Prospective Grant of Exclusive License: Development of Cripto-1 Point of Care (POC) Tests and Kits for the Detection of Cancer, 70830-70831 [2015-28832]

Download as PDF 70830 Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices Dated: November 10, 2015. Tammy Dean-Maxwell, Project Clearance Branch Liaison, NIGMS, NIH. [FR Doc. 2015–29085 Filed 11–13–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Opportunity for Public Comment on the Dietary Supplement Label Database This document, originally published on October 29, 2015 (80 FR 66549), has been amended to extend the comment receipt date to December 31, 2015. The Office of Dietary Supplements (ODS) at the National Institutes of Health, in partnership with the National Library of Medicine (NLM), has developed a Dietary Supplement Label Database (DSLD) that is compiling all information from the labels of dietary supplements marketed in the United States. ODS welcomes comments about features to add and functionality improvements to make so the DSLD may become a more useful tool to users. A federal stakeholder panel for the DSLD will consider all comments received. The ODS requests input from academic researchers, government agencies, the dietary supplement industry, and other interested parties, including consumers. The DSLD can be accessed online at https:// dsld.nlm.nih.gov. SUMMARY: To ensure full consideration, all comments must be received by 11:59 p.m. EST, December 31, 2015. ADDRESSES: Interested individuals and organizations should submit their responses to ODS@nih.gov. FOR FURTHER INFORMATION CONTACT: Richard Bailen MBA, MHA, Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, Room 3B01, Bethesda, MD 20892–7517, Phone: 301–435–2920, Fax: 301–480–1845, Email: ODS@ nih.gov. DATES: The DSLD is a free resource that captures all information present on dietary supplement labels as provided by the seller, including contents, ingredient amounts, and any health-related product statements, claims, and cautions. It also provides a downloadable photo of each label. Users can search for and organize this information in various ways. Research scientists, for example, could use the tkelley on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:47 Nov 13, 2015 Jkt 238001 DSLD to determine total nutrient intakes from food and supplements in populations they study. Health care providers can learn the content of products their patients are taking. Consumers might use the DSLD to search for and compare products of interest. The DSLD currently contains 50,000 labels, and it is expected to grow rapidly over the next three years to include most of the estimated 75,000+ dietary supplement products sold to American consumers. The DSLD is updated regularly to include any formulation changes and label information in a product. It also includes the labels of products that have been discontinued and are no longer sold. More information about the DSLD and its current capabilities is available at https:// www.dsld.nlm.nih.gov and at Dwyer et al., 2014.1 ODS would like to receive ideas and suggestions for how the DSLD might evolve. What features might be added, improved, or enhanced—for example, in capabilities related to search, sorting, organization, and downloading of information—that would make it a more valuable tool for users? Dated: November 5, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015–29177 Filed 11–13–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. 1 Dwyer JT, Saldanha LG, Bailen RA, et al. A free new dietary supplement label database for registered dietitian nutritionists. J Acad Nutr Diet. 2014;114(10):1512–7. PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, NIAID Clinical Trial Planning Grant (R34) and Implementation Cooperative Agreement (U01). Date: December 9, 2015. Time: 1:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3C100, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Frank S. De Silva, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room #3E72A, National Institutes of Health/ NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, (240) 669–5023, fdesilva@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: November 9, 2015. Natasha Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–28835 Filed 11–13–15; 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 Cancer National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, 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, Inc. (‘‘Beacon’’) located in Scottsdale, AZ, USA. A notice was previously published on December 6, 2013 in Volume 78, Number 235 for a period of thirty (30) days. Herein, the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is proposing a modification to the contents of the previous notice regarding the following intellectual property: SUMMARY: U.S. Provisional Patent Application No. 60/ 264,643 filed January 26, 2001 entitled ‘‘Detection and Quantification of Cripto1’’ [HHS Ref. No. E–290–2000/0–US–01]; E:\FR\FM\16NON1.SGM 16NON1 Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices PCT Application No. PCT/US02/02225 filed January 23, 2002 entitled ‘‘Detection and Quantification of Cripto-1’’ [HHS Ref. No. E–290–2000/0–PCT–02]; 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]; Canada Patent No. 2,434,694 issued September 18, 2012 entitled ‘‘Detection and Quantification of Cripto-1’’ [HHS Ref. No. E–290–2000/0–CA–04]; Australian Patent No. 2002236871 issued April 12, 2007 entitled ‘‘Detection and Quantification of Cripto-1’’ [HHS Ref. No. E–290–2000/0–AU–05]; Europe Patent No. 1370869 issued December 27, 2006 entitled ‘‘Detection and Quantification of Cripto-1’’ [HHS Ref. No. E–290–2000/0–EP–06] and validated in Germany [HHS Ref. No. E–290–2000/ 0–DE–08], France [HHS Ref. No. E–290– 2000/0–FR–09], Italy [HHS Ref. No. E– 290–2000/0–IT–10], Spain [HHS Ref. No. E–290–2000/0–ES–12], Ireland [HHS Ref. No. E–290–2000/0–IE–12], Great Britain [HHS Ref. No. E–290–2000/0–GB–13] and Switzerland [HHS Ref. No. E–290– 2000/0–CH–14]; Japan Patent No. 3821779 issued June 30, 2006 entitled ‘‘Detection and Quantification of Cripto-1’’ [HHS Ref. No. E–290–2000/0–JP–07]. 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 may be limited to the use of the Licensed Patent Rights to make, use and sell FDA approved and 510(k) cleared, or foreign equivalent, Point of Care (POC) tests, services and kits for the purpose of disease state recognition, detection, diagnosis, monitoring, association and risk-stratification of cancer. Only written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before December 1, 2015 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Rose Freel, Ph.D. Licensing and Patenting Manager, Technology Transfer Center, National Cancer Institute, 8490 Progress Drive, Riverside 5, Suite 400, Frederick, MD 21702; Telephone: (301) 624–1257; Email: rose.freel@nih.gov. SUPPLEMENTARY INFORMATION: Cripto-1 (Cr-1) is a member of the epidermal growth factor (EGF)-related families of peptides and is involved in the development and progression of various tkelley on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 19:47 Nov 13, 2015 Jkt 238001 human carcinomas. In particular, Cr-1 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 Cr-1, it may be possible to use the disclosed assay to detect and measure Cr-1 in human serum and/or plasma and possibly other physiological fluids. The previous notice published on December 6, 2013 contemplated the prospective grant of an exclusive license in a field of use that was limited to the use of the 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 riskstratification of colon and rectal cancer, breast cancer, and lung cancer. This notice serves to modify the prospective grant that may be limited to field of use as described in the Summary above. 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. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the NCI 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. 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: November 9, 2015. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2015–28832 Filed 11–13–15; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 70831 DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [167 A2100DD/AAKC001030/ A0A501010.999900] Johnson-O’Malley Program AGENCY: Bureau of Indian Affairs, Interior. ACTION: Tribal consultation meetings. The Bureau of Indian Education (BIE) will be conducting three consultation sessions to obtain oral and written comments on issues concerning the Johnson O’Malley (JOM) program. The sessions continue the previous dialogues conducted by the Bureau of Indian Affairs (BIA) and BIE in 2012 and 2015. SUMMARY: DATES: See the SUPPLEMENTARY INFORMATION section of this document for the dates of Tribal consultation sessions. We will consider all comments received by January 15, 2016, 4:30 p.m. EST. ADDRESSES: See the SUPPLEMENTARY INFORMATION section of this document for the location of these Tribal consultation sessions. Submit comments by mail or hand-deliver written comments to Ms. Jennifer L. Davis, Program Analyst-JOM, Bureau of Indian Education, 1951 Constitution Avenue NW., Mail Stop Room 312A–SIB Washington, DC 20245; facsimile to (202) 273–0030; or email to JOMComments@bia.gov. Ms. Jennifer L. Davis, Program Analyst-JOM, telephone (202) 208–4397. FOR FURTHER INFORMATION CONTACT: As required by 25 U.S.C. 2011(b), the purpose of this consultation is to provide Indian Tribes, school boards, parents, Indian organizations and other interested parties with an opportunity to comment on issues raised during previous consultation sessions and future plans for the JOM program. The topics for the JOM Tribal Consultation are use of the 2014 JOM student count and the JOM funding methodology for 2015, 2016, and thereafter. The issues will be described in more detail in a Tribal consultation booklet issued by the BIE before the consultation sessions. Tribal consultation sessions will be held on the following dates at the following location: SUPPLEMENTARY INFORMATION: E:\FR\FM\16NON1.SGM 16NON1

