National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting., 91774-91775 [2024-27047]

Download as PDF khammond on DSK9W7S144PROD with NOTICES 91774 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices Human Services, is contemplating the grant of an exclusive, sublicensable patent license to The Trustees of Columbia University in the City of New York, Columbia Technology Ventures, located in New York, New York to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before December 5, 2024 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Wade Green, Ph.D., Lead Technology Transfer and Patent Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Suite 2G, MSC9804, Rockville, MD 20852–9804, phone number 301–761–7505, or wade.green@nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: U.S. Provisional Patent Application Serial No. 68/ 428,826, filed November 30, 2022, titled ‘‘Peptides And Peptide Microarrays For Detection And Differentiation Of Antibody Responses To Ebola Virus And Other Pathogens’’ (HHS Reference No. E–028–2024–0–US–01) and International Patent Application No. PCT/US23/81625, filed on November 29, 2023, titled ‘‘Peptides And Peptide Microarrays For Detection And Differentiation Of Antibody Responses To Ebola Virus’’ (HHS Reference No. E– 028–2024–0–PC–01). All rights in these inventions have been assigned to The Trustees of Columbia University in the City of New York, Columbia Technology Ventures and the Government of the United States of America. The prospective patent license will be for the purpose of consolidating the patent rights with The Trustees of Columbia University in the City of New York, Columbia Technology Ventures, the co-owner of said rights, for commercial development and marketing. Consolidation of these coowned rights is intended to expedite development of the invention, consistent with the goals of the BayhDole Act codified as 35 U.S.C. 200–212. The prospective interinstitutional agreement will include an exclusive license for NIAID’s rights in these VerDate Sep<11>2014 18:39 Nov 19, 2024 Jkt 265001 jointly owned patents. It will be sublicensable, and any sublicenses granted by The Trustees of Columbia University in the City of New York Columbia Technology Ventures will be subject to the provisions of 37 CFR part 404. The subject patent rights are related to novel peptides that enable specific and sensitive serological detection of adaptive immune responses to a wide range of clinically important high threat pathogens circulating in sub-Saharan Africa on a wide range of platforms. These assays allow identification of individuals who have been immunized and/or infected with filoviruses. 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 may be granted unless within fifteen (15) days from the date of this published notice, the National Insitute of Allergy and Infectious 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. Dated: November 15, 2024. Jeremiah D. Mitzelfelt, Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2024–27096 Filed 11–19–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting Pursuant to section 1009 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 PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 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 Center for Advancing Translational Sciences Special Emphasis Panel; Tissue Chips in Space 2.0. Date: February 13–14, 2025. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Address: National Center for Advancing Translational Sciences, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD 20892 (Virtual). Contact Person: Alumit Ishai, Ph.D., Scientific Review Officer, Office of Grants Management and Scientific Review, National Center for Advancing Translational Sciences, National Institutes of Health, 9609 Medical Center Drive, Suite 1E504, Bethesda, MD 20892, (301) 827–5819, alumit.ishai@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: November 14, 2024. David W. Freeman, Supervisory Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–27046 Filed 11–19–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting. Pursuant to section 1009 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. E:\FR\FM\20NON1.SGM 20NON1 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Clinical Trial Readiness Review Meeting. Date: December 13, 2024. Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Address: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852. Meeting Format: Virtual Meeting. Contact Person: Ana Olariu, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH/DHHS, NSC, 6001 Executive Boulevard, Rockville, MD 20852, 301–496– 9223 Ana.Olariu@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS). Dated: November 14, 2024. David W. Freeman, Supervisory Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–27047 Filed 11–19–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request khammond on DSK9W7S144PROD with NOTICES Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–0361. Project: Zero Suicide in Health Systems Evaluation—New Package The Substance Abuse and Mental Health Services Administration (SAMHSA)’s Center for Mental Health Services (CMHS) is requesting clearance for the new data collection associated with the evaluation of the SAMHSA Zero Suicide in Health Systems (Zero Suicide Evaluation). The Zero Suicide program is authorized under the CURES Act. SAMHSA is required to evaluate the Zero Suicide grant, specifically (1) evaluate the activities supported by grants awarded, disseminate, as appropriate, the findings from the evaluation; and (2) provide appropriate information, training, and technical assistance, as appropriate, to eligible VerDate Sep<11>2014 18:39 Nov 19, 2024 Jkt 265001 entities that receive a grant under this section, in order to help such entities to meet the requirements of this section, including assistance