Notices of Funding Opportunities

Notice Support Administrative Supplements Embed Ethicists BRAIN Initiative Supported Research Notice Number: NOT-MH-18-034 Key Dates Release Date: 01, 2018 Related Announcements None Issued National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative aimed revolutionizing neuroscience through development application innovative technologies map neural circuits, monitor modulate activity, understand they contribute thoughts, sensations, emotions behavior. NIH issued variety Funding Opportunity Announcements FOAs) will support projects apply technologies understand neural circuit function the context specific circuits, resulting a diverse portfolio research the fundamental biology nervous system function.  purpose this announcement to notify research community NIH encouraging applications to PA-18-591 to integrate neuroethics perspectives approaches existing BRAIN Initiative awards. Supplement applications encouraged ongoing BRAIN Initiative projects can readily incorporate core ethical issues associated research focused the human brain resulting emerging technologies advancements research development supported the BRAIN Initiative. intent that efforts supported through administrative supplement be both complimentary integrative the transformative, breakthrough neuroscience discoveries supported through BRAIN Initiative.   an administrative supplement, work proposed needs be within scope the research is already supported. Research proposed supplement applications should clear relevance the BRAIN Initiative. proposed work cover pilot projects, resource development, personnel costs embedding neuroethics the research project. each case, work proposed should feasible complete within one-year timeframe with limited funds permitted. should also show promise becoming more substantial project might attract additional funding. Investigators should submit applications responses the parent active administrative supplement announcement https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html) using electronic submission. Electronic applications strongly encouraged.. Individual requests be more 100,000 direct costs exclusive Facilities Administrative costs sub-contracts may for year only. Requests must received June 15 funding FY 2018. Inquiries Please direct inquiries to: James Churchill National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: churchillj@mail.nih.gov 

Notice NINDS BRG, BRP, Translational Neural Devices, BRAIN Initiative: Next Generation Invasive Devices Recording, Modulation the Human Central Nervous System, Smart & Connected Health Program Applications Directed the Treatment Pain Notice Number: NOT-NS-18-052 Key Dates Release Date: March 27, 2018 Related Announcements PAR-18-206 PAR-18-208 RFA-NS-18-011 RFA-NS-18-012 RFA-NS-18-021 RFA-NS-18-022 RFA-NS-18-023 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) Bioengineering Research Grants BRG), Bioengineering Research Partnerships BRP), Translational Neural Devices, BRAIN Initiative: Next Generation Invasive Devices Recording Modulation the Human Central Nervous System, Smart Connected Health Funding Opportunity Announcements an area special interest.  NINDS like accelerate development devices the treatment pain. Investigators strongly encouraged contact appropriate Program Director prior submitting application. Applications be submitted to: PAR-18-206 (BRG), PAR-18-208 (BRP), RFA-NS-18-011 (Translational Neural Devices), RFA-NS-18-012 (Translational Neural Devices - SBIR), RFA-NS-18-021 (BRAIN Initiative), RFA-NS-18-022 (BRAIN Initiative), RFA-NS-18-023 (BRAIN Initiative - SBIR), and NSF-18-541 (Smart Connected Health).      Within BRG BRP programs, NINDS particularly interested bioengineering research advances technologies the potential decrease burden neurological disorders stroke, including pain. Examples areas interest include development validation invasive non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, other innovative methods.   Translational Neural Devices program interested receiving applications translational studies devices treat pain. Translational Neural Devices supports translational activities small clinical studies advance development invasive non-invasive therapeutic, diagnostic devices disorders affect nervous neuromuscular systems. Program activities, including translational bench animal studies, expected lead submission an Investigational Device Exemption IDE) the U.S. Food Drug Administration FDA) Institutional Review Board IRB) application a Non-Significant Risk NSR) study. program also support subsequent small clinical trial collect safety effectiveness data required support marketing application to inform final device design.   BRAIN Initiative: Next Generation Invasive Devices Recording Modulation the Human Central Nervous System program supports translational and/or clinical studies invasive recording and/or stimulating devices treat nervous system disorders, including support the submission an Investigational Device Exemption IDE) a Significant Risk SR) study obtain Institutional Review Board IRB) approval a Non-Significant Risk NSR) study, and/or small clinical trial e.g., Early Feasibility Study). small clinical trial should provide data answer key questions the function final design a device. This final device design require most, not all, the non-clinical testing the path more advanced clinical trials market approval. BRAIN Initiative includes both brain spinal cord this program like encourage translational clinical projects invasive recording and/or stimulating devices treat pain.    