[Federal Register Volume 68, Number 152 (Thursday, August 7, 2003)]
[Notices]
[Pages 47078-47079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0328]


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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements for 
sponsors electronically submitting notices of final disposition of 
investigational animals not intended for immediate slaughter.

DATES: Submit written or electronic comments on the collection of 
information by October 6, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, rm. 1061, 5630 Fishers Lane, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
Collection of information is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the proposed collection of information, FDA invites 
comments on: (1) Whether the proposed collection of information is 
necessary for the proper performance of FDA s functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDAs estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Guidance for Industry on How to Use E-Mail to Submit a Notice of Final 
Disposition of Animals Not Intended for Immediate Slaughter 21 CFR Part 
511 (OMB Control Number 0910-0453)--Extension

    CVM monitors the final disposition of food animals treated with

[[Page 47079]]

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).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  21 CFR
 Section/         No. of         Annual Frequency      Total Annual          Hours per          Total Hours
 FDA Form       Respondents       per Respondents        Responses           Response
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  3487                     12                  27                 324                0.81                 262
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\1\ There are no capital costs associated with this collection of information.

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

    Dated: July 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20061 Filed 8-6-03; 8:45 am]
BILLING CODE 4160-01-S