HHS HRSA add Final Rule to add vascularized composite allografts (VCAs) to NOTA

[Clark]

http://www.gpo.gov/fdsys/pkg/FR-2013-07-03/html/2013-15731.htm

[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Rules and Regulations]
[Pages 40033-40042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121

RIN 0906-AA73


Organ Procurement and Transplantation Network

AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: 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).

DATES: The final rule is effective July 3, 2014.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: On December 16, 2011, HHS published a notice
of proposed rulemaking (NPRM) in the Federal Register (76 FR 78216) to
include VCAs within the definition of organs covered by the OPTN final
rule and to make a corresponding change to the definition of human
organs covered by section 301 of NOTA. The NPRM provided for a 60-day
comment period and HHS received 29 comment letters raising a variety of
issues. HHS has carefully considered all comments in developing this
rule, as outlined in Section III below, presenting a summary of all
major comments and Departmental responses.

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