Notices of Funding Opportunities

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

Notice Expiration RFA-NS-17-008 BRAIN Initiative: SBIR Direct Phase II Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44)" Notice Number: NOT-NS-17-028 Key Dates Release Date: 24, 2017 Related Announcements RFA-NS-17-008  Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform extramural community the NINDS expiring RFA-NS-17-008 quot;BRAIN Initiative: SBIR Direct Phase II Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44)" due the expiration the SBIR Direct Phase II program.  Applications not accepted the October 18, 2017 application due date. Key Dates table updated accordingly: Key Dates Application Due Date(s) December 21, 2016 5:00 PM local time applicant organization. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date 24, 2017 Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: nick.langhals@nih.gov nbsp;

Notice Extend RFA-MH-17-245 BRAIN Initiative: Non-Invasive Neuromodulation - Mechanisms Dose/Response Relationships Targeted CNS Effects R01)" Notice Number: NOT-MH-16-023 Key Dates Release Date: September 16, 2016 Related Announcements RFA-MH-17-245 Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to extend RFA-MH-17-245 ldquo;BRAIN Initiative: Non-Invasive Neuromodulation - New Tools Techniques Spatiotemporal Precision R01)" invites application encourage optimization existing electrical magnetic stimulation methods. Part 1. Key Dates Currently reads:  Application Due Date(s): November 23, 2016 Scientific Merit Review: March 2017 Advisory Council Review: 2017 Earliest Start Date: September 2017 Expiration Date: November 24, 2016 Modified read: Application Due Date(s): November 23, 2016 October 13, 2017 Scientific Merit Review: March 2017 March 2018 Advisory Council Review: 2017 May 2018 Earliest Start Date: September 2017 September 2018 Expiration Date: October 14, 2017 other aspects this FOA remain same. Inquiries Please direct inquiries to: Fred Friedman, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-4058 Email: ffriedma@mail.nih.gov

Notice Extend RFA-MH-17-240 BRAIN Initiative: Non-Invasive Neuromodulation - New Tools Techniques Spatiotemporal Precision R01)" Notice Number: NOT-MH-16-024 Key Dates Release Date: September 16, 2016 Related Announcements RFA-MH-17-240 Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to extend RFA-MH-17-240 ldquo;BRAIN Initiative: Non-Invasive Neuromodulation - New Tools Techniques Spatiotemporal Precision R01)" invites application develop test novel tools methods neuromodulation go beyond existing variations. Part 1. Key Dates Currently reads:  Application Due Date(s): November 23, 2016 Scientific Merit Review: March 2017 Advisory Council Review: 2017 Earliest Start Date: September 2017 Expiration Date: November 24, 2016 Modified read: Application Due Date(s): November 23, 2016 October 13, 2017 Scientific Merit Review: March 2017 March 2018 Advisory Council Review: 2017 May 2018 Earliest Start Date: September 2017 September 2018 Expiration Date: October 14, 2017 other aspects this FOA remain same. Inquiries Please direct inquiries to: Fred Friedman, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-4058 Email: ffriedma@mail.nih.gov

Notice Extend RFA-MH-17-235 BRAIN Initiative: Foundations Non-Invasive Functional Human Brain Imaging Recording-Bridging Scales Modalities R01)" Notice Number: NOT-MH-16-025 Key Dates Release Date: September 16, 2016 Related Announcements RFA-MH-17-235 Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to extend RFA-MH-17-235 ldquo;BRAIN Initiative: Foundations Non-Invasive Functional Human Brain Imaging Recording - Bridging Scales Modalities R01)" invites application support effort will revolutionize our understanding the biological activity underlying, bioinformatic content data collected using contemporary non-invasive functional brain imaging techniques.  Part 1. Key Dates Currently reads:   Application Due Date(s): November 23, 2016 Scientific Merit Review: March 2017 Advisory Council Review: 2017 Earliest Start Date: September 2017 Expiration Date: November 24, 2016 Modified read: Application Due Date(s): November 23, 2016 October 13, 2017 Scientific Merit Review: March 2017 March 2018 Advisory Council Review: 2017 May 2018 Earliest Start Date: September 2017 September 2018 Expiration Date: October 14, 2017 other aspects this FOA remain same. Inquiries Please direct inquiries to: Jay Churchill, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: churchillj@mail.nih.gov

Notice Extend RFA-MH-17-220 BRAIN Initiative: Development Validation Novel Tools Analyze Cell-Specific Circuit-Specific Processes the Brain R01)" Notice Number: NOT-MH-16-026 Key Dates Release Date: September 16, 2016 Related Announcements RFA-MH-17-220 Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to extend RFA-MH-17-220 ldquo;BRAIN Initiative: Development Validation Novel Tools Analyze Cell-Specific Circuit-Specific Processes the Brain R01)" invites application develop validate novel tools facilitate detailed analysis complex circuits provide insights cellular interactions underlie brain function. Part 1. Key Dates Currently reads: Application Due Date s): November 2, 2016 Scientific Merit Review: March 2017 Advisory Council Review: 2017 Earliest Start Date: September 2017 Expiration Date: November 3, 2016 Modified read: Application Due Date(s): November 2, 2016 October 13, 2017 Scientific Merit Review: March 2017 March 2018 Advisory Council Review: 2017 May 2018 Earliest Start Date: September 2017 September 2018 Expiration Date: October 14, 2017 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Michelle Freund, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-1815 Email: BRAIN-info-NIMH@mail.nih.gov

