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AABB > Press Room > Comments

Comments Archive 

2008

Comments to NRC on Security and Continued Use of Cesium-137 Chloride Sources – 10/13/08
Comments to CMS on Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Rates – 9/2/08
Amicus 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 – 8/19/08
Comments to FDA on Draft Guidance on Re-entry of Donors Deferred Due to Reactive Tests Results for Anti-HBc – 8/15/08
Amendment to Comments submitted to FDA on 28 Jan. 2008 regarding “Draft Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility” – 8/8/08 (PDF)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 – 8/8/08
Comments to FDA on Draft Guidance on Considerations for Pancreatic Islet Cell Products – 8/8/08
Comments 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 – 7/25/08
Comments to FDA on Draft Guidance for Certifications to Accompany Drug, Biological Product and Device Applications/Submissions – 6/6/08
Comments to FDA on Draft Guidance for Validation of RMM for Sterility Testing of Cellular and Gene Therapy Products – 5/9/08
Comments to AHRQ on the Proposed Regulations for the Patients Safety and Quality Improvement Act of 2005 – 4/14/08
Comment to FDA on the Report of the Subcommittee on Science and Technology – 2/4/08
Comments to FDA on "Draft Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility" – 1/28/08 (PDF)

2007

Comments to FDA Requesting Comment Period Extension for Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use – 12/3/07
Comments by the AABB Plasma Task Force to FDA on the Direct Final Rule/Proposed Rule on the Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma – 10/30/07
Comments to FDA on the Direct Final Rule/Proposed Rule on the Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma – 10/30/07
Comments to FDA on Draft Guidance for Cooperative Manufacturing Arrangements for Licensed Biologics – 9/21/07
Comments to FDA on Draft Guidance for Cell Selection Devices – 9/19/07
Comments to FDA on Draft Guidance for Electronic Crossmatch – 9/12/07
Comments to CMS on Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Rates – 9/12/07
Joint Comments to U.S. Sens. Kennedy, Enzi, Clinton and Hatch on Wired for Health Care Quality Act – 6/4/07
Comments to CMS on Clinical Trial Coverage Proposal – 5/9/07
Joint Comments on Draft Guidance for Cord Blood Licensure – 4/16/07 (PDF)
Comments on Draft Guidance for Cord Blood Licensure – 4/16/07
Comments to FDA on Proposed National Drug Code Requirements for HCT/Ps – 1/24/07 (PDF)

2006

Comments to FDA on Donor Deferral for Transfusion in France Since 1980 – 9/18/06
DHQ Task Force Comments to FDA on Donor Deferral for Transfusion in France Since 1980 – 9/18/06 

2005

Joint Comments to FDA on Draft HIV/HCV NAT Guidance – 10/25/05
Recovered Plasma Task Force Comments to FDA on Recovered Plasma – 6/23/05
Comments to FDA on the Development of Plasma Standards for Transfusion – 6/23/05

2004

Comments to FDA on Stimulating Innovation in Medical Technologies – 11/15/04
Comments to JCAHO on Tissue Storage and Issuance Standards – 9/15/04
Comments to FDA on Draft Guidance Relating to Eligibility Determinations for Donors of HCT/Ps – 8/23/04
Comments to FDA on the Critical Path Initiative – 7/29/04
Comments to FDA on Guidance Relating to Donor History Questionnaire – 7/27/04
DHQ Task Force Comments to FDA on Guidance Relating to Donor History Questionnaire – 7/27/04
Comments to FDA on Electronic Records and Signatures – 7/8/04
Comments to FDA on Use of Focus Groups – 4/5/04
Comments to FDA on Electronic Labeling for Prescription Devices Under the Medical Device User Fee and Modernization Act of 2002 – 1/13/04

2003

Comments to FDA on Guidance Relating to Donor Questioning on Malaria Exposure – 12/29/03
Comments to FDA on Final Guidance Relating to SARS – 12/5/03
Comments to FDA on Proposed Revisions to Labeling and Storage Requirements – 10/27/03
Comments to FDA on Proposed Safety Reporting Requirements – 10/13/03
Comments to CMS on Hospital Outpatient Prospective Payment System and Rates – 10/6/03 (PDF)
Comments to FDA on Draft Guidance Relating to Syphilis Testing – 9/23/03
Proposal to FDA on Recovered Plasma – 6/6/03
Comments to FDA on Draft Guidance Relating to Electronic Records and Signatures – 4/28/03
Comments to FDA on Acceptable Circular of Information – 1/8/03

2002

UDHQ Task Force Comments to FDA on Guidance Relating to Self-Administered Questionnaires – 6/20/02
Comments to FDA on Draft Guidance Relating to Electronic Records, Electronic Signatures and Time Stamps – 5/16/02
Comments to FDA on Guidance Relating to Xenotransplantation – 5/8/02

2001

UDHQ Interorganizational Task Force Amended Comments to FDA on Draft Guidance Relating to CJD and vCJD – 11/15/01
Comments to FDA on Draft Guidance Relating to CJD and vCJD – 10/10/01
UDHQ Interorganizational Task Force Comments to FDA on Draft Guidance Relating to CJD and vCJD – 10/10/01
Circular of Information Task Force Comments to FDA on Draft Guidance Relating to CJD and vCJD – 10/10/01
Comments to FDA on Draft Guidance Relating to Xenotransplantation – 5/7/01
Comments to FDA on Draft Guidance Relating to Leukoreduction – 5/1/01
Joint Comments to DOT on Proposed Changes to Hazardous Materials Shipping Requirements – 4/23/01
Comments to FDA on Draft Guidance Relating to Donor Incentives – 3/3/01

2000

Comments to FDA on Draft Guidance Relating to Donor Questioning About Malaria Exposure – 9/5/00
Comments to FDA on Guidance Relating to Donor Deferral for Xenotransplantation Product Recipients – 2/23/00

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