[Federal Register Volume 65, Number 184 (Thursday, September 21, 2000)]
[Notices]
[Pages 57193-57194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1506]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on How to Use E-Mail to Submit a 
Notice of Final Disposition of Animals Not Intended for Immediate 
Slaughter

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 (the PRA).

DATES: Submit written comments on the collection of information by 
October 23, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 1025, 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 3507 of the 
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3507), FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance:
    Title: Guidance for Industry on How to Use E-Mail to Submit a 
Notice of Final Disposition of Animals Not Intended for Immediate 
Slaughter
    Description: The Center for Veterinary Medicine (CVM), monitors 
final disposition of food animals treated with investigational new 
animal drugs in situations where the treated animals do not enter the 
human food chain immediately at completion of the investigational 
study. CVM believes that monitoring of the final disposition of such 
food animals is consistent with its responsibility to protect the 
public health under the Federal Food, Drug, and Cosmetic Act. In 
addition, CVM believes that acceptable standards of study conduct, such 
as those set forth under 21 CFR 514.117, would include sponsors 
accounting for the disposition of all animals treated with 
investigational new animal drugs. Furthermore, CVM requests this 
information because some animals are held for 30 days after the 
investigational drug withdrawal period ends, and CVM does not request a 
notice of intent to slaughter for human food purposes for these 
animals. However, animals held for this period may still be sent for 
slaughter.
    This guidance document describes the procedures for persons who are 
sponsors of new animal drugs who wish to file a notice of final 
disposition of animals (NFDA) not intended for immediate slaughter, 
electronically on FDA Form No. 3487. The information sponsors should 
include on the form includes the sponsor's name, address, and 
information about the treated animals.
    Description of Respondents: The likely respondents for this 
collection of information are new animal drug sponsors who have 
conducted clinical investigations under 21 CFR 511.1(b).
    In the Federal Register of June 29, 2000 (65 FR 40104), FDA 
announced the availability of this guidance as a draft document and 
requested public comment. In response to this notice, no comments were 
received on the annual reporting burden. We, therefore, believe the 
annual reporting burden of 262 hours should remain unchanged.

[[Page 57194]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
          FDA Form No.                No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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3487                                  190               1.7           324               0.81         262
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden estimates in table 1 of this document resulted from 
discussions with new animal drug sponsors. The estimated burden 
includes NFDA's submitted on paper and by e-mail.

    Dated: September 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24266 Filed 9-20-00; 8:45 am]
BILLING CODE 4160-01-F