[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65533-65534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18901]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0432]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on How to Use E-Mail to Submit 
Information 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 extending Office of Management 
and Budget (OMB) approval on the existing reporting requirements 
relating to how one may submit information electronically to the Center 
for Veterinary Medicine (CVM), using e-mail.

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 Information to the 
Center for Veterinary Medicine--21 CFR 11.2 (OMB Control Number 0910-
0454--Extension)

    CVM accepts certain types of submissions electronically with no 
requirement for a paper copy. These types of documents are listed in 
public docket 97S-0251 as required by 21 CFR 11.2. CVM's ability to 
receive and process information submitted electronically is limited by 
its current information technology capabilities and the requirements of 
the Electronic Records; Electronic Signatures final regulation. CVM's 
guidance entitled ``Guidance for Industry 108: ``How to Submit 
Information in Electronic Format by E-Mail'' outlines general standards 
to be used for the submission of any information by e-mail.
    The likely respondents are sponsors for new animal drug 
applications.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                        No. of         Annual Frequency          Total Annual           Hours per
                 21 CFR Section                      Respondents         per Response            Responses\2\           Respondent        Total Hours
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11.2                                                             25                  5.62                      140                .08               11.2
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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 65534]]

    The number of respondents in table 1 of this document is 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, 3006. (140 x 
hours per response (.08) =11.2 total hours.)

    Dated: November 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18901 Filed 11-7-06; 8:45 am]
BILLING CODE 4160-01-S