[Federal Register: November 9, 2006 (Volume 71, Number 217)]
[Notices]
[Page 65827-65828]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no06-112]
[[Page 65827]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0433]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on 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 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 extending the Office of
Management and Budget (OMB) approval on the existing reporting
requirements for the information collection activity entitled ``How to
Use E-Mail to Submit a Notice of Final Disposition of Animals Not
Intended for Immediate Slaughter.''
DATES: Submit written or electronic comments on the collection of
information by January 8, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. 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 the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from 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.
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 (NFDA) not intended for immediate slaughter.
NFDAs have historically been submitted to CVM on paper. CVM's guidance
``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.
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. Respondents per Response Responses\2\ 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.
[[Page 65828]]
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: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19044 Filed 11-8-06; 8:45 am]
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