Department of Health and Human Services May 19, 2005 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry on Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients.'' This document is intended to provide guidance on the types of toxicity information that FDA recommends be provided to the agency to support the use of new excipients in drug products. Previously, such information was not available to drug sponsors in a written document. This information should allow drug sponsors to determine if a potential new excipient is safe to use in drug products.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2006
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2006, as required by statute. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), relating to Medicare payments and consolidated billing for SNFs. As part of this year's annual update, we are proposing to introduce refinements in the Resource Utilization Groups, version III (RUG-III), the case-mix classification system used under the SNF PPS.
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