[Federal Register Volume 90, Number 121 (Thursday, June 26, 2025)]
[Notices]
[Pages 27319-27320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11754]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0810]
Conducting Remote Regulatory Assessments--Questions and Answers;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Conducting
Remote Regulatory Assessments--Question and Answers.'' The final
guidance describes FDA's current thinking regarding its use of remote
regulatory assessments (RRAs) and provides answers to frequently asked
questions. FDA has used RRAs to conduct oversight, mitigate risk, meet
critical public health needs, and help evaluate compliance of FDA-
regulated products with applicable regulatory requirements.
DATES: The announcement of the guidance is published in the Federal
Register on June 26, 2025.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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-2022-D-0810 for ``Conducting Remote Regulatory Assessments;
Questions and Answers; Guidance for Industry.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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 https://www.regulations.gov.
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://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 https://www.regulations.gov 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 (OII), 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 OII at
[email protected]. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.
[[Page 27320]]
FOR FURTHER INFORMATION CONTACT: Ben Firschein, Office of Inspections
and Investigations, Division of Inspectorate Policy, Food and Drug
Administration, 12420 Parklawn Drive, Element Building, Rockville MD
20857, [email protected], 240-402-0613; or Patrick Clouser,
Office of Inspections and Investigations, Division of Inspectorate
Policy, Food and Drug Administration, Element Building, 12420 Parklawn
Dr., Rockville, MD 20857, [email protected], 240-402-5276.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Conducting Remote Regulatory Assessments--Questions and
Answers.'' The final guidance makes further revisions to and replaces
the revised draft guidance entitled ``Conducting Remote Regulatory
Assessments--Questions and Answers; Draft Guidance for Industry,''
which was announced in the Federal Register on January 26, 2024 (89 FR
5244) (hereafter, the ``revised draft guidance''). FDA issued the
revised draft guidance to describe the Agency's thinking regarding its
use of RRAs, to help increase the industry's understanding of voluntary
and mandatory RRAs, and to facilitate FDA's process for conducting
remote assessments for FDA-regulated products outside of the COVID-19
public health emergency. The revised draft guidance reflected
consideration of comments on a preceding draft guidance of the same
title as well as revisions to align with 2022 changes in law,\1\
including to address a requirement to issue guidance \2\ related to
section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (i.e.,
requests for records in advance of or in lieu of an inspection; such
requests are a type of RRA). The comment period for the revised draft
guidance ended on March 26, 2024.
---------------------------------------------------------------------------
\1\ See sections 3611, 3612, and 3613 of the Food and Drug
Omnibus Reform Act of 2022 (FDORA), enacted as part of the
Consolidated Appropriations Act, 2023, Public Law 117-328 (2022).
Among changes made by FDORA were adding (in addition to drug
establishments) device establishments, and sites, entities, or
facilities subject to bioresearch monitoring (BIMO) inspections, to
mandatory records request authority under section 704(a)(4) of the
FD&C Act.
\2\ FDORA section 3611(b)(2) required FDA to issue (or update)
guidance as draft, and then, issue final guidance, describing the
circumstances under which the Agency intends to use its authority to
issue requests for records or other information under section
704(a)(4) of the FD&C Act (as amended by FDORA), the processes for
firms to respond, and the factors for determining whether a facility
has appropriately and timely responded.
---------------------------------------------------------------------------
The final guidance additionally reflects consideration of comments
from interested parties on the revised draft guidance. Specifically,
the final guidance includes changes to: (1) distinguish more clearly
between mandatory and voluntary RRA requests; (2) clarify how FDA
intends to inform establishments of the terms of participation in
voluntary RRAs and obtain their consent to conduct the RRA; (3)
facilitate transparency and consistency in FDA's use of RRAs across
regulated products, as applicable; (4) clarify mechanisms for
electronic records reviews and conditions under which live data access
might occur; and (5) address concerns about confidentiality and
security of establishment information reviewed by FDA. The final
guidance also addresses the 2022 requirement for issuance of final
guidance \3\ relating to the Agency's use of section 704(a)(4) of the
FD&C Act.
---------------------------------------------------------------------------
\3\ Id.
---------------------------------------------------------------------------
The 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 ``Conducting Remote
Regulatory Assessments.'' 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.
FDA considered the applicability of Executive Order 14192, per OMB
guidance in M-25-20, and finds this action to be deregulatory in
nature.
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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov.
Dated: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11754 Filed 6-25-25; 8:45 am]
BILLING CODE 4164-01-P