Department of Health and Human Services June 3, 2009 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Revisions to FY 2009 Medicare Severity-Long-Term Care Diagnosis-Related Group (MS-LTC-DRG) Weights
This interim final rule with comment period implements revised Medicare severity long-term care diagnosis-related group (MS-LTC-DRG) relative weights for payment under the long-term care hospital (LTCH) prospective payment system (PPS) for federal fiscal year (FY) 2009. We are revising the MS-LTC-DRG relative weights for FY 2009 due to the misapplication of our established methodology in the calculation of the budget neutrality factor. The revised FY 2009 MS-LTC-DRG relative weights are effective for the remainder of FY 2009 (that is, from June 3, 2009 through September 30, 2009).
Medicare Program; Proposed Rate Year (RY) 2010 Medicare Severity-Long-Term Care Diagnosis-Related Group (MS-LTC-DRG) Relative Weights and High-Cost Outlier Fixed-Loss Amount
This supplemental proposed rule presents both proposed rate year (RY) 2010 Medicare severity-long-term care diagnosis-related group (MS-LTC-DRG) relative weights and a proposed RY 2010 high cost outlier (HCO) fixed-loss amount based on the revised fiscal year (FY) 2009 MS- LTC-DRG relative weights presented in an interim final rule with comment period published elsewhere in this Federal Register.
Food and Drug Administration Transparency Task Force; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to solicit recommendations from interested persons on ways in which FDA can make useful and understandable information about FDA activities and decisionmaking more readily available to the public.
Draft Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2008
This notice is a request for review of and comment on the Draft Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2008, available on the following Web site: https:// wwwnd.cdc.gov/publiccomments/. This document is for use by infection prevention staff, healthcare epidemiologists, healthcare administrators, nurses, other healthcare providers, and persons responsible for developing, implementing, and evaluating infection prevention and control programs for healthcare settings across the continuum of care. The guideline updates and expands the 1981 Guideline for Prevention of Catheter-associated Urinary Tract Infections.
Proposed Collection; Comment Request; 24-Hour Dietary Recall Method Comparison and the National Cancer Institute (NCI) Observational Feeding Studies
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Prospective Grant of Exclusive License: Use of N-Acetyl-Mannosamine and Derivatives Thereof to Treat Muscle Wasting Diseases and Kidney Diseases Related to Hyposialylation
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/932,451, filed May 31, 2007, now abandoned, [HHS Ref. No. E-217-2007/0-US-01]; PCT Patent Application No. PCT/ US2008/006895, filed May 30, 2008, [HHS Ref. No. E-217-2007/0-PCT-02], both of which are entitled, ``N-Acetyl-Mannosamine as a Therapeutic Agent'' (Inventors: Drs. Marjan Huizing, William A. Gahl, Irini Manoli, and Enriko Klootwijk, NHGRI) to New Zealand Pharmaceuticals, Ltd., having an office in at Palmerston North, New Zealand. The patent rights in these inventions have been assigned to the United States of America.
Draft Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and researchers entitled ``The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application.'' This draft guidance provides information to those using radioactive drugs for certain research purposes to help determine whether research studies may be conducted under an FDA-approved radioactive drug research committee, or whether research studies must be conducted under an investigational new drug application (IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA.
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