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Over the next several years, the FAS Research Development group will track and disseminate all funding opportunities related to the BRAIN Initiative. These funding opportunities will be sent to a targeted list of faculty. That list includes 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. All opportunities will be archived and recipients may unsubscribe at any time.
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BRAIN Initiative Opportunities
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National Institutes of Health
BRAIN Initiative: Pre-Applications for Industry Partnerships to Provide Early Access to Devices for Stimulation and Recording in the Human Central Nervous System (X02)
Sponsor Deadline for LOIs (requested): October 18, 2015
Sponsor Deadline for Pre-Applications: November 18, 2015
OSP Deadline: November 11, 2015
Award Information: No awards will be made under this FOA; meritorious pre-applications will result in the opportunity to submit a UG3/UH3 or UH3 application under RFA-NS-16-010 or RFA-NS-16-009
This FOA is intended to facilitate partnerships between clinical investigators and manufacturers of latest-generation stimulating and/or recording devices that are FDA-designated as Class III (invasive, posing significant risk of harm), to conduct clinical research in the central nervous system. As part of The BRAIN Initiative, NIH has initiated a Public-Private Partnership program (BRAIN PPP) to reduce barriers to negotiating such partnerships, and to ensure that new clinical studies leverage manufacturers' existing data demonstrating safety and utility of these devices. Safety and utility data for invasive devices are costly to obtain, yet they are necessary for regulatory approval of human research, and therefore pose a substantial barrier to research progress. For this program, NIH has entered into agreements with a number of manufacturers to make available next generation devices that can stimulate and/or record from the central nervous system and have sufficient data to enable new Non-Significant Risk (NSR) or Investigational Device Exemption (IDE) without the need for significant additional testing.
This FOA encourages X02 pre-applications to utilize manufacturer offered devices to perform exploratory clinical research studies, including but not limited to proof-of-concept studies for new therapeutic indications, new therapy modalities, or utilizing devices to address fundamental questions of human neurobiology. Although not required, the X02 pre-application process is encouraged for submission to companion announcements RFA-NS-16-010 or RFA-NS-16-009 (see below for these opportunities); applicants should read the appropriate companion FOA for the proposed project prior to submission. The X02 pre-applications will be evaluated by a panel of outside experts for scientific and technical merit. Investigators whose X02 pre-applications are judged to be meritorious will be notified of the opportunity to submit a UG3/UH3 or UH3 application under RFA-NS-16-009 or RFA-NS-16-010, and will be provided contact information to work with the relevant manufacturer to develop full applications. No awards will be made under this X02 FOA.
A technical assistance teleconference will be held for this announcement at a yet unspecified date, and prospective applicants are invited to participate. In order to support the number of participants on the conference call, participants are encouraged to send an email to BRAIN-FOAs@nih.gov to indicate their interest in participating, and will be notified of registration information as soon as it becomes available. Suggestions for questions to be addressed at this webinar may also be submitted to BRAIN-FOAs@nih.gov. Answers to the questions will be available on the BRAIN PPP website after the call.
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National Institutes of Health
BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3)
Sponsor Deadline for Applications: April 26, 2016
OSP Deadline: April 19, 2016
Award Information: Up to $2M per year in direct costs; the UG3 phase cannot exceed 4 years and the total duration of the UG3/UH3 phases combined may not exceed 5 years
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. All projects will have two phases. The program will utilize a cooperative agreement mechanism to support nonclinical testing (the initial UG3 phase) to support the filing 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 study (UH3 phase). The small clinical study 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 study 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 study.
Potential applicants should note that companion to this FOA is an X02 pre-application ( PAR-15-345), for researchers wishing to partner with corporate manufacturers of latest- or next-generation devices to take advantage of their existing safety and utility data for FDA or IRB approval of new clinical research studies. 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. Though not required, PAR-15-345 encourages X02 pre-applications from those investigators interested in collaborating with a device manufacturer through the BRAIN PPP. The X02 pre-applications will be evaluated by a panel of outside experts for scientific and technical merit. Investigators whose X02 pre-applications are judged to be meritorious will be notified of the opportunity to submit an application under RFA-NS-16-009 (UG3/UH3) or RFA-NS-16-010 (UH3), and will be provided contact information to work with the relevant manufacturer to develop full applications. Individuals, institutions or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to RFA-NS-16-009 or RFA-16-010 without an X02 pre-application.
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National Institutes of Health
BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3)
Sponsor Deadline for Applications: April 26, 2016
OSP Deadline: April 19, 2016
Award Information: Up to $2M per year in direct costs for up to 5 years
The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue a small clinical study 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 study 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 study 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 study to answer key questions about the function or final design of a device.
Potential applicants should note that companion to this FOA is an X02 pre-application ( PAR-15-345), for researchers wishing to partner with corporate manufacturers of latest- or next-generation devices to take advantage of their existing safety and utility data for FDA or IRB approval of new clinical research studies. 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.
Though not required, PAR-15-345 encourages X02 pre-applications from those investigators interested in collaborating with a device manufacturer through the BRAIN PPP. The X02 pre-applications will be evaluated by a panel of outside experts for scientific and technical merit. Investigators whose X02 pre-applications are judged to be meritorious will be notified of the opportunity to submit an application under RFA-NS-16-009 (UG3/UH3) or RFA-NS-16-010 (UH3), and will be provided contact information to work with the relevant manufacturer to develop full applications. Individuals, institutions or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to RFA-NS-16-009 or RFA-16-010 without an X02 pre-proposal.
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National Institutes of Health
BRAIN Initiative: Foundations of Non-Invasive Functional Human Brain Imaging and Recording - Bridging Scales and Modalities (R01)
Sponsor Deadline for LOIs (requested): December 6, 2015
Sponsor Deadline for Applications: January 6, 2016
OSP Deadline: December 30, 2015
Award Information: Up to $700,000 in direct costs per year for up to 5 years
This FOA aims to support transformative discoveries that will lead to breakthroughs in understanding human brain function. Guided by the long-term scientific plan, "BRAIN 2025: A Scientific Vision," this FOA specifically seeks to support efforts that will revolutionize our understanding of the biological activity underlying, and bioinformatic content of, data collected using contemporary non-invasive functional brain imaging techniques. The hope is that these transformative discoveries will lead to breakthroughs in understanding the dynamic activity of the human brain.
Making progress in overcoming obstacles in one discipline often requires research approaches from another discipline. Achieving the goals of this FOA will likely require collaborative efforts between imaging scientists, physicists, mathematicians, computational and informatic theorists, engineers, biologists, neuroscientists, clinical scientists, and behavioral scientists. If necessary to achieve the goals, investigators are strongly encouraged to form teams to work across the translational spectrum, including pre-clinical studies in small and large animal species. Partnerships with industry are also encouraged. It is anticipated that progress on specific key questions will be enhanced by interdisciplinary collaborations. This FOA is designed to provide resources to leverage transformative, interdisciplinary approaches to human brain imaging and functional evaluation techniques.
A Technical Assistance phone conference will be held for potential applicants on Monday, December 7, 2015, at 1:00-2:00pm EST. NIH staff will be available to answer questions related to this FOA. To obtain call-in information, please email BRAIN-info-NIMH@mail.nih.gov at least 24 hours prior to the call and specify the FOA number in the subject line or in the body of the email.
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Contact Us:
Questions about this announcement or proposal submission may be directed to Jennifer Corby
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