Department of Health and Human Services August 2006 – Federal Register Recent Federal Regulation Documents

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in PCT (application number pending) filed July 28, 2006 from U.S. provisional application 60/703,814 (E-167-2005/0-US-01), entitled ``System and Methods for Detecting and Characterizing Macromolecular Interactions in Solution'' (Inventors: Drs. Allen Minton and Arun Attri) to Wyatt Technology Corporation (hereafter Wyatt), having a place of business in Goleta, California. The patent rights in these inventions have been assigned to the United States of America.

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 informs interested parties of an opportunity to apply for the Frontier Extended Stay Clinic (FESC) demonstration, which is mandated by section 434 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. A FESC is designed to address the needs of seriously or critically ill or injured patients who, due to adverse weather conditions or other reasons, cannot be transferred to acute care hospitals, or patients who do not need a hospital level of care but need monitoring and observation for limited periods of time.

This notice announces a town hall meeting on the Medicare Provider Feedback Group (MPFG). The purpose of the meeting is to solicit the opinions of individual Medicare physicians, providers, and suppliers on selected policies and operational issues that affect providers that participate in the Medicare program. In addition, we will be soliciting input on how we can better serve the Medicare providers and suppliers. All Medicare providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, and other third-party billers, are invited to attend this meeting. We will consider facts and opinions obtained from individual Medicare physicians, providers, and suppliers. We will use the information obtained during the meeting as feedback on selected policy issues and on CMS provider and supplier communication activities and related topics. The meeting is open to the public, but attendance is limited to space available. Registered participants from the meeting may be contacted for follow-up meetings to solicit additional opinions and clarify any issues that may arise from the September 20, 2006 meeting.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the publication of the criteria FDA intends to use to accredit third parties to conduct inspections of eligible manufacturers of class II or class III medical devices.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR (a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in: PCT patent application PCT/US2004/041256 filed December 9, 2004, entitled: ``Methods for Suppressing an Immune Response or Treating a Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], to Sahajanand Medical Technologies Pvt. Ltd., registered as a private limited company in accordance with the Companies Act of India, having a principle place of business in Surat, India and U.S. headquarters in Gaithersburg, Maryland. The field of use may be limited to the use of 2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the treatment and prevention of stenosis and restenosis and/or other proliferative disorders. The United States of America is an assignee of the patent rights in these inventions. This notice replaces a notice published in 71 FR 46496, August 14, 2006, to correct the heading ``Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions with Nitrite Therapy'' to read ``Prospective Grant of Exclusive License: Treatment of Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor''.

This notice informs interested parties of an opportunity to apply to participate in a risk reduction/health management demonstration project. This notice also contains information on how to obtain the complete solicitation and supporting information.

This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, and the Deficit Reduction Act (DRA) of 2005. The proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2007. In addition, this proposed rule would revise the current list of procedures that are approved when furnished in a Medicare-approved ambulatory surgical center (ASC), which would be applicable to services furnished on or after January 1, 2007. Further, this proposed rule would revise the ASC facility payment system to implement provisions of the MMA and other applicable statutory requirements, and update the ASC payment rates. Changes to the ASC facility payment system and the payment rates would be applicable to services furnished on or after January 1, 2008. This proposed rule would revise the emergency medical screening requirements for critical access hospitals (CAHs). In addition, this proposed rule would support implementation of a restructuring of the contracting entities responsibilities and functions that support the adjudication of Medicare fee-for-service (FFS) claims. This restructuring is directed by section 1874A of the Act, as added by section 911 of the MMA. The prior separate Medicare intermediary and Medicare carrier contracting authorities under Title XVIII of the Act have been replaced with the Medicare Administrative Contractor (MAC) authority. This proposed rule would also continue to implement the requirements of the DRA that require that we expand the ``starter set'' of 10 quality measures that we used in FY 2005 and FY 2006 for the hospital Inpatient Prospective Payment System (IPPS) Reporting Hospital Quality Data for the Annual Payment Update (RHQDAPU) program. We began to adopt expanded measures effective for payments beginning in FY 2007. We are proposing to add additional quality measures to the expanded set of measures for FY 2008 payment purposes. These measures include the HCAHPS[supreg] survey, as well as Surgical Care Improvement Project (SCIP, formerly Surgical Infection Prevention (SIP)), and Mortality quality measures.