80_FR_53333 80 FR 53163 - Prospective Grant of Co-Exclusive License: Biomarkers for Acute Ischemic Stroke

80 FR 53163 - Prospective Grant of Co-Exclusive License: Biomarkers for Acute Ischemic Stroke

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 170 (September 2, 2015)

Page Range53163-53164
FR Document2015-21718

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.

Federal Register, Volume 80 Issue 170 (Wednesday, September 2, 2015) 
[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53163-53164]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: 
[email protected].

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

Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices 53163 T. Dorsam (FDA) (see FOR FURTHER Drug Discovery and for Pathophysiological Name of Committee: National Institute of INFORMATION CONTACT). Studies of CNS Disorders (R21/R33). Allergy and Infectious Diseases Special Date: October 6, 2015. Emphasis Panel; NIAID Investigator Initiated Dated: August 27, 2015. Time: 12:00 p.m. to 5:00 p.m. Program Project Applications (P01). Leslie Kux, Agenda: To review and evaluate grant Date: September 29, 2015. Associate Commissioner for Policy. applications. Time: 11:00 a.m. to 5:00 p.m. [FR Doc. 2015–21639 Filed 9–1–15; 8:45 am] Place: Hilton Alexandria Mark Center; Agenda: To review and evaluate grant 5000 Seminary Road; Alexandria, VA 22311. applications. BILLING CODE 4164–01–P Contact Person: David L Williams, Ph.D.; Place: National Institutes of Health, Room Scientific Review Officer; Center for 8F100, 5601 Fishers Lane, Rockville, MD Scientific Review; National Institutes of 20892, (Telephone Conference Call). DEPARTMENT OF HEALTH AND Health; 6701 Rockledge Drive, Room 5110, Contact Person: Thomas F. Conway, HUMAN SERVICES MSC 7854; Bethesda, MD 20892; (301)435– Scientific Review Officer, Scientific Review 1174; williamsdl2@csr.nih.gov. Program, Division of Extramural Activities, National Institutes of Health (Catalogue of Federal Domestic Assistance Room 3G51, National Institutes of Health, Program Nos. 93.306, Comparative Medicine; NIAID, 5601 Fishers Lane, MSC 9823, Center for Scientific Review; Notice of 93.333, Clinical Research, 93.306, 93.333, Bethesda, MD 20892–9823, 240–507–9685, Closed Meetings 93.337, 93.393–93.396, 93.837–93.844, thomas.conway@nih.gov. 93.846–93.878, 93.892, 93.893, National (Catalogue of Federal Domestic Assistance Pursuant to section 10(d) of the Institutes of Health, HHS) Program Nos. 93.855, Allergy, Immunology, Federal Advisory Committee Act, as and Transplantation Research; 93.856, Dated: August 27, 2015. amended (5 U.S.C. App.), notice is Microbiology and Infectious Diseases hereby given of the following meetings. Carolyn Baum, Research, National Institutes of Health, HHS) Program Analyst, Office of Federal Advisory The meetings will be closed to the Committee Policy. Dated: August 27, 2015. public in accordance with the David Clary, [FR Doc. 2015–21705 Filed 9–1–15; 8:45 am] provisions set forth in sections Program Analyst, Office of Federal Advisory BILLING CODE 4140–01–P 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Committee Policy. as amended. The grant applications and [FR Doc. 2015–21704 Filed 9–1–15; 8:45 am] the discussions could disclose DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–P confidential trade secrets or commercial HUMAN SERVICES property such as patentable material, and personal information concerning National Institutes of Health DEPARTMENT OF HEALTH AND individuals associated with the grant HUMAN SERVICES applications, the disclosure of which National Institute of Allergy and would constitute a clearly unwarranted Infectious Diseases; Notice of Closed National Institutes of Health invasion of personal privacy. Meetings