extension of temporary Waiver to Rule 59A-1.005(35)(a)2, Florida Administrative Code, from The American Association of Tissue Banks on behalf of the Petitioners Alamo Tissue Service, Allosource, Inc., Allotech, LLC, Axogen, Inc., Aziyo Biologics, ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-1.005Standards for OPOs, Tissue Banks and Eye Banks

NOTICE IS HEREBY GIVEN that on July 29, 2016, the Agency for Health Care Administration received a petition for extension of temporary Waiver to subparagraph 59A-1.005(35)(a)2, Florida Administrative Code, from The American Association of Tissue Banks on behalf of the Petitioners Alamo Tissue Service, Allosource, Inc., Allotech, LLC, Axogen, Inc., Aziyo Biologics, Inc., Bacterin International, Inc., Berkeley Advanced Biomaterials, Biodlogics, LLC, Biomet Interpore Cross, Biostructures, LLC, Bone Bank Allografts, Cellright Technologies, Community Tissue Services, Cryolife, Inc., DCI Donor Services, Gencure Tissue Center, Globus Medical, Inc., Lattice Biologics, Inc., Lifecell Corporation, Lifecell Corporation-Evans Way, Lifelink Tissue Bank, Lifelink Tissue Bank-Orlando, Lifenet Health, Lifenet Health Northwest, Lifenet Health Of Florida, Musculoskeletal Transplant Foundation-Edison, Musculoskeletal Transplant Foundation-Jessup, Musculoskeletal Transplant Foundation-Olyphant, Musculoskeletal Transplant Foundation-Redlands, Nuvasive, Inc., Nuvasive, Inc.-Memphis, Osiris Therapeutics, Inc., Pinnacle Transplant Technologies, LLC, Regenerative Biologics, Inc., Rocky Mountain Tissue Bank, RTI Donor Services, RTI Surgical, Inc.-Progress Blvd, RTI Surgical Inc.-Research Cir, Seaspine Sales, LLC, Spinalgraft Technologies, LLC, Stryker Spine, Translife Tissue Recovery Services, UMTB Biomedical, Inc., UMTB Donor Services Foundation – Jacksonville Satellite Recovery, Wright Medical Technology, Inc., Wright Medical Technology District Service Center Orlando, Wuxi Apptec, Inc., and Zimmer Etex. The Petition requests an extension of a previously granted temporary waiver of Florida Administrative Code subparagraph 59A-1.005(35)(a)2, requiring HTLV testing for donor tissue. Any interested person may file comments within 14 days of the publication of this notice with Dayle Mooney by email to [e-mail] or by fax to [phone].

A copy of the Petition for Variance or Waiver may be obtained by contacting: Laboratory Licensure Unit, Bureau of Health Facility Regulation, Agency for Health Care Administration, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308 or by email to [e-mail].