[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Rules and Regulations]
[Pages 40033-40042]
From the Federal Register Online via the Government Publishing 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.
I. Background
As discussed in the NPRM, the transplant community has referred to
the transplants of intact vascularized body parts such as hands and
faces as composite tissue allograft transplants. As tissues, these
components have been under the regulatory jurisdiction of the Food and
Drug Administration (FDA). For the reasons outlined in the NPRM, the
Secretary believes that these components, based on their clinical
characteristics, are more characteristic of organs as defined
specifically in NOTA and subsequently by regulation in the case of
intestines and blood vessels used in conjunction with organ
transplantation. For the purpose of this regulation, these components
are described as vascularized composite allografts (VCAs).
Human cells or tissue intended for implantation, transplantation,
infusion, or transfer into a human recipient are regulated as human
cells, tissues, and cellular and tissue-based products (or HCT/Ps). FDA
regulates HCT/Ps under section 361 of the Public Health Service Act (42
U.S.C. 264) and 21 CFR parts 1270 and 1271. Examples of such tissues
are bone, skin, corneas, ligaments, tendons, dura mater, heart valves,
hematopoietic stem/progenitor cells derived from peripheral and cord
blood, oocytes, and semen. FDA does not regulate the transplantation of
vascularized human organ transplants such as kidney, liver, heart,
lung, or pancreas. FDA regulations provide that ``vascularized human
organs for transplantation'' are not considered HCT/Ps. 21 CFR
1271.3(d)(1). HRSA oversees the transplantation of vascularized human
organs.
At present, face and hand allografts, and other body parts meeting
the proposed definition of VCAs, are not
[[Page 40034]]
explicitly excluded from the definition of HCT/Ps under FDA
regulations. Conversely, vascularized human organs for transplantation
are excluded from FDA's tissue regulations and are under HRSA's
purview.
On March 3, 2008, HRSA published a Request for Information (RFI) in
the Federal Register (73 FR 11420) seeking feedback from stakeholders
and the public as to whether VCAs should be included within the OPTN
final rule's definition of organs, and whether VCAs should be added to
the definition of human organs covered by section 301 of NOTA. HRSA
also sought feedback concerning the best way to specify VCAs if either
definition were implemented. HRSA considered the 11 comments received
in response to the RFI.
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 in the OPTN 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 agency
responses.
II. Summary of This Rule
Adding VCAs to the Definition of Organs Covered by the OPTN Final Rule
Based upon a review of the characteristics of VCAs and the comments
submitted by the public, the Secretary believes that VCAs should be
included within the definition of organs covered by the OPTN final rule
(42 CFR part 121). This rule also includes a change to the definition
of human organs covered by section 301 of NOTA to include VCAs. Once a
body part is defined as an organ under the OPTN final rule, such body
parts are excluded from the coverage of FDA regulations governing HCT/
Ps, 21 CFR 1271.3(d)(1).
Pursuant to this rule, for a body part to be defined as a VCA, it
must have all the following characteristics: A body part that is (1)
Vascularized and requires blood flow by surgical connection of blood
vessels to function after transplantation; (2) containing multiple
tissue types; (3) recovered from a human donor as an anatomical/
structural unit; (4) transplanted into a human recipient as an
anatomical/structural unit; (5) minimally manipulated (i.e., processing
that does not alter the original relevant characteristics of the organ
relating to the organ's utility for reconstruction, repair, or
replacement--examples of minimal manipulation include cutting,
grinding, and shaping of a VCA); (6) for homologous use (i.e., the
replacement or supplementation of a recipient's organ with an organ
that performs the same basic function or functions in the recipient as
in the donor, e.g., a hand from the donor is to be used as a hand in
the recipient); (7) not combined with another article such as a device;
(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 not
cryopreserved; and (9) susceptible to allograft rejection, generally
requiring immunosuppression that may increase infectious disease risk
to the recipient.
This definition identifies which body parts are now covered, while
providing flexibility to allow other body parts to be covered as the
field of VCA transplantation advances. Since the proposed rule, the
word ``generally'' has been added to the ninth criterion for technical
accuracy (e.g., in the case of identical twins where immunosuppression
may not occur). A non-exclusive list of body parts that meet the
definition for VCAs implemented in this rule include faces; limbs
(e.g., arms, hands, fingers, legs, toes); larynges; and abdominal
walls. Periodically, HRSA may publish an updated list of VCAs in the
Federal Register. In addition, this definition established those body
parts as organs under the OPTN final rule from other body parts that
are regulated as HCT/Ps under FDA's regulatory authority.
Additionally, a body part allocated as a VCA is intended to be used
``intact'' as a VCA until the transplant center receiving the VCA
determines that a portion or piece of the VCA is not needed for
transplantation. If portions of a VCA are not used in connection with
the same transplant (e.g., leftover bone or tendons from a limb
allocated as a VCA), such body parts must not be used for other
purposes including transplantation in a different anatomical location
in the recipient who received the VCA or in a different recipient. As
explained in the NPRM, disposition of such VCA remnants would be
subject to OPTN policies and state regulations. Because the definition
in this rule does not identify specific VCAs by name, we are amending
42 CFR 121.4(e) to make clear that the OPTN must identify the specific
body parts covered by any OPTN policy specific to VCAs. The purpose of
this rule is to ensure that all OPTN members and stakeholders
understand the body parts covered by OPTN policies specific to VCAs.
Once this rule goes into effect, revised 42 CFR 121.4 (e)(3) will
require the OPTN to ``identify all covered body parts in any policies
specific to vascularized composite allografts, defined in Sec.
121.2.'' Thus, before the OPTN adopts any VCA-specific policies, the
OPTN will need to list all covered body parts for clarity. This will
not require a regulatory process. Under this rule, any OPTN policy that
applies broadly to organs would apply to all body parts meeting the
definition for VCAs unless otherwise specified.
HRSA oversees transplantation of vascularized human organs through
the OPTN, which sets policies related to the procurement,
transplantation, and allocation of human organs. The OPTN serves the
critical role of matching donor organs to potential recipients on a
national basis. Issues concerning allocation and recipient safety are
similar for VCAs and for organs currently under the OPTN's auspices.
Additionally, the membership of the OPTN, which is charged with
developing policies consistent with the OPTN final rule, includes
professionals with expertise in the field. Therefore, the Secretary
believes that the OPTN, with HRSA's oversight, is able to effectively
address issues involving the regulation of the emerging field of VCA
transplantation.
The nature of the regulatory framework governing the operation of
the OPTN underlies the importance of including VCAs within the
definition of organs covered by the OPTN final rule. Under the OPTN
final rule, the OPTN must submit proposed policies for review and
approval by the Secretary (42 CFR 121.4). Upon consideration of public
comments on proposed policies that are considered significant, the
Secretary will determine whether to make such proposed policies
enforceable in accordance with section 121.4 of the OPTN final rule.
The Secretary may direct the OPTN to develop individual policies for
specific body parts that are defined as VCAs in addition to OPTN
policies that apply to all VCAs. Any transplant hospital that fails to
comply with any policy approved as enforceable by the Secretary under
this process may be subject to the enforcement sanctions delineated in
section 121.10 of the OPTN final rule, including possible termination
from the Medicare and Medicaid programs.
The Secretary has the following additional authorities provided by
the OPTN final rule (42 CFR 121.4(b)(2)),
[[Page 40035]]
which she may exercise in the case of policies extending to VCAs: The
Secretary may require the OPTN Board of Directors to provide to the
Secretary, at least 60 days prior to their proposed implementation,
proposed policies on matters that the Secretary directs. The Secretary
will refer such significant proposed policies to the Advisory Committee
on Organ Transplantation (ACOT), established under 42 CFR 121.12, and
publish them in the Federal Register for public comment. This is in
addition to the public comment process that is engaged in by the OPTN.
The Secretary also may seek the advice of the ACOT on other
proposed policies and publish them in the Federal Register for public
comment.
The Secretary will determine whether proposed policies are
consistent with NOTA and the OPTN final rule, taking into account the
views of the ACOT and public comments. Based on this review, the
Secretary may provide comments to the OPTN.
If the Secretary concludes that a proposed policy is inconsistent
with NOTA or the OPTN final rule, the Secretary may direct the OPTN to
revise the proposed policy consistent with the Secretary's direction.
If the OPTN does not revise the proposed policy in a timely manner, or
if the Secretary concludes that the proposed revision is inconsistent
with NOTA or the OPTN final rule, the Secretary may take such other
action as the Secretary determines appropriate, but only after
additional consultation with the ACOT on the proposed action.
Also, the Secretary has the authority under the OPTN final rule (42
CFR 121.4(a)(6)) to require the OPTN to develop policies on such
matters as the Secretary directs.
By including VCAs within the OPTN final rule's definition of
organs, transplants involving VCA will be subject to the requirements
of the OPTN final rule. For example, entities performing transplants
with covered organs must receive designation as an organ-specific
designated transplant program (in this case, a designation as a VCA-
specific transplant program) within an OPTN member institution. Members
must comply with data submission requirements of the OPTN final rule
and are subject to oversight by the OPTN for compliance with OPTN
policies, OPTN bylaws, and the OPTN final rule. Members may be subject
to federal enforcement actions for violations of federal regulations or
enforceable policies (those approved by the Secretary of Health and
Human Services) or for actions or inactions that indicate a risk to the
health of patients or to public safety. Also, OPTN members can be
subject to OPTN sanctions for violating OPTN bylaws and non-enforceable
OPTN policies (e.g., being declared a member not in good standing). The
OPTN will need to devise certain policies with respect to VCAs,
including allocation policies meeting the requirements set forth in the
OPTN final rule.
The Secretary is legally obliged, as part of her responsibilities
in administering the Medicare and Medicaid programs, to require
hospitals that transplant organs to comply with the rules and
requirements of the OPTN as a condition of their participation in
Medicare and Medicaid. (42 U.S.C. 1320b-8(a)(1)(B)). Because VCAs
currently are not included within the OPTN final rule's definition of
organs, the Secretary could not currently make any VCA allocation
policy enforceable. The inclusion of VCAs as covered organs under the
OPTN final rule will allow the Secretary to take appropriate
enforcement actions against an Organ Procurement Organization (OPO) or
transplant hospital for failing to comply with any OPTN retrieval and
allocation policy for VCAs, if such a policy has been approved as
enforceable by the Secretary under the process outlined above. It is
necessary to ensure that VCA organ allocation, whether pertaining to
isolated VCA transplants or combined/multi-organ transplants, is
consistent with OPTN final rule's goals, including that of an equitable
national system for organ allocation.
Even if some OPTN policies pertaining to VCA transplantation do not
become approved by the Secretary as enforceable, all institutions
performing VCA transplantation would be required to comply with the
provisions of the OPTN final rule (including the requirement that such
institutions become members of the OPTN and data submission
requirements). Further, such institutions could be subject to sanctions
by the OPTN for failure to comply with allocation and other OPTN
policies. For example, a member may be named a member not in good
standing by the OPTN for failing to comply with such a policy.
This rule includes one technical change to the regulation text
originally proposed in the NPRM. One of the proposed criteria for a
category of body parts to meet the definition of VCA was that it must
be ``susceptible to allograft rejection, requiring immunosuppression
that may increase infectious disease risk to the recipient.'' Although
this applies to all of the broad categories of these allografts (such
as limb, face, abdominal wall, etc), there could be a rare situation in
which the donor of a specific VCA allograft is either the identical
twin of the recipient or shares such highly concordant
histocompatibility matching markers in which case the recipient of the
VCA allograft would not require any immunosuppression. In addition,
there is potential for major advances in the field of immunologic
tolerance such that clinical interventions might eliminate the
susceptibility of allografts to rejection. Even though the recipient
would not require immunosuppression in such situations, these
categories of VCAs fall within the definition of VCAs in this notice.
For this reason, the list of criteria specified for the definition of
VCAs in the amended regulation (within 42 CFR 121.2) is modified to
read as follows: ``(9) susceptible to allograft rejection, generally
requiring immunosuppression that may increase infectious disease risk
to the recipient.''
Including VCAs Within the Definition of Human Organs Covered by Section
301 of NOTA
The Secretary has decided to include VCA within the definition of
human organs, as covered by section 301 of NOTA, which prohibits the
purchase or sale of human organs for human transplantation. This
criminal prohibition provides in part that ``[i]t shall be unlawful for
any person to knowingly acquire, receive, or otherwise transfer any
human organ for valuable consideration for use in human transplantation
if the transfer affects interstate commerce. The preceding sentence
does not apply with respect to human organ paired donation.'' (42
U.S.C. 274e(a).) Section 301 of NOTA defines the term ``human organ''
to mean ``the human (including fetal) kidney, liver, heart, lung,
pancreas, bone marrow, cornea, eye, bone, and skin or any subpart
thereof and any other human organ (or any subpart thereof, including
that derived from a fetus) specified by the Secretary of Health and
Human Services by regulation.'' (42 U.S.C. 274e(c)(1).)
As set forth by statute, the Secretary may add additional organs to
the definition of human organ covered by section 301 through rulemaking
to include the transplantation of additional human organs within
section 301's prohibition. The Secretary has previously exercised this
authority. Including VCAs within this definition of human organs may
subject persons violating its terms with respect to VCAs to criminal
penalties.
Through this rule, the Secretary adds VCAs to the list of human
organs covered by section 301 of NOTA. The
[[Page 40036]]
Secretary modifies 42 CFR 121.13, which includes the definition of
human organs covered by section 301 of NOTA, to include VCAs (as
defined through this regulation in revised section 121.2 of the OPTN
final rule). Subparts are being added to this definition to conform
with Public Law 100-607, which added subparts of covered human organs
to the statutory definition of human organs governed by section 301 of
NOTA.
III. Comments and Responses
HHS received a total of 29 comments from the public, including
transplant physicians and surgeons, health care professionals and other
individuals, transplant centers, professional transplant organizations,
and other non-profit organizations related to organ donation and
transplantation. Of the comments received, 27 supported adding VCAs to
the definition of organs covered by the OPTN final rule. The other two
comments were neither favorable nor unfavorable, but did not oppose the
proposal. Of the 27 supporting comments, 19 included various concerns
and suggestions. All comments were considered in developing this rule.
The following section presents a summary of all major issues raised in
the comment letters, grouped by subject, as well as a response to such
comments.
1. Use of VCA Portions for Non-VCA Transplants in Same Recipient
Comment: A commenter suggested that portions of a VCA not required
for organ transplantation (i.e., left over bone or tendons from a limb
allocated from VCA) should be permitted to be used to fully reconstruct
any anatomic area in that particular recipient. The commenter requested
that the statement ``such body parts cannot be used for transplantation
into a different anatomical location in the recipient,'' included in
the Preamble to the NPRM, be deleted from the proposed rule. The
commenter compares the use of additional tendons, nerves, vessels, fat
tissue, or spinal column to the current guidelines for use of blood
vessels recovered from a donor for the express purpose of assisting in
vascularization of an organ procured from the same donor and
transplanted to the same recipient. The comment also envisioned that
the use of donor bone marrow or fat tissue might reduce the amount of
required immunosuppression and should be treated in the same manner as
blood vessels for solid organ transplants.
Response: The Department does not agree with this recommended
change. The Secretary appreciates the intent of the commenter to make
use of available VCA portions for the benefit of patients. However, as
described in the NPRM, the Department expects that portions of a VCA
not used in connection with the same VCA transplant must not be used
for other purposes, including transplantation in a different anatomical
location in the recipient who received the VCA or in a different
recipient. Disposition of VCA remnants will be subject to OPTN policies
and state regulations. This provision is consistent with the current
regulatory status of blood vessels recovered with organs for
transplantation according to the OPTN final rule.
The term organ as defined by section 121.2 of the OPTN final rule
provides that ``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.''' Because VCAs are being included in this
definition of organs, blood vessels recovered in this way with VCAs
would also be considered part of the VCA. The addition of VCAs to the
OPTN final rule does not apply to the use of deceased donor bone marrow
since bone marrow does not meet the criteria for VCA designation.
2. Criteria for a VCA
Comment: A commenter indicated that the proposed definition of
organ is too broad and could cause confusion with HCT/Ps, especially
whole joints and other osteoarticular allografts (OAs) that are
currently regulated as HCT/Ps by FDA. The commenter indicated that only
two of the nine proposed criteria do not apply to OAs: the first
criterion, the requirement for blood flow by surgical revascularization
with blood vessel connection, and the ninth criterion, susceptibility
to allograft rejection requiring the use of immunosuppression. The
commenter suggested that for clarity and to avoid confusion this rule
specifically list OAs and those other HCT/Ps currently regulated by FDA
and not included as VCA organs.
Response: The Department does not agree with this comment. As
indicated in the NPRM: ``At the time of the RFI [2008], . . . HRSA
sought feedback from stakeholders and the public as to how VCAs should
be defined: . . . [either] (1) a broad regulatory definition describing
the common features of VCAs without listing covered body parts; or (2)
a definition listing body parts that would qualify as VCAs.'' And the
comments to the RFI suggested that VCAs should be included within the
definition of organs covered under the OPTN (10 out of 11 comments
supportive). In the NPRM, the Secretary proposed nine specific
characteristics to establish the criteria for a body part to meet the
definition of organ covered by the OPTN final rule. This approach is
intended to explain to the public which body parts would be presently
covered, while allowing other body parts that are transplanted to be
covered as the field advances. In addition, the Department received no
negative feedback in response to its request for information on
adopting this approach. Therefore, VCAs are defined in this rule
amendment by all nine specified criteria, not just one or several. As
indicated in the NPRM, for a body part to be defined as a VCA, it must
have all the nine characteristics. The examples described by the
commenter (whole joint and other OAs) do not meet at least two of these
criteria, so these allografts would not meet the definition of an organ
according to the OPTN final rule, as revised through this regulation.
3. OPTN Policy Development
Comment: Two comments included suggestions regarding OPTN policy
development for VCAs. They noted that VCA transplantation remains an
experimental field holding great promise and should be approached
carefully and thoughtfully as standards are developed to define and
measure success. According to the commenters, a nationwide VCA
Committee should be formed in preparation for OPTN policy approval and
to provide a national dialogue. The commenter suggested that this
committee should include representatives of centers that have performed
a clinical VCA transplantation in the United States in addition to the
major transplant and procurement societies. In addition, the commenter
suggested that the committee should work with the OPTN in developing a
5-10 year timeline to incorporate VCAs within the OPTN framework.
Response: The Department agrees with the commenters that VCA
transplantation is in its early phases and that the process for
developing OPTN policies for VCAs (including those that create
standards to define and measures success) should be approached
carefully and thoughtfully with input from a broad segment of the VCA
transplant community of professionals, institutions, and organizations.
The OPTN final rule (section 121.4) requires the OPTN to develop
policies ``with the
[[Page 40037]]
advice and interest of the OPTN membership and other interested
parties.'' Although the OPTN alone is responsible for establishing its
policies, the development of VCA policies may include the input of
other interested parties including transplantation surgeons,
physicians, and other professionals, transplant centers, OPOs, and
other institutions, transplant organizations, organ donor and
transplant patient representation, and the public. Although there is no
mechanism within the OPTN final rule to establish a formal committee
outside the OPTN governance structure, the OPTN has the flexibility to
gather additional information and input from experts in the field and
the public through various ad hoc Requests for Information and
scheduled open public forums. Incorporation of VCA policies within the
OPTN will be included as part of the ongoing OPTN strategic planning
process. Moreover, once this regulation goes into effect, all
transplant hospitals performing VCA transplantation and participating
in the Medicare or Medicaid programs will be required to be OPTN
members and, as such, will be able to participate in the development of
OPTN policies as members. 42 U.S.C. 1320b-8(a)(1)(B). The OPTN, in
consultation with HRSA, will decide upon the specific process by which
this input is obtained. As indicated in the VCA NPRM: ``The OPTN final
rule does allow some flexibility specific to each organ. The OPTN
sometimes fashions distinct organ-specific policies tailored to the
circumstances of transplanting particular organs. For example, the
training of professionals working for designated programs may vary by
organ and OPTN policies with respect to disease transmission protocols
and testing may diverge based on circumstances relating to particular
organs. Likewise, the particular characteristics of and circumstances
surrounding different types of organs lead to different OPTN allocation
policies.'' 76 FR at 78219.
Comment: One commenter requested that the Secretary provide the
OPTN guidance regarding flexibility for OPTN membership to programs and
groups that have not historically been focused on the field of
transplantation. The commenter strongly encourages the OPTN to accept
applications for medical/scientific or individual members that
encompass the viewpoint and expertise of the reconstructive surgeon and
their team/program as well as that of the conventional solid organ
transplant team.
Response: As indicated above, the Department agrees that the
process for development of OPTN policies for VCAs must be approached
carefully and thoughtfully with input from a broad segment of the VCA
transplant community of professionals, institutions, and organizations.
Because VCAs have not previously been included as organs under the OPTN
final rule, professionals with VCA programs affiliated with the current
OPTN members are not specifically identified by the OPTN as
reconstructive or VCA transplant surgeons or physicians or team members
within VCA programs. However, most current VCA transplant programs
operate within transplant hospitals that include transplant programs
for traditional organs (such as kidney, heart, liver, etc.), so the
parent institutions of these VCA transplant programs are already
members of the OPTN. The OPTN final rule (section 121.3 (b)(1))
requires that: ``The OPTN shall admit and retain as members the
following: (i) All OPOs; (ii) Transplant hospitals participating in the
Medicare or Medicaid programs and; (iii) Other organizations,
institutions, and individuals that have an interest in the fields of
organ donation or transplantation.'' Therefore, the OPTN final rule
provides the flexibility requested by the commenter for OPTN membership
to include appropriate VCA transplantation stakeholders.
Comment: One commenter expressed a preference that VCA allocation
should continue at this time as a locally driven process, developing
into a regional and national system as part of a long-term plan. The
commenter is concerned about the effects adding VCAs will have on the
current organ allocation system, such as technical issues and the
multiple extensive programmatic elements that need to be developed to
implement VCA allocation policies.
Response: The Department believes that development and
implementation of allocation policies for VCAs by the OPTN can be
complex and must be conducted in a thoughtful and deliberative manner
that is widely inclusive of the broad community of VCA stakeholders and
completely transparent to all. The OPTN final rule (section 121.8)
emphasizes that OPTN organ allocation policies shall be based on sound
medical judgment; shall seek to achieve the best use of organs; shall
be specific for each organ type; shall be designed to avoid wasting
organs, to avoid futile transplants, to promote patient access to
transplantation, and to promote the efficient management of organ
placement; and shall not be based on the candidate's place of residence
or place of listing (except to the extent required by other regulatory
requirements). As stated in the Preamble to the VCA NPRM: ``given the
relatively small numbers of other VCAs transplanted at this time, the
Secretary does not expect that the OPTN would develop allocation
policies for all VCAs within a short time frame. . . .'' 76 FR at
78218. We explained the Department's expectation that the OPTN will
initially create policies addressing hands and faces as these two VCAs
have been the most frequently performed VCA transplant procedures in
the U.S. and are the subject of extensive ongoing clinical research
programs by the Departments of Defense and Veterans Affairs. The
Department's position has not changed: we continue to expect that the
OPTN will develop allocation policies initially for hands and faces and
will wait to develop allocation policies for other organs until the
field has more clinically evolved and the need arises. The OPTN
utilizes organ-specific committees to discuss, draft, and propose
organ-specific policies, including those related to allocation. The
Department anticipates that the OPTN will establish similar
committee(s) containing experts in VCA transplantation. Initially,
these are likely to be committees or subcommittees for limb and/or face
transplantation. The concerns and issues brought up by the commenters
regarding allocation will be among the many issues discussed in detail
by organ-specific VCA committee(s). Each VCA is associated with its own
unique set of characteristics and clinical factors that the organ-
specific committee(s) can take into consideration when developing
allocation policies.
4. Impact on First Person Donor Authorization in State Registries
Comment: A commenter expressed concerns as to whether currently
registered organ donors would be automatically ``opted in'' (selected)
for donating VCAs (i.e., hand and/or face) or whether the organ donor
authorization registry for each state would need to be changed. The
commenter suggested drawing a distinction between ``life extending''
and ``not life extending'' VCAs and proposed that that each state
should institute a deceased organ registry where donors could ``opt
in'' (select specific organ designation) to elect to donate either
``life extending'' or ``not life extending'' organs (or both) while
also providing donors with the option to specifically exclude the
organs they do not wish to donate. Another commenter
[[Page 40038]]
recommended that a separate authorization be established for VCA
donation (presumably by states under applicable state laws).
At a meeting (February 28, 2012) of the ACOT, a committee member
commented that questions had been raised about whether consent to organ
donation generally (e.g., signing an organ donor card or designation in
a state registry) would suffice as consent to donate a VCA. The
committee member explained that, as a matter of public trust, a general
consent to organ donation should not be considered adequate to
constitute consent to donate a VCA.
Response: In the NPRM, the Secretary specifically requested
comments regarding the potential impact of including VCAs in the
definition of organs on organ donation efforts to increase
participation in deceased organ donor registries, signing organ donor
cards, and the general willingness of individuals to agree to be
deceased organ donors. Consent to donation is governed by state law.
The Uniform Anatomical Gift Act (UAGA) is a model law that addresses
issues including consent to donate organs from deceased donors. The
National Conference of Commissioners on Uniform State Laws have
promulgated three versions of the UAGA over time (1968, 1987, and
2006), each of which included a form of first person consent
(authorization), i.e., legally honoring the decision to donate organs
upon death by a person deemed competent to make such a decision. All
states have enacted laws based on one of the versions of the UAGA. Most
state laws on consent to organ and tissue donation are modeled on the
language used in the 2006 UAGA that refers to consent to donate a
``part'' of the body (meaning an organ, eye, or tissue, but not the
whole body). It is our understanding that most states have not clearly
defined organs and have not clearly delineated which body parts qualify
as organs as opposed to tissues for purposes of consent to donation.
Illinois law defines ``organ'' to mean ``a human kidney, liver, heart,
lung, pancreas, small bowel, or other transplantable vascular body part
as determined by the Organ Procurement and Transplantation Network, as
periodically selected by the U.S. Department of Health and Human
Services'' (755 ILCS 50/1-10). We defer to state officials on their
interpretation of state law. Putting aside Illinois law, it is our
understanding that reclassifying VCAs as organs in this regulation
should not affect their classification as organs, tissues, or other
body parts under state laws with respect to organ and tissue donation.
The hand and face have likely been considered tissue by most (if
not all) states since the first hand transplant was performed in the
U.S. in 1999. VCA transplantation (whether as tissue or organ) raises
the larger issue concerning the adequacy and clarity of information and
education provided to prospective donors who have consented to organ
and/or tissue donation or who have signed up on state donor registries.
Given that VCA transplantation is an emerging field, members of the
public may not understand the classification of such body parts under
state law (i.e., as organs, tissues, or otherwise as body parts), if
this matter has not yet been clarified by state law. Thus, we agree
with the commenter that questions of public trust may arise if
transparency is not kept in the forefront at every phase of the
donation process. For this reason, the Secretary encourages explicit
consent for VCAs from prospective donors (or next of kin) and that such
consent be as clear and meaningful as possible, and congruent with
actual donor intent, especially regarding whether the consent to donate
extends to VCAs specifically, and whether certain body parts should be
included or excluded. Because consent to donation is governed by state
law, the federal government may not resolve all of the issues related
to consent for VCA donation through federal regulation. The Department
believes that individual states should consider how the inclusion of
face, hand, and other VCAs as organs for transplantation might impact
the way that state offers the options for organ and tissue donation for
its donor authorization (``first person consent'') state registry. As
noted above, states establish laws that regulate first person consent
for organ and tissue donation registrations. Each state has the
authority to enact laws regarding the definition of organs and tissues
and develop policies about whether to provide its registrants the
option to specifically include or exclude the gift of specific body
parts (including VCAs). Thus, states retain the ability to designate
VCAs as either organ, tissue, or some other type of body part. With
this rule adding VCAs to organs covered under the OPTN final rule, some
states might identify a need to amend or revise current laws,
regulations, policies, and/or procedures that designate how VCAs are
categorized (e.g, organ, tissue, or other) within its donor
authorization state registry (``first person consent'') program. For
this reason, among others, this rule will be effective at 365 days
following publication in order to allow sufficient time for states to
accomplish these actions.
It is our understanding that OPOs must ensure that each organ
(including VCAs) is recovered in accordance with the consent
requirements of applicable state law. Although not always required in
cases where the donor has already provided first person consent on a
state registry, in the interest of full disclosure, transparency, and
the public trust, it is our understanding that OPOs obtain consent or
concurrence by the next of kin before proceeding with VCA donation.
Given the relatively new and transformative nature of VCA
transplantation, the Secretary encourages states and stakeholders to
consider best practices in informing the public about the opportunity
for VCA donation and obtaining consent or authorization to donate
organs and tissues generally and VCAs specifically based upon as full
information as possible.
In response to the comment regarding the distinction between life
saving and life enhancing organs, as indicated in the NPRM, ``The
Secretary does not agree with a direct demarcation between life saving
organ transplants and life enhancing organ transplants for the purposes
of defining organs under the OPTN final rule.'' 76 FR at 78218. Until
only recently, the kidney was considered life enhancing, not life
saving. Nonetheless, the kidney was the first organ successfully
transplanted and has always been included in the list of organs
governed by NOTA and OPTN final rule. States have other mechanisms and
approaches available for providing potential organ donors with first
person designation options on their state registries for selecting or
excluding specific body parts.
5. Impact of VCAs on Cost to OPTN Operations and Operational Efficiency
Comment: Six commenters expressed concerns regarding the cost of
defining VCAs as organs. Five commenters stated that additional
resources would be necessary for OPTN if oversight is expanded to
include VCAs. Two of these commenters indicated that significant
expenses would likely be incurred in the infancy of such an oversight
program and that oversight of VCA transplantation could consume
resources presently dedicated to the requirements of the OPTN's current
mission to provide oversight programs for procurement, allocation, and
transplantation of existing organs. Another commenter recommended that
VCAs should be incorporated into the current OPTN fee structure with
one fee
[[Page 40039]]
for all organ types. Two commenters recommended that the OPTN seek
additional and/or alternative funding mechanisms for VCA-related
expenditures and that it attempt to minimize the administrative burden
of adding operations related to VCA transplants. Another commenter
suggested that the Department of Health and Human Services work
collaboratively with the Departments of Defense and Veterans Affairs to
ensure adequate funding. One commenter expressed concern as to whether
the OPTN contractor can efficiently handle the current waiting list
along with new responsibilities that may result from adding VCA
transplants. The commenter stated that having too many regulations may
interfere with and slow down the process and affect administration of
the transplant program.
Response: Appropriate funding for the effective operation of the
OPTN is important for its national organ recipient matching,
allocation, policymaking, and oversight responsibilities. The major
costs to the OPTN to implement this rule and to incorporate VCAs within
the current OPTN operations will be primarily associated with adding
the relevant governance structures such as a VCA Committee. The
Department does not anticipate that extensive modifications to the
existing information technology infrastructure will be required. The
OPTN is funded by yearly appropriations by Congress as well as a
patient registration fee authorized under section 121.5(c) of the OPTN
final rule (which is approved by the Secretary). The Department
anticipates that its federal appropriated funds (not patient
registration fees), will be used to pay for the costs to the OPTN
associated with the initial implementation of VCA governance systems.
The Department does not agree that this rule will result in adverse
impact on OPTN operational efficiency. The small numbers of VCA
transplants to date in the U.S. and the steady but slow growth in this
field would suggest that the initial burden of VCAs, specifically face
and limbs, is anticipated to be small and is not likely to affect the
OPTN contractor's ability to handle the current waiting list along with
new VCA responsibilities, nor interfere with the OPTN's ability to
administer and regulate the organ transplant program.
6. Research Status of VCA Transplantation
Comment: Three comments emphasized the current and future research
aspects of VCAs. One commenter suggested continuing research during the
early phases of VCA transplantation with oversight by the OPTN. Another
suggested that, as an experimental field and given the small number of
VCA transplants at this time, VCA transplantation should be considered
as clinical research under the auspices of the OPTN. According to
commenters, the field should develop in a scholarly approach, not so
much to promote an academic development of this field, but rather to
insure the best and most sustainable outcomes for potential patients. A
third stated that VCA transplantation is not a life saving procedure,
yet does require immunosuppression and rehabilitation. This can lead to
allosensitization that may negatively impact future (more traditional)
life saving organ transplants. A comparison was made to kidneys: After
years of weighing the potential benefit of kidney transplant compared
with dialysis for patients with end stage renal disease, outcomes
analyses led to the now well accepted understanding that kidney
transplants are in fact life saving. The commenter expressed hope that
OPTN oversight would allow the creation of data sets that will assist
the community in deciding who would or would not benefit from VCA
transplantation.
Response: NOTA authorizes the OPTN to ``carry out studies and
demonstration projects for the purpose of improving procedures for
organ donation procurement and allocation'' (section 274(b)(2)(N)) but
makes no provision for clinical organ transplantation research by the
OPTN. The OPTN has no authority to direct and fund clinical research
but OPTN policies allow organs to be used for nonclinical research
purposes when those organs are not transplanted into human recipients.
Further, NOTA does not authorize the OPTN to designate any medical
procedure as experimental or investigational. Nevertheless, the
Secretary understands that further clinical research will be needed to
advance the field of VCA transplantation. For example, the OPTN
facilitated access to pancreatic islet cells from deceased pancreas
donors under clinical research protocols supported by the National
Institutes of Health (NIH). The OPTN and the Scientific Registry of
Transplant Recipients (SRTR) will continue to cooperate with the
transplant community and respond to requests from researchers for data
needed for bona fide research purposes related to transplanted organs,
including VCAs, in order to develop improved access and allocation for
VCAs, to improve VCA candidate selection, and to identify best
practices for optimal VCA transplant outcomes.
7. Risks of VCA Transplantation to Recipients
Comment: Two comments were related to the risks that VCA transplant
recipients encounter and the potential risk/benefit decisions that they
must make to opt for a VCA transplant. One comment stated that patients
should have more time to consider the pros and cons of surgery for non-
life extending VCA transplants. Given that such patients' lives are not
on the line, this commenter felt that these patients are in a better
situation to say ``no'' to surgeries they feel may be unsafe. Another
commented that the short term benefits of upper limb transplantation
could be observed, evaluated, and estimated in the first few years
after transplantation. However, the risks of adverse events continue
for the life of the patient and/or allograft. For this reason, and
given the potential serious morbidity, the commenter expressed that the
transplant community must continue to maximize benefit by careful
patient selection and continuing strict indications for upper limb
transplantation. The commenter suggested that this evaluation process
be performed under research and could continue for an entire generation
of upper limb transplant patients.
Response: The Department agrees that VCA transplantation poses
unique organ-specific risks and that close oversight and follow up are
needed for patient protections and to maximize the optimal benefit for
VCA recipients. This process will require deliberate and thorough
policymaking by the OPTN to develop appropriate policies for informed
consent, candidate registration, recipient follow up, and VCA
transplant program requirements for staffing, infrastructure, and
program policies for candidate selection criteria, pre- and post-
operative patient care, follow up, and quality improvement. As noted
above, NOTA makes no provision for clinical organ transplantation
research by the OPTN. This would also apply to VCA organs under this
regulation. Nevertheless, the Secretary understands that further
clinical research will be needed to advance the field of VCA
transplantation. The OPTN and the SRTR will continue to cooperate with
the transplant community and respond to requests from researchers for
data needed for bona fide research purposes related to transplanted
organs including VCAs.
Comment: A commenter indicated that due to the potential physical
and
[[Page 40040]]
psychological impact caused by rejection of a hand or face transplant,
the criteria for tissue typing compatibility based on antibody
screening and cross matching must be more stringent for VCA transplants
than in traditional solid organ transplants. The commenter suggested
that it is necessary to obtain a history of allosensitization,
including a history of number of pregnancies, number and type of
transfusions, history of recent vaccinations and infections, and a
history of previous organ and tissue allografts (including allogeneic
heart valves and connective tissues). Additional comments include
screening objectives, the frequency of screening, assignment of
unacceptable antigens, sample storage, and post-transplant testing.
Response: The Department agrees that VCA transplantation presents
unique aspects for the role of histocompatibility testing, tissue
typing and matching, allosensitization identification and monitoring,
and other potential factors that can affect the host immune response to
the allograft and impact its success or failure. These issues, along
with many others, will be considered as the OPTN develops policies for
incorporating specific VCA organs within its operations for candidate
registration requirements, organ allocation, recipient follow up, and
data collection.
The OPTN Histocompatibility Committee, composed of experts in the
field, considers issues relating to donor and recipient
histocompatibility, organ allocation, histocompatibility testing, and
histocompatibility laboratory and personnel qualifications. The goal of
the Committee's work is to promote patient safety, good transplant
outcomes, and best use of organs. It is the Histocompatibility
Committee's responsibility to establish new and/or amend existing
guidelines and policies in consideration of the unique aspects of VCA
organ histocompatibility. In doing so, unique VCA histocompatibility
concerns as raised by the commenter will be among the issues discussed.
Comment: A commenter expressed concern that as external (VCA)
transplants become more common, there may be an increasing possibility
of transplanting and transferring biometric identity data of the donor
to the recipient.
Response: The Department believes that reclassifying VCAs as
organs, rather than as HCT/Ps, does not affect the issues raised by the
commenter. Whether the VCA is considered an organ (under regulatory
oversight of HRSA and policy management by OPTN) or HCT/P (under
regulatory oversight of FDA), transplantation of VCAs (hand and face)
has been ongoing in the U.S. since 1999. These are the two most common
VCAs transplanted so far and will likely remain so for the near future.
A facial transplant results in a new face for the recipient as the
donor's facial soft tissues are attached to the unique bone structure
of the recipient. Therefore a recipient face scan is not likely to be
similar to that of the donor. Upper limb transplantation does result in
transferring the deceased donor's fingerprints and palm prints to the
recipient. Limb transplantation has been occurring in small numbers in
the U.S. since 1999. Issues related to biometric identity
authentication (potential ``identity transfer'') are addressed by
regulatory authorities and security and law enforcement agencies at all
levels of government. These issues are also addressed by nongovernment
entities responsible for their business practices and the integrity of
their financial operations.
8. Waiting List Criteria and Potential Live VCA Donors
Comment: One commenter requested clarification as to whether
veterans will be given preferred status for VCA transplantation and how
this rule will affect funding or reimbursement from veteran benefits,
Medicare/Medicaid, and private insurers.
Response: Wounded warriors returning from the conflicts in Iraq and
Afghanistan are anticipated to constitute a significant proportion of
potential candidates for limb and face transplants because of the
number of limb and face injuries sustained in these battle
environments. Nevertheless, organ allocation policies are not based on
employment or military/veteran status, but must comply with the
requirements of the OPTN final rule. The final rule does not determine
benefits, coverage policies, or reimbursement amounts for organ
transplantation from public or private insurers. The deceased donor (or
authorized next-of-kin) has the option for directed donation to the
extent permissible by applicable state and federal law.
Comment: One commenter questions how the VCA transplant waiting
list will be categorized (i.e., by gender or race) and whether the OPTN
will allow live donations or only recover a hand or face from someone
who is about to die.
Response: VCAs meet the definition of organs based on this rule and
are no different from any other organs previously listed under NOTA and
the OPTN final rule. Each transplant center has its own selection
criteria for accepting potential candidates for VCA transplant and
placing them on the waiting list. The OPTN final rule provides specific
allocation performance goals (42 CFR 121.8(b)), including:
``Standardizing the criteria for determining suitable transplant
candidates through the use of minimum criteria (expressed, to the
extent possible, through objective and measurable medical criteria) for
adding individuals to, and removing candidates from, organ transplant
waiting lists.'' The demographic categories mentioned by the commenter
are not criteria utilized for placement on the organ wait list.
Live donor organs are addressed by OPTN policies. The most common
are kidney and liver. Although a potential living donor may express a
desire to donate a VCA, no transplant center currently provides this
service. Organs are not procured in the U.S. from any person ``who is
about to die,'' but in fact are obtained either willingly from a living
donor or from a person who is already dead (deceased donor) with proper
authorization.
Economic and Regulatory Impact
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when rulemaking is
necessary, to select regulatory approaches that provide the greatest
net benefits (including potential economic, environmental, public
health, safety, distributive, and equity effects). In addition, under
the Regulatory Flexibility Act (RFA), if a rule has a significant
economic effect on a substantial number of small entities the Secretary
must specifically consider the economic effect of a rule on small
entities and analyze regulatory options that could lessen the impact of
the rule.
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, costs, benefits, incentives, equity, and
available information. Regulations must meet certain standards, such as
avoiding an unnecessary burden. Regulations that are significant
because of cost, adverse effects on the economy, inconsistency with
other agency actions, effects on the budget, or novel legal or policy
issues, require special analysis.
The Secretary has determined that minimal resources are required to
implement the requirements in this rule because organizations involved
(e.g., OPOs and transplant hospitals) already implement related
requirements for other organs in the OPTN rule (42 CFR 121.2).
Therefore, in accordance with the Regulatory Flexibility Act of 1980
[[Page 40041]]
(RFA), and the Small Business Regulatory Enforcement Act of 1996, which
amended the RFA, the Secretary certifies that this rule will not have a
significant impact on a substantial number of small entities.
The Secretary also has determined that this rule does not meet the
criteria for an economically significant rule as defined by Executive
Order 12866 and will have no major effect on the economy or federal
expenditures. The Department has determined that this rule is not a
major rule within the meaning of the statute providing for
Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it
will not have effects on state, local, and tribal governments or on the
private sector such as to require consultation under the Unfunded
Mandates Reform Act of 1995.
The provisions of this rule will not affect the following elements
of family well-being: family safety, family stability, marital
commitment; parental rights in the education, nurture, and supervision
of their children; family functioning, disposable income, or poverty;
or the behavior and personal responsibility of youth, as determined
under section 654(c) of the Treasury and General Government
Appropriations Act of 1999.
As stated above, this rule modifies the regulations governing the
OPTN and section 301 of NOTA based on legal authority.
Impact of the New Rule
This rule has the effect of including VCAs within the ambit of the
regulations governing the operation of the OPTN, and would include
transplanted human VCAs within the prohibition set forth at section 301
of NOTA. This rule authorizes the Secretary to take enforcement actions
against entities violating OPTN policies pertaining to the
transplantation of VCAs once such policies are approved as enforceable
by the Secretary. Even if the Secretary does not approve such policies
as enforceable, OPTN members may be subject to enforcement actions by
the OPTN for violations of OPTN policies extending to VCAs. OPTN
members will be required to comply with requirements set forth in the
OPTN final rule, including those pertaining to data submission, as
applied to VCAs. Finally, individuals violating section 301 of NOTA
with respect to VCA transplants may be subject to criminal penalties.
Paperwork Reduction Act of 1995
Prior to the amendments made through this regulation, the OPTN
final rule authorized information collection activities with respect to
``organs'' as defined in 42 CFR 121.2. See generally 42 CFR 121.11.
Because this regulation expands the definition of organs to encompass
VCAs, the OPTN final rule's existing information collection authorities
will now extend to information concerning VCAs. The current data
collection requirements in the OPTN final rule approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995 and assigned control numbers OMB No. 0915-0157 (for organ donors,
candidates, and recipients) and OMB No. 0915-0184 (for OPTN membership
application data) will be impacted by this rule because much of the
information collected on these forms will now be collected with respect
to VCA donors, candidates, and recipients, as well as VCA transplant
programs. The new collections, reporting and disclosure activities
(listed in the table below) will be submitted to OMB for approval in
accordance with OMB requirements.
Membership in the OPTN is determined by submission of application
materials to the OPTN demonstrating that the applicant meets all
required criteria for membership and will agree to comply with all
applicable provisions of NOTA. 42 U.S.C. 273 et seq. Section
1138(a)(1)(B) of the Social Security Act, as amended, 42 U.S.C. 1320b-
8(a)(1)(B), requires that hospitals in which transplants are performed
by members of, and abide by the rules and requirements (as approved by
the Secretary of HHS) of the OPTN as a condition of participation in
Medicare and Medicaid for the hospital. Section 1138 contains a similar
provision for the OPOs and makes membership in the OPTN and compliance
with its operating rules and requirements (as approved by the Secretary
of HHS), including those relating to data collection, mandatory for all
transplant programs and OPOs. The information is used predominantly to
match donor organs with recipients, to monitor compliance of member
organizations with OPTN policies and requirements to guide organ
allocation policy development, and to report periodically on the
clinical and scientific status of organ donation and transplantation in
this country.
The currently-approved data collections include worksheets and
reporting burden for organs and describe respondents as non-profit
institutions and small organizations, which would be the same for this
rule. The title, description, and respondent description of all
information collections relating to VCAs are shown (see table below)
with similar estimates of annual reporting and record keeping burden as
with other organs previously approved in the OPTN final rule.
