Skip to content
America's Blood Centers
  • About Us
    • About
    • Leadership
    • Committees
    • Partners
      • Stop the Bleed National Partnership
      • National Partnerships User Guide
    • ABC Strategic Plan
    • Foundation
    • Career Center
    • Membership Directory
    • Women’s Executive Leadership Community
    • Executive Fellows Program
    • Corporate Partner Council
    • ADRP
  • Advocacy
    • Advocacy Agenda
    • Priorities
      • Strengthening the Cyber Resilience of the Blood Community
      • Reducing Unnecessary Regulatory Burdens
      • Modernizing the Licensure Process
      • Exempt Blood Center LDTs from Diagnostic Regulation Reforms
      • Diversifying the Donor Base
      • Expanding the Use of Blood in Ambulances
      • Strengthening the Blood Supply
    • Act for Blood
    • State-Based Advocacy
      • Map of State Legislation
      • Legislation We’re Watching
    • Blood Advocacy Week
    • Letters and Comments
    • Grassroots Handbook
    • Action Center
  • Events
    • Advocacy Summit
    • ABC Annual Meeting
    • Rise & Lead Workshop
    • All Upcoming Events
    • 2025 Awards of Excellence
    • Sponsors
  • News
    • Press Releases
    • One Pagers and FAQs
    • All Latest News
    • For Media
  • Publications
    • ABC Newsletter
    • Blood Bulletin
    • U.S. Blood Donation Statistics and Public Messaging Guide
    • Vein to Vein: The Science of Blood Donation
    • A Vital Resource
    • Blood Centers Career Video
    • ABC Benchmark Surveys
    • The Value of Blood
    • Advertise
    • Grant Funding Guide πŸ”’
  • For Members
    • Collaborate πŸ”’
    • Recent Member Communications (MCNs) πŸ”’
    • Talking Points πŸ”’
    • Member Snapshot Survey Reports πŸ”’
    • ABC Newsletter Archives πŸ”’
    • Webinar Recordings πŸ”’
      • Advocacy Webinars πŸ”’
      • Donor Management Webinars πŸ”’
      • Human Resources Webinars πŸ”’
      • SMIT Journal Club Webinars πŸ”’
    • Resources
    • Get Involved
    • Directory
  • Resources
    • About Blood
    • Blood Safety
    • Promote Blood
    • Journey of Blood
    • Find a Blood Center
    • Current U.S. Blood Supply
    • DonatingBlood.org
  • HOSA Partners
  • Become an ABC Member
  • Member Login
America's Blood Centers
  • About Us
    • About
    • Leadership
    • Committees
    • Partners
      • Stop the Bleed National Partnership
      • National Partnerships User Guide
    • ABC Strategic Plan
    • Foundation
    • Career Center
    • Membership Directory
    • Women’s Executive Leadership Community
    • Executive Fellows Program
    • Corporate Partner Council
    • ADRP
  • Advocacy
    • Advocacy Agenda
    • Priorities
      • Strengthening the Cyber Resilience of the Blood Community
      • Reducing Unnecessary Regulatory Burdens
      • Modernizing the Licensure Process
      • Exempt Blood Center LDTs from Diagnostic Regulation Reforms
      • Diversifying the Donor Base
      • Expanding the Use of Blood in Ambulances
      • Strengthening the Blood Supply
    • Act for Blood
    • State-Based Advocacy
      • Map of State Legislation
      • Legislation We’re Watching
    • Blood Advocacy Week
    • Letters and Comments
    • Grassroots Handbook
    • Action Center
  • Events
    • Advocacy Summit
    • ABC Annual Meeting
    • Rise & Lead Workshop
    • All Upcoming Events
    • 2025 Awards of Excellence
    • Sponsors
  • News
    • Press Releases
    • One Pagers and FAQs
    • All Latest News
    • For Media
  • Publications
    • ABC Newsletter
    • Blood Bulletin
    • U.S. Blood Donation Statistics and Public Messaging Guide
    • Vein to Vein: The Science of Blood Donation
    • A Vital Resource
    • Blood Centers Career Video
    • ABC Benchmark Surveys
    • The Value of Blood
    • Advertise
    • Grant Funding Guide πŸ”’
  • For Members
    • Collaborate πŸ”’
    • Recent Member Communications (MCNs) πŸ”’
    • Talking Points πŸ”’
    • Member Snapshot Survey Reports πŸ”’
    • ABC Newsletter Archives πŸ”’
    • Webinar Recordings πŸ”’
      • Advocacy Webinars πŸ”’
      • Donor Management Webinars πŸ”’
      • Human Resources Webinars πŸ”’
      • SMIT Journal Club Webinars πŸ”’
    • Resources
    • Get Involved
    • Directory
  • Resources
    • About Blood
    • Blood Safety
    • Promote Blood
    • Journey of Blood
    • Find a Blood Center
    • Current U.S. Blood Supply
    • DonatingBlood.org
October 2, 2025

