Document ID: FDA-2010-D-0034-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on How to Submit Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter, etc.
Posted Date: 2010-04-29T04:00Z

[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Notices]               
[Page 22598]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap10-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0034]

 
Agency Information Collection Activities; Submission for Office 
and Management and Budget Review; Comment Request; Guidance for 
Industry on How to Submit a Notice of Final Disposition of 
Investigational Animals Not Intended for Immediate Slaughter in 
Electronic Format to the Center for Veterinary Medicine

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 June 
1, 2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0453. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 Submit a Notice of Final Disposition of 
Investigational Animals Not Intended for Immediate Slaughter in 
Electronic Format to the Center for Veterinary Medicine--(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 an 
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 the 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 
entitled ``How to Submit a Notice of Final Disposition of 
Investigational Animals not Intended for Immediate Slaughter in 
Electronic Format to CVM'' provides sponsors with an 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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                                                     Number of        Annual Frequency       Total Annual
         21 CFR Section/  Form No. 3487             Respondents         per Response         Responses \2\      Hours per  Response      Total Hours
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511.1(b)(5)                                                     40                  0.4                    16                   .08                  1.3
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
\2\ Electronic submissions received between January 1, 2008, and December 31, 2008.

    The number of respondents in table 1 of this document are the 
number of sponsors registered to make electronic submissions (40). The 
number of total annual responses is based on a review of the actual 
number of such submissions made between January 1, 2008, and December 
31, 2008. Thus, FDA estimates the total reporting burden at 1.3 hours 
(16 x .08= 1.3 total hours).

    Dated: April 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9901 Filed 4-28-10; 8:45 am]
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