Health Resources and Services Administration May 2007 – Federal Register Recent Federal Regulation Documents
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C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory Related Cord Blood Donor Demonstration Project
Public Law 109-129 requires the Secretary of Health and Human Services to establish a 3-year demonstration project for qualified cord blood banks to collect and store at no charge to families, umbilical cord blood units for families where a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. Umbilical cord blood units collected through the demonstration project do not count toward the current National Cord Blood Inventory (NCBI) goal of 150,000 cord blood units to be made available through the C.W. Bill Young Cell Transplantation Program. Qualified umbilical cord blood banks participating in the demonstration project must provide assurances that the cord blood units will be available for directed transplantation until such time as the cord blood unit is needed. Within 90 days of the termination of the demonstration project, the Secretary will submit to Congress a report on the outcomes of the project including recommendations with respect to the continuation of such a project. HRSA's Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in implementation of the related cord blood demonstration project. The purpose of this solicitation is to receive public input on the following: (1) The key questions that should be studied through this project; (2) the mechanism for funding this project; and, (3) umbilical cord blood bank liability. HRSA has identified the following key study questions to be considered in the design of this demonstration project: (1) What is the value and feasibility of implementing a long-term program modeled after this demonstration project; (2) how often and for what clinical indications are cord blood units banked through this project used for transplantation; (3) what is the breakdown of cord blood units collected, stored, and transplanted by race, ethnicity, and disease; (4) do those cord blood units, especially those released for transplant, represent rare Human Leukocyte Antigen (HLA) types such that the recipient would otherwise have been unable to find a matched unrelated donor; (5) how do transplant outcomes using these cord blood units compare to unrelated allogeneic umbilical cord blood transplants and unrelated allogeneic transplants using blood stem cells from adult donors; and, (6) what are the general physical characteristics of these units (e.g., total nucleated count, CD34+ content) and how does their quality compare to that of the general public inventory. HRSA proposes to invite the first cohort of umbilical cord blood banks receiving NCBI contracts to submit competitive proposals for participation in this demonstration project with an emphasis on: (1) Establishment of nationwide collections; and, (2) encouraging banks to subcontract with other experienced, high-quality cord blood banks to assist in their education, collection, processing, and storing efforts. HRSA has approximately $200,000 available for this demonstration project this fiscal year and anticipates selecting 2 or 3 banks to participate in this demonstration project to be funded through modification of their existing NCBI contracts with HRSA. HRSA recognizes the need for this service is likely greater than what can be satisfied in a limited demonstration project. Because of the great diversity in HLA types among African-Americans, HRSA recognizes that patients from this population are significantly less likely to find a suitably matched unrelated blood stem cell donor than patients from other racial or ethnic groups. Therefore, HRSA invites comments on the desirability of limiting participation to African- American families in which a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. HRSA understands that there may be special considerations associated with liability for those umbilical cord blood banks participating in this project. HRSA invites comment on how umbilical cord blood banks participating in this project may best address these concerns. Interested parties are invited to submit written comments on the key study questions, the funding approach, and umbilical cord blood bank liability for this demonstration project to the address below.
''Low Income Levels'' Used for Various Health Professions and Nursing Programs Included in Titles III, VII and VIII of the Public Health Service Act
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII and VIII of the Public Health Service (PHS) Act. The Department periodically publishes in the Federal Register low- income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ``low-income'' families.
National Advisory Council on the National Health Service Corps; Request for Nominations for Members
The Health Resources and Services Administration (HRSA) is requesting nominations to the National Advisory Council (NAC) on the National Health Service Corps (NHSC). NAC was established by 42 U.S.C. 254j; Section 337 of the Public Health Service Act, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of NHSC and related programs.
Announcement of a Change to the Awarding Factors Under the Fiscal Year 2007 New Access Points in High Poverty Counties (HRSA-07-069) Grant Opportunity
The Health Resources and Services Administration (HRSA) is announcing a change to the awarding factors under the HRSA-07-069 ``New Access Points in High Poverty Counties'' funding opportunity [issued on Grants.gov March 14, 2007] as they relate to awards made under the HRSA-07-067 ``New Access Points'' funding opportunity for the President's first Health Centers Initiative [issued on Grants.gov October 6, 2006]. In making award decisions for fiscal year (FY) 2007, HRSA will now consider granting the same organization a new access point award under HRSA-07-067 and HRSA-07-069. HRSA will consider more than one FY 2007 new access point award to an organization if, and only if each application submitted (by the same organization for the two different funding opportunities) proposes a separate and distinct project to serve different counties. That is, there must be no overlap or duplication of service area, target population, or sites. (Under previous HRSA policy, if an organization receives a grant award in FY 2007 under the first opportunity, HRSA-07-067, it could not be awarded funds in FY 2007 under HRSA-07-069). Applicants for HRSA-07-069 should also be aware that each new access point application must be complete and must be able to stand alone. The changes announced in this Federal Register Notice do not impact any HRSA policy for eligibility under the HRSA-07-069. Organizations continue to be eligible to submit one application under HRSA-07-069, irrespective of whether they applied under HRSA-07-067 or not. Additionally, all other awarding factors detailed in HRSA-07-069 remain the same. Reference: HRSA-07-069 is available online via the HRSA Web site at: https://www.hrsa.gov/grants/technicalassistance/pi2nap.htm or http:/ /www.grants.gov.
Request for Public Comment on Use of Rural Urban Commuting Areas (RUCAs)
The Health Resources and Services Administration's (HRSA) Office of Rural Health Policy (ORHP) has sought to identify clear, consistent, and data-driven methods of defining rural areas in the Metropolitan counties of the United States. ORHP has funded development of Rural-Urban Commuting Area (RUCA) codes as the latest version of the Goldsmith Modification. HRSA is seeking comments on ORHP's use of RUCAs to better target Rural Health funding and projects. While other agencies of HHS may choose to adopt ORHP's definition of ``rural'' there is no requirement that they do so and they may choose other, alternate definitions that best suit their program requirements.
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