Prospective Grant of an Exclusive Patent License: P2Y14 Receptor Antagonists To Treat Kidney and Lung Inflammation, 27858-27859 [2021-10816]

Download as PDF 27858 Federal Register / Vol. 86, No. 98 / Monday, May 24, 2021 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average burden per response (in hours) Number of responses per respondent Total annual burden hours requested Type of respondents Summer Internship Program Alumni Survey ........ Graduate Medical Education Graduate Survey .... Clinical Electives Program 1 Year Alumni Surveys. Pre Doctoral Students .. Physicians .................... Physicians .................... 280 350 100 1 1 1 20/60 20/60 20/60 93 117 33 Total ............................................................... ....................................... ........................ 1,434 ........................ 478 Dated: May 11, 2021. Frederick D. Vorck, Jr., Project Clearance Liaison, NIH Clinical Center, National Institutes of Health. [FR Doc. 2021–10815 Filed 5–21–21; 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: P2Y14 Receptor Antagonists To Treat Kidney and Lung Inflammation AGENCY: National Institutes of Health, HHS. ACTION: Notice. National Institute of Diabetes and Digestive and Kidney 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 Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Kantum Pharma Inc. (Kantum), located in Boston, Massachussets. DATES: Only written comments and/or applications for a license which are received by the National Institute of Diabetes and Digestive and Kidney Diseases’ Technology Advancement Office on or before June 8, 2021 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Betty B. Tong, Ph.D., Senior Licensing and Patenting Manager, NIDDK Technology Advancement Office, Telephone: 301–451–7836; Email: tongb@mail.nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Number of respondents Form name Intellectual Property 1. HHS Ref. No.: E–213–2015–0; Entitled: Triazole Derivatives as VerDate Sep<11>2014 17:32 May 21, 2021 Jkt 253001 P2Y14 Receptor Antagonists; Inventors: Kenneth Jacobson, Ph.D. et al (i) U.S. Patent No. 10,683,277; HHS Ref. No.: E–213–2015–0–US–05; Issue Date: June 16, 2020 (ii) EP Patent Application 16774825.0; HHS Ref. No.: E–213–2015–0–EP–04; Filing Date: April 19, 2018 (iii) Chinese Patent No. ZL 201680064441.5; HHS Ref. No.: E– 213–2015–0–CN–03; Issue Date: March 19, 2021 2. HHS Reference No. E–028–2018–1; Entitled: P2Y14 Receptor Antagonists Containing a Biaryl Core; Inventors: Kenneth Jacobson, Ph.D. et al (i) Australian Patent Application 2019218256; HHS Ref. No.: E–028– 2018–1–AU–02; Filing Date: July 28, 2020 (ii) Canadian Patent Application 3,090,788; HHS Ref. No.: E–028– 2018–1–CA–03; Filing Date: August 7, 2020 (iii) Chinese Patent Application 201980012696.0; HHS Ref. No.: E– 028–2018–1–CN–04; Filing Date: August 10, 2020 (iv) EP Patent Application 19707559.1; HHS Ref. No.: E–028– 2018–1–EP–05; Filing Date: July 20, 2020 (v) Japanese Patent Application 2020– 542580; HHS Ref. No.: E–028– 2018–1–JP–06; Filing Date: August 6, 2020 (vi) U.S. Patent Application 16/ 967,177; HHS Ref. No.: E–028– 2018–1–US–07; Filing Date: August 4, 2020 3. HHS Reference No. E–051–2021–0; Entitled: Heterocyclic P2Y14 Receptor Antagonists; Inventors: Kenneth Jacobson, Ph.D. et al (i) U.S. Provisional Patent Application No.: 62/643,015; HHS Ref. No.: E–051– 2021–0–US–01; Filing Date: January 18, 2021 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 The patent rights in these inventions have been assigned to the government of the United States of America. The prospective exclusive license’ territory may be worldwide and the field of use may be limited to ‘‘Commercial development of P2Y14 receptor antagonists for the prevention and treatment of conditions or diseases associated with inflammation in the kidney and lung in humans, as claimed in the Licensed Patent Rights’’. The inventions pertain to the composition and use of selective antagonists for the P2Y14 receptor, a purinergic G protein-coupled receptor that is activated by extracellular UDPglucose and related nucleotides. These P2Y14R antagonists can be developed as potential drug for the treatment of inflammation and other disorders associated with P2Y14R regulated functions. 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, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Diabetes and Digestive and Kidney 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 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. E:\FR\FM\24MYN1.SGM 24MYN1 Federal Register / Vol. 86, No. 98 / Monday, May 24, 2021 / Notices Dated: May 5, 2021. Charles D. Niebylski, Director, Technology Advancement Office, National Institute of Diabetes and Digestive and Kidney Diseases. A.L. Craig, Office of Privacy Management, telephone 202–475–3528, or fax 202– 372–8405, for questions on these documents. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2021–10816 Filed 5–21–21; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4140–01–P Public Participation and Request for Comments DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2021–0182] Collection of Information Under Review by Office of Management and Budget; OMB Control Number 1625– 0093 Coast Guard, DHS. Thirty-day notice requesting comments. AGENCY: ACTION: In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, 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: 1625–0093, Facilities Transferring Oil or Hazardous Materials in Bulk—Letter of Intent and Operations Manual; without change. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties. DATES: You may submit comments to the Coast Guard and OIRA on or before June 23, 2021. ADDRESSES: Comments to the Coast Guard should be submitted using the Federal eRulemaking Portal at https:// www.regulations.gov. Search for docket number [USCG–2021–0182]. Written comments and recommendations to OIRA for the proposed information collection should be sent within 30 days of publication of this notice to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. 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. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:32 May 21, 2021 Jkt 253001 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. These comments will help OIRA determine whether to approve the ICR referred to in this Notice. We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG–2021–0182], and must be received by June 23, 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 27859 alerts, you will be notified when comments are posted. We accept anonymous comments. All comments to the Coast Guard will be posted without change to https:// www.regulations.gov and will include any personal information you have provided. For more about privacy and submissions to the Coast Guard in response to this document, see DHS’s eRulemaking System of Records notice (85 FR 14226, March 11, 2020). For more about privacy and submissions to OIRA in response to this document, see the https://www.reginfo.gov, commentsubmission web page. OIRA posts its decisions on ICRs online at https:// www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625–0093. Previous Request for Comments This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (86 FR 14333, March 15, 2021) required by 44 U.S.C. 3506(c)(2). That notice elicited no comments. Accordingly, no changes have been made to the Collection. Information Collection Request Title: Facilities Transferring Oil or Hazardous Materials in Bulk—Letter of Intent and Operations Manual. OMB Control Number: 1625–0093. Summary: A Letter of Intent is a notice to the Coast Guard Captain of the Port that an operator intends to operate a facility that will transfer bulk oil or hazardous materials to or from vessels. An Operations Manual (OM) is also required for this type of facility. The OM establishes procedures to follow when conducting transfers and in the event of a spill. Need: Under 33 U.S.C. 1321 and Executive Order 12777 the Coast Guard is authorized to prescribe regulations to prevent the discharge of oil and hazardous substances from facilities and to contain such discharges. The Letter of Intent regulation is contained in 33 CFR 154.110 and the OM regulations are contained in 33 CFR part 154 subpart B. Forms: None. Respondents: Operators of facilities that transfer oil or hazardous materials in bulk. Frequency: On occasion. Hour Burden Estimate: The estimated burden has increased from 21,803 hours to 37,609 hours a year, due to an increase in the estimated annual number of responses. E:\FR\FM\24MYN1.SGM 24MYN1

