Prospective Grant of an Exclusive Patent License: Delivery of a Corrective Glucose-6-Phosphatase-Alpha Gene to Treat Glycogen Storage Disease Type 1a (GSD-Ia) in Humans, 33321-33322 [2021-13261]

Download as PDF Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices Opportunity on (770) 488–3210 as soon as possible. DEPARTMENT OF HEALTH AND HUMAN SERVICES On July 14, 2021, the National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Privacy, Confidentiality, and Security, will seek input from experts to examine solutions for improving the security posture of the healthcare industry. At the hearing, the Subcommittee will hear from invited experts on the range of security challenges affecting the health care industry and business partners. The Subcommittee will also hear about the range of policy options that may be available to the Department of Health and Human Services (HHS) and data stewards to improve the security posture of those organizations holding individually identifiable information (III), including federal, state, local, and tribal organizations. The Committee will use this input to identify and describe the changing security landscape and risks to the privacy and security of III held by the health care industry and highlight promising policies, practices, and technologies. The Committee will lay out integrative models for how best to secure individually identifiable information while enabling beneficial uses, services, and technologies. The Committee will formulate recommendations for the Secretary on actions that HHS might take and prepare a report for the Secretary. The Committee requests comments from the public in advance of the hearing to inform its deliberations and will consider them together with the input of subject matter experts at the hearing. Please submit comments to NCVHSmail@cdc.gov by close of business Tuesday, July 13, 2021. There also will be a public comment period at the meeting. The meeting times and topics are subject to change. Please refer to the NCVHS website for information and agenda updates. National Institutes of Health SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES Sharon Arnold, Associate Deputy Assistant Secretary for Planning and Evaluation, Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 2021–13329 Filed 6–23–21; 8:45 am] BILLING CODE 4150–05–P VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 Prospective Grant of an Exclusive Patent License: Delivery of a Corrective Glucose-6-PhosphataseAlpha Gene to Treat Glycogen Storage Disease Type 1a (GSD-Ia) in Humans National Institutes of Health, DHHS. ACTION: Notice. AGENCY: The National Institute of Child Health and Human Development, 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 foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to Panacea Opportunity, Ltd. DATES: Only written comments and/or applications for a license which are received by the National Institute of Child Health and Human Development c/o National Cancer Institute’s Technology Transfer Center on or before July 9, 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: Alan Hubbs, Ph.D., Senior Technology Transfer Manager at Telephone: (240)–276–5530 or Email: hubbsa@mail.nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: SUMMARY: Intellectual Property 1. Priority Application, U.S.P.T.O. No. 62/096,400, filed December 23, 2014 [HHS Reference No. E–039–2015/0–US– 01]; 2. PCT Patent Application No. PCT/ US2015/067338, filed December 22, 2015 [HHS Reference No. E–039–2015– 0–PCT–02]; 3. Pending Canadian Patent Application No. 2972038, filed on December 22, 2015, [HHS Reference No. E–039–2015–0–CA–03]; 4. Issued China Patent No. ZL201580076462.4, filed on December 22, 2015, Issued December 11, 2020 [HHS Reference No. E–039–2015–0– CN–04]; 5. Issued European Patent No. 2182936, filed December 22, 2015, Issued July 22, 2020 [HHS Reference No. E–039–2015–0–EP–05]; 6. Issued Israeli Patent No. 253103, filed on December 22, 2015, Issued PO 00000 Frm 00116 Fmt 4703 Sfmt 4703 33321 April 1, 2020 [HHS Reference No. E– 039–2015–0–IL–06]; 7. Issued Japan Patent No. 6824169, filed June 22, 2017, Issued January 14, 2021 [HHS Reference No. E–039–2015– 0–JP–07]; 8. Issued United States Patent No. 10,415,044, filed September 17, 2019, Issued September 17, 2019 [HHS Reference No. E–039–2015–0–US–08] 9. Pending United States Patent Application No. 16/526,327, filed July 30, 2019, [HHS Reference No. E–039– 2015–0–US–08] With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, 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 world-wide, and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Delivery of a corrective glucose-6-phosphatase-alpha gene to treat glycogen storage disease type 1a (GSD-Ia) in humans.’’ This technology discloses a gene therapy to treat glycogen storage disease type 1a (GSD-Ia) in humans using adeno-associated virus mediated delivery of a corrective glucose-6phosphatase-alpha (G6Pase-a) gene nucleic acid sequence that codes for a protein having an amino acid sequence that differs from the wildtype human amino acid sequence at amino acid position 293. 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 Child Health and Human Development 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\24JNN1.SGM 24JNN1 33322 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices Dated: June 11, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2021–13261 Filed 6–23–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Advisory General Medical Sciences Council, September 01, 2021, 09:30 a.m. to September 02, 2021, 05:00 p.m., National Institutes of Health, Natcher Building, 6707 Democracy Boulevard, Bethesda, MD 20892 which was published in the Federal Register on December 31, 2020, FR Doc 2020– 28902, 85 FR 86940. The meeting notice is amended to change the meeting date and time from September 1–2, 2021, 9:30 a.m. to 5:00 p.m. to September 9, 2021, 9:00 a.m. to 4:30 p.m. The meeting is partially closed to the public. Dated: June 14, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–13377 Filed 6–23–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES Eunice Kennedy Shriver National Institute of Child Health & Human Development; 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 Special Emphasis Panel; Newborn Screening Pilot Studies. Date: August 6, 2021. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710 B Rockledge Drive, Rm. 2131D, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Rm. 2131D, Bethesda, MD 20817, (301) 435–6680, skandasa@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: June 14, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–13348 Filed 6–23–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; 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 Child Health and Human Development Special Emphasis Panel; Program Project Grants for HIV Research in Perinatal HIV, Birth Outcomes and Neurodevelopment. Date: July 22–23, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Room 2131B, Bethesda, MD 20897 (Video Assisted Meeting). Contact Person: Luis E. Dettin, Ph.D., M.S., M.A., Scientific Review Officer, Scientific PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Rm. 2131B, Bethesda, MD 20892, (301) 827–8231, luis_dettin@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: June 14, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–13353 Filed 6–23–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Minority Health and Health Disparities; 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 on Minority Health and Health Disparities Special Emphasis Panel; Coordinating Center for Multiple Chronic Disease Disparities Research Centers (U24). Date: July 15, 2021. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Gateway Plaza, 7201 Wisconsin Ave., Bethesda, MD 20817 (Virtual Meeting). Contact Person: Ivan K. Navarro, Ph.D., Scientific Review Officer, Office of Extramural Research Administration, National Institute on Minority Health and Health Disparities, National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–827– 2061, ivan.navarro@nih.gov. Dated: June 15, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–13339 Filed 6–23–21; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33321-33322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Delivery of a 
Corrective Glucose-6-Phosphatase-Alpha Gene to Treat Glycogen Storage 
Disease Type 1a (GSD-Ia) in Humans

