[Federal Register Volume 68, Number 100 (Friday, May 23, 2003)]
[Notices]
[Pages 28236-28237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0198]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medicated Feed Mill License

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 for an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
for medicated feed mill licensing requirements.

DATES: Submit written or electronic comments on the collection of 
information by July 22, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (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, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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. A 
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 listed below.
    With respect to the following collection of information, FDA 
invites comments on: (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
    In the Federal Register of November 19, 1999 (64 FR 63195), FDA 
published a final rule implementing the feed mill licensing provisions 
of the Animal Drug Availability Act (the ADAA) of 1966 (Public Law 104-
250). The rule added a new part 515 to title 21 CFR to provide the 
requirements for medicated feed mill licensing.
    The rule set forth the information to be included in medicated feed 
mill license applications and supplemental applications. Also, it set 
forth criteria for, among other things, the approval and refusal to 
approve a medicated feed mill license application, as well as the 
criteria for the revocation and/or suspension of a license.
    Respondents to this collection of information are individuals or 
firms that manufacture medicated animal feed.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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    21 CFR           No. of         Annual Frequency     Total Annual
   Section        Recordkeepers       per Response         Responses      Hours per Response      Total Hours
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515.10(b)                    7                     1                7                   0.25                1.75
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515.11(b)                  100                     1              100                   0.25               25.00
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[[Page 28237]]

 
515.23                      25                     1               25                   0.25                6.25
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515.30(c)                    0.15                  1                0.15               24                   3.60
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Total Burden Hours                                                                                         36.6
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\1\ There are no capital cost or operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\ 1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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510.305                                    1,160               1           1,160            0.03           34.80
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated number of respondents is derived from agency data on 
the number of medicated feed manufacturers entering the market each 
year, changing ownership or address, requesting voluntary revocation of 
a medicated feed mill license, and those involved in revocation and/or 
suspension of a license. The estimate of the time required for this 
reporting requirement is based on the agency communication with 
industry.

    Dated: May 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12922 Filed 5-22-03; 8:45 am]
BILLING CODE 4160-01-S