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Notice Change Key Dates PAR-18-422 NINDS Efficacy Clinical Trials U01 Clinical Trial Required)" Notice Number: NOT-NS-20-018 Key Dates Release Date: November 08, 2019 Related Announcements PAR-18-422 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a change the Key Dates PAR-19-422 NINDS Efficacy Clinical Trials U01 Clinical Trial Required)" changes shown below italics). Funding Opportunity Announcement been extended one additional council round. dates been modified add following New Application Due Date: February 5, 2021, Revision, Resubmission Renewal date: March 5, 2021, and AIDS application Due Date: May 7, 2021. Currently Reads: Part 1. Overview Key Dates: Application Due Date(s) Standard dates apply 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) Standard AIDS dates apply, 5:00 PM local time applicant organization. All types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. first AIDS due date this FOA May 7, 2018. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date January 8, 2021 Modified Read: Part 1. Overview Key Dates: Application Due Date(s) Standard dates apply 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) Standard AIDS dates apply, 5:00 PM local time applicant organization. All types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. first AIDS due date this FOA May 7, 2018. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date 8, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Peter Gilbert, ScM National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0870 Email: pgilbert@nih.gov

Notice Change salary allowance K99 awardees PA-19-090 NIH Pathway Independence Award Parent K99/R00 Independent Basic Experimental Studies Humans Required)” Notice Number: NOT-NS-20-016 Key Dates Release Date: November 06, 2019 Related Announcements PA-19-090 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform community NINDS changing funding allowance K99/R00 applications NINDS. change apply new NINDS K99/R00 awards on after September 2019 NINDS Advisory Council meeting.   Currently, NINDS provides to 100,000 salary plus appropriate fringe benefit costs, plus to 20,000 research expenses) during K99 phase clinician-scientists are licensed practice clinically. will remain unchanged. all awardees are licensed practice clinically, NINDS currently provides to 50,000 salary plus appropriate fringe benefit costs, plus to 20,000 research expenses) during K99 phase. Effective awards at after September 2019 NINDS Advisory Council meeting , NINDS increase amount provided salary this cohort awardees up 75,000, maintain allowances the current amounts, during K99 phase. other NINDS policies regard the K99/R00 award remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. NINDS, Office Training amp; Workforce Development Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice Change salary allowance NINDS K99 awardees PA-19-129 NIH Pathway Independence Award Parent K99/R00 Independent Clinical Trial Required)" Notice Number: NOT-NS-20-007 Key Dates Release Date: November 05, 2019 Related Announcements PA-19-129 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform community NINDS changing funding allowance K99/R00 applications NINDS. change apply new NINDS K99/R00 awards at after September 2019 NINDS Advisory Council meeting.     Currently, NINDS provides to 100,000 salary plus appropriate fringe benefit costs, plus to 20,000 research expenses) during K99 phase clinician-scientists are licensed practice clinically. will remain unchanged. all awardees are licensed practice clinically, NINDS currently provides to 50,000 salary plus appropriate fringe benefit costs, plus to 20,000 research expenses) during K99 phase. Effective awards at after September 2019 NINDS Advisory Council meeting, NINDS increase amount provided salary this cohort awardees up 75,000, maintain allowances the current amounts, during K99 phase. other NINDS policies regard the K99/R00 award remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. NINDS, Office Training amp; Workforce Development Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice Change salary allowance NINDS K99 awardees PA-19-130 NIH Pathway Independence Award Parent K99/R00 Independent Clinical Trial Allowed)" Notice Number: NOT-NS-20-008 Key Dates Release Date: November 05, 2019 Related Announcements PA-19-130 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform community NINDS changing funding allowance K99/R00 applications NINDS. change apply new NINDS K99/R00 awards at after September 2019 NINDS Advisory Council meeting.   Currently, NINDS provides to 100,000 salary plus appropriate fringe benefit costs, plus to 20,000 research expenses) during K99 phase clinician-scientists are licensed practice clinically. will remain unchanged. all awardees are licensed practice clinically, NINDS currently provides to 50,000 salary plus appropriate fringe benefit costs, plus to 20,000 research expenses) during K99 phase. Effective awards at after September 2019 NINDS Advisory Council meeting, NINDS increase amount provided salary this cohort awardees up 75,000, maintain allowances the current amounts, during K99 phase. other NINDS policies regard the K99/R00 award remain unchanged. Inquiries Please direct inquiries to: Stephen Korn,Ph.D. NINDS, Office Training amp; Workforce Development Telephone: 301-496-4188 Email: korns@ninds.nih.gov nbsp;

