Prospective Grant of an Exclusive Patent License: Multi-Domain Amphipathic Helical Peptide for Use as A Human Therapeutic in Patients With Atherosclerotic Cardiovascular Disease, Including Patients Undergoing Cardiovascular Surgery Who Are at risk of Acute Kidney Injury, 43670-43671 [2021-17011]
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Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices
Title 5, U.S.C., section 4314 (c) (4),
which requires that members of
performance review boards be
appointed in a manner to ensure
consistency, stability, and objectivity in
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Courtney Billet
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Michael Lauer
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Lawrence Tabak
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Multi-Domain
Amphipathic Helical Peptide for Use as
A Human Therapeutic in Patients With
Atherosclerotic Cardiovascular
Disease, Including Patients
Undergoing Cardiovascular Surgery
Who Are at risk of Acute Kidney Injury
AGENCY:
[FR Doc. 2021–17039 Filed 8–9–21; 8:45 am]
BILLING CODE 4140–01–P
jbell on DSKJLSW7X2PROD with NOTICES
E–114–2004–0–
US–01.
E–114–2004–0–
PCT–02.
E–114–2004–0–
AU–03.
E–114–2004–0–
CA–04.
E–114–2004–0–
EP–05.
E–114–2004–0–
JP–06.
E–114–2004–0–
US–07.
E–114–2004–0–
US–08.
E–114–2004–0–
US–09.
E–114–2004–0–
CH–11.
E–114–2004–0–
DE–12.
E–114–2004–0–
ES–13.
E–114–2004–0–
FR–14.
E–114–2004–0–
GB–15.
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IT–16.
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US–17.
VerDate Sep<11>2014
Patent Application No.
Title
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
Multi-Domain Amphipathic
ods Of Their Use.
All U.S. and foreign patents and
applications claiming priority to any
member of the above.
The patent rights in these inventions
have been assigned or exclusively
17:05 Aug 09, 2021
Jkt 253001
section of
this notice. This is a first notice
intended to apprise the public of a
change in prospective licensee of the
subject intellectual property rights in
the stated field of use.
Only written comments and/or
applications for a license which are
received by the National Heart, Lung,
and Blood Institute on or before August
25, 2021 will be considered.
DATES:
Requests for copies of the
patent application, inquiries, and
ACTION: Notice.
comments relating to the contemplated
an exclusive patent license should be
SUMMARY: The National Heart, Lung, and
directed to: Michael Davis, J.D., Ph.D.,
Blood Institute, an institute of the
Senior Technology Transfer Manager, 31
National Institutes of Health,
Center Drive Room 4A29, MSC2479,
Department of Health and Human
Bethesda, MD 20892–2479, phone
Services, is contemplating the grant of
number 301–451–9032, or
an exclusive patent license to Phyxius
michael.davis4@nih.gov.
Therapeutics, Inc., a start-up company
incorporated as a C corporation under
SUPPLEMENTARY INFORMATION:
the laws of the state of Delaware, to
Intellectual Property
practice the inventions covered by the
HHS.
Dated: August 2, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
NIH REF No.
National Institutes of Health,
patent estate listed in the
SUPPLEMENTARY INFORMATION
ADDRESSES:
Filing Date
Issued Patent
No.
Issue Date
Helical Peptides And Meth-
60/619,392
10/15/04
........................
........................
Helical Peptides And Meth-
PCT/US2005/
10/14/05
........................
........................
Helical Peptides And Meth-
2005295640
10/14/05
2005295640
11/10/11
Helical Peptides And Meth-
2584048
10/14/05
2584048
08/09/16
Helical Peptides And Meth-
05815961.7
10/14/05
1812474
05/26/10
Helical Peptides And Meth-
2007–536912
10/14/05
5,091,679
09/21/12
Helical Peptides And Meth-
11/577,259
04/13/07
7,572,771
08/11/09
Helical Peptides And Meth-
12/497,443
07/02/09
8,071,746
12/06/11
Helical Peptides And Meth-
12/766,761
04/23/10
8,148,323
04/03/12
Helical Peptides And Meth-
05815961.7
10/14/05
1812474
05/26/10
Helical Peptides And Meth-
05815961.7
10/14/05
1812474
05/26/10
Helical Peptides And Meth-
05815961.7
10/14/05
1812474
05/26/10
Helical Peptides And Meth-
05815961.7
10/14/05
1812474
05/26/10
Helical Peptides And Meth-
05815961.7
10/14/05
1812474
05/26/10
Helical Peptides And Meth-
05815961.7
10/14/05
1812474
05/26/10
Helical Peptides And Meth-
13/407,132
02/28/12
8,835,378
09/16/14
licensed to the Government of the
United States of America.
