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Alzheimer's Disease its related Dementias AD/ADRD)-focused Administrative supplements NIH grants are focused Alzheimer's disease Notice Number: NOT-AG-18-008 Key Dates Release Date: April 12, 2018 Related Announcements NOT-AI-18-032 NOT-HD-18-010 PA-18-591 Issued National Institute Aging NIA) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Dental Craniofacial Research NIDCR) National Institute Deafness Other Communication Disorders NIDCD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Office Research Women’s Health ORWH) Office Strategic Coordination Common Fund) Purpose participating Institutes Centers ICs) inviting applications expand existing awards these ICs are currently focused Alzheimer’s disease AD) its related dementias ADRD) allow to develop focus AD/ADRD. Active awards project end dates FY 2019 later eligible. award not in terminal cost extension going no cost extension FY2018. administrative supplements work proposed needs be within scope the research training is already supported. Center awards resource awards most likely be able justify supplements they tend have broad content scope. research grants also qualify the current research on related topic such cognitive decline aging, caregiving, health disparities). possible topics include research the biology neurodegeneration, genetics, imaging, on pain perception communication. Topics also include possible connections existing conditions are being studied: such links cardiovascular other diseases, common pathways degeneration, sex influences incidence, on previously unidentified risk factors. Also work focuses advances methodology, machine learning other modeling, or on biostatistical tools have application research Alzheimer's its related dementias be appropriate. NIA developed website shows abstracts Reporter) a sample awards are recognized pursuing AD/ADRD research under current guidelines. site also includes description the categories research NIH currently identifies Alzheimer's disease Alzheimer's disease-related dementias. part the application investigators should submit abstract the proposed research shows relevance AD/ADRD. work include pilot projects, resource development. Investigators should submit applications responses the parent active administrative supplement PA: https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html Individual requests be more 250,000 direct costs exclusive Facilities Administrative costs sub-contracts except the information NHGRI below). Requests be one year support only.  Though supplement requests not limited one per parent grant, will consider substantial additional funding an award beyond scope. Also, before submitting supplement request, principal investigators strongly encouraged contact program officers the Institute, Center Office supporting award discuss whether proposed supplement within scope. Requests must received June 8 funding FY 2018. Institute, Center Office-specific Instructions National Human Genome Research Institute: NHGRI collaboration NIA support supplements NHGRI grants to 500,000 direct cost, support research accomplishes NIA’s research goals described this notice. NHGRI support studies provide generalizable methods knowledge all three scientific areas genome sciences, genomic medicine genomics society. Work proposed supplements must fall within scope the aims the NHGRI grant be supplemented. Investigators encouraged contact NHGRI Scientific Program Officer the grant be supplemented before preparing application, discuss relevance the proposed research the parent grant to Institute's research priorities. National Institute General Medical Sciences: NIGMS’s MIRA program provides support an investigator's overall program research within Institute’s mission, MIRA awardees not eligible this supplement program. Office Strategic Coordination:  Common fund awardees are interested applying should contact Dr. Ravi Basavappa the Office Strategic Coordination Common Fund) before applying. Review process IC conduct administrative reviews applications their IC separately. NIA make funds available up ten awards each the participating ICs is allocating to 20 million this cross-IC program. IC conduct administrative reviews applications their IC separately. NIA make funds available up ten awards each the participating ICs is allocating to 20 million this cross-IC program.   Criteria: 1.      the work proposed within scope the active award? 2.      the work proposed focused Alzheimer’s disease its related dementias? 3.      