Prospective Grant of an Exclusive Patent License: Development, Production, and Commercialization of Ebola Neutralizing Single Monoclonal Antibody for the Treatment of Ebola Virus Disease in Humans, 14331-14332 [2021-05235]
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Federal Register / Vol. 86, No. 48 / Monday, March 15, 2021 / Notices
Dated: March 10, 2021.
Lynette Wilson,
Federal Register Liaison, Department of
Health and Human Services.
Dated: March 9, 2021.
Daniel R Hernandez,
Federal Register Officer, National Institutes
of Health.
[FR Doc. 2021–05322 Filed 3–12–21; 8:45 am]
[FR Doc. 2021–05272 Filed 3–12–21; 8:45 am]
BILLING CODE 4120–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Engineered Tumor
Infiltrating Lymphocytes for Cancer
Therapy; Correction
Prospective Grant of an Exclusive
Patent License: Development,
Production, and Commercialization of
Ebola Neutralizing Single Monoclonal
Antibody for the Treatment of Ebola
Virus Disease in Humans
AGENCY:
National Institutes of Health,
HHS.
ACTION:
AGENCY:
Notice; correction.
The Department of Health and
Human Services, National Institutes of
Health published a Notice in the
Federal Register on February 25, 2021.
That Notice requires a correction in the
SUPPLEMENTARY INFORMATION section.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of February
25, 2021, in FR Doc. 2021–03873, on
page 11548, as found within the
SUPPLEMENTARY INFORMATION section,
correct to read:
khammond on DSKJM1Z7X2PROD with NOTICES
The use of the Licensed Patent Rights to
develop, manufacture, distribute, sell, and
use autologous tumor infiltrating lymphocyte
(TIL) adoptive cell therapy products for the
treatment of metastatic melanoma, lung,
breast, bladder, and HPV-positive cancers.
Specifically excluded from this Agreement
are cell therapy products involving TIL
genetically modified for reactivity against
cancer-specific mutations or TIL selected for
reactivity against cancer-specific mutations,
unless such cell therapy products are a
combination of unselected, unmodified TIL
therapy with the Licensee’s proprietary
technologies or the Licensee’s in-licensed
technologies.
The field of use described in the
Notice was found to be incorrect. The
correction addresses this discrepancy by
accurately stating the field of use which
the NIH intends to grant to Iovance
Biotherapeutics, Inc for the disclosed
federally owned invention.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Telephone: (240)–276–5484; Email:
andy.burke@nih.gov.
VerDate Sep<11>2014
16:36 Mar 12, 2021
National Institutes of Health,
HHS.
Jkt 253001
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. and European Patents and Patent
Applications listed in the
Supplementary Information section of
this Notice to Ridgeback
Biotherapeutics, L.P., located in Miami,
Florida.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Allergy and Infectious Diseases’
Technology Transfer and Intellectual
Property Office on or before March 30,
2021 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: Daniel Lee, J.D., Technology
Transfer and Patent Specialist, National
Institute of Allergy and Infectious
Diseases Technology Transfer and
Intellectual Property Office by email
(daniel.lee5@nih.gov) or phone (301–
761–6327).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
E–045–2015: Neutralizing Antibodies to
Ebolavirus Glycoprotein and Their Use
1. United States Provisional Patent
Application No. 62/087,087, filed 3
December 2014 (HHS Reference No. E–
045–2015–0–US–01);
2. International Patent Application
No. PCT/US2015/060733, filed 13
November 2015 (HHS Reference No. E–
045–2015–0–PCT–02);
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14331
3. European Patent Application No.
15797815.6, filed 13 November 2015
(HHS Reference No. E–045–2015–0–EP–
03); and
4. United States Patent No.
10,273,288, issued 30 April 2019 (HHS
Reference No. E–045–2015–0–US–05).
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: Development, production,
and commercialization of Ebola
neutralizing monoclonal antibody
mAb114, as a single antibody not in
combination with other monoclonal
antibodies, for the treatment of Ebola
virus disease in humans.
This technology discloses the
discovery, isolation, production, and
advancement in the development of
recombinant neutralizing antibodies
specific to the Ebola virus glycoprotein,
varying Ebola virus glycoprotein
recognition profiles, and increasing
neutralization potency for a therapeutic
in a patient diagnosed with Ebola virus.
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
Institute of Allergy and Infectious
Diseases 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
commercialization license. 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.
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14332
Federal Register / Vol. 86, No. 48 / Monday, March 15, 2021 / Notices
Dated: February 26, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–05235 Filed 3–12–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2021–0179]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0128
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting an
extension of its approval for the
following collection of information:
1625–0128, Prospect Questionnaire,
Chat Now Questionnaire, and the
Officer Program Application; without
change.
Our ICR describes the information we
seek to collect from the public. Before
submitting this ICR to OIRA, the Coast
Guard is inviting comments as
described below.
DATES: Comments must reach the Coast
Guard on or before May 14, 2021.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2021–0179] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public participation and
request for comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–6P), ATTN: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE, STOP
7710, Washington, DC 20593–7710.
FOR FURTHER INFORMATION CONTACT: A.L.
