[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]


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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.

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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\
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                                                                    Number of
                  21 CFR part                       Number of     responses per   Total annual           Average burden per response         Total hours
                                                   respondents     respondent       responses
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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
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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 part                       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.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  ..........................................       16,676
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\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\
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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 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
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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\
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                                                                    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
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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 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