the work likely stimulate additional activity leading progress AD/ADRD? Inquiries Please direct inquiries to: Robin A. Barr National Institute Aging NIA) Telephone: 301-402-7715 E-mail: BarrR@mail.nih.gov Crystal Wolfrey National Cancer Institute NCI) Telephone: 240-276-6277 E-mail: wolfreyc@mail.nih.gov Martha Flanders National Eye Institute NEI) Telephone: 301-451-2020 E-mail: Martha.flanders@nih.gov Jue Chen, Ph.D. National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0550 Email: jue.chen@nih.gov Bettie Graham National Human Genome Research Institute NHGRI) Telephone: 301-496-7531 E-mail: grahambj@exchange.nih.gov Abraham Bautista National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-443-9737 E-mail: Bautista@mail.nih.gov Michael Minnicozzi, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3532 Email: minnicozzim@niaid.nih.gov Melinda Nelson National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-435-5278 E-mail: nelsonm@exchange.nih.gov Randy King National Institute Biomedical Imaging Bioengineering NIBIB) Telephone:301-451-4780 E-mail: randy.king@nih.gov Judith Cooper National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061 E-mail: cooperj@nidcd.nih.gov Preethi Chander National Institute Dental Craniofacial Research NIDCR) Telephone: 301-827-4620 E-mail: Preethi.chander@nih.gov Luke Stoekel National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-741-9223 E-mail: luke.stoeckel@nih.gov Kevin Walton National Institute Drug Abuse NIDA) Telephone: 301-827-5980 kevin.walton@nih.gov Jonathan Hollander National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 E-mail: jonathan.hollander@nih.gov Janna Wehrle National Institute General Medical Sciences NIGMS) Telephone: 301451-6446 E-mail: wehrlej@nigms.nih.gov Jovier Evans National Institute Mental Health NIMH) Telephone: 301-443-1369 E-mail: jevans1@mail.nih.gov Roderick Corriveau National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 E-mail: roderick.corriveau@nih.gov Lois Tully National Institute Nursing Research NINR) Telephone: 301-594-5968 E-mail: lois.tully@nih.gov Adelaida Rosario National Institute Minority Health Health Disparities NIMHD) Telephone: 301-402-1366 E-mail: Adelaida.rosario@nih.gov Hua-Chuan Sim National Library Medicine NLM) Telephone: 301-594-4882 E-mail: simh@mail.nlm.nih.gov Marya Levintova Fogarty International Center FIC) Telephone: 301-496-1653 E-mail: levintovam@mail.nih.gov Dave Clark National Center Complementary Integrative Health NCCIH) Telephone: 301-827-1916 E-mail: dave.clark@nih.gov Stephanie Murphy Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Telephone: 301-435-0744 E-mail: Stephanie.murphy@nih.gov Chyren Hunter Office Research Women’s Health ORWH) Telephone: 301-402-1770 Email: hunterc@mail.nih.gov Ravi Basavappa Office Strategic Coordination OSC) Telephone: 301-435-7204 E-mail: ravikumar.basavappa@nih.gov

Notice NINDS Policy Submission Applications Containing Clinical Trials Notice Number: NOT-NS-18-054 Key Dates Release Date: April 3, 2018 Related Announcements NOT-NS-19-012 NOT-NS-16-034 RESCINDED NOT-NS-18-011  Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify policy submitting investigator-initiated clinical trial applications NINDS. Unless otherwise indicated NIH NINDS Funding Opportunity Announcements FOAs), clinical trials designed answer specific questions the safety, tolerability, efficacy, effectiveness, clinical management, and/or implementation pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions only supported NINDS submitted an NINDS clinical trials-specific FOA.  current list active NINDS clinical trials FOAs available at https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinic….   Applicants strongly advised consult NINDS program staff prior submitting clinical trial application determine appropriate funding opportunity announcement. Inquiries Please direct inquiries to: Peter Gilbert, Sc.M. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0870 Email: GilbertP@ninds.nih.gov  

Notice NINDS Participation PAR-18-733 Small Research Grants Analyses Data the Gabriella Miller Kids First Data Resource R03 - Clinical Trial Allowed)" Notice Number: NOT-NS-18-051 Key Dates Release Date: March 30, 2018 Related Announcements PAR-18-733 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participating PAR-18-733 Small Research Grants Analyses Data the Gabriella Miller Kids First Data Resource R03 - Clinical Trial Allowed)". following sections been updated reflect participation NINDS this FOA. Currently Reads: Part 1. Overview Information Components Participating Organizations Kennedy Shriver National Institute Child Health Human Development NICHD) National Heart, Lung, Blood Institute NHLBI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Dental Craniofacial Research NIDCR) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865; 93.837, 93.838, 93.839, 93.233; 93.273; 93.121   Modified Read: Part 1. Overview Information Components Participating Organizations Kennedy Shriver National Institute Child Health Human Development NICHD) National Heart, Lung, Blood Institute NHLBI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Dental Craniofacial Research NIDCR) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865; 93.837, 93.838, 93.839, 93.233; 93.273; 93.121; 93.853  following contacts been added: Section VII. Agency Contacts Scientific/Research Contact(s) Robert Riddle, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: rr260c@nih.gov Financial/Grants Management Contact(s) Tijuanna Decoster, Ph.D.  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-9231 E-mail: tijuanna.decoster@nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Robert Riddle, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: rr260c@nih.gov

