Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from AXOGEN, INC.; BACTERIN INTERNATIONL, INC.; BONE BANK ALLOGRAFTS; COMMUNITY TISSUE SERVICES-CALIFORNIA; COMMUNITY TISSUE SERVICES-DAYTON; COMMUNITY TISSUE SERVICES-...

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

RULE NO: RULE TITLE
59A-1.005: Standards for OPOs, Tissue Banks and Eye Banks

NOTICE IS HEREBY GIVEN that on April 08, 2010, the Agency for Health Care Administration, received a petition for Variance or Waiver from of subsection 59A-1.005(35), Florida Administrative Code, from AXOGEN, INC.; BACTERIN INTERNATIONL, INC.; BONE BANK ALLOGRAFTS; COMMUNITY TISSUE SERVICES-CALIFORNIA; COMMUNITY TISSUE SERVICES-DAYTON; COMMUNITY TISSUE SERVICES- INDIANA; COMMUNITY TISSUE SERVICES-NORTHWEST OHIO; COMMUNITY TISSUE SERVICES-PENNSYLVANIA; COMMUNITY TISSUE SERVICES-PORTLAND; COMMUNITY TISSUE SERVICES-TEXAS; CRYOLIFE, INC.; INTERPORE CROSS INTERNATIONAL; LIFECELL CORPORATION; LIFELINK FOUNDATION TISSUE BANK; LIFELINK TISSUE BANK-WOODLAND; LIFENET HEALTH; OSTOTECH, INC.; MUSCULOSKELETAL TRANSPLANT FOUNDATION; RTI BIOLOGICS, INC. – RESEARCH CIRCLE; SOUTHEAST TISSUE ALLIANCE, INC.; UNIVERSITY OF MIAMI TISSUE BANK; and WRIGHT MEDICAL TECHNOLOGY, INC. The petition requests a variance of rule provisions requiring HTLV testing for donor tissue. The specific provision on which the waiver is sought is subparagraph 59A-1.005(35)(a)2., Florida Administrative Code. The Petitioner in its request seeks a permanent variance from the rule due to substantial hardship.
A copy of the Petition for Variance or Waiver may be obtained by contacting: Shaddrick A. Haston, Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #3, Tallahassee, Florida 32308.