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Notice Change Key Dates RFA-NS-18-014 BRAIN Initiative: Targeted BRAIN Circuits Planning Projects - TargetedBCPP R34 Clinical Trial Allowed)" Notice Number: NOT-NS-19-034 Key Dates Release Date: April 18, 2019 Related Announcements RFA-NS-18-014 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) Office Behavioral Social Sciences Research OBSSR) Office Research Women’s Health ORWH) Purpose purpose this Notice to inform applicants a change the Key Dates RFA-NS-18-014 Targeted BRAIN Circuits Planning Projects - TargetedBCPP R34 Clinical Trial Allowed)". Three new receipt dates been added the FOA: November 6, 2019, July 1, 2020,and November 10, 2020. Additionally, Peer Review Contact changed Alexei Kondratyev, Ph.D. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) March 15, 2018; July 17, 2018; July 15, 2019 Scientific Merit Review June 2018; October 2018; October 2019 Advisory Council Review August 2018; January 2019; January 2020 Earliest Start Date September 2018; April 2019; April 2020 Expiration Date July 16, 2019 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) March 15, 2018; July 17, 2018; July 15, 2019; November 6, 2019; July 1, 2020; November 10, 2020 Scientific Merit Review June 2018; October 2018; October 2019; February 2020; October 2020; February 2021 Advisory Council Review August 2018; January 2019; January 2020; May 2020; January 2021; 2021 Earliest Start Date September 2018; April 2019; April 2020; June 2020; February 2021; June 2021 Expiration Date November 10, 2021 Currently Reads: Section II. Award Information Funds Available Anticipated Number Awards BRAIN Initiative partner componentsintend commit estimated total 2.5M fund 10 awards. Modified Read: Section II. Award Information Funds Available Anticipated Number Awards BRAIN Initiative partner componentsintend commit estimated total 2.5M fund 10 awards for FY21.   Currently Reads: Section VII. Agency Contact(s) Scientific/Research Contact(s) James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email:BRAINCircuits@NIH.GOV Peer Review Contact(s) Nick Gaiano, PhD Center Scientific Review CSR) Telephone: 301-435-1033 Email:nick.gaiano@nih.gov Modified Read: Section VII. Agency Contact(s) Scientific/Research Contact(s) Karen K David, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email:BRAINCircuits@NIH.GOV Peer Review Contact(s) Alexei Kondratyev, Ph.D. Center Scientific Review CSR) Telephone: 301-465-1785 Email: alexei.kondratyev@nih.gov other aspects this FOA remain same. Inquiries Please direct inquiries to: Karen K David, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: BRAINCircuits@nih.gov

Notice Intent Publish Reissuance RFA-NS-19-025" HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers U24 Clinical Trial Allowed)" Notice Number: NOT-NS-19-051 Key Dates Release Date:April 11, 2019 Estimated Publication Date Funding Opportunity Announcement: April 22, 2019 First Estimated Application Due Date: June 03, 2019 Earliest Estimated Award Date: November 01, 2019 Earliest Estimated Start Date: December 01, 2019 Related Announcements RFA-NS-19-025 Issued National Institutes Health NIH) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke intends re-issue Funding Opportunity Announcement FOA) solicit additional applications regional clinical centers associated clinical research sites the Early Phase Pain Investigation Clinical Network EPPIC-Net). EPPIC-Net be charged executing early phase trials high impact the treatment patients acute chronic pain. regional clinical centers ("hubs" their linked clinical research sites ("spokes") conduct clinical trials concert a network Clinical Coordinating Center CCC) a Data Coordinating Center DCC). Approximately ten regional clinical center Hubs anticipated be funded. purpose this notice to allow potential Hub applicants sufficient time develop meaningful plans collaborations their linked clinical center spokes support their application. EPPIC-Net part the NIH Helping End Addiction Long-Term HEAL) Initiative. EPPIC-Net enable exploratory clinical trials investigational drugs biologics, investigational devices, natural products, surgical procedures the treatment specific types pain. Thesetrials validate biomarkers, provide proof concept, otherwise contribute the justification proceeding not proceeding a futurePhase 3 trial e.g., informing go/no-go decisions). Interventions trials within EPPIC-Net be solicited the national international scientific community. Interventions e.g. investigational drugs, devices biologics) studied within EPPIC-Net be provided companies academic institutions. populations be studied include those well-defined pain conditions with high unmet needs, example chronic neuropathic, inflammatory nociceptive pain disorders adult pediatric populations. EPPIC-Net focus Phase 2 trials is anticipated be able run many five Phase 2 trials concurrently, addition biomarker validation studies. EPPIC-Net infrastructure also include repository HEAL initiative data samples facilitate future research discovery. TheEPPIC-Net Hubs work the EPPIC-Net CCC, DCC