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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  

Notice Change Allowable Appendix Materials PAR-17-312 NINDS Neuroscience Development Advancing Careers a Diverse Research Workforce R25)" Notice Number: NOT-NS-19-048 Key Dates Release Date: March 20, 2019 Related Announcements PAR-17-312 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change allowable Appendix Materials in PAR-17-312, NINDS Neuroscience Development Advancing Careers a Diverse Research Workforce R25)" update required information the Research Performance Progress Report RPPR). Appendix Currently Reads: not the Appendix circumvent page limits. Follow instructions the Appendix described the SF424 R&R) Application Guide. Modified Read: not the Appendix circumvent page limits. Follow instructions the Appendix described the SF424 R&R) Application Guide; any instructions provided here in addition the SF424 R&R) Application Guide instructions. Appendix meant provide additional details the following topics, not meant substitute clear descriptions the body the application. not include items than allowable materials described below, doing will result administrative withdrawal the application noncompliance. summary sheet listing the items included the Appendix be included the first Appendix attachment. following allowable Appendix materials: Evaluation Assessment Instruments. Applicants provide blank surveys, rubrics, and/or forms used a) document monitor trainee progress b) determine whether program its environment effective, inclusive, safe, supportive. Research Education Outcomes 4 pages).The application provide information table form outcomes subsequent educational/career progress appropriate career stage about recent past 5 years) participants including participants a pilot program) the pool potential applicants, such as: Aggregate number demographic characteristics participants Educational level participants Successful completion an undergraduate graduate degree neuroscience neuroscience-related field Subsequent enrollment an advanced degree program neuroscience neuroscience-related program Subsequent authorship scientific publications scientific presentations outside conferences a biomedical field Subsequent participation a formal research training career development program a neuroscience field Subsequent participation research a neuroscience field Subsequent employment promotion a research research-related biomedical field Subsequent independent research grant support NIH another source Participating Faculty 3 pages).The application may provide following information table form participating faculty: Faculty information: name, degree(s), academic rank, primary department program, research interest, training role i.e., PD/PI, preceptor, executive committee member, committee member, other) Mentoring record undergraduates, predoctorates, postdoctorates the last 10 years: number currently training, graduated/completed training, continued research related careers Applications exceed number allowed appendices the page limitation any the allowed materials be considered noncompliant will be reviewed. 3. Reporting Currently Reads: multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually. Continuation support not provided until required forms submitted accepted. Programs involve participants should report education the responsible conduct research complete a Training Diversity Report, accordance the RPPR Instruction Guide. Modified Read: multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually. When submitting RPPRs, funded programs expected provide evidence accomplishing research education objectives results the proposed evaluation plan. Continuation support not provided until required forms submitted accepted. Programs involve participants should report education the responsible conduct research complete a Training Diversity Report, accordance the RPPR Instruction Guide. other aspects this FOA remain same. Inquiries Please direct inquiries to: Lauren Ullrich PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7964 Email: lauren.ullrich@nih.gov

Request Information: Soliciting Input How Best Advance Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS) Research Notice Number: NOT-NS-19-045 Key Dates Release Date: March 15, 2019 Response Date: 1, 2019 per NOT-NS-19-057 ) Related Announcements NOT-NS-19-057 Issued National Institute Neurological Disorders Stroke NINDS) Purpose 2018 National Institute Neurological Disorders Stroke NINDS) formed Working Group the National Advisory Neurological Disorders Stroke NANDS) Council focused how best advance research myalgic encephalomyelitis chronic fatigue syndrome ME/CFS). Working Group, composed scientists, clinicians, representatives non-governmental organizations NGOs), individuals ME/CFS, charged with: identifying gaps opportunities ME/CFS research, considering unique opportunities NIH-supported ME/CFS research attract train pipeline new young investigators, identifying potential approaches enhance ongoing research collaboration communication between NGOs, individuals ME/CFS, researchers, federal agencies support research ME/CFS. NANDS Council Working Group ME/CFS