Department of Health and Human Services April 12, 2005 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Cancellation of the April 13, 2005 Advisory Board Meeting on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease Services
This notice cancels the April 13, 2005 Advisory Board Meeting on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease (ESRD) Services. We published the meeting notice in the Federal Register on March 25, 2005 (70 FR 15343).
Public Health Assessments Completed
This notice announces those sites for which ATSDR has completed public health assessments during the period from October through December 2004. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.
Guidance for Industry and Food and Drug Administration Staff; Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product.'' The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) delegates to the Office of Combination Products (OCP) responsibility for resolving disputes about the timeliness of premarket review of combination products. This guidance document provides information about presenting requests for resolution of disputes about the timeliness of premarket review of combination products.
National Vaccine Injury Compensation Program: Addition of Trivalent Influenza Vaccines to the Vaccine Injury Table
Through this notice, the Secretary announces that trivalent influenza vaccines are covered vaccines under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This notice serves to include trivalent influenza vaccines as covered vaccines under Category XIV (new vaccines) of the Vaccine Injury Table (Table), which lists the vaccines covered under the VICP. This notice ensures that petitioners may file petitions relating to trivalent influenza vaccines with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking.
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