
[Federal Register Volume 81, Number 200 (Monday, October 17, 2016)]
[Notices]
[Pages 71508-71510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25041]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 December 16, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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

[[Page 71509]]

information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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 (the 
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 recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)...................             877             260         228,020  1.......................................         228,020
225.28(c) and (d).............................             877              45          39,465  0.50 (30 minutes).......................        19,732.5
225.80(b)(2)..................................             877           1,600       1,403,200  0.12 (7 minutes)........................         168,384
225.102(b)(1).................................             877           7,800       6,840,600  0.08 (5 minutes)........................         547,248
225.110(b)(1) and (b)(2)......................             877           7,800       6,840,600  0.02 (1 minute).........................         136,812
225.115(b)(1) and (b)(2)......................             877               5           4,385  0.12 (7 minutes)........................           526.2
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................     1,100,722.7
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 71510]]


                                                     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 recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b) through (b)(8)......................             100             260          26,000  0.15 (9 minutes)........................           3,900
225.58(c) through (d).........................             100              36           3,600  0.50 (30 minutes).......................           1,800
225.80(b) (2).................................             100              48           4,800  0.12 (7 minutes)........................             576
225.102(b)(1) through (b)(5)..................             100             260          26,000  0.40 (24 minutes).......................          10,400
                                               ---------------------------------------------------------------------------------------------------------
    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 recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142.......................................           4,186               4          16,744  1.......................................          16,744
225.158.......................................           4,186               1           4,186  4.......................................          16,744
225.180.......................................           4,186              96         401,856  0.12 (7 minutes)........................          48,223
225.202.......................................           4,186             260       1,088,360  0.65 (39 minutes).......................         707,434
                                               ---------------------------------------------------------------------------------------------------------
    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 recordkeeper        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142.......................................           3,400               4          13,600  1.......................................          13,600
225.158.......................................           3,400               1           3,400  4.......................................          13,600
225.180.......................................           3,400              32         108,800  0.12 (7 minutes)........................          13,056
225.202.......................................           3,400             260         884,000  0.33 (20 minutes).......................         291,720
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         331,976
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of time required for record preparation and 
maintenance is based on Agency communications with industry. Other 
information needed to finally calculate the total burden hours (i.e., 
number of recordkeepers, number of medicated feeds being manufactured, 
etc.) is derived from Agency records and experience.

    Dated: October 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25041 Filed 10-14-16; 8:45 am]
BILLING CODE 4164-01-P


