[Federal Register Volume 90, Number 175 (Friday, September 12, 2025)]
[Notices]
[Pages 44194-44196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-17698]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-3031]
Alternative Tools: Assessing Drug Manufacturing Facilities
Identified in Pending Applications; 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
``Alternative Tools: Assessing Drug Manufacturing Facilities Identified
in Pending Applications.'' This guidance provides information to
applicants on how FDA intends to use alternative tools to assess drug
manufacturing facilities identified in a marketing application (i.e., a
new drug application (NDA), an abbreviated new drug application (ANDA),
a biologics license application (BLA), or a supplement to any of these
types of applications). As part of the negotiations relating to the
reauthorization of the Prescription Drug User Fee Act (PDUFA) and the
Biosimilar User Fee Act (BsUFA), as described in ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2023
Through 2027'' (PDUFA VII commitment letter) and ``Biosimilar
Biological Product Reauthorization Performance Goals and Procedures for
Fiscal Years 2023 Through 2027'' (BsUFA III commitment letter), FDA
agreed to issue guidance on the use of alternative tools to assess
manufacturing facilities named in pending applications and to
incorporate best practices from the use of such tools during the
Coronavirus Disease 2019 (COVID-19) pandemic. This guidance finalizes
the draft guidance of the same title issued on September 22, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on September 12, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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:
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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-2023-D-3031 for ``Alternative Tools: Assessing Drug Manufacturing
Facilities Identified in Pending Applications.'' 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 Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Jessica Dunn, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4214, Silver Spring, MD 20993-0002, 240-
402-8985; or Phillip Kurs, Center for Biologics Evaluation and
Research, Food and Drug Administration, 240-402-0467.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Alternative Tools: Assessing Drug Manufacturing Facilities
Identified in Pending Applications.'' This guidance provides
information to applicants on how FDA intends to use alternative tools
to assess drug manufacturing facilities identified in an NDA, an ANDA,
a BLA, or a supplement to any of these types of applications. As part
of the negotiations relating to the reauthorization of BsUFA and PDUFA,
FDA agreed to issue guidance on the use of alternative tools to assess
manufacturing facilities named in pending applications and to
incorporate best practices from the use of such tools during the COVID-
19 pandemic. This guidance, within the context of approval and
licensure decisions by FDA, describes the use of alternative tools to
assess manufacturing facilities identified in an NDA, an ANDA, or a BLA
to establish that these facilities meet the applicable requirements,
including under section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) and either section 505 of the FD&C Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act (42 U.S.C. 262). FDA
considered the applicability of Executive Order 14192, per OMB guidance
in M-25-20, and finds this action to be deregulatory in nature.
During the pandemic, FDA expanded its use of alternative tools to
evaluate drug manufacturing facilities to support regulatory decision
making when facility inspections were not feasible. The following
alternative tools were used during the COVID-19 public health
emergency:
Requesting records and other information, pursuant to
section 704(a)(4) of the FD&C Act (21 U.S.C. 374(a)(4)), directly from
facilities and other entities subject to inspection
Performing remote interactive evaluations (e.g., remote
live streaming video of operations, teleconferences, screen sharing)
Requesting existing inspection reports and other
information from trusted foreign regulatory partners through mutual
recognition agreements and other agreements
FDA has strategically used these tools within the context of
decisions related to preapproval inspections (PAIs) or prelicense
inspections (PLIs) to maximize facility assessment efficiency as part
of appropriate, risk-based assessments. Given the success of these
innovative approaches, FDA intends to continue risk-based use of these
alternative tools and to apply certain virtual technological
capabilities within a specific inspectional context defined within this
guidance. When used in advance or in lieu of PAIs and PLIs or to
support PAIs and PLIs, the appropriate use of these approaches will
help FDA maintain operational flexibility to support timely facility
evaluations and application decisions.
This guidance finalizes the draft guidance entitled ``Alternative
Tools: Assessing Drug Manufacturing Facilities Identified in Pending
Applications'' issued on September 22, 2023 (88 FR 65396). FDA
considered comments received on the draft guidance as the guidance was
finalized. Based on the comments received, FDA updated the guidance
with additional clarification on: (1) the recommended timeframe for
facilities to respond to section 704(a)(4) of the FD&C Act records
requests; (2) the timeframes for when facilities may expect to receive
requests from FDA to use a remote subject matter expert (SME) during an
inspection; (3) Agency efforts to coordinate logistical approaches and
technologies with facilities regarding FDA's use of alternative tools;
and (4) the effect of a facility declining to allow FDA to use a remote
SME or when a facility is unable to support the virtual interaction
with a remote SME.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Alternative Tools:
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Assessing Drug Manufacturing Facilities Identified in Pending
Applications.'' 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR parts 210 and 211 relating to current good manufacturing
practice requirements and electronic records and signatures have been
approved under OMB control numbers 0910-0139 and 0910-0303,
respectively. The collections of information in 21 CFR part 314
relating to the submission of NDAs and ANDAs have been approved under
OMB control number 0910-0001. The collections of information in 21 CFR
part 601 relating to the submission of BLAs have been approved under
OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https:/www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17698 Filed 9-11-25; 8:45 am]
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