Notice Participation PAR-18-721 Countermeasures Against Chemical Threats CounterACT) Exploratory/Developmental Projects Translational Research R21 Clinical Trial Allowed) Notice Number: NOT-NS-18-053 Key Dates Release Date: March 29, 2018 Related Announcements PAR-18-721 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose purpose this Notice to inform potential applicants the National Eye Institute NEI),  National Institute Environmental Health Sciences NIEHS), the National Institute Drug Abuse NIDA) participating PAR-18-721 Countermeasures Against Chemical Threats CounterACT) Exploratory/Developmental Projects Translational Research R21 Clinical Trial Allowed). following sections been updated reflect participation NINDS this FOA. Currently Reads: Part 1. Overview Information Components Participating Organizations National Institute Neurological Disorders Stroke NINDS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.853; 93.846 Modified Read: Part 1. Overview Information Components Participating Organizations National Institute Neurological Disorders Stroke NINDS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Eye Institute NEI) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS)   Catalog Federal Domestic Assistance CFDA) Number(s) 93.853; 93.846; 93.867; 93.279; 93.113 following contacts been added: Section VII. Agency Contacts Scientific/Research Contact(s) questions related ocular injury research:  Houmam Araj, Ph.D. National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov questions related pulmonary injury research: Srikanth S. Nadadur, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-5327 Email: nadadurs@niehs.nih.gov questions related pharmaceutical based agents: Kristopher Bough, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-443-9800 Email: boughk@nih.gov Financial/Grants Management Contact(s) Karen Robinson Smith National Eye Institute NEI) Telephone: 301-451-2020 Email: kyr@nei.nih.gov Lisa A. Edwards, MBA National Institute Environmental Health Sciences NIEHS) Telephone:  919-541-0751 E-mail: archer@niehs.nih.gov Amy Connolly National Institute Drug Abuse NIDA) Telephone: 301-827-4457 Email: connolla@mail.nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Shardell Spriggs, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov

Notice NINDS BRG, BRP, Translational Neural Devices, BRAIN Initiative: Next Generation Invasive Devices Recording, Modulation the Human Central Nervous System, Smart & Connected Health Program Applications Directed the Treatment Pain Notice Number: NOT-NS-18-052 Key Dates Release Date: March 27, 2018 Related Announcements PAR-18-206 PAR-18-208 RFA-NS-18-011 RFA-NS-18-012 RFA-NS-18-021 RFA-NS-18-022 RFA-NS-18-023 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) Bioengineering Research Grants BRG), Bioengineering Research Partnerships BRP), Translational Neural Devices, BRAIN Initiative: Next Generation Invasive Devices Recording Modulation the Human Central Nervous System, Smart Connected Health Funding Opportunity Announcements an area special interest.  NINDS like accelerate development devices the treatment pain. Investigators strongly encouraged contact appropriate Program Director prior submitting application. Applications be submitted to: PAR-18-206 (BRG), PAR-18-208 (BRP), RFA-NS-18-011 (Translational Neural Devices), RFA-NS-18-012 (Translational Neural Devices - SBIR), RFA-NS-18-021 (BRAIN Initiative), RFA-NS-18-022 (BRAIN Initiative), RFA-NS-18-023 (BRAIN Initiative - SBIR), and NSF-18-541 (Smart Connected Health).      Within BRG BRP programs, NINDS particularly interested bioengineering research advances technologies the potential decrease burden neurological disorders stroke, including pain. Examples areas interest include development validation invasive non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, other innovative methods.   Translational Neural Devices program interested receiving applications translational studies devices treat pain. Translational Neural Devices supports translational activities small clinical studies advance development invasive non-invasive therapeutic, diagnostic devices disorders affect nervous neuromuscular systems. Program activities, including translational bench animal studies, expected lead submission an Investigational Device Exemption IDE) the U.S. Food Drug Administration FDA) Institutional Review Board IRB) application a Non-Significant Risk NSR) study. program also support subsequent small clinical trial collect safety effectiveness data required support marketing application to inform final device design.   BRAIN Initiative: Next Generation Invasive Devices Recording Modulation the Human Central Nervous System program supports translational and/or clinical studies invasive recording and/or stimulating devices treat nervous system disorders, including support the submission an Investigational Device Exemption IDE) a Significant Risk SR) study obtain Institutional Review Board IRB) approval a Non-Significant Risk NSR) study, and/or small clinical trial e.g., Early Feasibility Study). small clinical trial should provide data answer key questions the function final design a device. This final device design require most, not all, the non-clinical testing the path more advanced clinical trials market approval. BRAIN Initiative includes both brain spinal cord this program like encourage translational clinical projects invasive recording and/or stimulating devices treat pain.    Smart Connected Health program https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504739) an interagency program between Institutes Centers the National Institutes Health NIH) the National Science Foundation NSF) supporting development technologies, analytics models supporting next generation health medical research through high-risk, high-reward advances computer information science, engineering technology, behavior, cognition, robotics imaging. NINDS interested applications next-generation multidisciplinary science encourages research pain a variety areas value health, such networking, pervasive computing, advanced analytics, sensor integration, privacy security, modeling socio-behavioral cognitive processes system process modeling. Inquiries Please direct inquiries to: Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov Michael Oshinsky, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

