Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act, 26464-26467 [2015-11048]
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Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations
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[FR Doc. 2015–11141 Filed 5–7–15; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 121
RIN 0906–AB05
Organ Procurement and
Transplantation: Implementation of the
HIV Organ Policy Equity Act
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Final rule.
asabaliauskas on DSK5VPTVN1PROD with RULES
AGENCY:
This final rule amends the
regulations implementing the National
Organ Transplant Act of 1984, as
amended, (NOTA) pursuant to statutory
requirements of the HIV Organ Policy
Equity Act (HOPE Act), enacted in 2013.
In accordance with the mandates of the
HOPE Act, this regulation removes the
current regulatory provision that
SUMMARY:
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requires the Organ Procurement
Transplantation Network (OPTN) to
adopt and use standards for preventing
the acquisition of organs from
individuals known to be infected with
human immunodeficiency virus (HIV).
In its place, this regulation includes
new requirements that organs from
individuals infected with HIV may be
transplanted only into individuals who
are infected with HIV before receiving
such organs and who are participating
in clinical research approved by an
institutional review board, as provided
by regulation. The only exception to this
requirement of participation in such
clinical research is if the Secretary
publishes a determination in the future
that participation in such clinical
research, as a requirement for
transplants of organs from individuals
infected with HIV, is no longer
warranted.
In addition, this regulatory change
establishes that OPTN standards must
ensure that any HIV-infected transplant
recipients are participating in clinical
research in accordance with the
research criteria to be published by the
Secretary. Alternately, if and when the
Secretary determines that participation
in such clinical research should no
longer be a requirement for transplants
with organs from donors infected with
HIV to individuals infected with HIV,
the regulation mandates that the OPTN
adopt and use standards of quality, as
directed by the Secretary, consistent
with the law and in a way that ensures
the changes will not reduce the safety of
organ transplantation.
DATES: This final rule is effective June
8, 2015.
FOR FURTHER INFORMATION CONTACT:
Robert W. Walsh, Director, Division of
Transplantation, Healthcare Systems
Bureau, Health Resources and Services
Administration, 5600 Fishers Lane,
Room 8W37, Rockville, MD 20857; or by
telephone (301) 443–7577.
SUPPLEMENTARY INFORMATION:
I. Background
The U.S. Department of Health and
Human Services (HHS), Health
Resources and Services
Administration’s (HRSA), Healthcare
Systems Bureau (HSB), Division of
Transplantation (DoT) is responsible for
overseeing the operation of the nation’s
Organ Procurement and Transplantation
Network (OPTN), which has
responsibilities including the equitable
allocation of donor organs for
transplantation. The allocation of organs
is guided by organ allocation policies
developed by the OPTN in accordance
with the regulations governing the
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operation of the OPTN (sometimes
referred to as the ‘‘OPTN final rule’’ and
herein referred to as ‘‘OPTN
regulations’’) (42 CFR part 121). The
OPTN is also charged with developing
policies on many subjects, including
standards of quality pertaining to organs
procured for use in transplantation. In
addition to the efficient and effective
allocation of donor organs through the
OPTN, the Secretary also supports
efforts to increase the supply of donor
organs made available through
transplantation.
II. Summary of the HOPE Act
Prior to the enactment of the HOPE
Act, Public Law 113–51 (November 21,
2013), NOTA required the OPTN to
adopt and use standards of quality for
preventing the acquisition of organs
from individuals known to be infected
with HIV. This requirement was further
incorporated into regulation at 42 CFR
121.6(b). Thus, OPTN members were
prohibited from transplanting organs
from individuals known to be infected
with HIV into patients (including
patients infected with HIV).
The HOPE Act made an important
change with respect to the
transplantation of organs from
individuals infected with HIV. Pursuant
to the HOPE Act, organs from
individuals infected with HIV may be
transplanted so long as two sets of
requirements are satisfied. First, organs
from individuals infected with HIV may
be transplanted only into individuals
who were infected with HIV prior to
receiving such an organ.
Second, transplants from individuals
infected with HIV are subject to one of
two oversight frameworks. Specifically,
under the initial framework envisioned
by the HOPE Act, all recipients of
organs from individuals infected with
HIV must be participating in clinical
research approved by an institutional
review board under research criteria to
be published by the Secretary as
described in the HOPE Act and the
standards of quality implemented by the
OPTN pursuant to the HOPE Act. Based
on this change, all transplant centers
conducting such clinical research will
be required to comply with research
criteria published by the Secretary
under subsection (a) of section 377E of
the Public Health Service Act, as
amended. Alternately, if the Secretary
determines that participation in such
clinical research is no longer warranted
as a requirement for transplants of
organs from individuals infected with
HIV, the Secretary will publish such a
determination. The Secretary must then,
consistent with the HOPE Act, direct the
OPTN to revise its standards, consistent
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Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations
with applicable law, in a way to ensure
that the changes will not reduce the
safety of organ transplantation. Such a
direction may only occur, if at all, after
the Secretary reviews the results of
scientific research in conjunction with
the OPTN to determine whether the
results warrant revision of the standards
of quality with respect to specific issues
identified in the HOPE Act.
