[Federal Register Volume 69, Number 5 (Thursday, January 8, 2004)]
[Notices]
[Pages 1299-1300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0328]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

DATES: Fax written comments on the collection of information by 
February 9, 2004.

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.

Guidance for Industry on How to Use E-Mail to Submit a Notice of Final 
Disposition of Animals Not Intended for Immediate Slaughter--(OMB 
Control Number 0910-0453)--Extension

    The Center for Veterinary Medicine (CVM) monitors the 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 the 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 
out in 21 CFR 514.117 would include sponsors accounting for the 
disposition of all animals treated with investigational new animal 
drugs.
    This guidance document describes the procedures that should be 
followed by sponsors who wish to file a notice of disposition 
electronically on FDA Form 3487. The information sponsors 
should include on the form includes the sponsor's name and address, and 
information about the investigational animals. The form has been 
revised at the request of the sponsors to add a box that can be checked 
if the submission amends a notice of disposition previously submitted 
to CVM and to allow for consistency across forms. The likely 
respondents to this collection of information are new animal drug 
sponsors who have conducted clinical studies under 21 CFR 511.1(b).
    In the Federal Register of August 7, 2003 (68 FR 47078), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 1300]]



             Table 1.--Estimated Annual Reporting Burden\1\
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                              Annual
 FDA Form       No. of      Frequency      Total    Hours per    Total
    No.      Respondents       per        Annual     Response    Hours
                            Respondent   Responses
------------------------------------------------------------------------
3487        12             27           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.


    Dated: December 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-347 Filed 1-7-04; 8:45 am]
BILLING CODE 4160-01-S