Sec. 3612. Bioresearch monitoring inspections
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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: 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. 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. 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— 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); preparing, conducting, or analyzing the results of a study described in subparagraph (E); or holding any records or other information described in subparagraph (B). A person described in this clause is— the sponsor of an application or submission specified in subparagraph (E); 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; 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 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). 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— permitting the Secretary to record or copy such information for purposes of this paragraph; 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 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. 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. An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner. The studies and submissions described in this subparagraph are each of the following: 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). Postmarket safety activities conducted under this Act or the Public Health Service Act. Any other clinical investigation of— a drug subject to section 505 or 512 of this Act or section 351 of the Public Health Service Act; or a device subject to section 520(g). 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. 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. . The Secretary shall— 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 subsection (a); and evaluate whether any updates are needed to facilitate the consistency of such processes and practices. The Secretary 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 subsection (a), 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. The Secretary shall— not later than 18 months after the date of enactment of this Act, issue draft guidance under subparagraph (A); and not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under subparagraph (A).
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Sec. 3612
Bioresearch monitoring inspections
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