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Rules Open for Comments
Notice: 19913923
Final Adopted Version in F.A.C.
Department:
AGENCY FOR HEALTH CARE ADMINISTRATION
Division:
Health Facility and Agency Licensing
Chapter:
CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS, TISSUE BANKS, AND EYE BANKS (IN MEMORY OF CHARLES ARLEIGH LINCOLN, PH.D.)
Overview
RULE:
59A-1.005
Standards for OPOs, Tissue Banks and Eye Banks
RULE FILE DATE:
12/28/2017
RULE EFFECTIVE DATE:
1/17/2018
HISTORY NOTES:
Rulemaking Authority
765.541(2) FS.
Law Implemented
765.541
,
765.542
,
765.543
,
765.545 FS.
History–New 11-26-92, Amended 8-20-96, 1-17-18.
OVERSIGHT COMMITTEE:
Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)
RELATED COURT CASES:
Division of Administrative Hearings
FEDERAL RULES
AND REGULATIONS:
Electronic Code of Federal Regulations
HOW TO LINK TO
THIS NOTICE:
http://flrules.org/gateway/ruleno.asp?id=59A-1.005&Section=0
REFERENCE MATERIALS:
Ref-09009 OPTN policies, effective April 6, 2017
Ref-09010 “PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission Through Organ Transplantation”, as published in Public Health Reports/July-August 2013/Volume 128
Ref-09011 21 CFR Part 1270, 2010 Edition
Ref-09012 21 CFR Part 1271, 2012 Edition
Ref-09014 42 CFR Parts 413, 441, 486, and 498, effective May 31, 2006
Ref-09015 Occupational Safety and Health Administration (OSHA) rules 29 Code of Federal Regulations (CFR) Part 1910.1030, effective April 3, 2012
Ref-09016 FDA Guidance for Industry “Eligibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-based Products (HCT / Ps)”, August 2007