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Notice Change Expiration Date Application Due Date PAR-16-155 NeuroNEXT Clinical Trials U01)" Notice Number: NOT-NS-17-034 Key Dates Release Date: June 12, 2017 Related Announcements PAR-16-155 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PAR-16-155 quot;NeuroNEXT Clinical Trials U01)" be extended one receipt cycle. additional non-AIDS application due date December 6, 2017 been added this FOA. FOA expires December 7, 2017. Key Dates table updated accordingly: Part 1. Overview Information Key Dates Application Due Date(s) August 2, 2016; December 6, 2016; April 4, 2017; August 3, 2017; December 6, 2017, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review October, 2016; February, 2017; June, 2017; October, 2017; February 2018 Advisory Council Review January, 2017; 2017; October, 2017; January, 2018; 2018 Earliest Start Date(s) March, 2017; July, 2017; December, 2017; May, 2018; September 2018 Expiration Date December 7, 2017 other aspects this FOA remain same. Inquiries Please direct inquiries to: Codrin Lungu, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 Email: lunguci@ninds.nih.gov nbsp;

Notice Modification the Data Submission Sharing Policies the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System Notice Number: NOT-NS-17-029 Key Dates Release Date: 31, 2017 Related Announcements NOT-NS-12-016 NOT-NS-14-022 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System supported a collaboration between National Institutes Health NIH) the Department Defense DoD) the expressed mission accelerate pace discovery advance research through data sharing, increase investigator collaboration comply Federal policies relating data sharing publically-funded research. FITBIR Informatics System provides traumatic brain injury TBI) research community a common platform exchanging data, protocols, research-related information.  optimize current FITBIR resources maximize data sharing compatibility quality, NIH, DoD, the FITBIR Policy committee made several changes FITBIR policy.  changes include reduction the overall scope data be shared the FITBIR system, modification the data submission schedule account management procedures.  looking the future, utility the FITBIR informatics system only realized there a commitment the TBI community use NINDS Common Data Elements CDE) TBI clinical research.  FITBIR Research Scope: Initially, expressed NOT-NS-12-016 was expected data all NIH-funded TBI clinical research projects regardless the size the budget, NIH grant funding mechanism expected submit data FITBIR.   new NIH FITBIR data submission policy streamlines types studies be submitted FITBIR, retains policy any TBI genomic studies generate large-scale genomic data, regardless the size the budget, NIH grant funding mechanism, should follow guidance the NIH GDS Policy data sharing.  new NIH TBI research data sharing via FITBIR policy be limited the following types NIH research: 1) TBI-related clinical trials; 2) unsolicited clinical TBI research grants a budget greater or equal 500,000/year direct costs; 3) ancillary studies, regardless budget, either TBI-related clinical trials clinical TBI research grants budgets greater or equal 500,000/year direct costs; 4) clinical TBI research grants awarded under funding opportunity announcements FOAs) specific requirements FITBIR data submission. rare instances, NIH program staff request data clinical research projects covered under new FITBIR data submission policy. Investigators involved TBI research studies do meet new data submission criteria also request permission submit data their NIH Program representative.  NIH program representative present request the FITBIR Data Integration Committee a decision.  Data Submission Schedule: new FITBIR data submission policy requires annual submission all clinical research outcome non-outcome data. NIH grants, reporting FITBR data submission progress should included part the studies’ annual Research Performance Progress Report.  Funds be restricted studies fail comply the annual data submission policy.  Furthermore, previous accelerated sharing Core Basic CDEs FITBIR outlined NOT-NS-14-022 no longer applicable. FITBIR Account Management:       FITBIR Data Submission accounts now valid the duration the period performance the grant. NINDS Common Data Element Compliance: NIH DoD provides support the development TBI CDEs.  effort involves TBI expert working groups forming consensus recommendations TBI-related outcome instruments non-outcome measures be used clinical research.  evidence-based recommendations founded existing literature can applied clinical research across severities brain injury. purpose the NINDS CDE effort to provide context enhance rigor, reproducibility transparency clinical research.  Consistent the CDE framework standardization, both DoD NIH strongly recommend CDE compliance all clinical TBI studies, particularly those a FITBIR data submission requirement.  Moreover, is highly recommended investigators align non-outcome measures existing non-outcome CDE forms have developed are available the NINDS CDE website through FITBIR.  any grant a FITBIR data submission requirement, non-compliance NINDS CDEs require programmatic approval. Studies investigating outcomes outside the TBI CDEs should NINDS CDEs found other disease areas through searching FITBIR Data Dictionary has over 400 form structures standardized instruments available.  with non-CDE usage, incorporating non-TBI CDEs requires prior Programmatic approval. Inquiries Please direct inquiries to: FITBIR Operations Team Email: FITBIR-ops@mail.nih.gov Website: https://fitbir.nih.gov/ nbsp;

Notice Change Application Due date Eligibility Requirements PAR-17-001 Emerging Global Leader Award K43)" Notice Number: NOT-TW-17-004 Key Dates Release Date: 31, 2017 Related Announcements PAR-17-001 Issued Fogarty International Center FIC) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Office Research Women's Health ORWH) Purpose purpose this Notice to inform applicants changes the Application Due Dates the Eligibility Requirements PAR-17-001 quot;Emerging Global Leader Award K43)". Specifically, Notices changes remaining due dates changes eligibility current former PDs/PIs some grants/awards. Part 1. Overview Information Key Dates Current Key Dates Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; December 14, 2017; December 13, 2018 AIDS Application Due Date(s): December 14, 2016; December 14, 2017; December 13, 2018 Scientific Merit Review: March 2017, March 2018, March 2019 Advisory Council Review: 2017, 2018, 2019 Earliest Start Date: July 2017, July 2018, July 2019 Expiration Date: December 14, 2018 Modified Key Dates Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; November 7, 2017; November 7, 2018 AIDS Application Due Date(s): December 14, 2016; November 7, 2017; November 7, 2018 Scientific Merit Review: March 2017; March 2018, March 2019 Advisory Council Review: 2017; 2018, 2019 Earliest Start Date: July 2017; July 2018, July 2019 Expiration Date: November 8, 2018 Part 2. Section III. Eligibility Information 1. Eligible Applicants Eligible Individuals Program Director/Principal Investigator) Degree Research Experience Requirements:  Currently reads Individuals are have the PD/PI direct recipient/grantee) a multi-year independent research grant an external research funding organization awarded the application due date not eligible. Modified read Individuals are have the PD/PI including Multiple PD/PI) a multi-year independent research grant an external research funding organization awarded the application due date not eligible. Individuals are have the PD/PI including Multiple PDs/PIs) exploratory/developmental grants two years less the NIH's Small Grant R03) and  Exploratory/Developmental Grant R21) remain eligible. Prospective applicants strongly encouraged contact FIC Scientific/Research contact prior preparing application discuss eligibility. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Christine Jessup, Ph.D Fogarty International Center FIC) Telephone: 301-496-1653 Email: Christine.Jessup@nih.gov

