Sec. 905. Enhance intra-agency coordination and public health assessment with regard to compliance activities

1,166 words·~5 min read·/bill/117/s/4348/rs/section-905

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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 Administration Safety and Landmark Advancements Act of 2022 . Subsections (b), (c), and

(e)shall be in effect beginning on the date of enactment of the Food and Drug Administration Safety and Landmark Advancements 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

(4)through (8), respectively; by inserting after paragraph

(2)the following: 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 (3)(A), by striking paragraph

(7)and inserting paragraph

(8).

(a)The amendments made by subsection

(a)shall apply beginning on the date of enactment of this Act.

(b)The amendments made by subsection

(b)shall apply beginning on the date that is 1 year after the date of enactment of this Act. Section 510(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h) ) is amended— in paragraph (6)— in subparagraph (A), by striking clause

(ii)and inserting the following: 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 calendar 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; the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspections described in clause (iv); 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); ; 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. . Section 902 of the FDA Reauthorization Act of 2017 ( 21 U.S.C. 355 note) is amended to read as follows: Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under subsection

(c)or

(j)of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), approval of a device under section 515 of such Act ( 21 U.S.C. 360e ), or clearance of a device under section 510(k) of such Act ( 21 U.S.C. 360(k) ) that were conducted during the previous calendar year. Such information shall include the following: The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including— the median time for drugs described in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(11)(A)(i) ); the median time for drugs described in section 506C(a) of such Act ( 21 U.S.C. 356c(a) ) only; and the median time for drugs on the drug shortage list in effect under section 506E of such Act ( 21 U.S.C. 356f ). The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(b) ) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs

(A)through

(C)of paragraph (1). The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting related to conditions observed by the Secretary during an inspection, to the time at which the Secretary concludes that corrective actions to resolve such conditions have been taken. The median time spent by staff of the Food and Drug Administration at a facility during an inspection, including— the median time when records were provided remotely in accordance with a request under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(4) ) in advance of the inspection; and the median time when a request for records pursuant to such section 704(a)(4) was not issued, or complied with, in advance of the inspection. The number and type of violations identified during inspections when a request for records pursuant to such section 704(a)(4) was issued and complied with in advance of the inspection, versus when a request for records pursuant to such section 704(a)(4) was not issued or complied with. The number of facilities that did not implement requested corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation, including the number of such times for each category of drugs listed in subparagraphs

(A)through

(C)of paragraph (1). .

Connectionstraces to 7

Traces to 7 documents

U.S. Code