Biden Signs Omnibus Bill With Provisions Related to the Blood Supply

January 02, 2023

President Joe Biden signed the Consolidated Appropriations Act, 2023, (H.R.2617) into law on Dec. 29. In addition to averting a government shutdown, the $1.7 trillion spending package contains several provisions championed by the blood community to support the safety and availability of the blood supply.

The package includes a provision resulting from AABB’s advocacy efforts stipulating that the Secretary of Health and Human Services lead coordination and collaboration between the federal government and blood community, including blood collectors, on issues related to the safety and availability of the blood supply. The bill also includes a separate provision that would exempt information from blood donors or potential blood donors from the Paperwork Reduction Act.

The package also includes funding for funding for entities the National Heart, Lung and Blood Institute and the Advanced Research Projects Agency for Health (ARPA-H), a new entity within the National Institutes for Health that aims to advance “high-potential, high-impact” biomedical and health research that cannot be readily accomplished through traditional research or commercial activity.

The package did not include the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would establish a new framework for the Food and Drug Administration to regulate in vitro clinical tests (IVCTs). In vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) would be regulated as IVCTs. FDA Commissioner Robert Califf, MD, has indicated that he will begin the rulemaking process to bring these tests under FDA’s regulatory umbrella. AABB will continue working with policymakers to educate them about the tests performed by the AABB community.