2013-11582. Meeting of the Advisory Committee on Blood and Tissue 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 is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.

DATES:

The meeting will take place Wednesday, June 5 from 8:00 a.m. to 5:00 p.m. and Thursday, June 6, 2013, from 8:00 a.m. to 4:00 p.m.

ADDRESSES:

Fishers Lane Conference Center, Terrace Level, 5635 Fishers Lane, Rockville, MD, 20852.

FOR FURTHER INFORMATION CONTACT:

Mr. James Berger, Designated Federal Officer, ACBTSA, and Senior Advisor for Blood and Tissue Safety Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, 1101 Wootton Parkway, Suite 250, Rockville, MD, 20852. Phone: [phone]; Fax [phone]; Email [e-mail].

SUPPLEMENTARY INFORMATION:

The ACBTSA shall provide advice to the Secretary through the Assistant Secretary for Health. The Committee advises on a range of policy issues to include: (1) Identification of public health issues through surveillance of blood, and tissue safety issues with national biovigilance data tools; (2) identification of public health issues that effect availability of blood, blood products, and tissues; (3) broad public health, ethical and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of various economic factors (e.g., product cost and supply) on safety and availability of blood, blood products, and tissues; (5) risk communications related to blood transfusion and tissue transplantation; and (6) identification of infectious disease transmission issues for blood, organs, blood stem cells and tissues. The Advisory Committee has met regularly since its establishment in 1997.

At the June 2013 meeting, the ACBTSA will hear updates on recent activities of the Department and its agencies in support of previous Committee recommendations.

In the past, the Committee has heard and made recommendations regarding policy implications related to emerging research developments involving blood and tissue products available for use during public health emergencies. The Committee noted that a nationally coordinated system to manage tissue supplies and distributions during a disaster does not exist. Past recommendations made by the ACBTSA may be viewed at www.hhs.gov/​bloodsafety.

The focus of the meeting will be to address whether the current blood center system in the United States is designed for optimal service delivery in the era of health care reform. In particular, the Committee hopes to address the services currently performed by blood centers that are essential to the U.S. health care system, how anticipated changes in health care may affect blood centers and the provision of services, as well as how the field of transfusion medicine will be defined in the next decade.

The public will have the opportunity to present their views to the Committee during a public comment session scheduled for June 6, 2013. 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 Designated Federal Officer 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, 2013. 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 the close of business on June 3, 2013. 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 Designated Federal Officer prior to the close of business on June 3, 2013.

Dated: May 9, 2013.

James J. Berger,

Designated Federal Official, ACBTSA and Senior Advisor for Blood and Tissue Safety Policy.