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Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

PA
Tuesday, October 13, 2020
Tuesday, October 24, 2023
333
PA-20-272

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notify Program Directors/Principal Investigators (PD(s)/PI(s)) holding specific types of NIH research grants listed in the full Funding Opportunity Announcement (FOA) that funds may be available for administrative supplements to meet increased costs that are within the scope of the approved award, but were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted. Applications for administrative supplements are considered prior approval requests (as described in Section 8.1.2.11 of the NIH Grants Policy Statement) and will be routed directly to the Grants Management Officer of the parent award. Although requests for administrative supplements may be submitted through this FOA, there is no guarantee that funds are available from the awarding IC or for any specific grant. All applicants are encouraged to discuss potential requests with the awarding IC. Additionally, prior to submission, applicants must review the awarding IC's web site to ensure they meet the IC's requirements. A list of those web sites is available at https://grants.nih.gov/grants/guide/admin_supp/index.htm.

BRAIN Initiative: Pilot resources for brain cell type-specific access and manipulation across vertebrate species (U01 Clinical Trial Not Allowed)

RFA
Thursday, September 17, 2020
Wednesday, October 20, 2021
U01
RFA-MH-20-556

Funding Opportunity Purpose

This FOA is related to the transformative project, "A Cell Type-Specific Armamentarium for Understanding Brain Function and Dysfunction," described in the "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" report of the Advisory Committee to the NIH Director BRAIN Initiative Working Group 2.0.

HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

RFA
Wednesday, September 16, 2020
Thursday, September 8, 2022
UG3/UH3
RFA-NS-21-010

Funding Opportunity Purpose

Reissue of RFA-NS-20-010: The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads towards clinical trials. Applicants must have a promising hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, and assembly of Investigational New Drug (IND) application. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

Notice of Special Interest: Administrative Supplement for the NINDS Research Education Program for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (Admin Supp)

Notice of Special Interest
Friday, September 11, 2020
Sunday, October 30, 2022
NOT-NS-20-038

Funding Opportunity Purpose

This Notice of Special Interest encourages administrative supplements for the NINDS Research Education Program for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (R25, PAR-13-384 and subsequent reissuances)

Notice of Special Interest (NOSI): Research in the Emergency Setting

Notice of Special Interest
Tuesday, September 8, 2020
Thursday, September 8, 2022
NOT-NS-20-005
Jeremy Brown

Funding Opportunity Purpose

Purpose The purpose of this Notice is to announce an interest in research addressing patients with emergency medical conditions, including trauma. Background Over 145 million people are seen in emergency departments across the US. Emergency departments are the source of twelve million admissions, or 35% of all hospital admissions and 14% of all outpatient visits. This includes over 27 million children under the age of 15, 23 million adults over the age of 65 and over 42 million visits for injuries and major trauma. When they learn of a patient's new symptoms, primary care providers often use the emergency department to obtain rapid diagnostic tests and a treatment plan. Emergency Departments are the only component of the country's healthcare system that is accessible at any time of the day or night, and by law they provide treatment regardless of the ability to pay. Rapid assessment and treatment within the first minutes or hours after the onset of illness plays a major role in determining both the trajectory of recovery and future healthcare costs. Research in the emergency setting offers a unique opportunity to improve not only the treatment of acute life-threatening disorders, but also a spectrum of common disorders that encompass a considerable burden of illness and account for a major component of health care costs.

Notice of Special Interest: Administrative Supplements for Connecting Pre-mortem Clinical Information with Post-Mortem Brain Analysis

Notice of Special Interest
Wednesday, August 26, 2020
Tuesday, June 29, 2021
333
NOT-NS-21-001
Debra Babcock

Funding Opportunity Purpose

The Lewy Body Dementias (LBD) are frequently misdiagnosed or underdiagnosed during life, and despite the development of diagnostic criteria at multiple expert consensus conferences, the gold standard for diagnosis remains post-mortem brain analysis. Improvement in diagnostic accuracy during life, and the development of good quality diagnostic biomarkers, would be greatly facilitated if comprehensive, longitudinal clinical and biological data obtained on patients during life were regularly linked with detailed post-mortem brain examination. In response to recommendations from the Alzheimer's Disease Related Dementias (ADRD) Summits convened by the NINDS in 2013, 2016, and 2019, longitudinal clinical data and biospecimens are being collected from patients with LBD and shared with the research community through the Parkinsons Disease Biomarker Program (PDBP). The PDBP is an NINDS-funded resource that collects standardized clinical data and biospecimens longitudinally on patients with Parkinson's Disease (PD) and PD-related disorders (including LBD) with the goal of accelerating the pace of biomarkers research. The PDBP currently has data and biospecimens on about 1900 subjects, some of whom have gone to autopsy, though relatively little post-mortem data on these subjects is available in PDBP at this time. This NOSI encourages researchers with extensive pre- and post-mortem data on patients with LBD to apply for supplemental funds to be used for the purpose of adding this data to the existing NINDSPDBP repository. Supplements may be requested by: Researchers who have previously contributed clinical and biospecimen data to the PDBP on patients with LBD while alive, and who wish to add the post-mortem autopsy data they have collected on the same patient(s) after their death.

Notice of Special Interest (NOSI): Platform Trials of Thrombectomy in Acute Stroke Treatment

Notice of Special Interest
Wednesday, August 5, 2020
Thursday, July 15, 2021
UG3/UH3
NOT-NS-20-095

Funding Opportunity Purpose

Notice Special Interest NOSI): Platform Trials Thrombectomy Acute Stroke Treatment Notice Number: NOT-NS-20-095 Key Dates Release Date: August 5, 20 First Available Due Date: October 14, 2020 Expiration Date: July 15, 2021 Related Announcements PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS issuing Notice Special Interest applications establish master protocol conduct platform trials treatments ischemic stroke due large vessel occlusion. Master protocols should incorporate advanced clinical trial methodologies such as, not limited to, Bayesian modeling, response adaptive randomization, shared controls, the ability treatment arms enter, leave, be combined. Master protocols must designed allow future addition trial questions. Strong representation expertise the neurology, neurosurgery, interventional communities required such multi-disciplinary approach will expected applicants. Research Objectives Recent pivotal interventional trials patients ischemic stroke due large vessel occlusion shown mechanical thrombectomy be highly beneficial certain groups patients to 24 hours after last known well. However, questions remain the potential benefit harm thrombectomy specific subgroups patients certain ischemic stroke phenotypes. Also interest considerations such pre-hospital care peri-procedural management strategies. Further, success mechanical thrombectomy raises possibility a new era neuroprotection patients large vessel ischemic stroke. Promising neuroprotectants failed trials predated successful reperfusion, well newer agents have potential remain untested, ripe consideration this new environment. NINDS interested master protocols enable platform trials answer above questions using seamless rolling approach. Trials further refine patient groups do do benefit mechanical thrombectomy, using management approaches, also open door testing neuroprotectant strategies an efficient, timely, cost-effective manner. Clinical study protocols consist acute short-term procedures are deemed Non-Significant Risk NSR) an Institutional Review Board IRB), Significant Risk SR) studies require Investigational Device Exemption IDE) the FDA. Evidence contact appropriate U.S. regulatory bodies e.g., IRB NSR studies and/or FDA the form either Pre-Submission meeting IDE submission SR studies recommended. Applicants must the resources ability do work without critically impacting high-priority, on-going NINDS research programs. Investigators planning submit application response the NOSI strongly encouraged contact program officer listed below discuss proposed project. Application Submission Information notice applies due dates or after October 14, 2020 subsequent receipt dates through July 14, 2021.  Applications this initiative must submitted using following funding opportunity announcement FOA) any reissues these announcement through expiration date this notice: PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-NS-20-095” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications non-responsive terms this NOSI be be considered the NOSI initiative. Applications nonresponsive terms this NOSI will not considered the NOSI initiative. Inquiries Please direct inquiries the Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)

PAR
Wednesday, July 29, 2020
Monday, July 24, 2023
UG3/UH3
PAR-20-285

Funding Opportunity Purpose

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

Ethical, Legal and Social Implications (ELSI) (Research R01 Clinical Trial Optional)

PAR
Tuesday, July 28, 2020
Thursday, July 20, 2023
R01
PAR-20-254
Khara Ramos

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites Research Project Grant (R01) applications that propose to study the ethical, legal and social implications (ELSI) of human genome research. Applications may propose studies using either single or mixed methods. Proposed approaches may include but are not limited to data-generating qualitative and quantitative approaches, legal, economic and normative analyses, and other types of analytical and conceptual research methodologies, such as those involving the direct engagement of stakeholders.

Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21) (Clinical Trial Optional)

PAR
Tuesday, July 28, 2020
Thursday, July 20, 2023
R21
PAR-20-255
Khara Ramos

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal and social implications (ELSI) of human genome research. These applications should propose single or mixed methods studies that break new ground, extend previous discoveries in new directions or develop preliminary data in preparation for larger studies. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information.

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