Health Resources and Services Administration August 2007 – Federal Register Recent Federal Regulation Documents

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PINs referenced above. After review and consideration of all comments received, the PINs may be amended to incorporate recommendations from the public. Once the PINs are finalized, they will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' The ``Response to Public Comments'' will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PINs. Where comments do not result in a revision to the PINs, explanations will be provided. Background: HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver preventive and primary care services to patients regardless of their ability to pay. Charges for health care services are set according to income. The purpose of the recently published draft PINs is to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project, including requests to include new specialty services and/or a new target population within the scope of the Federal project.

The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of July 31, 2007 (FR Doc. E7-14680), on page 41759, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915-0193). In the burden table, the total burden hours published are incorrect.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to establish a new system of records. The Stem Cell Therapeutic and Research Act of 2005 (the Act) authorizes the C.W. Bill Young Cell Transplantation Program (the Program) and provides for the collection, maintenance, and distribution of human blood stem cells for the treatment of patients and for research. The Program consists of four interrelated components each operated under a separate contract. The four components are: The Bone Marrow Coordinating Center; the Cord Blood Coordinating Center; the Office of Patient Advocacy/Single Point of Access; and the Stem Cell Therapeutic Outcomes Database. The contracts for operation of the Bone Marrow Coordinating Center, Cord Blood Coordinating Center, and Office of Patient Advocacy/Single Point of Access were awarded to the National Marrow Donor Program in September, 2006. A single contract for the Stem Cell Therapeutic Outcomes Database was awarded to the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin in September, 2006 as well. As identified by the Act, the Program is charged with: Operating a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients; operating a system for identifying, matching, and facilitating the distribution of donated umbilical cord blood units that are suitably matched to candidate patients; providing a means by which transplant physicians, other healthcare professionals, and patients can electronically search for and access all available adult marrow donors available through the Program; recruiting potential adult volunteer marrow donors; coordinating with other Federal programs to maintain and expand medical contingency response capabilities; carrying out informational and educational activities; providing patient advocacy services; providing case management services for potential donors; and collecting, analyzing, and publishing blood stem cell transplantation related data in a standardized electronic format. This system of records is required to comply with the implementation directives of the Act, Public Law 109-129. The records will be used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes.

A notice was published in the Federal Register (FR) on February 13, 2007, (Vol. 72, p. 6738-6739), describing HRSA's proposal to institute an exception to the Department of Health and Human Services' policy directive governing indirect cost recovery. The notice requested public comments on the proposed exception to Departmental policy requirements to be sent to HRSA no later than March 15, 2007. Three comments were received, one from a Poison Control Center (PCC) host institution (grant recipient) and two from individual PCCs. Two of the three commenters supported HRSA's plan to institute an exception from the grants policy directive, which would permanently limit indirect cost recovery to 10 percent for the Poison Control Center Stabilization and Enhancement Grant Programs.