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HHS/HRSA RIN: 0906-AB02 Publication ID: Fall 2016 
Title: Definition of Human Organ Under Section 301 of the National Organ Transplant Act of 1984 
Abstract:

This final rule clarifies that peripheral blood stem cells are included in the definition of bone marrow under section 301 of the National Organ Transplantation Act of 1984, as amended and codified in 42 U.S.C. 274e.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 109-129    Stem Cell Therapeutic and Research Act of 2005, as amended in 2010 by Pub. L. 111-264   
Legal Deadline:
Action Source Description Date
Final  Statutory  Congressional deadline  12/18/2016 

Overall Description of Deadline: On December 18, 2015, Public Law 114-104 was enacted and required the Secretary to issue a determination no later than December 18, 2016, as to whether peripheral blood stem cells and umbilical cord blood are "human organs" subject to NOTA section 301.

Statement of Need:

  • There are currently two methods to collect hematopoietic stem cells (HSCs) from a donor:  bone marrow aspiration, and apheresis following a drug regimen.  In the second category, granulocyte-colony-stimulating factors are administered over 4-5 days to stimulate the donor to produce and release HSCs from the bone marrow into the peripheral (circulating) blood, where they are collected by apheresis in one or two sessions for a total of 8 hours. 
  • A panel of the Ninth Circuit Court of Appeals has held that HSCs collected from peripheral blood are not human organs subject to the prohibition against transfer for valuable consideration established in section 301 of the National Organ Transplant Act of 1984 (NOTA).

Should donors begin to be compensated, that decision creates the potential for disparate compensation practices for HSCs collected by bone marrow aspiration and HSCs collected from peripheral blood.  The disparity could lead to fewer donations of HSCs by bone marrow aspiration, despite clear clinical preferences for such HSCs for certain patients and conditions.  It could also lead to a foreclosure of access to international donor registries, which continue to provide matched donors for patients in the United States.

Summary of the Legal Basis:

In 2011, a panel of the Ninth Circuit Court of Appeals held that HSCs from peripheral blood are not bone marrow under the prohibition in NOTA section 301.  Under this ruling, the transfer of HSCs in bone marrow would be subject to the prohibition in NOTA section 301, while HSCs obtained by mobilizing the donor to release HSCs from the bone marrow into the blood stream so that they may be recovered within days from the donor’s peripheral blood would not be subject to the prohibition.  The court further observed that, although NOTA section 301 authorized the Secretary to issue a regulation identifying additional human organs subject to that provision, HHS had not yet exercised its authority to identify peripheral blood stem cells as section 301 authorizes.  Flynn v. Holder , 684 F.3d 852 (9th Cir. 2012).  On December 18, 2015, Public Law 114-104 was enacted, which required the Secretary to issue a determination as to whether peripheral blood stem cells and umbilical cord blood are human organs subject to NOTA section 301 no later than December 18, 2016.

Alternatives:

Anticipated Costs and Benefits:

This proposed rule is not expected to have significant cost implications.

Risks:

Although the registry for HSC donors administered under statute as the C.W. Bill Young Cell Transplantation Program has continued to advise registrants that they will not be compensated for registering or donating their HSCs, compensation may become more common if we do not complete this rulemaking.  The implementation of payment for donors of peripheral blood stem cells could adversely affect the safety of donors who may proceed with donation even when they have concerns about the risks, as well as the safety of patients, if the lure of compensation leads donors to hide information about their communicable disease risks.  In addition, it may make donors less willing to donate HSCs by bone marrow aspiration, if by doing so they would forego compensation for donating of peripheral blood stem cells.  It could also foreclose access to international donors.  Such access is currently provided by reciprocal agreements with foreign registries, which require that donors of HSCs be uncompensated volunteers.

 In addition, disapproval of this action would mean that HHS would not meet the December 18, 2016, deadline Congress set for completion.  As drafted, the proposed rule elicited a few comments about the inclusion of umbilical cord blood within the scope of the proposed rule.  On December 18, 2015, Public Law 114-104 was enacted, which required the Secretary to issue a determination as to whether peripheral blood stem cells and umbilical cord blood are human organs subject to NOTA section 301 no later than December 18, 2016.

Timetable:
Action Date FR Cite
NPRM  10/02/2013  78 FR 60810   
NPRM Comment Period End  12/02/2013 
Final Rule  11/00/2016 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. James Bowman
Medical Director, Division of Transplantation
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, Room 12C-06,
Rockville, MD 20857
Phone:301 443-4861