Prospective Grant of an Exclusive Patent License: Development and Commercialization of Fusion Proteins for the Treatment of Growth Disorders and Diseases of Cartilage Degeneration

CourtNational Institutes Of Health
Citation87 FR 14022
Record Number2022-05140
Published date11 March 2022
14022
Federal Register / Vol. 87, No. 48 / Friday, March 11, 2022 / Notices
SUMMARY
: The Office of the Surgeon
General published a document in the
Federal Register of March 7, 2022,
requesting information regarding the
Impact of Health Information
Misinformation in the Digital
Information Environment in the United
States Throughout the COVID–19
Pandemic. The document included a
hyperlink in which the public will not
be able to access.
FOR FURTHER INFORMATION CONTACT
: Max
Lesko at COVIDMisinfoRFI@hhs.gov or
at (202) 893–5020.
SUPPLEMENTARY INFORMATION
:
Correction
In the Federal Register of March 7,
2022, in FR Doc. 2022–04777, on page
12713, in the third column, correct the
section which reads, ‘‘a. Starting with,
but not limited to, these common
examples of COVID–19 vaccine
misinformation documented by the
Centers for Disease Control and
Prevention (CDC), any aggregate data
and analysis on the prevalence of
COVID–19 misinformation on
individual platforms including exactly
how many users saw or may have been
exposed to instances of COVID–19
misinformation.’’ to read, ‘‘a. Starting
with but not limited to https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/facts.html of COVID–19
vaccine misinformation documented by
the Centers for Disease Control and
Prevention (CDC), any aggregate data
and analysis on the prevalence of
COVID–19 misinformation on
individual platforms including exactly
how many users saw or may have been
exposed to instances of COVID–19
misinformation.’’
Max Lesko,
Chief of Staff, Office of the Surgeon General.
[FR Doc. 2022–05132 Filed 3–10–22; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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 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
Allergy and Infectious Diseases Special
Emphasis Panel; American Women:
Assessing Risk Epidemiologically (AWARE)
(R01 Clinical Trial Optional).
Date: April 5, 2022.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22B,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Kristina S. Wickham,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22B,
Rockville, MD 20852, 301–761–5390,
kristina.wickham@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 7, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–05136 Filed 3–10–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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 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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK Data
Coordinating Center.
Date: April 5, 2022.
Time: 12:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health/NIDDK,
6707 Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Elena Sanovich, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7351, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–8886,
sanoviche@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: March 7, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–05135 Filed 3–10–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Fusion Proteins
for the Treatment of Growth Disorders
and Diseases of Cartilage
Degeneration
AGENCY
: National Institutes of Health,
HHS.
ACTION
: Notice.
SUMMARY
: The Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
Cancer Institute, both institutes of the
National Institutes of Health,
Department of Health and Human
Services, are contemplating the grant of
an Exclusive Patent License to practice
the inventions embodied in the Patents
and Patent Applications listed in the
Supplementary Information section of
this Notice to Cavalry Biosciences, Inc.
of San Francisco, CA.
DATES
: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before March 28, 2022 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: Richard T. Girards, Jr., Esq.,
MBA, Senior Technology Transfer
Manager, National Institutes of Health,
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14023
Federal Register / Vol. 87, No. 48 / Friday, March 11, 2022 / Notices
NCI Technology Transfer Center by
email (richard.girards@nih.gov) or
phone (240–276–6825).
Intellectual Property
E–003–2014: Agents That Specifically
Bind Matrilin-3 and Their Use/Cartilage
Targeting Agents and Their Use
1. United States Provisional Patent
Application No. 61/927,904, filed 15
January 2014 (HHS Reference No. E–
003–2014–0–US–01);
2. United States Patent No.
10,323,083, issued 18 June 2019 (HHS
Reference No. E–003–2014–0–US–06);
3. United States Patent No.
10,954,291, issued 23 March 2021 (HHS
Reference No. E–003–2014–0–US–07);
4. United States Patent Application
No. 17/177,644, filed 17 February 2021
(HHS Reference No. E–003–2014–0–US–
12);
5. International Patent Application
No. PCT/US2015/011433, filed 14
January 2015 (HHS Reference No. E–
003–2014–0–PCT–02);
6. Australia Patent No. 2015206515,
issued 26 March 2020 (HHS Reference
No. E–003–2014–0–AU–03);
7. Canada Patent Application No.
2931005, filed 14 January 2015 (HHS
Reference No. E–003–2014–0–CA–04);
8. European Patent No. 3 094 350 B1,
issued 04 March 2020 (HHS Reference
No. E–003–2014–0–EP–05) and all of its
national validations;
9. European Patent Application No.
19219282.1, filed 14 January 2015 (HHS
Reference No. E–003–2014–0–EP–11);
and
10. any and all other U.S. and ex-U.S.
patents and patent applications
claiming priority to any one of the
foregoing, now or in the future.
The patent and patent application
rights in these inventions have been
assigned and/or exclusively licensed to
the government of the United States of
America.
The prospective exclusive license
territory may be worldwide and the
fields of use may be limited to the
following: The manufacture,
distribution, sale and use of fusion
proteins for the treatment of (a) growth
disorders and (b) diseases of cartilage
degeneration.
These technologies disclose, e.g.,
monoclonal antibodies and antibody
fragments that specifically bind to
matrilin-3, conjugates including these
molecules, and nucleic acid molecules
encoding the antibodies, antigen
binding fragments and conjugates. Also
disclosed are compositions including
the disclosed antibodies, antigen
binding fragments, conjugates, and
nucleic acid molecules. Methods of
treating or inhibiting a cartilage disorder
in a subject, as well as methods of
increasing chondrogenesis in cartilage
tissue are further provided. The
methods can be used, for example, for
treating or inhibiting a growth plate
disorder in a subject, such as a skeletal
dysplasia or short stature.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR 404. The
prospective exclusive license will be
royalty bearing, and the prospective
exclusive license 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 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from 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, 2022.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2022–05140 Filed 3–10–22; 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; Advancing
Gender Inclusive Excellence (AGIE)—
Coordinating Center U54.
Date: April 8, 2022.
Time: 11:00 a.m. to 4:00 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: Shivani Sharma, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, (240) 507–7661,
shivani.sharma@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Initiative Research in Hematology.
Date: April 11, 2022.
Time: 2:00 p.m. to 8:00 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: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Endocrinology, Metabolism,
Nutrition and Reproductive Sciences.
Date: April 14, 2022.
Time: 10:00 a.m. to 8:00 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: Baskaran Thyagarajan,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 800B,
Bethesda, MD 20892, (301) 867–5309,
thyagarajanb2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Virology.
Date: April 15, 2022.
Time: 10:00 a.m. to 7:00 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: Kumud Singh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesa, MD 20892, (301) 761–7830,
kumud.singh@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)
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