Notice Change NINDS K99/R00 Eligibility Timeframe Parents Have Child during Standard K99/R00 Application Eligibility Window Notice Number: NOT-NS-18-042 Key Dates Release Date: March 26, 2018 - RESCINDED Related Announcements PA-18-397 PA-18-398 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform community a change NINDS policy regarding eligibility the K99/R00 Transition Independence Award. standard eligibility window the K99/R00 48 months postdoctoral research experience. research experience post-doctorate, whether a postdoctoral fellowship position, any position employment where is expectation research activity, continuation the predoctoral laboratory after leaving graduate program, counts towards K99/R00 eligibility clock. policy applies both new amended applications. Effective immediately publication this notice, NINDS extend K99/R00 eligibility window 8 months individuals who a child who born adopted during standard 48 month eligibility window. extension in addition any official leave absence is taken. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00) Notice Number: NOT-NS-18-041 Key Dates Release Date: March 21, 2018 Estimated Publication Date Funding Opportunity Announcement: 04/12/2018 First Estimated Application Due Date: 06/12/2018 Earliest Estimated Award Date: 04/01/2019 Earliest Estimated Start Date: 04/30/2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) 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 Center Complementary Integrative Health NCCIH) Purpose NINDS, other NIH Institutes Centers participating the BRAIN Initiative, intends publish BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00)."   program designed increase biomedical research workforce diversity foster strong cohort new, highly skilled well trained, NIH-supported, independent investigators diverse backgrounds including nationally underrepresented groups) working research areas supported the BRAIN Initiative, highlighted in BRAIN 2025: Scientific Vision. is designed facilitate timely transition outstanding postdoctoral researchers a research and/or clinical doctorate degree mentored, postdoctoral research positions independent, tenure-track equivalent faculty positions. Notice being provided allow potential applicants sufficient time develop meaningful mentoring teams responsive projects. FOA expected be published April 2018 an expected application due date June 2018.  FOA utilize K99/R00 funding activity. Details the planned FOA provided below. Research Initiative Details BRAIN Initiative K99/R00 award intended individuals diverse backgrounds including nationally underrepresented groups) are working research areas supported the BRAIN Initiative, have more five years postdoctoral research experience, who require least 12 months mentored research training career development K99 phase) before transitioning the independent research R00) phase the program.   All research areas within the BRAIN Initiative are encouraged including not limited engineering, computer science, statistics, mathematics, physics, chemistry neuroethics). Eligible individuals this program be U.S. citizens permanent residents fall one the categories defined the Notice NIH's Interest Diversity. Women been shown be underrepresented doctorate-granting research institutions senior faculty levels most biomedical-relevant disciplines the National Science Foundation and the purposes this funding opportunity announcement be considered eligible candidates this diversity program. Funding Information Estimated Total Funding   Expected Number Awards   Estimated Award Ceiling   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) Regional Organization  Applications not being solicited this time. nbsp; Inquiries Please direct inquiries to: Michelle Jones-London, PhD National Institute Neurological Disorders Stroke NINDS) 301-451-7966 jonesmiche@ninds.nih.gov nbsp;

