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Notice Clarification Language Project Characteristics PAR-18-550, Analytical Validation a Candidate Biomarker Neurological Disease U01 Clinical Trial Optional)e Notice Number: NOT-NS-19-021 Key Dates Release Date: November 8, 2018 Related Announcements PAR-18-549 PAR-18-550 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify language bullet four the Project Characteristics section Part. 2. Section I, Funding Opportunity Description for PAR-18-550 . Part 2. Full Text Announcement Section I. Funding Opportunity Description Project Characteristics Current Language bullet four: Applications this FOA should technologies already use soon be approved use clinical laboratories since is a technology development FOA. Revised Language bullet four: biomarker detection method must developed ready validation studies. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email:  mary.pelleymounter@nih.gov

Notice Changes RFA-AG-19-020 Clinical Trial Effects Statins Older Adults without Clinical Cardiovascular Disease U19 Clinical Trial Required)" Notice Number: NOT-AG-18-038 Key Dates Release Date: November 8, 2018 Related Announcements RFA-AG-19-020 Issued National Institute Aging NIA) National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) Purpose Notice being issued inform potential applicants changes RFA-AG-19-020 Clinical Trial Effects Statins Older Adults without Clinical Cardiovascular Disease U19 Clinical Trial Required)". NIA increasing funding contribution commitments NHLBI NINDS remaining same). a result, key dates, scope, funds available anticipated number awards, award budget, application instructions being revised described below. changes ensure the future clinical trial be sufficiently powered assess effects statins mild cognitive impairment dementia MCI+D) the study population defined the RFA. is anticipated achieving power require enrollment substantially than originally projected 17,000 participants. Having larger number participants important several reasons: larger number participants increase power the primary outcome will provide a greater power assess effects statins in a priori defined subgroups e.g. minorities, older age groups, participants frailty, etc.). larger sample size crucial assessing effects statins the important secondary outcomes MCI+D composite clinical cardiovascular disease events. narrower confidence intervals around hazard ratios treatment the larger sample provide, even no significant effect dementia MCI+D found, provide definitive evidence benefit lack benefit. larger sample size associated increase funding provide enhanced ascertainment MCI+D outcomes, further increasing power measuring effects MCI+D ensuring fewer events been missed. participants fail screening test not only referred a healthcare professional, they also contacted the study staff confirm diagnosis addition review the electronic health records. following revisions been to RFA-AG-19-020 revised text italicized): Part 1. Overview Information, Key Dates Open Date Earliest Submission Date): January 4, 2019 Letter Intent Due Date(s): January 4, 2019 Application Due Date(s): February 4, 2019, 5:00 PM local time applicant organization. All types non-AIDS applications  allowed this funding opportunity announcement due this date. late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review: May 2019 Advisory Council Review: August 2019 Earliest Start Date: September 2019 Expiration Date: February 5, 2019 Part 2. Full Text Announcement, Section I. Funding Opportunity Description Scope Research Requested NIA, NHLBI NINDS request applications a pragmatic trial a network consortium health care delivery systems HCS), together cover most the geographic regions the United States, a data coordinating center assess overall risks benefits statins adults = 75 years without clinical cardiovascular disease. Specifically, proposed trial should designed to: conducted a real-life healthcare delivery system setting Introduction pragmatic clinical trials" Rethinking Clinical Trials: Living Textbook Pragmatic Trials"). broad inclusion criteria use minimization, stratification another technique ensure enrollment a high number women, minorities, participants frailty, mobility limitations, cognitive impairment, comorbidities very old adults. Test effects moderate- high-intensity statin legally marketed the US approved the FDA) vs placebo administered up five years a blinded fashion the health care providers members the HCS participating the trial). Test effects interventions the universal primary health outcome survival free dementia persistent physical disability. Test effects the intervention two co-secondary outcomes: 1) composite clinical CVD events acute myocardial infarction, ischemic stroke transient ischemic attack, heart failure, death attributed cardiovascular disease) 2) MCI+D 90% power detect risk reduction 15%. secondary composite cardiovascular outcome should include acute myocardial infarction, stroke, heart failure may include cardiovascular components such to death attributed cardiovascular disease, urgent revascularization, acute coronary syndrome requiring hospitalization. Characterization the type heart failure well stroke subtype should considered. Assess effects interventions exploratory