Document ID: FDA-2010-D-0043-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference, etc.
Posted Date: 2010-05-13T04:00Z

[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Pages 26963-26964]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11453]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0043]

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 in Electronic Format 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 June 
14, 2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0452. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
P150-400B, Rockville, MD 20850, 301-796-3793.

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 a Request for a 
Meeting or Teleconference in Electronic Format to the Center for 
Veterinary Medicine--(OMB Control Number 0910-0452)--Extension

    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 Submit a Request for a Meeting or Teleconference 
in Electronic Format to CVM,'' provides sponsors with the option to 
submit a request for a meeting or teleconference as an e-mail 
attachment by the Internet. The likely respondents are sponsors for new 
animal drug applications.
    In the Federal Register of February 5, 2010 (75 FR 6035), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information.
    In response, two comments were received. One comment was completely 
outside the scope of the notice and the other requested that FDA meet 
openly with industry rather than closed sessions. Neither comment 
addressed the paperwork involved in the information collection.
    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
  FDA Form 3489       Respondents        per Response       Responses\2\         Response         Total Hours
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10.64                             40                2.4                 96                .08                7.7
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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 January 1, 2008, and December 31, 2008.

[[Page 26964]]

    The number of respondents in table 1 of this document is the number 
of sponsors registered to make electronic submissions (40). The number 
of total annual responses is based on a review of the actual number of 
such submissions made between January 1, 2008, and December 31, 2008 
(96 x hours per response (.08) = 7.7 total hours).

    Dated: May 10, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11453 Filed 5-12-10; 8:45 am]
BILLING CODE 4160-01-S