[Federal Register Volume 66, Number 60 (Wednesday, March 28, 2001)]
[Notices]
[Page 16949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


The Fourth Annual Educational Workshop--Current Topics in 
Regulatory Affairs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA), in cosponsorship with the 
Orange County Regulatory Affairs (OCRA) discussion group, is announcing 
its Fourth Annual Educational Workshop intended to give the drugs, 
devices, and biologics industries an opportunity to interact with FDA's 
reviewers and compliance officers from FDA's centers and district 
offices. The main focus of this interactive workshop is to provide 
regulatory updates, guidances, and recommendations regarding new 
product submissions, postapproval changes, and postmarketing issues.
    Date and Time: The meeting will be held on May 21 and 22, 2001, 
7:30 a.m. to 5 p.m.
    Location: The meeting will be held at The Irvine Marriott, 18000 
Von Karman Ave., Irvine, CA.
    Contact: Ramlah I. Oma, Food and Drug Administration, 19900 
MacArthur Blvd., suite 300, Irvine, CA 92612, 949-798-7611, FAX: 949-
798-7656, or Peri Ann DiRocco, OCRA discussion group, PMB 624, 5405 
Alton Pkwy., suite 5A, Irvine, CA 92604, voice/FAX: 949-348-9141, e-
mail: [email protected], www.ocra-dg.org.
    Registration and Requests for Oral Presentations: Space is limited. 
Preregistration and confirmation are required. Send registration 
information (including name, title, firm name, address, telephone, and 
fax number), written material, and requests to make oral presentations 
directly to the OCRA Web site.
    If you need special accommodations due to a disability, please 
contact Ramlah I. Oma at least 10 days in advance.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.

    Dated: March 20, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7565 Filed 3-27-01; 8:45 am]
BILLING CODE 4160-01-S