[Federal Register Volume 65, Number 184 (Thursday, September 21, 2000)]
[Notices]
[Pages 57194-57195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1316]


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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
October 23, 2000.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 to the Office of New Animal Drug 
Evaluation.

    Description: As part of new animal drug development, sponsors often 
meet with the Center for Veterinary Medicine (CVM), scientists to 
formulate a rational approach for studies to be conducted, and to 
discuss how they meet the statutory requirements for new animal drug 
approval under section 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b). Requests for meetings and teleconferences about new 
animal drug submissions are currently submitted to CVM on paper. CVM is 
responsible for developing and administering a guidance that explains 
how to adhere to the Electronic Records; Electronic Signatures 
regulations (21 CFR part 11). These regulations provide for the 
voluntary submission of parts or all of regulatory records in 
electronic format without an accompanying paper copy and complies with 
the Government Paperwork Elimination Act (GPEA). The GPEA requires 
Federal agencies, by October 21, 2003, to give persons who are required 
to maintain, submit, or disclose information, the option of doing so 
electronically, when practical, as a substitute for paper.
    This guidance document describes the procedure for persons who are 
new animal drug sponsors who wish to submit a request for a meeting or 
teleconference to the Office of New Animal Drug Evaluation by e-mail on 
FDA Form No. 3489. The information sponsors should include on the form 
are: The sponsor's name and address, a list of requested participants, 
an indication of audiovisual needs, and an agenda.
    Description of Respondents: The likely respondents for this 
collection of information are sponsors who will be conducting clinical 
investigations under 21 CFR 511.1(b). In the Federal Register of June 
29, 2000 (65 FR 40108), the FDA announced the availability of this 
guidance as a draft document and requested public comment on the 
proposed collection of information. No comments were received on the 
estimated annual reporting burden. We therefore believe the annual 
reporting burden of 116 hours should remain unchanged.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
   Form FDA No.       Respondents        per Response        Responses           Response         Total Hours
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    3,489                190                   .88             168                  0.69            116
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 57195]]

    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: September 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24267 Filed 9-20-00; 8:45 am]
BILLING CODE 4160-01-F