Notice Intent Publish Reissuance a Funding Opportunity Announcement Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls U54) Notice Number: NOT-NS-20-014 Key Dates Release Date: October 10, 2019 Estimated Publication Date Funding Opportunity Announcement: December 20, 2019 First Estimated Application Due Date: March 23, 2020 Earliest Estimated Award Date: September 15, 2020 Earliest Estimated Start Date: September 15, 2020 Related Announcements RFA-NS-19-022 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform research community The National Institute Neurological Disorders Stroke NINDS) intends reissue Funding Opportunity Announcement FOA) RFA-NS-19-022 "Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls PCS-EMA CWOW)." reissued, FOA continue utilize U54 grant mechanism. research priorities remain same will include points clarification. Modifications this FOA include addition research cores a reduction the number required research projects three projects a single research project. the initial FOA, reissued FOA solicit applications research discovering performing initial clinical validation biological measures be used prognosing monitoring recovery adolescents either clinically present or at risk developing prolonged/persistent concussive symptoms following exposure concussion and/or repetitive head impacts. biological measures should be incorporated risk stratification algorithms inform clinical care patient stratification future clinical trials. key component this FOA be broad sharing clinical, neuroimaging, physiological, biospecimen data further advance research the area persistent concussive symptoms early middle adolescent EMA; ages 11-17 years old) populations. Notice being provided allow potential applicants sufficient time develop meaningful collaborations an appropriate project design. FOA expected be published Winter 2019 an expected application due date Spring 2020. FOA utilize NIH Specialized Center Cooperative Agreement U54) activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights this area Traumatic Brain Injury TBI) begin consider applying this reissued FOA. addition, collaborative investigative teams combining expertise pediatrics, rehabilitation, biomarker development, proteomics, neuroimaging, risk assessment, / clinical outcomes research be encouraged, these investigators should also begin considering applying this FOA. U54 Center Without Walls CWOW) cooperative agreement mechanism employed this FOA support multi-site, multidisciplinary, research teams work synergistically discover, characterize, validate combination biological measures prognosis and/or monitoring recovery persistent concussive symptoms enrollment multiple points care e.g., Emergency Departments, urgent care clinics, primary care, concussion/sports medicine clinics, other specialty clinics) participants a variety injury mechanisms e.g., falls, sports, abusive head trauma, automobile accidents). Biological measures are responsive include, are limited to, neuroimaging, electroencephalography, oculomotor control, vestibular function, measures auditory processing speech production, autonomic responses, metabolomics, proteomics other biofluid-based assays. Analysis plans should include potential mediating factors such medication the type amount post-injury treatment rehabilitation provided participants. Components the U54 expected include following:(1) Administrative Core management reporting, establishing milestones, organizing communications among sites, resolving disputes; 2) Data Coordinating Core will responsible data curation, quality, submission the FITBIR informatics platform be able coordinate the NINDS biomarker repository BioSEND; 3) Research Cores will responsible maintaining data acquisition standard operating procedures specialized data analytics; 4) single research project will used address list research areas interest; 5) overall component describes overall structure, function, goals the CWOW. scientific project be expected include both 1) discovery / internal validation a 2) cross-site clinical validation stage. discovery stage should focus discovery biological measures persistent concussive symptoms. During internal validation stage, project be expected determine selectivity sensitivity a unique individual set biological measures prognosing / monitoring persistent concussive symptoms an EMA population across variety injury mechanisms. the cross-site clinical validation stage, biological markers have internally validated should collected, a new cohort participants, determine selectivity sensitivity these measures across multiple sites in multiple clinical contexts. Following validation, risk stratification algorithm prognosing and/or monitoring recovery persistent concussive symptoms an EMA population should developed. is expected the RFA require incorporation the NINDS Core TBI pediatric common data elements CDEs) appropriate Core CDEs the NINDS Sports Concussion CDE set. Additionally, RFA expected require use the NINDS CDEs both outcome non-outcome measures including, not limited demographics, medical injury history, history abusive injury, family history, medications, neuroimaging, rehabilitation strategy, standardized outcome assessments) described the NINDS CDE Project. FOA require data sharing schedule is consistent NINDS's TBI data submission policy NOT-NS-17-029. Further, ensure maximal value the project, data sharing plan require sharing a limited" clinical data set e.g., clinical assessment amp; outcome measures, symptom lists, mechanism injury, demographics, etc.) be available FITBIR a limited access public” state more 1-year after collection. FOA expect all biological specimens banked the NINDS BioSEND Biomarkers Repository. Note costs collection NOT included a component the NINDS BioSEND Biomarkers Repository award. Therefore, most costs the biospecimen banking borne the grantees utilizing resource NOT-NS-15-046) should budgeted in application. Funding Information Estimated Total Funding NINDS intends commit 2,000,000 direct costs per year Expected Number Awards NINDS intends fund to 1 award Estimated Award Ceiling 2,000,000 direct costs per year. 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) Small Business For-Profit Organization than Small Business) State Government Applications not being solicited this time.  Inquiries Please direct inquiries to: Patrick S. Frost Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 psfb@mail.nih.gov

