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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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by March 19, 2007.


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.

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Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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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 Burden1

21 CFR Section/FDA Form #No. of RespondentsAnnual Frequency per ResponseTotal Annual Responses2Hours per ResponseTotal Hours
10.65/FDA Form 3489256.24156.0812.5
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.
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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.)

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Dated: February 8, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-2579 Filed 2-14-07; 8:45 am]