Prospective Grant of Co-Exclusive Name of Committee: Healthcare Delivery Pursuant to section 10(d) of the and Methodologies Integrated Review Group; License: Biomarkers for Acute Federal Advisory Committee Act, as Ischemic Stroke Health Services Organization and Delivery Study Section. amended (5 U.S.C. App.), notice is hereby given of the following meetings. AGENCY: National Institutes of Health, Date: September 28–29, 2015. HHS. Time: 9:30 a.m. to 5:00 p.m. The meetings will be closed to the Agenda: To review and evaluate grant public in accordance with the ACTION: Notice. applications. provisions set forth in sections Place: Wyndham Grand Chicago 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., SUMMARY: This is notice, in accordance Riverfront; 71 East Wacker Drive; Chicago, IL as amended. The grant applications and with 35 U.S.C. 209 and 37 CFR part 404, 60601. the discussions could disclose that the National Institutes of Health, Contact Person: Jacinta Bronte-Tinkew, confidential trade secrets or commercial Department of Health and Human Ph.D.; Scientific Review Officer; Center for property such as patentable material, Services, is contemplating the grant of a Scientific Review; National Institutes of and personal information concerning co-exclusive patent license to practice Health; 6701 Rockledge Drive, Room 3164, the inventions embodied in U.S. Patent MSC 7770; Bethesda, MD 20892; (301) 806– individuals associated with the grant applications, the disclosure of which Application No. 13/580,571 filed 22 0009; brontetinkewjm@csr.nih.gov. August, 2012 and entitled ‘‘Biomarkers Name of Committee: Surgical Sciences, would constitute a clearly unwarranted invasion of personal privacy. for Acute Ischemic Stroke’’ [HHS Ref. Biomedical Imaging and Bioengineering No. E–023–2010/0–US–03] to CereDx, Integrated Review Group; Clinical Molecular Name of Committee: National Institute of Imaging and Probe Development. Inc., which is located in West Virginia. Allergy and Infectious Diseases Special The patent rights in this invention have Date: October 5–6, 2015. Emphasis Panel; NIAID Investigator Initiated Time: 8:00 a.m. to 5:00 p.m. Program Project Applications (P01). been assigned to the United States of Agenda: To review and evaluate grant Date: September 28, 2015. America. applications. Time: 10:00 a.m. to 5:00 p.m. The prospective co-exclusive license Place: Hilton Alexandria Mark Center; Agenda: To review and evaluate grant territory may be worldwide and the 5000 Seminary Road; Alexandria, VA 22311. applications. field of use may be limited to the use Contact Person: David L Williams, Ph.D.; Place: National Institutes of Health, Room of the diagnostics of ischemic stroke. Scientific Review Officer; Center for 3C100, 5601 Fishers Lane, Rockville, MD mstockstill on DSK4VPTVN1PROD with NOTICES DATES: Only written comments and/or Scientific Review; National Institutes of 20892, (Telephone Conference Call). Health; 6701 Rockledge Drive, Room 5110, applications for a license which are Contact Person: Zhuqing (Charlie) Li, received by the NIH Office of MSC 7854; Bethesda, MD 20892; (301)435– Ph.D., Scientific Review Officer, Scientific 1174; williamsdl2@csr.nih.gov. Review Program, Division of Extramural Technology Transfer on or before Name of Committee: Center for Scientific Activities, Room # 3G41B, National Institutes October 2, 2015 will be considered. This Review Special Emphasis Panel; of Health/NIAID, 5601 Fishers Lane, notice updates the Federal Register Development and Application of PET and MSC9823, Bethesda, MD 20892–9823, (240) Notice published in 80 FR 28633, SPECT Imaging Ligands as Biomarkers for 669–5068, zhuqing.li@nih.gov. Tuesday May 19, 2015. VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1

