Notice2023-12512
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
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
June 12, 2023
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 88 Issue 112 (Monday, June 12, 2023)</title>
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[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38058-38059]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12512]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0598]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Type A Medicated Articles
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 July 12, 2023.
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 0910-0154. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#2d7d7f6c7e594c4b4b6d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="4c1c1e0d1f382d2a2a0c2a282d6224243f622b233a">[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 Regulations for Type A Medicated
Articles--21 CFR Part 226
OMB Control Number 0910-0154--Extension
This information collection supports the implementation of FDA
statutory and regulatory requirements that govern current good
manufacturing practice (cGMP) for Type A medicated articles. A Type A
medicated article is an animal feed product containing a concentrated
drug diluted with a feed carrier substance. A Type A medicated article
is intended solely for use in the manufacture of another Type A
medicated article or a Type B or Type C medicated feed. Medicated feeds
are administered to animals for the prevention, cure, mitigation, or
treatment of disease or for growth promotion and feed efficiency.
Section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 351), governs current cGMP for drugs, including Type A medicated
articles, and these statutory requirements are codified in part 226 (21
CFR part 226).
Manufacturers are required to establish, maintain, and retain
records for Type A medicated articles including records to document
procedures required under the manufacturing process to assure that
proper quality control is maintained under part 226. Type A medicated
articles, which are not manufactured in accordance with these
regulations, are considered adulterated under section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)).
Description of Respondents: The respondents to this information
collection are manufacturers of Type A medicated articles.
In the Federal Register of January 31, 2023 (88 FR 6281), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 38059]]
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR part; activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
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226.42, 226.58, 226.80, 226.102, 226.110, and 65 1,370 89,050 ~1 hour.............................. 89,050
226.115; Recordkeeping and maintenance of
records for components used in the manufacture
of the medicated premixes, laboratory controls,
packaging and labeling, master formula and batch-
production, distribution records and complaint
files.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded.
The burden we attribute to recordkeeping activities associated with
the provisions in 21 CFR part 226 are assumed to be distributed among
the individual elements and averaged among respondents. Based on a
review of the information collection since our last request for OMB
approval, we have made no adjustments to our burden estimate.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12512 Filed 6-9-23; 8:45 am]
BILLING CODE 4164-01-P
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