As noted above, the HOPE Act directs
the Secretary to develop and publish
criteria for the conduct of research
relating to transplantation of organs
from donors infected with HIV into
individuals who are infected with HIV
before receiving an HIV-infected organ.
These research criteria will be
published in a separate document and
public comments will be solicited on
such research criteria.
The HOPE Act also requires the OPTN
to revise standards of quality for the
acquisition and transportation of
donated HIV-infected organs to the
extent determined necessary by the
Secretary to allow the conduct of
research in accordance with the
research criteria published by the
Secretary (unless and until such time
that the Secretary publishes a
determination that participation in such
clinical research is no longer warranted
for transplants involving organs from
donors infected with HIV).
Consistent with these directives, the
HOPE Act directs the Secretary to revise
current regulations (specifically, 42 CFR
121.6) that direct the OPTN to adopt
and use standards for preventing the
acquisition of organs from individuals
infected with HIV, which effectively
prevent the conduct of research relating
to the transplantation of organs
procured from individuals infected with
HIV into recipients infected with HIV.
The HOPE Act mandates that such
regulatory revisions are to be made not
later than two years after the date of
enactment of the HOPE Act. That two
year period will end on November 21,
2015. The Department is issuing this
final rule under that statutory directive.
asabaliauskas on DSK5VPTVN1PROD with RULES
III. Summary of This Final Rule
The Department issues this final rule
to fulfill the HOPE Act’s mandate that
the Secretary amend 42 CFR part 121 to
permit the conduct of research
involving the transplantation of organs
from individuals infected with HIV into
persons who are infected with HIV. This
final rule removes the current regulatory
prohibition against such transplants and
makes clear that HIV-infected
transplants may occur provided all of
the HOPE Act’s requirements are
satisfied.
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Although the HOPE Act also provides
the Secretary with discretion to
determine what criteria should apply to
the conduct of such research, the
Secretary is not promulgating such
research criteria as part of this
regulation. As noted above, the
Secretary will publish such research
criteria in a separate publication. The
purpose of this regulation is to modify
the regulations governing the operation
of the OPTN to make such regulations
consistent with the framework set forth
in the HOPE Act.
Once this regulation is effective, the
OPTN regulations will provide that
organs from individuals infected with
HIV may be transplanted only into
individuals who are infected with HIV
before receiving such organ(s). Thus, the
OPTN final rule will not permit the
transplantation of organs from
individuals infected with HIV into
individuals who are not infected with
HIV. In addition, organs from
individuals infected with HIV may only
be transplanted into recipients who are
participating in clinical research
approved by an institutional review
board, as defined in 45 CFR part 46,
under the forthcoming research criteria
to be published by the Secretary until
such time that the Secretary publishes a
determination that participation in such
clinical research, as a requirement for
transplants of organs from individuals
infected with HIV, is no longer
warranted. If the Secretary publishes
such a determination, that transplants of
organs from individuals infected with
HIV can occur outside of the Secretary’s
research criteria, she will do so using
appropriate procedures (e.g., notice and
comment rulemaking under the
Administrative Procedure Act unless
inapplicable or unless an exception
applies). At that time, and as outlined
in 42 CFR 121.6(b)(3), as added by this
final rule, the OPTN must adopt and use
standards of quality with respect to
organs infected with HIV as directed by
the Secretary, consistent with the
applicable statutory authority (42 U.S.C.
274), and in a way that ensures the
changes will not reduce the net safety of
organ transplantation. The Secretary
may also determine that further changes
to the OPTN regulations are warranted
if and when she determines that
transplants of organs from individuals
infected with HIV need not be
conducted in accordance with the
research criteria developed under the
HOPE Act. The Secretary may amend
the OPTN regulations and transplant
centers conducting transplants with
organs from donors infected with HIV
into recipients with HIV will be obliged
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26465
to comply with any new regulatory
provisions.
IV. Explanation of Final Rule Without
Notice and Comment
In accordance with the provisions of
the Administrative Procedure Act, 5
U.S.C. 553(b)(3)(B), agencies are
permitted to waive the use of notice and
comment procedures in issuing
regulations when such agencies, for
good cause, find that notice and public
comment procedures are impracticable,
unnecessary, or contrary to the public
interest and when agencies incorporate
their findings and a brief explanation of
their rationale in such regulations. The
amendment to 42 CFR 121.6 made by
this regulation is required by the HOPE
Act. 42 U.S.C. 274f–5(b)(2). Because the
changes made by this rule directly
implement changes to the governing
statute made by the HOPE Act, and
because the Secretary is not undertaking
discretionary rulemaking concerning the
OPTN (but is instead directly following
mandated changes in the law), the
Secretary has determined, under 5
U.S.C. 553, that it is unnecessary and
impracticable to follow proposed
rulemaking procedures in this instance.
Thus, the Secretary is waiving the
public notice and comment procedures
in the interest of implementing the
changes set forth in the HOPE Act, to
enable persons infected with HIV to
receive organs from individuals infected
with HIV as long as all of the
requirements set forth in the HOPE Act
are satisfied and to enable the OPTN to
revise its standards of quality,
consistent with the HOPE Act.
V. Economic and Regulatory Impact
Executive Order 12866 requires that
all regulations reflect consideration of
alternatives, costs, benefits, incentives,
equity, and available information.
Regulations require special analysis if
they are found to be ‘‘significant’’
because of their cost, adverse effects on
the economy, inconsistency with other
agency actions, budgetary impact, or the
raising of novel legal or policy issues. In
addition, the Regulatory Flexibility Act
of 1980 (RFA) requires that agencies
analyze regulatory proposals to
determine whether they create a
significant economic impact on a
substantial number of small entities. 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. ‘‘Small entity’’ is defined in the
RFA as ‘‘having the same meaning as
the terms ‘small business,’ ‘small
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08MYR1
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organization,’ and ‘small governmental
jurisdiction.’ ’’
The Secretary has determined that
minimal resources are required to
implement the requirements in this rule
because the initial phase of
implementation, after the Secretary
develops research criteria, will be the
conduct of research involving
transplants of organs from HIV-infected
donors into HIV-infected recipients. As
such, the change in standards of quality
will initially only impact Organ
Procurement Organizations and
transplant hospitals choosing to enroll
patients in research protocols. In
addition, the number of HIV-infected
transplants, and the number of
institutions performing HIV-infected
transplants, will be small. Cost and
burden estimates refer to the research
phase of implementation only. Should
the Secretary determine, after reviewing
the results of scientific research, that the
standards of quality referenced above
should be modified for the entire
transplant system, the Secretary will, in
accordance with the HOPE Act, direct
the OPTN to revise such standards,
consistent with applicable law and in a
way that ensures the changes will not
reduce the safety of organ
transplantation. At that time, the
Secretary may revise the Department’s
impact analysis. Therefore, in
accordance with the RFA and the Small
Business Regulatory Flexibility 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. This rule is not being
treated as a ‘‘significant regulatory
action’’ under section 3(f) of Executive
Order 12866. Accordingly, the rule has
not been reviewed by the Office of
Management and Budget.
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 based on legal authority.
VI. Impact of the New Rule
This rule has the effect of fulfilling
the HOPE Act’s statutory mandate
requiring the Secretary to amend OPTN
regulations to permit the conduct of
research involving the transplantation of
organs from individuals infected with
HIV into persons who are infected with
HIV. This final rule removes the current
regulatory prohibition against HIVinfected transplants and makes clear
that HIV-infected transplants may occur
so long as all of the requirements
described in the HOPE Act are satisfied.
OPTN members will be required to
comply with requirements set forth in
the OPTN final rule, including those
pertaining to data submission as set
forth in 42 CFR part 121, as applied to
organs recovered from HIV-infected
individuals.
VII. Paperwork Reduction Act of 1995
The Department has determined that
at this time, the amendment described
in this rule imposes minimal additional
data collection requirements beyond
those already imposed by current
regulations, which have been approved
by the Office of Management and
Budget. The current data collection
requirements in the OPTN final rule
approved by the 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 only slightly
impacted by this rule. Current OPTN
forms already include information about
HIV testing and a donor’s HIV status.
HRSA anticipates that OPTN candidate
registration forms will be updated in the
future to include a question regarding
the candidate’s participation in research
studies conducted under the authority
Number of
respondents
Form
Heart Candidate Registration ..............................................
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Responses
per
respondent
133
Fmt 4700
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of the Act. In addition, certain OMBapproved forms will be updated in the
future to include results of HIV blood
tests using Nucleic Acid Test (NAT)
methodology. However, the inclusion of
this information is not based upon the
regulatory changes made by the HOPE
Act, but is instead responsive to revised
Public Health Service guidelines
published in 2013. The burden for this
data collection is anticipated to be small
given the projected number of research
participants (<1% of annual transplants
at the outset). Finally, it is possible that
the OPTN will conduct additional data
collections to implement the changes in
law created by the Act. For example,
when the Secretary publishes research
criteria under the Act, it is possible that
such criteria will make
recommendations concerning data that
would be helpful for the Secretary to
review in assessing research on
transplants involving organs from
individuals infected with HIV. In that
event, the Department may choose to
incorporate some of those data elements
into OPTN forms and data collection.
