Department of Health and Human Services November 4, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending to January 4, 2010, the comment period for the draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens'' that appeared in the Federal Register of August 3, 2009 (74 FR 38439), as corrected on August 21, 2009 (74 FR 42311). In the notice of availability, FDA requested comments by November 2, 2009. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice extends the comment period for a proposed rule published in the Federal Register on September 29, 2009, (74 FR 49922). The proposed rule would implement a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient end-stage renal disease (ESRD) dialysis facilities. The proposed ESRD PPS would also replace the current basic case-mix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services. The comment period for the proposed rule, which would have ended on November 16, 2009, is extended for 30 days.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for the Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, HHS/HRSA/HSB/DoT, system of records number 09-15-0055. The purpose of this alteration is to add a new routine use for this system of records. In addition, this notice clarifies system location, how the records are stored, retrieved, and disposed.