

[Federal Register: February 11, 2008 (Volume 73, Number 28)]
[Notices]               
[Page 7747-7748]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe08-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Hemoglobin Based Oxygen Carriers: Current Status and Future 
Directions; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled: Hemoglobin Based Oxygen Carriers: Current Status and 
Future Directions. The purpose of the public workshop is to discuss the 
safety of hemoglobin-based oxygen carriers (HBOCs) as related to a 
variety of potential uses of these investigational products. We are 
having this discussion because clinical and nonclinical studies of 
HBOCs, as either blood substitutes or as resuscitation fluids, have 
raised questions about the safety of these products as a group. The 
public workshop will feature presentations and roundtable discussions 
led by experts from academic institutions, government, and industry.
    Date and Time: The public workshop will be held on April 29, 2008, 
from 8:30 a.m. to 5 p.m. and April 30, 2008, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Lister Hill 
Center Auditorium, Building 38A, National Institutes of Health, 8800 
Rockville Pike, Bethesda, MD 20894.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, 
e-mail: rhonda.dawson@fda.hhs.gov.
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, and telephone and fax numbers) to the 
contact person by April 11, 2008. There

[[Page 7748]]

is no registration fee for the public workshop. Early registration is 
recommended because seating is limited to 175 attendees. Registration 
on the day of the public workshop will be provided on a space available 
basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Rhonda Dawson at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: FDA; the National Heart, Lung, and Blood 
Institute, National Institutes of Health; and the Department of Health 
and Human Services' Office of the Secretary and Office of Public Health 
and Science are co-sponsoring this public workshop. The primary goal of 
the workshop is to discuss what is known about the safety of HBOCs, and 
possible paths forward for development of these products. Topics to be 
discussed on April 29, 2008, will include: (1) Introduction to the 
issues and unmet needs surrounding HBOC development, (2) overview of 
the physiology and chemistry of hemoglobin in HBOCs, (3) nitric oxide 
physiology and pathophysiology related to HBOCs, (4) review of 
nonclinical studies of HBOCs, (5) risk-benefit considerations in 
clinical trials of HBOCs, (6) proposed clinical indications for HBOCs, 
and (7) industry's experience with HBOC clinical trials. Panel 
deliberations on the safety and efficacy of HBOCs in various clinical 
settings and potential mechanisms of effects on organs will be the main 
topics of discussion on April 30, 2008. We also will discuss future 
development pathways with a focus on the use and development of animal 
models, biochemical redesign approaches, and alternative clinical 
designs where benefit exceeds risk.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.
    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. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A transcript of the public workshop will be available 
on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.


    Dated: February 4, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2397 Filed 2-8-08; 8:45 am]

BILLING CODE 4160-01-S
