This section contains comments that have been submitted to the government docket on issues of concern to the transfusion medicine and cellular therapies communities. Click on a link below to read current comments. For access to past comments, check our archive.
Joint Comments to FDA on the Draft Guidance on Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis - 5/22/13Comments to FDA on “Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products” - 2/26/13Comments to FDA on the “Unique Device Identification System” - 11/07/12Joint Comments to FDA on the Draft Guidance on Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria - 8/31/12Comments to HHS: RFI on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for MSM - 6/11/12Comments to FDA on “Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components.” - 1/23/12 (PDF)Comments to FDA on Bar Code Technologies for Drugs and Biological Products - 1/9/12Comments to CDC on Public Service Guideline for Reducing Transmission of HIV, HBV and HCV Through Solid Organ Transplantation - 12/22/11Joint Comments on Exceptions to FDA Sterility Testing Requirements (21 CFR 610.12) – 9/16/11Comments on Amendments to FDA Sterility Testing Requirements for Biological Products (21 CFR 610.12) – 9/16/11Comments to FDA on the Draft Guidance for Pre-Storage Leukoreduction of Whole Blood and Blood Components – 4/27/11Comments to FDA on Workshop Exploring Track and Trace System for Finished Prescription Drug Products – 4/15/11Comments to CMS on Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2011 – 8/30/10Comments to CMS on Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2011 Rates – 6/17/10Comments to Plasma Protein Therapeutics Association on Recovered Plasma Specification Draft – 4/14/10Comments to FDA on Transparency Task Force Initiatives – 4/12/10Comments: Questions From Cord Blood Licensure Workshop Submitted to FDA Docket – 4/8/10 – 4/8/10 (PDF)Comments to FDA on Proposed Rule on Informed Consent Elements – 2/25/10Comments to FDA for Draft IND Guidance on HPC-Cs – 01/14/10Comments to FDA on Draft Guidance on Blood Donor Suitability and Blood Safety and H1N1 Pandemic - 12-3-09Comments to CMS on Proposed 2010 Outpatient Payments for Blood Products – 08/31/09Comments to CMS on Proposed 2010 Outpatient Payments for Stem Cell Procedures – 08/28/09 (PDF)AABB Commends CMS for Recognizing Blood Costs in Inpatient Market Basket - 6/30/09Comments to FDA on Draft Guidance for Use of Serological Tests to Reduce Transmission Risk of T. cruzi Infection – 6/15/09Comments to FDA on cGTP and Additional Requirements for Manufacturers of HCT/Ps – 4/14/09Amended Comments to the FDA on SNIs and the National Drug Code – 4/6/09Comments to FDA on Adverse Event Reporting in Flu Pandemic – 2/9/09 (PDF)Comments to FDA on SNIs and the National Drug Code – 2/9/09 (PDF)Comments to NRC on Security and Continued Use of Cesium-137 Chloride Sources – 10/13/08Comments to CMS on Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Rates – 9/2/08Amicus Curiae Brief of ABC, AABB and ARC in Support of LifeSouth Community Blood Centers Inc. – 8/18/08 (PDF)Comments to The Joint Commission on Blood Management Candidate Performance Measures – 8/19/08Comments to FDA on Draft Guidance on Re-entry of Donors Deferred Due to Reactive Tests Results for Anti-HBc – 8/15/08Amendment to Comments submitted to FDA on 28 Jan. 2008 regarding “Draft Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility” – 8/8/08 (PDF)Summary of Draft Comments to be Submitted to TJC on Blood Management Performance Measures – 8/8/08Comments to FDA on Draft Guidance on Considerations for Pancreatic Islet Cell Products – 8/8/08Comments to the FDA on Proposed Rule on Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing – 8/1/08 (PDF)AABB West Nile Virus Task Force Comments to FDA on Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus – 7/25/08Comments to FDA on Draft Guidance for Certifications to Accompany Drug, Biological Product and Device Applications/Submissions – 6/6/08Comments to FDA on Draft Guidance for Validation of RMM for Sterility Testing of Cellular and Gene Therapy Products – 5/9/08Comments to AHRQ on the Proposed Regulations for the Patients Safety and Quality Improvement Act of 2005 – 4/14/08Comment to FDA on the Report of the Subcommittee on Science and Technology – 2/4/08Comments to FDA on "Draft Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility" – 1/28/08 (PDF)