Prospective Grant of Exclusivity Under Non-Exclusive Patent License: AAV Isolate and Fusion Protein Comprising Nerve Growth Factor Signal Peptide and Parathyroid Hormone, 67712-67713 [2021-25873]

Download as PDF 67712 Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. SUPPLEMENTARY INFORMATION: Description: This descriptive study aims to provide insight into the models that have been used to centralize services; organizations’ history of and impetus for centralizing services; the benefits, challenges, and costs of centralizing services from the perspectives of staff and clients; and how organizations have coordinated their centralized services virtually. This project will include site visits to three centralized community resource centers (CCRCs). The proposed information collection activities include interviews with staff, including leadership and administrative staff, frontline staff, finance staff, and IT/data staff, and focus groups with clients. The research team will also conduct observations of program activities. Respondents: Respondents will include leadership and administrative staff at the CCRC, staff who manage finances at the CCRC, staff who manage data and/or technology at the CCRC, staff who provide services directly to clients at the CCRC, and clients who have accessed services at the CCRC. ANNUAL BURDEN ESTIMATES Number of respondents (total over request period) Instrument Interview guide for administrative/leadership staff .......................................... Interview guide for frontline staff ..................................................................... Interview guide for finance staff ...................................................................... Interview guide for IT/data staff ....................................................................... Focus group guide for clients .......................................................................... Estimated Total Annual Burden Hours: 146. Authority: Authorized by the Social Security Act 1110 [42 U.S.C. 1310], appropriated by the Continuing Appropriations Act of 2019. John M. Sweet Jr., ACF/OPRE Certifying Officer. [FR Doc. 2021–25946 Filed 11–26–21; 8:45 am] BILLING CODE 4184–07–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusivity Under Non-Exclusive Patent License: AAV Isolate and Fusion Protein Comprising Nerve Growth Factor Signal Peptide and Parathyroid Hormone AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Institute of Diabetes and Digestive and Kidney Disease and National Institute of Dental and Craniofacial Research, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive rights under active Nonexclusive Patent License to practice the inventions embodied in the United States, European and Japan Applications listed in the Supplementary Information section of this notice to Atsena Therapeutics, Inc., khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:55 Nov 26, 2021 Jkt 256001 18 48 9 9 30 located in Durham, North Carolina, USA. DATES: Only written comments and/or applications for a license which are received by the National Institute of Diabetes and Digestive and Kidney Disease’s Technology Advancement Office on or before December 14, 2021 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Vladimir Knezevic, MD, (Senior) Advisor for Commercial Evaluation, Technology Advancement Office, Building 12A, Room 3011, Bethesda, MD 20817–5632 (for business mail), Telephone: (301) 435–5560; Email: vlado.knezevic@nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property I. European Patent National Stage: EP3294894 granted 2019–08–14, entitled ‘‘AAV isolate and fusion protein comprising nerve growth factor signal peptide and parathyroid hormone’’ (HHS Reference Number E–175–2015–1–EP–03), validated in Great Britain, France and Germany. II. Japanese Application No. 2017–558710 granted 2020–12–20, entitled ‘‘AAV isolate and fusion protein comprising nerve growth factor signal peptide and parathyroid hormone’’ (HHS Reference Number E–175– 2015–1–JP–04). III. U.S. Patent Application No. 15/573,214 filed 2017–11–10, entitled ‘‘AAV isolate and fusion protein comprising nerve growth factor signal peptide and parathyroid hormone’’ (HHS Reference Number E–175– 2015–1–US–05). IV. Canadian Patent Application No. 2,985,786 filed 2017–11–10, entitled ‘‘AAV PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Number of responses per respondent (total over request period) 1 1 1 1 1 Avg. burden per response (in hours) 1.25 1.25 1 1 1.5 Total/annual burden (in hours) 23 60 9 9 45 isolate and fusion protein comprising nerve growth factor signal peptide and parathyroid hormone’’ (HHS Reference Number E–175– 2015–1–CA–02). 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 treatment of limited number of monogenic inherited retinal diseases that affect the photoreceptors and/or retinal pigmented epithelium. The above-listed patent portfolio covers inventions directed to gene therapy and specifically, expression vectors and therapeutic methods of using such vectors. 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 Institute of Diabetes and Digestive and Kidney Disease 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 E:\FR\FM\29NON1.SGM 29NON1 Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices 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. Dated: November 22, 2021. Vladimir Knezevic, Senior Advisor for Commercial Evaluation, Technology Advancement Office, National Institute of Diabetes and Digestive and Kidney Disease. [FR Doc. 2021–25873 Filed 11–26–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting khammond on DSKJM1Z7X2PROD with NOTICES 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 Aging Special Emphasis Panel; Bone-Muscle Signaling II. Date: December 28, 2021. Time: 12:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20814 (Video Meeting). Contact Person: Nijaguna Prasad, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, 301–496–9667, nijaguna.prasad@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HOMELAND SECURITY National Institutes of Health Federal Emergency Management Agency National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting [Docket ID FEMA–2021–0002; Internal Agency Docket No. FEMA–B–2183] 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 Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Time-Sensitive Obesity PAR. Date: January 7, 2022. Time: 2:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Video Meeting). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, NIDDK, National Institutes of Health, Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898 barnardm@ extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: November 22, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–25874 Filed 11–26–21; 8:45 am] BILLING CODE 4140–01–P Dated: November 22, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–25872 Filed 11–26–21; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 16:55 Nov 26, 2021 Jkt 256001 67713 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Changes in Flood Hazard Determinations Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. AGENCY: This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The currently effective community number is shown in the table below and must be used for all new policies and renewals. SUMMARY: These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities. From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period. DATES: The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA ADDRESSES: E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67712-67713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusivity Under Non-Exclusive Patent 
License: AAV Isolate and Fusion Protein Comprising Nerve Growth Factor 
Signal Peptide and Parathyroid Hormone

