2014-22527. Meeting of the Advisory Committee on Blood and Tissue Safety and Availability

AGENCY:

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

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 Thursday, November 13, 2014, from 8:00 a.m. to 3:10 p.m., and Friday, November 14, 2014, from 8:00 a.m. to 3:45 p.m.

ADDRESSES:

Veteran Health Administration National Conference Center, 2011 Crystal Drive, Suite 150, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT:

Mr. James Berger, Designated Federal Officer, ACBTSA, and Senior Advisor for Blood and Tissue Safety Policy, Office of HIV/AIDS and Infectious Disease 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 affect 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 November 2014 meeting the ACBTSA will hear updates on recent activities of the Department and its agencies in support of previous Committee recommendations. Past recommendations made by the ACBTSA may be viewed at www.hhs.gov/​bloodsafety.

The focus of the meeting will be to address the implications of hemoglobin S testing in blood donors. In particular, the Committee will focus on the ethics of hemoglobin S testing as well as the perspective of affected members of the blood collecting and using community. The Committee will also continue its discussion of the current blood donor policy for men who have sex with men. A portion of the meeting will also be devoted to an emerging infectious disease, babesia, which could potentially impact the blood supply.

The public will have opportunities to present their views to the Committee during public comment sessions scheduled for November 13, 2014, and November 14, 2014. Comments regarding the men who have sex with men blood donation policy should be presented on November 13, 2014. Comments regarding hemoglobin S testing and emerging infectious disease testing should be presented on November 14, 2014. 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 sessions. Any member of the public who would like to participate in these sessions 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 November 10, 2014. 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 November 10, 2014. It is also requested that any member of the public who wishes to provide comments to the Committee utilizing electronic data projection submit the necessary material to the Designated Federal Officer prior to the close of business on November 10, 2014.

Dated: September 17, 2014.

James J. Berger,

Designated Federal Officer and Senior Advisor for Blood and Tissue Safety Policy.