Prospective Grant of Exclusive Patent License: Magnetic Resonance Imaging System and Method for the Measurement of Geometric Features of Axons (Including Without Limitation Diameter, Radius, Perimeter, Volume, Surface and Angle) for the Characterization and Diagnosis of Central Nervous System Diseases and Disorders, 11765-11766 [2018-05311]

Download as PDF 11765 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Type of respondents based on applicable section of regulation Average time per response (in hours) Frequency of responses Number of respondents Total annual burden hour Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4). Public Website Posting under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) from awardee Institutions. Under 42 CFR 50.606(c) or 45 CFR 94.6(c). 950 ................................................................. 1 12 11,400 2,000 .............................................................. 1 5 10,000 50 9 ................................................................. 3 10 18/60 45 Total .................................................. 136,143 .......................................................... 136,243 ........................ 677,295 4 Assuming that 3,000 Institutions solicit disclosures on an annual basis by sending a notification to all Investigators. an estimated 950 reports of Conflict of Interest are expected annually, the 2,000 responding Institutions must review all financial disclosures associated with PHS-funded awards to determine whether any conflicts of interest exist. Thus, the review burden of 76,000 hours is based upon estimates that it will take on the average 2 hours for an institutional official(s) to review each of 38,000 financial disclosures associated with PHS funded awards. The burden for developing a management plan for identified FCOI is estimated at 80 hours × 950 cases = 76,000 hours. 6 Assuming that this is a rare occurrence based on prior experience. 7 Assuming only a fraction of the newly identified SFIs will constitute FCOI. 8 Assuming only a fraction of the newly identified SFIs will constitute FCOI. 9 Number based on 50.605/94.5(a)(3)(i)—of those only a fraction will relate to a project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, but we are calculating the maximum estimated burden. 10 Assuming an average of 3 publications annually. 5 Although Dated: March 10, 2018. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2018–05384 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings daltland on DSKBBV9HB2PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: BTSS and SAT. Date: March 26, 2018. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Guo Feng Xu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 Health, 6701 Rockledge Drive, Room 5122, MSC 7854, Bethesda, MD 20892, 301–237– 9870, xuguofen@csr.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: Center for Scientific Review Special Emphasis Panel; PAR–17– 086/7: Tobacco Use and HIV in Low and Middle-Income Countries. Date: March 28, 2018. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Mark P. Rubert, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1775, rubertm@csr.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. (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: March 12, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–05307 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Magnetic Resonance Imaging System and Method for the Measurement of Geometric Features of Axons (Including Without Limitation Diameter, Radius, Perimeter, Volume, Surface and Angle) for the Characterization and Diagnosis of Central Nervous System Diseases and Disorders AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Brainvivo Ltd. (Brainvivo), located in Tel Aviv, Israel, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice. DATES: Only written comments and/or complete applications for a license which are received by the NCI Technology Transfer Center on or before April 2, 2018 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Surekha Vathyam, Ph.D., SUMMARY: E:\FR\FM\16MRN1.SGM 16MRN1 11766 Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702 Telephone: (240)-276–5530; Email: vathyams@mail.nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: • United States Provisional Patent Application No. 60/485,658, filed July 8, 2003, titled ‘‘Diffusion Tensor and Q-Space MRI Specimen Characterization’’ [HHS Reference No. E–079–2003/0–US–01], status: expired; • United States Provisional Patent Application No. 60/571,064, filed May 14, 2004, titled ‘‘Diffusion Tensor and Q-Space MRI Specimen Characterization’’ [HHS Reference No. E–079–2003/0–US–04], status: expired; • United States Patent Application No. 10/888,917, filed July 8, 2004, titled ‘‘Diffusion Tensor and Q-Space MRI Specimen Characterization’’ [HHS Reference No. E–079–2003/0–US–02], status: issued as Patent No. 7,643,863; • International Patent Application No. PCT/US2004/22027, July 8, 2004, titled ‘‘Diffusion Tensor and Q-Space MRI Specimen Characterization’’ [HHS Reference No. E–079–2003/0–PCT–03], status: expired; and • United States Patent Application No. 12/114,713, filed May 2, 2008, titled ‘‘Non-Invasive in vivo MRI Axon Diameter Measurement Methods’’ [HHS Reference No. E–079–2003/1–US–01], status: issued as Patent No. 8,380,280. With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America. The prospective Exclusive Patent License territory may be worldwide for the following field of use: daltland on DSKBBV9HB2PROD with NOTICES ‘‘Magnetic Resonance Imaging system and method for the measurement of geometric features of axons (including without limitation diameter, radius, perimeter, volume, surface and angle) for the characterization and diagnosis of Central Nervous System diseases and disorders.’’ A non-invasive, painless means for measuring axon diameter distribution (ADD) is disclosed in the intellectual property to be licensed, which has significance for imaging of the central nervous system, and for in vivo measurement of microanatomical (histological) features of nerves that are critically important in medicine, particularly, in neuroscience. ADD is VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 altered in abnormal development (possibly even in autism), in degenerative process (e.g., aging, alcoholism, Alzheimer’s disease) and diseases such as ALS (Lou Gehrig’s disease). The invention provides a painless way to measure microanatomical features previously measurable using invasive histological means requiring biopsy. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute 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. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice must be complete and in acceptable form by the expiration date of this Notice to be considered for a license. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: March 7, 2018. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2018–05311 Filed 3–15–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2018–0002; Internal Agency Docket No. FEMA–B–1812] Changes in Flood Hazard Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood SUMMARY: PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals. DATES: These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities. From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period. ADDRESSES: The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https:// msc.fema.gov for comparison. Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below. FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Map Information eXchange (FMIX) online at https:// www.floodmaps.fema.gov/fhm/fmx_ main.html. E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11765-11766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05311]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Magnetic Resonance 
Imaging System and Method for the Measurement of Geometric Features of 
Axons (Including Without Limitation Diameter, Radius, Perimeter, 
Volume, Surface and Angle) for the Characterization and Diagnosis of 
Central Nervous System Diseases and Disorders

