The U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) has published additional sustainable blood supply recommendations that will be considered via a vote at the next virtual meeting to discuss blood supply surge capacity scheduled for January 11th, according to a HHS notice in the Federal Register.
The committee previously published four blood supply surge capacity recommendations focused on a sustainable blood supply in September that came in the wake of ACBTSA’s July meeting on blood supply surge capacity. The additional sustainable blood supply recommendations are related to the committee suggesting HHS Secretary Xavier Becerra, JD “fund additional public awareness campaigns including funding for data analytics to increase the donor pool and determine effectiveness.” These new blood supply surge capacity recommendations include:
- “The Committee recommends that an agency within HHS be charged with safeguarding the availability of blood;
- [t]his agency should work closely with U.S. Food and Drug Administration so that regulatory measures developed for blood safety are balanced by the need to maintain blood availability.
- The Committee recommends that companies providing critical supplies for blood manufacturing and storage shall work with HHS funding agencies to develop and enact contingency plans to stabilize the blood supply chain.
- The Committee recommends that the Office of the Assistant Secretary for Health (OASH) or other HHS funding organization receive an enabling budget to be used for projects that stabilize the blood supply such as stockpile of key supplies and components.
- The Committee recommends that an HHS funding organization offer grant or contract funding that enables the development of novel means for extending the outdate of perishable materials in the stockpile.
- The Committee recommends that the ACBTSA convene a working group dedicated to developing a risk-gap analysis with associated business costs for the mitigations and contingencies associated with these temporary regulatory measures.
- The FDA should be engaged in this analysis to assess the risks.
- This work should be completed by the end of calendar year 2024.
- The Committee recommends that a Memorandum of Understanding (MOU) be negotiated with Canada to allow their blood and blood products into the U.S. and utilization of their testing laboratories to relieve transient strains in the blood supply brought about by emergencies.
- The MOU would be bi-directional.
- The FDA would participate in this work to assure the safety of the incoming blood from Canada or other countries.
- The Committee recommends OASH contract a qualified organization to develop a risk-capability analysis with business case development informed by actuarial science.
- This agency would be administered by the Administration for Strategic Preparedness and Response (ASPR) and OASH.
- Representatives from blood centers, hospital transfusion services, blood system supply chain agents, and health economists would provide input.”
America’s Blood Centers (ABC), in consultation with the ABC Board, Policy Council, and Scientific, Medical, and Technical Committee (SMT), is preparing to submit comments to the sustainable blood supply recommendations prior to the January ACBTSA meeting on blood supply surge capacity. ABC previously submitted comments in June regarding blood supply surge capacity, and in November in response to the ACBTSA’s initial sustainable blood supply recommendations.