outcomes, including not limited health-related quality life, muscle-related symptoms, incident diabetes, hospitalization any cause, medication adherence, major sources health care resource utilization. Ascertain outcomes a cost-efficient manner a high degree accuracy. sufficient power assess effects interventions high degree confidence. applicants strongly encouraged propose trial has 90% power assess effects interventions both primary secondary outcomes. Sample size calculations should designed accommodate high crossover rates between study treatment groups. Obtain biological samples at least 17,000 the participants that analysis biomarkers predictive harms benefits feasible the future. Periodically obtain sufficient number biological samples assess difference the serum LDL-cholesterol levels between two trial arms.   Include pre-specified analyses adequate power assess treatment risks benefits important subgroups e.g., men/women, older/younger, differing baseline health status, differing ethnicity). See Section VIII. Information for award authorities regulations. Part 2. Full Text Announcement, Section II. Award Information Funds Available Anticipated Number Awards: The number awards contingent upon NIH appropriations the submission a sufficient number meritorious applications. NIA intends commit to 6.0 million direct costs FY 2019 fund award. Across seven-year project period, issuing IC partner components intend commit estimated 60.2 million direct costs fund award. Award Budget: Application budgets cannot exceed 60.2 million direct costs across seven years need reflect actual needs the proposed project. Part 2. Full Text Announcement, Section IV. Application Submission Information PHS 398 Research Plan Overall) Specific Aims: Describe overall scientific objective the proposed trial; individual aims the proposed study; the individual components contribute these aims; the overall trial objective. For example, of aims propose  test effects moderate- high-intensity statin is legally marketed the US approved the FDA vs placebo the primary universal health outcome survival free dementia persistent physical disability on co-secondary outcomes: composite clinical CVD events acute myocardial infarction, ischemic stroke transient ischemic attack, heart failure, death attributed cardiovascular disease) MCI+D 90% power detect 15% effect. The secondary composite cardiovascular outcome should include acute myocardial infarction, stroke, heart failure may include cardiovascular components such to death attributed cardiovascular disease, urgent revascularization, acute coronary syndrome requiring hospitalization. Characterization the type heart failure well stroke subtype should considered. Exploratory outcomes, including not limited health-related quality life, muscle-related symptoms, incident diabetes, hospitalization any cause, medication adherence, major sources health care resource utilization also proposed.  Research Strategy: The scientific rationale need a clinical trial test proposed hypothesis intervention should well supported preliminary data, clinical and/or preclinical studies, information the literature and/or knowledge biological mechanisms. trials focusing clinical public health endpoints, need a trial testing safety, efficacy effectiveness an intervention could lead a change clinical practice, community behaviors health care policy should justified. trials focusing mechanistic, behavioral, physiological, biochemical, other biomedical endpoints, need a trial advance scientific understanding should also justified. Focus the project a whole address i) importance the problem the field the proposed trial addresses, ii) this trial improve scientific knowledge clinical practice geriatrics cardiology, iii) the preventive interventions target population be changed the proposed aims achieved. Describe preliminary data which trial based. applicants required include both description a table graph the overall project timeline key milestones. overall study timeline should include description key milestones need be met throughout lifecycle the clinical trial ensure success to advance through defined study phases described projects elsewhere this FOA. milestone defined a scheduled event the project timeline signifies completion a major project stage activity. Milestones must relevant, measurable, results-focused time-bound. applicants should clearly define justify selection the target population. is expected the study enroll adults 75 years age older without clinical cardiovascular disease. study should propose justify selection broad inclusion criteria use minimization, stratification another technique would result enrollment a high number women, minorities, participants frailty, mobility limitations, cognitive impairment, comorbidities very old adults applicants required justify proposed definitions the primary secondary outcomes their components. Selection definitions the exploratory outcomes, any, should also justified. plan should detail assumptions obtaining bio-specimens baseline at least 17,000 participants, in subset participants periodic intervals during trial the masked determination LDL cholesterol levels arm. PHS 398 Research Plan Vanguard Phase) Research Strategy: A one-year vanguard phase follow protocol refinement study