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.
Comments to FDA on “Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products” - 2/26/13Comments to FDA on the “Unique Device Identification System” - 11/07/12Joint Comments to FDA on the Draft Guidance on Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria - 8/31/12Comments to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of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for MSM - 6/11/12Comments to FDA on “Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and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to FDA Sterility Testing Requirements for Biological Products (21 CFR 610.12) – 9/16/11Comments to FDA on the Draft Guidance for Pre-Storage Leukoreduction of Whole Blood and Blood Components – 4/27/11Comments to FDA on Workshop Exploring Track and Trace System for Finished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on Informed Consent Elements – 2/25/10Comments to FDA for Draft IND Guidance on HPC-Cs – 01/14/10Comments to FDA on Draft Guidance on Blood Donor Suitability and Blood Safety and H1N1 Pandemic - 12-3-09Comments to CMS on Proposed 2010 Outpatient Payments for Blood Products –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)