Notice2022-09462
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 3, 2022
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
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<title>Federal Register, Volume 87 Issue 85 (Tuesday, May 3, 2022)</title>
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[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Notices]
[Pages 26210-26211]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09462]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4428]
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.
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SUMMARY: The Food and Drug Administration (FDA or we) is
[[Page 26211]]
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, 2022.
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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#431311021037222525032527226d2b2b306d242c35"><span class="__cf_email__" data-cfemail="cb9b998a98bfaaadad8badafaae5a3a3b8e5aca4bd">[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--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 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.
In the Federal Register of January 28, 2022 (87 FR 4620), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, the
comments were not responsive to the four collection of information
topics solicited.
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 (Sec. 515.10(b)).
Supplemental Feed Mill License Application 14 1 14 0.25 (15 minutes)....................... 3.5
using Form FDA 3448 (Sec. 515.11(b)).
Voluntary Revocation of Medicated Feed Mill 15 1 15 0.25 (15 minutes)....................... 3.75
License (Sec. 515.23).
Filing a Request for a Hearing on Medicated 1 1 1 4....................................... 4
Feed Mill License (Sec. 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.
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 (Sec.
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: April 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09462 Filed 5-2-22; 8:45 am]
BILLING CODE 4164-01-P
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