Document ID: FDA-2018-N-4428-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed
Mill License Application
Posted Date: 2022-01-28T05:00Z

[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4620-4622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01738]

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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, Agency, or we) 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 information collection 
provisions of medicated feed mill license reporting.

DATES: Submit either electronic or written comments on the collection 
of information by March 29, 2022.

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 March 29, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 29, 2022. 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-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, 240-402-7500.
     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

[[Page 4621]]

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, 240-402-7500.

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: 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 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 a Type B or Type C 
medicated 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 preapproval 
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) (21 CFR 515.11(b))). If a licensed 
facility is no longer manufacturing medicated animal feed under Sec.  
515.23 (21 CFR 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) (21 CFR 515.30(c)) to 
give reasons why a medicated feed mill license should not be refused or 
revoked.
    Under Sec.  510.305 (21 CFR 510.305) we require each applicant to 
maintain in a single accessible location: (a) A copy of the approved 
medicated feed mill license (Form FDA 3448) on the premises of the 
manufacturing establishment; and (b) Approved or index listed labeling 
for each Type B and/or Type C feed being manufactured on the premises 
of the manufacturing establishment or the facility where the feed 
labels are generated.
    FDA estimates 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  per response          Total hours
                                                 respondents     respondent       responses
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Medicated Feed Mill License Application using               5               1               5  0.25 (15 minutes)........................            1.25
 Form FDA 3448 (515.10(b)).
Supplemental Feed Mill License Application                 14               1              14  0.25 (15 minutes)........................             3.5
 using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill                15               1              15  0.25 (15 minutes)........................            3.75
 License (515.23).
Filing a Request for a Hearing on Medicated                 1               1               1  4........................................               4
 Feed Mill License (515.30(c)).
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    Total....................................  ..............  ..............  ..............  .........................................            12.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
 

[[Page 4622]]

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
         21 CFR section and activity              Number of      records per    Total annual       Average burden  per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
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Maintenance of Records for Approved Labeling              795               1             795  0.03 (2 minutes).........................              24
 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.

    Our estimated burden for the information collection reflects an 
overall decrease of 17 hours and a corresponding decrease of 105 
responses/records. We attribute this adjustment to a decrease in the 
number of submissions we received over the last few years.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01738 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P