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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 Extend Expiration Date PAR-15-195 NeuroNEXT Infrastructure Resource Access X01)" Notice Number: NOT-NS-18-003 Key Dates Release Date: August 14, 2017 Related Announcements PAR-15-195 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PAR-15-195 quot;NeuroNEXT Infrastructure Resource Access X01)" be extended one receipt cycle.  FOA expires March 13, 2018. Key Dates Table updated accordingly: Part 1. Overview Information Key Dates Currently reads: Application Due Date(s) Applications accepted continuous receipt, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates: Council Round: Receipt Window: November 13 - March 12 Council Round: October Receipt Window: March 13 - July 12 Council Round: January Receipt Window: July 13 - November 12 Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date November 13, 2017 Modified read Application Due Date(s) Applications accepted continuous receipt, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates: Council Round: Receipt Window: November 13 - March 12 Council Round: October Receipt Window: March 13 - July 12 Council Round: January Receipt Window: July 13 - November 12 Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date March 13, 2018 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Codrin Lungu, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301) 496-9135 Email: Codrin.Lungu@nih.gov nbsp;

NINDS Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) R41, R42, R43, R44) Notice: Programmatic Priorities Notice Number: NOT-NS-18-002 Key Dates Release Date: August 10, 2017 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to alert field program priorities relevant the SBIR STTR programs the National Institute Neurological Disorders Stroke NINDS). SBIR STTR programs include following objectives: stimulate technological innovation; meet federal research development R&D) needs; increase private sector commercialization innovations developed through federal R&D funding; foster encourage participation innovation entrepreneurship socially economically disadvantaged persons women-owned small businesses. NINDS uses SBIR STTR programs achieve mission the institute supporting innovative ideas different stages development, including applied bench research, translational research, early stage clinical trials. Notice underscores high programmatic priority given research seeks achieve goals the SBIR STTR programs. NINDS priorities given meritorious research proposals the greatest potential advance NINDS mission https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission). NINDS especially interested in: 1) Novel innovative technologies are new the SBIR STTR programs. 2) Technologies coming the SBIR STTR programs their first indication market opportunity. 3) Companies applicants are new the SBIR STTR programs. 4) NINDS Cooperative Agreement U44) Translational Programs. NINDS specific translational programs utilize SBIR cooperative agreement mechanism U44). eligible, companies encouraged apply through programs. NINDS SBIR STTR funding decisions based a combination factors: 1) potential high impact advancing NINDS mission the programmatic priorities described this Notice; 2) potential commercialization; 3) portfolio balance determine whether similar projects already funded, search NIH Reporter http://projectreporter.nih.gov/reporter.cfm); 4) quality the previous performance the applicant and/or company the SBIR and/or STTR program, including evidence Phase III activities; 5) Phase II applicants, results the Phase I; 6) peer review scores critiques; 7) availability funds. Inquiries Please direct inquiries to: Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov

Notice Informational Webinar RFA-NS-17-024 NINDS Clinical Research Sites the Network Excellence Neuroscience Clinical Trials NeuroNEXT site) U24)" Notice Number: NOT-NS-17-039 Key Dates Release Date: August 9, 2017 Related Announcements RFA-NS-17-024 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) be holding informational webinar August 16, 2017 4:00PM 5:00PM ET the Funding Opportunity Announcement FOA) RFA-NS-17-024, entitled quot;Clinical Research Sites the Network Excellence Neuroscience Clinical Trials NeuroNEXT sites) U24)". Please the link below register the webinar: https://attendee.gotowebinar.com/register/7983249748974135555 After registering, will receive confirmation E-mail containing information joining webinar. webinar provide introduction this FOA, provide information relevant the application, offer forum potential applicants ask questions. purpose this funding opportunity to invite sites participate a Clinical Site the Network Excellence Neuroscience Clinical Trials NeuroNEXT).  network provides robust, standardized accessible infrastructure, designed facilitate development conduct exploratory clinical trials neurological disorders. Participation this webinar, although encouraged, optional is required the submission an application. Inquiries Please direct inquiries to: Janice Cordell, RN, MPH National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-4299 Email: JC53A@nih.gov nbsp;

