02-11655. The Fifth Annual FDA/OCRA Educational Conference in Irvine, CA on Emerging Regulatory Issues and How to Handle Them; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA), in cosponsorship with the Orange County Regulatory Affairs Discussion Group (OCRA) is announcing its fifth annual educational conference entitled “Emerging Regulatory Issues and How to Handle Them.” The public workshop is intended to give the drugs, devices, and biologics industries an opportunity to interact with FDA reviewers and compliance officers from FDA's centers and district offices, as well as other industry experts. The main focus of this interactive workshop is to provide information regarding regulatory changes such as the antibioterrorism initiatives that are taking place within the Federal, State, and local agencies; how these activities are affecting the approval process of product submissions to FDA and Foreign governments; and how companies could prepare for an onslaught of new requirements as a result of the sweeping regulatory changes.

Date and Time: The public workshop will be held on June 3 and 4, 2002, from 7:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Irvine Marriott, 18000 Von Karman Ave., Irvine, CA 92612.

Contact: Ramlah Oma, FDA Los Angeles District Office, Food and Drug Administration, 19900 MacArthur Blvd., suite 300, Irvine, CA 92612, 949-798-7611, FAX [phone], or OCRA, PMB 624, 5405 Alton Pkwy., suite 5A, Irvine, CA 92604, 949-222-9022, FAX [phone], http://www.ocra-dg.org.

Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) to the contact person by May 15, 2002. Until May 15, 2002, registration fees are as follows: Members, $525.00; nonmembers, $600.00; and FDA/government/full-time students with proper identification, $275.00. After May 15, 2002, registration fees will be as follows: Members, $595.00; nonmembers, $675.00; and FDA/government/full-time students with proper identification, $325.00.

Dated: May 3, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.