Alternately, the OPTN may determine
independently that it wishes to capture
additional data with respect to OPTN
members participating in research under
the HOPE Act. This rule reflects the
Department’s current assessment as to
the likely data collections that will be
imposed by virtue of this regulation. If,
in the future, the Department or the
OPTN determine that additional data
should be collected in implementation
of this regulation, the Department will
notify the public of any proposed data
collections and solicit comments
consistent with the Paperwork
Reduction Act.
The estimated number of respondents
included in the table below is based on
the current number of OPTN transplant
hospital members. The number of
transplant hospital members will vary
as new members are approved for OPTN
membership, and/or members
relinquish their OPTN membership
when a member ceases activity related
to organ transplantation. As such, while
the total burden hours may change
slightly from the estimate below, the
table below is an accurate
representation of the current estimated
annual reporting burden.
The estimated annual reporting
burden is as follows:
Total
responses
1
E:\FR\FM\08MYR1.SGM
133
08MYR1
Hours per
response
0.08
Total
burden
hours
(cost)
11 ($286)
26467
Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations
Number of
respondents
Form
Responses
per
respondent
Total
responses
Total
burden
hours
(cost)
Hours per
response
Lung Candidate Registration ...............................................
Heart/Lung Candidate Registration .....................................
Kidney Candidate Registration ............................................
Pancreas Candidate Registration ........................................
Kidney/Pancreas Candidate Registration ............................
Pancreas Islet Candidate Registration ................................
Liver Candidate Registration ...............................................
Intestine Candidate Registration ..........................................
68
67
236
137
137
20
139
41
1
1
1
1
1
1
1
1
68
67
236
137
137
20
139
41
0.08
0.08
0.08
0.08
0.08
0.08
0.08
0.08
5 ($130)
5 ($130)
19 ($494)
11 ($286)
11 ($286)
2 ($52)
11 ($286)
3 ($78)
Total ..............................................................................
978
9
978
0.72
78 ($2,028)
List of Subjects in 42 CFR Part 121
Health care, Hospitals, Organ
transplantation, Reporting and
recordkeeping requirements.
Dated: April 21, 2015.
James Macrae,
Acting Administrator, Health Resources and
Services Administration.
Approved: May 1, 2015.
Sylvia M. Burwell,
Secretary.
Therefore, for the reasons stated in the
preamble, the Department of Health and
Human Services amends 42 CFR part
121 as follows:
PART 121—ORGAN PROCUREMENT
AND TRANSPLANTATION NETWORK
1. The authority citation for part 121
is revised to read as follows:
■
Authority: Sections 215, 371–76, and 377E
of the Public Health Service Act (42 U.S.C.
216, 273–274d, 274f–5); 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).
2. In § 121.6, revise paragraph (b) to
read as follows:
transplants of organs from individuals
infected with HIV, is no longer
warranted.
(2) Except as provided in paragraph
(b)(3) of this section, the OPTN shall
adopt and use standards of quality with
respect to organs from individuals
infected with HIV to the extent the
Secretary determines necessary to allow
the conduct of research in accordance
with the criteria described in paragraph
(b)(1)(ii)(A) of this section.
(3) If the Secretary has determined
under paragraph (b)(1)(ii)(B) of this
section that participation in clinical
research is no longer warranted as a
requirement for transplants of organs
from individuals infected with HIV, the
OPTN shall adopt and use standards of
quality with respect to organs from
individuals infected with HIV as
directed by the Secretary, consistent
with 42 U.S.C. 274, and in a way that
ensures the changes will not reduce the
safety of organ transplantation.
*
*
*
*
*
[FR Doc. 2015–11048 Filed 5–7–15; 8:45 am]
BILLING CODE 4165–15–P
■
§ 121.6
*
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DEPARTMENT OF THE INTERIOR
Organ procurement.
*
*
*
*
(b) HIV. (1) Organs from individuals
infected with human immunodeficiency
virus (HIV) may be transplanted only
into individuals who—
(i) Are infected with HIV before
receiving such organ(s); and
(ii)(A) Are participating in clinical
research approved by an institutional
review board, as defined in 45 CFR part
46, under the research criteria published
by the Secretary under subsection (a) of
section 377E of the Public Health
Service Act, as amended; or
(B) The Secretary has published,
through appropriate procedures, a
determination under section 377E(c) of
the Public Health Service Act, as
amended, that participation in such
clinical research, as a requirement for
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Fish and Wildlife Service
We make those changes in this
document.
DATES: Effective May 8, 2015.
FOR FURTHER INFORMATION CONTACT:
Anissa Craghead, 703–358–2445.
We
relocated our headquarters offices from
Arlington, Virginia, to Falls Church,
Virginia, on July 28, 2014. To ensure
regulated entities and the general public
have accurate contact information for
the Service’s offices, on July 29, 2014,
we published a final rule (79 FR 43961)
to update our headquarters addresses
throughout our regulations. We
inadvertently omitted two necessary
address changes in the regulations at 50
CFR 10.21. We make those changes in
this document.
