[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]


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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.

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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:

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                                     Number of     Responses per       Total         Hours per     Total  burden
              Form                  respondents     respondent       responses       response      hours  (cost)
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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)
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    Total.......................             978               9             978            0.72     78 ($2,028)
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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