soliciting input approaches strategies address charge the Working Group will the responses this Request Information RFI) help inform discussions how advance research ME/CFS. Information Requested NIH soliciting input all interested stakeholders, including researchers, health care providers, individuals ME/CFS, patient advocates health advocacy organizations, scientific professional organizations, federal agencies, well other interested members the public. Organizations strongly encouraged submit single response reflects views their organization membership a whole. Optional: Please indicate you a researcher, health care provider, individual ME/CFS, patient advocate, other interested party. you submitting response behalf an organization membership a whole, please indicate name your organization. Please provide perspective any all the following issues related the Working Group's charge: most compelling ME/CFS research needs. Strategies overcoming scientific challenges barriers progress ME/CFS research. Potential research resources, tools, and/or materials could help advance ME/CFS research enable early career investigators senior investigators new the ME/CFS field more easily conduct research. Relevant considerations strategies clinical ME/CFS research, including development validation data standards outcome measures. Overcoming challenges barriers establishing career ME/CFS research early career investigators those new the field. Approaches strengthen research career training ME/CFS investigators. Identifying related scientific areas may relevant ME/CFS strategies establishing collaborations experts those areas help advance ME/CFS research. Approaches reduce barriers prevent individuals ME/CFS participating research. example, might logistical challenges, such difficulty traveling a study site, might because an unwillingness undergo certain types research protocols. Strategies increasing ME/CFS research collaboration communication between relevant stakeholders. approaches may improve overall field ME/CFS research.   Responses be accepted through April 15 , 2019 . Responses voluntary may submitted anonymously. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. Responses be shared publicly an NIH website. Please not include any personally identifiable other information you not wish make public. proprietary, classified, confidential, sensitive information should included your response. request for information planning purposes only should be construed a solicitation as obligation the part the United States Government. NIH not any awards based responses this RFI pay the preparation any information submitted for Government's of such information. Inquiries Please direct inquiries to: Andrew Breeden, PhDNational Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-1917Email: andrew.breeden@nih.gov  Vicky Whittemore, PhD National Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-1917Email: vicky.whittemore@nih.gov

Notice a Parallel Funding Opportunity Announcement the Canadian Institutes Health Research – Institute Neurosciences, Mental Health Addiction CIHR-INMHA) Notice Number: NOT-NS-19-049 Key Dates Release Date: March 14, 2019 Related Announcements RFA-NS-19-022 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD)National Institute Neurological Disorders Stroke NINDS) Purpose February 7, 2019, NIH issued following Funding Opportunity Announcement FOA): RFA-NS-19-022, Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls PCS-EMA CWOW) U54 Clinical Trial Allowed) programmatic goals compatible, parallel funding a research program have positive synergistic effects the level scope research leveraging interests investments all involved agencies. Toward such goals, Canadian Institutes Health Research - Institute Neurosciences, Mental Health Addiction CIHR-INMHA) establish a parallel funding program to support single research project conducted Canadian research institutes facilities Canadian investigators, within PCS-EMA CWOW RFA-NS-19-022) selected funding NINDS NICHD. CIHR-INMHA expects provide to 250,000 Canadian dollars) per year this funding opportunity. CIHR-INMHA funding expected to supplant the equivalent amount funds the PCS-EMA CWOW’s award budget provided NIH will change total amount direct costs available, detailed RFA-NS-19-022. funding opportunity published the CIHR website by March 14, 2019. participate the CIHR-INMHA parallel funding opportunity, applications RFA-NS-19-022 a Canadian-based research component must also submit parallel abbreviated application CIHR-INMHA details requested support the Canadian component the PCS-EMA CWOW the CIHR website details). Canadian component must an integrated part a Research Project/s an application RFA-NS-19-022. PCS-EMA CWOW applications, or without Canadian Component, be reviewed using standard NIH panel review process. such, PCS-EMA CWOW application be reviewed accordance the review criteria outlined RFA-NS-19-022. Funds CIHR-INMHA only applicable the CWOW selected funding NINDS NICHD. NINDS, NICHD CIHR intend fund future years their respective components the awarded CWOW based the availability appropriations applicable policies. the extent permissible under applicable laws, regulations policies, Canadian research team expected function participate all the PCS-EMA CWOW activities, including involvement the CWOW’s leadership committees teleconferences, annual semi-annual meetings, publications, any additional PCS-EMA CWOW endeavors. applicable rules regulations under Freedom Information Act 5 USC552) Canadian Privacy Act be followed. NIH Data Sharing Policies outlined in NOT-OD-03-032 apply well TBI Clinical Research sharing policies outlined in NOT-NS-17-029. Inquiries Please direct inquiries to: Patrick Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-1447 Email: psfb@mail.nih.gov

