[Federal Register Volume 64, Number 155 (Thursday, August 12, 1999)]
[Notices]
[Page 44023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20845]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Criteria for Safety and Efficacy Evaluation of Oxygen
Therapeutics as Red Cell Substitutes; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Criteria for Safety and Efficacy Evaluation of
Oxygen Therapeutics as Red Cell Substitutes.'' This public workshop is
intended to examine the current status of the safety of red cell
substitutes at both the basic and preclinical science levels and review
the clinical experiences gained by manufacturers in the course of the
development of these products. The public workshop also is intended to
address problems of efficacy evaluation and risk/benefit assessments in
trauma and surgery.
Date and Time: The public workshop will be held on September 27,
1999, 8 a.m. to 5 p.m., and on September 28, 1999, 8 a.m. to 12:30 p.m.
Location: The public workshop will be held at the National
Institutes of Health, Natcher Conference Center, Bldg. 45, Balconies A,
B, and C, 45 Center Dr., Bethesda, MD.
Contact: Joseph Wilczek, Center for Biologics Evaluation and
Research (HFM-350), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-6129, FAX 301-827-2843.
Registration and Requests for Oral Presentations: Early
registration by Friday, September 10, 1999, is recommended. Mail or fax
registration information (including name, title, firm name, address,
telephone, and fax number) to Joseph Wilczek (address above). On-site
registration, which will begin at 7 a.m., will be done on a space
available basis on the day of the workshop. There is no registration
fee for the workshop. Space is limited, therefore, interested parties
are encouraged to register early. If you need special accommodations
due to disability, please contact Joseph Wilczek at least 7 days in
advance. Requests for oral presentations should be sent by September
13, 1999, to Abdulilah Alayash, Center for Biologics Evaluation and
Research, Division of Hematology, Bldg. 29, rm. 112, 8800 Rockville
Pike, Bethesda, MD 20892, 301-827-3813, FAX 301-435-4034, or e-mail
``Alayash@cber.fda.gov''.
Agenda: The public workshop is intended to discuss a variety of
issues concerning the safety and efficacy of red blood cell
substitutes. The goals of the public workshop are to: (1) Review
current understanding of toxicity issues, (2) define clinical endpoints
for clinical trials in hemorrhagic shock and elective surgery, (3)
consider whether physiological endpoint(s) could be used as surrogates
in lieu of mortality and/or morbidity, and (4) discuss the therapeutic
``risk vs. benefit'' in using hemoglobin and fluorochemical-based
products in trauma and surgery.
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- , Rockville, MD 20857,
approximately 15 working days after the public workshop at cost of 10
cents per page. The public workshop transcript will also be available
on the Center for Biologics Evaluation and Research website at ``http:/
/www.fda.gov/cber/minutes/workshop-min.htm''.
Dated: August 6, 1999
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-20845 Filed 8-11-99; 8:45 am]
BILLING CODE 4160-01-F
