[Federal Register Volume 65, Number 184 (Thursday, September 21, 2000)]
[Notices]
[Pages 57192-57193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24265]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1505]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Guidance for Industry on How to Use E-Mail to Submit a 
Notice of Intent to Slaughter for Human Food Purposes

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. 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 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed

[[Page 57193]]

collection of information to OMB for review and clearance.
    Title: Guidance for Industry on How to Use E-Mail to Submit a 
Notice of Intent to Slaughter for Human Food Purposes
    Description: Under Sec. 511.1(b) ( 21 CFR 511.1(b)), the Center for 
Veterinary Medicine (CVM) issues slaughter authorizations for food 
animals treated with investigational new animal drugs. To assist with 
monitoring the slaughter of food animals treated with investigational 
new animal drugs, a slaughter authorization letter is sent to sponsors 
by CVM which states that they must submit slaughter notices each time 
such animals are to be slaughtered unless the authorization letter 
waives that notice. Currently, slaughter notices are submitted to CVM 
on paper (OMB Control No. 0910-0117). This guidance will give sponsors 
the option to submit a slaughter notice as an e-mail attachment to CVM 
by the Internet.
    This final guidance describes the procedures for persons who are 
sponsors of new animal drugs and who wish to file a slaughter notice on 
FDA Form No. 3488 by e-mail. The information that should be filed on 
the form includes: Identification of the sponsor, the animals to be 
slaughtered, and the compound used to treat the animals.
    Description of Respondents: The likely respondents for this 
collection of information are animal drug sponsors who have conducted 
clinical investigations under Sec. 511.1(b). In the Federal Register of 
June 29, 2000 (65 FR 40106), FDA announced availability of this 
guidance as a draft document and requested public comment on the 
proposed collection of information. No comments were received on the 
estimated annual reporting burden. We therefore believe the annual 
reporting burden estimate of 27 hours should remain unchanged.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours Per
   FDA Form No.       Respondents        Per Response        Responses           Response         Total Hours
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     3488                190                  0.35              66                  0.41             27
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Submitting a slaughter notice electronically represents a new 
medium for submission of information currently submitted on paper. The 
estimates in table of this document resulted from discussions with 
sponsors about the time necessary to complete this form.

    Dated: September 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24265 Filed 9-20-00; 8:45 am]
BILLING CODE 4160-01-F