other hubs selected particular studies. Hub envisioned a regional medical center is center excellence encompassing medical expertise neurology, anesthesiology, rheumatology, obstetrics/gynecology, pediatrics, orthopedics, physical medicine, gastroenterology, and/or subspecialties providing care patients pain. Hub willenroll patients along its network 2-10 research spokes will additionally provide scientific leadership administrative oversight its multiple spokes. notice informs clinical centers excellence the forthcoming solicitation applications EPPIC-Net hubs. Research Initiative Details Hub must a flexible network Spokes. principal function the Spokes to provide access a sufficiently large patient population support trial enrollment. Spokes should selected increase access patients a particular pain disease pain syndrome, encompass patients underserved communities, and/or complement Hub providing access specific research clinical expertise. each clinical trial, Hub be expected assemble network 2-10 Spokes specifically tailored the needs that particular trial. Since requirements each clinical trial vary, identity configuration Spokes be unique each trial. Therefore, Hub should relationships a number potential Spokes the ability add Spokes appropriate the study. demonstrate ability attract Spokes, applicant requested identify, the time application, five Spokes committed participation at least clinical trial.Since five initial Spokes unlikely be able meet possible future clinical trial requirements, Hub need incorporate plan mechanism recruiting additional Spokes needed. Funding Information Estimated Total Funding TBD Expected Number Awards TBD 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) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time.  Inquiries Please direct inquiries to: Barbara I. Karp, M.D.National Institute Neurological Disorders Stroke NINDS)301-496-0150karpb@ninds.nih.gov

Notice Correction Application Types Allowed RFA-NS-19-017 HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)" Notice Number: NOT-NS-19-052 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-017 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform potential applicants a correction Application Types Allowed in response to RFA-NS-19-017 "HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)". Renewal Direct Phase II applications allowed this Funding Opportunity Announcement.  notice be effective the June 21, 2019 application due date subsequent due dates. following section of RFA-NS-19-017 has modified shown bold-italics below): Currently Reads: Section II. Award Information Funding Instrument: Cooperative Agreement: support mechanism used there be substantial Federal scientific programmatic involvement. Substantial involvement means that, after award, NIH scientific program staff assist, guide, coordinate, participate project activities. Section VI.2 additional information the substantial involvement this FOA. Application Types Allowed: Revision New Fast-Track) New Phase II* SBIR Direct Phase II Only) Renewal(Phase II* Direct Phase II allowed) Resubmission phases) The OER Glossary and SF424 R&R) Application Guide provide details these application types. Modified Read: Section II. Award Information Funding Instrument: Cooperative Agreement: support mechanism used there be substantial Federal scientific programmatic involvement. Substantial involvement means that, after award, NIH scientific program staff assist, guide, coordinate, participate project activities. Section VI.2 additional information the substantial involvement this FOA. Application Types Allowed: Revision New Fast-Track) New Phase II* SBIR Direct Phase II Only) Renewal (Phase II) Resubmission phases) The OER Glossary and SF424 R&R) Application Guide provide details these application types. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice Change Key Dates RFA-NS-19-016 HEAL Initiative: Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional)" Notice Number: NOT-NS-19-053 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-016 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Office Research Women’s Health ORWH) Purpose purpose this notice to change Key Dates in RFA-NS-19-016 "HEAL Initiative: Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional)". Specifically, additional receipt been added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) January 9, 2019, March 22, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 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 April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read: Application Due Date(s) January 9, 2019, March 22, 2019, May 20, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 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 April 2019, June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice Change Key Dates RFA-NS-19-017 HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)" Notice Number: NOT-NS-19-054 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-017 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Office Research Women’s Health ORWH) Purpose purpose this notice