ABC Letter to the FDA on its Proposal to Eliminate HBsAg Testing for Blood Donations

By America's Blood Centers

America’s Blood Centers (ABC) submitted this letter to the Food and Drug Administration (FDA) in response to a draft guidance on testing blood donations for Hepatitis B Surface Antigen (HBsAg). ABC, representing a significant portion of the U.S. and Canadian blood supply, strongly supports the FDA’s proposal to remove the HBsAg testing requirement for whole blood and blood components. We argue that nucleic acid tests (NAT) and hepatitis B core antigen (anti-HBc) testing are sufficient to reduce the risk of hepatitis B virus (HBV) transmission.

Additionally, ABC urges the FDA to consider removing the HBsAg testing requirement for Recovered Plasma and to update current testing requirements for human T-lymphotropic virus types I and II (HTLV-I/II). We propose a one-time donor testing for HTLV-I/II antibodies coupled with effective leukoreduction for donors of whole blood and blood components intended for transfusion. ABC supports these changes based on declining prevalence of infections, low incidence among repeat donors, and the effectiveness of current prevention methods. ABC views these updates as crucial steps in maintaining a safe and available blood supply while ensuring that testing requirements are evidence-based and justified.

Download this document
Posted in Letters and Comments
Share this

Recent Posts

  • ABC Letter to the FDA on its Proposal to Eliminate HBsAg Testing for Blood Donations
  • Blood Community Letter to FDA in Response to Draft Guidance on Hepatitis B Testing for Blood Donations
  • Liberal Transfusion Strategy Recommended for Cardiac Patients
  • ABC Member Centers Host Congressional Site Visits
  • America’s Blood Centers Marks Sickle Cell Awareness Month with Urgent Call for More Diverse Blood Donors

Categories

  • ABC Newsletter
  • Blood Bulletin
  • Letters and Comments
  • News
  • One-Pagers and FAQs
  • Press Releases

Contact

abc-60-logo

1717 K Street NW, Suite 900
Washington, DC 20006

Tel:Β 202-393-5725

Fax:Β 202-899-2621

Link to Instagram Account - Americas Blood Centers
  • About Us
    • About
    • Leadership
    • Committees
    • Partners
      • Stop the Bleed National Partnership
      • National Partnerships User Guide
    • ABC Strategic Plan
    • Foundation
    • Career Center
    • Membership Directory
    • Women’s Executive Leadership Community
    • Executive Fellows Program
    • Corporate Partner Council
    • ADRP
  • Advocacy
    • Advocacy Agenda
    • Priorities
      • Strengthening the Cyber Resilience of the Blood Community
      • Reducing Unnecessary Regulatory Burdens
      • Modernizing the Licensure Process
      • Exempt Blood Center LDTs from Diagnostic Regulation Reforms
      • Diversifying the Donor Base
      • Expanding the Use of Blood in Ambulances
      • Strengthening the Blood Supply
    • Act for Blood
    • State-Based Advocacy
      • Map of State Legislation
      • Legislation We’re Watching
    • Blood Advocacy Week
    • Letters and Comments
    • Grassroots Handbook
    • Action Center
  • Events
    • Advocacy Summit
    • ABC Annual Meeting
    • Rise & Lead Workshop
    • All Upcoming Events
    • 2025 Awards of Excellence
    • Sponsors
  • News
    • Press Releases
    • One Pagers and FAQs
    • All Latest News
    • For Media
  • Publications
    • ABC Newsletter
    • Blood Bulletin
    • U.S. Blood Donation Statistics and Public Messaging Guide
    • Vein to Vein: The Science of Blood Donation
    • A Vital Resource
    • Blood Centers Career Video
    • ABC Benchmark Surveys
    • The Value of Blood
    • Advertise
    • Grant Funding Guide πŸ”’
  • For Members
    • Collaborate πŸ”’
    • Recent Member Communications (MCNs) πŸ”’
    • Talking Points πŸ”’
    • Member Snapshot Survey Reports πŸ”’
    • ABC Newsletter Archives πŸ”’
    • Webinar Recordings πŸ”’
      • Advocacy Webinars πŸ”’
      • Donor Management Webinars πŸ”’
      • Human Resources Webinars πŸ”’
      • SMIT Journal Club Webinars πŸ”’
    • Resources
    • Get Involved
    • Directory
  • Resources
    • About Blood
    • Blood Safety
    • Promote Blood
    • Journey of Blood
    • Find a Blood Center
    • Current U.S. Blood Supply
    • DonatingBlood.org
  • Sitemap
  • Privacy Policy
  • Terms of Use
Become a Member
Member Login

Copyright Β© 2025Β Β© America's Blood Centers. All Rights Reserved.

Website by Yoko Co

Scroll To Top