This comprehensive comment letter from America’s Blood Centers (ABC) to the U.S. Department of Health and Human Services (HHS) outlines numerous recommendations to reduce regulatory burdens on blood centers while maintaining safety standards. The letter addresses several key areas, including streamlining the licensure process for new blood donation sites, eliminating outdated testing requirements for hepatitis B and HTLV, revising malaria testing guidelines, lowering platelet content requirements, and allowing more flexibility in plasma storage and whole blood processing times. ABC also proposes changes to donor eligibility assessments, suggests developing a pre-approved variance process for operational changes, and recommends allowing cold-stored platelets for broader use. Throughout the letter, ABC provides detailed rationales for each recommendation, citing scientific evidence, international practices, and potential cost savings. This document offers a thorough overview of current challenges in blood banking regulation and proposes evidence-based solutions to enhance efficiency and blood product availability.
