E7-6052. The 10th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of meeting.

The Food and Drug Administration (FDA) is announcing the following conference: 10th Annual Educational Conference co-sponsored 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 questions and answers, 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 11 and 12, 2007, from 7:30 a.m. to 5 p.m.

Location: The conference will be held at the Irvine Marriott, 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, www.ocra-dg.org. Contact ATD at 949-387-9046.

Before May 11, 2007, registrations fees are as follows: $575.00 for members, $625.00 for non-members and $400.00 for FDA/Govt/Students. After May 11, 2007, $625.00 for members, $725.00 for non-members, and $400.00 for FDA/Govt/Students.

OCRA student rate applies to those individuals enrolled in a Regulatory or Quality related academic program at an accredited institution. Proof of enrollment required.

The registration fee will cover actual expenses including refreshments, lunch, materials, parking and speaker expenses. If you need special accommodations due to a disability, please contact Linda Hartley at least 10 days in advance.

Dated: March 26, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.