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[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94740-94742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28036]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4687]

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: Either electronic or written comments on the collection of 
information must be submitted by January 28, 2025.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 28, 2025. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received 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-2024-N-4687 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; 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 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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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

[[Page 94741]]

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

    This information collection helps support implementation of 
statutory and regulatory provisions related to medicated animal feed 
mill licensing. 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 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)). 
This form may be submitted via U.S. mail or electronically to a 
dedicated email address, [email protected]. 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. Form FDA 3448 may be 
accessed on our website at: https://www.fda.gov/about-fda/reports-manuals-forms/forms.
    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; activity                          Number of     responses per   Total annual      Average burden per    Total hours
                                                                      respondents     respondent       responses            response
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515.10(b), 515.11(b); Medicated Feed Mill License Application and               34               1              34        0.25 (15 minutes)          8.5
 Supplemental Applications using Form FDA 3448....................
515.23; Voluntary Revocation of Medicated Feed Mill License.......              14               1              14        0.25 (15 minutes)          3.5
515.30; Filing a Request for a Hearing on Medicated Feed Mill                    1               1               1                        4            4
 License..........................................................
                                                                   -------------------------------------------------------------------------------------
    Total.........................................................  ..............  ..............              49  .......................           16
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate that respondents will spend 15 minutes to assemble the 
necessary information, prepare, and submit an application for a feed 
mill license or revocation of a feed mill license. We estimate that 
respondents will spend 4 hours to prepare their request for a hearing.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                    Number of
     21 CFR Part; activity          Number of      records per    Total annual   Average burden per  Total hours
                                  recordkeepers   recordkeeper       records        recordkeeping
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510.305; Maintenance of Records             779               1             779  0.03 (2 minutes)..           23
 for Approved Labeling for Each
 ``Type B'' and ``Type C'' Feed.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimates on our recent experience with the existing 
medicated feed mill license application process. Our estimated burden 
for the information collection reflects an overall increase of 2.5 
hours. We

[[Page 94742]]

attribute this adjustment to a slight increase in the overall number of 
submissions we received over the last few years.

    Dated: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28036 Filed 11-27-24; 8:45 am]
BILLING CODE 4164-01-P
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