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

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).

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.