Opportunity Information: Apply for RFA NS 16 011
Apply for RFA NS 16 011
- The HHS-NIH11 in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867,.
- This funding opportunity was created on Dec 18, 2015 and posted on Dec 18, 2015.
- Applicants must submit their applications by Apr 26, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The BRAIN Initiative grant opportunity seeks to support small businesses in developing advanced devices for recording and stimulating the human central nervous system to address nervous system disorders. This funding aims to facilitate both non-clinical and clinical studies that are essential for obtaining necessary regulatory approvals, such as an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval.
Eligible activities include developing clinical prototypes, conducting safety and efficacy tests, and preparing for small clinical studies, like Early Feasibility Studies. These studies are crucial for gathering information that goes beyond what is achievable through traditional non-clinical methods, especially given the innovative nature of the devices. The ultimate goal is to generate valuable data to refine device design and function, paving the way for more extensive clinical trials and eventual market entry.
Frequently Asked Questions (FAQs)
1) What is the purpose of this BRAIN Initiative grant opportunity?
This opportunity supports small businesses developing advanced devices that can record from and/or stimulate the human central nervous system, with the aim of addressing nervous system disorders. The funding is intended to help generate the kinds of data needed to move innovative devices toward broader clinical testing and eventual market entry.
2) Who is the intended applicant for this funding?
The opportunity is aimed at small businesses working on advanced central nervous system recording and stimulation devices.
3) What types of devices are in scope?
Devices designed to record and/or stimulate the human central nervous system are in scope, particularly those being developed to address nervous system disorders.
4) What stages of development does the funding support?
The funding supports development activities that bridge non-clinical and clinical work. It is designed to facilitate both non-clinical studies and clinical studies that are essential steps on the pathway to regulatory and ethics approvals and larger clinical trials.
5) What are examples of eligible activities under this opportunity?
Examples of eligible activities include developing clinical prototypes, conducting safety and efficacy tests, and preparing for small clinical studies such as Early Feasibility Studies.
6) Does this opportunity support clinical studies?
Yes. The opportunity is intended to facilitate clinical studies, including small clinical studies like Early Feasibility Studies, when they are essential to move the device forward.
7) Does this opportunity support non-clinical studies?
Yes. The opportunity supports non-clinical studies that are essential for progressing toward required approvals and for informing subsequent clinical work.
8) Why are small clinical studies (like Early Feasibility Studies) emphasized?
Small clinical studies can provide information that may not be achievable using traditional non-clinical methods alone, especially when devices are highly innovative. These studies can help generate practical human-use data that informs design and function.
9) What regulatory or oversight approvals are referenced in the opportunity?
The opportunity specifically references the need for approvals such as an Investigational Device Exemption (IDE) and/or Institutional Review Board (IRB) approval as part of the pathway for conducting certain clinical studies.
10) Is obtaining an IDE or IRB approval part of what the funding is meant to support?
The funding aims to facilitate studies that are essential for obtaining necessary regulatory and ethics approvals, including an IDE and/or IRB approval, where applicable to the proposed work.
11) What kinds of testing are expected to be supported?
The opportunity identifies safety and efficacy tests as eligible activities, supporting the generation of data needed to improve the device and advance it toward broader clinical evaluation.
12) What is meant by "clinical prototypes" in this context?
Based on the opportunity description, clinical prototypes are device versions developed with the intention of being used in clinical-oriented evaluation, including preparation for small clinical studies, and to generate data that informs device refinement.
13) What is the overall goal of the studies supported by this funding?
The overall goal is to generate valuable data to refine device design and function, enabling progress toward more extensive clinical trials and eventual market entry.
14) How does this funding help innovative devices in particular?
Because innovative devices may raise questions that cannot be fully answered through traditional non-clinical methods, the supported non-clinical and clinical work is intended to produce evidence that clarifies performance, safety, and real-world use considerations needed to advance development.
15) What outcomes should a funded project be working toward?
Funded projects should be working toward generating data that supports refinement of the device, readiness for larger clinical trials, and progress along the pathway toward eventual market entry.
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| Funding Opportunity |
|---|
| BRAIN Initiative: SBIR Direct to Phase II Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44) Apply for RFA NS 16 018 Funding Number: RFA NS 16 018 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $1,500,000 |
| Education and Health: New Frontiers (R01) Apply for PAR 16 080 Funding Number: PAR 16 080 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Education and Health: New Frontiers (R03) Apply for PAR 16 079 Funding Number: PAR 16 079 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $50,000 |
| Education and Health: New Frontiers (R21) Apply for PAR 16 078 Funding Number: PAR 16 078 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Basic Biopsychosocial Mechanisms and Processes in the Management of Chronic Conditions (R21) Apply for PAR 16 095 Funding Number: PAR 16 095 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Obesity Policy Evaluation Research (R01) Apply for PA 16 165 Funding Number: PA 16 165 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Administrative Supplements for Research on Sleep Disturbances and Impact on Chronic Pain (Admin Supp) Apply for PA 16 164 Funding Number: PA 16 164 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $100,000 |
| Mentored Research Scientist Development Award (Parent K01) Apply for PA 16 190 Funding Number: PA 16 190 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Revision Applications for U.S-South Africa Program for Collaborative Biomedical Research (U01) Apply for RFA AI 16 040 Funding Number: RFA AI 16 040 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Revision Applications for U.S-South Africa Program for Collaborative Biomedical Research (R01) Apply for RFA AI 16 039 Funding Number: RFA AI 16 039 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Building Interdisciplinary Research Careers in Women's Health (K12) Apply for RFA OD 16 013 Funding Number: RFA OD 16 013 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $500,000 |
| BRAIN Initiative: Foundations of Non-Invasive Functional Human Brain Imaging and Recording - Bridging Scales and Modalities (R01) Apply for RFA MH 17 235 Funding Number: RFA MH 17 235 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $700,000 |
| BRAIN Initiative: New Concepts and Early-Stage Research for Large-Scale Recording and Modulation in the Nervous System (R21) Apply for RFA EY 17 001 Funding Number: RFA EY 17 001 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| BRAIN Initiative: Exploratory Targeted BRAIN Circuits Projects - eTargetedBCP (R21) Apply for RFA NS 17 015 Funding Number: RFA NS 17 015 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations (Admin Supp) Apply for PA 17 098 Funding Number: PA 17 098 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $100,000 |
| BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP (U01) Apply for RFA NS 18 008 Funding Number: RFA NS 18 008 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01) Apply for RFA NS 18 010 Funding Number: RFA NS 18 010 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP (U01 Clinical Trial Not Allowed) Apply for RFA NS 18 029 Funding Number: RFA NS 18 029 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Clinical Trial Required) Apply for RFA NS 19 002 Funding Number: RFA NS 19 002 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Clinical Trial Not Allowed) Apply for RFA NS 19 003 Funding Number: RFA NS 19 003 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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