Smart Connected Health program https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504739) an interagency program between Institutes Centers the National Institutes Health NIH) the National Science Foundation NSF) supporting development technologies, analytics models supporting next generation health medical research through high-risk, high-reward advances computer information science, engineering technology, behavior, cognition, robotics imaging. NINDS interested applications next-generation multidisciplinary science encourages research pain a variety areas value health, such networking, pervasive computing, advanced analytics, sensor integration, privacy security, modeling socio-behavioral cognitive processes system process modeling. Inquiries Please direct inquiries to: Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov Michael Oshinsky, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

Notice Intent Publish Funding Opportunity Announcement BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00) Notice Number: NOT-NS-18-041 Key Dates Release Date: March 21, 2018 Estimated Publication Date Funding Opportunity Announcement: 04/12/2018 First Estimated Application Due Date: 06/12/2018 Earliest Estimated Award Date: 04/01/2019 Earliest Estimated Start Date: 04/30/2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Center Complementary Integrative Health NCCIH) Purpose NINDS, other NIH Institutes Centers participating the BRAIN Initiative, intends publish BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00)."   program designed increase biomedical research workforce diversity foster strong cohort new, highly skilled well trained, NIH-supported, independent investigators diverse backgrounds including nationally underrepresented groups) working research areas supported the BRAIN Initiative, highlighted in BRAIN 2025: Scientific Vision. is designed facilitate timely transition outstanding postdoctoral researchers a research and/or clinical doctorate degree mentored, postdoctoral research positions independent, tenure-track equivalent faculty positions. Notice being provided allow potential applicants sufficient time develop meaningful mentoring teams responsive projects. FOA expected be published April 2018 an expected application due date June 2018.  FOA utilize K99/R00 funding activity. Details the planned FOA provided below. Research Initiative Details BRAIN Initiative K99/R00 award intended individuals diverse backgrounds including nationally underrepresented groups) are working research areas supported the BRAIN Initiative, have more five years postdoctoral research experience, who require least 12 months mentored research training career development K99 phase) before transitioning the independent research R00) phase the program.   All research areas within the BRAIN Initiative are encouraged including not limited engineering, computer science, statistics, mathematics, physics, chemistry neuroethics). Eligible individuals this program be U.S. citizens permanent residents fall one the categories defined the Notice NIH's Interest Diversity. Women been shown be underrepresented doctorate-granting research institutions senior faculty levels most biomedical-relevant disciplines the National Science Foundation and the purposes this funding opportunity announcement be considered eligible candidates this diversity program. Funding Information Estimated Total Funding   Expected Number Awards   Estimated Award Ceiling   Primary CFDA Numbers TBD Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Regional Organization  Applications not being solicited this time. nbsp; Inquiries Please direct inquiries to: Michelle Jones-London, PhD National Institute Neurological Disorders Stroke NINDS) 301-451-7966 jonesmiche@ninds.nih.gov nbsp;

Notice Change Receipt Dates BRAIN Initiative: Theories, Models Methods Analysis Complex Data the Brain R01 Clinical Trial Allowed) Notice Number: NOT-EB-18-005 Key Dates Release Date: February 07, 2018 Related Announcements RFA-EB-17-005 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to change Application Due Dates BRAIN Initiative:  Theories, Models Methods Analysis Complex Data the Brain R01 Clinical Trial Allowed) RFA-EB-17-005) Currently reads: Application Due Date(s): December 15, 2017; October 17, 2018; October 17, 2019 Revised read: Application Due Dates(s): December 15, 2017; September 4, 2018; September 3, 2019 Currently reads: Scientific Merit Review: 2018, March 2019, March 2020 Revised read: Scientific Merit Review: 2018, February 2019, February 2020 Currently reads: Advisory Council Review: August 2018, August 2019, August 2020 Revised read: Advisory Council Review: August 2018, 2019, 2020 Inquiries Please direct inquiries to: Grace C.Y. Peng, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: BRAINTheoriesFOA@mail.nih.gov

