[Federal Register: July 12, 2002 (Volume 67, Number 134)]
[Notices]               
[Page 46196]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy02-69]                         


[[Page 46196]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Evidence Based Assisted Reproductive Technologies; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) in cosponsorship with the 
National Institutes of Health (NIH), and Department of Health and Human 
Services (DHHS), Office of Women's Health is announcing the following 
public workshop entitled: ``Evidence Based Assisted Reproductive 
Technologies (ART).'' The topics to be discussed include: (1) The FDA 
regulatory framework; (2) methods of supporting research in this area 
by NIH; and (3) scientific, social, ethical and policy issues 
concerning ART.
    Date and Time: The public workshop will be held on September 18, 
2002, from 8:30 a.m. to 4:30 p.m., and September 19, 2002, from 8 a.m. 
to 12 a.m.
    Location: The public workshop will be held at Lister Hill Center, 
Bldg. 38A, NIH, 8600 Rockville Pike, Bethesda, MD.
    Contact Person: For information about this notice: Michael D. 
Anderson, Center for Biologics Evaluation and Research (HFM-17), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-6210, FAX 301-594-1944.
    For information about the public workshop: Melanie Whelan, Center 
for Biologics Evaluation and Research (HFM-40), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3079, 
FAX 301-827-3843, or e-mail: whelan@cber.fda.gov.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to Melanie Whelan (see 
Contact Person) by Friday, September 6, 2002. The registration form is 
available at http://www.fda.gov/cber/meetings.htm. There is no 
registration fee for the public workshop. Space is limited, therefore 
interested parties are encouraged to register early. There will be no 
onsite registration.
    If you need special accommodations due to a disability, please 
contact Melanie Whelan at least 7 days in advance.

SUPPLEMENTARY INFORMATION: This public workshop will provide a forum 
for discussion of scientific, social, ethical, and policy issues 
related to ART. The public workshop will be of primary interest to 
consumers, researchers, academia, ART practitioners, and sponsors of 
clinical trials evaluating novel ART. The goals of the public workshop 
are to: (1) Assess the usefulness of animal models in evaluating the 
safety and efficacy of human ART, and (2) identify social and ethical 
issues specific to ART. These issues are of interest to FDA, NIH, and 
DHHS to guide development of scientific initiatives, policy, and 
regulations in this area and to identify areas where research funding 
may be needed.
    Transcripts: Transcripts of the public workshop 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. The transcript of the workshop will also be available on the 
Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: July 8, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-17584 Filed 7-11-02; 8:45 am]
BILLING CODE 4160-01-S