Notices. Notice

1,848 words·~8 min read·/register/2008/02/21/08-743

A 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 an Exclusive License: Development and Commercialization of Therapeutic Products for Breast Cancer AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S.

Patent Application No. 09/693,600 filed October 20, 2000 entitled “Method and Composition for Enhancing Immune Response” [E-037-2001/1-US-01]; Japanese Patent Application No. 2002-555834 filed October 22, 2001 entitled “Method and Composition for Enhancing Immune Response” [E-037-2001/1-JP-03]; and European Patent Application No. 01989341.1 filed October 22, 2001 entitled “Method and Composition for Enhancing Immune Response” [E-037-2001/1-EP-04]; to ODC Therapy, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for breast cancer patients expressing high levels of serum or plasma IgE.

DATES: Only written comments and/or license applications which are received by the National Institutes of Health on or before April 21, 2008 will be considered. ADDRESSES: Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Mojdeh Bahar, J.D., M.A., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD. 20852-3804.

Telephone:

(301)435-2950; Facsimile:

(301)402-0220; E-mail: *baharm@od.nih.gov* . SUPPLEMENTARY INFORMATION: The invention relates to a method of inhibiting tumor growth which comprises the administration of an IL-13 inhibitor. Additionally, the invention relates to a method and composition for enhancing an immune response in a subject by administering to a subject an inhibitor of IL-13 or an inhibitor of an NK-T cell. The method can be used to prevent growth of a tumor in a subject, *e.g.* , to inhibit tumor recurrence or metastasis. The method can also be used to enhance a response to a vaccine in a subject. IL-13 is an interleukin which has potent immunomodulatory effects. It is primarily secreted by TH2 lymphocytes. This invention relates to the discovery of a role for IL-13 in the down-regulation of tumor immunosurveillance. Using a mouse model in which tumors show a growth-regression-recurrence pattern, the mechanisms for down-regulation of cytotoxic T lymphocyte-mediated tumor immunosurveillance was investigated. It was discovered that interleukin 4 receptor (IL-4R) knockout mice, and downstream signal transducer and activator of transcription 6 (STAT6) knockout mice, but not IL-4 knockout mice, resisted tumor recurrence. Thus, IL-13, the only other cytokine that uses the IL-4R-STAT6 pathway, was discovered to have a role in the down-regulation of tumor immunosurveillance. 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 sixty

(60)days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 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 11, 2008. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-3165 Filed 2-20-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Regulatory Approved Clinical Diagnostics for Anti-HPV16 L1 Serum Antibody Detection in HPV Vaccine Recipients 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 worldwide license to practice the invention embodied in HHS Ref. No. E-253-1993/0 and certain foreign rights under HHS Ref. No. E-166-1992 including U.S. Patent 5,437,951, U.S. Patent 5,985,610, U.S. Patent 5,871,998, U.S. Patent 5,716,620, U.S. Patent 5,744,142, U.S. Patent 5,756,284, U.S. Patent 5,709,996, U.S. Patent Application 09/316,487, U.S. Patent Application 10/371,846, International Patent Application PCT/US93/08342, European Patent Application 93921353.4, European Patent Application 040104531.1, European Patent Application 040783235, Australian Patent 683220, Australian Patent Application 2004203609, Canadian Patent No. 2,143,845, Japanese Patent Applications 1994-507481, Japanese Patent Applications 2001-101791 and continuation and divisional patents and patent applications thereof, entitled “Self-Assembling Recombinant Papillomavirus HPV16 Capsid Proteins,” to Biotrin International, Ltd., a limited liability company formed under the laws of the European Union and the Republic of Ireland. The United States of America is the assignee of the patent rights of the above inventions. The contemplated exclusive license may be granted in the field of regulatory approved clinical diagnostics for serum anti-HPV16 L1 antibody detection in HPV vaccine recipients. DATE: Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before April 21, 2008 will be considered. ADDRESSES: Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone:

(301)435-5019; Facsimile:

(301)402-0220; E-mail: *shmilovm@mail.nih.gov* . A signed confidentiality nondisclosure agreement may be required to receive copies of the patent applications. SUPPLEMENTARY INFORMATION: The patent applications intended for licensure disclose and/or cover the following: E-253-1993 and E-166-1992, “Self-Assembling Recombinant Papillomavirus Capsid Proteins of HPV16,” Lowy et al. Recombinant human papillomavirus 16 capsid proteins that are capable of self-assembly into capsomer structures and viral capsids that comprise conformational antigenic epitopes. The capsomer structures and viral capsids, consisting of the capsid proteins that are expression products of a bovine, monkey or human papillomavirus L1 conformational coding sequence proteins, can be prepared for use in ELISA or cell-based immunoassays for detecting the level of serum antibody in recipients of a vaccine against HPV16. The self-assembling capsid proteins can also be used as elements of diagnostic immunoassay procedures for papillomavirus infection. 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 sixty

(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. 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: February 14, 2008. David Sadowski, Deputy Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-3162 Filed 2-20-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R9-MB-2008-N0031] Wildlife and Sport Fish Restoration Program AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of priority list. SUMMARY: We, the U.S. Fish and Wildlife Service (FWS), announce the FY 2008 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, AFWA submits a list of projects to us each year to consider for funding under 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 projects on the list, but all projects funded must be on the list. 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 regulated hunting or trapping of wildlife or to regulated angling 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, bowhunting, 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 nine recommended projects. We recommend them for funding in 2008, 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: Dated: January 29, 2008. H. Dale Hall, Director, U.S. Fish and Wildlife Service. BILLING CODE 4310-55-P EN21FE08.002 [FR Doc. 08-743 Filed 2-20-08; 8:45am]

Connectionstraces to 5

Traces to 5 documents

U.S. Code

CFR