Notice2026-03326
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program
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Published
February 20, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with CGMP for drugs, finished pharmaceuticals, including active pharmaceutical ingredients (APIs), and the advanced manufacturing technologies (AMT) designation program.
Full Text
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<title>Federal Register, Volume 91 Issue 34 (Friday, February 20, 2026)</title>
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[Federal Register Volume 91, Number 34 (Friday, February 20, 2026)]
[Notices]
[Pages 8249-8251]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03326]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0746]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice (CGMP):
Manufacturing, Processing, Packing, and Holding of Drugs; GMP for
Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients)
and the Advanced Manufacturing Technologies Designation Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
CGMP for drugs, finished pharmaceuticals, including active
pharmaceutical ingredients (APIs), and the advanced manufacturing
technologies (AMT) designation program.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 21, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 21, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2026-N-0746 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice (CGMP): Manufacturing, Processing, Packing, and Holding of
Drugs; GMP for Finished Pharmaceuticals (Including Active
Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies
Designation Program.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Kelly Covington, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5661,
<a href="/cdn-cgi/l/email-protection#a0f0f2e1f3d4c1c6c6e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="6d3d3f2c3e190c0b0b2d0b090c4305051e430a021b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
[[Page 8250]]
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Current Good Manufacturing Practice (CGMP): Manufacturing, Processing,
Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals
(Including Active Pharmaceutical Ingredients), and the Advanced
Manufacturing Technologies Designation Program
OMB Control Number 0910-0139--Revision
This information collection supports statutory and regulatory
requirements that govern the manufacture, processing, packing, or
holding of finished pharmaceuticals, including active pharmaceutical
ingredients (APIs). Under section 501(a)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is
adulterated if the methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or holding do not conform to
or are not operated or administered in conformity with CGMP
regulations. FDA is responsible for enforcing the FD&C Act as well as
related statutes, including the Public Health Service Act. Congress
enacted these laws to ensure that covered products meet applicable
requirements regarding the safety, identity and strength, and the
quality and purity characteristics they purport or are represented to
possess and are labeled with adequate warnings and instructions for
use.
The pharmaceutical or drug quality-related regulations appear in
several parts of Title 21 Code of Federal Regulations (CFR) (Food and
Drugs), including sections in parts 1 through 99, 200 through 299, 300
through 499, 600 through 799, and 800 through 1299. The regulations
enable a common understanding of the regulatory process by describing
requirements to be followed by drug manufacturers, applicants, and FDA.
The information collection also supports regulations codified under
parts 610 and 680 (21 CFR parts 610 and 680), which reference certain
CGMP regulations in part 211 (see Sec. Sec. 610.12(g), 610.13(a)(2),
610.18(d), 680.2(f), and 680.3(f)). The information collection
requirements help FDA ensure compliance with applicable requirements
and meet its public health protection responsibilities.
The information collection also includes FDA's Center for Drug
Evaluation and Research's (CDER) Program for the Recognition of
Voluntary Consensus Standards Related to Pharmaceutical Quality. The
National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-
113) and Circular A-119 by the Office of Management and Budget (OMB)
have established Federal Government policies to improve the internal
management of the executive branch by directing agencies to use
voluntary consensus standards developed or adopted by a standards
developing organization--rather than Government-unique standards--
except where these standards are inconsistent with applicable law or
otherwise impractical. The guidance document entitled, ``CDER's Program
for the Recognition of Voluntary Consensus Standards Related to
Pharmaceutical Quality'' (July 2023), outlines justifications for why a
standard may be recognized wholly, partly, or not at all. (The guidance
document is available for download from our website at: CDER's Program
for the Recognition of Voluntary Consensus Standards Related to
Pharmaceutical Quality [verbar] FDA.) The guidance document also
communicates that interested parties may request recognition of a
standard. We intend on finalizing the guidance document upon OMB
approval of the attendant information collection.
The information collection also covers activities associated with
FDA's Advanced Manufacturing Technologies (AMT) Designation Program, as
provided for in section 506L of the FD&C Act (21 U.S.C. 356l) and added
by section 3213 of the Food and Drug Omnibus Reform Act of 2022
(FDORA). The guidance document entitled, Advanced Manufacturing
Technologies Designation Program, (December 2024), communicates the
statutory goals, scope, and framework of the AMT program. The guidance
document is available for download from our internet site at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-manufacturing-technologies-designation-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-manufacturing-technologies-designation-program</a>.
We are revising the information collection to remove activities and
burden attributable to medical gas requirements. Through rulemaking on
June 18, 2024, (89 FR 51738) (RIN 0910-AC53), current good
manufacturing practice requirements applicable to medical gas are now
established in 21 CFR parts 213 and 230 and accounted for under OMB
control number 0910-0906.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden--APIs and Finished Pharmaceuticals \1\ \2\
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Number of
Information collection Number of records per Total annual Average burden per Total
activity recordkeepers recordkeeper records recordkeeping hours
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CGMP API Manufacturers........ 1,260 256 322,560 0.82 (49.2 minutes).... 264,499
CGMP Finished Pharmaceuticals 3,270 299 977,730 0.64 (38 minutes)...... 625,747
Manufacturers (excludes
medical gases).
Voluntary Consensus Standard 9 1 9 1...................... 9
Activities.
AMT Program Activities, 20 1 20 10..................... 200
including designation
requests.
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Total..................... .............. ............ 1,300,319 ....................... 890,455
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
\2\ Records and burden per activity have been averaged and rounded.
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Our estimated burden for the information collection reflects a
decrease of 396,293 hours and 639,491 responses annually, resulting
from removal of burden attributable to information collection for
medical gas requirements. We have otherwise retained currently approved
estimates, noting that the AMT activity element has been inadvertently
omitted from our burden summary table that appears at <a href="http://www.reginfo.gov">www.reginfo.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03326 Filed 2-19-26; 8:45 am]
BILLING CODE 4164-01-P
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