Document ID: FDA-2012-N-1181-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medicated Feed Mill License Application
Posted Date: 2013-05-10T04:00Z

[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Pages 27402-27404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11126]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1181]

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

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.

[[Page 27403]]

DATES: Fax written comments on the collection of information by June 
10, 2013.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@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 Licensing Application--21 CFR Part 515 (OMB Control 
Number 0910-0337)--Extension

    The Animal Drug Availability Act (ADAA) of October 9, 1996, amended 
section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b) to replace the system for the approval of specific medicated feed 
with a general licensing system for feed mills. Before passage of the 
ADAA, medicated feed manufacturers were required to obtain approval of 
Medicated Feed Applications (MFAs) in order to manufacture certain 
types of medicated feeds. An individual approved MFA was required for 
each and every applicable medicated feed. The ADAA streamlined the 
paperwork process for gaining approval to manufacture medicated feeds 
by replacing the MFA system with a facility license for each medicated 
feed manufacturing facility. Implementing regulations are at 21 CFR 
part 515.
    In the Federal Register of December 21, 2012 (77 FR 75635), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received; however, it was 
unrelated to the information collection.
    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     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Medicated Feed Mill License                 20               1              20  0.25............               5
 Application Using Form FDA                                                     (15 minutes)....
 3448 (515.10(b)).
Supplemental Feed Mill License              40               1              40  0.25............              10
 Application Using Form FDA                                                     (15 minutes)....
 3448 (515.11(b)).
Voluntary Revocation of                     40               1              40  0.25............              10
 Medicated Feed Mill License                                                    (15 minutes)....
 (515.23).
Filing a Request for a Hearing               1               1               1  4...............               4
 on 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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                                                    No. of
        21 CFR section              No. of       responses per   Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
----------------------------------------------------------------------------------------------------------------
Maintenance of Records for                 950               1             950  0.03............            28.5
 Approved Labeling for Each                                                     (2 minutes).....
 ``Type B'' and ``Type C''
 Labeling (510.305).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 27404]]

    Estimated annual reporting burden on industry is 29 hours as shown 
in table 1. Industry estimates it takes about 15 minutes (0.25) to 
submit the application. We estimate 100 original and supplemental 
applications, and voluntary revocations for a total of 25 hours (100 
submissions x 0.25 (15 minutes)). An additional 4 hours is added for 
the rare notice of opportunity for a hearing to not approve or revoke 
an application. Finally, we estimate 28.5 hours for maintaining and 
retrieving labels as required by 21 CFR 510.305. We estimated 2 minutes 
(0.03 hour) for each of approximately 950 licensees. Total burden for 
reporting and recordkeeping would be 57.5 hours.

    Dated: May 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11126 Filed 5-9-13; 8:45 am]
BILLING CODE 4160-01-P