[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38058-38059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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