Department of Health and Human Services December 20, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a change of location and time for the upcoming public workshop on marketed unapproved drugs. Registration for the public workshop is closed. A new address and time are given for those persons who have previously registered with FDA.

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 No. 7,081,518, issued July 25, 2006, entitled ``Anti-Mesothelin Antibodies Having High-Affinity Binding'' [E-139-1999/0-US-07]; European Patent Application No. 00937925.6, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E-139-1999/ 0-EP-04]; Japanese Patent Application No. 2001-500670, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E- 139-1999/0-JP-05]; Mexican Patent Application No. PA/a/2001/01195, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E-139-1999/0-MX-06]; and Canadian Patent Application No. 2374398, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E-139-1999/0-CA-03] to Cambridge Antibody Technology, Ltd., which has offices in Cambridge, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the SSIP immunoconjugate and variants thereof for the treatment of mesothelin expressing cancers.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Department of Health and Human Services is amending its acquisition regulations (HHSAR) to make administrative and editorial changes to reflect organizational title changes resulting from Office of the Secretary (OS) and Operating Division (OPDIV) reorganizations and to update or remove outdated text and references. The intent of the final rule is to bring the HHSAR up to date and to make the HHSAR consistent with the latest amendments to the Federal Acquisition Regulations (FAR).