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Clinical Validation of Candidate Biomarkers for Neurological Diseases (U01 Clinical Trial Optional)

PAR
Wednesday, February 14, 2018
Tuesday, September 8, 2020
U01
PAR-18-664

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice.

Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional)

PAR
Tuesday, February 13, 2018
Thursday, September 10, 2020
U54
PAR-18-657
David A. Jett

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s). The mission of the CounterACT program is to foster and support research and development of new and improved therapeutics for chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. The scope of the research includes target and candidate identification and characterization, through candidate optimization and demonstration of in vivo efficacy consistent with the product's intended use in humans. For applicants submitting U54 renewal applications, research under this FOA should culminate in an optimized lead compound ready for advanced development. The Centers will contain at least three research projects supported by an administrative core, up to three optional scientific cores, and a research education core. Each research project must include milestones that create discrete go or no-go decision points in a progressive translational study plan.

NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed)

PA
Friday, February 9, 2018
Friday, January 8, 2021
R13
PA-18-648

Funding Opportunity Purpose

The purpose of the NIH Research Conference Grant (R13) is to support high quality conferences that are relevant to the public health and to the scientific mission of the participating Institutes and Centers.

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Monday, February 5, 2018
Clinical Trials Research
Wednesday, January 6, 2021
U44
PAR-18-628

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).

Disease Mechanisms of Prenatal and Pediatric Hydrocephalus (R01 Clinical Trial Not Allowed)

PA
Thursday, February 1, 2018
Saturday, May 8, 2021
R01
PA-18-622

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research of prenatal and pediatric hydrocephalus. This FOA intends to solicit hydrocephalus research projects that examine the developmental etiology (intrinsic factors including genetics) and acquired etiology (extrinsic factors including hemorrhage and infection) of prenatal and/or pediatric hydrocephalus. Studies should focus on understanding the molecular, cellular and developmental mechanisms involved in the pathogenesis of prenatal and/or pediatric hydrocephalus.

NINDS Exploratory Clinical Trials for Small Business (R42) - Clinical Trial Required

PAR
Thursday, February 1, 2018
Clinical Trials Research
Wednesday, January 6, 2021
R42
PAR-18-617

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only STTR Phase II and Fast-Track applications are supported under this program. STTR Phase I applications are only accepted as part of a Fast-track application.

NINDS Exploratory Clinical Trials for Small Business (R44) - Clinical Trial Required

PAR
Thursday, February 1, 2018
Clinical Trials Research
Wednesday, January 6, 2021
R44
PAR-18-618

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.

Tools to Enhance the Study of Prenatal and Pediatric Hydrocephalus (R21 Clinical Trial Not Allowed)

PA
Thursday, February 1, 2018
Saturday, May 8, 2021
R21
PA-18-623

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to encourage research grant applications that propose to develop or substantially modify existing cutting-edge tools that will advance prenatal and/or pediatric hydrocephalus research. The primary objective of this FOA is to remove barriers to hydrocephalus research that are due to scarcity of tools to investigate both the disease mechanisms and alternative therapies (non-shunt) in a rigorous manner. Applications should aim to transform the field of prenatal and/or pediatric hydrocephalus research by generating tools including animal and cell models, novel methods and innovative technologies that will be widely used throughout the neuroscience community to understand disease mechanisms and/or developing therapeutics.

Change of Grantee Organization (Type 7 Parent Clinical Trial Optional)

PA
Friday, January 26, 2018
Clinical Trials Research
Tuesday, January 26, 2021
777
PA-18-590

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notify grantee organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of grantee organization may be submitted in response to this FOA. This assumes such a change is programmatically permitted for the particular grant. Applications for change of grantee organization are considered prior approval requests (as described in Section 8.1.2.7 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although requests for change of grantee organization may be submitted through this FOA, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

Successor-in-Interest (Type 6 Parent Clinical Trial Optional)

PA
Friday, January 26, 2018
Clinical Trials Research
Tuesday, January 26, 2021
666
PA-18-589

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notify grantee organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of grantee organization status, often referred to in this announcement as Successor-In-Interest, may be submitted in response to this FOA. Applications for change of grantee organization status are considered prior approval requests (as described in Section 8.1.2.8 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although successor-in-interest requests may be submitted through this FOA, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

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