Notice2024-28036
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 230 (Friday, November 29, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94740-94742]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28036]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#154547544661747373557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="6a3a382b391e0b0c0c2a0c0e0b44020219440d051c">[email protected]</span></a>.
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, <a href="/cdn-cgi/l/email-protection#e8a58d8c818b899c8d8cae8d8d8c9bbc8d8985a5898184a88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="4c012928252f2d3829280a2929283f18292d21012d25200c2a282d6224243f622b233a">[email protected]</span></a>. 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: <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section; activity Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Part; activity Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
510.305; Maintenance of Records 779 1 779 0.03 (2 minutes).. 23
for Approved Labeling for Each
``Type B'' and ``Type C'' Feed.
----------------------------------------------------------------------------------------------------------------
\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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 29, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.