[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Notices]
[Page 41476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16963]


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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.

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    The Food and Drug Administration (FDA), Los Angeles District 
Office, in cosponsorship with the Orange County Regulatory Affairs 
Discussion Group (OCRA) is announcing a workshop intended to give the 
medical products industry (drugs and medical devices) an opportunity to 
learn and discuss the process by which the FDA centers and district 
offices review new product applications. Reviewing staff from the 
Center for Drug Evaluation and Research and the Center for Devices and 
Radiological Health will make presentations to provide guidance on the 
elements of submissions to make the review process more effective.
    Date and Time: The workshop will be held on July 10 and 11, 2000, 
from 7:30 a.m. to 5 p.m.
    Location: The workshop will be held at the Doubletree Hotel, 3050 
Bristol St., Costa Mesa, CA 92626.
    Contact: Ramlah Oma, FDA Los Angeles District Office, 19900 
MacArthur Blvd., Irvine, CA 92612-2445, 949-798-7612, or FAX 949-798-
7771, for further information including a registration form.
    Registration: Space is limited. Preregistration and confirmation is 
required. Registration forms can be obtained on the Internet at http://www.ocra-dg.org by clicking on ``OCRA Meetings'' or from the contact 
person listed above. There is a $325 registration fee if postmarked by 
June 30, 2000 ($375 on or after July 1) payable to OCRA. Send the 
registration fee and form to PeriAnn DiRocco at OCRA Submissions 
Conference, PMB 624, 5405 Alton Pkwy., suite 5A, Irvine, CA 92604, FAX 
and voice 949-348-9141. The registration fee will cover actual expenses 
including refreshments, lunch, materials, and speaker expenses. After 
July 4, 2000, please call 949-348-9141 to check for space availability.
    If you need special accommodations due to a disability, please 
contact Ramlah Oma at least 7 days in advance.

    Dated: June 28, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16963 Filed 6-29-00; 4:37 pm]
BILLING CODE 4160-01-F