BRAIN Initiative Multi-Council Working Group Clearance Initiative Concepts FY2017 Notice Number: NOT-NS-16-041 Key Dates Release Date: September 6, 2016 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 Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative an ambitious multi-agency effort announced President Obama April 2013. Specific goals NIH contributions the Initiative formulated over year-long planning process culminated the release BRAIN 2025: Scientific Vision, seminal planning document produced a working committee the Advisory Council the NIH Director. NIH continues be guided this document by input the BRAIN Multi-Council Working Group MCWG), committee includes Advisory Council members each the ten NIH Institutes Centers ICs) contributing the BRAIN Initiative.  upcoming fiscal year represents transition point the BRAIN Initiative, goals scaling efforts a number specific areas: 1.  Census Brain Cell Types 2.  Tools Cells Circuits 3.  Technologies Neural Recording Modulation 4.  Human Imaging Neuromodulation 6.  Technology Dissemination Training 7.  Small Business Awards 8.  Data Coordination 9.  Neuroethics fund ambitious goals this transition, President’s budget calls a total appropriation 195 million, has matched exceeded proposals House Senate appropriations subcommittees.  its most recent meeting August 2, 2016, MCWG provided clearance BRAIN FY 2017 initiatives.  Investigators interested particular research areas encouraged review listing cleared initiatives, includes contact information NIH Program staff each area.  Links this information be found the following url:  Multi-Council Working Group.   Interested parties also encouraged subscribe the BRAIN Update post https://brainupdate.nih.gov/), issues periodic announcements including new funding opportunities.  Inquiries Please direct inquiries to: Edmund Ned) Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email: Edmund.Talley@nih.gov email strongly preferred) Gregory K. Farber, Ph.D. National Institute Mental Health NIMH) Telephone:  301-435-0778 Email: farberg@mail.nih.gov

Request Information RFI): Guidance Opportunities Neuroethics NIH BRAIN Initiative) Notice Number: NOT-MH-16-014 Key Dates Release Date: 27, 2016 Response Date: July 29, 2016 Related Announcements None     Issued NIH BRAIN Initiative braininitiative.nih.gov) National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose is Request Information RFI) soliciting input identify set core ethical issues associated research involving human brain resulting advancements neurotechnology research development. Background BRAIN Initiative: Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative® aimed revolutionizing our understanding the human brain. accelerating development application innovative technologies, researchers be able produce new dynamic picture the brain that, the first time, show individual cells complex neural circuits interact both time space. work well underway http://www.braininitiative.nih.gov) the application the innovative tools technologies ultimately lead new ways treat prevent brain disorders. NIH one several federal agencies involved the BRAIN Initiative. Planning the NIH component the BRAIN initiative guided the long-term scientific plan, ldquo;BRAIN 2025: Scientific Vision,” details seven high-priority research areas calls a sustained federal commitment 4.5 billion over 12 years. address current challenges lay more stable foundation future generations researchers, NIH seeking input the community opportunities areas/topics where ethical issues related neuroscience research might considered. overall aim to integrate ethical insight progress under BRAIN Initiative, proactively consider ethical implications the research. Information Requested NIH strives maximize impact the taxpayers’ investments biomedical research. Specific this RFI, input researchers, academic institutions, professional societies other stakeholders solicited potential topics explore where BRAIN Initiative might invest resources the area neuroethics, particularly pertaining emerging neurotechnologies. While welcome input the community any areas germane neuroethics, are particularly interested feedback the following topics: Areas policy guidance might useful Principal Investigators Institutional Review Boards regarding emerging neuroethics issues associated neurotechnology research development. welcome responses point specific strengths weaknesses current policies suggestions how can expand and/or improve policies. evolving breadth neural data associated issues such as: should own data research participant, investigator, institution, public)? Storage data the cloud, via federated databases?) security concerns should access these data whom, quickly, how long, types data)? Privacy concerns protection discrimination those whose neural data shared Unintended uses data Special considerations associated novel neuromodulation neuroimaging technologies: Activation monitoring devices does it, is done) Responsibility the long-term maintenance such devices Security regarding telemetry data remote storage devices Potential culpability concerns regarding predictions neural data Informed consent issues, specifically pertaining studies using novel neurotechnologies Establishing greater uniformity the informed consent process participant perspective the consent process consent permits/hinders is possible technological advances Issues special populations such pregnant women, children, those physical and/or intellectual disabilities cognitive impairment to best integrate neuroethics, appropriate, workshops training opportunities when communicating neuroscience research findings to: Press Lay public Political leaders Scientific Community Translation new tools technologies neuroscience research contexts beyond clinic/bench: Ethics commercialization, public-private partnerships, wider application imaging technologies commercial purposes, conflicts interest use ex vivo human brain tissue; including ownership privacy issues Specific neuroethics questions could addressed using focused research approach Any issues respondents feel relevant to Submit Response Responses must submitted electronically through BRAIN-info-nimh@mail.nih.gov July 29, 2016. RFI for planning purposes only should be construed a solicitation applications an obligation the part the government. The government not pay the preparation any information submitted for government’s of information. NIH use information submitted response this RFI its discretion will provide comments any responder's submission. Responses the RFI be reflected future funding opportunity announcements. information provided be analyzed, appear reports, may shared publicly an NIH website. Respondents advised the government under obligation acknowledge receipt the information provide feedback respondents respect any information submitted. proprietary, classified, confidential, sensitive information should included your response. government reserves right use any non-proprietary technical information any resultant solicitation(s), policies procedures. Inquiries Please direct inquiries to: Email: BRAIN-info-nimh@mail.nih.gov