section 506C–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1 ) on or after March 31, 2024. Section 510(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h) ) is amended— in paragraph (6)— in the matter preceding subparagraph (A), by striking Beginning in 2014, not and inserting Not ; by amending subparagraph
(A)to read as follows: the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year; the number of such registered establishments in each region of interest ; the number of such domestic establishments and the number of such foreign establishments, including the number of establishments in each region of interest, that the Secretary inspected in the previous fiscal year; the number of inspections to support actions by the Secretary on applications under section 505 of this Act or section 351 of the Public Health Service Act, including the number of inspections to support actions by the Secretary on supplemental applications, including changes to manufacturing processes, the Secretary conducted in the previous fiscal year; the number of routine surveillance inspections the Secretary conducted in the previous fiscal year, including in each region of interest; the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspections described in clause (iv), including in each region of interest; and the number of inspections the Secretary has recognized pursuant to an agreement entered into pursuant to section 809, or otherwise recognized, for each of the types of inspections described in clauses
(v)and (vi), including for inspections of establishments in each region of interest. ; in subparagraph (B), by striking ; and and inserting a semicolon; in subparagraph (C), by striking the period and inserting ; and ; and by adding at the end the following: the status of the efforts of the Food and Drug Administration to expand its recognition of inspections conducted or recognized by foreign regulatory authorities under section 809, including any obstacles to expanding the use of such recognition. ; and by adding at the end the following: For purposes of paragraph (6)(A), the term region of interest means a foreign geographic region or country, including the People’s Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate. .
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- 21 USC 356c–1(a)
- 21 USC 356c–1
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Sec. 3616
Enhancing coordination and transparency on inspections
Cite21 USC 356c–1(a)
Cite21 USC 356c–1
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