[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Page 3587-3588]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

             Table 1.--Estimated Annual Reporting Burden\1\
              No. of       Frequency      Total       Hours per    Total
Form No.   Respondents        per         Annual      Response     Hours
                          Respondent    Responses
3489       12             14            168              0.69      116
\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]