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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
Jill Morris

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
Tuesday, April 6, 2021
R42
PAR-18-617
Emily Caporello

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
Tuesday, April 6, 2021
R44
PAR-18-618
Emily Caporello

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.

Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed )

PA
Thursday, January 25, 2018
Wednesday, September 8, 2021
333
PA-18-592

Funding Opportunity Purpose

The Office of Research on Women's Health (ORWH) and participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) announce the continuation of the program for administrative supplements to research grants to support individuals with high potential to re-enter an active research career after an interruption for family responsibilities or other qualifying circumstances. The purpose of these supplements is to encourage such individuals to re-enter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals to update their existing research skills and knowledge.

NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials Optional)

PAR
Tuesday, January 9, 2018
Clinical Trials Research
Tuesday, April 6, 2021
U44
PAR-18-563

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials 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. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.

BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 - Clinical Trial Required)

RFA
Thursday, December 21, 2017
Tuesday, February 23, 2021
UH3
RFA-NS-18-023
Nick Langhals

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 - Clinical Trial Required)

RFA
Thursday, December 21, 2017
Translational Research
Tuesday, February 23, 2021
UG3/UH3
RFA-NS-18-021
Nick Langhals

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational and clinical studies for recording and/or stimulating devices to treat nervous system disorders and better understand the human brain. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and a subsequent small clinical trial (e.g., Early Feasibility Study). The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional nonclinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)

RFA
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Tuesday, February 23, 2021
U44
RFA-NS-18-022
Kari Ashmont

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical trial (e.g., Early Feasibility Study). Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

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