[Federal Register Volume 85, Number 43 (Wednesday, March 4, 2020)]
[Notices]
[Pages 12790-12792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04461]



[[Page 12790]]

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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: Submit either electronic or written comments on the collection 
of information by May 4, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 4, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 4, 2020. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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 ``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.
     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.

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 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

[[Page 12791]]

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 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.
    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.
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\
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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.

[[Page 12792]]

 
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\
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                                                                  Number of
                21 CFR section                    Number of      records per    Total annual       Average  burden per  recordkeeping       Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142 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 mix-ups 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  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                         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.
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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    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: February 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04461 Filed 3-3-20; 8:45 am]
 BILLING CODE 4164-01-P