2012-9968. The 15th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference in Irvine, CA; “Sustainable Regulatory Practices”

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of conference.

The Food and Drug Administration (FDA) is announcing the following conference: The 15th Annual Educational Conference cosponsored 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 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 6 and 7, 2012, 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, 5319 University Dr., suite 641, Irvine, CA 92612, 949-387-9046, Fax: [phone], Web site: 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 Web site, www.ocra-dg.org. Contact Attention to Detail, 949-387-9046.

Before May 8, 2012, registration fees are as follows: $675 for members, $725 for non-members and $475 for FDA/Government/Students.^[1] After May 8, 2012, fees will be $725 for members, $775 for non-members, and $475 for FDA/Government/Students.^[2] There will also be a 1-day rate of $425 for OCRA members and $475 for non-members.

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 before the conference.

Dated: April 20, 2012.

Leslie Kux,

Assistant Commissioner for Policy.

Footnotes

1.  OCRA Student Rate applies to those individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. Proof of enrollment is required.

2.  See footnote 1.