Notices of Funding Opportunities

Soliciting Feedback the BRAIN Initiative Notice Number: NOT-NS-18-075 Key Dates Release Date: July 23, 2018 Response Date: November 15, 2018 Related Announcements NOT-NS-19-041 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 Request Information RFI) to solicit input how best accomplish ambitious vision the Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative® set forth BRAIN 2025: Scientific Vision. NIH soliciting input all interested stakeholders, including members the scientific community, trainees, academic institutions, private sector, health professionals, professional societies, advocacy groups, patient communities, well other interested members the public. Background BRAIN Initiative aims develop new tools technologies understand manipulate networks cells the brain. BRAIN 2025: Scientific Vision serves the strategic plan the BRAIN Initiative NIH outlines overarching vision, seven high level scientific priorities, many specific goals. Designed be achieved over least decade, first five years BRAIN 2025 emphasizes development tools technology, the next five years shifts emphasis using tools make fundamental discoveries how brain circuits work what goes wrong disease. BRAIN Initiative well underway see  http://www.braininitiative.nih.gov ), we now approaching midpoint. this time, NIH seeking feedback the BRAIN Initiative's progress on opportunities moving forward given current state the science. NIH established new BRAIN Initiative Advisory Committee the NIH Director ACD) Working Group will provide scientific guidance the ACD how best continue accelerate ambitious vision the BRAIN Initiative. ACD-WG use responses this RFI, along information gathered through series public workshops, help inform discussions the BRAIN Initiative's progress potential updates the plan moving forward. Information Requested Please submit: Ideas new tools technologies have potential transform brain circuit research. Suggestions fundamental questions brain circuit function humans animal models could addressed new technologies. Considerations data sharing infrastructure policies. Areas topics research the ethical implications BRAIN Initiative-supported emerging neurotechnologies advancements their applications. Approaches disseminating new tools technologies well training broader neuroscience research community. Any topic relevant the strategic plan the BRAIN Initiative. to Submit Response assure consideration, responses must received November 15, 2018. Responses this RFI must submitted electronically using web-based form https://www.braininitiative.nih.gov/rfi.aspx via email BRAINFeedback@nih.gov  BRAIN RFI" the subject line. Responses this RFI voluntary. Any personal identifiers be removed responses compiled.  Individual feedback not provided any responder. Proprietary, classified, confidential, sensitive information should be included your response. This Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it. Please note the U.S. Government not pay the preparation any comment submitted for use that comment. Inquiries Please direct inquiries to: Email: BRAINFeedback@nih.gov

Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-021 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3)" Notice Number: NOT-NS-18-065 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-021 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-021 BRAIN Initiative:  Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov   Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44)" Notice Number: NOT-NS-18-066 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-022 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov   Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov   Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-023 BRAIN Initiative: Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System" Notice Number: NOT-NS-18-067 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-023 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-023 BRAIN Initiative: Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UH3 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same.   Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice Correction Key Dates RFA-NS-18-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trial Allowed) Notice Number: NOT-NS-18-070 Key Dates Release Date: 23, 2018 Related Announcements RFA-NS-18-029 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a correction the Key Dates RFA-NS-18-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trial Allowed)".  Specifically, Advisory Council Review dates January 2019 and January 2020 and Earliest Start Dates February 2019 and February 2020. Part 1. Overview Information Key Dates Currently Reads: Advisory Council Review January 2019 Earliest Start Date February 2019 Modified Read: Advisory Council Review January 2019 and January 2020 Earliest Start Date February 2019 and February 2020 other aspects this FOA remain same. Inquiries Please direct inquiries to: James Gnadt, PhD  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-9964  Email: BRAINCircuits@nih.gov

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 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 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