Department of Health and Human Services July 14, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 28 of 28
Medical Devices; Anesthesiology Devices; Neurological Devices; Denial of Request for Change in Classification of Breathing Frequency Monitor and Electroencephalograph
The Food and Drug Administration (FDA) is denying the petitions submitted by IM Systems to reclassify the SleepCheck, the ActiTrac, and PAM-RL devices from class II (special controls) to class I (general controls). The agency is denying the petitions because the petitioner failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices.
Oral Dosage Form New Animal Drugs; Ivermectin Paste
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for oral use of ivermectin paste in horses for treatment and control of various internal parasites or parasitic conditions.
Determination That PHENERGAN (Promethazine Hydrochloride) Tablets, 12.5 Milligrams and 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that PHENERGAN (promethazine hydrochloride (HCl)) tablets, 12.5 milligrams (mg) and 50 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for promethazine HCl tablets, 12.5 mg and 50 mg.
Office of the National Coordinator; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the seventh 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.C., App.).
Office of the National Coordinator; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the seventh meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the seventh meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Meeting
This notice announces the seventh meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Privacy Act of 1974, as Amended; Computer Matching Program
In compliance with the Privacy Act of 1974, as amended by Pub. L. 100-503, the Computer Matching and Privacy Protection Act of 1988, we are publishing a notice of a computer matching program. The purpose of this computer match is to identify specific individuals who are receiving benefits from the VA and also receiving payments pursuant to various benefit programs administered by both HHS and Department of Agriculture. ACF will facilitate this program on behalf of the State Public Assistance Agencies (SPAAs) that participate in the Public Assistance Reporting Information System (PARIS) for verification of continued eligibility for public assistance. The match will utilize Department of Veterans Affairs (VA) records and SPAA records.
Prospective Grant of Exclusive License: Convection Enhanced Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to the Central Nervous System
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 worldwide license to practice the invention embodied: HHS. Ref. No. E-202-2002 ``Method for Convection Enhanced Delivery of Therapeutic Agents,'' Provisional Patent Application, 60/413,673; International Patent Application PCT/US03/30155, U.S. Patent Application Serial No. 10/528,310; European Patent Applications Serial No. 03756863.1; Australian Patent Application No. 2003299140; Canadian Patent Application No. 2,499,573; and HHS Ref. No. E-206-2000/0 and/1 ``Method for Increasing the Distribution of Therapeutic Agents;'' and ``Method for Increasing the Distribution of Nucleic Acids;'' Provisional, Patent Application 60/250,286; Provisional Patent Application No. 60/286,308; U.S. Patent Application No. 09/999,203; U.S. Patent Application No. 10/132,681; and Canadian Patent Application No. 2327208, to MedGenesis Therapeutix, Inc. a Canadian company having its headquarters in Victoria, British Columbia. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in a field of use limited to the convection enhanced delivery and tracking of gadolinium conjugated peptides, polypeptides or lipid-based therapeutic agents within the central nervous system of subjects with cancer, Parkinson's disease, Dementia with Lewy bodies or Alzheimer's disease.
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.
Chafee National Youth in Transition Database
The Administration for Children and Families (ACF) is proposing to add regulations at 45 CFR part 1356 to require States to collect and report data to ACF on youth who are receiving independent living services and the outcomes of certain youth who are in foster care or who age out of foster care. This proposed rule implements the data collection requirements of the Foster Care Independence Act of 1999 (Public Law 106-169) as incorporated into the Social Security Act at section 477.
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