[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55556-55557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 of a collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the medicated feed mill licensing applications.

DATES:  Submit written or electronic comments on the collection of 
information by December 28, 2009.

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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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, 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 License 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 (the 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                    Annual Frequency        Total Annual
              21 CFR Section                 No. of  Respondents      per Response            Responses        Hours per  Response       Total Hours
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515.10(b)                                                     20                     1                    20                  0.25                     5
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515.11(b)                                                     75                     1                    75                  0.25                 18.75
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515.23                                                        40                     1                    40                  0.25                    10
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515.30(c)                                                   0.15                     1                  0.15                    24                   3.6
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Total Burden Hours                                                                                                                                 37.35
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                   No. of           Annual Frequency        Total Annual
              21 CFR Section                    Recordkeepers       per Recordkeeping          Records          Hours per  Record        Total Hours
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510.305                                                    1,070                     1                 1,070                  0.03                 32.10
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.


[[Page 55557]]

    The estimated annual reporting burden on industry is 37.35 hours as 
shown in table 1 of this document. Industry estimates it takes about 1/
4 hour to submit the application. We estimate 135 original and 
supplemental applications, and voluntary revocations for a total of 
33.75 hours (135 submissions x 1/4 hour). An additional 3.6 hours is 
added for the rare notice of opportunity for a hearing to not approve 
or revoke an application. Finally, we estimate 30 hours for maintaining 
and retrieving labels as required by 21 CFR 510.305 and shown in table 
2 of this document. We estimated 0.03 hours for each of the 
approximately 1,000 licensees. Thus, the total annual burden for 
reporting and recordkeeping requirements is estimated to be 67.35 
hours.

    Dated: October 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25915 Filed 10-27-09; 8:45 am]
BILLING CODE 4160-01-S