Document ID: FDA-2018-N-4428-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
Posted Date: 2022-05-03T04:00Z

[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Notices]
[Pages 26210-26211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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)).
                                               ---------------------------------------------------------------------------------------------------------
    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