[Federal Register: March 3, 2008 (Volume 73, Number 42)]
[Notices]
[Page 11420-11422]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr08-60]
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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-
[[Page 11421]]
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: jburdick@hrsa.gov.
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: EOrtiz-Rios@hrsa.gov. 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 EOrtiz-
Rios@hrsa.gov 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.
[[Page 11422]]
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]
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