Prospective Grant of Exclusive License: Treatment of Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor, 49465-49466 [E6-13936]

Download as PDF Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Notices Name of Committee: National Institute on Aging Special Emphasis Panel, Reproductive Hormones and the Brain I. Date: September 6, 2006. Time: 11 a.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, 2C212, Bethesda, MD 20814, (Telephone Conference Call). Contact Person: Bita Nakhai, PhD, Scientific Review Administrator, Scientific Review Office, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301–402– 7701, nakhaib@nia.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute on Aging Special Emphasis Panel, Genes Responsible for Prolonged Existence I. Date: September 21, 2006. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Bita Nakhai, PhD, Scientific Review Administrator, Scientific Review Office, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301–402– 7701, nakhaib@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 15, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06–7085 Filed 8–22–06; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Co-Exclusive License: Method for Diagnosis of Atherosclerosis National Institutes of Health, Public Health Service, HHS. ACTION: Notice. sroberts on PROD1PC70 with NOTICES AGENCY: 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 a worldwide co-exclusive license to practice the invention embodied in: PCT Application No. US2005/031469 filed 9/ 2/2005, titled ‘‘Method for Diagnosis of Atherosclerosis’’ referenced at DHHS as VerDate Aug<31>2005 16:04 Aug 22, 2006 Jkt 208001 E–276–2004/2–PCT–01 to OrthoClinical Diagnostics, Inc., having a place of business in the state of New Jersey. The field of use may be limited to an FDA approved clinical diagnostic product for atherosclerosis. The United States of America is the assignee of the patent rights in this invention. The territory may be worldwide. This announcement is the second Notice to grant a license to this technology. The initial Notice was published in 70 FR 39525, July 8, 2005. Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before October 23, 2006 will be considered. DATES: Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Fatima Sayyid, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; telephone: (301) 435–4521; facsimile: (301) 402–0220; e-mail: sayyidf@mail.nih.gov. ADDRESSES: The subject PCT application is related to the field of vascular disease and biomarkers FOS and DUSP1 as expressed in peripheral blood or secreted into serum. The prospective co-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 co-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. 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. SUPPLEMENTARY INFORMATION: Dated: August 15, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–13935 Filed 8–22–06; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 49465 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Treatment of Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR (a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in: PCT patent application PCT/US2004/041256 filed December 9, 2004, entitled: ‘‘Methods for Suppressing an Immune Response or Treating a Proliferative Disorder’’ [HHS Reference Number: E–259–2003/0–PCT– 02], to Sahajanand Medical Technologies Pvt. Ltd., registered as a private limited company in accordance with the Companies Act of India, having a principle place of business in Surat, India and U.S. headquarters in Gaithersburg, Maryland. The field of use may be limited to the use of 2-(4piperazinyl)-8-phenyl-4H-1-benzopyran4-one (LY303511), for the treatment and prevention of stenosis and restenosis and/or other proliferative disorders. The United States of America is an assignee of the patent rights in these inventions. This notice replaces a notice published in 71 FR 46496, August 14, 2006, to correct the heading ‘‘Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions with Nitrite Therapy’’ to read ‘‘Prospective Grant of Exclusive License: Treatment of Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor’’. DATES: Only written comments and/or application for a license, which are received by the NIH Office of Technology Transfer on or before October 13, 2006 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: Susan Carson, D.Phil., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; email: carsonsu@od.nih.gov; telephone: (301) 435–5020; facsimile: (301) 402– 0220. SUPPLEMENTARY INFORMATION: The search for specific kinase inhibitors is E:\FR\FM\23AUN1.SGM 23AUN1 49466 Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Notices an active area of drug development as there is a continued need for effective anti-proliferative therapeutics with acceptable toxicities. The core invention is a novel method of use of one of the 4H-1-benzopyran-4-one derivatives (LY303511) which has been shown to target mTOR and casein kinase 2 (CK2) without affecting P13K activity (JPET, May 26, 2005, doi: 10.1124/ jpet.105.083550). Proof of concept data is available in an in vivo human zenograft PC–3 prostate tumor model, without observed toxicity. In vitro data suggests that 2-(4-piperazinyl)-8-pheynl4H-1-benzopyran-4-one and derivatives may be effective in treating inflammatory, autoimmune and other proliferative disorders including restenosis and a variety of cancers. Method of use claims are directed to derivatives of 2-(4-piperazinyl)substituted 4H-1-benzopyran-4-one compounds as anti-proliferative, immunosuppressive, anti-inflammatory, anti-restenosis and anti-neoplastic agents. 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, by the date referenced above, 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: August 15, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6–13936 Filed 8–22–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY sroberts on PROD1PC70 with NOTICES United States Secret Service Submission For Review; Extension Of Currently Approved Information Collection Requests United States Secret Service (USSS), Department of Homeland Security. AGENCY: VerDate Aug<31>2005 16:04 Aug 22, 2006 Jkt 208001 30-day Notice and request for comments. ACTION: SUMMARY: The Department of Homeland Security (DHS) has submitted the following information collection requests (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995: 1620–0002. The information collections were previously published in the Federal Register on June 15, 2006, at Vol. 71, No. 115, pages 34635 and 34636, allowing for OMB review and a 60-day public comment period. Comments received by DHS are being reviewed as applicable. This notice allows for an additional 30 days for public comments. DATES: Comments are encouraged and will be accepted until September 22, 2006. This process is conduced in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Office of Management and Budget, Attn: Desk Officer for Homeland Security, Office of Management and Budget Room 10235, Washington, DC 20503; telephone 202– 395–7316. The Office of Management and Budget is particularly interested in comments which: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the form(s) and instructions should be directed to: United States Secret Service, Security Clearance Division, Attn: ATSAIC Lawrence Tucker, Clearance and Access Branch, 950 H Street, NW., Washington, DC 20373–5824. Telephone number: (202) 406–5979. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires each Federal agency to provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The notice for this proposed information collection contains the following: (1) The name of the component of the U.S. Department of Homeland Security; (2) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (3) OMB Control Number, if applicable; (4) Title; (5) Summary of the collection; (6) Description of the need for, and proposed use of, the information; (7) Respondents and frequency of collection; and (8) Reporting and/or Recordkeeping burden. The Department of Homeland Security invites public comment. The Department of Homeland Security is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department, including whether the information will have practical utility; (2) is the estimate of burden for this information collection accurate; (3) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (4) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. All comments will become a matter of public record. In this document the U.S. Secretary Service is soliciting comments concerning the following information collection: Title: Contractor Personnel Access Application. OMB No.: 1620–0002. Form Number: SSF 3237. Abstract: Respondents are all Secret Service contractor personnel requiring access to Secret Service controlled facilities in performance of their contractual duties. These contractors, if approved for access, will require escorted, unescorted, and staff-like access to Secret Service controlled facilities. Responses to questions on the SSF 3237 yield information necessary for the adjudication of eligibility for facility access. Agency: Department of Homeland Security, United States Secret Service. Frequency: On occasion. Type of Review: Extension of a currently approved collection. Affected Public: Individuals. Estimated Number of Respondents: 5,000 respondents. SUPPLEMENTARY INFORMATION: E:\FR\FM\23AUN1.SGM 23AUN1

