Notice2026-10188
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 21, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 91 Issue 98 (Thursday, May 21, 2026)</title>
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[Federal Register Volume 91, Number 98 (Thursday, May 21, 2026)]
[Notices]
[Pages 29968-29969]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10188]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0746]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 22, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0139. Also include the FDA docket
number found in brackets in the heading of this document.
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#401012011334212626002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="feaeacbfad8a9f9898be989a9fd096968dd0999188">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 7 99, 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
[[Page 29969]]
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.
In the Federal Register of February 20, 2026 (91 FR 8249), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although three comments were received, the
comments were not responsive to the four collection of information
topics solicited.
FDA estimates 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 activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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CGMP API Manufacturers....................... 1,260 256 322,560 0.82 (49.2 minutes)....................... 264,499
CGMP Finished Pharmaceuticals Manufacturers 3,270 299 977,730 0.64 (38 minutes)......................... 625,747
(excludes medical gases).
Voluntary Consensus Standard Activities...... 9 1 9 1......................................... 9
AMT Program Activities, including designation 20 1 20 10........................................ 200
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.
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. 2026-10188 Filed 5-20-26; 8:45 am]
BILLING CODE 4164-01-P
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