[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                               ---------------------------------------------------------------------------------------------------------
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                21 CFR section                     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
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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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   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                          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.
                                               ---------------------------------------------------------------------------------------------------------
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                               ---------------------------------------------------------------------------------------------------------
    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