[Federal Register Volume 68, Number 153 (Friday, August 8, 2003)]
[Notices]
[Pages 47331-47332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0198]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Requirements for Medicated Feed Mill License

AGENCY: Food

[[Page 47332]]

 and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
September 8, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 0910-0037)--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 of 1966 (Public Law 104-250). The 
rule added a new 21 CFR part 515 to provide the requirements for 
medicated feed mill licensing.
    The rule sets forth the information to be included in medicated 
feed mill license applications and supplemental applications. It also 
sets forth the 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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                                                                          Annual
                                                              No. of    Frequency    Total      Hours     Total
                      21 CFR Section                       Respondents     per       Annual      per      Hours
                                                                        Responses  Responses  Response
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515.10                                                             7           1          7      0.25      1.75
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515.11                                                           100           1        100      0.25     25.00
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515.23                                                            25           1         25      0.25      6.25
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515.30                                                          0.15           1       0.15     24.00      3.60
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Total Burden Hours                                         ...........  .........  .........  ........     36.6
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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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                                                                     Annual       Total
                 21 CFR Section                       No. of     Frequency per   Annual     Hours per     Total
                                                  Recordkeepers  Recordkeeping   Records  Recordkeeper    Hours
----------------------------------------------------------------------------------------------------------------
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: August 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20201 Filed 8-7-03; 8:45 am]
BILLING CODE 4160-01-S