Department of Health and Human Services January 26, 2005 – Federal Register Recent Federal Regulation Documents
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Amendment To Extend for One Year the January 24, 2003, Declaration Regarding Administration of Smallpox Countermeasures, as Amended on January 24, 2004
Concern that terrorists may have access to the smallpox virus and attempt to use it against the American public and United States Government facilities abroad continues to exist. The January 24, 2003, declaration regarding administration of smallpox countermeasures, as amended on January 24, 2004, is extended for one year until and including January 23, 2006.
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.
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.
Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Autoimmune Disease
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,083,503, entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of autoimmune diseases, allergic responses, and graft rejection'' (DHHS Reference E-137-1991/0-US-03); U.S. Patent No. 5,989,546 entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of allergic responses'' (DHHS Reference E-137-1991/0- US-04); U.S. Patent No. 5,935,575, entitled ``Interleukin-4 stimulated T lymphocyte cell death for the treatment of allergic disorders'' (DHHS Reference E-151-1992/0-US-11); U.S. Patent Application No. 08/431,644 filed May 2, 1995 entitled ``Modified Myelin Basic Protein Molecules'' (DHHS Reference E-033-1996/0-US-01); and U.S. Patent Application No. 08/482,114 filed June 7, 1995 entitled ``Modified Proteolipid Protein Molecules'' (DHHS Reference E- 128-1996/1-US-01); to Apogenix Biotechnology AG, having a place of business in Heidelberg, Germany. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory will be worldwide and the field of use may be limited to therapeutics for the treatment of Multiple Sclerosis.
National Heart, Lung, and Blood Institute (NHLBI); Opportunity for a Cooperative Research and Development Agreement (CRADA) to Identify and Explore Epigenetic Regulatory Elements for Diagnostic and Therapeutics Purposes
The National Heart, Lung, and Blood Institute (NHLBI) is seeking Cooperative Research and Development Agreement (CRADA) collaborator(s) to work with investigators in the Laboratory of Molecular Immunology (LMI) to identify epigenetic regulatory elements that may be involved in the disease development of T and/or B cell leukemia/lymphoma and other cancers via genome-wide analysis of acetylation islands using the Genome-Wide Mapping Technique (GMAT). Representative disease-specific acetylation islands will be explored for diagnostic and therapeutic purposes.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary consumer survey entitled ``Allergen Labeling of Food Products Consumer Preference Survey'' and an experimental study entitled ``Experimental Study on Allergen Labeling of Food Products.''
Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Safety Evaluation of Drug Combinations.'' The guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), copackaged products, and adjunctive therapies.
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