start-up phase. Objectives this phase to demonstrate study's ability recruit retain participants; deliver intervention; ascertain adjudicate outcomes. Regarding outcomes, detailed description how primary composite study outcome two co-secondary outcomes -- composite clinical CVD events MCI+D -- be collected. Any validation studies the secondary cardiovascular outcome be initiated the characterization the types heart failure. During phase, study also confirm loss follow-up cross-over rates; primary secondary outcome event rates the control group the intercluster coefficient correlation used sample size power calculations. one more these differ the original estimate, investigators required amend power calculations. the end the vanguard phase, grantees should submit the DSMB review its semi-annual meeting report justifying transitioning the study implementation phase. NIA NHLBI consider DSMB's recommendations will the following criteria evaluate whether vanguard phase reached objectives the study should continue: actual recruitment rate not lower 75% the target. rates between 75% 90% the target, DSMB report should include plan describing detail and the recruitment goal be met within allocated study budget.  revised study power calculated based upon observed: a) loss follow-up cross over rates; b) primary secondary outcome event rates the control group; c) intercluster coefficient correlation; d) estimated final N not lower 85%. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sergei Romashkan, MD, Ph.D. National Institute Aging NIA) Telephone: 301-435-3047 Email: romashks@nia.nih.gov

Notice Change Key Dates RFA-NS-18-026 NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research P50 Clinical Trial Optional)" Notice Number: NOT-NS-19-015 Key Dates Release Date: November 7, 2018 Related Announcements RFA-NS-18-026 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change Key Dates RFA-NS-18-026 NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research P50 Clinical Trial Optional)".  Specifically, first receipt date change January 4, 2019 January 11, 2019. Part 1. Overview Key Dates Currently Reads: Open Date December 4, 2018 Application Due Date(s) January 4, 2019, 5:00 PM local time applicant organization. All types non-AIDS applicationsallowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 5, 2019 Modified Read: Open Date December 11, 2018 Application Due Date(s) January 11, 2019, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 12, 2019 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov

Notice Change Key Dates RFA-NS-18-027 Exploratory Grant NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls P20 Clinical Trial Optional)" Notice Number: NOT-NS-19-016 Key Dates Release Date: November 7, 2018 Related Announcements RFA-NS-18-027 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change Key Dates RFA-NS-18-027 Exploratory Grant NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls P20 Clinical Trial Optional)."  Specifically, first receipt date change January 4, 2019 January 11, 2019. Part 1. Overview Key Dates Currently Reads: Open Date December 4, 2018 Application Due Date(s) January 4, 2019, 5:00 PM local time applicant organization. All types non-AIDS applicationsallowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 5, 2019 Modified Read: Open Date December 11, 2018 Application Due Date(s) January 11, 2019, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date late applications be accepted this Funding Opportunity Announcement. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date January 12, 2019   other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov

Notice NINDS Policy Submission Applications PA-19-055 NIH Research Project Grant Parent R01 Clinical Trial Required). NINDS Only accepts Clinical Trial Applications Proposing Mechanistic Studies Clinical Trial Parent R01 Notice Number: NOT-NS-19-012 Key Dates Release Date: November 5, 2018 Related Announcements PA-19-055 NOT-NS-18-054 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to announce NINDS's policy submission applications to PA-19-055 "NIH Research Project Grant (Parent R01 Clinical Trial Required)."  NINDS only accept applications the NIH Research Project Grant Parent R01 Clinical Trial Required) Funding Opportunity Announcement FOA) its reissues propose human mechanistic trials/studies meet NIH's definition a clinical trial that fall within NINDS research priorities. NIH defines clinical trial A research study which or human subjects prospectively assigned one more interventions may include placebo other control) evaluate effects those interventions health-related biomedical behavioral outcomes.” ( NOT-OD-15-015) NIH defines mechanistic clinical trial follows: mechanistic study designed understand biological behavioral process, pathophysiology a disease, the mechanism action an intervention.” NINDS supports hypothesis-driven mechanistic clinical trial studies basic and/or translational discovery research healthy human subjects in pathobiology, pathophysiology, neuropathology neurological disorders. goal to address basic questions to interrogate concepts biology, behavior, pathophysiology will provide insight understanding neurological disorders. Such studies seek understand biological behavioral process, the mechanism