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HHS/HRSA RIN: 0906-AB02 Publication ID: Spring 2017 
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: Completed Actions 
Major: No  Unfunded Mandates: No 
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.

Timetable:
Action Date FR Cite
NPRM  10/02/2013  78 FR 60810   
NPRM Comment Period End  12/02/2013 
NPRM Withdrawn  08/01/2017 
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