[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47147-47149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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: 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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of        Total
   21 CFR section; activity       Number of      responses per      annual       Average burden per       Total
                                 respondents       respondent     responses           response            hours
----------------------------------------------------------------------------------------------------------------
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.
                              ----------------------------------------------------------------------------------
    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        Total
   21 CFR section; activity       Number of       records per       annual       Average burden per       Total
                                recordkeepers     recordkeeper     records          recordkeeping         hours
----------------------------------------------------------------------------------------------------------------
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.
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ...............  ...........  ........................    16,676
----------------------------------------------------------------------------------------------------------------
\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.
                              ----------------------------------------------------------------------------------
    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        Total
   21 CFR section; activity       Number of       records per       annual       Average burden per       Total
                                recordkeepers     recordkeeper     records          recordkeeper          hours
----------------------------------------------------------------------------------------------------------------
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.
                              ----------------------------------------------------------------------------------
    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 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