Request Information RFI): Need Biologic Reagents, Imaging, Genetic Cognitive Behavioral Assessment Tools Facilitate Use Marmosets Biomedical Research Notice Number: NOT-AG-19-045 Key Dates Release Date: October 7, 2019 Related Announcements NOT-AG-20-001 Issued Office Research Infrastructure Programs ORIP) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Deafness other Communication Disorders NIDCD)? Purpose Request Information RFI) seeks input current challenges key bottlenecks the of marmosets animal models biomedical research. principal objectives include identification the needs species-specific biologic reagents, genetic behavioral analytic tools technologies, other crucial resources would advance use marmosets research facilitate translation modalities this organism. Background Nonhuman primates NHP) the closest evolutionary relatives humans, whom share anatomical, physiological, gene interactions features. common marmoset Callithrix jacchus) of increasing importance biomedical research worldwide. New World primate known cooperative social behavior, cognition, communication, potentially makes a good model organism help understand wide range human diseases. Marmosets smaller easier house rhesus macaques give birth twice year versus once every year two years, aiding multi-generational experiments. Because marmosets mature age quickly bigger monkeys, are potentially also good model organism study development aging. a nonhuman primate species several unique reproductive, physiological, and behavioral advantages, marmosets uniquely positioned accelerate progress biomedical research. Additionally, marmoset’s brain fewer gyri a macaque’s, making easier image record activity its surface. marmoset a research model enjoyed substantial growth over past decade largely through grass-roots, researcher-initiated projects. While ventures been remarkably productive, several bottlenecks must addressed the model reach full potential a keystone system addressing NIH’s stated goal enhance health, lengthen life, reduce illness disability humans. response the unprecedented growth demand marmosets following reports genome editing successful propagation transgenes marmoset offspring, NIH launched new initiatives cooperative agreements) expand number marmoset colonies to optimize housing, breeding, use research. NIH now seeking stakeholder feedback guide development priorities accelerate research using marmosets models human diseases to facilitate translation these findings human conditions treatment. Notice seeks solicit public comment the challenges, gap areas, bottlenecks experienced the marmoset research community. Feedback obtained through Notice other outreach efforts help inform development research infrastructure priorities biomedical research involving marmosets a model organism. Information Requested Stakeholder feedback requested any all, not limited to, following topics: Development distribution key biological reagents tools would facilitate use marmosets animal models accelerate translation results Types tools biomarkers facilitate physiological behavioral studies marmosets reference genome sequence annotation expected be available the research community soon--will be sufficient? Identified needs relation improving genetic diversity, animal husbandry, diet, shipping animals between sites Information other key areas where NIH facilitate research using marmosets Submitting Response comments must submitted via email text as attached electronic document. Please address response to manuel.moro@nih.gov by October 23, 2019. Include Notice number the subject line. Response this RFI voluntary. Responders free address any all categories listed above. submitted information be reviewed NIH staff. request for information planning purposes only should be construed a solicitation as obligation the part the Federal Government. NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government's of such information. NIH use information submitted response this RFI its discretion will provide comments any responder's submission. However, responses the RFI be reflected future funding opportunity announcements. information provided be analyzed may aggregated presentations reports. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. proprietary, classified, confidential, sensitive information should included your response. Government reserves right use any non-proprietary technical information any resultant solicitation(s). Inquiries Please direct inquiries to: Manuel H. Moro, DVM, MPH, PhD, Dipl ACVPM Program Director Division Aging Biology National Institute Aging NIA) Telephone: 301-480-1796 Email: manuel.moro@nih.gov

Notice Extension the Response Date NOT-NS-19-079 Request Information: Input the National Institute Neurological Disorders Stroke Strategic Planning Process" Notice Number: NOT-NS-20-010 Key Dates Release Date: September 27, 2019 Related Announcements NOT-NS-19-079 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends response date NOT-NS-19-079 Request Information: Input the National Institute Neurological Disorders Stroke Strategic Planning Process." following sections NOT-NS-19-079 been updated: Key Dates Current Response Date: October 01, 2019 New Response Date: November 01, 2019 other aspects the RFI remain same. Inquiries Please direct inquiries to: NINDS Strategic Planning Email: NINDSStrategicPlan@nih.gov

