[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Notices]
[Page 3587-3588]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja04-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0327]
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 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 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
February 25, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: 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--
(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. 3606(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 scientists in the Center for Veterinary
Medicine's (CVM) 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 Act (21 U.S.C. 360b).
Requests for meetings and teleconferences 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 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 audio-visual equipment that will be
[[Page 3588]]
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.
In the Federal Register of August 7, 2003 (68 FR 47079), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
No. of Frequency Total Hours per Total
Form No. Respondents per Annual Response Hours
Respondent Responses
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3489 12 14 168 0.69 116
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
Dated: January 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1502 Filed 1-23-04; 8:45 am]
BILLING CODE 4160-01-S