Department of Health and Human Services August 3, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Determination of Regulatory Review Period for Purposes of Patent Extension; CYMBALTA
The Food and Drug Administration (FDA) has determined the regulatory review period for CYMBALTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; EMEND
The Food and Drug Administration (FDA) has determined the regulatory review period for EMEND and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CLINACOX
The Food and Drug Administration (FDA) has determined the regulatory review period for CLINACOX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; IPLEX
The Food and Drug Administration (FDA) has determined the regulatory review period for IPLEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
New Animal Drugs; Change of Sponsor; Isoflurane
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an abbreviated new animal drug application (ANADA) for isoflurane, U.S.P., from Rhodia UK Ltd. to Nicholas Piramal India Ltd. UK.
Oral Dosage Form New Animal Drugs; Kanamycin, Bismuth Subcarbonate, Activated Attapulgite
The Food and Drug Administration (FDA) is amending the animal drug regulations to remove inactive ingredients from the specifications for an oral suspension and for tablets containing kanamycin, bismuth subcarbonate, and activated attapulgite; and to consolidate and reformat these sections. These actions are being taken to improve the accuracy and readability of the animal drug regulations.
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Record Workgroup Meeting
This notice announces the eighth meeting of the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the eighth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the eighth meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2007 and Deficit Reduction Act of 2005 Changes to Medicare Payment for Oxygen Equipment and Capped Rental Durable Medical Equipment; Proposed Rule
This proposed rule would set forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies. In addition, this proposed rule would set forth policy changes related to Medicare payment for certain durable medical equipment for the purpose of implementing sections 1834(a)(5) and 1834(a)(7) of the Social Security Act, as amended by section 5101 of the Deficit Reduction Act of 2005. We are also inviting comments on a number of issues including payments based on reporting quality data and health information technology, as well as how to improve data transparency for consumers.
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