Government-Owned Inventions; Availability for Licensing, 48319-48320 [2018-20664]
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amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices
would benefit from harmonization,
consistency, clarity, simplification, and/
or coordination.
The SACHRP meeting will open to the
public at 8:30 a.m., on Tuesday, October
16, 2018, followed by opening remarks
from Dr. Jerry Menikoff, Director of
OHRP and Dr. Stephen Rosenfeld,
SACHRP Chair.
The SAS and SOH subcommittees
will present their recommendations
regarding the description of ‘‘key
information,’’ as required by the revised
Common Rule at § 46.116(a)(5)(i). This
will be followed by a discussion of
recommendations of the interpretation
of the revised Common Rule’s
exemptions § 46.104(d)(1) and (2) for
HHS funded research. Lastly, the
committee will continue its July
discussions on the Office of Inspector
General Report, July 7, 2017: ‘‘OHRP
Generally Conducted Its Compliance
Activities Independently, But Changes
Would Strengthen Its Independence.’’
The Wednesday, October 17, meeting
will begin at 8:30 a.m. The SAS
subcommittee will present and discuss
recommendations on the interpretation
of ‘‘reasonably available’’ at § 46.408(b),
as well as discuss issues surrounding
payment of subjects for participation in
research. Modifications to the previous
day’s work will be discussed and
finalized. The meeting will adjourn at
approximately 4:00 p.m., October 17,
2018.
Time for public comment sessions
will be allotted both days. On-site
registration is required for participation
in the live public comment session.
Note that public comment must be
relevant to topics currently being
addressed by the SACHRP. Individuals
submitting written statements as public
comment should email or fax their
comments to SACHRP at SACHRP@
hhs.gov at least five business days prior
to the meeting.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify one of
the designated SACHRP points of
contact at the address/phone number
listed above at least one week prior to
the meeting.
Dated: September 14, 2018.
Julia G. Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2018–20676 Filed 9–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meetings
48319
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: September 18, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–20666 Filed 9–21–18; 8:45 am]
BILLING CODE 4140–01–P
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: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; T32
Institutional Training Grants.
Date: October 10, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Nakia C. Brown, Ph.D.,
Scientific Review Officer, 6701 Democracy
Blvd., RM 816, Bethesda, MD 20892, 301–
827–4905, brownnac@mail.nih.gov.
Name of Committee: Arthritis and
Musculoskeletal and Skin Diseases Initial
Review Group; Arthritis and Musculoskeletal
and Skin Diseases Clinical Trials Review
Committee.
Date: October 16–17, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn, 7301 Waverly
Street, Bethesda, MD 20814.
Contact Person: Nakia C. Brown, Ph.D.,
NIAMS/Scientific Review Officer, 6701
Democracy Blvd., RM 816, Bethesda, MD
20892, 301–827–4905, brownnac@
mail.nih.gov.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; AMSC
Member Conflict.
Date: October 29, 2018.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Democracy One, 6701 Democracy
Blvd., Bethesda, MD 20892.
Contact Person: Yasuko Furumoto, Ph.D.,
NIAMS/Scientific Review Officer, 6701
Democracy Blvd., RM 816, Bethesda, MD
20892, 301–451–6520, yasuko.furumoto@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Yogikala Prabhu, Ph.D., 301–761–7789;
prabhuyo@niaid.nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
A New Class of Immunomodulatory
Drugs for Multiple Sclerosis
Description of Technology: Multiple
sclerosis (MS) is an autoimmune disease
caused by activated autoimmune T
lymphocytes in patients resulting in
inflammatory demyelination in the
central nervous system. Current
treatments are focused on functional
control of these activated autoimmune T
cells, but these treatments are nonspecific T cell inhibitors and have
serious, sometimes fatal side effects. A
specific therapy aimed at eliminating
these autoimmune T cells through
restimulation-induced cell death (RICD)
could cure the disease and overcome the
fatal side effects of current therapies.
E:\FR\FM\24SEN1.SGM
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48320
Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices
NIAID inventors have identified a multivalent tolerogen (MMPt), which can
specifically elicit RICD of the activated,
disease causing autoimmune T cells
without compromising the general T
cell-dependent immunity in the host.
Animal studies have demonstrated that
MMPt exerts robust therapeutic effects
on both monophasic as well as
relapsing-remitting type of the disease,
indicating its medical applicability for
treating MS patients with active disease.
NIAID is seeking partners to develop
this multi-valent peptide to improve its
efficacy for use in clinical trials.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications:
• Therapeutics
Competitive Advantages:
• Tolerogen induced elimination of
activated autoimmune T cells will
overcome the fatal side effects of
current therapies
• Treatment of all types of MS patients
Development Stage:
amozie on DSK3GDR082PROD with NOTICES1
• Preclinical (In vitro and in vivo
animal studies)
Inventors: Dr. Michael J. Lenardo
(NIAID), Dr. Lixin Zheng (NIAID), Dr.
Jian Li (NIAID), Dr. Jae Lee (NIAID), and
Dr. Wei Lu (NIAID).
