Comments to FDA Requesting Comment Period Extension for Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use – 12/3/07Comments 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 – 10/30/07Comments to FDA on the Direct Final Rule/Proposed Rule on the Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma – 10/30/07Comments to FDA on Draft Guidance for Cooperative Manufacturing Arrangements for Licensed Biologics – 9/21/07Comments to FDA on Draft Guidance for Cell Selection Devices – 9/19/07Comments to FDA on Draft Guidance for Electronic Crossmatch – 9/12/07Comments to CMS on Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Rates – 9/12/07Joint Comments to U.S. Sens. Kennedy, Enzi, Clinton and Hatch on Wired for Health Care Quality Act – 6/4/07Comments to CMS on Clinical Trial Coverage Proposal – 5/9/07Joint Comments on Draft Guidance for Cord Blood Licensure – 4/16/07 (PDF)Comments on Draft Guidance for Cord Blood Licensure – 4/16/07Comments to FDA on Proposed National Drug Code Requirements for HCT/Ps – 1/24/07 (PDF)
Comments to FDA on Donor Deferral for Transfusion in France Since 1980 – 9/18/06DHQ Task Force Comments to FDA on Donor Deferral for Transfusion in France Since 1980 – 9/18/06
Joint Comments to FDA on Draft HIV/HCV NAT Guidance – 10/25/05Recovered Plasma Task Force Comments to FDA on Recovered Plasma – 6/23/05Comments to FDA on the Development of Plasma Standards for Transfusion – 6/23/05
Comments to FDA on Stimulating Innovation in Medical Technologies – 11/15/04 Comments to JCAHO on Tissue Storage and Issuance Standards – 9/15/04Comments to FDA on Draft Guidance Relating to Eligibility Determinations for Donors of HCT/Ps – 8/23/04 Comments to FDA on the Critical Path Initiative – 7/29/04 Comments to FDA on Guidance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 – 7/27/04Comments to FDA on Electronic Records and Signatures – 7/8/04 Comments to FDA on Use of Focus Groups – 4/5/04Comments to FDA on Electronic Labeling for Prescription Devices Under the Medical Device User Fee and Modernization Act of 2002 – 1/13/04
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 – 10/13/03Comments 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 – 6/6/03Comments to FDA on Draft Guidance Relating to Electronic Records and Signatures – 4/28/03Comments to FDA on Acceptable Circular of Information – 1/8/03
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 – 5/16/02Comments to FDA on Guidance Relating to Xenotransplantation – 5/8/02
UDHQ Interorganizational Task Force Amended Comments to FDA on Draft Guidance Relating to CJD and vCJD – 11/15/01Comments to FDA on Draft Guidance Relating to CJD and vCJD – 10/10/01UDHQ Interorganizational Task Force Comments to FDA on Draft Guidance Relating to CJD and vCJD – 10/10/01Circular of Information Task Force Comments to FDA on Draft Guidance Relating to CJD and vCJD – 10/10/01Comments to FDA on Draft Guidance Relating to Xenotransplantation – 5/7/01Comments to FDA on Draft Guidance Relating to Leukoreduction – 5/1/01Joint Comments to DOT on Proposed Changes to Hazardous Materials Shipping Requirements – 4/23/01Comments to FDA on Draft Guidance Relating to Donor Incentives – 3/3/01
Comments to FDA on Draft Guidance Relating to Donor Questioning About Malaria Exposure – 9/5/00Comments to FDA on Guidance Relating to Donor Deferral for Xenotransplantation Product Recipients – 2/23/00