AGENCY: National Institutes of Health, DHHS.

ACTION: Notice.

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

SUMMARY: The National Institute of Child Health and Human Development, 
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 foreign 
Patents and Patent Applications listed in the Supplementary Information 
section of this notice to Panacea Opportunity, Ltd.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Child Health and Human 
Development c/o National Cancer Institute's Technology Transfer Center 
on or before July 9, 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: Alan Hubbs, Ph.D., Senior Technology Transfer 
Manager at Telephone: (240)-276-5530 or Email: [email protected].

SUPPLEMENTARY INFORMATION:  The following represents the intellectual 
property to be licensed under the prospective agreement:

Intellectual Property

    1. Priority Application, U.S.P.T.O. No. 62/096,400, filed December 
23, 2014 [HHS Reference No. E-039-2015/0-US-01];
    2. PCT Patent Application No. PCT/US2015/067338, filed December 22, 
2015 [HHS Reference No. E-039-2015-0-PCT-02];
    3. Pending Canadian Patent Application No. 2972038, filed on 
December 22, 2015, [HHS Reference No. E-039-2015-0-CA-03];
    4. Issued China Patent No. ZL201580076462.4, filed on December 22, 
2015, Issued December 11, 2020 [HHS Reference No. E-039-2015-0-CN-04];
    5. Issued European Patent No. 2182936, filed December 22, 2015, 
Issued July 22, 2020 [HHS Reference No. E-039-2015-0-EP-05];
    6. Issued Israeli Patent No. 253103, filed on December 22, 2015, 
Issued April 1, 2020 [HHS Reference No. E-039-2015-0-IL-06];
    7. Issued Japan Patent No. 6824169, filed June 22, 2017, Issued 
January 14, 2021 [HHS Reference No. E-039-2015-0-JP-07];
    8. Issued United States Patent No. 10,415,044, filed September 17, 
2019, Issued September 17, 2019 [HHS Reference No. E-039-2015-0-US-08]
    9. Pending United States Patent Application No. 16/526,327, filed 
July 30, 2019, [HHS Reference No. E-039-2015-0-US-08]
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, 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 world-wide, and the field of use may 
be limited to the use of Licensed Patent Rights for the following: 
``Delivery of a corrective glucose-6-phosphatase-alpha gene to treat 
glycogen storage disease type 1a (GSD-Ia) in humans.''
    This technology discloses a gene therapy to treat glycogen storage 
disease type 1a (GSD-Ia) in humans using adeno-associated virus 
mediated delivery of a corrective glucose-6-phosphatase-alpha (G6Pase-
[alpha]) gene nucleic acid sequence that codes for a protein having an 
amino acid sequence that differs from the wildtype human amino acid 
sequence at amino acid position 293.
    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 Child Health and Human Development 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 33322]]


    Dated: June 11, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-13261 Filed 6-23-21; 8:45 am]
BILLING CODE 4140-01-P
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