[Federal Register Volume 73, Number 42 (Monday, March 3, 2008)]
[Notices]
[Pages 11420-11422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Organ Procurement and Transplantation Network

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

ACTION: Request for information.

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SUMMARY: HRSA, Healthcare Systems Bureau, Division of Transplantation 
(DoT) is in the process of information-

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gathering to assist in determining whether it should engage in 
rulemaking with respect to vascularized composite allografts, described 
more fully below. The purpose of this solicitation is to receive 
feedback from stakeholders and the public on the following questions: 
(1) Whether vascularized composite allografts should be included within 
the definition of organs covered by the regulations governing the 
operation of the Organ Procurement and Transplantation Network (OPTN) 
(referred to here as the ``final rule''), and regulated as such, and 
the likely impact of such an amendment; (2) whether vascularized 
composite allografts should be added to the definition of human organs 
covered by section 301 of the National Organ Transplant Act of 1984, as 
amended, (NOTA) and the likely impact of such an addition; and (3) if 
either of these changes are pursued, the optimal way to define 
vascularized composite allografts for the above-described purposes.
    This Request for Information is limited to information-gathering 
and is not a proposal to make any determinations regarding Federal 
oversight of vascularized composite allografts.

DATES: Written comments must be received at HRSA by May 2, 2008. 
Comments will be made publicly available by submitting a written 
request to the address below.
    In addition, HRSA will hold a meeting to which the public and all 
stakeholders are invited for discussion and recommendations about the 
issues described above. The meeting will be held on Friday, April 4, 
2008, from 10 a.m. to 4 p.m., at the Parklawn Building, 5600 Fishers 
Lane, Rockville, MD 20057.

ADDRESSES: Please send all written comments to James F. Burdick, M.D., 
Director, Division of Transplantation, Healthcare Systems Bureau, 
Health Resources and Services Administration, 5600 Fishers Lane, 
Room12C-06, Rockville, Maryland 20857; telephone (301) 443-7577; fax 
(301) 594-6095; or e-mail: [email protected].
    Requests to attend the meeting in person should be addressed to 
Elizabeth Ortiz-Rios, M.D., M.P.H., Chief Medical Officer, Division of 
Transplantation, Healthcare Systems Bureau, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, 
Maryland 20857; telephone (301) 443-4423; fax (301) 594-6095; or e-
mail: [email protected]. A call-in number will be provided for 
individuals who would like to participate by phone. The call-in 
information will be posted in the `Highlights' section on the home page 
of http://www.organdonor.gov. If you plan to participate by phone, we 
request that you notify Dr. Ortiz-Rios by e-mail at [email protected] no later than March 24, 2008, so that we can better 
estimate the number of phone lines that will be needed. Please include 
in the subject line of electronic correspondence ``Vascularized 
Composite Allografts.''
    Docket: For access to the docket to read background documents or 
comments received, phone (301) 443-7577 to schedule an appointment to 
view public comments.

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, 
Division of Transplantation, Healthcare Systems Bureau, Health 
Resources and Services Administration, at the contact information cited 
above.

SUPPLEMENTARY INFORMATION:

Background and General Questions

    The first successful hand transplant in the United States was 
performed in 1999. Worldwide there have been over two dozen limb 
transplants, at least two transplants of portions of the face, and a 
small number of transplants of other such anatomical parts (e.g., 
abdominal wall, vascularized skeletal muscle, uterus, digits, thymus). 
Although the body parts involved vary significantly, two 
characteristics that are shared in such transplants are that they are 
susceptible to ischemia (damage or death from lack of blood flow) and 
their need for revascularization, done through a surgical reconnection 
of blood vessels to accomplish the transplant, as opposed to secondary 
ingrowth of vessels. In viable vascularized transplants, 
immunosuppression is necessary to prevent or treat rejection. This 
immunosuppression has risks, which have been justified in patients 
needing organs as presently defined in the final rule, because of their 
lifesaving potential. In the past, the risks of immunosuppression have 
inhibited transplantation of vascularized composite allografts because 
the risks associated with the prolonged use of immunosuppressive drugs 
were thought to exceed the expected benefits of the transplant. 
However, the powerful impact these transplants can have to overcome and 
improve the quality of life for individuals with grievous disabilities 
has become increasingly apparent. Coupled with this, immunosuppressive 
management for these transplants has improved so that risks associated 
with immunosuppression, such as cancer, infection, or other morbidities 
in recipients are lessened considerably. For these reasons, it is 
likely that the numbers of vascularized composite allografts 
transplanted will increase in the future. Given this anticipated 
increase, HRSA is considering the advisability of proposing that such 
transplants (i.e., transplants of vascularized composite allografts) be 
regulated under the final rule and governed by section 301 of NOTA.
    HRSA is considering whether to propose that viable vascularized 
composite allografts, or body segments, be considered organs subject to 
the oversight of the OPTN under the authority of the final rule. This 
might be accomplished by adding vascularized composite allografts to 
the final rule's definition of organs through rulemaking. Currently, 
the final rule defines 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.' '' Once a body part is considered an organ 
under the final rule, transplants involving such organs are subject to 
the requirements of the final rule. For example, entities performing 
transplants with the organs must receive designation as an organ-
specific designated transplant program within an OPTN member 
institution. In addition, OPTN members must comply with the final 
rule's data submission requirements with respect to the transplants 
performed. In addition, OPTN members are subject to oversight by the 
OPTN contractor for compliance with OPTN policies regarding donor 
screening and allocation, and may be subject to enforcement actions for 
violations of such policies.

