81 FR 37602 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

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.

[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37602-37603]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0511]


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 July 
11, 2016.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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--Revision

    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 (the 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 (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 have made minor 
editorial revisions to Form FDA 3448, including the addition of a 
dedicated field for the submitter's email address in the contact 
information section. We estimate that the revisions will not change the 
amount of time necessary to complete the form.
    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)). If a licensed facility is no longer 
manufacturing medicated animal feed under Sec.  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) to give reasons why a medicated feed mill license should not 
be refused or revoked.
    In the Federal Register of March 9, 2016 (81 FR 12509), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment, which was not 
responsive to the comment request.
    We estimate the burden of this collection of information as 
follows:

[[Page 37603]]



                                                     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                   20               1              20  0.25 (15 minutes).........................               5
 using Form FDA 3448 (515.10(b)).
Supplemental Feed Mill License Application                40               1              40  0.25 (15 minutes).........................              10
 using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill               40               1              40  0.25 (15 minutes).........................              10
 License.
(515.23)....................................
Filing a Request for a Hearing on Medicated                1               1               1  4.........................................               4
 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 Labeling             890               1             890  0.03 (2 minutes)..........................              27
 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.

    These estimates are based on our experience with medicated feed 
mill license applications. We estimate that we will receive 20 
medicated feed mill license applications, 40 supplemental applications, 
40 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 890 licensees will keep the records 
required by 21 CFR 510.305 expending a total of 27 hours annually.

    Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13790 Filed 6-9-16; 8:45 am]
BILLING CODE 4164-01-P