[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Notices]
[Pages 75635-75636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension and to allow 60 days for public 
comment in response to the notice. This notice solicits comments on the 
medicated feed mill licensing system.

DATES: Submit written or electronic comments on the collection of 
information by February 19, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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., PIFO-410B, 
Rockville, MD 20850, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information,

[[Page 75636]]

including each proposed extension of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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.
    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
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Medicated Feed Mill License                   20               1              20             .25               5
 Application Using Form FDA 3448
 (Sec.   515.10(b)).............
Supplemental Feed Mill License                40               1              40             .25              10
 Application Using Form FDA 3448
 (Sec.   515.11(b)).............
Voluntary Revocation of                       40               1              40             .25              10
 Medicated Feed Mill License
 (Sec.   515.23)................
Filing a Request for a Hearing                 1               1               1            4                  4
 on Medicated Feed Mill License
 (Sec.   515.30(c)).............
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    Total.......................  ..............  ..............  ..............  ..............              29
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\1\ There are no capital costs or maintenance costs associated with this information collection.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                           21 CFR section                               Number of      responses per     Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records        recordkeeper
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Maintenance of Records for Approved Labeling for Each ``Type B''                950                1              950             0.03             28.5
 and ``Type C'' Labeling (Sec.   510.305)..........................
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\1\ There are no capital costs or maintenance costs associated with this information collection.

    Estimated annual reporting burden on industry is 29 hours as shown 
in table 1. Industry estimates it takes about 15 minutes (.25) to 
submit the application. We estimate 100 original and supplemental 
applications, and voluntary revocations for a total of 25 hours (100 
submissions x .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 .03 hours 
for each of approximately 950 licensees. Total burden for reporting and 
recordkeeping would be 57.5 hours.

    Dated: December 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30738 Filed 12-20-12; 8:45 am]
BILLING CODE 4160-01-P