[Federal Register Volume 65, Number 195 (Friday, October 6, 2000)]
[Notices]
[Pages 59852-59853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1395]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 
November 6, 2000.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: 
Desk Officer for FDA.

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: In compliance with section 44 U.S.C. 3507, 
FDA has submitted the following proposed collection of information to 
OMB for review and clearance.

Medicated Feed Mill License 21 CFR Part 515--(OMB Control Number 
0910-0337)--Extension

    Description: This rule sets forth the information to be included in 
a medicated feed mill license application and subsequent supplemental 
applications. In addition, it provides criteria for the approval and 
nonapproval of a medicated feed mill license application and the 
criteria for the revocation and/or suspension of a license. More 
specifically, Sec. 515.10(b) specifies requirements for submitting a 
completed medicated feed mill license application, using Form FDA 3448. 
Section 515.11(b) specifies requirements for supplemental medicated 
feed applications for a change in ownership and/or a change in mailing 
address for the facility cite, using Form FDA 3448. Section 515.23 sets 
forth written requirements for voluntary revocation of a medicated feed 
mill license by a sponsor on the grounds that the facility

[[Page 59853]]

no longer manufacture any animal feed. Section 515.30(c) details 
requirements for filing a request for a hearing by a sponsor to give 
reasons why a medicated feed mill license application should not be 
refused or revoked and Sec. 510.305(b) (21 CFR 510.305 (b)), requires 
maintenance of approved labeling for each Type B and/or Type C 
medicated feed being manufactured on the premises of the manufacturing 
establishment or the facility where the feed labels are generated.
    Description of Respondents: Respondents to this collection of 
information are individuals or firms that manufacture medicated animal 
feed. In the Federal Register of July 26, 2000 (65 FR 45987), FDA 
published a 60-day notice concerning the proposed extension of this 
collection of information and requested comments. In response to this 
notice, no comments were received on the estimated annual reporting and 
recordkeeping burden. We therefore believe that the total burden 
estimate of 72 hours for the annual reporting and recordkeeping burden 
should remain unchanged.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1</SUP>
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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515.10(b)                             100               1             100               0.25           25
515.11(b)                              25               1              25               0.25            6.25
515.23                                 50               1              50               0.25           12.25
515.30(c)                               0.15            1               0.15           24               3.6
Total burden hours                                                                                     47.10
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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<SUP>1</SUP>
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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(b)                            100               1             100                .25          25
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\1\There are no capital cost or operating and maintenance cost associated with this collection of information.

    The estimate for the number of respondents is derived from agency 
data, i.e. the number of medicated feed manufacturers entering the 
market each year, change in ownership or address, requests for 
voluntary revocation of a medicated feed mill license, revocation and/
or suspension of a license. The estimate of the time required for the 
reporting and recordkeeping requirements is based on the agency 
communication with industry.

    Dated: October 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-25699 Filed 10-5-00; 8:45 am]
BILLING CODE 4160-01-F