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Comments

​​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 comments specific to the cellular therapies community check here. For access to past comments, check our archive.

2017

Comments to the National Preparedness and Response Science Board (NPRSB) and National Advisory Committee on Children and Disasters (NACCD) - 04-13-17

Joint Comments to the FDA on “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion,” Draft Guidance for Industry - 04-12-17

Joint Comments to the FDA on “Labeling of Red Blood Cell Units with Historical Antigen Typing Results,” Draft Guidance for Industry - 03-30-17

Joint Comments to the FDA on “Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion Draft Guidance for Industry” - 02-08-17

2016

Joint Comments to the FDA on "Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products" - 11/23/16

Comments to FDA on “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods" - 9/26/16

Joint Comments to CMS on Proposed Regarding Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for CY 2017: HCPCS Codes for Blood Products - 9/6/16

Comments to CMS on Proposed Rule Regarding Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for CY 2017: Payment Rates - 9/2/16

Comments to CMS on Proposed Rule Regarding Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for CY 2017: HCPCS Codes for Blood Products - 9/2/16

Comments to FDA on "Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing" - 8/10/16

Comments to CMS on Medicare Proposed Hospital Inpatient Rule for Fiscal Year 2017 - 6/17/16

Comments to FDA on “Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories” Proposed Rule - 5/31/16

​Joint Comments to FDA to on “Recommendations for Donor Screening, Deferral, and Product Management To Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry" - 5/26/16

Joint Comments to FDA on “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion” Draft Guidance - 5/16/16

Comments to FDA on “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry" - 3/31/16

Joint Comments to FDA on “Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus” Draft Guidance - 3/2/16 

2015

Comments to CMS on Proposed Decision on Coverage for HSCTs for Sickle Cell Disease - 11/25/15

Joint Comments to CMS on Proposed Rule “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs” - 8/31/15

Comments to CMS on Proposed Rule “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs” - 8/31/15

Comments to FDA to on the Draft Guidance for Revised Recommendations for Reducing the Risk of HIV by Blood Products - 7/14/15 

Comments to CMS Supporting Inclusion of HSCT for Sickle Cell Disease in the National Coverage Determination - 5/29/15

Comments to FDA, Pertinent to Circular for Blood and Blood Components, on Proposed Rule “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products” - 5/18/15

Comments to FDA, Pertinent to Cellular Therapies, on Proposed Rule “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products” - 5/18/15

Comments to FDA on Draft Guidance “Current Good Manufacturing Practice Requirements for Combination Products” - 4/29/15

Comments to FDA on Draft Guidance “Investigating and Reporting Adverse Reactions Related to HCT/Ps Regulated Solely under Section 361 of the PHS Act and 21 CFR Part 1271” - 4/21/15

Comments to FDA on Draft Guidance for Industry “Bacterial Testing by Blood and Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion” - 3/9/15 (PDF)

Comments to FDA on Draft Guidance for Industry “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff” - 2/23/15   

Comments to FDA on Draft Guidance for Industry “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations" - 2/23/15

Joint Comments to FDA on the Draft Guidance "Framework for Regulatory Oversight of Laboratory Developed Tests" - 2/2/15

Joint Comments to FDA on the Draft Guidance "Notification and Medical Device Reporting for Laboratory Developed Tests" - 2/2/15

Comments to CMS on Continued Use of the Hemoglobin – Copper Sulfate – Non-automated Test - 1/6/15

20​​14

Comments to FDA on Draft Guidance for Industry: "Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception" - 12/22/14

Comments to CMS on the 2015 Proposed Rule for Hospital Outpatient Prospective Payment and Ambulatory Surgical Payment Systems and Quality Reporting Programs - 9/2/14

Joint Comments to FDA on "Draft Guidance for Industry and Food and Drug Administration Staff: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - 8/21/14

Comments to FDA on "Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products" - 5/8/14

Comments to FDA on "Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis)" - 1/31/14

Comments to FDA on "Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products" – 1/21/14

Comments to FDA on the Proposed Rule “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products" – 1/3/14

2013

Comments to CMS on the Proposed Rule “Changes to CLIA Enforcement Actions for Proficiency Testing Referral” - 11/18/13

Comments to FDA on “Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements”  – 7/29/13

Comments to CMS on the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System for Proposed FY 2014 Rates – 6/25/13

Comments to FDA on “Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products” - 2/26/13

2012

Comments to FDA on the “Unique Device Identification System” - 11/07/12

Comments to HHS: RFI on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for MSM - 6/11/12

Comments to FDA on "Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments"  - 1/9/12