Department of Health and Human Services October 12, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Food Safety and Inspection Service (FSIS), the Agricultural Research Service (ARS) and the Center for Nutrition Policy and Promotion (CNPP) are announcing a public meeting entitled ``Approaches to Reducing Sodium Consumption.'' FDA and FSIS recently published a Federal Register notice that announced the establishment of dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction. The purpose of the public meeting is to provide interested persons an opportunity to discuss the topics raised in the earlier notice.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 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 61/040,005 entitled ``Human Monoclonal Antibodies Specific for Mesothelin'' [HHS Ref. E-079-2008/0-US-01], PCT Application PCT/US2009/038228 entitled ``Human Monoclonal Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-PCT-02], Australian patent application AU 2009228361 entitled ``Human Monoclonal Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-AU-03], Canadian patent application CA 2718321 entitled ``Human Anti-Mesothelin Monoclonal Antibodies'' [HHS Ref. E-079-2008/0-CA-04], European patent application EP 09726082.2 entitled ``Human Monoclonal Antibody Against Mesothelin'' [HHS Ref. E-079-2008/0-EP-05], U.S. patent application 12/934,060 entitled ``Human Anti-Mesothelin Monoclonal Antibodies '' [HHS Ref. E- 079-2008/0-US-06], and all related continuing and foreign patents/ patent applications for the technology family, to Sanomab, Ltd. 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, and the field of use may be limited to:

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 Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and Boxed Warning'' sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.