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Code · REGISTER · 2007-02-26 · National Institutes of Health, Public Health Service, HHS · Notices

Notices. Notice

2,933 words·~13 min read·/register/2007/02/26/07-830

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BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Use of Recombinant Yeast Expressing CEA for the Prevention and Treatment of Cancer 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 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 6,756,038 and PCT Application Serial No. PCT/US98/19794 and foreign equivalents thereof, entitled “Agonist and Antagonist Peptides of Carcinoembryonic Antigen (CEA)” (E-099-1996/0) and U.S. Patent 6,969,582 and PCT Application Serial No. PCT/US99/26866 and foreign equivalents thereof, entitled “A Recombinant Vector Expressing Multiple Costimulatory Molecules and Uses Thereof” (E-256-1998/0), to GlobeImmune Inc., which is located in Louisville, Colorado. 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 recombinant Saccharomyces cerevisiae expressing CEA for the prevention and treatment of cancer. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 27, 2007 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to:
Michelle A. Booden, PhD., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone:
(301)451-7337; Facsimile:
(301)402-0220; E-mail: *boodenm@mail.nih.gov* . SUPPLEMENTARY INFORMATION: The technology describes the composition and use of nucleic acid sequences that encode agonist and one antagonist peptide variants of the human carcinoembryonic antigen
(CEA)peptide, including but not limited to CAP-1. CEA is an antigen, which is expressed on the surface of various types of cancer cells. It is capable of stimulating a specific cytolytic T cell response, as is CAP-1, which is a highly immunogenic epitope of CEA. Therefore, CAP-1 agonists which are capable of eliciting a CEA-specific cytolytic T cell response, such as those identified by the inventors, may represent potential immunogens for use as therapeutic agents or vaccines against various cancers, and possibly also for use against autoimmune diseases. In fact, at least one of the agonist peptides appears to be more immunogenic than the native CAP-1 peptide. CAP-1 antagonists which are capable of reducing or eliminating this T cell response, such as the antagonist peptide variant identified by the inventors, may represent potential agents for use against autoimmune responses to CEA or to agonist peptide variants thereof. 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 Part 404.7. The prospective exclusive license may be granted unless within sixty
(60)days from the date of this published notice, the 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 Part 404.7. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted 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: February 16, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-3153 Filed 2-23-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences 2008-2012 Strategic Plan ACTION: Notice with request for comments. SUMMARY: NIGMS is initiating a strategic planning process that will culminate in the NIGMS Strategic Plan for 2008-2012. To assist with this process, NIGMS requests input from scientists, scientific organizations, and other interested parties. The goal of this strategic planning process is to identify Institute priorities and guide decision-making over the next five years. Information about NIGMS can be found at *http://www.nigms.nih.gov/* . DATES: In order to ensure full consideration, responses must be submitted by 12 midnight EDT on March 20, 2007. ADDRESSES: Interested individuals and organizations should submit their responses to *http://www.nigms.nih.gov/About/StrategicPlan/Input.htm* . SUPPLEMENTARY INFORMATION: Background The mission of the National Institute of General Medical Sciences (NIGMS) is to support basic research whose results lay the foundation for the diagnosis, treatment, and prevention of disease. NIGMS-funded researchers seek to answer important questions in fields such as cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biochemistry, chemistry, bioinformatics, and computational biology, and in selected cross-cutting clinical areas that affect multiple organ systems. NIGMS also provides leadership in promoting the diversity of the scientific workforce and in training the next generation of scientists to assure the vitality and continued productivity of basic research. NIGMS has embarked on a strategic planning process to identify Institute priorities to guide decision-making over the next five years. To assure the broadest possible input, NIGMS is inviting the scientists, scientific organizations, and other interested parties to respond electronically to a series of questions, listed below. • What factors should NIGMS consider in deciding how to set its priorities with respect to new and existing areas of support? • What factors should NIGMS consider in deciding how to set its priorities with respect to research training? • What new or emerging areas, approaches, or technologies in basic biomedical research should NIGMS pursue? • As part of its efforts to maintain a balanced research portfolio, how can NIGMS best encourage and support research that is highly innovative and/or risky? • Are there areas of current NIGMS research activity that should receive less emphasis? • How can NIGMS enhance its communication with the scientific community and the public? • How can NIGMS more effectively promote and encourage greater diversity in the biomedical research workforce? You may also submit other comments relevant to NIGMS that are not specifically addressed in these questions. Responses will be limited to approximately 500 words per question. All information provided will be processed and analyzed with strict anonymity. *Contact Person:* Judith H. Greenberg, PhD., National Institute of General Medical Sciences, National Institutes of Health, Building 45, Room 2AS25, 45 Center Drive, MSC 6200, Bethesda, Maryland 20892-6200; 301-594-0943; *greenbej@nigms.nih.gov.* Dated: February 16, 2007. Jeremy M. Berg, Director, National Institute of General Medical Sciences, National Institutes of Health. [FR Doc. E7-3152 Filed 2-23-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Availability of an Environmental Assessment and Receipt of an Application for Amendment to an Incidental Take Permit for the Green Diamond Resource Company Habitat Conservation Plan for the Northern Spotted Owl, Del Norte and Humboldt Counties, CA AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability and receipt of application. SUMMARY: Green Diamond Resource Company (Green Diamond) (previously Simpson Timber Company) has applied to the Fish and Wildlife Service (Service) to amend its existing incidental take permit