to change Key Dates in RFA-NS-19-017 "HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)". Specifically, additional receipt been added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) January 9, 2019, March 22, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 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 April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read: Application Due Date(s) January 9, 2019, March 22, 2019, May 2 0, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 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 April 2019, June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice Change Key Dates RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)" Notice Number: NOT-NS-19-055 Key Dates Release Date: April 10, 2019 Related Announcements RFA-NS-19-018 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Office Research Women’s Health ORWH) Purpose purpose this notice to change Key Dates in RFA-NS-19-018 "HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)". Specifically, additional receipt been added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) January 9, 2019, March 22, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 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 April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read:  Application Due Date(s) January 9, 2019, March 22, 2019, May 20, 2019 , June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 , 5:00 PM local time applicant organization. All types non-AIDS applicationsallowed 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 April 2019, June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice Change Key Dates RFA-EB-18-003 HEAL Initiative: Translational Development Devices Treat Pain U18 Clinical Trial Allowed)" Notice Number: NOT-NS-19-056 Key Dates Release Date: April 10, 2019 Related Announcements RFA-EB-18-003 Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) Purpose purpose this notice to change Key Dates in RFA-EB-18-003 "HEAL Initiative: Translational Development Devices Treat Pain U18 Clinical Trial Allowed)". Specifically, additional receipt date has added the August Council round May 20, 2019 changes in bold italics below). Although letter intent not required, not binding, does enter the review a subsequent application, applicants strongly encouraged submit letter intent this receipt date, allow IC staff estimate potential review workload plan review. Part 1. Overview Key Dates Currently Reads: Application Due Date(s) March 22, 2019, June 20, 2019, October 22, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 22, 2021 , 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 April 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date July 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 Modified Read:  Application Due Date(s) March 22, 2019, May 20, 2019 , June 20, 2019, October 22, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 22, 2021 , 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 June 2019, June 2019, November 2019, March 2020, June 2020, November 2020, March 2021, June 2021 Advisory Council Review August 2019, August 2019, January 2020, 2020, August 2020, January 2021, 2021, August 2021 Earliest Start Date October 2019, October 2019, March 2020, July 2020, October 2020, March 2021,July 2021, October 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michael B. Wolfson National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email:Michael.Wolfson@nih.gov Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:nick.langhals@nih.gov

Notice Change Response Date NOT-NS-19-045 " Request Information: Soliciting Input How Best Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS) Research" Notice Number: NOT-NS-19-057 Key Dates Release Date: April 05, 2019 Related Announcements NOT-NS-19-045 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform respondents a change the response date NOT-NS-19-045 Request Information: Soliciting Input How Best Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS) Research." response date change April 15, 2019 May 1, 2019 changes appear in bold italics below). Currently Reads: Key Dates: Release Date: March 15, 2019 Response Date: April 15, 2019 Modified Read: Key Dates: Release Date: March 15, 2019 Response Date: May 1, 2019 Currently Reads: to Submit Response: Response this RFA must submitted electronically using web-based form. Responses be accepted through April 15, 2019. Modified Read: to Submit Response: Response this RFA must submitted electronically using web-based form. Responses be accepted through May 1, 2019. other aspects this notice remain unchanged. Inquiries Please direct inquiries to: Andrew Breeden, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email:andrew.breeden@nih.gov Vicky Whittemore, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email:vicky.whittemore@nih.gov

