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

[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]

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.

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