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Your Privacy Choices
As part of its advocacy efforts, AATB sends letters and other communications to the FDA and other government agencies on issues and policies impacting the tissue banking industry and professionals. Read the letters below to learn about the work AATB is doing on these key issues.
2025 Government Advocacy Correspondence
- April 29, 2025: AATB Statement on Ongoing Concerns and Formal Request for Rescission of Sepsis and MTB Guidance Documents Following Meeting with OMB
- April 9, 2025: AATB Letter to FDA Commissioner on Sepsis and Mtb
- March 27, 2025: AATB Letter to FDA on Sepsis and Mtb Guidance Documents
- March 7, 2025: AATB's Written Comments and Slides Regarding the February 25, 2025, workshop on “Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development"
- February 6, 2025: AATB's Comments Regarding Four Draft Guidance Documents Published by FDA on January 6, 2025
- February 3, 2025: In Re: FDA-2024-N-4821, Food and Drug Administration’s Best Practices for Food and Drug Administration Communication with Interested Parties: Draft Report for Public Comment; Availability
- January 15, 2025: AATB’s Response to FDA Mtb and Sepsis Final Guidance Documents
2024 Government Advocacy Correspondence
- December 10, 2024: AATB Statement for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Multi-MAC Town Hall Meeting
- November 25, 2024: In Re: Health Canada’s update to the CAN/CSA-Z900.2.2.:22 “Tissues for transplantation” standard to eliminate the requirement for tissue donors to be screened for a history of active or past Ebola virus infection.
- October 22, 2024: In Re: Update on Recent Tissue Bank Submissions to the Tissue Reference Group
- September 6, 2024: In Re: CMS-1807-P, Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments
- June 6, 2024: In Re: FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease (RCDAD), and Withdrawal of Guidance titled “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products”
- May 31, 2024: In Re: LCDs/LCAs – Skin Substitute Grafts/Cellular and Tissue-Based Products (CTPs) for the Treatment of Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs)
- April 29, 2024: In Re: H.R. 7085, the BIOSECURE Act, and S. 3558, the Prohibiting Foreign Access to American Genetic Information Act of 2024
- April 3, 2024: Allograft Tissue Historically Regulated as 361 HCT/Ps in response to the Veterans Affairs’ request of contract holders to provide “FDA Designation Letters” regarding regulatory classification of HCT/Ps. PLEASE NOTE: This is not an all-inclusive list and represents those HCT/Ps that have historically been regulated as “361 HCT/Ps”. In order to be regulated solely under PHS 361 and 21 CFR 1271, HCT/Ps must meet the criteria in 21 CFR 1271.10(a)
- February 29, 2024: Testimony for the Record House: Committee on Energy and Commerce Health Subcommittee, “Legislative Proposals to Support Patients with Rare Diseases”
- February 27, 2024: In Re: Docket No. FDA-2023-N-3392, Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes
- February 21, 2024: In Re: Docket No. FDA-2024-N-0008
- February 9, 2024: In Re: Request that tissue banks submit RFD/TRG letters for 361 tissue products
- January 26, 2024: In Re: Docket No. FDA-2023-N-5653, Draft Report and Plan on Best Practices for Guidance
2023 Government Advocacy Correspondence
- November 7, 2023: AATB Thanks CMS Contractors for Withdrawal of LCDs/LCAs — In Re: L36690, A56696– Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers - 3 letters
- September 8, 2023: In Re: L36690, A56696– Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers - 3 letters
- September 6, 2023: In Re: CMS-1784-P, Medicare and Medicaid Programs; CY 2024 Payment Policies under the Physician Fee Schedule and Other Changes
- August 2, 2023: In Re: CMS-3421-NC, Medicare Program; Transitional Coverage for Emerging Technologies
- March 23, 2023: Testimony for the Record Before the House Committee on Appropriations, Labor, Health and Human Services, Education, and Related Agencies Subcommittee Public Witness Hearing
- January 18, 2023: In Re: Feedback in Response to the CMS Skin Substitutes Town Hall
2022 Government Advocacy Correspondence
- December 30, 2022: In Re: CMS-1772-FC, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; etc.
- November 18, 2022: In Re: Proposed LCD – Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL) (DL36690)
- November 14, 2022: In Re: Draft Guidance – Computer Software Assurance for Production and Quality System Software (Docket No. 2022-19763)
- September 28, 2022: In Re: FDA-2022-D-1385, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
- September 14, 2022: In Re: Docket No. FDA-2022-D-0745 for “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry”
- September 13, 2022: In Re: Docket No. CMS-1772-P, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; etc.
- September 6, 2022: In Re: Docket No. CMS-1770-P, Medicare and Medicaid Programs; CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes
- September 6, 2022: In Re: Lessons Learned from Recent Tissue Bank Submissions to the Tissue Reference Group
- June 17, 2022: In Re: Docket No. FDA-2021-N-1212, Wound Healing Scientific Workshop; Public Workshop; Request for Comments
- March 22, 2022: In RE: Recent MAC Coverage Policies Related to Certain Injectable Birth Tissue Products
- January 31, 2022: In Re: CMS-3409-NC, Request for Information: Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities
2021 Government Advocacy Correspondence
- October 5, 2021: In Re: Special Consideration for HCT/Ps receiving a BLA
- September 7, 2021: In Re: Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)
- September 7, 2021: In Re: Electronic Summary of Records for 361 HCT/Ps
- April 7, 2021: In Re: FDA Safety Communication on March 31, 2021 titled Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates