Response to Solicitation on Organ Procurement and Transplantation Network (OPTN) Living Donor Guidelines, 34946-34948 [E6-9401]
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Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
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[FR Doc. E6–9414 Filed 6–15–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Response to Solicitation on Organ
Procurement and Transplantation
Network (OPTN) Living Donor
Guidelines
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Response to solicitation of
comments.
AGENCY:
SUMMARY: A notice was published in the
Federal Register on January 23, 2006
(Vol. 71, No. 14, pages 3519–3520). The
purpose of this notice was to solicit
comments to assist HRSA in
determining whether criteria developed
by the Organ Procurement and
Transplantation Network (OPTN)
concerning organs procured from living
donors, including those concerning the
allocation of organs from living donors,
should be given the same status, and be
subject to the same enforcement actions,
as other OPTN policies.
FOR FURTHER INFORMATION CONTACT:
James F. Burdick, M.D., Director,
Division of Transplantation, Healthcare
Systems Bureau, Health Resources and
Services Administration, Parklawn
Building, Room 12C–06, 5600 Fishers
Lane, Rockville, Maryland 20857;
telephone (301) 443–7577; fax (301)
594–6095; or e-mail: jburdick@hrsa.gov.
SUPPLEMENTARY INFORMATION: Congress
has provided specific authority under
sections 372 of the Public Health
Service (PHS) Act, as amended, 42
U.S.C. 274 for the creation of a national
OPTN, which is, among other things, to
facilitate a donor and recipient
matching system; establish membership
criteria and medical criteria for
allocating donated organs; and provide
opportunities to members of the public
to comment with respect to proposed
criteria.
The OPTN Final Rule (42 CFR part
121) governs the operations of the OPTN
and is intended to help achieve the most
equitable and medically effective use of
human organs that are donated in trust
for transplantation. Under the final rule,
the OPTN is to develop policies on a
variety of issues, including ‘‘[p]olicies
for the equitable allocation of cadaveric
organs [now referred to as deceased
donor organs].’’ 42 CFR 121.4(a)(1).
Under the final rule, allocation policies
developed by the OPTN under section
121.8 of the final rule will be considered
enforceable when and if the Secretary
approves the policies as such.
Enforceable OPTN policies are subject
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to the sanctions described in section
121.10(c)(1) of the final rule. Nonenforceable OPTN policies may still be
subject to lesser sanctions by the OPTN
(e.g., an OPTN member being designated
a Member Not in Good Standing).
Although the authorizing statute does
not distinguish between transplants
using organs from living donors and
those using organs from deceased
donors, the final rule does not include
a requirement that the OPTN develop
policies concerning the equitable
allocation of living donor organs. Until
recently, OPTN policies have
predominantly focused on issues related
to organ donation and transplantation of
deceased donor organs.
However, several widely publicized
living donor deaths have caused the
OPTN to implement new practices of
reviewing and approving, on an
advisory basis, the qualifications of
living donor transplant programs.
Additionally, the increased incidence of
altruistic living donations has prompted
the OPTN to consider policies that are
patient-focused yet address the unique
circumstances pertaining to the recovery
and transplantation of living donor
organs. Section 121.4(a)(6) of the final
rule provides that the OPTN shall be
responsible for developing policies on a
variety of topics, including ‘‘[p]olicies
on such matters as the Secretary
directs.’’ In accordance with that
authority, the Healthcare Systems
Bureau directed the OPTN to develop
allocation guidelines for organs from
living donors and other policies
necessary and appropriate to promote
the safety and efficacy of living donor
transplantation for the donor and
recipient. It further advised the OPTN
that all living donation policies (other
than data reporting policies) should be
considered as best practices or
voluntary guidelines and not subject to
regular OPTN sanctions (even those
available with respect to violation of
non-enforceable policies) until the
public has had an opportunity to
comment on the matter.
In the January 23, 2006, Federal
Register notice, comments were
requested to assist HRSA in determining
whether OPTN living donor guidelines
should be given the same status of other
OPTN policies, i.e., be treated as
policies developed in accordance with
42 CFR 121.8, and be subject to the
same enforcement actions. The
Secretary explained that if he decided
these questions in the affirmative, OPTN
policies relating to living donors would
be treated the same as other OPTN
policies developed in accordance with
section 121.8 of the final rule. In other
words, OPTN policies concerning living
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Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
donors would not be considered
enforceable policies under section
121.10 of the final rule, and violations
of such policies would not be subject to
the sanctions described in section
121.10(c)(1), unless and until the
Secretary approved such policies as
enforceable.
During the comment period, HRSA
received 29 comments from individuals
affiliated with or representing
universities, hospitals, professional
associations, and living donation
advocacy organizations; a healthcare
accreditation organization; transplant
recipients; and family members of
donors, recipients and candidates.
Twenty of these comments explicitly
referenced changing the status of OPTN
living donor guidelines. The remaining
nine comments expressed views about
various aspects of the national
transplant system not directly related to
the solicitation of comments.
HRSA thanks the respondents for the
quality and thoroughness of their
comments. The comments and HRSA’s
decision are discussed below.
wwhite on PROD1PC61 with NOTICES
I. Living Donor OPTN Policies
Consistent With Other OPTN Policies
The majority of respondents indicated
that OPTN living donor guidelines
should be given the same status of other
OPTN policies. Of the 20 comments that
explicitly referenced changing the status
of OPTN living donor guidelines, 17
were supportive of giving OPTN living
donor guidelines the same status, and
subjecting these to the same
enforcement actions, as other OPTN
policies. Supportive comments were
received from representatives of
academia, transplant surgeons, living
donors who had positive donation
experiences, living donors who had
negative donation experiences, family
members of living donors who died or
who experienced complications as a
result of the donation, living donation
advocacy organizations, transplant
administrators, the professional
societies representing transplant
surgeons and transplant physicians,
transplant candidate/recipient advocacy
organizations, the organization serving
as the current OPTN contractor, and an
organization that accredits hospitals.
Supportive comments cited the
appropriateness of OPTN involvement
in policies relating to living donors,
including donor evaluation, informed
consent, evaluation of surgical outcomes
and complications, protection of living
donors, peri-operative care, organ
allocation, qualifications of transplant
programs, and transplant program
compliance with living donor policies.
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A few comments indicated opposition
to giving OPTN living donor guidelines
the same status as other OPTN policies.
A family member of two kidney
transplant candidates who died on the
waiting list is now an advocate of
potential living donors and recipients
meeting on the Internet and is opposed
to the OPTN’s involvement in living
donor policy making because of the
perception that the OPTN discourages
living donor transplants resulting from
such meetings. Another opponent of
OPTN involvement is waiting for a liver
transplant and does not trust the OPTN
policymaking process because of the
perception that wealthier candidates
receive priority for donor organs. One
data manager from a large transplant
program commented that mandating
data collection on living donors was
unlikely to increase donor follow-up
form completion rates unless the
donors’ insurance companies can be
persuaded to pay for follow-up visits.
HRSA appreciates each of these
comments.
II. OPTN Living Donor Policy Making
Authority—Organ Allocation
Comments supportive of OPTN
involvement in living donor policy
making expressed varying views
regarding the scope of policies the
OPTN should consider. Of the 17
comments that were supportive of
OPTN involvement, five suggested areas
in which the OPTN should not become
involved. One comment did not
advocate an intrusive role for the OPTN
in the allocation of living donor organs
or ethical review of local living donor
practices. A transplant administrator
offered the similar caution that altruistic
living donors may feel a sense of
connection to their local transplant
center and may not want their organs
allocated to a distant center. A
representative of the professional
society for transplant surgeons offered a
comment to HRSA that the OPTN Final
Rule does not authorize the OPTN to
establish policies for living donor organ
allocation. In response to this, HRSA
emphasizes that its authority to direct
the OPTN to develop living donor organ
allocation policies is granted in
§ 121.4(a)(6) of the OPTN Final Rule
which permits the Secretary to develop
policies on such other matters as the
Secretary directs. The wording in
§ 121.8(a) of the final rule referring to
policies ‘‘for the equitable allocation of
cadaveric organs’’ should not be
construed as a limitation of the
Secretary’s policy making authority over
living donation.
A representative of a living donor
advocacy organization commented that
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34947
OPTN policies should not interfere with
the right of an altruistic living donor to
direct their organ to a specific
individual. We agree. Section 121.8(h)
of the OPTN Final Rule permits the
allocation of an organ to a recipient
named by those authorized to make the
donation. Because we are directing the
OPTN to develop living donor
allocation policies under section 121.8
of the final rule, section 121.8(h) will
apply to living donation equally as it
applies to deceased donation.
III. OPTN Living Donor Policy Making
Authority—Donor Evaluation
Supportive comments varied in their
level of support for OPTN involvement
in developing policies for living donor
evaluation. Of the 17 comments that
were supportive, two were opposed to
OPTN policymaking in this area. One
comment from a representative of the
professional organization for transplant
surgeons and another from a transplant
surgeon asserted that the OPTN should
not develop policy in the area of donor
evaluation because there is no clear
clinical consensus regarding the policies
or standards that should be followed.
HRSA believes it is very likely that
should the OPTN consider policy
making in the area of living donor
evaluation that members of OPTN
committees and the Board of Directors
will consider this perspective and
abandon policy making in the absence
of clear clinical consensus.
Additionally, through its public
comment process transplant
professionals also have the opportunity
to advise the OPTN of the lack of clear
clinical consensus, should it exist.
IV. OPTN Living Donor Policy
Making—Living Donor Follow-up
Several comments stated greater
attention should be given to
understanding the impact of donation
on living donors. One commenter who
represents the professional organization
for transplant professionals
recommended more Federal funding for
a live organ donor database. A comment
from a living donor who is a healthcare
professional and living donor advocate
asserted that there should be mandatory
policies to protect living donors and a
central source of outcome data via a
living donor registry. A comment from
a transplant surgeon supports more
OPTN involvement in living donor data
collection and monitoring living donor
outcomes. A comment from a
representative of a healthcare
accreditation organization stated it is
appropriate for the OPTN to establish
additional policies to promote the safety
of living donor transplantation. A
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Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
comment from the mother of a living
donor and recipient who both
experienced post-transplant
complications asserted that stronger
policies should be developed to ensure
living donor safety.
Conclusion
HRSA has reviewed and considered
each aspect of each comment and has
determined that OPTN living donor
guidelines should be given the same
status of other OPTN policies as
discussed in the Federal Register Notice
published on January 23, 2006. Under
42 CFR 121.4(a)(6), the Secretary directs
the OPTN to develop policies regarding
living organ donors and living organ
donor recipients, including policies for
the equitable allocation of living donor
organs, in accordance with section 121.8
of the final rule. Thus, the OPTN shall
develop such policies in the same
manner, and with the same public
comment process, that it does for
policies on deceased organ donors and
deceased organ donor recipients. Noncompliance with such policies shall
subject OPTN members to the same
consequences as noncompliance with
policies concerning deceased organ
donors and deceased organ donor
recipients developed under the final
rule.
Dated: June 9, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6–9401 Filed 6–15–06; 8:45 am]
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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Name of Committee: National Human
Genome Research Institute Special Emphasis
Panel; Sequencing Centers Review.
Date: July 13, 2006.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Hotel Rouge, 1315 16th Street,
NW., Washington, DC 20036.
Contact Person: Rudy O. Pozzatti, PhD,
Scientific Review Administrator, Office of
Scientific Review, National Human Geonome
Research Institute, National Institutes of
Health, Bethesda, MD 20892. 301–402–0838.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: June 12, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
National Institute of Child Health and
Human Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Gonadotropin
Inhibitors: A Structural Biology Approach To
Immunocontraception.
Date: July 6, 2006.