Notice Availability Administrative Supplements NIH Grants Promote Implementation Research Brain Nervous System Disorders Low- Middle-Income Countries Notice Number: NOT-TW-19-003 Key Dates Release Date: April 03, 2019 Related Announcements PA-18-279 PA-18-280 RFA-MH-16-350 PAR-16-174 RFA-17-650 PAR-18-267 RFA-18-706 PAR-18-007 PA-18-363 PAR-17-001 PA-18-393 PA-18-394 PAR-18-717 Issued Fogarty International Center FIC) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to solicit administrative supplement applications implementation research/ research training existing awards brain nervous system related topics low- middle-income countries LMICs). One-year supplements active NIH neuro-related grants under eligible mechanisms, be requested. Eligible parent grants must focused neuro-health is used here denote prevention, diagnosis, treatment, rehabilitation neurological, neuropsychiatric, developmental, addiction behavioral disorders enhancing improving, cognitive, motor other neurological function. supplement request support pilot research research training projects activities related implementation science global neuro-health must based and within scope an existing grant the primary performance site an eligible LMIC. goal these projects and/or activities to help accelerate translation evidence policy practice effective interventions brain nervous system disorders within community population-level programs, services, strategies scale, within LMICs. supplement FOA Notice supports proposals activities including not limited to: 1) extension neuro-health research results through applications development targeted implementation research research capacity building LMICs 2) integration neuro-health related implementation research existing and/or planned health practice, programming policy. Proposals must: within scope the active parent award be research research-related activities the parent grant LMIC site. be currently focused primarily implementation research add implementation research, research training planning activities, expand current implementation science activities, a primary focus the supplement, within scope the program. Propose address or implementation research/ research capacity building objectives likely stimulate additional activity leading progress neuro-health related implementation research Address priority the IC issued parent award Background: the purposes this supplement request define implementation research application implementation science strategies research develop, test, adopt integrate evidence-based health interventions the context clinical community settings. gap between promise scientifically-proven health interventions brain neurological disorders their successful implementation standard care the real world persists. Implementation research the potential address challenge is critical determining to develop scale effective implementation evidence-based strategies address today’s key global health problems. Implementation research studies should assume empirically-supported interventions be integrated any service setting applied any patient group population without attention local context, nor a unidirectional flow information e.g., publishing recommendation, trial, guideline) sufficient achieve practice policy change. Relevant intervention studies should develop knowledge base how" interventions integrated within real-world practice settings patient populations, will likely require than distribution information the interventions. Research models, theories conceptual frameworks the implementation process encouraged move away an exclusively top-down" approach a greater emphasis the resources local care settings the needs multiple stakeholders. main purpose these supplements to develop pilot implementation research projects activities extending global neuro-health research results the parent grant. goal these pilot projects and/or activities to help further develop accelerate application translation effective interventions brain neurological disorders medical/clinical, community population-level programs services LMICs. Proposed activities under supplement should and/or contribute the development the knowledge base effective scale of evidence-based interventions developed, adapted tested the local context. Implementation Science Objectives: Proposed research research training should host-country driven address questions implementation scientifically-proven interventions neuro-health. Where possible, within goal building the parent grant, includes research training related activities strengthen implementation research capacity. Implementation research goals address include: - Communication collaboration between researchers research end users program implementers, health practitioners, policy-makers); - Cost-effective, novel, innovative research methods demonstrate effective interventions be implemented brought scale; - Innovative methods the study implementation scale-up proven interventions achieve improved health outcomes; - Dissemination research findings, implementation scale-up proven health interventions neuro-health. - Using, testing evaluation strategies implement interventions related health promotion, prevention, screening, early detection, diagnosis, effective treatments proven clinical procedures guidelines integrated existing care systems