Currently there are approximately 12 hand, 4 face, and 1 abdominal
wall transplant programs in the U.S., although only 9 have actually
performed a clinical transplant operation to date. The current rate of
VCA transplants is less than 10 a year for hands and less than one a
year for faces and abdominal walls). For reporting calculations
(below), we have projected a total of 10 VCA transplant programs, each
registering 2 candidates a year to the waiting list and each program
performing 1 transplant procedure a year. The data burden calculation
(see table below) assumes that data associated with entering deceased
donor information is already accounted in the current OMB approved data
collection forms and does not represent additional data collection
burden resulting from this final rule. Specifically, it is reasonable
to assume that any donor that would be considered a VCA donor is also
considered to be a donor for other organs already covered by this rule.
The hourly rate used for calculation of total burden cost to
respondents is the average hourly wage for a transplant data
coordinator ($26.00). This rate reflects the median annual salary and
benefits for a Data Control Clerk II (www.salary.com). The total annual
respondent burden hours (42.5) represents 4.2 hours ($109.20) per
respondent.
Title: Organ Procurement and Transplantation Network.
Description: Information will be collected from transplant
hospitals, OPOs, and histocompatibility laboratories predominantly for
the purpose of matching donor VCAs with potential recipients,
monitoring compliance of member organizations with system rules,
conducting statistical analyses, and developing policies relating to
organ procurement and transplantation.
The practical utility of the data collection is further enhanced by
requirements that the OPTN must report a variety of data to the
Secretary, including data on performance by organ and status category,
including program-specific data, OPO-specific data, data by program
size, and data aggregated by organ procurement area, OPTN region, the
nation as a whole, and other geographic areas (42 CFR 121.8(c)(3)). The
OPTN must also transmit proposed allocation policies and performance
indicators, which will be used to assess the likely effects of policy
changes and
[[Page 40042]]
to ensure that the proposed policies are consistent with the OPTN final
rule.
The OPTN and Scientific Registry must make available to the public
timely and accurate information concerning the performance of
transplant programs, and must respond to requests from the public for
data needed for bona fide research or analysis purposes or to assess
the performance of the OPTN or Scientific Registry, to assess
individual transplant programs, or for other purposes (42 CFR
121.11(b)(1)(iv) and 42 CFR 121.11(b)(1)(v) and 42 CFR
121.11(b)(1)(vi)).
The OPTN must provide to each member OPO and transplant hospital
the plans and procedures for reviewing applications and for monitoring
compliance with these rules and OPTN policies. The OPTN must also
report to the Secretary on OPOs and transplant hospitals that may not
be in compliance with these rules or OPTN policies, and on their
progress toward compliance.
The OPTN and Scientific Registry are required to maintain and
manage the information on candidates, donors and recipients.
Description of Respondents: Non-profit institutions and small
organizations.
The estimated annual reporting burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Section Form respondents respondent responses response hours (cost)
------------------------------------------------------------------------------------------------------------------------------------------
121.5(b)...................... VCA Candidate Registration 10 2 20 0.30 6 ($156)
121.6(c)...................... Submitting criteria for 10 1 10 0.5 5 ($130)
VCA acceptance
(reporting).
121.6(c)...................... Sending criteria to OPOs 10 1 10 0.5 5 ($130)
(disclosure).
121.7(b)(4)................... Reasons for Refusal....... 10 1 10 0.1 1 ($26)
121.9(b)...................... Designated transplant 10 1 10 2 20 ($520)
program requirements.
121.11(b)(2).................. VCA Registration.......... 10 1 10 0.25 2.5
121.11(b)(2).................. VCA Follow up............. 10 1 10 0.20 2 ($52)
121.11(b)(2).................. Post-transplant malignancy 10 1 10 0.08 1 ($26)
-------------------------------------------------------------------------------------------------------------------------
Total..................... .......................... 139 9 90 14.6 42.5 ($1105)
--------------------------------------------------------------------------------------------------------------------------------------------------------
List of Subjects in 42 CFR Part 121
Health care, Hospitals, Organ transplantation, Reporting and record
keeping requirements.
Dated: February 8, 2013.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
Approved: February 14, 2013.
Kathleen Sebelius,
Secretary.
Accordingly, 42 CFR part 121 is amended as set forth below:
PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK
0
1. The authority citation for part 121 continues to read as follows:
Authority: Sections 215, 371-376 of the Public Health Service
Act (42 U.S.C. 216, 273-274d); sections 1102, 1106, 1138 and 1871 of
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh);
and section 301 of the National Organ Transplant Act, as amended (42
U.S.C. 274e).
0
2. Amend Sec. 121.2 by revising the definition for ``Organ'' and
adding a definition for Vascularized composite allograft'' to read as
follows:
Sec. 121.2 Definitions.
* * * * *
Organ means a human kidney, liver, heart, lung, pancreas, intestine
(including the esophagus, stomach, small and/or large intestine, or any
portion of the gastrointestinal tract) or vascularized composite
allograft (defined in this section). 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.''
* * * * *
Vascularized composite allograft means a body part:
(1) That is vascularized and requires blood flow by surgical
connection of blood vessels to function after transplantation;
(2) Containing multiple tissue types;
(3) Recovered from a human donor as an anatomical/structural unit;
(4) Transplanted into a human recipient as an anatomical/structural
unit;
(5) Minimally manipulated (i.e., processing that does not alter the
original relevant characteristics of the organ relating to the organ's
utility for reconstruction, repair, or replacement);
(6) For homologous use (the replacement or supplementation of a
recipient's organ with an organ that performs the same basic function
or functions in the recipient as in the donor);
(7) Not combined with another article such as a device;
(8) Susceptible to ischemia and, therefore, only stored temporarily
and not cryopreserved; and
(9) Susceptible to allograft rejection, generally requiring
immunosuppression that may increase infectious disease risk to the
recipient.
* * * * *
0
3. In Sec. 121.4, add paragraph (e)(3) to read as follows:
Sec. 121.4 OPTN policies: Secretarial review and appeals.
* * * * *
(e) * * *
(3) Identify all covered body parts in any policies specific to
vascularized composite allografts, defined in Sec. 121.2.
0
4. Revise Sec. 121.13 to read as follows:
Sec. 121.13 Definition of Human Organ Under section 301 of the
National Organ Transplant Act of 1984, as amended.
Human organ, as covered by section 301 of the National Organ
Transplant Act of 1984, as amended, means the human (including fetal)
kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone,
skin, intestine (including the esophagus, stomach, small and/or large
intestine, or any portion of the gastrointestinal tract) or any
vascularized composite allograft defined in Sec. 121.2. It also means
any subpart thereof, including that derived from a fetus.
[FR Doc. 2013-15731 Filed 7-2-13; 8:45 am]
BILLING CODE 4165-15-P