The prospective exclusive license
territory may be worldwide and in fields
of use that may be limited to use as a
human therapeutic in patients with
PO 00000
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atherosclerotic cardiovascular disease
(ASCVD), including patients undergoing
cardiovascular surgery who are at risk of
acute kidney injury.
The patents listed above cover an
invention directed to peptides or
E:\FR\FM\10AUN1.SGM
10AUN1
Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Notices
peptide analogs with multiple
amphipathic alpha helical domains that
promote lipid efflux from cells via an
ABCA1-dependent pathway. This
invention is also directed to methods of
identifying non-cytotoxic peptides that
promote ABCA1-dependent lipid efflux
from cells, and to methods of using
multi-domain amphipathic alpha helical
peptides or peptide analogs to treat or
inhibit dyslipidemic disorders.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing. The prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Heart, Lung, and Blood 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 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 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.
Bruce D. Goldstein,
Director, Office of Technology Transfer and
Development, National Heart, Lung, and
Blood Institute.
[FR Doc. 2021–17011 Filed 8–9–21; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
[Docket Number—DHS–2021–0037]
Agency Information Collection
Activities: Office of the Immigration
Detention Ombudsman Intake Form
Department of Homeland
Security (DHS).
ACTION: 60-Day Notice and request for
comments; Office of the Immigration
Detention Ombudsman Intake Form,
1601–0030, Extension without change.
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
The Department of Homeland
Security, will submit the following
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB) for review and clearance in
SUMMARY:
VerDate Sep<11>2014
17:05 Aug 09, 2021
Jkt 253001
accordance with the Paperwork
Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted until October 12, 2021.
ADDRESSES: You may submit comments,
identified by docket number Docket #
DHS–2021–0037 at:
Æ Federal rulemaking Portal: https://
www.regulations.gov. Please follow the
instructions for submitting comments.
Instructions: All submissions received
must include the agency name and
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0037. All comments received will be
posted without change to https://
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personal information provided.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
SUPPLEMENTARY INFORMATION: The
Department of Homeland Security’s
(DHS) Office of the Immigration
Detention Ombudsman (OIDO) is an
independent office tasked with
resolving individual complaints from or
about individuals in immigration
detention regarding the potential
violation of immigration detention
standards or other potential misconduct.
OIDO was established by Congress (Sec.
106 of the Consolidated Appropriations
Act, 2020, Pub. L. 116–93). Its intake
form is intended for use by individuals
wishing to submit a complaint to OIDO.
Information collected will provide the
office with details about the allegations
the submitter seeks to have OIDO
address.
The information collected on this
form will allow OIDO to identify: (1)
The individual submitting the
complaint and their contact
information; (2) the detained individual
who is the subject of the complaint; (3)
the government-owned or contracted
facility where the individual is or was
detained and for how long; and (4)
relevant details about the complaint. All
of this information will be used by
OIDO to investigate, resolve, and if
appropriate, provide redress.
The use of this form is the most
efficient means for collecting and
processing the required data. Initially,
collection will be via a paper form,
which may be obtained from OIDO staff
conducting routine visits in detention
facilities. The form will also be available
for download from the OIDO website.
The PDF form will be able to be
completed online, printed out, and
submitted to OIDO by email, mail, or
fax, or handed to a staff member in a
detention facility.
After approval of the form described
in this supporting statement, an
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electronic version will be developed so
that submitters may complete and file
via the OIDO website. The paper version
will continue to be available; it will be
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method may result in processing delays
for OIDO to complete data entry.
This information collection does not
have an impact on small businesses or
other small entities.
If this information is not collected,
OIDO will not be able to accomplish its
Congressional mandate to provide
assistance to individuals who may be
affected by misconduct, excessive force,
or other violations of law or detention
standards.
The assurance of confidentiality
provided to the respondents for this
information collection is based on the
forthcoming Privacy Impact Assessment
for the Immigration Detention
Ombudsman Case Management System
(ID–CMS) (Summer 2021). Additionally,
the information collected is covered by
DHS/ALL–020 Department of Homeland
Security Internal Affairs, April 28, 2014,
79 FR 23361 and DHS/ALL–025 Law
Enforcement Authority in Support of
the Protection of Property Owned,
Occupied, or Secured by the
Department of Homeland Security
System of Records, June 14, 2017, 82 FR
27274.
This information collection was
constructed in compliance with
regulations and authorities under the
purview of the DHS Privacy Office, DHS
OCIO, DHS Records Management, and
OMB regulations regarding data
collection, use, sharing, storage,
information security, and retrieval of
information.