(ITP)for the federally threatened northern spotted owl ( *Strix occidentalis caurina* ; “NSO”). The existing ITP was issued in 1992, in association with a Habitat Conservation Plan
(Plan)and Implementation Agreement (IA), pursuant to section 10(a)(1)(B) of the Endangered Species Act
(Act)of 1973, as amended. The proposed ITP amendment would authorize the take of eight additional owl pairs on Green Diamond's ownership in Humboldt and Del Norte counties, California. These additional takes would be authorized during the existing permit term expiring in 2022, and would provide Green Diamond operational flexibility while they and the Service further consider and evaluate the findings of a 10-year, comprehensive Plan review. The application for permit amendment includes proposed amendments to the existing IA and Plan, which describe the proposed action and the measures that Green Diamond will undertake to minimize and mitigate take of the NSO. DATES: Written comments must be received on or before April 27, 2007. ADDRESSES: Send written comments to Ms. Amedee Brickey, ES Program Manager, U.S. Fish and Wildlife Service, 1655 Heindon Road, Arcata, California 95521. You also may send comments by facsimile to 707-822-8411. FOR FURTHER INFORMATION CONTACT: Mr. Gary Falxa, [see ADDRESSES ] or call 707-822-7201. SUPPLEMENTARY INFORMATION: Availability of Documents You may obtain copies of these documents for review by contacting the above office. Documents also will be available for public inspection, by appointment, during normal business hours at the Arcata Fish and Wildlife Office [see ADDRESSES ] and at each of the following libraries:
(1)Eureka Main Library, 1313 3rd Street, Eureka, CA; telephone: 707-269-1900.
(2)Fortuna Branch, Humboldt County Library, 775 14th Street, Fortuna, CA; telephone: 707-725-3460.
(3)Arcata Branch, Humboldt County Library, 500 7th Street, Arcata, CA; telephone: 707-822-5924.
(4)Del Norte County Library, 190 Price Mall, Crescent City, CA; telephone: 707-464-9793. Background Section 9 of the Act and Federal regulations prohibit the “take” of fish and wildlife species listed as endangered or threatened. Take of federally listed fish and wildlife is defined under the Act to include “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct.” The Service may, under limited circumstances, issue permits to authorize incidental take (i.e., take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity). Regulations governing incidental take permits for threatened and endangered species are found in 50 CFR 17.32 and 17.22. On September 17, 1992, the Service issued an ITP to the Applicant authorizing take of up to 50 NSO pairs in accordance with conditions set forth in the Plan and an IA. The ITP was issued in response to a permit application with an associated Habitat Conservation Plan for timber harvesting on the firm's properties in Del Norte, Humboldt, Mendocino, and Trinity counties, California. The effects of the proposed ITP were analyzed and described in an Environmental Assessment
(EA)prepared and issued by the Service (Notice of Availability, **Federal Register** , May 27, 1992). Green Diamond is proposing to amend its ITP to authorize take of up to eight additional NSO pairs on that part of its ownership, currently about 416,533 acres, on the west slopes of the Klamath Mountains and the Coast Range in Humboldt and Del Norte counties, California. The Applicant anticipates that these takes would be in the form of displacement of NSO pairs, incidental to timber harvest activities in or near NSO nest sites or activity centers. To mitigate take of eight additional owl pairs, Green Diamond proposes, in addition to measures in the existing Plan, to conduct new research on the habitat overlap and interaction between the NSO and barred owl ( *Strix varia* ), and to re-establish, through year 2012, a special management area of about 20,310 acres on its ownership, within which Green Diamond would not take owls. The Service's EA considers the environmental consequences of three alternatives, including:
(1)The Proposed Project Alternative, which consists of issuance of an amended ITP and implementation of the additional Plan measures;
(2)an alternative that provides for the take of eight additional owl pairs (similar to the Proposed Action), plus release for harvest entry of three set-aside areas that are otherwise not available for timber harvest during the term of the ITP; and
(3)the No Action Alternative, which provides for continued implementation of measures contained in the existing Plan and associated IA, and the level of incidental take authorized in the existing 1992 ITP. National Environmental Policy Act Proposed permit issuance triggers the need for compliance with the National Environmental Policy Act (NEPA). Accordingly, as the NEPA lead agency, the Service is providing this notice of the availability and is making the EA available for public review. Public Review The Service invites the public to review the EA and amendments to the Plan and IA during a 60-day public comment period [see DATES ]. Written comments from interested parties are welcome to ensure that the issues of public concern related to the proposed action are identified. