Comments Archive

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Comments to FDA on Draft Guidance for Cooperative Manufacturing Arrangements for Licensed Biologics – 9/21/07
Comments to FDA on Draft Guidance for Cell Selection Devices – 9/19/07
Comments to FDA on Draft Guidance for Electronic Crossmatch – 9/12/07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Joint Comments on Draft Guidance for Cord Blood Licensure – 4/16/07 (PDF)
Comments on Draft Guidance for Cord Blood Licensure – 4/16/07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)

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
Comments to FDA on Draft Guidance Relating to West Nile Virus – 5/18/05

2004
Comments to FDA on Quality Systems Approach to Pharmaceutical cGMPs – 12/3/04
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Comments to FDA on Draft Guidance Relating to Eligibility Determinations for Donors of HCT/Ps – 8/23/04 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 Final Guidance Relating to IRB Review of Stand-Alone HIPAA Authorizations – 11/21/03
Comments to FDA on Proposed Revisions to Labeling and Storage Requirements – 10/27/03
Comments to FDA on Guidance Relating to West Nile Virus – 10/22/03
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
Comments to FDA on Proposed Bar Code Labeling/ISBT 128 Requirements – 6/10/03
Proposal to FDA on Recovered Plasma – 6/6/03
Joint Comments to Plasma Protein Therapeutics Association on Proposed Standards for Recovered Plasma – 4/30/03
Comments to FDA on Draft Guidance Relating to Electronic Records and Signatures – 4/28/03
Comments to HHS on Blood Supply Monitoring Program – 3/3/03
Comments to FDA on Acceptable Circular of Information – 1/8/03

2002
Comments to FCC on Telephone Consumer Protection – 12/6/02
Comments to FDA on Draft Guidance Relating to Electronic Records – 11/26/02
UDHQ Task Force Comments to FDA on Guidance Relating to Self-Administered Questionnaires – 6/20/02
Comments to FDA on Guidance Relating to Modified Lot-Release Specification for Hepatitis B Surface Antigens – 5/16/02
Comments to FDA on Guidance Relating to Use of NAT to Reduce Risk of HIV-1 and HCV Transmission – 5/16/02
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
Comments to FDA on Draft Guidance Relating to Validation of Electronic Record and Signatures – 12/21/01
UDHQ Interorganizational Task Force Amended Comments to FDA on Draft Guidance Relating to CJD and vCJD – 11/15/01
Comments to CMS on Hospital Outpatient Prospective Payment System – 10/3/01
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 Proposed Changes to Current Good Tissue Practices – 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
Comments of Lookback Taskforce to FDA on Current Good Manufacturing Practice: Lookback Regarding HCV Infection – 2/14/01
Comments of Lookback Taskforce to HCFA on Proposed Rule – 42 CFR part 482 Medicare and Medicaid Programs; Hospital Conditions of Participation: Laboratory Services – 1/15/01

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

1999
Coalition for Blood Safety Comments to FDA on Supplements/Changes to Approved Application – 9/9/99
Comments of HCV Task Force to OMB on FDA Draft Guidance for HCV Lookback – 8/20/99
Comments of HCV Task Force to FDA on Draft Guidance for HCV Lookback – 8/16/99
Comments to FDA on Draft U.S. Consensus Standard for Uniform Labeling Using ISBT 128 – 2/17/99

1998
Comments to FDA on Guidance for Industry Current Good Manufacturing Practice for Blood and Blood Components for Anti-HCV – 10/2/98