0906-AB02 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS Definition of Human Organ Under Section 301 of the National Organ Transplant Act of 1984

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.

]]> Other Significant Previously Published in The Unified Agenda Completed Actions No No Not Yet Determined Pub. L. 109-129 Stem Cell Therapeutic and Research Act of 2005, as amended in 2010 by Pub. L. 111-264 Statutory Final 12/18/2016 Congressional 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. Yes NPRM 10/02/2013 78 FR 60810 NPRM Comment Period End 12/02/2013 NPRM Withdrawn 08/01/2017 No No Undetermined No No No No James Bowman Dr. Medical Director, Division of Transplantation 0906 Health Resources and Services Administration HRSA 301 443-4861 5600 Fishers Lane, Room 12C-06, Rockville MD 20857