with selection and implementation of evidence. The goal of the Zero Suicide program is the reduction of suicide and suicide attempts across America, focusing on individuals who are 25 years and older. The purpose of this program is to implement the Zero Suicide intervention and prevention model for adults throughout a health system or systems. The Zero Suicide model is a comprehensive, multi-setting approach to suicide prevention in health systems. To accomplish this critical, lifesaving work, it is essential that the effectiveness of these programs be evaluated on an ongoing basis, with implementation of suicide prevention programs continually informed by highquality evaluation results. SAMHSA will use this data to reduce suicide ideation, suicide attempts, and deaths due to suicide. SAMHSA has awarded new grants and continued funding to 25 grantees, Cohort 5 (15 grantees) with project period of Sept 30, 2023, to Sept 29, 2028; and Cohort 4 (10 grantees; includes one tribal organization) with project period of March 31, 2021, to March 30, 2026. SAMHSA has requested funding for 11 grantees to be funded as Cohort 6 in the fiscal year 2025. The Zero Suicide Evaluation is designed to evaluate the implementation, effectiveness, and overall impact of the Zero Suicide program upon grantees in the United States. The evaluation will assess Zero Suicide program activities implemented by grantees and ultimately provide SAMHSA with the information needed to understand and document program effectiveness on reducing suicide morbidity and mortality, specifically among those who encounter the healthcare system. While acknowledging the lack of evidence for cultural adaptations to evidence-based and empirically supported treatments and interventions, and that research has not been conducted with historically marginalized and underserved communities (e.g., Black, Asian, Autistic, Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual Plus (LGBTQIA+), and others), Zero Suicide pushes systems to ensure that clients’ cultural contexts are considered and honored in what treatments are offered and how those treatments are adapted. Thus, with behavioral health equity as a central component woven throughout the Zero PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 91775 Suicide Framework, the proposed evaluation will ensure that each study includes specific behavioral health equity tenets to ensure a culturally specific understanding of Zero Suicide implementation, outcomes, and impacts. The Zero Suicide Evaluation includes four studies: Systems Change, Work Force, Consumer Experience, and Impact. The purpose of the Systems Change Study is to understand how grantees are implementing the Zero Suicide Program. The Systems Change Study collection instruments include the: Prevention Strategies Inventory (PSI), Behavioral Health Provider Survey (BHPS), Case Studies, and Cost Sub-Studies. The purpose of the Workforce Study is to document staff awareness and perceptions associated with the Zero Suicide activities implemented by Zero Suicide-participating Healthcare Organizations (HCOs). The Workforce Study instruments include the: Work Force Survey (WFS), Training Activity Summary Page (TASP), and the Training Utilization and Preservation Survey (TUPS). The purpose of Consumer Experience Study is to understand the relationship between Zero Suicide activities and key clinical outcomes (i.e., suicide risk, depression), along with consumer perceptions of care, access to care, services received, and treatment adherence. The Consumer Experience Study instruments include the: BHPS, Consumer Experience Survey (CES), Clinical Outcomes Form (COF), and Grantee Performance Data. The Impact Study will use secondary data and quasi-experimental designs to develop a control group and estimate the causal impact of the Zero Suicide Program on suicide morbidity and mortality. Ultimately, the purpose of the Zero Suicide Evaluation is to build the program’s knowledge base of effectiveness by thoroughly describing the implementation, outcomes, and impact of a program meant to reduce deaths by suicide. The total annualized burden is an estimated 15,504 respondents for the Zero Suicide instruments, with a combined hourly estimate to be 4,902 hours. Burden estimates are based on the data collection requirements and the number of respondents. The estimated response burden to collect this information associated with the Zero Suicide Evaluation annualized over the requested 3-year clearance period is presented below: E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91774-91775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27047]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke; Notice 
of Closed Meeting.

    Pursuant to section 1009 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.


[[Page 91775]]


    Name of Committee: National Institute of Neurological Disorders 
and Stroke Special Emphasis Panel; Clinical Trial Readiness Review 
Meeting.
    Date: December 13, 2024.
    Time: 10:00 a.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Address: National Institutes of Health, Neuroscience Center, 
6001 Executive Boulevard, Rockville, MD 20852.
    Meeting Format: Virtual Meeting.
    Contact Person: Ana Olariu, Ph.D., Scientific Review Officer, 
Scientific Review Branch, Division of Extramural Activities, NINDS/
NIH/DHHS, NSC, 6001 Executive Boulevard, Rockville, MD 20852, 301-
496-9223 [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.853, 
Clinical Research Related to Neurological Disorders; 93.854, 
Biological Basis Research in the Neurosciences, National Institutes 
of Health, HHS).

    Dated: November 14, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee 
Policy.
[FR Doc. 2024-27047 Filed 11-19-24; 8:45 am]
BILLING CODE 4140-01-P

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