[Federal Register Volume 71, Number 217 (Thursday, November 9, 2006)]
[Notices]
[Pages 65827-65828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19044]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0433]


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 extending the Office of 
Management and Budget (OMB) approval on the existing reporting 
requirements for the information collection activity entitled ``How to 
Use E-Mail to Submit a Notice of Final Disposition of Animals Not 
Intended for Immediate Slaughter.''

DATES:  Submit written or electronic comments on the collection of 
information by January 8, 2007.

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, 5630 Fishers Lane, rm. 1061, 
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, Jr., Office of the 
Chief Information Officer (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 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 of information, 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 following collection of information, FDA 
invites comments on these topics: (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 FDA's 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 
514.117(b)(2) and 21 CFR 511.1(b)(5); (OMB Control Number 0910-0453)--
Extension

    The Center for Veterinary Medicine (CVM) monitors the final 
disposition of investigational animals where such animals do not enter 
the human food chain immediately at the completion of the 
investigational study. CVM's monitoring of the final disposition of 
investigational food animals is intended to ensure that unsafe residues 
of new animal drugs do not get into the food supply. CVM issues a 
slaughter authorization letter to investigational new animal drug 
(INAD) sponsors that sets the terms under which investigational animals 
may be slaughtered (21 CFR 511.1(b)(5)). Also in this letter, CVM 
requests that sponsors submit a notice of final disposition of 
investigational animals (NFDA) not intended for immediate slaughter. 
NFDAs have historically been submitted to CVM on paper. CVM's guidance 
``How to Use E-Mail to Submit a Notice of Final Disposition of Animals 
Not Intended for Immediate Slaughter'' provides sponsors with the 
option to submit an NFDA as an e-mail attachment to CVM via the 
Internet.
    The likely respondents are INAD sponsors.
    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
     Form No.         Respondents        per Response       Responses\2\         Response         Total Hours
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511.1(b)(5)/Form                  25               1.44                 36                .08              2.88
 FDA 3487
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Electronic submissions received between July 1, 2005, and June 30, 2006.


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    The number of respondents in table 1 are the number of sponsors 
registered to make electronic submissions (25). The number of total 
annual responses is based on a review of the actual number of such 
submissions made between July 1, 2005, and June 30, 2006 (36 x hours 
per response (.08) = 2.88 total hours).

    Dated: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19044 Filed 11-8-06; 8:45 am]
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