[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65535-65536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0434]


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 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 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 extending Office of Management 
and Budget (OMB) approval of existing reporting requirements on 
electronic submission of requests for meetings, in person or via 
teleconference, to discuss with animal drug sponsors studies to be 
conducted and how to meet the statutory requirements for drug approval 
under the Federal Food, Drug, and Cosmetic Act. Requests for meetings 
about new animal drug submissions were previously submitted on paper 
copy to the Center for Veterinary Medicine (CVM).

DATES:  Submit written or electronic comments on the collection of 
information by January 8, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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 the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from 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.

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

    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 entitled ``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 by the Internet.
    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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                                                               Annual Frequency                                     Hours per
  21 CFR Section/FDA Form      No. of  Respondents      per Response      Total Annual Responses\2\       Respondent            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.

    The number of respondents in table 1 of this document is 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).


[[Page 65536]]


    Dated: November 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18911 Filed 11-7-06; 8:45 am]
BILLING CODE 4160-01-S