BRAIN Initiative: Notice Support Research the Fundamental Neurobiology Pain Processing Notice Number: NOT-NS-18-008 Key Dates Release Date: September 12, 2017 Related Announcements None Issued National Institutes Health NIH) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative aimed revolutionizing neuroscience through development application innovative technologies map neural circuits, monitor modulate activity, understand they contribute thoughts, sensations, emotions behavior.  NIH issued variety Funding Opportunity Announcements FOAs) will support projects apply technologies understand neural circuit function the context specific circuits, resulting a diverse portfolio research the fundamental biology nervous system function.  purpose this announcement to notify research community NIH welcomes BRAIN Initiative applications targeting central nervous system nociceptive pain circuits, appropriate the goals requirements specific BRAIN Initiative FOAs.  Pain conditions represent important public health problem NIH continues support research pain pathologies through normal Institute Center appropriations. However, pain nociception also components normal nervous system function, the BRAIN Initiative committed understanding pain circuits along brain circuits underlying sensory, motor, cognitive emotional functions.  is expected the unique opportunities the BRAIN Initiative enable production detailed maps pain circuits, the adoption powerful new tools monitoring modulating pain circuit activity, leading significant advances the understanding pain nociception. a list past open BRAIN Initiative FOAs.  information goals requirements specific BRAIN FOAs, contact Scientific/Program staff listed the text the respective announcements.  Inquiries Please direct inquiries to: James Gnadt, PhD  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-9964  Email: BRAINCircuits@NIH.GOV   

Notice Encourage Eligible NIH BRAIN Initiative Awardees Apply PA-16-288 Research Supplements Promote Diversity Health-Related Research" Notice Number: NOT-MH-17-048 Key Dates Release Date:   September 1, 2017 Related Announcements PA-16-288 RFA-MH-15-200 RFA-MH-15-225 RFA-NS-15-003 RFA-NS-15-004 RFA-NS-15-005 RFA-NS-15-006 RFA-NS-15-008 RFA-EB-15-006 RFA-EY-16-001 RFA-MH-16-750 RFA-MH-16-775 RFA-MH-16-810 RFA-MH-16-815 RFA-NS-16-006 RFA-NS-16-007 RFA-NS-16-008 RFA-NS-16-009 RFA-NS-16-010 RFA-NS-16-011 RFA-NS-16-018 RFA-EB-17-001 RFA-EB-17-002 RFA-EY-17-001 RFA-MH-17-210 RFA-MH-17-215 RFA-MH-17-220 RFA-MH-17-225 RFA-MH-17-230 RFA-MH-17-235 RFA-MH-17-240 RFA-MH-17-245 RFA-MH-17-256 RFA-MH-17-257 RFA-MH-17-260 RFA-NS-17-003 RFA-NS-17-004 RFA-NS-17-005 RFA-NS-17-006 RFA-NS-17-007 RFA-NS-17-014 RFA-NS-17-015 RFA-NS-17-018 RFA-NS-17-019 Issued National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Neurological Disorders Stroke NINDS) Purpose Notice encourages eligible awardees the BRAIN Initiative community apply administrative supplements response PA-16-288, quot;Research Supplements Promote Diversity Health-Related Research." NIH a strong interest the diversity the NIH-funded workforce NOT-OD-15-053 NOT-OD-15-089 details) encourages institutions diversify student populations enhancing participation individuals groups identified nationally underrepresented the biomedical, clinical, behavioral, social sciences. BRAIN Initiative 2025 report stated quot;the BRAIN Initiative should a catalyst will drive outstanding young people enter area their most creative career stage." NIH diversity supplement offers opportunity existing BRAIN awardees request additional funds train mentor next generation researchers underrepresented groups will contribute advancing goals the BRAIN Initiative. Among U.S. citizens U.S. institutions, percentage neuroscience trainees underrepresented groups declines the graduate 14%) the postdoctoral level 9%), to 5% the neuroscience tenure-stream faculty 2011 Survey Report Neuroscience Departments Programs). Based data the recently published 2015 Survey Earned Doctorates, 15% the U.S. citizens earning PhDs neuroscience neurobiology year from underrepresented groups, suggesting relatively little change the diversity neuroscience graduate students the first half this decade. Program Directors/Principal Investigators PD/PI) active BRAIN Initiative research program grants thus encouraged identify individuals nationally underrepresented groups support mentorship under auspices this administrative supplement. Individuals the identified groups eligible throughout continuum high school the faculty level. activities proposed the supplement application must fall within scope the parent grant, both advance objectives the parent grant support research training professional development the supplement candidate. BRAIN Initiative PIs strongly encouraged incorporate training activities will help prepare supplement candidate conduct rigorous research relevant the goals the BRAIN Initiative 2025 Report. Educational goals the NIH component the BRAIN Initiative BRAIN 2025: Scientific Vision) include acquisition quantitative skills, appropriate and integration newly developed tools, technologies methods developed under BRAIN Initiative, consideration the ethical implications neuroscience research. BRAIN 2025 Report notes individuals should obtain robust grounding quantitative reasoning, principles, techniques during training. special focus training quantitative neuroscience, i.e., theory statistics biologists, exposing physicists, engineers statisticians experimental neuroscience. BRAIN 2025 Report strongly encourages scientists cross traditional areas expertise conduct interdisciplinary research, acknowledges need attract investigators faculty recruits neuroscience quantitative disciplines, e.g., statistics, computer science, physics, mathematics, engineering.   