[Federal Register Volume 71, Number 14 (Monday, January 23, 2006)]
[Notices]
[Pages 3519-3520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Health Resources and Services Administration; Organ Procurement 
and Transplantation Network Status of Living Donor Guidelines

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

[[Page 3520]]


ACTION: Request for public comment.

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SUMMARY: The purpose of this solicitation of comments is to assist HRSA 
in determining whether criteria developed by the Organ Procurement and 
Transplantation Network (OPTN) concerning organs procured from living 
donors, including those concerning the allocation of organs from living 
donors, should be given the same status, and be subject to the same 
enforcement actions, as other OPTN policies.

DATES: Written comments must be submitted to the office in the address 
section below by mail or e-mail on or before February 22, 2006.

ADDRESSES: Please send all written comments to James F. Burdick, M.D., 
Director, Division of Transplantation, Healthcare Systems Bureau, 
Health Resources and Services Administration, Room 12C-06, Parklawn 
Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 
443-7577; fax (301) 594-6095; or e-mail: [email protected].

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, 
Division of Transplantation, Healthcare Systems Bureau, Health 
Resources and Services Administration, Parklawn Building, Room 12C-06, 
5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443-7577; 
fax (301) 594-6095; or e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Congress has provided specific authority 
under Sections 372 of the Public Health Service (PHS) Act, as amended, 
42 U.S.C. 274 for the creation of a national OPTN, which is, among 
other things, to facilitate a donor and recipient matching system; 
establish membership criteria and medical criteria for allocating 
donated organs; and provide opportunities to members of the public to 
comment with respect to proposed criteria.
    The OPTN Final Rule (42 CFR part 121) governs the operations of the 
OPTN and is intended to help achieve the most equitable and medically 
effective use of human organs that are donated in trust for 
transplantation. Under the final rule, the OPTN is to develop policies 
on a variety of issues, including ``[p]olicies for the equitable 
allocation of cadaveric organs [now referred to as deceased donor 
organs].'' 42 CFR 121.4(a)(1). Under the final rule, allocation 
policies developed by the OPTN under section 121.8 of the final rule 
will be considered enforceable when and if the Secretary approves the 
policies as such. Enforceable OPTN policies are subject to the 
sanctions described in section 121.10(c)(1) of the final rule. Non-
enforceable OPTN policies may still be subject to lesser sanctions by 
the OPTN (e.g., an OPTN member being designated a member not in good 
standing).
    Although the authorizing statute does not distinguish between 
transplants using organs from living donors from those using organs 
from deceased donors, the final rule does not include a requirement 
that the OPTN develop policies concerning the equitable allocation of 
living donor organs. Until recently, OPTN policies have predominantly 
focused on issues related to organ donation and transplantation of 
deceased donor organs.
    However, several widely publicized living donor deaths have caused 
the OPTN to implement new practices of reviewing and approving, on an 
advisory basis, the qualifications of living donor transplant programs. 
Additionally, the increased incidence of altruistic living donations 
has prompted the OPTN to consider policies that are patient-focused yet 
address the unique circumstances pertaining to the recovery and 
transplantation of living donor organs. Section 121.4(a)(6) of the 
final rule provides that the OPTN shall be responsible for developing 
policies on a variety of topics, including ``[p]olicies on such matters 
as the Secretary directs.'' In accordance with that authority, the 
Healthcare Systems Bureau directed the OPTN to develop allocation 
guidelines for organs from living donors and other policies necessary 
and appropriate to promote the safety and efficacy of living donor 
transplantation for the donor and recipient. It further advised the 
OPTN that all living donation policies (other than data reporting 
policies) should be considered as best practices or voluntary 
guidelines and not subject to regular OPTN sanctions (even those 
available with respect to violation of non-enforceable policies) until 
the public has had an opportunity to comment on the matter.
    The purpose of this solicitation of comments is to assist HRSA in 
determining whether OPTN living donor guidelines should be given the 
same status of other OPTN policies, i.e., be treated as policies 
developed in accordance with 42 CFR 121.8, and be subject to the same 
enforcement actions. If the Secretary decides these questions in the 
affirmative, OPTN policies relating to living donors would be treated 
the same as other OPTN policies developed in accordance with section 
121.8 of the final rule. In other words, OPTN policies concerning 
living donors would not be considered enforceable policies under 
section 121.10 of the final rule, and violations of such policies would 
not be subject to the sanctions described in section 121.10(c)(1), 
unless and until the Secretary approved such policies as enforceable.

    Dated: January 13, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-661 Filed 1-20-06; 8:45 am]
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