Department of Health and Human Services November 2, 2009 – Federal Register Recent Federal Regulation Documents
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Medical Examination of Aliens-Removal of Human Immunodeficiency Virus (HIV) Infection From Definition of Communicable Disease of Public Health Significance
Through this final rule, the Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), is amending its regulations to remove ``Human Immunodeficiency Virus (HIV) infection'' from the definition of communicable disease of public health significance and remove references to ``HIV'' from the scope of examinations for aliens.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Public Health Notification Readership Survey (Formerly Known as “Safety Alert/Public Health Advisory Readership Survey”)
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination and Declaration Regarding Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the then Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009-H1N1 Influenza A, or 2009-H1N1 influenza) that affects or has significant potential to affect national security. On July 24 and October 1, 2009 the Secretary renewed that determination of a public health emergency. On the basis of this determination, on October 20, 2009 the Secretary declared an emergency justifying the authorization of emergency use of the antiviral product peramivir accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a). The Secretary also specified that this declaration is a declaration of emergency as defined in the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antiviral peramivir.
Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients. Peramivir is a drug that is not approved by FDA. FDA is issuing the Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of peramivir. The Authorization follows the determination by then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (then Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as ``2009-H1N1 Influenza'') that affects, or has the significant potential to affect, national security. The determination has been renewed. On the basis of such determination, the Secretary declared an emergency justifying the authorization of the emergency use of the antiviral peramivir, accompanied by emergency use information, subject to the terms of any authorization issued under the act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. The notice of the declaration of the Secretary is announced elsewhere in this issue of the Federal Register.
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the paperwork associated with abbreviated new animal drug applications submitted to the Center for Veterinary Medicine, FDA.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee scheduled for November 20, 2009. This meeting was announced in the Federal Register of October 16, 2009 (74 FR 53274). The postponement is due to a scheduling conflict. A future meeting date will be announced in the Federal Register.
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