Applicants requested state, the first sentence the Research Strategy, the parent grant awarded a BRAIN Initiative award, to state specific FOA the parent grant e.g., RFA-NS-16-006). Inclusion this information facilitate processing the supplement application.  some cases, diversity supplement be submitted a multiple-PD/PI MPI) BRAIN Initiative award is awarded a foreign institution. Specifically, diversity supplement be submitted the supplement candidate meets eligibility criteria specified PA-16-288, will work a subaward MPI a domestic institution. Potential applicants encouraged confirm eligibility the Program contact listed below.  BRAIN diversity supplement awardees, appropriate the duration their support career stage, strongly encouraged participate annual PD/PI meetings in activities. Applicants request funds, addition the research costs specified PA-16-288, enable supplement candidate attend annual PD/PI meeting the Washington, DC area. request additional funds should reasonable well justified the application.  Before submitting application, applicants encouraged review supplemental guidance BRAIN Initiative diversity supplement applications the NIH BRAIN Initiative web site. Consultation the Program Official the qualifying BRAIN award the individual named under Inquiries below also strongly encouraged confirm candidate eligibility to obtain technical assistance. Supplement applications be evaluated the BRAIN Initiative research training committee, committee Program staff the Institutes Centers participating the NIH BRAIN Initiative.  Applications be considered according the following schedule: Application Due Date                                    Funding Decision October 1, 2017 December 1, 2017              January 30, 2018 December 2, 2017 February 15, 2018          March 31, 2018 February 16, 2018 April 15, 2018                 30, 2018 April 16, 2018 June 15, 2018                       July 30, 2018 tracking purposes, applicants encouraged inform Dr. Nancy Desmond via email BRAIN.Initiative.Training@nih.gov) a diversity supplement application submitted. Please include PD/PI name grant number the subject line this email. Inquiries Please direct inquiries to: Nancy L Desmond, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3107 Email: BRAIN.Initiative.Training@nih.gov 

Notice Clarification the Device Requirement RFA-NS-17-005 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3)" Notice Number: NOT-NS-18-004 Key Dates Release Date: August 18, 2017 Related Announcements RFA-NS-17-005 Issued National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to add language concerning device-based study requirements RFA-NS-17-005.  is expected proposed devices include ability synchronize peripheral ambulatory behavioral signals recorded brain signals. current language reads: Part 2.  Full Text Announcement Section 1. Funding Opportunity Description Objectives this FOA projects must two phases, UG3 UH3.  initial UG3 phase support nonclinical testing support filing an IDE an SR study to obtain IRB approval an NSR clinical study.  projects start the UG3 phase, the length the UG3 phase depend the maturity the project entry.  Only those UG3 projects have met specific criteria below) transition the subsequent UH3 phase after NIH administrative review.  UH3 phase support small clinical study.  Projects which only clinical phase proposed should submitted under RFA-NS-17-006, utilizes UH3 activity code. FOA milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, making go/no-go decisions.  NIH staff also provide assistance academic investigators familiarizing with clinical device development process the criteria needed advance therapeutic leads diagnostics the clinic.  expectations the program in line those industry regards advancing devices through translational development pipeline.  such, inherent high rate attrition expected within program. Scope the FOA UG3 Scope Examples studies can proposed during non-clinical phase include, are limited to: Non-GLP Good Laboratory Practice) animal studies develop surgical techniques relevant the device, define relevant therapeutic parameters, refine device design preparation subsequent GLP testing regulatory approval vitro animal testing meet FDA recognized ISO/ASTM Standards Activities become GMP Good Manufacturing Practice) compliant Activities bring development process under Design Quality Systems Control Device, software firmware design verification validation activities GLP compliant large animal model safety and/or testing an implanted device language been modified now reads: Part 2. Full Text Announcement Section 1. Funding Opportunity Description Objectives this FOA projects must two phases, UG3 UH3.  initial UG3 phase support nonclinical testing support filing an IDE an SR study to obtain IRB approval an NSR clinical study.  projects start the UG3 phase, the length the UG3 phase depend the maturity the project entry.  Only those UG3 projects have met specific criteria below) transition the subsequent UH3 phase after NIH administrative review.  UH3 phase support small clinical study.  Projects which only clinical phase proposed should submitted under RFA-NS-17-006, utilizes UH3 activity code. Proposed next generation devices strongly encouraged incorporate ability synchronize peripheral, ambulatory behavioral data signals.  signals must synchronized real time, analysis be done an online offline manner.  Data does have be stored board the device may streamed out, long it does interfere significantly the naturalistic behavior i.e., participant must be required carry around large personal computer them synchronization occur).  Behavioral signals be those captured a phone GPS, keyboard usage, accelerometer, etc.), smartwatch, related peripheral behavioral capture device. FOA milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, making go/no-go decisions.  NIH staff also provide assistance academic investigators familiarizing with clinical device development process the criteria needed advance therapeutic leads diagnostics the clinic.  expectations the program in line those industry regards advancing devices through translational development pipeline.  such, inherent high rate attrition expected within program. Scope the FOA UG3 Scope Examples studies can proposed during non-clinical phase include, are limited to: Non-GLP Good Laboratory Practice) animal studies develop surgical techniques relevant the device, define relevant therapeutic parameters, refine device design preparation subsequent GLP testing regulatory approval vitro animal testing meet FDA recognized ISO/ASTM Standards Activities become GMP Good Manufacturing Practice) compliant Activities bring development process under Design Quality Systems Control nbsp;Device, software firmware design verification validation activities Device, software, firmware design activities related synchronization naturalistic behavioral data neural recordings GLP compliant large animal model safety and/or testing an implanted device other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Clarification the Device Requirement BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44)" Notice Number: NOT-NS-18-006 Key Dates Release Date: August 18, 2017 Related Announcements RFA-NS-17-007 Issued National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to add language concerning device-based study requirements RFA-NS-17-007. is expected proposed devices include ability synchronize peripheral ambulatory behavioral signals recorded brain signals. current language reads: Part 2.  Full Text Announcement Section 1. Funding Opportunity Description Objectives this FOA projects must two phases, Phase and Phase II, using Fast-track mechanism.  initial Phase will support non-clinical testing toward filing an IDE an SR study obtaining IRB approval an NSR clinical study.  projects start Phase I, the length Phase will depend the maturity the project entry.  Only those Phase projects have met specific criteria below) transition the subsequent Phase II after NIH administrative review.  Phase II support small clinical study. FOA milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, making go/no-go decisions.  NIH staff also provide assistance academic investigators familiarizing with clinical device development process the criteria needed advance therapeutic leads diagnostics the clinic.  expectations the program in line those industry regards advancing devices through translational development pipeline.  such, inherent high rate attrition expected within program. Scope the FOA U44 Phase Scope Examples Examples studies can proposed during non-clinical Phase include, are limited to: Non-GLP Good Laboratory Practice) animal studies develop surgical techniques relevant the device, define relevant therapeutic parameters, refine device design preparation subsequent GLP testing regulatory approval vitro animal testing meet FDA recognized ISO/ASTM Standards Activities become GMP Good Manufacturing Practice) compliant Activities bring development process under Design Quality Systems Control Device, software firmware design verification validation activities GLP compliant large animal model safety and/or testing an implanted device language been modified now reads: Part 2. Full Text Announcement Section 1. Funding Opportunity Description Objectives this FOA projects must two phases, Phase and Phase II, using Fast-track mechanism.  initial Phase will support non-clinical testing toward filing an IDE an SR study obtaining IRB approval an NSR clinical study.  projects start Phase I, the length Phase will depend the maturity the project entry.  Only those Phase projects have met specific criteria below) transition the subsequent Phase II after NIH administrative review.  Phase II support small clinical study. Proposed next generation devices strongly encouraged incorporate ability synchronize peripheral, ambulatory behavioral data signals.  signals must synchronized real time, analysis be done an online offline manner.  Data does have be stored board the device may streamed out, long it does interfere significantly the naturalistic behavior i.e., participant must be required carry around large personal computer them synchronization occur).  Behavioral signals be those captured a phone GPS, keyboard usage, accelerometer, etc.), smartwatch, related peripheral behavioral capture device. FOA milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, making go/no-go decisions.  NIH staff also provide assistance academic investigators familiarizing with clinical device development process the criteria needed advance therapeutic leads diagnostics the clinic.  expectations the program in line those industry regards advancing devices through translational development pipeline.  