neuro-health. Research/ research training also encouraged focuses the adoption, implementation sustainability evidence-based practices clinical community settings through studies on: - implementation multiple evidence-based practices meet complex needs patients diverse systems care; - systematic identification intervention components must modified most effective local adaptation evidence-based practices; - to influence organizational structure, climate, culture, processes enable dissemination implementation information the implementation effective interventions. Approaches implementation research/ research training include team science, community-based participatory research, action research related frameworks engage stakeholders end users throughout research process. in-country LMIC partners must clearly involved the supplement application. Proposed research/ research training related research activities should address synergies country public health plans and/or national health research priorities, where appropriate. Plans facilitate synergy should included part the supplement application. strategy include, example, letter the Ministry Health stating the neuro-health implementation research/ research training being developed be valuable develop evidence base the country’s policies programming. Specific Research Interests the FOA Sponsors: Participating NIH Institutes Centers ICs) provided specific statements interest this FOA below. Applicants obtain information research interests each the NIH participants this FOA their web sites through Scientific/Research contact listed this announcement. Fogarty International Center FIC) is interested supplement applications eligible neuro-health related R01 D43 FIC grants relevant the neuro-health implementation science research focus this Notice the FIC mission subject funds available). Parent grants their first year funding on extension not eligible FIC supplement funding under Notice. FIC Strategic plan http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) includes following relevant goals: 1) Stimulate innovation the development implementation technologies other locally-relevant solutions address global health problems; 2) Support research research training implementation science; National Institute Mental Health(NIMH) interested implementation questions facing LMICs their efforts expand access evidence-based mental health care, improve quality mental health care, and/or foster evidence-based policy program development mental health. Supplement applications considered relevant NIMH priorities under FOA include, are limited to, those propose to: Develop and/or validate implementation measures use mental health care across low-resource settings Identify test mechanisms system- provider-level change are causally associated quality care and/or therapeutic endpoints existing data model test causal relations among interventions, intervention targets, proximal distal clinical) outcomes Optimize uptake, effectiveness, quality mental health screening, assessment, intervention varied settings e.g., medical non-medical) Estimate costs integrating mental health care alternative delivery settings e.g., schools, chronic disease care, social services, justice settings) Evaluate dissemination strategies e.g., social marketing, technology-based, social media, peer network) increase awareness increase demand mental health screening, assessment, intervention services Assess implementation needs e.g., knowledge, skills, training, practice) health care providers HIV care treatment settings respect screening, assessment, care mental disorders Identify key tasks related mental health care are amenable management HIV care treatment teams, can used guide development implementation strategies integrating mental health care HIV care Develop test innovative implementation strategies training, supporting, supervising HIV care providers the effective delivery a basic package mental health services Build research capacity implementation science theory methods within LMICs and/or foster evidence-based policy program development mental health National Institute Neurological Disorders Stroke NINDS) interested supporting mechanistic, epidemiological, prevention, translational clinical research across spectrum neurological, neuromuscular, neuroinfectious neurovascular diseases disorders all ages. addition prevalent neurological disorders stroke, NINDS also interested supporting research capacity building areas rare neglected neurological diseases are relevant the collaborating LMICs NINDS Disorder Indexhttp://www.ninds.nih.gov/disorders/disorder_index.htm). NINDS like encourage development networks neuro-related topical disease-related areas e.g., stroke, epilepsy other high burden neurological disorders LMICs) linked existing programs resources LMICs e.g., MEPI, H3Africa, other NIH-funded projects) share capacity building activities conduct collaborative research. Under FOA, NINDS interested implementation research-related applications lay groundwork future clinical trials, such conducting surveys available patient populations, developing clinical trial protocols training materials, establishing trial infrastructure recruiting treating subjects collecting, receiving, storing distributing study drugs, processing data laboratory specimens. Applicants interested clinical trials neurological disorders within NINDS mission also referred NINDS clinical trial-specific funding announcements PAR-17-202 and PAR-17-122, PAR-17-314 ). National Institute Drug Abuse: The mission the National Institute Drug Abuse NIDA) to advance science the causes consequences drug and addiction to apply knowledge improve individual public health. NIDA International Program fosters international cooperative research the exchange information substance disorder researchers around globe. Although international researchers receive NIDA support through direct foreign grant, most international research supported through domestic grant a foreign component, where principal investigator a U.S. institution works a researcher another country. this FOA, eligible NIDA projects must conducting research a low and/or middle-income country LMIC) focuses neuro-health specific substance disorders. NIDA research projects seeking supplemental funds must a sufficiently developed program, practice intervention warrant incorporation pilot feasibility research implementation will lead a full-scale implementation study e.g., clinical trial), ultimately lead the adoption delivery interventions and/or services LMICs. Projects must include involvement in-country LMIC partners, outlined above the FOA. implementation research should demonstrate relevance the US. Research LMICs focused implementation science interest NIDA include, are limited to, following examples: Early stage implementation research capacity identify address organizational factors facilitate delivery evidence-based programs, practices interventions LMIC systems settings Feasibility research determine approaches delivering substance prevention treatment interventions rural and/or hard reach community settings, developed through collaborative partnerships Pilot feasibility research optimize interventions delivery LMIC systems settings Pilot research support use hybrid effectiveness-implementation designs LMICs Feasibility research develop models multi-level interventions e.g., target patients organizations) the adoption, implementation utilization evidence-based substance prevention treatment interventions Research develop cross-system collaborations e.g., health education) support delivery evidence-based prevention treatment interventions Investigators should submit applications responses the parent active administrative supplement PA, Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)”: https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html Supplements existing clinical trials allowed, addition a new clinical trial was a part the parent award not allowed. Before submitting supplement request, principal investigators strongly encouraged contact program officer, the program contact the Institute, Center Office supporting parent award discuss whether proposed supplement within scope the project the priorities the IC supporting parent award with any questions. Award Project Period be eligible, parent award must receive funds FY19 Oct. 1, 2018-Sept. 30, 2019) may be an extension period. request for year funding. Budget Supplement budget requests the one-year supplement cannot exceed 100,000 direct costs exclusive Facilities Administrative costs sub-contracts, 50% the direct costs the current parent award, whichever less. Requests must reflect actual needs the proposed project. Modular categorical budgets permitted. Eligible Individuals Program Director/Principal Investigator) Individual(s) submitting PD/PIs must hold active grant cooperative agreement an eligible neuro-health topic an eligible LMIC. supplements parent awards include multiple PDs/PIs, supplement be requested any all PDs/PIs accordance the existing leadership plan) submitted the awardee institution the parent award. Submitting Application additional information, the parent program announcement Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-591. part the application investigators should submit no than one-page abstract the proposed research shows relevance the existing grant implementation research/ research training goals articulates component(s) any IC-specific priorities the supplement addressing. Applicants should begin supplement application abstract stating: application being submitted PA-18-591 accordance NOT-TW-19-003." Page Limits: NIH consider supplements a Research Strategy of no than 6 pages, addition the abstract. Supplements should submitted electronically if allowed parent mechanism. addition, applicants strongly encouraged notify program contact the institute is supporting parent award list below) an application been submitted response this FOA facilitate efficient processing the request. Requests must received 5:00 PM Pacific Daylight Time P.D.T.) May 22, 2019. Institute, Center IC) Office-specific Instructions Review process IC conduct administrative reviews applications submitted their IC separately. Criteria: 1. the parent grant proposed supplement related neuro-health under definition the Notice) is work proposed within scope the active award? 