Craig, Office of Privacy Management,
telephone 202–475–3528, or fax 202–
372–8405, for questions on these
documents.
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SUMMARY:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:36 Mar 12, 2021
Jkt 253001
Public Participation and Request for
Comments
This notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. chapter 35, as amended. An
ICR is an application to OIRA seeking
the approval, extension, or renewal of a
Coast Guard collection of information
(Collection). The ICR contains
information describing the Collection’s
purpose, the Collection’s likely burden
on the affected public, an explanation of
the necessity of the Collection, and
other important information describing
the Collection. There is one ICR for each
Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology.
In response to your comments, we
may revise this ICR or decide not to seek
an extension of approval for the
Collection. We will consider all
comments and material received during
the comment period.
We encourage you to respond to this
request by submitting comments and
related materials. Comments must
contain the OMB Control Number of the
ICR and the docket number of this
request, [USCG–2021–0179], and must
be received by May 14, 2021.
Submitting Comments
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that website’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted.
We accept anonymous comments. All
comments received will be posted
without change to https://
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www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
submissions in response to this
document, see DHS’s eRulemaking
System of Records notice (85 FR 14226,
March 11, 2020).
Information Collection Request
Title: Prospect Questionnaire, Chat
Now Questionnaire, and the Officer
Program Application.
OMB Control Number: 1625–0128.
Summary: This collection contains
the recruiting website gocoastguard.com
Prospect Questionnaire (CGRC–1130),
Chat Now Questionnaire (CGRC–1132),
and the Officer Program Application
(CGRC–1131) that are used to screen
active duty, reserve, enlisted, and officer
applicants.
Need: The information is needed to
initiate the recruiting and
commissioning of active duty, reserve,
enlisted, and officer members. 14 U.S.C.
2701 authorizes the United States Coast
Guard to recruit personnel for military
service. The information requested on
the gocoastguard.com website is
collected in accordance with Section
503 of Title 10 U.S.C. and may be used
to identify and process individuals
interested in applying for enlistment or
commission into the United States Coast
Guard or Coast Guard Reserve.
Forms: Online Application plus hard
copy of the Prospect Questionnaire
(CGRC–1130), and/or the Officer
Program Application (CGRC–1131) if a
prospect does not use
gocoastguard.com, but contacts a
recruiter directly.
Respondents: Approximately 50,000
applicants apply annually to initiate the
screening process.
Frequency: Applicants may apply
more than once, by initially completing
the Chat Now Questionnaire (CGRC–
1132) to answer questions on eligibility
and may apply for both enlisted and
officer programs through the Prospect
Questionnaire (CGRC–1130) and/or
Officer Program Application (CGRC–
1131).
Hour Burden Estimate: The estimated
burden remains 97,686 hours a year.
Authority: The Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended.
Dated: March 9, 2021.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S.
Coast Guard.
[FR Doc. 2021–05265 Filed 3–12–21; 8:45 am]
BILLING CODE 9110–04–P
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[Federal Register Volume 86, Number 48 (Monday, March 15, 2021)]
[Notices]
[Pages 14331-14332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05235]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development,
Production, and Commercialization of Ebola Neutralizing Single
Monoclonal Antibody for the Treatment of Ebola Virus Disease in Humans
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases, an
institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an Exclusive Patent
License to practice the inventions embodied in the U.S. and European
Patents and Patent Applications listed in the Supplementary Information
section of this Notice to Ridgeback Biotherapeutics, L.P., located in
Miami, Florida.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Allergy and Infectious
Diseases' Technology Transfer and Intellectual Property Office on or
before March 30, 2021 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: Daniel Lee, J.D., Technology Transfer and Patent
Specialist, National Institute of Allergy and Infectious Diseases
Technology Transfer and Intellectual Property Office by email
([email protected]) or phone (301-761-6327).
SUPPLEMENTARY INFORMATION:
Intellectual Property
E-045-2015: Neutralizing Antibodies to Ebolavirus Glycoprotein and
Their Use
1. United States Provisional Patent Application No. 62/087,087,
filed 3 December 2014 (HHS Reference No. E-045-2015-0-US-01);
2. International Patent Application No. PCT/US2015/060733, filed 13
November 2015 (HHS Reference No. E-045-2015-0-PCT-02);
3. European Patent Application No. 15797815.6, filed 13 November
2015 (HHS Reference No. E-045-2015-0-EP-03); and
4. United States Patent No. 10,273,288, issued 30 April 2019 (HHS
Reference No. E-045-2015-0-US-05).
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: Development,
production, and commercialization of Ebola neutralizing monoclonal
antibody mAb114, as a single antibody not in combination with other
monoclonal antibodies, for the treatment of Ebola virus disease in
humans.
This technology discloses the discovery, isolation, production, and
advancement in the development of recombinant neutralizing antibodies
specific to the Ebola virus glycoprotein, varying Ebola virus
glycoprotein recognition profiles, and increasing neutralization
potency for a therapeutic in a patient diagnosed with Ebola virus.
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 Institute of
Allergy and Infectious Diseases 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.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent
commercialization license. 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.
[[Page 14332]]
Dated: February 26, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-05235 Filed 3-12-21; 8:45 am]
BILLING CODE 4140-01-P