Intellectual Property: HHS Reference
No. E–064–2015, U.S. Provisional Patent
Application Numbers: 62/130,285 filed
March 9, 2015 and 62/219,851 filed
September 17, 2015, and US PCT
application PCT/US2016/021571 filed
on March 9, 2016. Entered National
Stage filing in US, EU, Canada, and
Australia.
Licensing Contact: Yogikala Prabhu,
Ph.D., 301–761–7789; prabhuyo@
niaid.nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize the MMPt peptide to
improve its efficacy for use in clinical
trials.
For collaboration opportunities,
please contact Yogikala Prabhu, Ph.D.,
301–761–7789; prabhuyo@
niaid.nih.gov.
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Dated: September 18, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–20664 Filed 9–21–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee on
Research on Women’s Health.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
will also be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://
videocast.nih.gov/).
Name of Committee: Advisory Committee
on Research on Women’s Health.
Date: October 23, 2018.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: Opening Remarks, Director’s
Report, Scientific Presentations, ORWH
SCORE Program Update, and Strategic Plan
Launch.
Place: National Institutes of Health,
Building 31, 6th Floor, Conference Room 10,
31 Center Drive, Bethesda, MD 20892.
Contact Person: Elizabeth Spencer, R.N.,
Deputy Director, Office of Research on
Women’s Health, Executive Secretary,
ACRWH, National Institutes of Health, 6707
Democracy Blvd., Room 7W444, Bethesda,
MD 20817, 301–402–1770,
elizabeth.spencer@nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
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business or professional affiliation of the
interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
orwh.od.nih.gov/, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: September 18, 2018.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–20665 Filed 9–21–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the NIH Clinical Center
Research Hospital Board.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: NIH Clinical Center
Research Hospital Board.
Date: October 19, 2018.
Time: 9:00 a.m. to 3:25 p.m.
Agenda: Discussion of Patient Safety.
Place: National Institutes of Health,
Building 31, 6th Floor, Room: 6C6, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Gretchen Wood, Staff
Assistant, Office of the Director, National
Institutes of Health, One Center Drive,
Building 1, Bethesda, MD 20892, 301–496–
4272, woodgs@nih.gov.
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]]>Agencies
[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48319-48320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20664]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The invention listed below is owned by an agency of the U.S.
Government and is available for licensing to achieve expeditious
commercialization of results of federally-funded research and
development. Foreign patent applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
FOR FURTHER INFORMATION CONTACT: Yogikala Prabhu, Ph.D., 301-761-7789;
[email protected]. Licensing information and copies of the patent
applications listed below may be obtained by communicating with the
indicated licensing contact at the Technology Transfer and Intellectual
Property Office, National Institute of Allergy and Infectious Diseases,
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed
Confidential Disclosure Agreement will be required to receive copies of
unpublished patent applications.
SUPPLEMENTARY INFORMATION: Technology description follows.
A New Class of Immunomodulatory Drugs for Multiple Sclerosis
Description of Technology: Multiple sclerosis (MS) is an autoimmune
disease caused by activated autoimmune T lymphocytes in patients
resulting in inflammatory demyelination in the central nervous system.
Current treatments are focused on functional control of these activated
autoimmune T cells, but these treatments are non-specific T cell
inhibitors and have serious, sometimes fatal side effects. A specific
therapy aimed at eliminating these autoimmune T cells through
restimulation-induced cell death (RICD) could cure the disease and
overcome the fatal side effects of current therapies.
[[Page 48320]]
NIAID inventors have identified a multi-valent tolerogen (MMPt), which
can specifically elicit RICD of the activated, disease causing
autoimmune T cells without compromising the general T cell-dependent
immunity in the host. Animal studies have demonstrated that MMPt exerts
robust therapeutic effects on both monophasic as well as relapsing-
remitting type of the disease, indicating its medical applicability for
treating MS patients with active disease. NIAID is seeking partners to
develop this multi-valent peptide to improve its efficacy for use in
clinical trials.
This technology is available for licensing for commercial
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as
well as for further development and evaluation under a research
collaboration.
Potential Commercial Applications:
Therapeutics
Competitive Advantages:
Tolerogen induced elimination of activated autoimmune T cells
will overcome the fatal side effects of current therapies
Treatment of all types of MS patients
Development Stage:
Preclinical (In vitro and in vivo animal studies)
Inventors: Dr. Michael J. Lenardo (NIAID), Dr. Lixin Zheng (NIAID),
Dr. Jian Li (NIAID), Dr. Jae Lee (NIAID), and Dr. Wei Lu (NIAID).
Intellectual Property: HHS Reference No. E-064-2015, U.S.
Provisional Patent Application Numbers: 62/130,285 filed March 9, 2015
and 62/219,851 filed September 17, 2015, and US PCT application PCT/
US2016/021571 filed on March 9, 2016. Entered National Stage filing in
US, EU, Canada, and Australia.
Licensing Contact: Yogikala Prabhu, Ph.D., 301-761-7789;
[email protected].
Collaborative Research Opportunity: The National Institute of
Allergy and Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate or commercialize the MMPt peptide to improve its
efficacy for use in clinical trials.
For collaboration opportunities, please contact Yogikala Prabhu,
Ph.D., 301-761-7789; [email protected].
Dated: September 18, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-20664 Filed 9-21-18; 8:45 am]
BILLING CODE 4140-01-P
