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
    • 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
    • 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
February 10, 2025

Blood Community Comments on FDA HCT/P Guidances

By America's Blood Centers

America’s Blood Centers, the Association for the Advancement of Blood & Biotherapies, and the American Red Cross (ARC) have submitted four joint comment letters to the U.S. Food and Drug Administration (FDA) regarding human cells, tissues, and cellular and tissue-based products (HCT/Ps) draft guidances. The February 5th blood community comments on FDA’s HCT/P guidances addressed:

  • Recommendations for Determining Eligibility of Donors of HCT/Ps;
  • Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by HCT/Ps;
  • Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by HCT/Ps; and
  • Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by HCT/Ps.

The blood community comments on FDA’s HCT/P donor eligibility guidance regarding requested an extended implementation period of at least one year to, β€œallow facilities to focus on successful implementation of changes to highly complex systems which must be updated, tested, and validated for performance [including] changes to the establishment computer system, HCT/P Donor History Questionnaires, flowcharts, Circular of Information, policies and procedures, and extensive staff training and education.”

While all four comment letters expressed support for the FDA draft guidance recommendations and updated guidance formats by the FDA, the blood community asked the agency in the comments on the HIV risk draft guidance, the HBV risk draft guidance, and the HCV risk draft guidance to provide clarification of the risk assessment timeframe for the secondary sexual partner through a, β€œtimebound recommendation for the secondary sexual partner similar to the recommendations for blood donors in the May 2023 guidance.”

SUBSCRIBE TO THE ABC NEWSLETTER FOR THESE STORIES AND MORE.

Posted in ABC Newsletter
Share this

Recent Posts

  • Over 100 Organizations Thank America’s Blood Donors on World Blood Donor Day
  • America’s Blood Centers Honors Senator Murray and Congresswoman Miller-Meeks for Support of U.S. Blood Supply
  • Over 100 Organizations Launch Blood Advocacy Week 2025 Urging Congress to Make the Blood Supply a National Priority
  • Blood Transfusions and Hospice
  • ABC Applauds Introduction of Bipartisan Legislation to Expand Access to Blood Transfusions in Hospice Care

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
    • 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