Notice2023-15487
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
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
July 21, 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 139 (Friday, July 21, 2023)</title>
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[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47147-47149]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0601]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Medicated Feeds
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 August 21, 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 0910-0152. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#134341524067727575537577723d7b7b603d747c65"><span class="__cf_email__" data-cfemail="4a1a180b193e2b2c2c0a2c2e2b64222239642d253c">[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 Medicated Feeds--21
CFR Part 225
OMB Control Number 0910-0152--Extension
Under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351), FDA has the statutory authority to issue current
good manufacturing practice (CGMP) regulations for drugs, including
medicated feeds. Medicated feeds are
[[Page 47148]]
administered to animals for the prevention, cure, mitigation, or
treatment of disease, or growth promotion and feed efficiency.
Statutory requirements for CGMPs have been codified under part 225 (21
CFR part 225). Medicated feeds that are not manufactured in accordance
with these regulations are considered adulterated under section
501(a)(2)(B) of the FD&C Act. Under part 225, a manufacturer is
required to establish, maintain, and retain records for a medicated
feed, including records to document procedures required during the
manufacturing process to assure that proper quality control is
maintained. Such records would, for example, contain information
concerning receipt and inventory of drug components, batch production,
laboratory assay results (i.e., batch and stability testing), labels,
and product distribution.
This information is needed so that FDA can monitor drug usage and
possible misformulation of medicated feeds to investigate violative
drug residues in products from treated animals and to investigate
product defects when a drug is recalled. In addition, FDA will use the
CGMP criteria in part 225 to determine whether the systems and
procedures used by manufacturers of medicated feeds are adequate to
ensure that their feeds meet the requirements of the FD&C Act as to
safety, and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the FD&C
Act.
A license is required when the manufacturer of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required, and the recordkeeping requirements are less demanding,
for those medicated feeds for which FDA has determined that the drugs
used in their manufacture need less control. Respondents to this
collection of information are commercial feed mills and mixers/feeders.
In the Federal Register of February 6, 2023 (88 FR 7741), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
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
[Registered licensed commercial feed mills] \1\
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Number of Total
21 CFR section; activity Number of responses per annual Average burden per Total
respondents respondent responses response hours
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225.42(b)(5) through (8) 791 260 205,660 1....................... 205,660
requires records of receipt,
storage, and inventory
control of medicated feeds.
225.58(c) and (d) requires 791 45 35,595 0.5 (30 minutes)........ 17,798
records of the results of
periodic assays for
medicated feeds that are in
accord with label
specifications and also
those medicated feeds not
within documented
permissible assay limits.
225.80(b)(2) requires that 791 1,600 1,265,600 0.12 (7 minutes)........ 151,872
verified medicated feed
label(s) be kept for 1 year.
225.102(b)(1) through (5), 791 7,800 6,169,800 0.08 (5 minutes)........ 493,584
requires records of master
record files and production
records for medicated feeds.
225.110(b)(1) and (2) 791 7,800 6,169,800 0.02 (1 minute)......... 123,396
requires maintenance of
distribution records for
medicated feeds.
225.115(b)(1) and (2) 791 5 3,955 0.12 (7 minutes)........ 475
requires maintenance of
complaint files by the
medicated feed manufacturer.
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Total.................... ............... ............... ........... ........................ 992,785
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden
[Registered licensed mixer/feeders] \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
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225.42(b)(5) through (8) 100 260 26,000 0.15 (9 minutes)........ 3,900
requires records of receipt,
storage, and inventory
control of medicated feeds.
225.58(c) and (d) requires 100 36 3,600 0.5 (30 minutes)........ 1,800
records of the results of
periodic assays for
medicated feeds that are in
accord with label
specifications and also
those medicated feeds not
within documented
permissible assay limits.
225.80(b)(2) requires that 100 48 4,800 0.12 (7 minutes)........ 576
verified medicated feed
label(s) be kept for 1 year.
225.102(b)(1) through (5) 100 260 26,000 0.4 (24 minutes)........ 10,400
requires records of master
record files and production
records for medicated feeds.
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Total.................... ............... ............... ........... ........................ 16,676
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Recordkeeping Burden
[Nonregistered non-licensed commercial feed mills] \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
225.142 requires procedures 4,357 4 17,428 1....................... 17,428
for identification, storage,
and inventory control
(receipt and use) of Type A
medicated articles and Type
B medicated feeds.
[[Page 47149]]
225.158 requires records of 4,357 1 4,357 4....................... 17,428
investigation and corrective
action when the results of
laboratory assays of drug
components indicate that the
medicated feed is not in
accord with the permissible
assay limits.
225.180 requires 4,357 96 418,272 0.12 (7 minutes)........ 50,193
identification, storage, and
inventory control of
labeling in a manner that
prevents label mix-ups and
assures that correct labels
are used for medicated feeds.
225.202 requires records of 4,357 260 1,132,820 0.65 (39 minutes)....... 736,333
formulation, production, and
distribution of medicated
feeds.
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Total.................... ............... ............... ........... ........................ 821,382
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden
[Nonregistered non-licensed mixer/feeders] \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeper hours
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225.142 requires procedures 3,400 4 13,600 1....................... 13,600
for identification, storage,
and inventory control
(receipt and use) of Type A
medicated articles and Type
B medicated feeds.
225.158 requires records of 3,400 1 3,400 4....................... 13,600
investigation and corrective
action when the results of
laboratory assays of drug
components indicate that the
medicated feed is not in
accord with the permissible
assay limits.
225.180 requires 3,400 32 108,800 0.12 (7 minutes)........ 13,056
identification, storage, and
inventory control of
labeling in a manner that
prevents label mix-ups and
assures that correct labels
are used for medicated feeds.
225.202 requires records of 3,400 260 884,000 0.33 (20 minutes)....... 291,720
formulation, production, and
distribution of medicated
feeds.
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Total.................... ............... ............... ........... ........................ 331,976
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall decrease of 10,435 hours and an increase of 831,545 records
since the last OMB approval. We attribute this adjustment due to an
increase in the number of non-registered, non-licensed commercial
medicated feed mills and decrease in non-licensed medicated feed mill
recordkeeping the last few years.
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15487 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P
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