Prospective Grant of Exclusive License: Development of Cripto-1 Point of Care (POC) Tests and Kits for the Detection of Colon and Rectal Cancer, Breast Cancer, and Lung Cancer, 73553 [2013-29099]

Download as PDF Federal Register / Vol. 78, No. 235 / Friday, December 6, 2013 / Notices Dated: December 2, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–29097 Filed 12–5–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Development of Cripto-1 Point of Care (POC) Tests and Kits for the Detection of Colon and Rectal Cancer, Breast Cancer, and Lung Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, 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 the following U.S. Patents and Patent Applications to Beacon Biomedical LLC (‘‘Beacon’’) located in Scottsdale, AZ, USA. SUMMARY: emcdonald on DSK67QTVN1PROD with NOTICES Intellectual Property: U.S. Patent No.7,078,176 issued July 18, 2006 entitled ‘‘Detection and Quantification of Cripto-1’’ [HHS Ref. No. E–290–2000/0–US–03] and foreign equivalents thereof. The patent rights in these inventions have been assigned to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use will be limited to the use of Licensed Patent Rights to develop FDA approved and/or 510K cleared Point of Care (POC) tests and kits for the purpose of disease state recognition, detection, diagnosis, monitoring, association and risk-stratification of colon and rectal cancer, breast cancer, and lung cancer. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before January 6, 2014 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Eggerton Campbell, Ph.D. Licensing and Patenting Manager, Cancer Branch, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– VerDate Mar<15>2010 17:28 Dec 05, 2013 Jkt 232001 5282; Facsimile: (301) 435–4013; Email: Eggerton.Campbell@.nih.gov. DEPARTMENT OF HOMELAND SECURITY Cripto-1 (CR1) is a member of the epidermal growth factor (EGF)-related families of peptides and is involved in the development and progression of various human carcinomas. In particular, CR1 overexpression has been detected in 50– 90% of carcinomas of the colon, pancreas, stomach, gallbladder, breast, lung, endometrium and cervix. Current methodologies of cancer detection, e.g. immunohistochemistry, can be time consuming, inconvenient and oftentimes, inaccurate, and therefore, a need exists for more efficient, reliable and less time consuming methods of detection. The invention relates to such a method of detection. This test could be used to more effectively screen and perhaps stage cancers. Additionally, should particular tumor cells, e.g. breast tumor cells, express a sufficiently high level of CR1, it may be possible to use the disclosed assay to detect and measure CR1 in human serum and/or plasma and possibly other physiological fluids. 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 thirty (30) 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 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. 73553 United States Immigration and Customs Enforcement SUPPLEMENTARY INFORMATION: Dated: December 2, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–29099 Filed 12–5–13; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Agency Information Collection Activities: Comment Request 30-Day Notice of Information Collection for Review; Form No. I–246, Application for Stay of Removal or Deportation; OMB Control No. 1653– 0021. ACTION: The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), will submit the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published in the Federal Register to obtain comments from the public and affected agencies. The information collection was previously published in the Federal Register on September 16, 2013, Vol. 78 No. 23447 allowing for a 60 day comment period. USICE received no comments during this period. The purpose of this notice is to allow an additional 30 days for public comments. Written comments and suggestions regarding items contained in this notice and especially with regard to the estimated public burden and associated response time should be directed to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for U.S. Immigration and Customs Enforcement, Department of Homeland Security, and sent via electronic mail to oira_ submission@omb.eop.gov or faxed to (202) 395–5806. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points: (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 agencies 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, E:\FR\FM\06DEN1.SGM 06DEN1

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[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Notices]
[Page 73553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Development of Cripto-1 
Point of Care (POC) Tests and Kits for the Detection of Colon and 
Rectal Cancer, Breast Cancer, and Lung Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
Part 404, 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 the following U.S. 
Patents and Patent Applications to Beacon Biomedical LLC (``Beacon'') 
located in Scottsdale, AZ, USA.

    Intellectual Property: U.S. Patent No.7,078,176 issued July 18, 
2006 entitled ``Detection and Quantification of Cripto-1'' [HHS Ref. 
No. E-290-2000/0-US-03] and foreign equivalents thereof.

    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use will be limited to the use of Licensed Patent Rights 
to develop FDA approved and/or 510K cleared Point of Care (POC) tests 
and kits for the purpose of disease state recognition, detection, 
diagnosis, monitoring, association and risk-stratification of colon and 
rectal cancer, breast cancer, and lung cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
January 6, 2014 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Eggerton Campbell, Ph.D. Licensing and Patenting Manager, 
Cancer Branch, Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
Telephone: (301) 435-5282; Facsimile: (301) 435-4013; Email: 
Eggerton.Campbell@.nih.gov.

SUPPLEMENTARY INFORMATION: Cripto-1 (CR1) is a member of the epidermal 
growth factor (EGF)-related families of peptides and is involved in the 
development and progression of various human carcinomas. In particular, 
CR1 overexpression has been detected in 50-90% of carcinomas of the 
colon, pancreas, stomach, gallbladder, breast, lung, endometrium and 
cervix. Current methodologies of cancer detection, e.g. 
immunohistochemistry, can be time consuming, inconvenient and 
oftentimes, inaccurate, and therefore, a need exists for more 
efficient, reliable and less time consuming methods of detection. The 
invention relates to such a method of detection. This test could be 
used to more effectively screen and perhaps stage cancers. 
Additionally, should particular tumor cells, e.g. breast tumor cells, 
express a sufficiently high level of CR1, it may be possible to use the 
disclosed assay to detect and measure CR1 in human serum and/or plasma 
and possibly other physiological fluids.
    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 
thirty (30) 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 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: December 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-29099 Filed 12-5-13; 8:45 am]
BILLING CODE 4140-01-P