C.W. Bill Young Transplantation Program Information.doc

HEALTH AND HUMAN SERVICES

HEALTH RESOURCES AND SERVICES ADMINISTRATION

C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM

Program Structure HRSA awarded a number of contracts for the C.W. Bill Young Cell Transplantation Program (Program) in 2006. Contracts were awarded to the National Marrow Donor Program for the following components of the Program: the Cord Blood Coordinating Center; the Bone Marrow Coordinating Center; and, the Office of Patient Advocacy/Single Point of Access. A single award was made to the Medical College of Wisconsin’s Center for International Blood and Marrow Transplant Research to operate the Stem Cell Therapeutic Outcomes Database. In November 2006, HRSA made the first awards to umbilical cord blood banks for National Cord Blood Inventory (NCBI) collections. The following organizations received contracts through this first cycle of funding: Duke University Medical Center and Health Systems; the University of Texas M.D. Anderson Cancer Center; the New York Blood Center; the Puget Sound Blood Center; StemCyte Inc.; and, the University of Colorado at Denver Health and Sciences. In September 2007, HRSA made two additional awards to umbilical cord blood banks for NCBI collections. The following organizations received contracts through the second cycle of funding: the Texas Cord Blood Bank at the South Texas Blood and Tissue Center and the St. Louis Cord Blood Bank at SSM Cardinal Glennon Children’s Hospital. HRSA established the Secretary’s Advisory Council on Blood Stem Cell Transplantation according to the process outlined by the Federal Advisory Committee Act. In the future, with the advice of the Advisory Council, HRSA will be recognizing an accrediting organization(s) for cord blood banks participating in the Program. The following schematic shows the contracting structure for the Program:

Interim Nature of Certain Program Requirements To begin collection of high-quality cord blood units for the NCBI expeditiously, HRSA has established interim requirements for the initial implementation of the Program. These requirements were established based on considerable consultation with experts and interested parties, and on relevant publications. In establishing future policies and requirements for the Program, HRSA intends to consult with the Advisory Council and to provide additional, broader opportunity for comment by the interested public.

Accreditation Requirements HRSA has not yet completed the process of recognizing one or more cord blood bank accrediting organizations for purposes of this program. This RFP requires, as a condition of eligibility, that banks be accredited by one of the established accreditation programs for cord blood banks (i.e., AABB or the Foundation for the Accreditation of Cellular Therapy). Depending on the outcome of HRSA’s recognition decision, participating banks may need to apply for accreditation or re-accreditation by a recognized organization within a reasonable time.

Regulations and Changes in Program Requirements HRSA may issue regulations with respect to the NCBI and the C.W. Bill Young Cell Transplantation Program. Also, since the field of cord blood transplantation is rapidly evolving, HRSA may need to amend some Program requirements based on new data or consultation with the Advisory Council and other parties. These developments may require changes in some requirements of this contract. In such circumstance, the contractor will be given a reasonable time to accommodate changes.