05-8050. The Eighth Annual FDA-Orange County Regulatory Affairs Educational Conference; “Reality of Regulatory Affairs”

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of meeting.

The Food and Drug Administration (FDA) is announcing its eighth annual educational conference cosponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the drug, device, and biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the centers and district offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive question and answer and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues.

Date and Time: The conference will be held on June 15 and 16, 2005, from 7:30 a.m. to 5 p.m.

Location: The conference will be held at the Irvine Marriot Hotel, 18000 Von Karman Ave., Irvine, CA 92612.

Contact: Linda Hartley, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949-608-4413, FAX: [phone], or OCRA, Attention to detail (ATD), 5319 University Dr., suite 641, Irvine, CA 92612, 949-387-9046, FAX: [phone], Web site: www.ocra-dg.org.

Registration and Meeting Information: See OCRA Web site at www.ocra-dg.org. Contact ATD at 949-387-9046.

Before May 6, 2005, registrations fees are as follows: $495.00 for members, $550.00 for nonmembers, and $325.00 for FDA/government/full time students with proper identification.

After May 6, 2005: $545.00 for members, $595.00 for nonmembers, and $325.00 for FDA/government/full time students with the proper identification.

The registration fee will cover actual expenses including refreshments, lunch, materials and speaker expenses.

If you need special accommodations due to a disability, please contact Linda Hartley (see Contact) at least 10 days in advance.

Dated: April 15, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.