action an intervention. NINDS supports biomarker studies may provide information physiological function, target engagement novel therapeutics, and/or mechanisms therapeutic responses. submitted studies defined clinical trials noted above) do seek answer specific questions safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions. preventive, therapeutic, services interventions. Such designs should submitted an NINDS clinical trial-specific funding announcement listed the NINDS website at https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinic…). Applicants strongly advised consult NINDS program staff prior submitting application human subjects determine appropriate funding opportunity. Examples types applications intended be supported NINDS under NIH Parent Clinical Trial R01 FOA include, are limited to: Studies which manipulation physiological behavioral) used answer basic science questions normal brain function. Studies develop, validate, and/or apply novel measures brain signaling circuits healthy humans including, example, PET, SPECT, other neuroimaging approaches, well biomarkers physiological processes. Studies use experimental manipulation e.g., CNS active drugs, direct neurostimulation cognitive task activating specific neural circuit) order understand normal functioning the pathophysiology a neurological disorder, do aim demonstrate clinical improvement. Studies involve prospective of efficacious interventions e.g., biomedical, behavioral, cognitive, therapeutic approaches), where intent to obtain biospecimens e.g., blood, patient-derived induced pluripotent stem cells) identify genetic risk associations, novel biomarkers, examine disease process, characterize mechanisms therapeutic response. Studies which intervention demonstrated efficacy that population being studied understand mechanisms response, non-response, risk adverse effects the efficacious intervention.  following types clinical trials not intended be supported NINDS under NIH Parent Clinical Trials R01 FOA:   Studies do meet NIH definition clinical trial. Early-stage trials novel treatment approaches humans are prerequisite clinical efficacy trials pharmacological, device, behavioral intervention development. Studies develop conduct tests the clinical efficacy/effectiveness treatments. Studies have safety, clinical efficacy, clinical management, and/or implementation its principal aim. Resource Does human subjects research study meet definition a clinical trial? Inquiries Please direct inquiries to: Claudia Moy, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 Email: moyc@ninds.nih.gov

Notice Extend Expiration Date Change Receipt Dates PAR-18-835 Global Brain Nervous System Disorders Research Across Lifespan R01 Clinical Trials Optional) Notice Number: NOT-TW-18-007 Key Dates Release Date: November 01, 2018 Related Announcements PAR-18-835 Issued Fogarty International Center FIC ) National Eye Institute NEI ) National Institute Aging NIA ) Eunice Kennedy Shriver  National Institute Child Health Human Development NICHD ) National Institute Deafness Other Communication Disorders NIDCD ) National Institute Environmental Health Sciences NIEHS ) National Institute Mental Health NIMH ) National Institute Neurological Disorders Stroke NINDS )  Purpose purpose this Notice to inform interested applicants additional participating IC language an additional application due date the Funding Opportunity Announcement FOA) PAR-18-835 "Global Brain Nervous System Disorders Research Across Lifespan R01 Clinical Trials Optional)". additional application due date, November 6, 2020, been added this FOA. FOA expires November 7, 2020.  Part 1. Overview Information Key Dates   Currently Reads Posted Date June 19, 2018 Open Date Earliest Submission Date) October 7, 2018 Letter Intent Due Date 30 days before application due date Application Due Date(s) November 7, 2018; November 7, 2019, 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. AIDS Application Due Date(s) November 7, 2018; November 7, 2019, 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 February 2019; February 2020  Advisory Council Review 2019; 2020 Earliest Start Date(s) June 2019 Expiration Date November 8, 2019 Due Dates E.O. 12372 Applicable Revised read:   Posted Date June 19, 2018 Open Date Earliest Submission Date) October 7, 2018 Letter Intent Due Date 30 days before application due date Application Due Date(s) November 7, 2018; November 7, 2019), November 6, 2020 by 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. AIDS Application Due Date(s) November 7, 2018; November 7, 2019, November 6, 2020 by 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 February 2019; February 2020, February 2021 Advisory Council Review 2019; 2020; May 2021 Earliest Start Date(s) June 2019 Expiration Date November 7, 2020 Due Dates E.O. 12372 Applicable Inquiries Please direct inquiries to: Kathleen Michels, Ph.D. Fogarty International Center FIC) Telephone:  301-496-1653 Email:  brainfic@nih.gov

