Document ID: FDA-2010-D-0034-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2010-02-05T05:00Z

[Federal Register: February 5, 2010 (Volume 75, Number 24)]
[Notices]               
[Page 6037-6038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe10-86]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 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 
the information collection activity ``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.''

DATES:  Submit written or electronic comments on the collection of 
information by April 6, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 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.

[[Page 6038]]

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--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 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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21 CFR Section/       No. of         Annual Frequency       Total Annual        Hours per
 Form No. 3487     Respondents         per Response         Responses\2\         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 costs 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: January 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2527 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S