53164 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices ADDRESSES: Requests for copies of the DEPARTMENT OF HEALTH AND National Institute of Drug Abuse, the patent application, inquiries, comments, HUMAN SERVICES National Institutes of Health (NIH) will and other materials relating to the publish periodic summaries of proposed contemplated co-exclusive license National Institutes of Health projects to be submitted to the Office of should be directed to: Uri Reichman, Management and Budget (OMB) for Ph.D., MBA, Licensing and Patenting National Institute of Allergy and review and approval. Manager, Office of Technology Transfer, Infectious Diseases; Notice of Closed Written comments and/or suggestions National Institutes of Health, 6011 Meeting from the public and affected agencies Executive Boulevard, Suite 325, Pursuant to section 10(d) of the are invited to address one or more of the Rockville, MD 20852–3804. Telephone: Federal Advisory Committee Act, as following points: (1) Whether the (301) 435–4616; Facsimile: (301) 402– amended (5 U.S.C. App.), notice is proposed collection of information is 0220; Email: reichmau@mail.nih.gov. hereby given of the following meeting. necessary for the proper performance of The meeting will be closed to the the function of the agency, including SUPPLEMENTARY INFORMATION: This whether the information will have technology is directed to gene public in accordance with the provisions set forth in sections practical utility; (2) The accuracy of the biomarkers for the diagnosis and agency’s estimate of the burden of the potential treatment of acute ischemic 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and proposed collection of information, stroke. Stroke is the third leading cause including the validity of the of death in the United States, of which the discussions could disclose methodology and assumptions used; (3) 87% are ischemic stroke and result in confidential trade secrets or commercial The quality, utility, and clarity of the death within 30 days in 8–12% of the property such as patentable material, information to be collected; and (4) cases. Currently, recombinant tissue and personal information concerning Minimize the burden of the collection of plasminogen activator (rtPA, trade name individuals associated with the contract information on those who are to alteplase), is the only FDA approved proposals, the disclosure of which respond, including the use of ischemic stroke treatment, and it is only would constitute a clearly unwarranted appropriate automated, electronic, effective when administered to patients invasion of personal privacy. mechanical, or other technological within three hours from the onset of Name of Committee: National Institute of collection techniques or other forms of symptoms. Unfortunately, the median Allergy and Infectious Diseases Special information technology. time from stroke symptom onset to Emphasis Panel; Microbiology and Infectious To Submit Comments and for Further Diseases Biological Resource Repository Information: To obtain a copy of the presentation to the emergency (MID–BRR). department is 3–6 hours. Although data collection plans and instruments, Date: September 25, 2015. advances in neuroimaging and clinical Time: 8:30 a.m. to 12:00 p.m. submit comments in writing, or request management have helped with patient Agenda: To review and evaluate contract more information on the proposed survival rates, these techniques are not proposals. project, contact: Albert Avila, Ph.D., infallible and at times result in Place: National Institutes of Health; Room Director, Office of Diversity and Health misdiagnosis. The biomarkers identified 2C100; 5601 Fishers Lane; Rockville, MD Disparities, NIDA, NIH, 6001 Executive in this technology may be used to 20892; (Telephone Conference Call). Blvd., Room 3106, Rockville, MD 20852, develop a diagnostic testing device for Contact Person: Annie Walker-Abbey; or call non-toll-free number (301) 443– Scientific Review Officer; Scientific Review 0441 or Email your request, including determining stroke subtype in the field. Program; NIAID/NIH/DHHS; 5601 Fishers your address to: aavila@nida.nih.gov. The prospective co-exclusive license Lane, Room 3E70A; Rockville, MD 20852; Formal requests for additional plans and will be royalty bearing and will comply 240–627–3390; aabbey@niaid.nih.gov. instruments must be requested in with the terms and conditions of 35 (Catalogue of Federal Domestic Assistance writing. U.S.C. 209 and 37 CFR part 404. The Program Nos. 93.855, Allergy, Immunology, Comment Due Date: Comments prospective co-exclusive license may be and Transplantation Research; 93.856, Microbiology and Infectious Diseases regarding this information collection are granted unless within thirty (30) days best assured of having their full effect if from the date of this published notice, Research, National Institutes of Health, HHS) received within 60 days of the date of the NIH receives written evidence and Dated: August 27, 2015. this publication. argument that establishes that the grant David Clary, Proposed Collection: NIDA Summer of the license would not be consistent Program Analyst, Office of Federal Advisory Research Internship Program, 0925– with the requirements of 35 U.S.C. 209 Committee Policy. NEW, National Institute on Drug Abuse, and 37 CFR part 404. [FR Doc. 2015–21703 Filed 9–1–15; 8:45 am] NIDA, National Institutes of Health Applications for a license in the field BILLING CODE 4140–01–P (NIH). of use filed in response to this notice Need and Use of Information will be treated as objections to the grant Collection: The NIDA Summer Research of the contemplated co-exclusive DEPARTMENT OF HEALTH AND Internship program introduces high license. Comments and objections HUMAN SERVICES school and undergraduate students of submitted to this notice will not be underrepresented populations to made available for public inspection National Institutes of Health substance abuse research through and, to the extent permitted by law, will Proposed Collection; 60-Day Comment internships with NIDA grantees at not be released under the Freedom of Request; Application Forms for the universities across the United States and mstockstill on DSK4VPTVN1PROD with NOTICES Information Act, 5 U.S.C. 552. NIDA Summer Research Internship Puerto Rico. Students intern with NIDA Program (NIDA) principal investigators for 8–10 weeks Dated: August 28, 2015. during the summer. The internship Richard U. Rodriguez, SUMMARY: In compliance with the experience may include laboratory Acting Director, Office of Technology requirement of Section 3506(c)(2)(A) of experiments, formal courses, data Transfer, National Institutes of Health. the Paperwork Reduction Act of 1995, collection, data analysis, patient [FR Doc. 2015–21718 Filed 9–1–15; 8:45 am] for opportunity for public comment on recruitment, manuscript preparation, BILLING CODE 4140–01–P proposed data collection projects, the literature reviews and library research. VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1


Document Created: 2018-02-26 10:10:38
Document Modified: 2018-02-26 10:10:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly 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.
FR Citation80 FR 53163 
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