Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 04-1502 · Docket No. 2003N-0327

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.

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 Burden 1 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. [FR Doc. 04-1502 Filed 1-23-04; 8:45 am]