Notice Information: Clinical Trials Explore Non-Addictive Therapeutics Pain Conditions under Early Phase Pain Investigation Clinical Network EPPIC-Net) Notice Number: NOT-NS-19-043 Key Dates Release Date: March 13, 2019 Related Announcements RFA-NS-19-023 RFA-NS-19-024 RFA-NS-19-025 NOT-NS-19-075 Issued National Institute Neurological Disorders Stroke NINDS) Purpose April 2018, NIH launched HEAL Helping End Addiction Long-term) Initiative, aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. major goal the HEAL Initiative to spur development effective, non-addictive treatments reduce burden illness due pain to reduce risk addiction. Over past 2 years, NIH gathered input experts the U.S. Food Drug Administration FDA), academia, the private sector identify key gaps opportunities the development new treatments pain. Through consultations, NIH identified need a sophisticated clinical trial network design execute innovative early phase trials promising non-addictive pain therapies well-characterized patient cohorts pain conditions high unmet need. Early Phase Pain Investigation Clinical Network EPPIC-Net) EPPIC-Net seeks to improve treatment acute chronic pain reduce reliance opioids accelerating early phase testing non-addictive pharmacologic device strategies industry academic investigators alleviating pain. NIH broad input the appropriate NIH Advisory Council reach to industry academia interventions be tested EPPIC-Net. will lower burden early phase clinical testing provide strong evidence guide decisions proceeding later phase trials a pain indication. a continually learning network, EPPIC-Net researchers provide needed knowledge clinical populations, biomarkers, innovative means testing therapies the research community the singular goal accelerating process making effective therapies pain available the public reducing reliance opioids. goals the clinical trials EPPIC-Net to: Test new treatments early-stage trials using therapeutic candidates (“assets” encompassing small molecules, biologics, devices) Go/No-Go criteria inform decisions move toward efficacy trials regulatory approval. Test new treatments early-stage trials using assets help establish a specific therapeutic pathway holds promise a next generation device, small molecule biologic. Validate biomarkers utility tests target engagement proof principle could used enable accelerate discovery, development, approval new, non-addictive pain therapies. Develop test innovative clinical trial paradigms establish best means testing variety pain therapies. Establish well-characterized patient cohorts specific pain conditions outcome measures utility early-stage trials. Continuously learn experience engineer ever-improved early phase testing new pain therapies over time. scientific focus the clinical trials EPPIC-Net open all pain conditions. research infrastructure EPPIC-Net be established through previously published funding opportunities RFA-NS-19-023, RFA-NS-19-024, RFA-NS-19-025) will composed a Clinical Coordinating Center CCC), Data Coordinating Center DCC), regional Clinical Hubs linked clinical sites. Application Process Clinical Trials EPPIC-Net Stage 1. Asset submission review: Applicants submit preliminary information their drug device (“asset”), target condition population, available preclinical early phase clinical drug/device data proposed study design through template. Interested applicants visit www.ninds.nih.gov/EPPICNet for information to alerted asset application templates made available. objective review process be used select high ranking applications. high-ranking applications proceed the next stage. Stage 2. Development review a detailed dossier”: Successful applicants stage 1 be invited develop more detailed proposal (“dossier”) will submitted a second objective review process. high-ranking proposals proceed the next stage. Stage 3. Protocol development, research site selection, implementation: Successful applicants work the investigators EPPIC-Net develop tailored clinical trial protocol, will receive final round objective review. protocols be subject final approval NIH then funded through Other Transaction OT) mechanism. use Other Transaction Authority enable NIH rapidly initiate clinical trials EPPIC-Net adapt new knowledge technologies emerge. Inquiries Please direct inquiries to: Barbara I. Karp, M.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0150 E-mail: karpb@ninds.nih.gov

