[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
21 CFR Section / No. of Annual Frequency Total Annual
Form No. Respondents per Response Responses\2\ Hours per Response Total Hours
----------------------------------------------------------------------------------------------------------------
511.1(b)(5)/ Form 25 1.44 36 .08 2.88
FDA 3487
----------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-S