Department of Health and Human Services October 30, 2012 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Development of Chemopreventive Treatments for Head and Neck Squamous Cell Carcinoma
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, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions embodied in PCT Patent Application No. PCT/US2009/054478, U.S. Patent Application No. 13/059,335 and foreign equivalents thereof entitled ``Chemopreventive of Head and Neck Squamous Cell Carcinoma'' (HHS Ref. No. E-302-2008/0) and PCT Patent Application No. PCT/IL2010/000694, U.S. Patent Application No. 13/391,756 and foreign equivalents thereof entitled ``Prevention and Treatment of Oral and Lips Diseases Using Sirolimus and Derivatives Sustained Release Delivery Systems for Local Application to the Oral Cavity'' (HHS Ref. No. E-282-2009/0) to Rapamycin Holdings, Inc., which is located in San Antonio, TX. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to use of the Licensed Patent Rights for the prevention and treatment of head and neck cancers. Upon the expiration or termination of the exclusive evaluation option license, Rapamycin Holdings, Inc. will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the exclusive evaluation option license.
Prospective Grant of Exclusive Evaluation Option License: Pre-clinical Evaluation of Human Therapeutics Utilizing Ubiquitin Based Fusion Proteins With Apoptosis Modifying Proteins Such as BCL-XL
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, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions covered under the scope of United States Patent No. 6,737,511 issued May 18, 2004 entitled ``Receptor-mediated Uptake of an Extracellular BCL- xL Fusion Protein Inhibits Apoptosis'' (HHS Ref. No. E-073- 1999/0-US-02; Inventors Richard Youle et al.) and International Patent Application No. PCT/US2012/032762 filed April 9, 2012 entitled ``Ubiquitin Fusions for Improving the Efficacy of Cytosolic Acting Targeted Toxins'' (HHS Ref. No. E-150-2011/0-PCT-02; Inventors Christopher Bachran et al.) to Medicenna Therapeutics, (``MEDICENNA'') a Canada based company. The patent rights in this invention have been assigned to the government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to the pre-clinical evaluation of lead therapeutic candidates for the development of human therapeutics within the field of cancer and neurological diseases. Upon expiration or termination of the exclusive evaluation option license, MEDICENNA will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader territory than granted in the exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.
Notice of Intent To Make Changes in the State Title V Maternal and Child Health Block Grant Allocations
The Health Resources and Services Administration's (HRSA) Maternal and Child Health Bureau (MCHB) plans to move forward in implementing annual changes to the State Title V MCH Block Grant allocations, beginning in Federal Fiscal Year (FY) 2013, using the U.S. Census Bureau's 3-year American Community Survey (ACS) poverty estimates. Title V MCH Block Grant funds are currently allocated to states based in part on a calculation of the number of children living in poverty (in an individual state) as compared to the total number of children living in poverty in the United States. Historically, data for the number of children in poverty in each state came from the Decennial Census. As the Census Bureau has replaced the Decennial Census long- form sample questionnaire with the ACS, MCHB plans to use the ACS as its source for this data. In order to maintain balance between precision and currency, annual changes to the State Title V MCH Block Grant allocations will be based on a rolling average of the 3-year ACS poverty estimates. Yearly changes in the MCH Block Grant allocations for individual states will be buffered by the use of shared data for two of the three data years in the rolling period estimate. According to the U.S. Census Bureau, the ACS is the best source of survey-based state-level income and poverty estimates. Moreover, ACS child poverty estimates are produced annually, and their use will allow the Block Grant allocation proportions to be updated more frequently than every 10 years.
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