[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7741-7743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02446]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0601]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Medicated Feeds
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the recordkeeping requirements for
manufacturers of medicated animal feeds.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 7, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 7, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-N-0601 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice Regulations for Medicated Feeds.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's
[[Page 7742]]
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden--Registered Licensed Commercial Feed Mills \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (8) requires records of 791 260 205,660 1......................................... 205,660
receipt, storage, and inventory control of
medicated feeds.
225.58(c) and (d) requires records of the 791 45 35,595 0.50 (30 minutes)......................... 17,798
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 791 1,600 1,265,600 0.12 (7 minutes).......................... 151,872
feed label(s) be kept for 1 year.
225.102(b)(1) through (5), requires records of 791 7,800 6,169,800 0.08 (5 minutes).......................... 493,584
master record files and production records for
medicated feeds.
225.110(b)(1) and (2) requires maintenance of 791 7,800 6,169,800 0.02 (1 minute)........................... 123,396
distribution records for medicated feeds.
225.115(b)(1) and (2) requires maintenance of 791 5 3,955 0.12 (7 minutes).......................... 475
complaint files by the medicated feed
manufacturer.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. .......................................... 992,785
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
21 CFR part Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. .......................................... 16,676
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 7743]]
Table 3--Estimated Annual Recordkeeping Burden--Nonregistered Non-Licensed Commercial Feed Mills \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142 requires procedures for identification, 4,357 4 17,428 1......................................... 17,428
storage, and inventory control (receipt and
use) of Type A medicated articles and Type B
medicated feeds.
225.158 requires records of investigation and 4,357 1 4,357 4......................................... 17,428
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 4,357 96 418,272 0.12 (7 minutes).......................... 50,193
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 formulation, 4,357 260 1,132,820 0.65 (39 minutes)......................... 736,333
production, and distribution of medicated
feeds.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. .......................................... 821,382
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142 requires procedures for identification, 3,400 4 13,600 1......................................... 13,600
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.
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 mix-ups 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.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. .......................................... 331,976
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02446 Filed 2-3-23; 8:45 am]
BILLING CODE 4164-01-P