Department of Health and Human Services April 8, 2008 – Federal Register Recent Federal Regulation Documents

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 (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Serial Numbers 60/758,819, filed January 13, 2006 and 60/812,566, filed June 9, 2006; PCT filed (PCT/US2007/000774) on January 12, 2007, entitled ``Codon Optimized IL-15 and IL-15RAlpha Genes for Expression in Mammalian Cells'' (HHS Ref. E-254-2005/2) to Marine Polymer Technologies, Inc., having a place of business in Danvers, Massachusetts. The patent rights in these inventions have been assigned to the United States of America.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The guidance is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.