80 FR 26464 - Grants for Education Programs in Occupational Safety and Health

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service

Federal Register Volume 80, Issue 89 (May 8, 2015)

Page Range		26464-26464
FR Document		2015-11141

Federal Register, Volume 80 Issue 89 (Friday, May 8, 2015)

[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Rules and Regulations]
[Page 26464]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 86


Grants for Education Programs in Occupational Safety and Health

CFR Correction

0
In Title 42 of the Code of Federal Regulations, Parts 1 to 399, revised 
as of October 1, 2014, on page 668, in Sec.  86.33, in paragraph (b), 
remove the term ``068''.

[FR Doc. 2015-11141 Filed 5-7-15; 8:45 am]
 BILLING CODE 1505-01-D

26464 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations

effective on May 5, 2015, as provided in requires the Organ Procurement operation of the OPTN (sometimes
the February 19, 2015 direct final rule. Transplantation Network (OPTN) to referred to as the ‘‘OPTN final rule’’ and
Accordingly, the amendments to 40 adopt and use standards for preventing herein referred to as ‘‘OPTN
CFR 80.1453, 80.1616 and 80.1621 on the acquisition of organs from regulations’’) (42 CFR part 121). The
February 19, 2015 (80 FR 9078), are individuals known to be infected with OPTN is also charged with developing
withdrawn as of May 5, 2015. human immunodeficiency virus (HIV). policies on many subjects, including
In its place, this regulation includes standards of quality pertaining to organs
List of Subjects in 40 CFR Part 80 new requirements that organs from procured for use in transplantation. In
Environmental protection, individuals infected with HIV may be addition to the efficient and effective
Administrative practice and procedure, transplanted only into individuals who allocation of donor organs through the
Air pollution control, Confidential are infected with HIV before receiving OPTN, the Secretary also supports
business information, Diesel fuel, Fuel such organs and who are participating efforts to increase the supply of donor
additives, Gasoline, Imports, in clinical research approved by an organs made available through
Incorporation by reference, Labeling, institutional review board, as provided transplantation.
Motor vehicle pollution, Penalties, by regulation. The only exception to this II. Summary of the HOPE Act
Petroleum, Reporting and recordkeeping requirement of participation in such
requirements. clinical research is if the Secretary Prior to the enactment of the HOPE
publishes a determination in the future Act, Public Law 113–51 (November 21,
Dated: April 30, 2015.
that participation in such clinical 2013), NOTA required the OPTN to
Gina McCarthy, adopt and use standards of quality for
research, as a requirement for
Administrator. preventing the acquisition of organs
transplants of organs from individuals
[FR Doc. 2015–10487 Filed 5–6–15; 4:15 pm]
infected with HIV, is no longer from individuals known to be infected
BILLING CODE 6560–50–P
warranted. with HIV. This requirement was further
In addition, this regulatory change incorporated into regulation at 42 CFR
establishes that OPTN standards must 121.6(b). Thus, OPTN members were
DEPARTMENT OF HEALTH AND ensure that any HIV-infected transplant prohibited from transplanting organs
HUMAN SERVICES recipients are participating in clinical from individuals known to be infected
research in accordance with the with HIV into patients (including
Public Health Service research criteria to be published by the patients infected with HIV).
Secretary. Alternately, if and when the The HOPE Act made an important
42 CFR Part 86 Secretary determines that participation change with respect to the
in such clinical research should no transplantation of organs from
Grants for Education Programs in individuals infected with HIV. Pursuant
Occupational Safety and Health longer be a requirement for transplants
to the HOPE Act, organs from
with organs from donors infected with
individuals infected with HIV may be
CFR Correction HIV to individuals infected with HIV,
transplanted so long as two sets of
the regulation mandates that the OPTN
■ In Title 42 of the Code of Federal requirements are satisfied. First, organs
adopt and use standards of quality, as
Regulations, Parts 1 to 399, revised as of from individuals infected with HIV may
directed by the Secretary, consistent
October 1, 2014, on page 668, in § 86.33, be transplanted only into individuals
with the law and in a way that ensures
in paragraph (b), remove the term who were infected with HIV prior to
the changes will not reduce the safety of
‘‘068’’. receiving such an organ.
organ transplantation. Second, transplants from individuals
[FR Doc. 2015–11141 Filed 5–7–15; 8:45 am]
DATES: This final rule is effective June infected with HIV are subject to one of
BILLING CODE 1505–01–D 8, 2015. two oversight frameworks. Specifically,
FOR FURTHER INFORMATION CONTACT: under the initial framework envisioned
DEPARTMENT OF HEALTH AND Robert W. Walsh, Director, Division of by the HOPE Act, all recipients of
HUMAN SERVICES Transplantation, Healthcare Systems organs from individuals infected with
Bureau, Health Resources and Services HIV must be participating in clinical
42 CFR Part 121 Administration, 5600 Fishers Lane, research approved by an institutional
Room 8W37, Rockville, MD 20857; or by review board under research criteria to
RIN 0906–AB05 telephone (301) 443–7577. be published by the Secretary as
SUPPLEMENTARY INFORMATION: described in the HOPE Act and the
Organ Procurement and
standards of quality implemented by the
Transplantation: Implementation of the I. Background OPTN pursuant to the HOPE Act. Based
HIV Organ Policy Equity Act
The U.S. Department of Health and on this change, all transplant centers
AGENCY: Health Resources and Services Human Services (HHS), Health conducting such clinical research will
Administration (HRSA), Department of Resources and Services be required to comply with research
Health and Human Services (HHS). Administration’s (HRSA), Healthcare criteria published by the Secretary
ACTION: Final rule. Systems Bureau (HSB), Division of under subsection (a) of section 377E of
Transplantation (DoT) is responsible for the Public Health Service Act, as
SUMMARY: This final rule amends the overseeing the operation of the nation’s amended. Alternately, if the Secretary
asabaliauskas on DSK5VPTVN1PROD with RULES

regulations implementing the National Organ Procurement and Transplantation determines that participation in such
Organ Transplant Act of 1984, as Network (OPTN), which has clinical research is no longer warranted
amended, (NOTA) pursuant to statutory responsibilities including the equitable as a requirement for transplants of
requirements of the HIV Organ Policy allocation of donor organs for organs from individuals infected with
Equity Act (HOPE Act), enacted in 2013. transplantation. The allocation of organs HIV, the Secretary will publish such a
In accordance with the mandates of the is guided by organ allocation policies determination. The Secretary must then,
HOPE Act, this regulation removes the developed by the OPTN in accordance consistent with the HOPE Act, direct the
current regulatory provision that with the regulations governing the OPTN to revise its standards, consistent

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Document Created: 2018-02-21 10:24:37
Document Modified: 2018-02-21 10:24:37

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
FR Citation		80 FR 26464

80 FR 26464 - Grants for Education Programs in Occupational Safety and Health

DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health Service

Federal Register Volume 80, Issue 89 (May 8, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service