Notice Change Key Date PAR-19-170 Progression Markers Cognitive Impairment Parkinson's Disease Dementia R01 Clinical Trial Allowed)" Notice Number: NOT-NS-19-046 Key Dates Release Date: March 11, 2019 Related Announcements PAR-19-170 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a change the Advisory Council Review Date PAR-19-170 Progression Markers Cognitive Impairment Parkinson's Disease Dementia R01 Clinical Trial Allowed)". Advisory Council Review Date change August 2019 to October 2019. Currently Reads: Part 1. Overview Key Dates Advisory Council Review August 2019 Modified Read: Part 1. Overview Key Dates Advisory Council Review October 2019 other aspects this FOA remain same. Inquiries Please direct inquiries to: Debra Babcock, PhD, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dbabcock@mail.nih.gov

Notice Change Key Date PAR-19-167 Development Validation Advanced Mammalian Models Alzheimer's Disease-Related Dementias ADRD) R61/R33 Clinical Trial Allowed)" Notice Number: NOT-NS-19-047 Key Dates Release Date: March 11, 2019 Related Announcements PAR-19-167 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a change the Advisory Council Review Date PAR-19-167 Development Validation Advanced Mammalian Models Alzheimer's Disease-Related Dementias ADRD) R61/R33 Clinical Trial Allowed)". Advisory Council Review Date change August 2019 to October 2019. Currently Reads: Part 1. Overview Key Dates Advisory Council Review August 2019 Modified Read: Part 1. Overview Key Dates Advisory Council Review October 2019 other aspects this FOA remain same. Inquiries Please direct inquiries to: Amelie Gubitz, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email:gubitza@ninds.nih.gov

Notice Changes RFA-AI-19-002 HIV/AIDS Clinical Trials Networks Statistical Data Management Centers UM1 Clinical Trial Required)" Notice Number: NOT-AI-19-051 Key Dates Release Date: March 11, 2019 Related Announcements RFA-AI-19-002 Issued National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants two changes to RFA-AI-19-002 "HIV/AIDS Clinical Trials Networks Statistical Data Management Centers UM1 Clinical Trial Required)". Notice removes specific text Part 2. Section and Part 2. Section IV. Part 2: Full Text Announcement Section I. Funding Opportunity Description Statistical Data Management Center Specific Responsibilities Data Collection Management Funding Opportunity Announcement FOA) currently reads: SDMC provides, maintains, supports updates commercial off-the-shelf COTS) clinical trial management systems include electronic data capture EDC) are interoperable the laboratory information management systems LIMS). systems provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network including CTUs/CRSs Protocol-Specific sites. Both clinical trial management systems laboratory information management systems must 21CFR part 11 ICH E6 compliant. DAIDS reserves right audit vendors their sub-contractors. needed, SDMC interfaces, integrates adapts information system(s) be interoperable NIAID systems. SDMC supports collecting, storing providing data accordance regulatory requirements defined FDA ICH collaborating other DAIDS-affiliated SDMCs the development data elements do currently exist within CDISC. SDMC provides specific capabilities including: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. EDC system must interoperable fully integrated that data various sources be merged yield generalizable results. system provides targeted source data verification. SDMC establish procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies. Electronic Health Record EHR) Systems used SDMC ensure interoperability the EHR data the EDC system maintain record EHR systems used each clinical research site status data sharing agreements. SDMC provides timely data access, statistical analysis reports for: Safety Oversight, the Safety Oversight committees. Clinical research site protocol-specific reports: Provide reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS its IC partners purposes clinical monitoring. Funding Opportunity Announcement FOA) modified read without italicized language above: SDMC provides, maintains, supports updates commercial off-the-shelf COTS) clinical trial management systems include electronic data capture EDC) are interoperable the laboratory information management systems LIMS). systems provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network including CTUs/CRSs Protocol-Specific sites. Both clinical trial management systems laboratory information management systems must 21CFR part 11 ICH E6 compliant. DAIDS reserves right audit vendors their sub-contractors. needed, SDMC interfaces, integrates adapts information system(s) be interoperable NIAID systems. SDMC supports collecting, storing providing data accordance regulatory requirements defined FDA ICH collaborating other DAIDS-affiliated SDMCs the development data elements do currently exist within CDISC. SDMC provides specific capabilities including: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. EDC system must interoperable fully integrated that data various sources be merged yield generalizable results. system provides targeted source data verification. SDMC establish procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies. SDMC provides timely data access, statistical analysis reports for: Safety Oversight, the Safety Oversight