Document ID: FDA-2018-N-4428-0002
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: 2019-07-18T04:00Z

[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34398-34399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15284]

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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) 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: Fax written comments on the collection of information by August 
19, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0337. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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, 
PRAStaff@fda.hhs.gov.

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 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 part 515 
(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))). 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 pre-approval 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.
    In the Federal Register of December 26, 2018 (83 FR 66280), 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\
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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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated Feed Mill License Application                 14               1              14  0.25 (15 minutes)...........................               4
 using Form FDA 3448 (515.10(b)).
Supplemental Feed Mill License Application              54               1              54  0.25 (15 minutes)...........................              14
 using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed                  29               1              29  0.25 (15 minutes)...........................               7
 Mill License (515.23).
Filing a Request for a Hearing on                        1               1               1  4...........................................               4
 Medicated Feed Mill License (515.30(c)).
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................................              29
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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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of Records for Approved                    837               1             837  0.03 (2 minutes)............................              25
 Labeling for Each ``Type B'' and ``Type
 C'' Feed (510.305).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 34399]]

    These estimates are based on our experience with medicated feed 
mill license applications. We estimate that we will receive 14 
medicated feed mill license applications, 54 supplemental applications, 
29 requests for voluntary revocation, and that these submissions will 
take approximately 15 minutes per response, as shown in table 1, rows 1 
through 3. We estimate that preparing a request for a hearing under 
Sec.  515.30(c) takes approximately 4 hours, as shown in table 1, row 
4. In table 2, we estimate that 837 licensees will keep the records 
required by 21 CFR 510.305, expending a total of 25 hours annually.
    Our estimated burden for the information collection reflects an 
overall decrease of 2 hours and a corresponding decrease of 56 
responses/records. We attribute this adjustment to a net decrease in 
the number of submissions we received over the last few years.

    Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15284 Filed 7-17-19; 8:45 am]
BILLING CODE 4164-01-P