SUPPLEMENTARY INFORMATION:
List of Subjects in 50 CFR Part 10
Exports, Fish, Imports, Law
enforcement, Plants, Transportation,
Wildlife.
Regulation Promulgation
Accordingly, we amend part 10 of
subchapter A of chapter I, title 50 of the
Code of Federal Regulations, as set forth
below:
PART 10—GENERAL PROVISIONS
1. The authority citation for part 10
continues to read as follows:
■
50 CFR Part 10
[Docket No. FWS–HQ–BPHR–2014–0028;
FXGO16600954000–134–FF09B30000]
Authority: 16 U.S.C. 668a–d, 703–712,
742a–j–l, 1361–1384, 1401–1407, 1531–1543,
3371–3378; 18 U.S.C. 42; 19 U.S.C. 1202.
RIN 1018–BA52
■
Addresses of Headquarters Offices
2. Amend § 10.21 by revising
paragraph (a) and the first sentence of
paragraph (b) to read as follows:
AGENCY:
§ 10.21
On July 29, 2014, the U.S.
Fish and Wildlife Service (we)
published a final rule to update the
addresses of our headquarters offices in
our regulations. We inadvertently
omitted two necessary address changes.
(a) Mail forwarded to the Director for
law enforcement purposes should be
addressed to Chief, Office of Law
Enforcement, at the address provided at
50 CFR 2.1(b).
(b) Mail sent to the Director regarding
permits for the Convention on
International Trade in Endangered
Species of Wild Fauna and Fauna
(CITES), injurious wildlife, Wild Bird
Fish and Wildlife Service,
Interior.
ACTION: Final rule; technical
amendment.
SUMMARY:
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Director.
08MYR1
]]>Agencies
[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Rules and Regulations]
[Pages 26464-26467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11048]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 121
RIN 0906-AB05
Organ Procurement and Transplantation: Implementation of the HIV
Organ Policy Equity Act
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends the regulations implementing the
National Organ Transplant Act of 1984, as amended, (NOTA) pursuant to
statutory requirements of the HIV Organ Policy Equity Act (HOPE Act),
enacted in 2013. In accordance with the mandates of the HOPE Act, this
regulation removes the current regulatory provision that requires the
Organ Procurement Transplantation Network (OPTN) to adopt and use
standards for preventing the acquisition of organs from individuals
known to be infected with human immunodeficiency virus (HIV).
In its place, this regulation includes new requirements that organs
from individuals infected with HIV may be transplanted only into
individuals who are infected with HIV before receiving such organs and
who are participating in clinical research approved by an institutional
review board, as provided by regulation. The only exception to this
requirement of participation in such clinical research is if the
Secretary publishes a determination in the future that participation in
such clinical research, as a requirement for transplants of organs from
individuals infected with HIV, is no longer warranted.
In addition, this regulatory change establishes that OPTN standards
must ensure that any HIV-infected transplant recipients are
participating in clinical research in accordance with the research
criteria to be published by the Secretary. Alternately, if and when the
Secretary determines that participation in such clinical research
should no longer be a requirement for transplants with organs from
donors infected with HIV to individuals infected with HIV, the
regulation mandates that the OPTN adopt and use standards of quality,
as directed by the Secretary, consistent with the law and in a way that
ensures the changes will not reduce the safety of organ
transplantation.
DATES: This final rule is effective June 8, 2015.
FOR FURTHER INFORMATION CONTACT: Robert W. Walsh, Director, Division of
Transplantation, Healthcare Systems Bureau, Health Resources and
Services Administration, 5600 Fishers Lane, Room 8W37, Rockville, MD
20857; or by telephone (301) 443-7577.
SUPPLEMENTARY INFORMATION:
I. Background
The U.S. Department of Health and Human Services (HHS), Health
Resources and Services Administration's (HRSA), Healthcare Systems
Bureau (HSB), Division of Transplantation (DoT) is responsible for
overseeing the operation of the nation's Organ Procurement and
Transplantation Network (OPTN), which has responsibilities including
the equitable allocation of donor organs for transplantation. The
allocation of organs is guided by organ allocation policies developed
by the OPTN in accordance with the regulations governing the operation
of the OPTN (sometimes referred to as the ``OPTN final rule'' and
herein referred to as ``OPTN regulations'') (42 CFR part 121). The OPTN
is also charged with developing policies on many subjects, including
standards of quality pertaining to organs procured for use in
transplantation. In addition to the efficient and effective allocation
of donor organs through the OPTN, the Secretary also supports efforts
to increase the supply of donor organs made available through
transplantation.