Revision: Notice Correction Application Instructions RFA-HL-19-008: Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)e Notice Number: NOT-HL-18-609 Key Dates Release Date: March 21, 2018 Related Announcements NOT-HL-18-592 Rescinded RFA-HL-19-008 Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) 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) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Purpose December 22, 2017, NHLBI Participating ICs issued RFA-HL-19-008 "Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)". Notice replaces NOT-HL-18-592 to alert scientific community a correction the list attachments required the application.   Part 2. Section IV. Application Submission Information Current Language:   SF424 R&R) Project Information    instructions the SF424 R&R) Application Guide must followed. Attachments: The attachment listed below must completed attached the application not peer reviewed.   Clinical Research Site History description the Clinical Research Site's history research program must provided an attachment using filename Clinical Research Site History.pdf" may exceed 4 pages. Provide details each bullet below:   Document Clinical Research Site's ability implement diversified portfolio research protocols including ancillary research projects. Document key CRS personnel leadership HIV-related comorbidity research, through publication accepted manuscripts, first last author. Describe purpose, frequency methods previous CRS interactions community advocacy groups.   Revised Language:   SF424 R&R) Project Information    1. Clinical Research Site History description the Clinical Research Site's history research program must provided an attachment using filename Clinical Research Site History.pdf" may exceed 4 pages. Provide details each bullet below:   Document Clinical Research Site's ability implement diversified portfolio research protocols including ancillary research projects. Document key CRS personnel leadership HIV-related comorbidity research, through publication accepted manuscripts, first last author. Describe purpose, frequency methods previous CRS interactions community advocacy groups. 2. Technical Details Specifications Assessments Procedures Technical details specifications assessments procedures, grouped listed component, must provided an attachment using filename Technical Specifications.pdf". Inquiries Please direct inquiries to: Sean Altekruse, DVM, MPH, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-1290 Email: altekrusesf@mail.nih.gov

NINDS Notice Clarify Types Clinical Trial Applications NINDS Support Under PA-18-159 Mechanisms, Models, Measurement, & Management Pain Research R21 - Clinical Trial Optional)" Notice Number: NOT-NS-18-016 Key Dates Release Date: March 19, 2018 Related Announcements PA-18-159 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify types clinical trials NINDS support under Funding Opportunity Announcement PA-18-159, Mechanisms, Models, Measurement, Management Pain Research R21 Clinical Trial Optional)". applications submitted this FOA propose clinical trials, NINDS support applications propose human mechanistic trials/studies meet NIH's definition a clinical trial that fall within NINDS research priorities.    Resources Does human subjects research study meet definition a clinical trial? Part 2. Full Text Announcement Section I. Funding Opportunity Description   Translational Research   Currently reads:   Specific NINDS: NINDS not accept clinical trials under FOA.  Applicants submitting applications NINDS contain clinical trial must submit one the NINDS FOAs specifically designed clinical trials see:   http://www.ninds.nih.gov/research/clinical_research/index.htm ).   Modified read:   Specific NINDS: NINDS only support Clinical Trial applications under FOA propose human mechanistic trials/studies meet NIH's definition a clinical trial that fall within NINDS research priorities.    NIH defines clinical trial ldquo;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 PA-18-159 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 that an 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 this FOA:   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.   other aspects this FOA remain unchanged.   Inquiries Please direct inquiries to: Michael L. Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

Informational Webinar Alzheimer's Disease Related Dementia ADRD) Funding Opportunity Announcements FOAs) PAR-18-661, RFA-NS-18-015, RFA-NS-18-025 RFA-NS-18-024 Notice Number: NOT-NS-18-050 Key Dates Release Date: March 15, 2018 Related Announcements PAR-18-661 RFA-NS-18-015 RFA-NS-18-025 RFA-NS-18-024 Issued National Institute Neurological Disorders Stroke NINDS)   Purpose National Institute Neurological Disorders Stroke NINDS) hold pre-application informational webinar on March 19th, 2018 1:00-2:00 pm ET for following Funding Opportunity Announcements FOAs): PAR-18-661 Pathway Target Identification Alzheimer's Disease Related Dementias ADRDs) U01 Clinical Trial Allowed) RFA-NS-18-015 Structural Biology Alzheimer's Disease Related Dementias ADRDs) Proteinopathies U01 Clinical Trial Allowed) RFA-NS-18-025 Center without Walls PET Ligand Development Alzheimer's disease related dementias ADRDs) U19 - Clinical Trial Optional) RFA-NS-18-024 Lewy Body Dementia Center Without Walls CWOW) U54 Clinical Trial Allowed)   webinar provide brief introduction each FOA highlight key components requirements the different phases the grant mechanisms.   Information how join webinar video audio coordinates, including passwords) provided below: Join Webinar Meeting https://nih.webex.com/join/sutherlandmnih.gov   |  622 274 563       Join phone 1-650-479-3208 Call-in toll number US/Canada)  Access code: 622 274 563  Global call-in numbers   Participation this webinar, although encouraged, optional is required the submission an application.   Inquiries Please direct inquiries to: Margaret Sutherland, PhD Program Director National Institute Neurological Disorders Stroke Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov