Notice Removal Matching Requirement Instructions RFA-NS-19-016 HEAL Initiative: Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional)". Notice Number: NOT-NS-19-030 Key Dates Release Date : February 05, 2019 Related Announcements RFA-NS-19-016 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions RFA-NS-19-016 HEAL Initiative: Translational Devices Treat Pain(UG3/UH3)". will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  notice be effective the next application due date March 22, 2019 subsequent application due dates. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contributionof federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018. applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributionsrequired under announcement. See45 CFR 75.306for additional details. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Modified toRead: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Currently Reads: Section III. Eligibility Information 2. Cost Sharing grantees a for-profit organization, FOA does require cost sharing, defined the NIH Grants Policy Statement. information cost matching requirements in Section IV.2 R&R Modular Budget. Modified Read: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants Cost matching documented in-kind contributions required for-profit organizations responding this FOA. for-profit awardee required match funds provide least 50% matching funds documented in-kind contributions a rate not less 50% the the total-Federally awarded amount direct costs, well facilities administrative costs), stipulated Public Law 115-141, Consolidated Appropriations Act 2018. Federal funds not used a source matching funds. Generally, cost matching requirements not met the following sources: a) Costs borne another Federal grant sub award; b) Costs contributions toward cost sharing another Federal grant, Federal procurement contract, any award Federal funds; c) Cost services property financed income earned contractors under contract the recipient sub recipient); d) Program income; e) Patient incentives. for-profit organization be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applicants must submit budgets clearly document total costs, source amount matching funds, how valuation determined the case in-kind contributions, well the Federal Institutional non-Federal) components the budget. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award. NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See45 CFR 75.306for additional details. Budget Justification:All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred. costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Budget Justification: All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred. costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: instructions the SF424 R&R) Application Guide must followed. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. For-profit applicants must include letter(s) support confirming the required secured cost matching cash; in-kind commitments such salary, consultant costs, equipment) available confirm the essential personnel the authority within organization allocate resources.    Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. Currently Reads: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE).  Special award condition specific this FOA: grantee a for-profit organization funded under announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.  See 45 CFR 75.306 for additional details.   Matching funds must non-Federal funds set aside this project are available the source(s) identified the application, committed by recipient. Cost matching be evaluated the awarding office ensure this requirement being met. Compliance the matching requirement must verified an annual basis must documented the annual final FFR.   Modified Read: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE) 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 Removal Matching Requirement Instructions RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)". Notice Number: NOT-NS-19-032 Key Dates Release Date : February 05, 2019 Related Announcements RFA-NS-19-018 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)". will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  notice be effective the next application due date March 22, 2019 subsequent application due dates. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contributionof federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018. applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributionsrequired under announcement. See45 CFR 75.306for additional details. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Modified toRead: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Currently Reads: Section III. Eligibility Information 2. Cost Sharing grantees a for-profit organization, FOA does require cost sharing, defined the NIH Grants Policy Statement. information cost matching requirements in Section IV.2 R&R Modular Budget. Modified Read: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants Cost matching documented in-kind contributions required for-profit organizations responding this FOA. for-profit awardee required match funds provide least 50% matching funds documented in-kind contributions a rate not less 50% the the total-Federally awarded amount direct costs, well facilities administrative costs), stipulated Public Law 115-141, Consolidated Appropriations Act 2018. Federal funds not used a source matching funds. Generally, cost matching requirements not met the following sources: a) Costs borne another Federal grant sub award; b) Costs contributions toward cost sharing another Federal grant, Federal procurement contract, any award Federal funds; c) Cost services property financed income earned contractors under contract the recipient sub recipient); d) Program income; e) Patient incentives. for-profit organization be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applicants must submit budgets clearly document total costs, source amount matching funds, how valuation determined the case in-kind contributions, well the Federal Institutional non-Federal) components the budget. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award. NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See45 CFR 75.306for additional details. Budget Justification:All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred. costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Budget Justification: All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred. costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: instructions the SF424 R&R) Application Guide must followed. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. For-profit applicants must include letter(s) support confirming the required secured cost matching cash; in-kind commitments such salary, consultant costs, equipment) available confirm the essential personnel the authority within organization allocate resources.    Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. Currently Reads: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE).  Special award condition specific this FOA: grantee a for-profit organization funded under announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.  See 45 CFR 75.306 for additional details.   Matching funds must non-Federal funds set aside this project are available the source(s) identified the application, committed by recipient. Cost matching be evaluated the awarding office ensure this requirement being met. Compliance the matching requirement must verified an annual basis must documented the annual final FFR.   Modified Read: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE) 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 Publish Funding Opportunity Announcement Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls CWOW) U54 Clinical Trial Optional) Notice Number: NOT-NS-19-027 Key Dates Release Date:January 07, 2019 Estimated Publication Date Funding Opportunity Announcement: February 10, 2019 First Estimated Application Due Date: April 12, 2019 Earliest Estimated Award Date: October 01, 2019 Earliest Estimated Start Date: October 01, 2019 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 research discovering validating biological measures be used assessing, prognosing, monitoring recovery adolescents either clinically present or at risk developing prolonged/persistent concussive symptoms following exposure repetitive head impacts and/or concussion. biological measures should be incorporated risk stratification algorithms inform clinical care patient stratification future clinical trials. A key component this FOA be broad sharing clinical, neuroimaging, physiological, biospecimen data to further advance research the area persistent concussive symptoms early middle adolescent EMA; ages 11-17 years old) populations. Notice being provided allow potential applicants sufficient time develop meaningful collaborations appropriate projects. FOA expected be published Winter 2019 an expected application due date Spring 2019. FOA utilize NIH Specialized Center Cooperative Agreement U54) activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights this area Traumatic Brain Injury TBI) begin consider applying this new FOA. addition, collaborative investigations combining expertise pediatrics, rehabilitation, biomarker development, proteomics, neuroimaging, risk assessment, clinical outcomes research be encouraged, these investigators should also begin considering applying this application. FOA utilize U54 Cooperative Agreement Center Without Walls CWOW) mechanism will included multi-site, multidisciplinary, research teams work synergistically discover, characterize, validate combination biological measures prognosis and/or monitoring recovery persistent concussive symptoms enrollment multiple points care e.g., Emergency Departments, urgent care clinics, primary care, concussion/sports medicine clinics, other specialty clinics) participants a variety injury mechanisms e.g., falls, sports, abusive head trauma, automobile accidents). Biological measures are responsive include, are limited neuroimaging, electroencephalography, oculomotor control, vestibular function, measures auditory processing speech production, autonomic responses, metabolomics, proteomics, other biofluid-based assays. Applications' analysis plans also expected include potential mediating factors such medication the type amount post-injury treatment rehabilitation provided participants. U54 should include following:(1) Administrative Core management reporting, establishing milestones, organizing communications among sites, resolving disputes; 2) Data Coordinating Core will responsible data curation, quality, submission the Federal Interagency Traumatic Brain Injury Research FITBIR) informatics platform be able coordinate the NINDS biomarker repository BioSEND; 3) least three research projects will used address list research areas interest. Scientific projects be expected include both 1) discovery / internal validation, 2) external validation stage their project. the discovery stage, research project should focus discovery biological measures persistent concussive symptoms. Where feasible, project's biological measures should collected across research projects sites. During internal validation stage, projects be expected determine selectivity sensitivity a unique individual set biological measures assessing, prognosing, / monitoring persistent concussive symptoms an EMA population. external validation, of research projects should collect full set biological measures be validated determine selectivity sensitivity these measures across multiple sites in multiple clinical contexts. Following validation, risk stratification algorithm prognosing monitoring recovery persistent concussive symptoms an EMA population should developed. is expected the FOA require incorporation the NINDS Core TBI pediatric common data elements CDEs) appropriate Core CDEs the NINDS Sports Concussion CDE set. Additionally, FOA expected require use the NINDS CDEs both outcome non-outcome measures including, not limited demographics, medical injury history, history abusive injury, family history, medications, neuroimaging, rehabilitation strategy, standardized outcome assessments) described theNINDS CDE Project. FOA require data sharing schedule is consistent NINDS's TBI data submission policy NOT-NS-17-029. Further, ensure maximal value the project, data sharing plan require sharing a limited" clinical data set e.g., clinical assessment amp; outcome measures, symptom lists, mechanism injury, demographics, etc.) be available FITBIR a limited access public” state more 1-year after collection. FOA also expect all biological specimens be banked the NINDS BioSEND Biomarkers Repository. Note costs collection NOT included a component the NINDS BioSEND Biomarkers Repository award. Therefore, most costs the biospecimen banking borne the grantees utilizing resource seeNOT-NS-15-046) should budgeted in application. Funding Information Estimated Total Funding 2,000,000 direct costs Expected Number Awards NINDS intends fund to 1 award. Estimated Award Ceiling TBD Primary CFDA Numbers 93.853 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Indian/Native American Tribal Government Federally Recognized) Applications not being solicited this time.  nbsp; Inquiries Please direct inquiries to: Patrick S. Frost Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 psfb@mail.nih.gov

Notice Interest Advancing Research Acute Flaccid Myelitis Guillain-Barre Syndrome Notice Number: NOT-NS-19-029 Key Dates Release Date: December 20, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Purpose recent increase cases a polio-like illness children called Acute Flaccid Myelitis AFM) drawn attention gaps understanding its causes treatment. Both AFM Guillain-Barre Syndrome GBS) rare neurological conditions characterized acute onset muscle weakness paralysis believed be triggered an infectious agent. Affected individuals lose ability walk disrupted breathing be life threatening. currently available treatments, recovery often incomplete resulting long-term neurological deficits. purpose this Notice to announce the National Institute Neurological Disorders Stroke NINDS), National Institute Allergy Infectious Diseases NIAID), the Eunice Kennedy ShriverNational Institutes Child Health Human Development NICHD) encourage new applications request supplements existing grants competitive revisions administrative supplements) support basic, translational, and/or clinical research the causes, diagnosis, prevention treatment AFM, GBS other acute neurological conditions muscle weakness/paralysis triggered infectious agents related immune responses. Applications should submitted through ldquo;parent” funding opportunity announcements FOAs), through existing FOAs supported NINDS, NIAID, NICHD. Areas programmatic interest include, are limited to: Identifying etiology these neurological conditions, including infectious agents, immunological factors, other genetic environmental susceptibility factors Understanding pathogenesis these neurological conditions the central peripheral nervous systems musculoskeletal system. might include natural history studies cases study acute disease long-term sequelae Characterizing immunologic landscape e.g., immune profiling, genome sequencing) among AFM- GBS-affected individuals determining relationship related immune responses disease Developing model systems e.g. animal, cell organ culture) study pathogenesis serve screening platforms more reliable diagnosis, prevention therapy development Diagnosing conditions, including infectious agent detection, serology, genetics, imaging- electrophysiology-based techniques Developing biomarkers diagnostic, prognostic, predictive pharmacodynamic/response) use preclinical therapy development clinical studies these conditions Developing treatments, including potential novel therapies drug/biologic repurposing Testing strategies the rehabilitation patients affected these conditions, including conventional novel modalities, intense physiotherapies, and/or assistive technologies. variety Parent institute-specific FOAs available applicants, including Research R), Cooperative Agreement U), Career Development K), Fellowship F) awards which NINDS, NIAID, NICHD participate NINDS funding opportunities https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities; NICHD funding opportunities ((https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs/parent and active FOAs https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs). Interested applicants encouraged contact program staff listed below guidance selecting appropriate FOA. Inquiries Please direct inquiries to: Adam L. Hartman, M.D. National Institute Neurological Disorders amp; Stroke Neuroscience Center Telephone: 301-496-9135 Email: adam.hartman@nih.gov Bill G. Kapogiannis, M.D. Eunice Kennedy Shriver National Institutes Child Health Human Development Telephone: 301-402-0698 Email: kapogiannisb@mail.nih.gov Walla Dempsey, Ph.D. National Institute Allergy Infectious Diseases Telephone: 240-292-4197 E-mail: wdempsey@niaid.nih.gov