[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7044-7045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0432]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 Information to the 
Center for Veterinary Medicine--21 CFR 11.2 (OMB Control Number 0910-
0454)--Extension

    The Center for Veterinary Medicine (CVM) accepts certain types of 
submissions electronically with no requirement for a paper copy. These 
types of documents are listed in public docket 1992S-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.
    In the Federal Register of November 8, 2006 (71 FR 65533), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    The likely respondents for this collection of information are 
sponsors for new animal drug applications.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 7045]]



                                 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\         Response         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.

    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: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2470 Filed 2-13-07; 8:45 am]
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