2. the proposed implementation research-related work relevant the parent grant? well does enhance goals the parent grant? 3. Does work proposed address or of components listed under implementation research objectives? 4. Does work proposed scientific merit and/or increase implementation research capacity neuro-health? 5. the work likely stimulate additional activity leading progress implementation research? 6. Does work address priority the IC issued parent award applicable-see IC interests”)?   Inquiries Please direct inquiries to: Kathleen Michels, Ph.D. Fogarty International Center FIC) Telephone: 301-435-6031 Email: michelsk@ficod.fic.nih.gov Beverly Pringle, Ph.D.National Institute Mental Health NIMH)Telephone: 301-443-3725Email: bpringle@mail.nih.gov Belinda Sims, Ph.D.National Institute Drug Abuse NIDA)Telephone: 301-443-6504Email: bsims@nida.nih.gov Dallas Anderson, Ph.D. National Institute Aging NIA) Telephone: 301-496-9350 Email: andersda@nia.nih.gov Claudia Moy, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 Email: MoyC@ninds.nih.gov

Request Information the Proposal Updating Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative Plan Notice Number: NOT-NS-19-041 Key Dates Release Date: March 28, 2019 Response Date: 15, 2019 Related Announcements NOT-NS-18-075 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 Request Information RFI) to solicit input potential strategies updating goals set forth in BRAIN 2025: Scientific Vision(https://www.braininitiative.nih.gov/sites/default/files/pdfs/brain2025_…) keep pace the advancing science supported this bold research initiative. draft findings reflect wide array stakeholder input solicited the Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative Working Group the Advisory Committee the NIH Director ACD). NIH soliciting input all interested stakeholders, including members the scientific community, private sector, health professionals, professional societies, advocacy groups, patient communities, other interested members the public. Background BRAIN Initiative® a trans-agency effort public private partners started 2014 the goal understanding the brain works. NIH been guided thus far by BRAIN 2025: Scientific Vision, outlined set findings consideration the NIH ACD based scientific input the community. document describes overarching vision, scientific priority areas, specific goals the BRAIN Initiative NIH used guide investments. the last five years, NIH implemented recommendations this document issued multiple Funding Opportunity Announcements aimed reaching goals. these awards, scientific community made much progress identifying manipulating neural circuits using newly developed neurotechnologies see http://www.braininitiative.nih.gov). scientific progress necessitates, the original Working Group the ACD anticipated, revisiting the BRAIN 2025recommendations updating prospective implementation the BRAIN Initiative accordingly. 2018 NIH established both new BRAIN Initiative Working Group the ACD https://acd.od.nih.gov/working-groups/brain2.0.html) a BRAIN Initiative Neuroethics Subgroup https://acd.od.nih.gov/working-groups/brain2.0-subgroup.html) review recent scientific progress propose updates the BRAIN Initiative scientific neuroethical strategic plans the ACD’s consideration. Working Group hosted multiple public workshops, town halls, a previous RFI https://grants.nih.gov/grants/guide/notice-files/NOT-NS-18-075.html) obtain feedback the progress future the BRAIN Initiative. Using information, Working Group the ACD sharing initial findings the next stage the BRAIN Initiative Cells Circuits, Toward Cures,found here: https://www.braininitiative.nih.gov/strategic-planning/acd-working-grou…). draft now open public comment via RFI. BRAIN Initiative Working Group the ACD use responses received through RFI revise findings appropriate before transmitting final document ACD consideration June 2019. Information Requested Please submit feedback related the following themes the proposed document: Scientific research priorities the BRAIN Initiative Approaches training tool dissemination the BRAIN Initiative Considerations data sharing within BRAIN Initiative Integration neuroethics the BRAIN Initiative Any feedback relevant to From Cells Circuits, Toward Cures to Submit Response ensure consideration, responses must received May 15, 2019. Responses this RFI must submitted electronically using web-based form at https://www.braininitiative.nih.gov/strategic-planning/acd-working-grou… via email to BRAINFeedback@nih.gov with BRAIN RFI" the subject line. Responses this RFI voluntary. Individual feedback not provided any responder. Proprietary, classified, confidential, sensitive information should be included your response. Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it. Please note the U.S. Government not pay the preparation any comment submitted for use that comment. Inquiries Please direct inquiries to: Email: BRAINFeedback@nih.gov