committees. Clinical research site protocol-specific reports: Provide reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS its IC partners purposes clinical monitoring. Section IV. Application Submission Information 2. Content Form Application Submission Sub-section B. Data Collection Management Funding Opportunity Announcement FOA) currently reads: Describe clinical trial management systems how will provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network research agenda being supported including CTUs/CRSs Protocol-Specific sites. Describe nature type data be collected, how data taken together address overall goals objectives network clinical studies the network will supported. Describe policies procedures interfacing, integrating or adapting information system(s) interact clinical research management systems such NIAID N-CRMS other information systems components specified NIAID. Describe capabilities for: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. interoperable fully integrated electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant Title 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. targeted source data verification. Describe procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies Describe process timelines reports, data access statistical analysis Safety Oversight, the Safety Oversight committees. Clinical research site protocol specific reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS purposes clinical monitoring. Determining co-enrollment protocol status reports. Describe procedures interoperability the EHR data the EDC system Electronic Health Record EHR) Systems used. Describe documentation maintain a record EHR systems used each clinical research site. Describe procedures compliance with NIAID DAIDS policies, regulations procedures. Describe procedures used guide software development including project planning, requirements definition, system design, implementation, integration testing, deployment, maintenance, system retirement. Describe validation processes. Describe efforts establish processes methods common architecture the clinical research community including defining technical standards, identifying security requirements, identifying integrating existing resources, promoting use clinical research data are machine readable that adhere the FAIR findable, accessible, interoperable, re-useable) principles. Describe implementation use validated data collection systems, forms formats, identify any innovations adapting database systems structures accommodate various clinical site, laboratory collaborator needs. Address compliance 21 CFR 11, HIPAA, ability support data interchange standards. Describe alignment workflow systems. Describe system subject randomization procedures strict maintenance blinding throughout studies. Describe procedures used study randomization, randomization systems supported web-based allocation, touch tone allocation, permuted block allocation, etc.), procedures verification validation eligibility prior randomization. Describe integration your randomization system the workflow ability generate protocol status reports. Describe system capabilities the validated laboratory information management system track specimens. Describe the SDMC support Good Data Practices. Describe efforts develop implement standard uniform protocols data collection e.g., Common Data Elements CDE]). Outline process timeline the SDMC prepare the implementation an individual study including electronic Case Report Form eCRFs), protocol-specific site-specific randomization data entry screens, other study-related materials needed. Describe plans shift current data collection management practices address changes regulatory requirements opportunities provided information technology advances any advantage may over existing methodologies. Describe project management system forecasting timelines protocols the need provide data management, collection, retrieval data. Include process ongoing tracking planned versus actual milestones. Describe plans communications and the LOC means adjusting resources needed meet agreed upon protocol schedules. Funding Opportunity Announcement FOA) modified read without italicized language above: Describe clinical trial management systems how will provide data collection, exchange, storage, tracking retrieval clinical laboratory data the network research agenda being supported including CTUs/CRSs Protocol-Specific sites. Describe nature type data be collected, how data taken together address overall goals objectives network clinical studies the network will supported. Describe policies procedures interfacing, integrating or adapting information system(s) interact clinical research management systems such NIAID N-CRMS other information systems components specified NIAID. Describe capabilities for: Interactive Response Technology IRT) System subject registration randomization laboratory information management system integrates IRT manage study specimens real time, use the SDMC, study sites, laboratories others. interoperable fully integrated electronic data capture clinical data EDC) system(s) associated electronic case report forms ECRFs) are compliant Title 21 Code Federal