[Federal Register Volume 68, Number 152 (Thursday, August 7, 2003)]
[Notices]
[Pages 47079-47080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0327]


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 
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 public comment on the reporting 
requirements for sponsors electronically requesting meetings or 
teleconferences with the Center for Veterinary Medicine's (CVM), Office 
of New Animal Drug Evaluation (ONADE).

DATES: Submit written or electronic comments on the collection of 
information by October 6, 2003.

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, rm. 1061, 5630 Fishers Lane, 
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, Office of Management 
Programs (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 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, 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: (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 Use E-Mail to Submit a Request for a 
Meeting or Teleconference to the Office of New Animal Drug Evaluation--
21 CFR Part 511 (OMB Control Number 0910-0452)--Extension

    ``Any person intending to file a new animal drug application or 
abbreviated application is entitled to request meetings and/or 
teleconferences to reach agreement regarding a submission or 
investigational requirement (21 U.S.C. 360b(b)(3)). Every person 
outside the Federal Government may request a meeting with 
representative(s) of FDA to discuss a matter (21 CFR 10.65(c))''.
    Sponsors often meet with CVM scientists in CVM's Office of New 
Animal Drug Evaluation to formulate a rational approach to studies to 
be conducted and to discuss how to meet the statutory requirements for 
new animal drug approval under section 512 of the Federal Food, Drug, 
and Cosmetic

[[Page 47080]]

Act (21 U.S.C. 360b). Requests for meetings and teleconferences about 
NAD submissions are currently submitted on paper to CVM.
    This guidance document describes the procedure for persons to 
submit a request for a meeting or teleconference electronically on FDA 
Form No. 3489. The information sponsors should include on the form 
includes the sponsor's name and address, a list of agency participants, 
an agenda, and notification of audiovisual equipment that will be 
needed. The form has been updated to allow sponsors to indicate whether 
the request amends a previous request for a meeting and to allow for 
consistency across forms. The likely respondents to this collection of 
information are new animal drug sponsors.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                Total
 Form No.    No. of  Respondents     Annual  Frequency per      Annual    Hours per Response      Total Hours
                                           Respondent         Responses
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FDA Form                        12                       14          168          0.69              116
 3489
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There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in table 1 of this document resulted from discussions 
with new animal drug sponsors. The estimated burden includes requests 
for meetings or teleconferences submitted by e-mail and on paper.

    Dated: July 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20062 Filed 8-6-03; 8:45 am]
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