Department of Health and Human Services May 30, 2007 – 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), a federal agency under the Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in HHS Ref. No. E-261-1998 ``Methods and Devices for Isolation and Analysis of Cellular Protein Content;'' U.S. Patent 6,969,614; and E-039-2003/0 ``Combinatorial Therapy for Protein Signaling Diseases,'' U.S. Patent Application No. 10/798,799 filed March 10, 2004; to Theranostics Health, LLC, a Limited Liability Company formed under the laws of the state of Delaware and having a principle place of business in Rockville, Maryland. The United States of America is the assignee of the patent rights in the above inventions. The contemplated exclusive license may be granted a field limited to proteomic diagnostics for cancer requiring regulatory approval.

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 to practice the invention embodied in: PCT/US99/13856 filed June 18, 1999, preceded by U.S. Provisional Patent Application Serial No. 60/089,842 (HHS Ref. E-136-1998/0-US-01), filed June 19, 1999, entered the national stage filing in June 1999 in Korea Patent Application No. 10-2000-7014479; in Mexico Patent Application No. 012525; in Australia Patent Application No. 46972/99; in Canada Patent Application No. 2335464; in Brazil Patent Application No. PI9911385-6; in U.S. Patent No. 6,706,729 and filed DIV in U.S. Patent Application No. 10/738,062 in December 2003; in EPO Patent Application No. 99930428.0 and validated in Germany, France, United Kingdom, Italy and Ireland in November 2006, entitled ``Novel Thioesters and Uses Thereof'', Inventors: Drs. James A. Turpin (NCI), Yongsheng Song (NCI), John K. Inman (NIAID), Mingjun Huang (NCI), Anders Wallqvist (NCI), Andrew Maynard (NCI), David G. Covell (NCI), William G. Rice (NCI), and Ettore Appella (NCI); PCT/US02/23924 filed July 25, 2002, preceded by U.S. Provisional Patent Application Serial No. 60/310,133 (E-329-2000/0-US-01), filed August 3, 2001, entered the national stage filing in February 2004 in EPO Patent Application No. 02756732.0; in Australia Patent Application No. 2003322721; in Canada Patent Application No. 2456083 and U.S. Patent Application No. 10/485,165, entitled ``Acylthiols and Component Thiol Compositions as Anti-HIV and Anti-Retroviral Agents'', Inventors: Drs. John K. Inman (NIAID), Atul Goel (NCI), Ettore Appella (NCI), and Jim A. Turpin (NCI);

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 18, 2007, pages 2286-2287 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled, ``Interim Melamine and Melamine Analogues Safety/Risk Assessment.'' The interim safety/risk assessment describes the risk to human health associated with eating pork, chicken, fish, and eggs from animals that were inadvertently fed animal feed that contained melamine and its analogues (cyanuric acid, ammelide and ammeline). FDA is seeking public comment on the interim safety/risk assessment to assist the agency and the Food Safety and Inspection Service (FSIS) at the U. S. Department of Agriculture (USDA) in the ongoing investigation of contaminated vegetable protein products imported from China that were mislabeled as ``wheat gluten'' and ``rice protein concentrate,'' and ensuring the safety of the U.S. food supply.

This notice establishes the data that are available from the National Plan and Provider Enumeration System (NPPES). In addition, this notice addresses who may have access to the data or may receive data from the system, the processes for requesting and receiving data, and the conditions under which data may be disclosed.