Notice2025-21224
Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability
Primary source
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Published
November 26, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Cross-Center Master Files: Where to Submit." The draft guidance provides recommendations to industry, specifically master file holders, regarding where (i.e., to which FDA center) to submit a master file that is referenced in and intended to support more than one regulatory submission for which the lead center for those submissions may vary or where the information in the master file may need to be accessed and reviewed by more than one center to support review of the referencing submission(s). The recommendations apply to master files submitted to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and certain types of master files submitted to the Center for Veterinary Medicine (CVM).
Full Text
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<title>Federal Register, Volume 90 Issue 226 (Wednesday, November 26, 2025)</title>
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[Federal Register Volume 90, Number 226 (Wednesday, November 26, 2025)]
[Notices]
[Pages 54330-54332]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21224]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-5715]
Cross-Center Master Files: Where To Submit; Draft Guidance for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, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Cross-Center Master Files: Where to Submit.'' The draft guidance
provides recommendations to industry, specifically master file holders,
regarding where (i.e., to which FDA center) to submit a master file
that is referenced in and intended to support more than one regulatory
submission for which the lead center for those submissions may vary or
where the information in the master file may need to be accessed and
reviewed by more than one center to support review of the referencing
submission(s). The recommendations apply to master files submitted to
the Center for Biologics Evaluation and Research (CBER), the Center for
Drug Evaluation and Research (CDER), the Center for Devices and
Radiological Health (CDRH), and certain types of master files submitted
to the Center for Veterinary Medicine (CVM).
DATES: Submit either electronic or written comments on the draft
guidance by February 24, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
[[Page 54331]]
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-2025-D-5715 for ``Cross-Center Master Files: Where to Submit.''
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
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 draft guidance to
the Office of Combination Products, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm. 5129, 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Stephanie Shapley, Office of
Combination Products/Office of the Chief Medical Officer, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20993, 301-796-4836, <a href="/cdn-cgi/l/email-protection#26555243564e47484f4308554e47564a435f66404247084e4e5508414950"><span class="__cf_email__" data-cfemail="a5d6d1c0d5cdc4cbccc08bd6cdc4d5c9c0dce5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a> or
<a href="/cdn-cgi/l/email-protection#2645494b444f4847524f49486640424708414950"><span class="__cf_email__" data-cfemail="b6d5d9dbd4dfd8d7c2dfd9d8f6d0d2d798d1d9c0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Cross-Center Master Files: Where to Submit.'' The draft
guidance provides recommendations to master file holders regarding
where (i.e., to which center) to submit a master file: (1) that is
referenced in and intended to support more than one regulatory
submission for which the lead center for those submissions may vary, or
(2) where the information in the master file may need to be accessed
and reviewed by more than one center to support review of the
referencing submission(s). When a master file would be accessed by more
than one center, it is referred to as a cross-center master file. The
recommendations in this draft guidance apply to master files submitted
to CBER, CDER, CDRH, and to master files submitted to CVM other than
CVM veterinary master file types VI, VII, and VIII and their Public
Master Files. The recommendations, once finalized, are for new master
file submissions going forward.
Master files are voluntary submissions to FDA used to provide
confidential, detailed information about facilities, processes, or
articles used in the manufacturing, processing, packaging, and storing
of one or more FDA-regulated biological products, drugs, devices, or
combination products. Master files can contain other types of
information as well (e.g., nonclinical evaluations such as toxicology
information, shared system risk evaluation and mitigation strategy).
The draft guidance provides background on master files, including
examples of scenarios in which staff from more than one center might
access and review the master file; recommendations for determining the
hosting center for a master file for combination products and for non-
combination products; and hypothetical examples to illustrate the
recommendations for determining the hosting center. These
recommendations are intended to help master file holders to determine
which center to submit their master file. In turn, this may help master
file holders identify any center-specific master file submission
recommendations applicable to their situation.
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 ``Cross-Center
Master Files: Where to Submit.'' 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may
[[Page 54332]]
generate, relevant for Executive Order 14192.
II. Paperwork Reduction Act of 1995
While this draft 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 part 314 relating to the submission of drug master files, new
drug applications, and abbreviated new drug applications have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR part 312 relating to the submission of
investigational new drug applications have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
601 relating to the submissions of biologics licensed applications have
been approved under OMB control number 0910-0338. The collections of
information in 21 CFR part 514 relating to the submission of veterinary
drug master files have been approved under OMB control number 0910-
0032. The collections of information in 21 CFR part 511 relating to the
submission of new animal drugs for investigational use have been
approved under OMB control number 0910-0117. The collections of
information in 512(n)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(n)(1)) relating to the submission of an Abbreviated New
Animal Drug Application have been approved under OMB control number
0910-0669. The collections of information in 21 CFR part 820 relating
to device master files have been approved under OMB control number
0910-0073; the collections of information in 21 CFR part 812 relating
to IDE submissions are approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 807, subpart E, relating to
510(k) submissions are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814, subparts A through E,
relating to premarket approval, are approved under OMB control number
0910-0231; and the collections of information in 21 CFR part 860,
subpart D, relating to De Novo requests are approved under OMB control
number 0910-0844.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <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. 2025-21224 Filed 11-25-25; 8:45 am]
BILLING CODE 4164-01-P
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