[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Notices]
[Pages 7440-7441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2579]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0434]


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 a Request for a Meeting or 
Teleconference to the Office Of New Animal Drug Evaluation

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 
19, 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.

How to Use E-Mail to Submit a Request for a Meeting or Teleconference 
to the Office Of New Animal Drug Evaluation--21 CFR 10.65 (OMB Control 
Number 0910-0452)--Extension

    The Center for Veterinary Medicine (CVM) holds meetings and /or 
teleconferences when a sponsor requests a presubmission conference 
under 21 CFR 514.5, or requests a meeting to discuss general questions. 
Generally, meeting requests are submitted to CVM on paper. However, CVM 
now allows registered sponsors to submit information electronically, 
and to request meetings electronically, if they determine this is more 
efficient and time saving for them. CVM's guidance ``On How to Use E-
Mail to Submit a Request for a Meeting or Teleconference to the Office 
of New Animal Drug Evaluation'' provides sponsors with the option to 
submit a request for a meeting or teleconference as an e-mail 
attachment via the internet.
    In the Federal Register of November 8, 2006 (71 FR 65535), FDA 
published a 60-day notice soliciting comments on the proposed 
collection of information requirements. In response to that notice, no 
comments were received.
    The likely respondents are sponsors for new animal drug 
applications.
    CVM estimates the burden for this information collection activity 
as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  21 CFR Section/FDA Form       No. of       Annual Frequency     Total Annual       Hours per
                     Respondents      per Response       Responses\2\       Response       Total Hours
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10.65/FDA Form 3489                     25               6.24                156             .08            12.5
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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 7441]]

    The number of respondents in Table 1 of this document 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. (156 x hours per response (.08) = 12.5 total hours.)

    Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2579 Filed 2-14-07; 8:45 am]
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