Time: 10 a.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852 (Telephone Conference Call).
Contact Person: Jon M. Ranhand, PhD,
Scientist Review Administrator, Division of
Scientific Review, National Institute of Child
Health and Human Development, NIH, 6100
Executive Boulevard, Room 5B01, Bethesda,
MD 20892. (301) 435–6884.
ranhandj@mail.nih.gov.
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Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Global Profiling of
Molecular Errors Associated With Human
Spermatogenic Disorder.
Date: July 6, 2006.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852 (Telephone Conference Call).
Contact Person: Jon M. Ranhand, PhD,
Scientist Review Administrator, Division of
Scientific Review, National Institute of Child
Health and Human Development, NIH, 6100
Executive Boulevard, Room 5B01, Bethesda,
MD 20892. (301) 435–6884.
ranhandj@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Immunodominant
Ovarian Antigens Involved in Premature
Ovarian Failure.
Date: July 7, 2006.
Time: 10 a.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852 (Telephone Conference Call).
Contact Person: Jon M. Ranhand, PhD,
Scientist Review Administrator, Division of
Scientific Review, National Institute of Child
Health and Human Development, NIH, 6100
Executive Boulevard, Room 5B01, Bethesda,
MD 20892. (301) 435–6884.
ranhandj@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: June 12, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
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National Institute of Arthritis and
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The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
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]]>Agencies
[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34946-34948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9401]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Response to Solicitation on Organ Procurement and Transplantation
Network (OPTN) Living Donor Guidelines
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Response to solicitation of comments.
-----------------------------------------------------------------------
SUMMARY: A notice was published in the Federal Register on January 23,
2006 (Vol. 71, No. 14, pages 3519-3520). The purpose of this notice was
to solicit comments to assist HRSA in determining whether criteria
developed by the Organ Procurement and Transplantation Network (OPTN)
concerning organs procured from living donors, including those
concerning the allocation of organs from living donors, should be given
the same status, and be subject to the same enforcement actions, as
other OPTN policies.
FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director,
Division of Transplantation, Healthcare Systems Bureau, Health
Resources and Services Administration, Parklawn Building, Room 12C-06,
5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443-7577;
fax (301) 594-6095; or e-mail: jburdick@hrsa.gov.
SUPPLEMENTARY INFORMATION: Congress has provided specific authority
under sections 372 of the Public Health Service (PHS) Act, as amended,
42 U.S.C. 274 for the creation of a national OPTN, which is, among
other things, to facilitate a donor and recipient matching system;
establish membership criteria and medical criteria for allocating
donated organs; and provide opportunities to members of the public to
comment with respect to proposed criteria.
The OPTN Final Rule (42 CFR part 121) governs the operations of the
OPTN and is intended to help achieve the most equitable and medically
effective use of human organs that are donated in trust for
transplantation. Under the final rule, the OPTN is to develop policies
on a variety of issues, including ``[p]olicies for the equitable
allocation of cadaveric organs [now referred to as deceased donor
organs].'' 42 CFR 121.4(a)(1). Under the final rule, allocation
policies developed by the OPTN under section 121.8 of the final rule
will be considered enforceable when and if the Secretary approves the
policies as such. Enforceable OPTN policies are subject to the
sanctions described in section 121.10(c)(1) of the final rule. Non-
enforceable OPTN policies may still be subject to lesser sanctions by
the OPTN (e.g., an OPTN member being designated a Member Not in Good
Standing).
Although the authorizing statute does not distinguish between
transplants using organs from living donors and those using organs from
deceased donors, the final rule does not include a requirement that the
OPTN develop policies concerning the equitable allocation of living
donor organs. Until recently, OPTN policies have predominantly focused
on issues related to organ donation and transplantation of deceased
donor organs.
However, several widely publicized living donor deaths have caused
the OPTN to implement new practices of reviewing and approving, on an
advisory basis, the qualifications of living donor transplant programs.
