2011-8283. The 14th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference in Irvine, California: New Regulatory Challenges

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of conference.

The Food and Drug Administration (FDA) is announcing the following conference: 14th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the drug, device, biologics, and dietary supplement industries with an opportunity to interact with FDA reviewers and compliance officers from the centers and District Offices, as well as from 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 Q & A, 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 8 and 9, 2011, from 7:30 a.m. to 5 p.m.

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

Contact: Linda Hartley, Office of Regulatory Affairs, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, Voice: 949-608-4413, Fax: [phone]; or Orange County Regulatory Affairs Discussion Group, Attention to Detail, 5319 University Dr., suite 641, Irvine, CA 92612, Voice: 949-387-9046, Fax: [phone], Web site: http://www.ocra-dg.org. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

Registration and Meeting Information: See OCRA's Web site at http://www.ocra-dg.org. Contact Attention to Detail at 949-387-9046.

Before May 1, 2011, registrations fees are as follows: $675.00 for members, $725.00 for non-members and $475.00 for FDA/Government/Students.* After May 1, 2011, $725.00 for members, $775.00 for non-members, and $475.00 for FDA/Government/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 (see Contact) at least 10 days in advance.

Transcripts: Transcripts will not be available for the conference.

Dated: April 1, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.