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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
Thursday, October 22, 2020
UH3
RFA-NS-18-023

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
Thursday, October 22, 2020
UG3/UH3
RFA-NS-18-021

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
Thursday, October 22, 2020
U44
RFA-NS-18-022

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.

NeuroNEXT Clinical Trials (U01 - Clinical Trial Optional)

PAR
Thursday, December 21, 2017
Friday, January 8, 2021
U01
PAR-18-528

Funding Opportunity Purpose

This FOA encourages 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 a future trial, for biomarker validation studies, or for proof of mechanism 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). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional)

PAR
Wednesday, December 20, 2017
Translational Research, Clinical Trials Research
Saturday, May 8, 2021
U44
PAR-18-543
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional)

PAR
Wednesday, December 20, 2017
Translational Research
Saturday, May 8, 2021
U01
PAR-18-542
Chris Boshoff

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

BRAIN Initiative: Targeted BRAIN Circuits Planning Projects TargetedBCPP (R34 - Clinical Trials Not Allowed)

RFA
Thursday, December 14, 2017
Wednesday, November 10, 2021
R34
RFA-NS-18-014

Funding Opportunity Purpose

This R34 FOA solicits applications that offer a limited scope of aims and an approach that will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent Targeted Brain Circuits Projects - TargetedBCP R01, as described in the companion FOA (RFA-NS-18-009). Applications should be exploratory research projects that use innovative, methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior.

NINDS Faculty Development Award to Promote Diversity in Neuroscience Research (K01) - Clinical Trial Not Allowed

PAR
Thursday, December 7, 2017
Workforce Diversity
Saturday, May 8, 2021
K01
PAR-18-490

Funding Opportunity Purpose

The purpose of the NINDS Faculty Development Award to Promote Diversity in Neuroscience Research (K01) is to diversify the pool of independent neuroscience research investigators by providing junior faculty with research cost support, protected research time and career stage appropriate professional development mentorship in neuroscience research. Individuals from backgrounds underrepresented in biomedical research are eligible for support under this award if they have doctoral research degrees (Ph.D. or equivalent) and are in the first 3 years of a faculty tenure track or equivalent position at the time of award.

NINDS Faculty Development Award to Promote Diversity in Neuroscience Research (K01) - Clinical Trial Required

PAR
Thursday, December 7, 2017
Workforce Diversity
Saturday, May 8, 2021
K01
PAR-18-486

Funding Opportunity Purpose

The purpose of the NINDS Faculty Development Award to Promote Diversity in Neuroscience Research (K01) is to diversify the pool of independent neuroscience research investigators by providing junior faculty with research cost support, protected research time and career stage appropriate professional development mentorship in neuroscience research. Individuals from backgrounds underrepresented in biomedical research are eligible for support under this award if they have doctoral research degrees (Ph.D. or equivalent) and are in the first 3 years of a faculty tenure track or equivalent position at the time of award.

NINDS Advanced Postdoctoral Career Transition Award to Promote Diversity in Neuroscience Research (K22) - Clinical Trial Not Allowed

PAR
Monday, December 4, 2017
Workforce Diversity
Saturday, May 8, 2021
K22
PAR-18-469

Funding Opportunity Purpose

The NINDS Advanced Postdoctoral Career Transition Award to Promote Diversity is designed to enhance the participation of highly trained early career investigators from diverse backgrounds underrepresented in neuroscience research. This opportunity provides individuals from diverse backgrounds with strong training in neuroscience with the resources and tools that will help facilitate a transition to a stable and productive independent research position. Individuals from diverse backgrounds underrepresented in neuroscience research are eligible for support under this award if they have doctoral research degrees (Ph.D., Ph.D./M.D. or equivalent) and between 2 and 5 years of postdoctoral prior research training at the time of application. The primary objectives of this Funding Opportunity Announcement (FOA) are to: (1) assist talented scientists from underrepresented groups to transition from postdoctoral training to a secure, independent research position and (2) enhance the conditions that promote establishing a strong and innovative independent program of research.

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