[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41594-41596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14797]
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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, Health and Human Services (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 10, 2020.
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 0910-0152. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852, 301-796-7726,
[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 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 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 or not the systems and
procedures used by manufacturers of medicated feeds are adequate to
assure 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 mixer/feeders.
In the Federal Register of March 4, 2020 (85 FR 12790), we
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:
Table 1--Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills) 1
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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225.42(b)(5) through (8) requires records of 825 260 214,500 1....................................... 214,500
receipt, storage, and inventory control of
medicated feeds.
225.58(c) and (d) requires records of the 825 45 37,125 0.50 (30 minutes)....................... 18,562.50
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 verified medicated 825 1,600 1,320,000 0.12 (7 minutes)........................ 158,400
feed label(s) be kept for 1 year.
225.102(b)(1) through (5), requires records of 825 7,800 6,435,000 0.08 (5 minutes)........................ 514,800
Master Record Files and production records
for medicated feeds.
225.110(b)(1) and (2) requires maintenance of 825 7,800 6,435,000 0.02 (1 minute)......................... 128,700
distribution records for medicated feeds.
[[Page 41595]]
225.115(b)(1) and (2) requires maintenance of 825 5 4,125 0.12 (7 minutes)........................ 495
complaint files by the medicated feed
manufacturer.
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Total..................................... .............. .............. .............. ........................................ 1,035,457.50
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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
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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225.42(b)(5) through (8) requires records of 100 260 26,000 0.15 (9 minutes)........................ 3,900
receipt, storage, and inventory control of
medicated feeds.
225.58(c) and (d) requires records of the 100 36 3,600 0.50 (30 minutes)....................... 1,800
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 verified medicated 100 48 4,800 0.12 (7 minutes)........................ 576
feed label(s) be kept for 1 year.
225.102(b)(1) through (5) requires records of 100 260 26,000 0.40 (24 minutes)....................... 10,400
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 Unlicensed Commercial Feed Mills) 1
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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225.142 requires procedures for 4,186 4 16,744 1....................................... 16,744
identification, storage, and inventory
control (receipt and use) of Type A medicated
articles and Type B medicated feeds.
225.158 requires records of investigation and 4,186 1 4,186 4....................................... 16,744
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 identification, storage, and 4,186 96 401,856 0.12 (7 minutes)........................ 48,223
inventory control of labeling in a manner
that prevents label mixups and assures that
correct labels are used for medicated feeds.
225.202 requires records of formulation, 4,186 260 1,088,360 0.65 (39 minutes)....................... 707,434
production, and distribution of medicated
feeds.
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Total..................................... .............. .............. .............. ........................................ 789,145
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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 Unlicensed Mixer/Feeders) 1
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
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225.142 requires procedures for 3,400 4 13,600 1....................................... 13,600
identification, storage, and inventory
control (receipt and use) of Type A medicated
articles and Type B medicated feeds.
225.158 requires records of investigation and 3,400 1 3,400 4....................................... 13,600
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.
[[Page 41596]]
225.180 requires identification, storage, and 3,400 32 108,800 0.12 (7 minutes)........................ 13,056
inventory control of labeling in a manner
that prevents label mixups and assures that
correct labels are used for medicated feeds.
225.202 requires records of formulation, 3,400 260 884,000 0.33 (20 minutes)....................... 291,720
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 a
decrease of 65,265.20 hours. We attribute this adjustment to a decrease
in the number of respondents for Registered Licensed Commercial Feed
Mills. Medicated Feed Mill licensing is voluntary. Firms may withdraw
if they go out of business or if they change the source of the drug and
a license is not required.
Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14797 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P