[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7045-7046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0433]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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 a 
proposed collection of information 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 March 
16, 2007.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-6974.

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: 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--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 not intended for immediate slaughter (NFDA). 
NFDAs have historically been submitted to CVM on paper. CVM's guidance 
on ``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.
    In the Federal Register of November 9, 2006 (71 FR 65827), FDA 
published a 60-day notice soliciting public comment on the proposed 
collection of information requirements. In response to that notice, no 
comments were received.
    The likely respondents for this collection are are INAD sponsors.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7046]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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 21 CFR Section /      No. of       Annual Frequency     Total Annual
     Form No.        Respondents      per Response       Responses\2\     Hours per 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.

    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: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2485 Filed 2-13-07; 8:45 am]
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