Notice Extend Expiration Date Change Receipt Dates PAR-18-836 Global Brain Nervous System Disorders Research Across Lifespan R21 Clinical Trial Optional) Notice Number: NOT-TW-18-008 Key Dates Release Date: October 30, 2018 Related Announcements PAR-18-836 Issued Fogarty International Center FIC) National Institute Aging NIA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Dental Craniofacial Research NIDCR) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD Purpose purpose this Notice to inform interested applicants additional participating IC language an additional application due date the Funding Opportunity Announcement FOA) PAR-18-836 "Global Brain Nervous System Disorders Research Across Lifespan R21 Clinical Trial Optional)". additional application due date, November 6, 2020, been added this FOA. FOA expires November 7, 2020.  Part 1. Overview Information Key Dates   Currently Reads Posted Date June 19, 2018 Open Date Earliest Submission Date) October 7, 2018 Letter Intent Due Date 30 days before application due date Application Due Date(s) November 7, 2018; November 7, 2019, 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. AIDS Application Due Date(s) November 7, 2018; November 7, 2019), 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 February 2019; February 2020  Advisory Council Review 2019; 2020 Earliest Start Date(s) June 2019 Expiration Date November 8, 2019 Due Dates E.O. 12372 Applicable nbsp; Revised read:  Posted Date June 19, 2018 Open Date Earliest Submission Date) October 7, 2018 Letter Intent Due Date 30 days before application due date Application Due Date(s) November 7, 2018; November 7, 2019), November 6, 2020 by 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. AIDS Application Due Date(s) November 7, 2018; November 7, 2019, November 6, 2020 by 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 February 2019; February 2020, February 2021 Advisory Council Review 2019; 2020; May 2021 Earliest Start Date(s) June 2019 Expiration Date November 7, 2020 Due Dates E.O. 12372 Applicable Inquiries Please direct inquiries to: Kathleen Michels, Ph.D. Fogarty International Center FIC)  Telephone: 301-496-1653  Email: FIC-NCD@mail.nih.gov 

Request Information RFI): Soliciting Input Priorities Progress Alzheimer's Disease-Related Dementias Research Notice Number: NOT-NS-19-011 Key Dates Release Date: October 29, 2018 Response Date: December 20, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) Purpose purpose this time-sensitive Request Information RFI) to seek input scientists, clinicians, patients, families, caregivers, advocates, the broader dementia community the most important needs promising opportunities Alzheimer's disease-related dementias ADRD) research.  Background The National Plan Address Alzheimer’s Disease, mandated the National Alzheimer's Project Act annually updated since 2012, includes goals the research, clinical care long-term services support are needed meet challenge addressing Alzheimer’s disease Alzheimer's disease-related dementias AD/ADRD).  Goal 1 the National Plan to prevent effectively treat Alzheimer’s disease related dementias 2025. help achieve goal, National Institutes Health NIH) convenes triennial summits develop recommendations advancing research AD ADRD.  Recommendations developed through summits become part the National Plan prioritized research milestones guide future NIH investments AD/ADRD research. May 2013, National Institute Neurological Disorders Stroke NINDS), collaboration the National Institute Aging NIA), convened first ADRD Summit, Alzheimer’s Disease-Related Dementias: Research Challenges Opportunities ADRD 2013) that established prioritized recommendations ADRD research.  March 2016, second ADRD Summit, Alzheimer's Disease-Related Dementias Summit 2016 ADRD 2016), assessed progress updated recommendations the 2013 Summit.  resulted a total 37 new revised research milestones for Lewy body dementia LBD), frontotemporal degeneration FTD), multiple etiology dementias MED), vascular contributions cognitive impairment dementia VCID), including recommendations cross-cutting topics such health disparities dementia dementia nomenclature. purpose this time-sensitive Request Information RFI) to seek input scientists, clinicians, patients, families, caregivers, advocates, the broader dementia community the most important needs promising opportunities Alzheimer's disease-related dementias ADRD) research.  information submitted response this RFI be used committees scientists, clinicians, other members the public revise update ADRD 2016 research recommendations.  draft recommendations be presented the public further input ADRD Summit 2019, will take place March 14-15, 2019, the main NIH campus Bethesda, MD.  Register attend ADRD 2019 at https://meetings.ninds.nih.gov/?ID=21149.  Registration free open the public.)  Information Requested National Institute Neurological Disorders Stroke invites interested stakeholders, including scientists, health professionals, patients, families, caregivers, advocacy groups, private sector, the general public, provide comments suggestions regarding ADRD research recommendations came of 2016 Summit became ADRD research milestones the National Plan Address Alzheimer's disease.  