04-1502. 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 ...

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: [phone].

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 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 Burden¹

Form No.	No. of Respondents	Annual Frequency per Respondent	Total Annual Responses	Hours per Response	Total Hours
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.