Department of Health and Human Services February 25, 2009 – Federal Register Recent Federal Regulation Documents

This notice, in accordance with 35 U.S.C. 209(c)(l) and 37 CFR 404.7(a)(l)(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 U.S. Patent Application 60/854,978 [HHS Ref. E-157-2006/0-US-01], PCT Patent Application PCT/US2007/082683 [HHS Ref. E-157-2006/1-PCT-01], U.S. Patent Application 11/925,334 [HHS Ref. E-157-2006/1-US-02], all entitled ``Methods to Identify Patients at Risk of Developing Adverse Events During Treatment With Antidepressant Medication'', and all continuing applications and foreign counterparts, to NeuroMark, Inc., which has offices in Boulder, CO. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, licensees will need to address the medical usefulness of multi-gene test formats should data be developed to support such approaches and the term of the agreement may be commensurate with commercial incentives and public health needs. The field of use may be limited to:

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 a co- exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 12/296,328 entitled, ``Human IGF-I-Specific and IGF-I and IGF-II Cross-Reactive Human Monoclonal Antibodies'' and all foreign counterparts [HHS Ref. No. E-336-2005/0] to Trubion Pharmaceuticals, Inc., which is located in Seattle, Washington. The patent rights in this invention have been assigned to the United States of America. The prospective co-exclusive license territory may be worldwide and the field of use may be limited to the use of the antibodies and their method of use in the Licensed Patent Rights for the treatment of human cancers.

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 FDA's need to collect additional information in the Importer's Entry Notice.