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., Bacterin ...

 

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 August 5, 2014, 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., Bacterin International, Inc.-Biologics Division, Berkeley Advanced Biomaterials, Bone Bank Allografts, Community Tissue Services-Dayton, Cryolife, Inc., DCI Donor Services, Etex Corporation, Gencure Tissue Center, Globus Medical, Inc., Hans Biomed Corporation, Interpore Cross International, Isotis Orthobiologics, Inc., Lattice Biologics, Inc., Lifecell Corporation-Evans Way, Lifecell Corporation-One Millenium Way, Lifelink Tissue Bank-Delaney Creek, Lifelink Tissue Bank-Orlando, Lifenet Health, Lifenet Health Northwest, Lifenet Health Of Florida, Medtronic Osteotech, Inc., Musculoskeletal Transplant Foundation-Edison, Musculoskeletal Transplant Foundation-Jessup, Musculoskeletal Transplant Foundation-Olyphant, Musculoskeletal Transplant Foundation-Redlands, Nuvasive, Inc., Nuvasive, Inc.-Memphis, Nuvasive Inc.-Paramus, Osiris Therapeutics, Inc., Parametrics Medical, Pinnacle Transplant Technologies, LLC, Regenerative Biologics, Inc., Rocky Mountain Tissue Bank, RTI Donor Services, RTI Surgical, Inc.-Progress Blvd, RTI Surgical Inc.-Research Cir, Shire Regenerative Medicine, Inc., Spinalgraft Technologies, LLC., TBI-San Francisco, Tissuenet, Translife Tissue Recovery Services, University of Miami Tissue Bank, Wright Medical Technology, Inc., and Wuxi Apptec, Inc. The Petition requests an extension of a previously granted 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 Carlton Enfinger 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].