Notice2025-07584
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
May 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 83 (Thursday, May 1, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18679-18680]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07584]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4687]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medicated Feed Mill
License Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 2, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0337. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#57070516042336313117313336793f3f2479303821"><span class="__cf_email__" data-cfemail="9ececcdfcdeafff8f8def8faffb0f6f6edb0f9f1e8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medicated Feed Mill License Application
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 (Sec. 515.10(b) (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#5b163e3f32383a2f3e3f1d3e3e3f280f3e3a36163a32371b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="1b567e7f72787a6f7e7f5d7e7e7f684f7e7a76567a72775b7d7f7a35737368357c746d">[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: https://
[[Page 18680]]
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.
In the Federal Register of November 29, 2024 (89 FR 94740), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of responses per annual Average burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
515.10(b), 515.11(b); 34 1 34 0.25 (15 minutes)......... 8.5
Medicated Feed Mill License
Application and
Supplemental Applications
using Form FDA 3448.
515.23; Voluntary Revocation 14 1 14 0.25 (15 minutes)......... 3.5
of Medicated Feed Mill
License.
515.30; Filing a Request for 1 1 1 4......................... 4
a Hearing on Medicated Feed
Mill 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 Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
510.305; Maintenance of 779 1 779 0.03 (2 minutes).......... 23
Records 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 attribute this adjustment to a slight increase in the overall
number of submissions we received over the last few years.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07584 Filed 4-30-25; 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 May 1, 2025.
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.