Notice of Availability of Final Policy Guidance
HRSA is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2007-09) to describe and clarify HRSA's current policy and process for resolving issues and conflicts related to health center service area overlap. The PIN, ``Service Area Overlap: Policy and Process,'' and the Agency's ``Response to Public Comments'' are available on the Internet at http://bphc.hrsa.gov/chc/sao.htm.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue- based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).
Organ Procurement and Transplantation Network
This Final Rule sets forth the Secretary's decision to include intestines within the definition of organs covered by the regulations governing the operations of the Organ Procurement and Transplantation Network. The Secretary under the authority granted by section 301 of the National Organ Transplant Act, as amended, further effects a corresponding change to the definition of human organs covered in the statute with this Final Rule.
National Practitioner Data Bank; Announcement of Proactive Disclosure Service (PDS) Opening Date and User Fees
The Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), is announcing the implementation of a Proactive Disclosure Service (PDS) Prototype. The PDS is being offered as an alternative to the periodic querying of the National Practitioner Data Bank (NPDB). It was developed in response to the growing interest of healthcare entities in on-going monitoring of practitioner credentials. Authorized Data Bank entities can choose to enroll all of their practitioners in PDS or enroll some practitioners while continuing to periodically query on others using the regular query methods. The query fee for periodic queries remains $4.75 per name. Entities with PDS enrolled practitioners will be notified within one business day of the NPDB's receipt of a report on any of their enrollees. While entities can expect to receive reports sooner with PDS, the format of and the information contained in a report, as well as the information required to be reported will remain the same. Initially, the PDS is being offered as a prototype. The annual subscription fee, during the prototype period, is $3.25 per practitioner. This rate is subject to change after the prototype period is complete.