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]

Download as PDF 43670 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 performance appraisals and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register. The following persons will serve on the NIH Performance Review Board, which oversees the evaluation of performance appraisals of NIH Senior Executive Service (SES) members: Alfred Johnson, Chair Courtney Billet Michael Gottesman Darla Hayes Michael Lauer Kathleen Stephan 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. E–114–2004–0– IT–16. E–114–2004–0– 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 Frm 00047 Fmt 4703 Sfmt 4703 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] BILLING CODE 4140–01–P 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: http:// www.regulations.gov. Please follow the instructions for submitting comments. Instructions: All submissions received must include the agency name and docket number Docket # DHS–2021– 0037. All comments received will be posted without change to http:// www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received, go to http:// 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 43671 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 noted on the form that using the paper 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 agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be 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 10AUN1

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