Health Resources and Services Administration April 27, 2006 – Federal Register Recent Federal Regulation Documents

Public Law 109-129 requires the Secretary of Health and Human Services to recognize one or more cord blood accreditation entities for the accreditation of cord blood banks participating in the collection and maintenance of umbilical cord blood units for the National Cord Blood Inventory. These cord blood units will be made available for unrelated donor blood stem cell transplants through the C.W. Bill Young Cell Transplantation Program. The HRSA, Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in the determination of which cord blood bank accreditation program(s) to recognize on an interim basis for the initial cycle of funding for the National Cord Blood Inventory. The purpose of this solicitation is to receive public input on the following: (1) Approaches to accreditation required to ensure quality cord blood bank operations (including collection sites); (2) Utilization of accreditation programs to ensure product quality and best practices; (3) Degree to which accreditation standards are evidence based and supported by published literature; (4) Extent to which accreditation standards allow for variations in cord blood bank practices; (5) Criteria for the Secretary to consider in recognizing cord blood bank accrediting programs for the National Cord Blood Inventory, C.W. Bill Young Cell Transplantation Program. The HRSA intends for this interim process to be followed by a formal, more comprehensive recognition process that will include input from both the Advisory Council, once it is established, and the interested public as required in the legislation. The purpose of this Notice is to invite interested parties to register for and participate in either of two conference calls, described below, that HRSA is scheduling to obtain comment on factors relevant to determining which accrediting organization(s) to recognize for the initial cycle of funding under the National Cord Blood Inventory.