Notice2025-23404
Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability
Primary source
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Published
December 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Processes and Practices Applicable to Bioresearch Monitoring Inspections." This final 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 guidance covers 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.
Full Text
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<title>Federal Register, Volume 90 Issue 242 (Friday, December 19, 2025)</title>
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[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Pages 59531-59532]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23404]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-5021]
Processes and Practices Applicable to Bioresearch Monitoring
Inspections; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Processes
and Practices Applicable to Bioresearch Monitoring Inspections.'' This
final 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 guidance covers 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: The announcement of this guidance is published in the Federal
Register on December 18, 2025.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-5021 for ``Processes and Practices Applicable to Bioresearch
Monitoring Inspections.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://
[[Page 59532]]
www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Division of Inspectorate Policy, Office of Inspections and
Investigations, Food and Drug Administration, Element Building, 12420
Parklawn Dr., Rockville, MD 20852. Send one self-addressed adhesive
label to assist the office in processing your requests. The guidance
may also be obtained by mail by emailing the Office of Inspections and
Investigations at <a href="/cdn-cgi/l/email-protection#024d4b4b526d6e6b617b517663646471426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="a4ebededf4cbc8cdc7ddf7d0c5c2c2d7e4c2c0c58accccd78ac3cbd2">[email protected]</span></a>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Darby Hull, Office of Inspections and
Investigations, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Silver Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#c682a7b4a4bfe88eb3aaaa86a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="d195b0a3b3a8ff99a4bdbd91b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>, 301-
796-5949.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Processes and Practices Applicable to Bioresearch Monitoring
Inspections.'' This finalizes the draft guidance entitled ``Processes
and Practices Applicable to Bioresearch Monitoring Inspections;
Guidance for Industry,'' which was announced in the Federal Register on
June 5, 2024 (89 FR 48170) (hereafter, the ``draft guidance'').
FDA is issuing this final 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 provision 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 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 and animal trial participants 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 confirming that the following two guidances will be
withdrawn upon publication of this guidance, as their substance is
superseded by this final guidance and other guidances and related
documents described in this final 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.''
FDA received 15 comments on the draft guidance. The comments
primarily came from industry (including trade and professional
associations). The comment period for the draft guidance ended on
August 5, 2024. Commenters expressed interest in the Agency's current
practices with respect to accessing electronic databases during an
inspection, the logistics of the Agency's inspection pre-announcement
notices and communications, and types of communication after an
inspection.
This final guidance reflects consideration of the public comments
on the draft guidance. Specifically, the final guidance, among other
things, contains changes to: (1) clarify the Agency's practices for
accessing and obtaining copies of electronic records; (2) provide
additional details with respect to the Agency's inspection pre-
announcement notices and communications; and (3) offer additional
information on post-inspection communications.
This final guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The final guidance
represents 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
This 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 revised guidance
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23404 Filed 12-18-25; 8:45 am]
BILLING CODE 4164-01-P
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