II. Summary of the HOPE Act
Prior to the enactment of the HOPE Act, Public Law 113-51 (November
21, 2013), NOTA required the OPTN to adopt and use standards of quality
for preventing the acquisition of organs from individuals known to be
infected with HIV. This requirement was further incorporated into
regulation at 42 CFR 121.6(b). Thus, OPTN members were prohibited from
transplanting organs from individuals known to be infected with HIV
into patients (including patients infected with HIV).
The HOPE Act made an important change with respect to the
transplantation of organs from individuals infected with HIV. Pursuant
to the HOPE Act, organs from individuals infected with HIV may be
transplanted so long as two sets of requirements are satisfied. First,
organs from individuals infected with HIV may be transplanted only into
individuals who were infected with HIV prior to receiving such an
organ.
Second, transplants from individuals infected with HIV are subject
to one of two oversight frameworks. Specifically, under the initial
framework envisioned by the HOPE Act, all recipients of organs from
individuals infected with HIV must be participating in clinical
research approved by an institutional review board under research
criteria to be published by the Secretary as described in the HOPE Act
and the standards of quality implemented by the OPTN pursuant to the
HOPE Act. Based on this change, all transplant centers conducting such
clinical research will be required to comply with research criteria
published by the Secretary under subsection (a) of section 377E of the
Public Health Service Act, as amended. Alternately, if the Secretary
determines that participation in such clinical research is no longer
warranted as a requirement for transplants of organs from individuals
infected with HIV, the Secretary will publish such a determination. The
Secretary must then, consistent with the HOPE Act, direct the OPTN to
revise its standards, consistent
[[Page 26465]]
with applicable law, in a way to ensure that the changes will not
reduce the safety of organ transplantation. Such a direction may only
occur, if at all, after the Secretary reviews the results of scientific
research in conjunction with the OPTN to determine whether the results
warrant revision of the standards of quality with respect to specific
issues identified in the HOPE Act.
As noted above, the HOPE Act directs the Secretary to develop and
publish criteria for the conduct of research relating to
transplantation of organs from donors infected with HIV into
individuals who are infected with HIV before receiving an HIV-infected
organ. These research criteria will be published in a separate document
and public comments will be solicited on such research criteria.
The HOPE Act also requires the OPTN to revise standards of quality
for the acquisition and transportation of donated HIV-infected organs
to the extent determined necessary by the Secretary to allow the
conduct of research in accordance with the research criteria published
by the Secretary (unless and until such time that the Secretary
publishes a determination that participation in such clinical research
is no longer warranted for transplants involving organs from donors
infected with HIV).
Consistent with these directives, the HOPE Act directs the
Secretary to revise current regulations (specifically, 42 CFR 121.6)
that direct the OPTN to adopt and use standards for preventing the
acquisition of organs from individuals infected with HIV, which
effectively prevent the conduct of research relating to the
transplantation of organs procured from individuals infected with HIV
into recipients infected with HIV. The HOPE Act mandates that such
regulatory revisions are to be made not later than two years after the
date of enactment of the HOPE Act. That two year period will end on
November 21, 2015. The Department is issuing this final rule under that
statutory directive.
III. Summary of This Final Rule
The Department issues this final rule to fulfill the HOPE Act's
mandate that the Secretary amend 42 CFR part 121 to permit the conduct
of research involving the transplantation of organs from individuals
infected with HIV into persons who are infected with HIV. This final
rule removes the current regulatory prohibition against such
transplants and makes clear that HIV-infected transplants may occur
provided all of the HOPE Act's requirements are satisfied.
Although the HOPE Act also provides the Secretary with discretion
to determine what criteria should apply to the conduct of such
research, the Secretary is not promulgating such research criteria as
part of this regulation. As noted above, the Secretary will publish
such research criteria in a separate publication. The purpose of this
regulation is to modify the regulations governing the operation of the
OPTN to make such regulations consistent with the framework set forth
in the HOPE Act.
Once this regulation is effective, the OPTN regulations will
provide that organs from individuals infected with HIV may be
transplanted only into individuals who are infected with HIV before
receiving such organ(s). Thus, the OPTN final rule will not permit the
transplantation of organs from individuals infected with HIV into
individuals who are not infected with HIV. In addition, organs from
individuals infected with HIV may only be transplanted into recipients
who are participating in clinical research approved by an institutional
review board, as defined in 45 CFR part 46, under the forthcoming
research criteria to be published by the Secretary until such time that
the Secretary publishes a determination that participation in such
clinical research, as a requirement for transplants of organs from
individuals infected with HIV, is no longer warranted. If the Secretary
publishes such a determination, that transplants of organs from
individuals infected with HIV can occur outside of the Secretary's
research criteria, she will do so using appropriate procedures (e.g.,
notice and comment rulemaking under the Administrative Procedure Act
unless inapplicable or unless an exception applies). At that time, and
as outlined in 42 CFR 121.6(b)(3), as added by this final rule, the
OPTN must adopt and use standards of quality with respect to organs
infected with HIV as directed by the Secretary, consistent with the
applicable statutory authority (42 U.S.C. 274), and in a way that
ensures the changes will not reduce the net safety of organ
transplantation. The Secretary may also determine that further changes
to the OPTN regulations are warranted if and when she determines that
transplants of organs from individuals infected with HIV need not be
conducted in accordance with the research criteria developed under the
HOPE Act. The Secretary may amend the OPTN regulations and transplant
centers conducting transplants with organs from donors infected with
HIV into recipients with HIV will be obliged to comply with any new
regulatory provisions.