Agencies

[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70830-70831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28832]


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

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 Cancer

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 
404, that the National Cancer Institute, 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, 
Inc. (``Beacon'') located in Scottsdale, AZ, USA. A notice was 
previously published on December 6, 2013 in Volume 78, Number 235 for a 
period of thirty (30) days. Herein, the National Cancer Institute, 
National Institutes of Health, Department of Health and Human Services, 
is proposing a modification to the contents of the previous notice 
regarding the following intellectual property:

U.S. Provisional Patent Application No. 60/264,643 filed January 26, 
2001 entitled ``Detection and Quantification of Cripto-1'' [HHS Ref. 
No. E-290-2000/0-US-01];

[[Page 70831]]

PCT Application No. PCT/US02/02225 filed January 23, 2002 entitled 
``Detection and Quantification of Cripto-1'' [HHS Ref. No. E-290-
2000/0-PCT-02];
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];
Canada Patent No. 2,434,694 issued September 18, 2012 entitled 
``Detection and Quantification of Cripto-1'' [HHS Ref. No. E-290-
2000/0-CA-04];
Australian Patent No. 2002236871 issued April 12, 2007 entitled 
``Detection and Quantification of Cripto-1'' [HHS Ref. No. E-290-
2000/0-AU-05];
Europe Patent No. 1370869 issued December 27, 2006 entitled 
``Detection and Quantification of Cripto-1'' [HHS Ref. No. E-290-
2000/0-EP-06] and validated in Germany [HHS Ref. No. E-290-2000/0-
DE-08], France [HHS Ref. No. E-290-2000/0-FR-09], Italy [HHS Ref. 
No. E-290-2000/0-IT-10], Spain [HHS Ref. No. E-290-2000/0-ES-12], 
Ireland [HHS Ref. No. E-290-2000/0-IE-12], Great Britain [HHS Ref. 
No. E-290-2000/0-GB-13] and Switzerland [HHS Ref. No. E-290-2000/0-
CH-14];
Japan Patent No. 3821779 issued June 30, 2006 entitled ``Detection 
and Quantification of Cripto-1'' [HHS Ref. No. E-290-2000/0-JP-07].

    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 may be limited to the use of the Licensed Patent 
Rights to make, use and sell FDA approved and 510(k) cleared, or 
foreign equivalent, Point of Care (POC) tests, services and kits for 
the purpose of disease state recognition, detection, diagnosis, 
monitoring, association and risk-stratification of cancer.

DATES: Only written comments and/or applications for a license which 
are received by the NCI Technology Transfer Center on or before 
December 1, 2015 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Rose Freel, Ph.D. Licensing and Patenting Manager, 
Technology Transfer Center, National Cancer Institute, 8490 Progress 
Drive, Riverside 5, Suite 400, Frederick, MD 21702; Telephone: (301) 
624-1257; Email: rose.freel@nih.gov.

SUPPLEMENTARY INFORMATION: Cripto-1 (Cr-1) 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, 
Cr-1 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 Cr-1, it may be possible to use 
the disclosed assay to detect and measure Cr-1 in human serum and/or 
plasma and possibly other physiological fluids.
    The previous notice published on December 6, 2013 contemplated the 
prospective grant of an exclusive license in a field of use that was 
limited to the use of the 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. This notice serves to modify the prospective 
grant that may be limited to field of use as described in the Summary 
above.
    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. The prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the NCI 
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.
    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: November 9, 2015.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2015-28832 Filed 11-13-15; 8:45 am]
BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.