Agencies

[Federal Register Volume 86, Number 98 (Monday, May 24, 2021)]
[Notices]
[Pages 27858-27859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10816]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: P2Y14 Receptor 
Antagonists To Treat Kidney and Lung Inflammation

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: National Institute of Diabetes and Digestive and Kidney 
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 
Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION 
section of this notice to Kantum Pharma Inc. (Kantum), located in 
Boston, Massachussets.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Diabetes and Digestive and 
Kidney Diseases' Technology Advancement Office on or before June 8, 
2021 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Betty B. Tong, Ph.D., Senior Licensing and 
Patenting Manager, NIDDK Technology Advancement Office, Telephone: 301-
451-7836; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

1. HHS Ref. No.: E-213-2015-0; Entitled: Triazole Derivatives as P2Y14 
Receptor Antagonists; Inventors: Kenneth Jacobson, Ph.D. et al
    (i) U.S. Patent No. 10,683,277; HHS Ref. No.: E-213-2015-0-US-05; 
Issue Date: June 16, 2020
    (ii) EP Patent Application 16774825.0; HHS Ref. No.: E-213-2015-0-
EP-04; Filing Date: April 19, 2018
    (iii) Chinese Patent No. ZL 201680064441.5; HHS Ref. No.: E-213-
2015-0-CN-03; Issue Date: March 19, 2021
2. HHS Reference No. E-028-2018-1; Entitled: P2Y14 Receptor Antagonists 
Containing a Biaryl Core; Inventors: Kenneth Jacobson, Ph.D. et al
    (i) Australian Patent Application 2019218256; HHS Ref. No.: E-028-
2018-1-AU-02; Filing Date: July 28, 2020
    (ii) Canadian Patent Application 3,090,788; HHS Ref. No.: E-028-
2018-1-CA-03; Filing Date: August 7, 2020
    (iii) Chinese Patent Application 201980012696.0; HHS Ref. No.: E-
028-2018-1-CN-04; Filing Date: August 10, 2020
    (iv) EP Patent Application 19707559.1; HHS Ref. No.: E-028-2018-1-
EP-05; Filing Date: July 20, 2020
    (v) Japanese Patent Application 2020-542580; HHS Ref. No.: E-028-
2018-1-JP-06; Filing Date: August 6, 2020
    (vi) U.S. Patent Application 16/967,177; HHS Ref. No.: E-028-2018-
1-US-07; Filing Date: August 4, 2020
3. HHS Reference No. E-051-2021-0; Entitled: Heterocyclic P2Y14 
Receptor Antagonists; Inventors: Kenneth Jacobson, Ph.D. et al
    (i) U.S. Provisional Patent Application No.: 62/643,015; HHS Ref. 
No.: E-051-2021-0-US-01; Filing Date: January 18, 2021

    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license' territory may be worldwide and 
the field of use may be limited to ``Commercial development of P2Y14 
receptor antagonists for the prevention and treatment of conditions or 
diseases associated with inflammation in the kidney and lung in humans, 
as claimed in the Licensed Patent Rights''.
    The inventions pertain to the composition and use of selective 
antagonists for the P2Y14 receptor, a purinergic G protein-coupled 
receptor that is activated by extracellular UDP-glucose and related 
nucleotides. These P2Y14R antagonists can be developed as potential 
drug for the treatment of inflammation and other disorders associated 
with P2Y14R regulated functions.
    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, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Institute of Diabetes and Digestive and Kidney 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 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.


[[Page 27859]]


    Dated: May 5, 2021.
Charles D. Niebylski,
Director, Technology Advancement Office, National Institute of Diabetes 
and Digestive and Kidney Diseases.
[FR Doc. 2021-10816 Filed 5-21-21; 8:45 am]
BILLING CODE 4140-01-P

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