Background Analysis: US HHS Advisory Committee to Review Public Health Service Guidelines on Reducing HIV, HBV, and HCV through Organ Transplantation – APR 15-16, 2019 (ACBTSA)

Announcement

The US Department of Health & Human Services (HHS) has scheduled a meeting of the Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA) for Monday to Tuesday, April 15-16, 2019. The committee will discuss and develop appropriate recommendations for potential updates to the Public Health Service (PHS) Guideline on Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) through Organ Transplantation.

Background – PHS Guideline on Reducing HIV, HBV, and HCV through Organ Transplantation

In 1994, the PHS, a Division of the HHS, issued a guideline for preventing HIV transmission through transplantation of human tissue and organs. In 2013, the PHS expanded the guideline to incorporate the prevention of HBV and HCV, while also narrowing its focus to organ transplantation and associated blood vessel conduits, noting that the FDA had implemented more comprehensive regulations for cell and tissue products.

The intent of the guideline is to provide risk-related recommendations to personnel of organ procurement organizations (OPOs); transplant center personnel, including physicians, nurses, administrators, and clinical coordinators; laboratory personnel responsible for testing and storing donor and recipient specimens; and individuals responsible for developing, implementing, and evaluating infection prevention and control programs for OPOs and transplant centers.

Agenda

At the upcoming meeting, the committee will hear presentations from public and private sector stakeholders and public comments regarding the guideline. The committee will explore important questions to consider as the guideline is examined for any necessary updates. 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.

Regulatory Background – Establishment of the ACBTSA

The ACBTSA provides advice to the HHS Secretary through the Assistant Secretary for Health (ASH) on a range of policy issues related to blood, blood products, and tissues. In 1995, the National Academies Institute of Medicine (IOM), now known as the National Academy of Medicine, issued three significant reports on blood safety and availability. These reports were based on an industry-wide roundtable exploration of the topic. In response to the IOM reports, the Advisory Committee on Blood Safety & Availability (ACBSA) and the executive-level Blood Safety Council (BSC) were established under the Office of the ASH (OASH). In 2012, HHS re-chartered the BSC into the HHS Blood, Organ, and Tissue Senior Executive Council (BOTSEC) and re-chartered the ABCSA into the federal Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA). Both expansions added the purview to explore and coordinate public health issues related to tissue products and donor-derived infectious disease complications of transplantation in organs and blood stem cells. OASH placed the council, committee, and staff into the Office of HIV/AIDS and Infectious Disease Policy (OASH/OHAIDP).  In OHAIDP, staff members identify nationally significant topics for committee and council deliberations and explore policy and programmatic solutions to the recommendations provided to the HHS Secretary and the Assistant Secretary.

The ACBTSA consists of voting members who represent a diverse group of health professionals, patient advocates, and scientists; representatives from blood, tissue, and organ professional organizations; and relevant manufacturing and healthcare organizations. In addition, there are non-voting ex-officio members from HHS Agencies and the Department of Defense.

Except for 2017, the committee has met at least once a year, in accordance with the estimated meeting frequency described in the Committee’s charter. Recommendations from the Committee are posted at the following website: https://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/advisory-committee/recommendations/index.html.

What’s Next?

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none Other: blood safety

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.