IV. Explanation of Final Rule Without Notice and Comment
In accordance with the provisions of the Administrative Procedure
Act, 5 U.S.C. 553(b)(3)(B), agencies are permitted to waive the use of
notice and comment procedures in issuing regulations when such
agencies, for good cause, find that notice and public comment
procedures are impracticable, unnecessary, or contrary to the public
interest and when agencies incorporate their findings and a brief
explanation of their rationale in such regulations. The amendment to 42
CFR 121.6 made by this regulation is required by the HOPE Act. 42
U.S.C. 274f-5(b)(2). Because the changes made by this rule directly
implement changes to the governing statute made by the HOPE Act, and
because the Secretary is not undertaking discretionary rulemaking
concerning the OPTN (but is instead directly following mandated changes
in the law), the Secretary has determined, under 5 U.S.C. 553, that it
is unnecessary and impracticable to follow proposed rulemaking
procedures in this instance.
Thus, the Secretary is waiving the public notice and comment
procedures in the interest of implementing the changes set forth in the
HOPE Act, to enable persons infected with HIV to receive organs from
individuals infected with HIV as long as all of the requirements set
forth in the HOPE Act are satisfied and to enable the OPTN to revise
its standards of quality, consistent with the HOPE Act.
V. Economic and Regulatory Impact
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, costs, benefits, incentives, equity, and
available information. Regulations require special analysis if they are
found to be ``significant'' because of their cost, adverse effects on
the economy, inconsistency with other agency actions, budgetary impact,
or the raising of novel legal or policy issues. In addition, the
Regulatory Flexibility Act of 1980 (RFA) requires that agencies analyze
regulatory proposals to determine whether they create a significant
economic impact on a substantial number of small entities. 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. ``Small
entity'' is defined in the RFA as ``having the same meaning as the
terms `small business,' `small
[[Page 26466]]
organization,' and `small governmental jurisdiction.' ''
The Secretary has determined that minimal resources are required to
implement the requirements in this rule because the initial phase of
implementation, after the Secretary develops research criteria, will be
the conduct of research involving transplants of organs from HIV-
infected donors into HIV-infected recipients. As such, the change in
standards of quality will initially only impact Organ Procurement
Organizations and transplant hospitals choosing to enroll patients in
research protocols. In addition, the number of HIV-infected
transplants, and the number of institutions performing HIV-infected
transplants, will be small. Cost and burden estimates refer to the
research phase of implementation only. Should the Secretary determine,
after reviewing the results of scientific research, that the standards
of quality referenced above should be modified for the entire
transplant system, the Secretary will, in accordance with the HOPE Act,
direct the OPTN to revise such standards, consistent with applicable
law and in a way that ensures the changes will not reduce the safety of
organ transplantation. At that time, the Secretary may revise the
Department's impact analysis. Therefore, in accordance with the RFA and
the Small Business Regulatory Flexibility 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. This rule is not being treated as a
``significant regulatory action'' under section 3(f) of Executive Order
12866. Accordingly, the rule has not been reviewed by the Office of
Management and Budget.
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 based on legal authority.
VI. Impact of the New Rule
This rule has the effect of fulfilling the HOPE Act's statutory
mandate requiring the Secretary to amend OPTN regulations to permit the
conduct of research involving the transplantation of organs from
individuals infected with HIV into persons who are infected with HIV.
This final rule removes the current regulatory prohibition against HIV-
infected transplants and makes clear that HIV-infected transplants may
occur so long as all of the requirements described in the HOPE Act are
satisfied. OPTN members will be required to comply with requirements
set forth in the OPTN final rule, including those pertaining to data
submission as set forth in 42 CFR part 121, as applied to organs
recovered from HIV-infected individuals.
