United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-07-03 article Rules and Regulations D09002ee1c7fb48ca D09002ee1c7fb497b United States Department of Health and Human Services originator org United States Government Agency or Subagency HHS is issuing this final rule (herein referred to as "this rule") to add vascularized composite allografts (VCAs) as specified herein to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (herein referred to as the OPTN final rule). When it enacted the National Organ Transplant Act in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Prior to this rule, the OPTN final rule defined covered organs as "a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.' " This rule also includes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (NOTA). 78 FR 40033 https://www.govinfo.gov/app/details/FR-2013-07-03/2013-15731 2013-15731 fr03jy13-20 RIN 0906-AA73 4165-15-P https://www.govinfo.gov/app/details/FR-2013-07-03/2013-15731 https://www.govinfo.gov/content/pkg/FR-2013-07-03/html/2013-15731.htm https://www.govinfo.gov/content/pkg/FR-2013-07-03/pdf/2013-15731.pdf Health Care Hospitals Organ Transplantation Reporting and Record Keeping Requirements 10 p. 40033 40042 78 FR 40033 Title 42 Part 121 42 CFR Part 121 RIN 0906-AA73 Organ Procurement and Transplantation Network; Federal Register Vol. 78, Issue RULE 2013-15731 DEPARTMENT OF HEALTH AND HUMAN SERVICES 2014-07-03 4165-15-P 2013-15731 Final rule.

HHS is issuing this final rule (herein referred to as "this rule") to add vascularized composite allografts (VCAs) as specified herein to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (herein referred to as the OPTN final rule). When it enacted the National Organ Transplant Act in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Prior to this rule, the OPTN final rule defined covered organs as "a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.' " This rule also includes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (NOTA).

The final rule is effective July 3, 2014. James Bowman, M.D., Medical Director, Division of Transplantation, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857, or by telephone (301) 443-7577. Health Care Hospitals Organ Transplantation Reporting and Record Keeping Requirements Organ Procurement and Transplantation Network , www.salary.com Vol. 78, no. 128 Office of the Federal Register, National Archives and Records Administration 2013-07-03 continuing daily deposited born digital 434 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-07-03 P0b002ee1850aa2ec 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03jy13 https://www.govinfo.gov/app/details/FR-2013-07-03 https://www.govinfo.gov/content/pkg/FR-2013-07-03/pdf/FR-2013-07-03.pdf https://www.govinfo.gov/content/pkg/FR-2013-07-03/xml/FR-2013-07-03.xml fdlp 39957 40380 DGPO 2013-07-03 2024-06-03 FR-2013-07-03 machine generated eng FR FR-2013-07-03 78 128