Notices. Notice
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/register/2006/11/13/06-9163A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Field of Use: Treatment of Inflammatory Diseases Using Ghrelin AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: 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:
U.S. Provisional Patent application, S/N 60/569,819 filed May 11, 2004, entitled “Methods for Inhibiting Proinflammatory Cytokine Expression Using Ghrelin,” converted to PCT on May 11, 2005 (E-016-2004/0-PCT-02), (Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric Schaffer, and Dzung Nguyen) (NIA), to Sapphire Therapeutics, Inc. (Hereafter Sapphire), having a place of business in Bridgewater of NJ. The patent rights in these inventions have been assigned to the United States of America.
DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before January 12, 2007 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Sally Hu, PhD, M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; e-mail: *hus@od.nih.gov;* telephone:
(301)435-5606; facsimile:
(301)402-0220. SUPPLEMENTARY INFORMATION: The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. E-016-2004/0-US-01 provides methods for treating inflammation by inhibiting pro-inflammatory cytokine expression using Ghrelin, or a fragment thereof. Inflammation could be caused by a variety of viral, bacterial, fungal, or parasitic infections. The invention also provides methods for treating loss of appetite, and sepsis. Ghrelin, a naturally occurring peptide hormone was shown to be the ligand for growth hormone secretagogue receptor (GHS-R ), and is mainly produced by the epithelial cells in the stomach. Ghrelin exerts many important actions in the body, including stimulation of growth hormone secretion, induction of appetite, and regulation of energy expenditure. Ghrelin directly controls human growth hormone and insulin growth factor expression by human immune cells. The inventors showed that Ghrelin exerts anti-inflammatory effects by inhibiting the secretion of acute and chronic cytokines, including IL-1, IL-6, TNF-α, IFN-γ, IL-12, chemokines, and CSF *in vitro* and in *in vivo* mouse models of sepsis and inflammation. This invention can be useful for treatment of various inflammatory disorders, including inflammatory bowel disease, Crohn's disease, rheumatoid arthritis, multiple sclerosis, atherosclerosis, endotoxemia, and graft-versus-host disease. It can also be used as a treatment for loss of appetite and sepsis. The field of use may be limited to the use of Ghrelin as a novel drug to treat a range of inflammatory diseases. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: October 30, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-19051 Filed 11-9-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Notice of Intent To Prepare a Draft Environmental Impact Statement for Department of Homeland Security, Customs and Border Protection, Office of Border Patrol, Laredo Sector, Laredo North and South Station's Road Improvement and Non-Native Vegetation Removal Project AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of Intent to Prepare a Draft Environmental Impact Statement (DEIS). SUMMARY: The U.S. Army Corps of Engineers on behalf of the U.S. Customs and Border Protection
(CBP)will prepare a Draft Environmental Impact Statement pursuant to the National Environmental Policy Act of 1969
(NEPA)for the construction and improvement of existing patrol roads and the removal of non-native (giant cane, *Arundo donax* ) vegetation along 111 miles of the Rio Grande (Proposed Action) in Webb County, Texas. The U.S. Customs and Border Protection is the decision-making agency for this project. This EIS is being prepared in support of the proposal by the Office of Border Patrol's
(OBP)Laredo North and Laredo South Stations for controlling and deterring the influx of illegal immigration and contraband into the United States. Due to the increased violent activity in Nuevo Laredo, Mexico and increase in drug trafficking in Webb County, the Secretary of Homeland Security has mandated this effort as the top priority of the OBP's Laredo Sector. The Laredo Sector has a need to secure the border by obtaining an unobstructed line of sight to the Rio Grande and a continuous patrol road. These actions are intended to gain and maintain control of the border to further prevent the influx of illegal aliens and drugs into the United States. Prior NEPA documents, developed to address those project portions which have been previously constructed or proposed to be constructed, will be incorporated into the DEIS by reference. Direct project impacts of the remaining portions of the project, as well as cumulative impacts of the comprehensive project, will also be addressed. Pursuant to the Council on Environmental Quality's regulations, a scoping process will be conducted. As part of this process, a public workshop/open house will be held to identify issues of concern for analysis during the NEPA process. DATES: The meeting dates are: 1. December 5, 2006, 5 p.m. to 8 p.m., Carrizo Springs, TX. 2. December 6, 2006, 5 p.m. to 8 p.m., Laredo, TX. ADDRESSES: The meeting locations are: 1. Carrizo Springs—Carrizo Springs Intermediate School, 300 N. 7th Street, Carrizo Springs, TX 78834. 2. Laredo—Holiday Inn—Civic Center, 800 Garden Street, Laredo, TX 78040. FOR FURTHER INFORMATION CONTACT: Glenn Bixler, DHS Engineering Construction and Support Office, U.S. Army Corps of Engineers, 819 Taylor St., Room 3A14, Fort Worth, Texas 76102. Phone:
(817)886-1713 and Fax:
(817)886-6499. SUPPLEMENTARY INFORMATION: *Alternatives.* Alternatives to be covered by the DEIS will include various alignments and configurations within the narrow geographic scope dictated by the international border (typically 300 feet from the United States bank of the Rio Grande). Other reasonable alternatives (to include the required “No Action” alternative) identified will also be fully examined. *Scoping Process.* During the preparation of the EIS, there will be numerous opportunities for public involvement, including scoping and review. Two open house public scoping meetings are scheduled (see DATES ). The purpose of the meetings is to inform the public of the proposed action and identify issues and concerns regarding this project. Appropriate displays and exhibits will be provided to inform meeting participants of potential alternatives and actions. Representatives from the CBP, OBP, U.S. Army Corps of Engineers, and private contractors will be present to provide the public with information and address questions. The meetings will be conducted in an informal format. No formal presentation will be conducted during the meeting. Oral and written comments will be accepted at the public scoping meetings or by mail until February 20, 2006. *DEIS Preparation.* Public notice will be given in the **Federal Register** concerning the availability of the DEIS for public review and comments. Mark A. Gable, T.I. Program Manager (NM/TX)/Environmental Program Manager, Dallas Facility Division, Customs and Border Protection. [FR Doc. 06-9163 Filed 11-9-06; 8:45 am]
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