Since the BRAIN Initiative's launch in 2013, FAS Research Development has disseminated information via this newsletter about all of the funding opportunities related to the initiative. We send this newsletter to a targeted list of faculty, including  faculty affiliates  of the  Center for Brain Science  (CBS) and the  Mind Brain Behavior  (MBB) Interfaculty Initiative. This project is being carried out in collaboration with the Center for Brain Science.  Please feel free to forward this newsletter  to interested colleagues. All Harvard University faculty and administrators may subscribe here , and recipients may unsubscribe at any time. For an archive of past newsletters, or for information about additional Research Development support (finding funding, proposal development resources, etc.), please visit the Research Development website .  
Funding Opportunities
Sponsor Deadline for Letters of Intent (requested):  30 days prior to the Full Proposal deadline 
OSP Deadline:  5 business days prior to submission 
Sponsor Deadlines for Full Proposals: February 23, 2018; June 21, 2018; October 22, 2018; February 21, 2019; June 21, 2019; October 21, 2019; February 21, 2020; June 22, 2020; October 21, 2020
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. The duration of the UG3 phase cannot exceed 4 years and the total duration of the UG3/UH3 phases combined may not exceed 5 years. The NIH anticipates providing $10M per year to fund an estimated 5 to 7 awards.  
   
The purpose of this 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.

Individuals, institutions or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or RFA-NS-18-023.
Sponsor Deadline for Letters of Intent (requested):  30 days prior to the Full Proposal deadline 
OSP Deadline:  5 business days prior to submission 
Sponsor Deadlines for Full Proposals: February 23, 2018; June 21, 2018; October 22, 2018; February 21, 2019; June 21, 2019; October 21, 2019; February 21, 2020; June 22, 2020; October 21, 2020
Award Information: Application budgets are not limited but need to reflect the actual needs of the proposed project. Budgets should rarely exceed $2M per year. The total duration may not exceed 5 years. The NIH anticipates providing $10M per year to fund an estimated 5 to 7 awards. 
  
The purpose of this 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.

Individuals, institutions or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or  RFA-NS-18-021.
News & Announcements
Questions about this newsletter or proposal submission may be directed to:

Jennifer Corby
Research Development Officer
jcorby@fas.harvard.edu | 617-495-1590

To see previous BRAIN Initiative Funding Newsletters, please visit our  email archive.
Research Development | Research Administration Services | research.fas.harvard.edu