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The Eunice Kennedy Shriver National Institute for Child Health 
and Human Development (NICHD), an institute of the National Institutes 
of Health, Department of Health and Human Services, is contemplating 
the grant of an Exclusive Patent License to Brainvivo Ltd. (Brainvivo), 
located in Tel Aviv, Israel, to practice the inventions embodied in the 
patent applications listed in the Supplementary Information section of 
this notice.

DATES: Only written comments and/or complete applications for a license 
which are received by the NCI Technology Transfer Center on or before 
April 2, 2018 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Surekha Vathyam, Ph.D.,

[[Page 11766]]

Senior Technology Transfer Manager, NCI Technology Transfer Center, 
9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 
(for business mail), Rockville, MD 20850-9702 Telephone: (240)-276-
5530; Email: [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement:
     United States Provisional Patent Application No. 60/
485,658, filed July 8, 2003, titled ``Diffusion Tensor and Q-Space MRI 
Specimen Characterization'' [HHS Reference No. E-079-2003/0-US-01], 
status: expired;
     United States Provisional Patent Application No. 60/
571,064, filed May 14, 2004, titled ``Diffusion Tensor and Q-Space MRI 
Specimen Characterization'' [HHS Reference No. E-079-2003/0-US-04], 
status: expired;
     United States Patent Application No. 10/888,917, filed 
July 8, 2004, titled ``Diffusion Tensor and Q-Space MRI Specimen 
Characterization'' [HHS Reference No. E-079-2003/0-US-02], status: 
issued as Patent No. 7,643,863;
     International Patent Application No. PCT/US2004/22027, 
July 8, 2004, titled ``Diffusion Tensor and Q-Space MRI Specimen 
Characterization'' [HHS Reference No. E-079-2003/0-PCT-03], status: 
expired; and
     United States Patent Application No. 12/114,713, filed May 
2, 2008, titled ``Non-Invasive in vivo MRI Axon Diameter Measurement 
Methods'' [HHS Reference No. E-079-2003/1-US-01], status: issued as 
Patent No. 8,380,280.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
for the following field of use:

    ``Magnetic Resonance Imaging system and method for the 
measurement of geometric features of axons (including without 
limitation diameter, radius, perimeter, volume, surface and angle) 
for the characterization and diagnosis of Central Nervous System 
diseases and disorders.''

    A non-invasive, painless means for measuring axon diameter 
distribution (ADD) is disclosed in the intellectual property to be 
licensed, which has significance for imaging of the central nervous 
system, and for in vivo measurement of microanatomical (histological) 
features of nerves that are critically important in medicine, 
particularly, in neuroscience. ADD is altered in abnormal development 
(possibly even in autism), in degenerative process (e.g., aging, 
alcoholism, Alzheimer's disease) and diseases such as ALS (Lou Gehrig's 
disease). The invention provides a painless way to measure 
microanatomical features previously measurable using invasive 
histological means requiring biopsy.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective Exclusive Patent License will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the National Cancer Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
completed license application, will not be treated confidentially, and 
may be made publicly available.
    License applications submitted in response to this Notice must be 
complete and in acceptable form by the expiration date of this Notice 
to be considered for a license. License applications submitted in 
response to this Notice will be presumed to contain business 
confidential information and any release of information in these 
license applications will be made only as required and upon a request 
under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: March 7, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2018-05311 Filed 3-15-18; 8:45 am]
 BILLING CODE 4140-01-P

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