Department of Health and Human Services May 5, 2005 – Federal Register Recent Federal Regulation Documents

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application Serial No. 60/611,789, entitled ``Method of Detecting Cancer Based On Immune Reaction To BORIS'' filed September 21, 2004 (E-241-2004/0-US-01); U.S. Provisional Patent Application Serial No. 60/358,889, entitled ``Brother of The Regulator of Imprinted Sites (BORIS)'' filed February 22, 2001 (E-227-2001/0-US-01); PCT Application No. PCT/US03/05186, entitled ``Brother of The Regulator of Imprinted Sites (BORIS)'' filed February 21, 2003 (E-227-2001/0-PCT-02); and U.S. Patent Application Serial No. 10/505,377, entitled ``Brother of The Regulator of Imprinted Sites (BORIS)'' filed August 19, 2004 (E-227-2001/-0-US-03), to NewLink Genetics Corporation, having a place of business in Ames, Iowa. The prospective exclusive territory may be United States, Canada, Europe and Japan, and the field of use may be limited to manufacture and sale of Analyte Specific Reagents or FDA-approved in vitro diagnostics for cancer and cancer predisposition.

The National Toxicology Program (NTP) continuously solicits and accepts nominations for toxicological studies to be undertaken by the program. Nominations of substances of potential human health concern are received from federal agencies, the public and other interested parties. These nominations are subject to several levels of review before selections for testing are made and toxicological studies are designed and implemented. This notice (1) provides brief background information and study recommendations regarding 15 nominations for NTP study (Table 1), (2) solicits public comment on the nominations and study recommendations, and (3) requests the submission of additional relevant information for consideration by the NTP in its continued evaluation of these nominations. An electronic copy of this announcement, Internet links to electronic versions of supporting documents for each nomination, and further information on the NTP and the NTP Study Nomination and Review Process can be accessed through the NTP Web site (https:// ntp.niehs.nih.gov/; select ``Nominations to the Testing Program'').

The Food and Drug Administration (FDA) is proposing to amend the agency's food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement ``Keep Refrigerated'' appears on the principal display panel (PDP) or information panel. This proposed rule, if finalized, will provide the industry greater flexibility in the placement of safe handling instructions on egg cartons, while continuing to provide consumers with this important information. This proposed action is in response to numerous requests from the egg industry.