[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66280-66282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27812]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4428]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medicated Feed Mill License Application

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 medicated feed mill licensing system.

DATES: Submit either electronic or written comments on the collection 
of information by February 25, 2019.

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 February 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 25, 2019. 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

[[Page 66281]]

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-2018-N-4428 for ``Medicated Feed Mill License Application.'' 
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.gpo.gov/fdsys/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, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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.

Medicated Feed Mill License Application--21 CFR Part 515--OMB Control 
Number 0910-0337--Extension

    Feed manufacturers that seek to manufacture feed using Category II, 
Type A medicated articles or manufacture certain liquid and free-choice 
feed, using Category I, Type A medicated articles that must follow 
proprietary formulas or specifications are required to obtain a 
facility license under section 512 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360b). Our regulations in part 515 
(21 CFR part 515) establish the procedures associated with applying for 
a facility license. We require that a manufacturer seeking a facility 
license submit a completed medicated feed mill license application 
using Form FDA 3448 (21 CFR 515.10(b)). We use the information 
submitted to establish that the applicant has made the certifications 
required by section 512 of the FD&C Act, to register the mill, and to 
schedule a pre-approval inspection.
    We require the submission of a supplemental medicated feed mill 
license application for a change in facility ownership or a change in 
facility address (Sec.  515.11(b)). If a licensed facility is no longer 
manufacturing medicated animal feed under Sec.  515.23, a manufacturer 
may request voluntary revocation of a medicated feed mill license. An 
applicant also has the right to file a request for hearing under Sec.  
515.30(c) to give reasons why a medicated feed mill license should not 
be refused or revoked.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
  21 CFR section and activity      Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Medicated Feed Mill License                 14               1              14  0.25 (15                       4
 Application using Form FDA                                                      minutes).
 3448 (515.10(b)).
Supplemental Feed Mill License              54               1              54  0.25 (15                      14
 Application using Form FDA                                                      minutes).
 3448 (515.11(b)).
Voluntary Revocation of                     29               1              29  0.25 (15                       7
 Medicated Feed Mill License                                                     minutes).
 (515.23).

[[Page 66282]]

 
Filing a Request for a Hearing               1               1               1  4...............               4
 on Medicated Feed Mill
 License (515.30(c)).
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    Total.....................  ..............  ..............  ..............  ................              29
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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 \1\
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                                                   Number of                     Average burden
  21 CFR section and activity      Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
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Maintenance of Records for                 837               1             837  0.03 (2 minutes)              25
 Approved Labeling for Each
 ``Type B'' and ``Type C''
 Feed (510.305).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    These estimates are based on our experience with medicated feed 
mill license applications. We estimate that we will receive 14 
medicated feed mill license applications, 54 supplemental applications, 
29 requests for voluntary revocation, and that these submissions will 
take approximately 15 minutes per response, as shown in table 1, rows 1 
through 3. We estimate that preparing a request for a hearing under 
Sec.  515.30(c) takes approximately 4 hours, as shown in table 1, row 
4. In table 2, we estimate that 837 licensees will keep the records 
required by 21 CFR 510.305 expending a total of 25 hours annually.
    Our estimated burden for the information collection reflects an 
overall decrease of 2 hours and a corresponding decrease of 56 
responses/records. We attribute this adjustment to a net decrease in 
the number of submissions we received over the last few years.

    Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27812 Filed 12-21-18; 8:45 am]
BILLING CODE 4164-01-P