[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Page 22598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9901]
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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 [email protected]. 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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