Document ID: FDA-2010-D-0043-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2010-02-05T05:00Z

[Federal Register: February 5, 2010 (Volume 75, Number 24)]
[Notices]               
[Page 6035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe10-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements 
regarding how to use e-mail to submit a request for a meeting or 
teleconference in electronic format to the Center for Veterinary 
Medicine (CVM).

DATES:  Submit written or electronic comments on the collection of 
information by April 6, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Guidance for Industry on How to Submit a Request for a Meeting or 
Teleconference in Electronic Format to The Center for Veterinary 
Medicine--21 CFR 10.65 (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. 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.

    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: January 28, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2459 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S