Additionally, the increased incidence of altruistic living donations
has prompted the OPTN to consider policies that are patient-focused yet
address the unique circumstances pertaining to the recovery and
transplantation of living donor organs. Section 121.4(a)(6) of the
final rule provides that the OPTN shall be responsible for developing
policies on a variety of topics, including ``[p]olicies on such matters
as the Secretary directs.'' In accordance with that authority, the
Healthcare Systems Bureau directed the OPTN to develop allocation
guidelines for organs from living donors and other policies necessary
and appropriate to promote the safety and efficacy of living donor
transplantation for the donor and recipient. It further advised the
OPTN that all living donation policies (other than data reporting
policies) should be considered as best practices or voluntary
guidelines and not subject to regular OPTN sanctions (even those
available with respect to violation of non-enforceable policies) until
the public has had an opportunity to comment on the matter.
In the January 23, 2006, Federal Register notice, comments were
requested to assist HRSA in determining whether OPTN living donor
guidelines should be given the same status of other OPTN policies,
i.e., be treated as policies developed in accordance with 42 CFR 121.8,
and be subject to the same enforcement actions. The Secretary explained
that if he decided these questions in the affirmative, OPTN policies
relating to living donors would be treated the same as other OPTN
policies developed in accordance with section 121.8 of the final rule.
In other words, OPTN policies concerning living
[[Page 34947]]
donors would not be considered enforceable policies under section
121.10 of the final rule, and violations of such policies would not be
subject to the sanctions described in section 121.10(c)(1), unless and
until the Secretary approved such policies as enforceable.
During the comment period, HRSA received 29 comments from
individuals affiliated with or representing universities, hospitals,
professional associations, and living donation advocacy organizations;
a healthcare accreditation organization; transplant recipients; and
family members of donors, recipients and candidates. Twenty of these
comments explicitly referenced changing the status of OPTN living donor
guidelines. The remaining nine comments expressed views about various
aspects of the national transplant system not directly related to the
solicitation of comments.
HRSA thanks the respondents for the quality and thoroughness of
their comments. The comments and HRSA's decision are discussed below.
I. Living Donor OPTN Policies Consistent With Other OPTN Policies
The majority of respondents indicated that OPTN living donor
guidelines should be given the same status of other OPTN policies. Of
the 20 comments that explicitly referenced changing the status of OPTN
living donor guidelines, 17 were supportive of giving OPTN living donor
guidelines the same status, and subjecting these to the same
enforcement actions, as other OPTN policies. Supportive comments were
received from representatives of academia, transplant surgeons, living
donors who had positive donation experiences, living donors who had
negative donation experiences, family members of living donors who died
or who experienced complications as a result of the donation, living
donation advocacy organizations, transplant administrators, the
professional societies representing transplant surgeons and transplant
physicians, transplant candidate/recipient advocacy organizations, the
organization serving as the current OPTN contractor, and an
organization that accredits hospitals.
Supportive comments cited the appropriateness of OPTN involvement
in policies relating to living donors, including donor evaluation,
informed consent, evaluation of surgical outcomes and complications,
protection of living donors, peri-operative care, organ allocation,
qualifications of transplant programs, and transplant program
compliance with living donor policies.
A few comments indicated opposition to giving OPTN living donor
guidelines the same status as other OPTN policies. A family member of
two kidney transplant candidates who died on the waiting list is now an
advocate of potential living donors and recipients meeting on the
Internet and is opposed to the OPTN's involvement in living donor
policy making because of the perception that the OPTN discourages
living donor transplants resulting from such meetings. Another opponent
of OPTN involvement is waiting for a liver transplant and does not
trust the OPTN policymaking process because of the perception that
wealthier candidates receive priority for donor organs. One data
manager from a large transplant program commented that mandating data
collection on living donors was unlikely to increase donor follow-up
form completion rates unless the donors' insurance companies can be
persuaded to pay for follow-up visits. HRSA appreciates each of these
comments.
II. OPTN Living Donor Policy Making Authority--Organ Allocation
Comments supportive of OPTN involvement in living donor policy
making expressed varying views regarding the scope of policies the OPTN
should consider. Of the 17 comments that were supportive of OPTN
involvement, five suggested areas in which the OPTN should not become
involved. One comment did not advocate an intrusive role for the OPTN
in the allocation of living donor organs or ethical review of local
living donor practices. A transplant administrator offered the similar
caution that altruistic living donors may feel a sense of connection to
their local transplant center and may not want their organs allocated
to a distant center. A representative of the professional society for
transplant surgeons offered a comment to HRSA that the OPTN Final Rule
does not authorize the OPTN to establish policies for living donor
organ allocation. In response to this, HRSA emphasizes that its
authority to direct the OPTN to develop living donor organ allocation
policies is granted in Sec. 121.4(a)(6) of the OPTN Final Rule which
permits the Secretary to develop policies on such other matters as the
Secretary directs. The wording in Sec. 121.8(a) of the final rule
referring to policies ``for the equitable allocation of cadaveric
organs'' should not be construed as a limitation of the Secretary's
policy making authority over living donation.
A representative of a living donor advocacy organization commented
that OPTN policies should not interfere with the right of an altruistic
living donor to direct their organ to a specific individual. We agree.
Section 121.8(h) of the OPTN Final Rule permits the allocation of an
organ to a recipient named by those authorized to make the donation.
Because we are directing the OPTN to develop living donor allocation
policies under section 121.8 of the final rule, section 121.8(h) will
apply to living donation equally as it applies to deceased donation.
III. OPTN Living Donor Policy Making Authority--Donor Evaluation
Supportive comments varied in their level of support for OPTN
involvement in developing policies for living donor evaluation. Of the
17 comments that were supportive, two were opposed to OPTN policymaking
in this area. One comment from a representative of the professional
organization for transplant surgeons and another from a transplant
surgeon asserted that the OPTN should not develop policy in the area of
donor evaluation because there is no clear clinical consensus regarding
the policies or standards that should be followed. HRSA believes it is
very likely that should the OPTN consider policy making in the area of
living donor evaluation that members of OPTN committees and the Board
of Directors will consider this perspective and abandon policy making
in the absence of clear clinical consensus. Additionally, through its
public comment process transplant professionals also have the
opportunity to advise the OPTN of the lack of clear clinical consensus,
should it exist.
IV. OPTN Living Donor Policy Making--Living Donor Follow-up
Several comments stated greater attention should be given to
understanding the impact of donation on living donors. One commenter
who represents the professional organization for transplant
professionals recommended more Federal funding for a live organ donor
database. A comment from a living donor who is a healthcare
professional and living donor advocate asserted that there should be
mandatory policies to protect living donors and a central source of
outcome data via a living donor registry. A comment from a transplant
surgeon supports more OPTN involvement in living donor data collection
and monitoring living donor outcomes. A comment from a representative
of a healthcare accreditation organization stated it is appropriate for
the OPTN to establish additional policies to promote the safety of
living donor transplantation. A
[[Page 34948]]
comment from the mother of a living donor and recipient who both
experienced post-transplant complications asserted that stronger
policies should be developed to ensure living donor safety.
Conclusion
HRSA has reviewed and considered each aspect of each comment and
has determined that OPTN living donor guidelines should be given the
same status of other OPTN policies as discussed in the Federal Register
Notice published on January 23, 2006. Under 42 CFR 121.4(a)(6), the
Secretary directs the OPTN to develop policies regarding living organ
donors and living organ donor recipients, including policies for the
equitable allocation of living donor organs, in accordance with section
121.8 of the final rule. Thus, the OPTN shall develop such policies in
the same manner, and with the same public comment process, that it does
for policies on deceased organ donors and deceased organ donor
recipients. Non-compliance with such policies shall subject OPTN
members to the same consequences as noncompliance with policies
concerning deceased organ donors and deceased organ donor recipients
developed under the final rule.
Dated: June 9, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-9401 Filed 6-15-06; 8:45 am]
BILLING CODE 4165-15-P