such, inherent high rate attrition expected within program. Scope the FOA U44 Phase Scope Examples studies can proposed during non-clinical Phase include, are limited to: Non-GLP Good Laboratory Practice) animal studies develop surgical techniques relevant the device, define relevant therapeutic parameters, refine device design preparation subsequent GLP testing regulatory approval vitro animal testing meet FDA recognized ISO/ASTM Standards Activities become GMP Good Manufacturing Practice) compliant Activities bring development process under Design Quality Systems Control Device, software firmware design verification validation activities Device, software, firmware design activities related synchronization naturalistic behavioral data neural recordings GLP compliant large animal model safety and/or testing an implanted device other aspects this FOA remain unchanged Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Intent Reissue Funding Opportunity Announcement BRAIN Initiative: Proof Concept Development Early Stage Next Generation Human Brain Imaging R01) Notice Number: NOT-EB-17-005 Key Dates Release Date: July 28, 2017 Estimated Publication Date Announcement: September 2017 First Estimated Application Due Date: December 2017 Earliest Estimated Award Date: September 2018  Earliest Estimated Start Date: September 2018  Related Announcements NOT-EB-17-006 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose NIH Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative intends reissue RFA-EB-17-001, Proof Concept Development Early Stage Next Generation Human Brain Imaging, modifications. funding opportunity aims support early stage development entirely new novel noninvasive human brain imaging technologies methods will lead transformative advances our understanding the human brain. FOA solicits unusually bold potentially transformative approaches supports small scale, proof concept development based exceptionally innovative, original and/or unconventional concepts.  Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published September2017 an expected application due date Winter 2017. FOA utilize R01 activity code. Details the planned FOA provided below Research Initiative Details Notice encourages investigators expertise insights this area noninvasive human brain imaging technologies methods begin consider applying this new FOA. FOA solicits unusually bold potentially transformative approaches supports small scale, proof concept development human brain imaging based exceptionally innovative, original and/or unconventional concepts. goal to accelerate early stage development promising entirely new concepts require initial stage development testing before launching full scale tool development. Applications submitted response this FOA should focus innovative approaches proof principle initial stage development breakthrough, noninvasive imaging technology measure human brain processes ways are currently unachievable via imaging technologies live persons. proposed concepts approaches expected be high-risk, high-impact, disruptive. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Shumin Wang, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-594-9001 Email: shumin.wang@nih.gov

Notice Intent Reissue Funding Opportunity Announcement BRAIN Initiative: Development Next Generation Human Brain Imaging Tools Technologies U01) Notice Number: NOT-EB-17-006 Key Dates Release Date: July 28, 2017 Estimated Publication Date Announcement: September 2017 First Estimated Application Due Date: December 2017 Earliest Estimated Award Date: September 2018  Earliest Estimated Start Date: September 2018  Related Announcements NOT-EB-17-005 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose NIH Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative intends reissue RFA-EB-17-002, Development Next Generation Human Brain Imaging Tools Technologies, modifications. funding opportunity aims support full development entirely new next generation noninvasive human brain imaging tools methods will lead transformative advances our understanding the human brain. FOA seeks innovative applications are ready full-scale development breakthrough technologies the intention delivering working tools within timeframe the BRAIN Initiative. FOA represents second stage the tool/technology development effort started RFA-MH-14-217 RFA-MH-15-200. Notice being provided allow potential applicants sufficient time develop meaningful collaborations appropriate projects.  FOA expected be published September 2017 an expected application due date Winter 2017. FOA utilize U01 activity code. Details the planned FOA provided below Research Initiative Details Notice encourages investigators expertise insights this area noninvasive human brain imaging technologies methods begin consider applying this new FOA. FOA solicits applications proposing full development next generation human brain imaging breakthrough technologies would overcome existing barriers. developed, such technologies enable imaging measuring brain processes ways are currently unachievable, thereby acquiring fundamental novel insight how human brain organized functions. FOA provide needed resources support teams meet grand challenges developing novel transformative interdisciplinary approaches human brain imaging. intended outcome bold, high-impact, disruptive tools methods human neuroscience can used practically ethically healthy humans irrespective disease state. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Shumin Wang, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-594-9001 Email: shumin.wang@nih.gov