83 FR 60804 - Change to the Definition of “Human Organ” Under Section 301 of the National Organ Transplant Act of 1984; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 228 (November 27, 2018)

This document withdraws a proposed rule published in the Federal Register on October 2, 2013. The proposed rule sought public comment on the proposed change in the definition of ``human organ'' in section 301 of the National Organ and Transplant Act of 1984, as amended, (NOTA) to explicitly incorporate hematopoietic stem cells within peripheral blood in the definition of ``bone marrow.'' HHS received over 500 comments on the proposed rule. Given the number of substantive comments, at this time HHS has decided to consider the issue further and may issue an NPRM in the future.

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Proposed Rules]
[Page 60804]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121

RIN 0906-AB02


Change to the Definition of ``Human Organ'' Under Section 301 of 
the National Organ Transplant Act of 1984; Withdrawal

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Proposed rule; Withdrawal.

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SUMMARY: This document withdraws a proposed rule published in the 
Federal Register on October 2, 2013. The proposed rule sought public 
comment on the proposed change in the definition of ``human organ'' in 
section 301 of the National Organ and Transplant Act of 1984, as 
amended, (NOTA) to explicitly incorporate hematopoietic stem cells 
within peripheral blood in the definition of ``bone marrow.'' HHS 
received over 500 comments on the proposed rule. Given the number of 
substantive comments, at this time HHS has decided to consider the 
issue further and may issue an NPRM in the future.

DATES: The proposed rule published on October 2, 2013 (78 FR 60810) is 
withdrawn as of November 27, 2018.

ADDRESSES: Division of Transplantation, 5600 Fishers Lane, Room 8W63, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Frank L. Holloman, MPA, Acting 
Division Director, Division of Transplantation, 5600 Fishers Lane, Room 
8W63, Rockville, MD 20852. Telephone: (301) 443-7577.

SUPPLEMENTARY INFORMATION: 
    On March 1, 2017, President Trump issued Executive Order 13777, 
``Enforcing the Regulatory Reform Agenda,'' to implement and enforce 
regulatory reform (82 FR 12285 2/24/2017). Executive Order 13777 
directed each Federal agency to establish a Regulatory Reform Task 
Force to identify regulations that are ``outdated, unnecessary, or 
ineffective.'' In accordance with guidance from Executive Orders 13777 
and 13771 (January 30, 2017, titled ``Regulatory Freeze Pending 
Review''), HHS's Task Force identified the proposed change in 
definition of ``human organ'' as a candidate for withdrawal at this 
time.

    Dated: November 13, 2018.
George Sigounas,
Administrator, Health Resources and Services Administration.
    Dated: November 20, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-25833 Filed 11-26-18; 8:45 am]
 BILLING CODE 4165-15-P