Prospective Grant of Co-Exclusive License: Biomarkers for Acute Ischemic Stroke, 53163-53164 [2015-21718]

Download as PDF Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices T. Dorsam (FDA) (see FOR FURTHER INFORMATION CONTACT). Dated: August 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–21639 Filed 9–1–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings mstockstill on DSK4VPTVN1PROD with NOTICES 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 meetings. The meetings 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. Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Health Services Organization and Delivery Study Section. Date: September 28–29, 2015. Time: 9:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Wyndham Grand Chicago Riverfront; 71 East Wacker Drive; Chicago, IL 60601. Contact Person: Jacinta Bronte-Tinkew, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 3164, MSC 7770; Bethesda, MD 20892; (301) 806– 0009; brontetinkewjm@csr.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Clinical Molecular Imaging and Probe Development. Date: October 5–6, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Alexandria Mark Center; 5000 Seminary Road; Alexandria, VA 22311. Contact Person: David L Williams, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 5110, MSC 7854; Bethesda, MD 20892; (301)435– 1174; williamsdl2@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Development and Application of PET and SPECT Imaging Ligands as Biomarkers for VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 Drug Discovery and for Pathophysiological Studies of CNS Disorders (R21/R33). Date: October 6, 2015. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Alexandria Mark Center; 5000 Seminary Road; Alexandria, VA 22311. Contact Person: David L Williams, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 5110, MSC 7854; Bethesda, MD 20892; (301)435– 1174; williamsdl2@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: August 27, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–21705 Filed 9–1–15; 8:45 am] BILLING CODE 4140–01–P 53163 Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01). Date: September 29, 2015. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 8F100, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Thomas F. Conway, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3G51, National Institutes of Health, NIAID, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, 240–507–9685, thomas.conway@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: August 27, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–21704 Filed 9–1–15; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings National Institutes of Health 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 meetings. The meetings 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. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01). Date: September 28, 2015. Time: 10:00 a.m. to 5:00 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: Zhuqing (Charlie) Li, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room # 3G41B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC9823, Bethesda, MD 20892–9823, (240) 669–5068, zhuqing.li@nih.gov. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Prospective Grant of Co-Exclusive License: Biomarkers for Acute Ischemic Stroke 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 a co-exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 13/580,571 filed 22 August, 2012 and entitled ‘‘Biomarkers for Acute Ischemic Stroke’’ [HHS Ref. No. E–023–2010/0–US–03] to CereDx, Inc., which is located in West Virginia. The patent rights in this invention have been assigned to the United States of America. The prospective co-exclusive license territory may be worldwide and the field of use may be limited to the use of the diagnostics of ischemic stroke. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 2, 2015 will be considered. This notice updates the Federal Register Notice published in 80 FR 28633, Tuesday May 19, 2015. SUMMARY: E:\FR\FM\02SEN1.SGM 02SEN1 53164 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated co-exclusive license should be directed to: Uri Reichman, Ph.D., MBA, Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804. Telephone: (301) 435–4616; Facsimile: (301) 402– 0220; Email: reichmau@mail.nih.gov. ADDRESSES: This technology is directed to gene biomarkers for the diagnosis and potential treatment of acute ischemic stroke. Stroke is the third leading cause of death in the United States, of which 87% are ischemic stroke and result in death within 30 days in 8–12% of the cases. Currently, recombinant tissue plasminogen activator (rtPA, trade name alteplase), is the only FDA approved ischemic stroke treatment, and it is only effective when administered to patients within three hours from the onset of symptoms. Unfortunately, the median time from stroke symptom onset to presentation to the emergency department is 3–6 hours. Although advances in neuroimaging and clinical management have helped with patient survival rates, these techniques are not infallible and at times result in misdiagnosis. The biomarkers identified in this technology may be used to develop a diagnostic testing device for determining stroke subtype in the field. 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 part 404. The prospective co-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 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 co-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. mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: August 28, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015–21718 Filed 9–1–15; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Microbiology and Infectious Diseases Biological Resource Repository (MID–BRR). Date: September 25, 2015. Time: 8:30 a.m. to 12:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health; Room 2C100; 5601 Fishers Lane; Rockville, MD 20892; (Telephone Conference Call). Contact Person: Annie Walker-Abbey; Scientific Review Officer; Scientific Review Program; NIAID/NIH/DHHS; 5601 Fishers Lane, Room 3E70A; Rockville, MD 20852; 240–627–3390; aabbey@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: August 27, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–21703 Filed 9–1–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Application Forms for the NIDA Summer Research Internship Program (NIDA) In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 National Institute of Drug Abuse, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) 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 the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Albert Avila, Ph.D., Director, Office of Diversity and Health Disparities, NIDA, NIH, 6001 Executive Blvd., Room 3106, Rockville, MD 20852, or call non-toll-free number (301) 443– 0441 or Email your request, including your address to: aavila@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NIDA Summer Research Internship Program, 0925– NEW, National Institute on Drug Abuse, NIDA, National Institutes of Health (NIH). Need and Use of Information Collection: The NIDA Summer Research Internship program introduces high school and undergraduate students of underrepresented populations to substance abuse research through internships with NIDA grantees at universities across the United States and Puerto Rico. Students intern with NIDA principal investigators for 8–10 weeks during the summer. The internship experience may include laboratory experiments, formal courses, data collection, data analysis, patient recruitment, manuscript preparation, literature reviews and library research. E:\FR\FM\02SEN1.SGM 02SEN1

Agencies

[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53163-53164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Biomarkers for Acute 
Ischemic Stroke

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 a co-exclusive patent 
license to practice the inventions embodied in U.S. Patent Application 
No. 13/580,571 filed 22 August, 2012 and entitled ``Biomarkers for 
Acute Ischemic Stroke'' [HHS Ref. No. E-023-2010/0-US-03] to CereDx, 
Inc., which is located in West Virginia. The patent rights in this 
invention have been assigned to the United States of America.
    The prospective co-exclusive license territory may be worldwide and 
the field of use may be limited to the use of the diagnostics of 
ischemic stroke.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
October 2, 2015 will be considered. This notice updates the Federal 
Register Notice published in 80 FR 28633, Tuesday May 19, 2015.

[[Page 53164]]


ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated co-exclusive 
license should be directed to: Uri Reichman, Ph.D., MBA, Licensing and 
Patenting Manager, Office of Technology Transfer, National Institutes 
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804. Telephone: (301) 435-4616; Facsimile: (301) 402-0220; Email: 
reichmau@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This technology is directed to gene 
biomarkers for the diagnosis and potential treatment of acute ischemic 
stroke. Stroke is the third leading cause of death in the United 
States, of which 87% are ischemic stroke and result in death within 30 
days in 8-12% of the cases. Currently, recombinant tissue plasminogen 
activator (rtPA, trade name alteplase), is the only FDA approved 
ischemic stroke treatment, and it is only effective when administered 
to patients within three hours from the onset of symptoms. 
Unfortunately, the median time from stroke symptom onset to 
presentation to the emergency department is 3-6 hours. Although 
advances in neuroimaging and clinical management have helped with 
patient survival rates, these techniques are not infallible and at 
times result in misdiagnosis. The biomarkers identified in this 
technology may be used to develop a diagnostic testing device for 
determining stroke subtype in the field.
    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 
part 404. The prospective co-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 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 co-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: August 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-21718 Filed 9-1-15; 8:45 am]
BILLING CODE 4140-01-P

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