Notice Change Application Due Dates PAR-17-277 NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment Recovery Resource Access X01)" Notice Number: NOT-NS-17-032 Key Dates Release Date:   May 26, 2017 Related Announcements PAR-17-277 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to change Application Due Date the October Council round PAR-17-277 quot;NIH StrokeNet Clinical Trials Biomarker Studies Stroke, Treatment, Recovery Resource Access X01)". Part 1. Overview Information Key Dates Currently reads: Application Due Date(s) Applications accepted continuous receipt. Council Round                   Receipt Window January                             June 11 – October 10 May                                  October 11 – February 10 October                             February 10 – June 10 , 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. nbsp; nbsp; Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. nbsp; Modified read: nbsp; Application Due Date(s) Applications accepted continuous receipt. Council Round                   Receipt Window January                             June 11 – October 10 May                                  October 11 – February 10 October                             February 11 – June 10 , 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. nbsp; Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. nbsp; nbsp; Inquiries Please direct inquiries to: Claudia Scala Moy, PhD National Institute Neurological Disorders amp; Stroke NINDS) Telephone: 301-496-9135 Email: moyc@ninds.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 Information: Alignment Among Disease Definitions Utilized Govern Genetic Genomic Data Sharing Studies Involving Alzheimer's Disease Notice Number: NOT-AG-17-007 Key Dates Release Date: 1, 2017 Related Announcements None Issued National Institute Aging NIA) National Institute Neurological Disease Stroke NINDS) Purpose BACKGROUND: Notice updates disease definitions accepted within broad concept Alzheimer's disease it applies sharing samples data, informed consent, as relates scientific discovery Alzheimer’s disease research. aligns Alzheimer's disease concept the term used the National Alzheimer's Project Act NAPA) Public Law 111-375. community scientists performing studies dementia identified need this update. Notice's primary intent to define scope application the language it be used requests access data through NIH-approved data storage sites in recruitment subjects studies.    IMPLEMENTATION: NIH developed procedure obtain community participation the language alignment. consensus reached and approved the Alzheimer's Disease Sequencing Project ADSP) investigators institutions. Based the state the science, NIH supportive the update.  Under NAPA, Alzheimer’s disease defined include Alzheimer’s Disease Related Dementias ADRDs) research other activities will lead a decrease the growing public heath burden caused dementia our aging population NAPA 2012 2013, and NAPA 2016). National Plan address Alzheimer’s disease defines ADRDs include dementia due to:  1.    Frontotemporal Dementia FTD) including Frontotemporal Lobar Degeneration FTLD), Primary Progressive Aphasia PPA), Progressive Supranuclear Palsy PSP), Corticobasal degeneration CBD) Pick’s Disease 2.   Lewy Body Dementia LBD) including Dementia Lewy Bodies DLB), Parkinson’s Disease Dementia PDD) 3.   Vascular Dementia including vascular dementia, vascular cognitive impairment VCI), multi-infarct dementia, post-stroke dementia, vascular brain injury 4.   Mixed pathologies 5.   Down syndrome update the Alzheimer’s disease definition apply studies already submitted NIH-approved data storage sites such dbGaP the NIA Genetics Alzheimer's Disease Data Storage Site NIAGADS), well to new existing studies will submitted these other approved data storage sites. update supported scientific advances over number years understanding variety pathologies genetic influences give rise the full spectrum dementia those diagnosed AD. Therefore, effective the date release this notice, NIH begin permitting access data an ldquo;Alzheimer’s disease only” data limitation the data access request includes research Alzheimer’s disease the ADRDs delineated above. Updating definition Alzheimer's disease used establish data-sharing criteria allow advancement research dementia-causing disease processes are commonly embedded and/or difficult distinguish AD during life. clarification allow approved users Alzheimer's disease genomic data pursue research is fully congruent the NAPA definition the current state the science the field. Inquiries Please direct inquiries to: Marilyn Miller, Ph.D. National Institute Aging NIA) Telephone: 301-496-9350  Email: millerm@nia.nih.gov Roderick Corriveau, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: roderick.corriveau@nih.gov nbsp;

Notice Extend Expiration Date PA-14-068 Neurobiology Migraine R01)" Notice Number: NOT-NS-17-027 Key Dates Release Date:   April 27, 2017 Related Announcements PA-14-068 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Part 1. Overview Information purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PA-14-068 quot;Neurobiology Migraine R01)" be extended one receipt cycle.  FOA expires September 8, 2017. Key Dates Table updated accordingly: Part 1. Overview Information Key Dates Application Due Date(s) nbsp; Standard dates 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date September 8, 2017 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Michael L. Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

Notice Intent Publish Funding Opportunity Announcement Translational Neural Devices Program U44) Notice Number: NOT-NS-17-023 Key Dates Release Date: April 25, 2017 Estimated Publication Date Announcement: July 2017  First Estimated Application Due Date: October 2017  Earliest Estimated Award Date: February 2018  Earliest Estimated Start Date: June 2018  Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications milestone-driven projects involving translational activities small clinical studies advance development therapeutic diagnostic devices disorders affect nervous system. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published July 2017 an expected application due date October 2017. FOA utilize U44 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages SBIR-eligible small businesses expertise insights neurotherapeutic neurodiagnostic devices begin consider applying this new FOA. initiative a successor the prior NINDS Cooperative Research Enable Advance Translational Enterprises CREATE Devices) program ended early 2017. Fast-Track phased U44 cooperative agreement mechanism milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, appropriate go/no-go decision-making. projects have phases, Phase and Phase II. initial phase support translational device activities leading submission an Investigational Device Exemption IDE) the US Food Drug Administration FDA) Institutional Review Board IRB) application a Non-Significant Risk NSR) study. projects start Phase but duration Phase will depend the maturity the project entry. Only successful Phase projects have met milestones other requirements be eligible transition Phase II after NIH administrative review. Phase II support Early Feasibility Study a small clinical study. is expected devices within scope this program either: very close the final system' manufactured using very close the same manufacturing process the device be marketed studied a larger clinical trial following completion this project, or  require early feasibility clinical data inform final device design manufacturing processes. is also expected devices within scope this program either received Pre-Submission feedback the FDA will conduct Pre-Submission the FDA the first year Phase I. expectations the program in line those industry regards advancing devices through developmental pipeline. such inherent high rate attrition expected within program. Applicants strongly encouraged consult NINDS program staff plans an application being developed. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1447 Email: nick.langhals@nih.gov nbsp;

Notice Intent Publish Funding Opportunity Announcement Translational Neural Devices Program UG3/UH3) Notice Number: NOT-NS-17-024 Key Dates Release Date: April 25, 2017 Estimated Publication Date Announcement: July 2017  First Estimated Application Due Date: October 2017  Earliest Estimated Award Date: February 2018 Earliest Estimated Start Date: June 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications milestone-driven projects involving translational activities small clinical studies advance development therapeutic diagnostic devices disorders affect nervous system. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published July 2017 an expected application due date October 2017. FOA utilize UG3/UH3 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights neurotherapeutic neurodiagnostic devices begin consider applying this new FOA. initiative a successor the prior NINDS Cooperative Research Enable Advance Translational Enterprises CREATE Devices) program ended early 2017. UG3/UH3 cooperative agreement mechanism milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, appropriate go/no-go decision-making. projects have phases. initial UG3 phase support translational device activities leading submission an Investigational Device Exemption IDE) the US Food Drug Administration FDA) Institutional Review Board IRB) application a Non-Significant Risk NSR) study. projects start the UG3 phase the duration UG3 depend the maturity the project entry. Only successful UG3 projects have met milestones other requirements be eligible transition the second UH3 phase after NIH administrative review. UH3 phase support Early Feasibility Study a small clinical study. is expected devices within scope this program either: very close the final system' manufactured using very close the same manufacturing process the device be marketed studied a larger clinical trial following completion this project, or  require early feasibility clinical data inform final device design manufacturing processes. is also expected devices within scope this program either received Pre-Submission feedback the FDA will conduct Pre-Submission the FDA the first year the UG3 phase. expectations the program in line those industry regards advancing devices through developmental pipeline. such inherent high rate attrition expected within program. Applicants strongly encouraged consult NINDS program staff plans an application being developed. Early contact provides opportunity NINDS program staff discuss program scope, entry criteria, goals, to provide information guidance how develop competitive application. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1447 Email: nick.langhals@nih.gov Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov nbsp;

Notice Extend Expiration Date PA-14-069 Neurobiology Migraine R21)" Notice Number: NOT-NS-17-026 Key Dates Release Date: April 25, 2017 Related Announcements PA-14-069 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Part 1. Overview Information purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PA-14-069 Neurobiology Migraine R21)" be extended one receipt cycle.  FOA expires September 8, 2017. Key Dates Table updated accordingly: Part 1. Overview Information Key Dates Application Due Date(s) Standard dates 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date September 8, 2017 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Michael L. Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov