83 FR 11765 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 52 (March 16, 2018)

Page Range		11765-11766
FR Document		2018-05311

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.

Federal Register, Volume 83 Issue 52 (Friday, March 16, 2018)

[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Pages 11765-11766]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05311]


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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.

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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

Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11765

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average time
Type of respondents based on applicable Frequency of Total annual
Number of respondents per response
section of regulation responses burden hour
(in hours)

Under 42 CFR 50.605(a)(4) or 45 CFR 950 ................................................................. 1 12 11,400
94.5(a)(4).
Public Website Posting under 42 CFR 2,000 .............................................................. 1 5 10,000
50.605(a)(5) or 45 CFR 94.5(a)(5)
from awardee Institutions.
Under 42 CFR 50.606(c) or 45 CFR 50 9 ................................................................. 3 10 18/60 45
94.6(c).

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.
5 Although an estimated 950 reports of Conflict of Interest are expected annually, the 2,000 responding Institutions must review all financial dis-
closures 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 associ-
ated 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.

Dated: March 10, 2018. Health, 6701 Rockledge Drive, Room 5122, DEPARTMENT OF HEALTH AND
Lawrence A. Tabak, MSC 7854, Bethesda, MD 20892, 301–237– HUMAN SERVICES
Deputy Director, National Institutes of Health. 9870, xuguofen@csr.nih.gov.
[FR Doc. 2018–05384 Filed 3–15–18; 8:45 am] This notice is being published less than 15 National Institutes of Health
BILLING CODE 4140–01–P days prior to the meeting due to the timing
limitations imposed by the review and Prospective Grant of Exclusive Patent
funding cycle. License: Magnetic Resonance Imaging
DEPARTMENT OF HEALTH AND System and Method for the
Name of Committee: Center for Scientific
HUMAN SERVICES Review Special Emphasis Panel; PAR–17–
Measurement of Geometric Features of
086/7: Tobacco Use and HIV in Low and
Axons (Including Without Limitation
National Institutes of Health Middle-Income Countries.
Diameter, Radius, Perimeter, Volume,
Date: March 28, 2018. Surface and Angle) for the
Center for Scientific Review; Notice of Characterization and Diagnosis of
Time: 11:00 a.m. to 2:00 p.m.
Closed Meetings Agenda: To review and evaluate grant Central Nervous System Diseases and
Pursuant to section 10(d) of the applications. Disorders
Federal Advisory Committee Act, as Place: National Institutes of Health, 6701 AGENCY: National Institutes of Health,
amended, notice is hereby given of the Rockledge Drive, Bethesda, MD 20892 HHS.
following meetings. (Virtual Meeting).
ACTION: Notice.
The meetings will be closed to the Contact Person: Mark P. Rubert, Ph.D.,
public in accordance with the Scientific Review Officer, Center for SUMMARY: The Eunice Kennedy Shriver
provisions set forth in sections Scientific Review, National Institutes of National Institute for Child Health and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Health, 6701 Rockledge Drive, Room 5218,
Human Development (NICHD), an
as amended. The grant applications and MSC 7852, Bethesda, MD 20892, 301–435–
institute of the National Institutes of
the discussions could disclose 1775, rubertm@csr.nih.gov.
Health, Department of Health and
confidential trade secrets or commercial This notice is being published less than 15 Human Services, is contemplating the
property such as patentable material, days prior to the meeting due to the timing grant of an Exclusive Patent License to
and personal information concerning limitations imposed by the review and Brainvivo Ltd. (Brainvivo), located in
individuals associated with the grant funding cycle. Tel Aviv, Israel, to practice the
applications, the disclosure of which (Catalogue of Federal Domestic Assistance inventions embodied in the patent
would constitute a clearly unwarranted Program Nos. 93.306, Comparative Medicine; applications listed in the
invasion of personal privacy. 93.333, Clinical Research, 93.306, 93.333, Supplementary Information section of
Name of Committee: Center for Scientific 93.337, 93.393–93.396, 93.837–93.844, this notice.
Review Special Emphasis Panel; Member 93.846–93.878, 93.892, 93.893, National
DATES: Only written comments and/or
Conflict: BTSS and SAT. Institutes of Health, HHS)
Date: March 26, 2018. complete applications for a license
Time: 2:00 p.m. to 4:00 p.m. Dated: March 12, 2018. which are received by the NCI
daltland on DSKBBV9HB2PROD with NOTICES

Agenda: To review and evaluate grant Melanie J. Pantoja, Technology Transfer Center on or before
applications. Program Analyst, Office of Federal Advisory April 2, 2018 will be considered.
Place: National Institutes of Health, 6701
Committee Policy. ADDRESSES: Requests for copies of the
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call). [FR Doc. 2018–05307 Filed 3–15–18; 8:45 am] patent applications, inquiries, and
Contact Person: Guo Feng Xu, Ph.D., BILLING CODE 4140–01–P comments relating to the contemplated
Scientific Review Officer, Center for Exclusive Patent License should be
Scientific Review, National Institutes of directed to: Surekha Vathyam, Ph.D.,

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Document Created: 2018-03-16 01:12:18
Document Modified: 2018-03-16 01:12:18

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		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.
FR Citation		83 FR 11765

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 52 (March 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health