There are no changes to the
information being collected and there is
no change to the estimated burden
associated with this collection.
The Office of Management and Budget
is particularly interested in comments
which:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
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proposed collection of information,
including the validity of the
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collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
E:\FR\FM\10AUN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 151 (Tuesday, August 10, 2021)]
[Notices]
[Pages 43670-43671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17011]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Multi-Domain
Amphipathic Helical Peptide for Use as A Human Therapeutic in Patients
With Atherosclerotic Cardiovascular Disease, Including Patients
Undergoing Cardiovascular Surgery Who Are at risk of Acute Kidney
Injury
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Heart, Lung, and Blood Institute, an institute of
the National Institutes of Health, Department of Health and Human
Services, is contemplating the grant of an exclusive patent license to
Phyxius Therapeutics, Inc., a start-up company incorporated as a C
corporation under the laws of the state of Delaware, to practice the
inventions covered by the patent estate listed in the Supplementary
Information section of this notice. This is a first notice intended to
apprise the public of a change in prospective licensee of the subject
intellectual property rights in the stated field of use.
DATES: Only written comments and/or applications for a license which
are received by the National Heart, Lung, and Blood Institute on or
before August 25, 2021 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated an exclusive patent license
should be directed to: Michael Davis, J.D., Ph.D., Senior Technology
Transfer Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD
20892-2479, phone number 301-451-9032, or [email protected].
SUPPLEMENTARY INFORMATION: Intellectual Property
----------------------------------------------------------------------------------------------------------------
Patent
NIH REF No. Title Application Filing Date Issued Patent Issue Date
No. No.
----------------------------------------------------------------------------------------------------------------
E-114-2004-0-US-01............ Multi-Domain 60/619,392 10/15/04 .............. ..............
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-PCT-02........... Multi-Domain PCT/US2005/ 10/14/05 .............. ..............
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-AU-03............ Multi-Domain 2005295640 10/14/05 2005295640 11/10/11
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-CA-04............ Multi-Domain 2584048 10/14/05 2584048 08/09/16
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-EP-05............ Multi-Domain 05815961.7 10/14/05 1812474 05/26/10
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-JP-06............ Multi-Domain 2007-536912 10/14/05 5,091,679 09/21/12
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-US-07............ Multi-Domain 11/577,259 04/13/07 7,572,771 08/11/09
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-US-08............ Multi-Domain 12/497,443 07/02/09 8,071,746 12/06/11
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-US-09............ Multi-Domain 12/766,761 04/23/10 8,148,323 04/03/12
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-CH-11............ Multi-Domain 05815961.7 10/14/05 1812474 05/26/10
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-DE-12............ Multi-Domain 05815961.7 10/14/05 1812474 05/26/10
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-ES-13............ Multi-Domain 05815961.7 10/14/05 1812474 05/26/10
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-FR-14............ Multi-Domain 05815961.7 10/14/05 1812474 05/26/10
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-GB-15............ Multi-Domain 05815961.7 10/14/05 1812474 05/26/10
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-IT-16............ Multi-Domain 05815961.7 10/14/05 1812474 05/26/10
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
E-114-2004-0-US-17............ Multi-Domain 13/407,132 02/28/12 8,835,378 09/16/14
Amphipathic
Helical
Peptides And
Methods Of
Their Use.
----------------------------------------------------------------------------------------------------------------
All U.S. and foreign patents and applications claiming priority to
any member of the above.
The patent rights in these inventions have been assigned or
exclusively licensed to the Government of the United States of America.
The prospective exclusive license territory may be worldwide and in
fields of use that may be limited to use as a human therapeutic in
patients with atherosclerotic cardiovascular disease (ASCVD), including
patients undergoing cardiovascular surgery who are at risk of acute
kidney injury.
The patents listed above cover an invention directed to peptides or
[[Page 43671]]
peptide analogs with multiple amphipathic alpha helical domains that
promote lipid efflux from cells via an ABCA1-dependent pathway. This
invention is also directed to methods of identifying non-cytotoxic
peptides that promote ABCA1-dependent lipid efflux from cells, and to
methods of using multi-domain amphipathic alpha helical peptides or
peptide analogs to treat or inhibit dyslipidemic disorders.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing.
The prospective exclusive license may be granted unless within fifteen
(15) days from the date of this published notice, the National Heart,
Lung, and Blood 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
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 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.
Bruce D. Goldstein,
Director, Office of Technology Transfer and Development, National
Heart, Lung, and Blood Institute.
[FR Doc. 2021-17011 Filed 8-9-21; 8:45 am]
BILLING CODE 4140-01-P