VII. Paperwork Reduction Act of 1995
The Department has determined that at this time, the amendment
described in this rule imposes minimal additional data collection
requirements beyond those already imposed by current regulations, which
have been approved by the Office of Management and Budget. The current
data collection requirements in the OPTN final rule approved by the 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 only
slightly impacted by this rule. Current OPTN forms already include
information about HIV testing and a donor's HIV status. HRSA
anticipates that OPTN candidate registration forms will be updated in
the future to include a question regarding the candidate's
participation in research studies conducted under the authority of the
Act. In addition, certain OMB-approved forms will be updated in the
future to include results of HIV blood tests using Nucleic Acid Test
(NAT) methodology. However, the inclusion of this information is not
based upon the regulatory changes made by the HOPE Act, but is instead
responsive to revised Public Health Service guidelines published in
2013. The burden for this data collection is anticipated to be small
given the projected number of research participants (<1% of annual
transplants at the outset). Finally, it is possible that the OPTN will
conduct additional data collections to implement the changes in law
created by the Act. For example, when the Secretary publishes research
criteria under the Act, it is possible that such criteria will make
recommendations concerning data that would be helpful for the Secretary
to review in assessing research on transplants involving organs from
individuals infected with HIV. In that event, the Department may choose
to incorporate some of those data elements into OPTN forms and data
collection. Alternately, the OPTN may determine independently that it
wishes to capture additional data with respect to OPTN members
participating in research under the HOPE Act. This rule reflects the
Department's current assessment as to the likely data collections that
will be imposed by virtue of this regulation. If, in the future, the
Department or the OPTN determine that additional data should be
collected in implementation of this regulation, the Department will
notify the public of any proposed data collections and solicit comments
consistent with the Paperwork Reduction Act.
The estimated number of respondents included in the table below is
based on the current number of OPTN transplant hospital members. The
number of transplant hospital members will vary as new members are
approved for OPTN membership, and/or members relinquish their OPTN
membership when a member ceases activity related to organ
transplantation. As such, while the total burden hours may change
slightly from the estimate below, the table below is an accurate
representation of the current estimated annual reporting burden.
The estimated annual reporting burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form respondents respondent responses response hours (cost)
----------------------------------------------------------------------------------------------------------------
Heart Candidate Registration.... 133 1 133 0.08 11 ($286)
[[Page 26467]]
Lung Candidate Registration..... 68 1 68 0.08 5 ($130)
Heart/Lung Candidate 67 1 67 0.08 5 ($130)
Registration...................
Kidney Candidate Registration... 236 1 236 0.08 19 ($494)
Pancreas Candidate Registration. 137 1 137 0.08 11 ($286)
Kidney/Pancreas Candidate 137 1 137 0.08 11 ($286)
Registration...................
Pancreas Islet Candidate 20 1 20 0.08 2 ($52)
Registration...................
Liver Candidate Registration.... 139 1 139 0.08 11 ($286)
Intestine Candidate Registration 41 1 41 0.08 3 ($78)
-------------------------------------------------------------------------------
Total....................... 978 9 978 0.72 78 ($2,028)
----------------------------------------------------------------------------------------------------------------
List of Subjects in 42 CFR Part 121
Health care, Hospitals, Organ transplantation, Reporting and
recordkeeping requirements.
Dated: April 21, 2015.
James Macrae,
Acting Administrator, Health Resources and Services Administration.
Approved: May 1, 2015.
Sylvia M. Burwell,
Secretary.
Therefore, for the reasons stated in the preamble, the Department
of Health and Human Services amends 42 CFR part 121 as follows:
PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK
0
1. The authority citation for part 121 is revised to read as follows:
Authority: Sections 215, 371-76, and 377E of the Public Health
Service Act (42 U.S.C. 216, 273-274d, 274f-5); 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. In Sec. 121.6, revise paragraph (b) to read as follows:
Sec. 121.6 Organ procurement.
* * * * *
(b) HIV. (1) Organs from individuals infected with human
immunodeficiency virus (HIV) may be transplanted only into individuals
who--
(i) Are infected with HIV before receiving such organ(s); and
(ii)(A) Are participating in clinical research approved by an
institutional review board, as defined in 45 CFR part 46, under the
research criteria published by the Secretary under subsection (a) of
section 377E of the Public Health Service Act, as amended; or
(B) The Secretary has published, through appropriate procedures, a
determination under section 377E(c) of the Public Health Service Act,
as amended, that participation in such clinical research, as a
requirement for transplants of organs from individuals infected with
HIV, is no longer warranted.
(2) Except as provided in paragraph (b)(3) of this section, the
OPTN shall adopt and use standards of quality with respect to organs
from individuals infected with HIV to the extent the Secretary
determines necessary to allow the conduct of research in accordance
with the criteria described in paragraph (b)(1)(ii)(A) of this section.
(3) If the Secretary has determined under paragraph (b)(1)(ii)(B)
of this section that participation in clinical research is no longer
warranted as a requirement for transplants of organs from individuals
infected with HIV, the OPTN shall adopt and use standards of quality
with respect to organs from individuals infected with HIV as directed
by the Secretary, consistent with 42 U.S.C. 274, and in a way that
ensures the changes will not reduce the safety of organ
transplantation.
* * * * *
[FR Doc. 2015-11048 Filed 5-7-15; 8:45 am]
BILLING CODE 4165-15-P
