Department of Health and Human Services November 3, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA), in collaboration with the United States Department of Agriculture, Food Safety and Inspection Service (FSIS), is announcing a public meeting regarding product tracing systems for food intended for humans and animals. The purpose of the meeting is to stimulate and focus a discussion about mechanisms to enhance product tracing systems for food. This discussion will help FDA and FSIS determine what short and long term steps the two agencies should take to enhance the current tracing system.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``ICH S2 Genetic Toxicology Issues.'' The 1-day public workshop is intended to seek constructive input from experts in the field of genetic toxicology on proposed changes to the International Conference on Harmonisation (ICH) guidance ``S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use'' that was published in March 2008.

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 patent license to practice the inventions embodied in U.S. Patent Application No. 12/281,589 and PCT Application No. PCT/US07/ 05555 entitled ``Materials and Methods Directed to Asparagine Synthetase and Asparaginase Therapies'' (HHS Ref. No. E-132-2006/2), to the French-based ERYtech Pharma LLC which is located in Lyon, France (with an additional office in Philadelphia, Pennsylvania). The patent rights in this invention have been assigned to the United States of America.