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The National Institute of Diabetes and Digestive and Kidney 
Disease and National Institute of Dental and Craniofacial Research, 
institutes of the National Institutes of Health, Department of Health 
and Human Services, are contemplating the grant of an exclusive rights 
under active Non-exclusive Patent License to practice the inventions 
embodied in the United States, European and Japan Applications listed 
in the Supplementary Information section of this notice to Atsena 
Therapeutics, Inc., located in Durham, North Carolina, USA.

DATES: Only written comments and/or applications for a license which 
are received by the National Institute of Diabetes and Digestive and 
Kidney Disease's Technology Advancement Office on or before December 
14, 2021 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: Vladimir Knezevic, MD, (Senior) Advisor for 
Commercial Evaluation, Technology Advancement Office, Building 12A, 
Room 3011, Bethesda, MD 20817-5632 (for business mail), Telephone: 
(301) 435-5560; Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    I. European Patent National Stage: EP3294894 granted 2019-08-14, 
entitled ``AAV isolate and fusion protein comprising nerve growth 
factor signal peptide and parathyroid hormone'' (HHS Reference 
Number E-175-2015-1-EP-03), validated in Great Britain, France and 
Germany.
    II. Japanese Application No. 2017-558710 granted 2020-12-20, 
entitled ``AAV isolate and fusion protein comprising nerve growth 
factor signal peptide and parathyroid hormone'' (HHS Reference 
Number E-175-2015-1-JP-04).
    III. U.S. Patent Application No. 15/573,214 filed 2017-11-10, 
entitled ``AAV isolate and fusion protein comprising nerve growth 
factor signal peptide and parathyroid hormone'' (HHS Reference 
Number E-175-2015-1-US-05).
    IV. Canadian Patent Application No. 2,985,786 filed 2017-11-10, 
entitled ``AAV isolate and fusion protein comprising nerve growth 
factor signal peptide and parathyroid hormone'' (HHS Reference 
Number E-175-2015-1-CA-02).

    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 treatment of limited number of 
monogenic inherited retinal diseases that affect the photoreceptors 
and/or retinal pigmented epithelium.
    The above-listed patent portfolio covers inventions directed to 
gene therapy and specifically, expression vectors and therapeutic 
methods of using such vectors.
    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 
Institute of Diabetes and Digestive and Kidney Disease 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

[[Page 67713]]

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.

    Dated: November 22, 2021.
Vladimir Knezevic,
Senior Advisor for Commercial Evaluation, Technology Advancement 
Office, National Institute of Diabetes and Digestive and Kidney 
Disease.
[FR Doc. 2021-25873 Filed 11-26-21; 8:45 am]
BILLING CODE 4140-01-P
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