Regulations CFR) Part 11 Health Insurance Portability Accountability Act HIPAA) remote/direct data entry transmission subject data study sites laboratories the central data management location. targeted source data verification. Describe procedures alternative data capture e.g., system off-line data entry internet connection not available) described in NIAID DAIDS policies Describe process timelines reports, data access statistical analysis Safety Oversight, the Safety Oversight committees. Clinical research site protocol specific reports such accrual, demographics, protocol deviations, data queries, timeliness data submission, response queries quality assurance purposes for protocol project management. Clinical research source data collected studies sponsored/funded NIAID/DAIDS purposes clinical monitoring. Determining co-enrollment protocol status reports. Describe procedures compliance with NIAID DAIDS policies, regulations procedures. Describe procedures used guide software development including project planning, requirements definition, system design, implementation, integration testing, deployment, maintenance, system retirement. Describe validation processes. Describe efforts establish processes methods common architecture the clinical research community including defining technical standards, identifying security requirements, identifying integrating existing resources, promoting use clinical research data are machine readable that adhere the FAIR findable, accessible, interoperable, re-useable) principles. Describe implementation use validated data collection systems, forms formats, identify any innovations adapting database systems structures accommodate various clinical site, laboratory collaborator needs. Address compliance 21 CFR 11, HIPAA, ability support data interchange standards. Describe alignment workflow systems. Describe system subject randomization procedures strict maintenance blinding throughout studies. Describe procedures used study randomization, randomization systems supported web-based allocation, touch tone allocation, permuted block allocation, etc.), procedures verification validation eligibility prior randomization. Describe integration your randomization system the workflow ability generate protocol status reports. Describe system capabilities the validated laboratory information management system track specimens. Describe the SDMC support Good Data Practices. Describe efforts develop implement standard uniform protocols data collection e.g., Common Data Elements CDE]). Outline process timeline the SDMC prepare the implementation an individual study including electronic Case Report Form eCRFs), protocol-specific site-specific randomization data entry screens, other study-related materials needed. Describe plans shift current data collection management practices address changes regulatory requirements opportunities provided information technology advances any advantage may over existing methodologies. Describe project management system forecasting timelines protocols the need provide data management, collection, retrieval data. Include process ongoing tracking planned versus actual milestones. Describe plans communications and the LOC means adjusting resources needed meet agreed upon protocol schedules. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Phillip Renzullo, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3041 Email:prenzullo@niaid.nih.gov

Notice Extend Expiration Date RFA-NS-19-010 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain UG3/UH3 Clinical Trial Allowed)" Notice Number: NOT-NS-19-040 Key Dates Release Date: March 7, 2019 Related Announcements RFA-NS-19-010 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants the expiration Date RFA-NS-19-010 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain UG3/UH3 Clinical Trial Allowed)" be extended one council round changes shown inbold italicsbelow). additional due date been added this FOA,June 4, 2019.. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019 March 6, 2019, 5:00PM local time applicant organization. Alltypes 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. AIDS Application Due Date(s) January 9, 2019 March 6, 2019, 5:00PM local time applicant organization. Alltypes AIDS AIDS-related 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 March 2019 June 2019 Advisory Council Review 2019 August 2019 Earliest Start Date June 2019 September 2019 Expiration Date March 7, 2019 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019, March 6, 2019, andJune 4, 2019by 5:00PM local time applicant organization. Alltypes 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. AIDS Application Due Date(s) January 9, 2019, March 6, 2019, andJune 4, 2019by 5:00PM local time applicant organization. Alltypes AIDS AIDS-related 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 March 2019, June 2019,October 2019 Advisory Council Review 2010, August 2019,August 2019 Earliest Start Date June 2019, September 2019,February 2020 Expiration Date June 5, 2019 other aspects this FOA remain same. Inquiries Please direct inquiries to: Charles Cywin, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email:charles.cywin@nih.gov