Notice Extension NINDS Faculty Development Award Promote Diversity Neuroscience Research K01) up 5 Years Support Notice Number: NOT-NS-18-001 Key Dates Release Date: August 9, 2017 Related Announcements PAR-16-219 Issued National Institute Neurological Disorders Stroke NINDS) Purpose notice to extend duration the NINDS Faculty K01 up 5 years support. Current Instructions Award Project Period total project period not exceed 3 years. Section VI. Award Administration Information 1. Award Notices the application under consideration funding, NIH request just-in-time" information the applicant described the NIH Grants Policy Statement. formal notification the form a Notice Award NoA) be provided the applicant organization successful applications. NoA signed the grants management officer the authorizing document will sent via email the grantee’s business official. Awardees must comply any funding restrictions described in Section IV.5. Funding Restrictions. Selection an application award not authorization begin performance. Any costs incurred before receipt the NoA at recipient's risk. costs be reimbursed only the extent considered allowable pre-award costs. Any application awarded response this FOA be subject terms conditions found the Award Conditions Information NIH Grants website.  includes any recent legislation policy applicable awards is highlighted this website. Revised Instructions Award Project Period total project period not exceed 5 years. Initial budget period be awarded 3 years a continuation years 4 5 contingent administrative review NINDS staff. internal NINDS review assess whether investigator applied a major research grant R01, R15, equivalent) a federal e.g., NIH, NSF, DOD, DARPA, etc.) non-federal source e.g., non-profit, society, foundation, institute). NINDS anticipates most Diversity Faculty K01 awards be 5 year awards applicants should propose research plan reflects total project period to 5 years); however, the year 3 administrative review determines an investigator not applying appropriate research grants making sufficient progress towards preliminary data such submission, award not extended. Section VI. Award Administration Information 1. Award Notices the application under consideration funding, NIH request just-in-time" information the applicant described the NIH Grants Policy Statement. formal notification the form a Notice Award NoA) be provided the applicant organization successful applications. NoA signed the grants management officer the authorizing document will sent via email the grantee’s business official. Awardees must comply any funding restrictions described in Section IV.5. Funding Restrictions. Selection an application award not authorization begin performance. Any costs incurred before receipt the NoA at recipient's risk. costs be reimbursed only the extent considered allowable pre-award costs. Any application awarded response this FOA be subject terms conditions found the Award Conditions Information NIH Grants website.  includes any recent legislation policy applicable awards is highlighted this website. is anticipated the terms award include, not limited to, following: initial Notice Grant Award be three years a special term an additional years support conditional upon receipt a letter requesting additional years support other supporting documentation demonstrating sufficient progress toward faculty independence. letter should submitted an attachment under question G.1 the RPPR, addresses Special Award Terms FOA Requirements. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7966 Email: jonesmiche@ninds.nih.gov  

Notice NINDS Withdrawal Participation the NIH Exploratory/Developmental Research Grant Program Parent R21)" PA-16-161 Notice Number: NOT-NS-17-037 Key Dates Release Date:   July 28, 2017 Related Announcements PA-16-161 Issued National Institute Neurological Disorders Stroke NINDS)  Purpose purpose this Notice to inform applications effective January 8, 2018, NINDS no longer participate the NIH Exploratory/Developmental Research Grant Program Parent R21), will accept any applications new resubmission) response the Parent R21 Funding Opportunity Announcement FOA) PA-16-161. last application due dates NINDS accept applications under Parent R21 FOA be October 16, 2017 non-AIDS new applications, November 16, 2017 non-AIDS resubmission applications, January 7, 2018 AIDS AIDS-related applications. NINDS continue accept R21 applications neuroscience projects relevant the scientific mission https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission) the NINDS through separate NINDS Program Announcement. Information the relevance an application the NINDS research mission be found contacting appropriate NINDS program staff member. Program staff contacts be found at: https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Program-Directors. Inquiries Please direct inquiries to: Karrah Benson National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0838 Email: karrah.benson@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

