[Federal Register: August 12, 1999 (Volume 64, Number 155)]
[Notices]               
[Page 44023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au99-73]                         

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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