Government-Owned Inventions; Availability for Licensing

CourtNational Institutes Of Health
Citation86 FR 60894
Record Number2021-24028
Published date04 November 2021
60894
Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices
and Hematology Research, National Institutes
of Health, HHS)
Dated: October 29, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–24029 Filed 11–3–21; 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
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; PAR Panel:
Fogarty HIV Research Training Program for
Low- and Middle-Income Country
Institutions.
Date: December 2–3, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maureen Shuh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–480–4097,
maureen.shuh@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Genes, Genomes and Genetics.
Date: December 6, 2021.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Elena Smirnova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5187,
MSC 7840, Bethesda, MD 20892, 301–357–
9112, smirnove@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics
Focused on Alzheimer’s Disease and
Alzheimer’s-Related Dementia.
Date: December 7–8, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Tara Roshell Earl, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1007C,
Bethesda, MD 20892, (301) 451–3946, earltr@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Respiratory Sciences.
Date: December 13–14, 2021.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ghenima Dirami, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4122,
MSC 7814, Bethesda, MD 20892, (240) 498–
7546, diramig@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: October 31, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–24053 Filed 11–3–21; 8:45 am]
BILLING CODE 4140–01–P
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
:
Peter Soukas, J.D., 301–496–2644;
peter.soukas@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.
Recombinant Chimeric Bovine/Human
Parainfluenza Virus 3 Expressing
SARS–CoV–2 Spike Protein and Its Use
Description of Technology
Vaccines for SARS–CoV–2 are
increasingly available under emergency
use authorizations; however, indications
are currently limited to individuals
twelve (12) years or older. They also
involve intramuscular immunization,
which does not directly stimulate local
immunity in the respiratory tract, the
primary site of SARS–CoV–2 infection,
shedding and spread. While the major
burden of COVID–19 disease is in
adults, infection and disease also occur
in infants and young children,
contributing to viral transmission.
Therefore, the development of safe and
effective pediatric COVID–19 vaccines
is important. Ideally, a vaccine should
be effective as a single dose, should
induce mucosal immunity with the
ability to restrict SARS–CoV–2 infection
and respiratory shedding, and should
easily coordinate with vaccines for other
illnesses, such as HPIV3.
The live-attenuated vaccine
candidates are based on a recombinant
chimeric bovine/human parainfluenza
virus 3 (rB/HPIV3) vector expressing
prefusion-stabilized versions of the
Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS–CoV–2) Spike (S)
protein. The B/HPIV3–SARS CoV–2
vaccine candidates are designed to be
administered intranasally by drops or
spray to infants and young children.
The vaccines are expected to induce
durable and broad systemic and
respiratory mucosal immunity against
SARS–CoV–2 and HPIV3.
Immunogenicity and protective efficacy
against SARS–CoV–2 challenge was
confirmed in experimental animals
including non-human primates. Based
on experience with this B/HPIV3
platform and other live-attenuated PIV
vaccine candidates in previous pediatric
clinical studies, the present candidates
are anticipated to be well-tolerated in
humans, including infants and young
children, and are available for clinical
evaluation. The National Institute of
Allergy and Infectious Diseases has
extensive experience and capability in
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60895
Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices
evaluating live-attenuated respiratory
virus vaccine candidates in pediatric
clinical studies, including PIV vaccine
candidates, and opportunity for
collaboration exists.
This technology is available for
nonexclusive 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
Viral diagnostics
Vaccine research
Competitive Advantages
Ease of manufacture
B cell and T cell activation
Low-cost vaccines
Intranasal administration/needle-
free delivery
Development Stage
In vivo data assessment (animal)
Inventors: Ursula Buchholz (NIAID),
Shirin Munir (NIAD), Cyril Le Nouen
(NIAID), Xueqiao Liu (NIAID), Cindy
Luongo (NIAID), Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–239–2020–0—U.S. Provisional
Application No. 63/180,534, filed April
27, 2021.
Licensing Contact: Peter Soukas, J.D.,
301–496–2644; peter.soukas@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 for development of a
vaccine for respiratory or other
infections. For collaboration
opportunities, please contact Peter
Soukas, J.D., 301–496–2644;
peter.soukas@nih.gov.
Dated: October 29, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–24028 Filed 11–3–21; 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
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: Risk Prevention and Health
Behavior.
Date: November 30, 2021.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Pamela Jeter, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 10J08,
Bethesda, MD 20892, (301) 435–2591,
pamela.jeter@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–19–
222: Small Grants for New Investigators to
Promote Diversity in Health-Related Research
(R21 Clinical Trial Optional).
Date: December 6, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jonathan K. Ivins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2190,
MSC 7850, Bethesda, MD 20892, (301) 594–
1245, ivinsj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuropharmacology and
Physiology.
Date: December 8, 2021.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Christine Jean DiDonato,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1014J,
Bethesda, MD 20892, (301) 435–1042,
didonatocj@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: October 29, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–24027 Filed 11–3–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
meeting of the Biomedical Informatics,
Library and Data Sciences Review
Committee.
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 grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
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: Biomedical
Informatics, Library and Data Sciences
Review Committee (BILDS).
Date: March 3, 2022.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Contact Person: Zoe E. Huang, MD, Chief
Scientific Review Officer, Scientific Review
Office, Extramural Programs, National
Library of Medicine, National Institutes of
Health (NIH), 6705 Rockledge Drive, Suite
500, Bethesda, MD 20892–7968, 301–594–
4937, huangz@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: October 29, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–24033 Filed 11–3–21; 8:45 am]
BILLING CODE 4140–01–P
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