Meetings: New Product Applications; FDA Review Process; interactive workshop,

[Federal Register: June 23, 1999 (Volume 64, Number 120)]

[Notices]

[Page 33489]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr23jn99-80]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

The FDA Review Process for New Product Applications: An Interactive Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop.

The Food and Drug Administration (FDA), Los Angeles District, in cosponsorship with the Orange County Regulatory Affairs Discussion Group (OCRA) is announcing the following workshop: The FDA Review Process for New Product Applications: An Interactive Workshop, which is intended to give the medical products industry (drugs, biologics, and medical devices) an opportunity to learn and discuss the process by which the centers and district offices review new product applications. Reviewing staff from the Centers for Biologics, Devices, and Drugs will make presentations regarding the elements of submissions that make the review process more efficient.

Date and Time: The workshop will be held on July 12 and 13, 1999, from 7:30 a.m. to 5 p.m.

Location: The workshop will be held at the Irvine Marriott, 18000 Von Karman Ave., Irvine, CA, 949-553-0100.

Contact: Sandi Velez, Los Angeles District Office, Food and Drug Administration, 19900 MacArthur Blvd., Irvine, CA 92612-2445, 949-798- 7748 or FAX 949-798-7715, for further information including a registration form.

Registration: Space is limited. Preregistration and confirmation are required. Registration forms can be obtained at the OCRA web site ``http://www.ocra-dg.org'' or from Sandi Velez at the numbers given previously. There is a $250 registration fee if postmarked by June 30, 1999 ($275 after July 1, 1999) payable to OCRA. The registration fee and form should be sent to PeriAnn DiRocco at OCRA Submissions Conference, 5405 Alton Pkwy., suite 5A-624, Irvine, CA 92604, FAX and voice 949-348-9141, and received no later than July 7, 1999. The registration fee will cover actual expenses incurred by OCRA including refreshments, lunch, materials, parking fees, and speaker expenses.

If you need special accommodations due to disability, please contact Sandi Velez at least 7 days in advance.

Dated: June 17, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy Coordination.

[FR Doc. 99-16091Filed6-21-99; 2:29 pm]

BILLING CODE 4160-01-F