[Federal Register Volume 64, Number 120 (Wednesday, June 23, 1999)]
[Notices]
[Page 33489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16091]


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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, 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. 99-16091 Filed 6-21-99; 2:29 pm]
BILLING CODE 4160-01-F