milestones be found at https://aspe.hhs.gov/alzheimers-disease-related-dementias-adrd-summit-2…; Information provide be used inform new revised research milestones will generated ADRD 2019. Please submit: comments suggestions regarding the current ADRD research milestones -- examples include comments how current milestones be revised, most promising areas research the research community should focus efforts based knowledge gap research needs, any new research questions draft recommendations should address based scientific progress we've since ADRD 2016, particular areas ADRD research the field made most progress on, etc. any research activities organization supported are alignment the ADRD research milestones, information the progress organization made towards milestones to Submit Response assure full consideration, responses must received December 20, 2018.  Responses this RFI must submitted via email to ADRD2019@ninds.nih.gov with ADRD Summit RFI" the subject line. Responses this RFI voluntary.  Submitted information not considered confidential.  Proprietary, classified, confidential, sensitive information should be included your response.  United States U.S.) Government reserves right use any non-proprietary technical information any resultant solicitation(s). RFI for planning purposes only is a solicitation applications an obligation the part the 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.  NIH use information submitted response this RFI its discretion will provide individual feedback any responder. information provided be analyzed may appear reports. Inquiries Please direct inquiries to: Sophia Jeon, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-435-7571 Email: ADRD2019@ninds.nih.gov

Notice Change Application Due Date Administrative Supplement the NINDS Research Education Program Residents Fellow Neurosurgery, Neuropathology, Neuroradiology Emergency Medicine Admin Supplement) Notice Number: NOT-NS-19-013 Key Dates Release Date: October 24, 2018 Related Announcements PA-17-442 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) PA-17-442 "Administrative Supplement the NINDS Research Education Program Residents Fellows Neurology, Neurosurgery, Neuropathology, Neuroradiology, Emergency Medicine Admin Supp).  Specifically, October 15, 2018 receipt date been extended to November 2, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) October 31, 2017, October 15, 2018 October 15, 2019 5:00PM local time applicant organization. Modified Read: Application Due Date(s) October 31, 2017, November 2, 2018, October 15, 2019 5:00PM local time applicant organization. other aspects this FOA remain same. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disease Stroke NINDS)) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional) Notice Number: NOT-NS-19-009 Key Dates Release Date:October 23, 2018 Estimated Publication Date Funding Opportunity Announcement: November 15, 2018 First Estimated Application Due Date: December 15, 2018 Earliest Estimated Award Date: 15, 2018 Earliest Estimated Start Date: July 01, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) other NIH Institutes Centers participating the HEAL Helping End Addiction Long-term) Initiative, intends publish Funding Opportunity Announcement FOA) support development therapeutic, diagnostic, rehabilitative technologies pain. focus this FOA be support preclinical development demonstration safe, effective, non-addictive device-based technologies approaches treat pain. goal the program be demonstrate treatment using credible neural targets device-based interventions and/or diagnostics pain, building upon latest mechanistic knowledge the anatomy physiology central, spinal, peripheral pathways involved pain. FOA facilitate translation new devices overcoming key challenges identified during preliminary proof-of-concept studies. scope the program includes technology optimization, regulatory activities enable IDE/IRB approvals, a subsequent clinical study. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published 2018 an expected application due date 2018. FOA utilize UG3/UH3 activity code. Details the planned FOA provided below. Research Initiative Details Translational research develop new medical devices the focus this FOA. Applications this FOA should be hypothesis-driven, should propose design-directed technology development. Applications be expected have rigorous mechanistic biological rationale, scientifically sound assays test system, a near final device design. is also expected applications include supporting data the mechanism therapy, rehabilitation, diagnosis been demonstrated humans bench top, ex vivo, in silico, in vitro, and/or in vivo models representative the intended patient population indication. is anticipated there be restrictions invasiveness i.e., devices be non-invasive, minimally invasive, invasive). Devices utilize any viable modality focally interact the nervous system, such optical, electrical, magnetic, acoustic, chemical/pharmaceutical, microfluidic, combinations thereof. FOA not specific any pain condition patient population. Funding Information Estimated Total Funding Issuing IC partner components intend issue 5-7 awards 2019. Awards issued under FOA part funds set aside support HEAL Helping End Addiction Long-term) initiative. Expected Number Awards TBD Estimated Award Ceiling TBD Primary CFDA Numbers TBD 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) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization   Applications not being solicited this time.    Inquiries Please direct inquiries to: Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 Nick.Langhals@nih.gov