H.R. 7667 — what changed
Food and Drug Amendments of 2022
From Engrossed in House to Received in Senate. 1 section amended between Engrossed in House and Received in Senate.
Sec. 721 Factory inspection
In general— Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking “restricted devices” each place it appears and inserting “devices”.
Records or other information—
renumbered
was (3)(3)
Establishments— Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended—
renumbered
was (3)(3)(3)
by striking “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug” and inserting “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or that is subject to inspection under paragraph (5)(C),”; and
renumbered
was (3)(3)(4)
by inserting after “a sufficient description of the records requested” the following: “and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection”.
added
Guidance—
removed
Guidance—
renumbered
was (3)(4)(2)
In general— The Secretary of Health and Human Services shall issue or update guidance describing—
renumbered
was (3)(4)(2)(3)
circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, as amended by paragraph (1);
renumbered
was (3)(4)(2)(4)
processes for responding to such requests electronically or in physical form; and
renumbered
was (3)(4)(2)(5)
factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.
renumbered
was (3)(4)(3)
Timing— The Secretary of Health and Human Services shall—
renumbered
was (3)(4)(3)(3)
not later than 1 year after the date of enactment of this Act, issue draft guidance under subparagraph (A); and
renumbered
was (3)(4)(3)(4)
not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A).
Bioresearch monitoring inspections—
renumbered
was (4)(3)
In general— Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the end the following:
“(5) Bioresearch monitoring inspections
“(A) In general—The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this Act or the Public Health Service Act, enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.
“(B) Information subject to inspection—An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.
“(C) Sites and facilities subject to inspection
“(i) Sites and facilities described—The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—
“(I) developing an application or other submission to the Secretary under this Act or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);
“(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or
“(III) holding any records or other information described in subparagraph (B).
“(ii) Persons described—A person described in this clause is—
“(I) the sponsor of an application or submission specified in subparagraph (E);
“(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;
“(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or
“(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).
“(D) Conditions of inspection
“(i) Access to information subject to inspection—Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—
“(I) permitting the Secretary to record or copy such information for purposes of this paragraph;
“(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and
“(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.
“(ii) No effect on applicability of provisions for protection of proprietary information or trade secrets—Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.
“(iii) Reasonableness of inspections—An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.
“(E) Studies and submissions described—The studies and submissions described in this subparagraph are each of the following:
“(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this Act or the Public Health Service Act for marketing authorization of a product described in paragraph (1).
“(ii) Postmarket safety activities conducted under this Act or the Public Health Service Act.
“(iii) Any other clinical investigation of—
“(I) a drug subject to section 505 or 512 of this Act or section 351 of the Public Health Service Act; or
“(II) a device subject to section 520(g).
“(iv) Any other submissions made under this Act or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.
“(F) Clarification—This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to the date of enactment of this paragraph, the Secretary lacked the authority to conduct such inspections, including under this Act or the Public Health Service Act.”
added
Review of processes and practices; guidance for industry—
removed
Review of processes and practices; guidance for industry—
renumbered
was (4)(4)(2)
In general— The Secretary of Health and Human Services shall—
renumbered
was (4)(4)(2)(3)
review processes and practices in effect as of the date of enactment of this Act applicable to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1); and
renumbered
was (4)(4)(2)(4)
evaluate whether any updates are needed to facilitate the consistency of such processes and practices.
added
Guidance—
removed
Guidance—
renumbered
was (4)(4)(3)(2)
In general— The Secretary of Health and Human Services shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), including with respect to the types of records and information required to be provided, best practices for communication between the Food and Drug Administration and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct, to the extent not specified in existing publicly available Food and Drug Administration guides and manuals for such inspections.
renumbered
was (4)(4)(3)(3)
Timing— The Secretary of Health and Human Services shall—
renumbered
was (4)(4)(3)(3)(3)
not later than 18 months after the date of enactment of this Act, issue draft guidance under clause (i); and
renumbered
was (4)(4)(3)(3)(4)
not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under clause (i).