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the office listed in the ADDRESSES section of this notice. All materials received will become part of the administrative record. Our practice is to make comments, including names, home addresses, home phone numbers, and email addresses of respondents, available for public review. Individual respondents may request that we withhold their names and/or homes addresses, etc., but if you wish us to consider withholding this information you must state this prominently at the beginning of your comments. In addition, you must present a rationale for withholding this information. This rationale must demonstrate that disclosure would constitute a clearly unwarranted invasion of privacy. Unsupported assertions will not meet this burden. In the absence of exceptional, documentable circumstances, this information will be released. We will always make submissions from organizations or businesses, and from individuals identifying themselves as representatives of or officials of organizations or businesses, available for public inspection in their entirety. This notice is provided pursuant to section 10(a) of the Act and the regulations for implementing NEPA, as amended (40 CFR 1506.6). We will evaluate the application, associated documents, and comments submitted thereon to determine whether the application meets the requirements of NEPA regulations and section 10(a) of the Act. If we determine that those requirements are met, we will issue an amended permit to the Green Diamond. We will make our final permit decision no sooner than 60 days from the date of this notice. Dated: February 20, 2007. Ken McDermond, Deputy Manager, California/Nevada Operations Office, Sacramento, California. [FR Doc. E7-3176 Filed 2-23-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Multistate Conservation Grant Program; Priority List for Conservation Projects AGENCY: Fish and Wildlife Service, Department of the Interior. ACTION: Notice of receipt of priority list. SUMMARY: We, the U.S. Fish and Wildlife Service (FWS), announce the FY 2007 priority list of wildlife and sport fish conservation projects from the Association of Fish and Wildlife Agencies (AFWA). As required by the Wildlife and Sport Fish Restoration Programs Improvement Act of 2000, each year AFWA submits a list of projects to us for consideration of funding by the Multistate Conservation Grant Program. We then review and award grants from this list. ADDRESSES: John C. Stremple, Multistate Conservation Grants Program Coordinator, Division of Federal Assistance, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Mail Stop MBSP-4020, Arlington, Virginia 22203. FOR FURTHER INFORMATION CONTACT: John C. Stremple,
(703)358-2156 (phone) or *John_Stremple@fws.gov* (e-mail). SUPPLEMENTARY INFORMATION: The Wildlife and Sport Fish Restoration Programs Improvement Act of 2000 (Improvement Act, Pub. L. 106-408) amended the Pittman-Robertson Wildlife Restoration Act (16 U.S.C. 669 *et seq.* ) and the Dingell-Johnson Sport Fish Restoration Act (16 U.S.C. 777 *et seq.* ) and established the Multistate Conservation Grant Program. The Improvement Act authorizes us to award grants of up to $3 million annually from funds available under each of the Restoration Acts, for a total of up to $6 million annually. We may award grants from a list of priority projects recommended to us by AFWA. The FWS Director, exercising the authority of the Secretary of the Interior, need not fund all AFWA-recommended projects, but may fund recommended projects on the list only. Grantees under this program may use funds for sport fisheries and wildlife management and research projects, boating access development, hunter safety and education, aquatic education, fish and wildlife habitat improvements and other purposes consistent with the enabling legislation. To be eligible for funding, a project must benefit fish and/or wildlife conservation in at least 26 States, or in a majority of the States in any one FWS region, or it must benefit a regional association of State fish and wildlife agencies. We may award grants to a State, a group of States, or one or more nongovernmental organizations. For the purpose of carrying out the National Survey of Fishing, Hunting and Wildlife-Associated Recreation, we may award grants to the FWS, if requested by AFWA, or to a State or a group of States. Also, AFWA requires all project proposals to address its National Conservation Needs, which are announced annually by AFWA at the same time as its request for proposals. Further, applicants must provide certification that no activities conducted under a Multistate Conservation Grant will promote or encourage opposition to the regulated hunting or trapping of wildlife or to the regulated angling for or taking of fish. Eligible project proposals are reviewed and ranked by AFWA Committees and interested nongovernmental organizations that represent conservation organizations, sportsmen's organizations, and industries that support or promote fishing, hunting, trapping, recreational shooting, bow hunting, or archery. AFWA's Committee on National Grants recommends a final list of priority projects to the directors of State fish and wildlife agencies for their approval by majority vote. By statute, AFWA then must transmit the final, approved list to the FWS for funding under the Multistate Conservation Grant Program by October 1. This year, we received a list of 11 recommended projects. They are recommended for funding in 2007, contingent on the Multistate Conservation Grant Program receiving additional funds as specified in the Safe, Accountable, Flexible, and Efficient Transportation Equity Act of 2005 (Pub. L. 109-059) passed in August 2005. AFWA's recommended list follows: BILLING CODE 4310-55-P EN26FE07.011 Dated: January 21, 2007. Kenneth Stansell, Acting Director, U.S. Fish and Wildlife Service. [FR Doc. 07-830 Filed 2-23-07; 8:45 am]
Connectionstraces to 5
4 references not yet in our index
  • 50 CFR 17.32
  • 40 CFR 1506.6
  • Pub. L. 106-408
  • Pub. L. 109-059
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cites case law
Notices
Notice
Cite50 CFR 17.32
Cite40 CFR 1506.6
Pub. L.Pub. L. 106-408
Pub. L.Pub. L. 109-059
Cites 9Cited by 0 across 0 sources
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