The Definition of Organs Under the Final Rule

    HRSA is seeking feedback from stakeholders and from the public 
about the advisability of exploring rulemaking to include vascularized 
composite allografts within this definition of organs, as well as the 
potential ramifications of such a change. If, upon consideration of 
public comments, HRSA is persuaded that such a change may be warranted, 
HRSA may initiate rulemaking setting forth a more specific set of 
proposals.

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    For example, HRSA is interested in the public's assessment of the 
likely impact if OPTN policies concerning issues such as membership 
designation to receive organs, the retrieval of organs, allocation of 
organs, data collection and reporting, and OPTN policy compliance 
oversight were extended to vascularized composite allograft 
transplants. HRSA seeks feedback concerning whether regulation under 
the OPTN final rule would be effective in addressing special safety and 
allocation issues presented by vascularized composite allograft 
transplants as the field grows. Further, HRSA is interested in the 
public's assessment as to whether the clinical aspects of transplants 
of such vascularized composite allografts are more analogous to 
transplants of organs, as defined currently by the final rule, than to 
conventional tissue transplantation without surgical revascularization.
    Presently, it is HRSA's understanding that these transplants of 
vascularized composite allografts are done by individual arrangements 
with local organ procurement organizations (OPOs) to allow retrieval of 
the needed structure during routine deceased donor organ retrievals. 
However, some of these vascularized composite allografts, e.g., testes, 
ovaries, or other endocrine glands, may come from living donors. HRSA 
is interested in perceived vulnerabilities concerning the current 
regulatory status of such transplants and the potential benefits of 
subjecting such transplants to the oversight of the OPTN and HRSA under 
the final rule.

The Definition of Human Organs Under Section 301 of NOTA

    HRSA is also seeking feedback as to whether it should explore 
rulemaking to add vascularized composite allografts to the definition 
of human organs covered by section 301 of NOTA, as well as the 
potential consequences of such an action. Section 301 prohibits the 
purchase, sale, or other exchange for valuable consideration of human 
organs for transplantation. Although the statute lists covered human 
organs, the Secretary is authorized to add to this list through 
rulemaking. ``Human organ,'' as defined by NOTA and modified by the 
Secretary, means ``the human (including fetal) kidney, liver, heart, 
lung, pancreas, bone marrow, cornea, eye, bone, skin, and intestine, 
including the esophagus, stomach, small and/or large intestine, or any 
portion of the gastrointestinal tract.'' Adding to the definition of 
human organs covered by section 301 would make transfers of organs 
meeting the statute's requirements subject to its criminal sanctions. 
If, after receiving public comments, HRSA is persuaded that a change to 
this definition may be appropriate, HRSA may initiate rulemaking 
setting forth a more specific set of proposals.

Defining Vascularized Composite Allografts

    To assist the Secretary in the event that he proposes, through 
rulemaking, to add vascularized composite allografts to the definition 
of organs covered by the final rule and/or to the definition of human 
organs governed by section 301 of NOTA, HRSA seeks feedback from 
stakeholders and from the public as to how such allografts should be 
defined. HRSA has identified two potential approaches.
    Under the first approach, a regulatory definition could be broad, 
describing the features of the allografts without listing particular 
body parts. Under such an approach, the definition might extend to 
transplants of body parts that are not known to have been performed 
clinically to date, or even to body parts whose transplantation has not 
yet been envisioned. HRSA is interested in what elements would need to 
be included in such a definition in order to be broad enough to cover 
the universe of intended body parts, but narrow enough to put the 
public on notice as to which parts meet the regulatory definitions of 
organs. Shared characteristics that might be included in a regulatory 
definition could include some or all of the following: (1) A 
vascularized allograft containing multiple tissue types; (2) recovered 
from a human donor as an anatomical/structural unit; (3) transplanted 
into a human recipient as an anatomical/structural unit; (4) minimally 
manipulated, as defined by FDA in Title 21 CFR 1271.3(f); (5) for 
homologous use as defined by FDA in Title 21 CFR 1271.3(c); (6) not 
combined with another article such as a device; (7) used fresh and not 
cryopreserved; (8) susceptible to ischemia and, therefore, only stored 
temporarily (e.g., cold storage in preservation medium and intended for 
implantation into a recipient within hours of the recovery); and (9) 
susceptible to allograft rejection which requires immunosuppression 
that may increase infectious disease risk to the recipient. HRSA seeks 
feedback from the public as to whether some or all of these 
characteristics describe vascularized composite allografts, which would 
be included in the definition of organ. HRSA invites feedback on such 
an approach as well as the particular characteristics listed here and 
invites suggestions concerning the advisability of including any 
additional characteristics.
    Under a second alternative, HRSA could propose a definition that 
lists specific body parts to be added to the definition of organs 
(e.g., face, hand, etc.). HRSA seeks feedback as to the feasibility of 
creating such a definition, which body parts should be included in such 
a definition, and whether such a definition would necessarily exclude 
certain body parts for which transplantation might be possible, but has 
not been performed to date (either in the United States or 
internationally).
    Following this comment period and meeting, if HRSA decides to 
proceed with rulemaking to include vascularized composite allografts in 
the definition of organ, this decision will be written and published as 
a Notice of Proposed Rulemaking.

    Dated: February 20, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-3994 Filed 2-29-08; 8:45 am]
BILLING CODE 4165-15-P