Agencies

[Federal Register Volume 71, Number 163 (Wednesday, August 23, 2006)]
[Notices]
[Pages 49465-49466]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13936]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of 
Proliferative Disorders Using an Unexpected mTOR Kinase Inhibitor

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 (a)(1)(i), that the National Institutes of Health (NIH), Department 
of Health and Human Services (HHS), is contemplating the grant of an 
exclusive license to practice the invention embodied in: PCT patent 
application PCT/US2004/041256 filed December 9, 2004, entitled: 
``Methods for Suppressing an Immune Response or Treating a 
Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], 
to Sahajanand Medical Technologies Pvt. Ltd., registered as a private 
limited company in accordance with the Companies Act of India, having a 
principle place of business in Surat, India and U.S. headquarters in 
Gaithersburg, Maryland. The field of use may be limited to the use of 
2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the 
treatment and prevention of stenosis and restenosis and/or other 
proliferative disorders. The United States of America is an assignee of 
the patent rights in these inventions.
    This notice replaces a notice published in 71 FR 46496, August 14, 
2006, to correct the heading ``Prospective Grant of Exclusive License: 
Treatment of Cardiovascular Conditions with Nitrite Therapy'' to read 
``Prospective Grant of Exclusive License: Treatment of Proliferative 
Disorders Using an Unexpected mTOR Kinase Inhibitor''.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
October 13, 2006 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: Susan Carson, D.Phil., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; e-mail: carsonsu@od.nih.gov; 
telephone: (301) 435-5020; facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: The search for specific kinase inhibitors is

[[Page 49466]]

an active area of drug development as there is a continued need for 
effective anti-proliferative therapeutics with acceptable toxicities. 
The core invention is a novel method of use of one of the 4H-1-
benzopyran-4-one derivatives (LY303511) which has been shown to target 
mTOR and casein kinase 2 (CK2) without affecting P13K activity (JPET, 
May 26, 2005, doi: 10.1124/ jpet.105.083550). Proof of concept data is 
available in an in vivo human zenograft PC-3 prostate tumor model, 
without observed toxicity. In vitro data suggests that 2-(4-
piperazinyl)-8-pheynl-4H-1-benzopyran-4-one and derivatives may be 
effective in treating inflammatory, autoimmune and other proliferative 
disorders including restenosis and a variety of cancers. Method of use 
claims are directed to derivatives of 2-(4-piperazinyl)-substituted 4H-
1-benzopyran-4-one compounds as anti-proliferative, immunosuppressive, 
anti-inflammatory, anti-restenosis and anti-neoplastic agents.
    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, by the date 
referenced above, 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: August 15, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E6-13936 Filed 8-22-06; 8:45 am]
BILLING CODE 4140-01-P
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