Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-12319 · Docket No. FDA-2023-D-5021

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The draft guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA's Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The draft guidance is intended to cover the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct.

Dates

Submit either electronic or written comments on the draft guidance by August 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background FDA is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” FDA is issuing this draft guidance to comply with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act, 2023. This section of FDORA directs FDA to issue guidance describing the processes and practices applicable to inspections of certain sites and facilities, to the extent not specified in existing publicly available FDA guides and manuals for such inspections. These sites and facilities are inspected under FDA's Bioresearch Monitoring (BIMO) inspection program. Specifically, this draft guidance addresses the following (to the extent not publicly available in FDA guides and manuals): the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct. FDA's BIMO program is a comprehensive portfolio of programs designed to assess and monitor all aspects of the conduct and reporting of FDA-regulated research as well as certain postmarketing activities through on-site inspections, investigations, and Remote Regulatory Assessments. The BIMO program was established to assess the quality and integrity of data submitted to the Agency in support of regulatory decision-making, as well as to provide for protection of the rights, safety, and welfare of human trial participants and animal subjects involved in FDA-regulated research. The program assesses compliance with statutory requirements and FDA's regulations governing the conduct of nonclinical and clinical studies, and applicable postmarketing activities. FDA also is announcing that the following two guidances will be withdrawn upon finalization of this guidance, as their substance is superseded by this draft guidance and other guidances and related documents described in this draft guidance: the 2010 “Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators,” and the 2006 “Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: FDA Institutional Review Board Inspections.” This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this revised draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov. Dated: May 31, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-12319 Filed 6-4-24; 8:45 am]