2011-11128. Meeting of the Advisory Committee on Blood Safety and Availability

AGENCY:

Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health.

ACTION:

Notice.

SUMMARY:

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public.

DATES:

The meeting will take place Tuesday, June 7, and Wednesday June 8, 2011, from 8:30 a.m. to 5 p.m.

ADDRESSES:

National Institute of Health, Building 31, Conference Room 6, Bethesda, MD 20892.

FOR FURTHER INFORMATION CONTACT:

Mr. James Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety, Office of the Assistant Secretary for Health, Department of Health and Human Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852, [phone], Fax [phone], e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

The ACBSA shall provide advice to the Secretary through the Assistant Secretary for Health. The Committee shall advise on a range of policy issues to include: (1) Definition of public health parameters around safety and availability of the blood supply and blood products, (2) broad public health, ethical and legal issues related to transfusion, and transplantation safety, and (3) the implications for safety and availability of various economic factors affecting product cost and supply.

In keeping with its established mission, the Committee will also be asked to review and provide comments to the Department on two World Health Assembly (WHA) resolutions related to transfusion, and transplantation safety. http://apps.who.int/​gb/​ebwha/​pdf_​files/​WHA63/​A63_​R22-en.pdf On June 7, 2011, the Committee will be asked to review the WHA 63.22 on human organ and tissue transplantation and if appropriate, make recommendations on areas of enhanced safety. Specifically areas of collecting data including adverse events and reactions on the practices, safety, quality, efficacy, epidemiology and ethics of donations and transplantation will be considered as it relates to safety. Concerns for a globally consistent coding system for human cells, tissues and organs to facilitate national and international traceability of materials of human origin for transplantation will be solicited. In addition, the Committee will be asked for comments or recommendations on developing and promoting international best practices.

On June 8, 2011, the Committee will be asked to review and comment on WHA 63.12 regarding the availability, safety and quality of blood products. http://apps.who.int/​gb/​ebwha/​pdf_​files/​WHA63/​A63_​R12-en.pdf Specifically the Committee will be asked to review the current status of safe and rational use of blood products in patient blood management and assess the current status in the U.S.

In addition, the Committee will be asked to comment on the areas of safety and sustainability of providing blood and blood products that should be addressed by the Committee in future meetings.

The public will have the opportunity to present their views to the Committee during a public comment session scheduled for June 7, 2011. Comments will be limited to five minutes per speaker and must be pertinent to the discussion. Pre-registration is required for participation in the public comment session. Any member of the public who would like to participate in this session is encouraged to contact the Executive Secretary at his/her earliest convenience to register for time (limited to 5 minutes) and registration must be prior to close of business on June 3, 2011. If it is not possible to provide 30 copies of the material to be distributed, then individuals are requested to provide a minimum of one (1) copy of the document(s) to be distributed prior to 11:30 a.m. Eastern Daylight Time on June 6, 2011. It is also requested that any member of the public who wishes to provide comments to the Committee utilizing electronic data projection to submit the necessary material to the Executive Secretary prior to the close of business on June 6, 2011. Electronic comments must adhere to disability accessibility guidelines (Section 508 compliance).

Dated: May 3, 2011.

James J. Berger,

Associate Public Health Advisor for Blood, Organ and Tissue Safety.