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 Monday, April 15, 2019, from 8:00 a.m.-4:30 p.m. and Tuesday, April 16, 2019, from 8:30 a.m.-4:00 p.m.

ADDRESSES:

U.S. Department of Health & Human Services, Hubert H. Humphrey Building, (Conference Room 800), 200 Independence Ave. SW, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT:

Mr. James Berger, Designated Federal Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L100, Washington, DC 20024. Phone: (202) 795-7697; Fax: (202) 691-2102; Email: ACBTSA@hhs.gov.

SUPPLEMENTARY INFORMATION:

The ACBTSA provides 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 survey and 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 Committee has met regularly since its establishment in 1997.

In 2013, updates were made to the original 1994 Public Health Service Guidelines on Reducing HIV, HBV, and HCV through Organ Transplantation (“PHS Guidelines”). Public and private-sector stakeholders in organ transplantation are now seeking to explore potential important updates to the PHS Guidelines in order to maintain accordance with current health sector circumstances.

The Committee will meet on April 15-16, 2019 to receive presentations from various public and private sector stakeholders and to listen to public comments regarding the PHS Guidelines. The Committee will explore important questions to consider as the PHS Guidelines are examined for any such necessary updates. Finally, the Committee will discuss and develop appropriate recommendations for HHS consideration. Additional topics that are pertinent to the mission of the Committee may be added to the agenda.

The public will have an opportunity to present their views to the Committee during public comment sessions scheduled for the second day of the meeting. 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 required to submit their name, email, and comment summary prior to close of business on April 8, 2019. If it is not possible to provide 30 copies of the material to be distributed at the meeting, 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 April 8, 2019. 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 April 8, 2019.