Solicitation Nominations the 2017 National Institute Neurological Disorders Stroke NINDS) Landis Award Outstanding Mentorship Notice Number: NOT-NS-17-025 Key Dates Release Date: July 25, 2017 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose Excellent mentorship superior training critical the development exceptional future scientists. National Institute Neurological Disorders Stroke NINDS) recognize importance places outstanding mentorship training through new annual award, NINDS Landis Award Outstanding Mentorship. year, to five 5) faculty members are considered be outstanding mentors trainers be awarded 100,000 direct costs), be used foster advancement additional students postdoctorates towards independent research career. NINDS hopes this tangible award impress upon scientific community a whole, faculty institutional leaders particular, high value NINDS places outstanding training mentorship the need faculty institutions emphasize dedication mentorship addition outstanding research accomplishments. Selection this new award be based nomination those have first-hand knowledge an individual’s outstanding mentorship. Current former trainees nominate faculty members have served their mentors. Faculty members nominated two more mentees then invited submit additional information needed the selection process. Eligible individuals this award must in tenure-track equivalent faculty position hold active NINDS R01, R35 P01 at least year left their grant the time award. full details the award, the selection process, be found Landis Mentor Award. Because outstanding mentors exist each career stage, have different levels mentorship accomplishments, NINDS rotate eligibility requirements year. the first 3 years FY2018, 2019, 2020), NINDS seek nominations junior faculty mentors the 5th – 12th year the start their first tenure track equivalent position), mid-career mentors the 13th – 20th year the start their first tenure-track equivalent position), senior faculty mentors (>20 years their first tenure-track equivalent position), respectively. NINDS select awardees among nominated individuals conduct outstanding, rigorous research have shown dedication superior mentorship training. this notice, NINDS invites nominations outstanding mentors are 5 12 years the start their first tenure-track equivalent faculty positions.  Although nominees not an extensive track record mentorship, will have, the earliest stage their independent research careers, demonstrated dedication helping trainees towards goal becoming exceptional, successful, independent scientists. making mentorship awards these individuals, NINDS intends send strong message it recognizes time effort have dedicated the careers others to active training individuals conduct outstanding, rigorous, high-impact research. award meant encourage junior faculty dedicate themselves strong mentorship training others, addition their own research productivity, to encourage institutional leaders place high value training mentorship its faculty. Nomination. Nominations the NINDS Landis Mentor Award be accepted ONLY current former trainees the nominated individual. nominate current former mentor, individuals should click Landis Mentor Award complete nomination form December 15, 2017. following information be requested: Nominator's name current position Name individual being nominated nominee) Current institution email address nominee Start date nominee’s first tenure-track equivalent position Relationship nominator nominee dates mentorship, position nominator mentored nominee e.g. Former Current Graduate Student, Postdoctoral Fellow, etc.]) Statement describing basis the nomination. description should include: made/makes nominated individual exceptional mentor/trainer; are specific examples extraordinary dedication mentorship personally experienced witnessed; does individual to ensure trainees conduct highest quality research respect scientific premise, experimental design analysis; were specific nominee activities influenced nominator’s growth a neuroscientist. a nomination be considered, of above information must provided via nomination form found Landis Mentor Award. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Informational Webinar NINDS PAR-16-112 Biomarkers Discovery Parkinsonism U01)" Notice Number: NOT-NS-17-036 Key Dates Release Date: July 21, 2017 Related Announcements PAR-16-112 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) be holding informational webinar July 31, 2017 12-1:30 pm EST the Funding Opportunity Announcement FOA) PAR-16-112, entitled Biomarkers Discovery Parkinsonism U01)". webinar provide brief introduction the FOA current resources available through NINDS Parkinson's disease Biomarkers Program PDBP).  Clinical laboratory based biomarker discovery projects supported under FOA include research directed towards identification and/or replication of: 1) diagnostic, prognostic progression biomarkers differentiate synucleinopathies tauopathies; 2) diagnostic, prognostic progression biomarkers sub-types Parkinson's disease PD) including genetically defined cohorts, biologically defined cohorts idiopathic PD ethnic subgroups idiopathic PD.  inclusion cutting edge approaches such telemedicine mobile technology monitoring encouraged. join WebEx meeting following link telephone information provided:   https://nih.webex.com/join/sutherlandmnih.gov   |  622 274 563       Join phone  1-650-479-3208 Call-in toll number US/Canada)  1-877-668-4493 Call-in toll-free number US/Canada)  Access code: 622 274 563  Global call-in numbers  |  Toll-free calling restrictions Participation this webinar, although encouraged, optional is required the submission an application. Inquiries Please direct inquiries to: Margaret Sutherland, PhD National Institute Neurological Disorders Stroke Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov