[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Pages 26963-26964]
From the Federal Register Online via the Government Publishing 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 [email protected]. 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]
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