Department of Health and Human Services April 1, 2010 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Development of PANVAC and Tumor Associated Antigens as Cancer Vaccines
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Bavarian Nordic Immunotherapeutics (``BNIT'') located in Mountain View, CA, USA.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Proposed Comment Request for Review of ACF Disaster Case Management Implementation Guide; Office of Human Services Emergency Preparedness and Response
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Administration for Children and Families (ACF), Office of Human Services Emergency Preparedness and Response (OHSEPR) intends to submit notice in the Federal Register for comments on the ACF Disaster Case Management Implementation Guide, dated December 2009.
Beverages: Bottled Water; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until June 1, 2010 the comment period for the proposed rule, published in the Federal Register of August 4, 1993 (58 FR 41612), amending the quality standard for bottled water (currently in 21 CFR 165.110(b)). In the 1993 proposed rule, FDA proposed to revise the bottled water quality standard to establish or modify the allowable levels for 5 inorganic chemicals and 18 synthetic organic chemicals, and to maintain the existing allowable level for the inorganic chemical sulfate. In a final rule published March 26, 1996 (61 FR 13258), FDA maintained the existing allowable level for sulfate and adopted the proposed allowable levels for the 5 inorganic chemicals and 17 of the synthetic organic chemicals, but deferred final action on the proposed allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP). FDA is reopening the comment period on the 1993 proposed rule to seek further comment on finalizing the allowable level for DEHP in the bottled water quality standard.
Medical Devices; Technical Amendment
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct statutory and regulatory references to ensure accuracy, consistency, and clarity in the agency's regulations.
Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment
The Food and Drug Administration (FDA) is amending its administrative regulations. This action is being taken to ensure accuracy and clarity in agency regulations.
Revision of Organization and Conforming Changes to Regulations
The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organization change in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Direct Final Rule
The Food and Drug Administration (FDA) is amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure
The Food and Drug Administration (FDA) is proposing to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. Elsewhere in this issue of the Federal Register, we are publishing a companion direct final rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw the direct final rule.
Ophthalmic and Topical Dosage Form New Animal Drugs; Orbifloxacin, Mometasone Furoate Monohydrate, and Posaconazole Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of a suspension containing orbifloxacin, mometasone furoate monohydrate, and posaconazole for the treatment of otitis externa in dogs.
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