Notice NINDS's Participation NOT-DE-19-013 Clarifications Regarding Institutional Eligibility PAR-19-134 Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Allowed)" Notice Number: NOT-NS-20-011 Key Dates Release Date: September 27, 2019 Related Announcements NOT-DE-19-013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to announce National Institute Neurological Disorder Stroke's participation NOT-DE-19-013 Clarifications Regarding Institutional Eligibility PAR-19-134 Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Allowed)". following section been updated reflect participation NINDS this Notice. Currently Reads: Issued by: National Institute Dental Craniofacial Research NIDCR) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) Modified Read: Issued by: National Institute Dental Craniofacial Research NIDCR) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Cancer Institute NCI) other aspects this notice remain same. Inquiries Please direct inquiries to: Letitia Weigand, Ph.D.National Institute Neurological Disorders Stroke NINDS)301-496-4188 letitia.weigand@nih.gov

Clarifications Regarding Institutional Eligibility PAR-19-135 Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Required)" Notice Number: NOT-NR-19-010 Key Dates Release Date: September 25, 2019 Related Announcements PAR-19-135 NOT-DE-19-013 NOT-MH-20-002 Issued National Institute Nursing Research NINR) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) Purpose purpose this Notice to provide potential applicants clarifications regarding eligibility information for PAR-19-135, Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Required). Specifically, changes pertain determinations institutional eligibility submitting R15 REAP applications for receiving R15 REAP awards. Accordingly, text several specified sections the funding opportunity announcement modified follows: Part 1. Funding Opportunity Purpose, second paragraph. Currently reads: Eligible institutions e.g., university college) must award NIH-relevant baccalaureate advanced degrees health professions advanced degrees biomedical behavioral sciences have received less 6 million per year NIH support total costs) 4 the last 7 fiscal years. this FOA college a stand-alone entity not component a university system. reads: Eligible institutions e.g., university college a unique Employer Identification Number EIN]) must award NIH-relevant baccalaureate advanced degrees health professions have received more 6 million per year NIH support both direct F&A/indirect costs) 4 the last 7 fiscal years. For institutions composed multiple schools colleges, 6 million funding limit based the amount NIH funding received the institution a whole meaning schools colleges within institution). other words, funding all institution’s health professional schools, graduate schools, colleges all institution’s non-health professional schools colleges are part the institution considered together summed total NIH funding determining institutional eligibility. institutions multiple campuses, eligibility be considered each individual campus e.g. main, satellite, etc.) only a separate EIN established each campus. institutions use EIN all campuses, eligibility determined all campuses e.g. main, satellite, etc.) together. Section I, Funding Opportunity Description, first paragraph, last sentences Currently reads: this FOA college a stand-alone entity not component a university system. new program called Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools. reads: new program called Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools. Section III. Eligibility Information, 1. Eligible Applicants subsection under Eligible Organizations that currently reads: addition, organizations must meet following criteria the time submission: applicant organization must an accredited public non-profit private school grants baccalaureate advanced degrees health professions section below more details) advanced degrees biomedical behavioral sciences. applicant institution not received research support the NIH totaling than 6 million per year both direct F&A/indirect costs) 4 the last 7 years Section I. Funding Opportunity Description definition institution"). year defined a federal fiscal year: October 1 through September 30. Note all activity codes included this calculation except following: C06, S10, all activity codes starting a G. now changed read: addition, organizations must meet following criteria the time submission: applicant organization must an accredited public non-profit private school grants baccalaureate advanced degrees health professions section below more details) advanced degrees biomedical behavioral sciences. applicant institution not received research support the NIH totaling than 6 million per year both direct F&A/indirect costs) 4 the last 7 years. year defined a federal fiscal year: October 1 through September 30. NOTE: institutions composed multiple schools colleges, 6 million funding limit based the amount NIH funding received the institution a whole meaning schools colleges within institution). other words, funding all institution’s health professional schools, graduate schools, colleges all institution’s non-health professional schools colleges are part the institution considered together summed total NIH funding determining institutional eligibility. Note all activity codes included this calculation except following: C06, S10, all activity codes starting a G. changes effective October 25, 2019. other aspects of PAR-19-135 remain unchanged. Inquiries Please direct inquiries to: Michelle R.J. Hamlet, Ph.D. National Institute Nursing Research Telephone: (301) 594-5962 Email: michelle.hamlet@nih.gov Christopher L. Hatch, Ph.D. National Cancer Institute NCI) Telephone: 240-276-6454 Email: ch29v@nih.gov Li Lin, Ph.D. National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-827-7749 Email: linli@mail.nih.gov Rene Etcheberrigaray National Institute Aging NIA) Telephone: 301-451-9798 Email: rene.etcheberrigaray@nih.gov the Scientific/Research Contact person and/or Financial/Grants Management Contact person another participating NIH institute center listed Section VII PAR-19-134) you want consider application.

Notice Intent Publish Funding Opportunity Announcement Data Harmonization, Curation Secondary Analysis Existing Clinical Datasets R61/R33 Clinical Trial Allowed) Notice Number: NOT-NS-19-071 Key Dates Release Date: September 16, 2019 Estimated Publication Date Funding Opportunity Announcement: November 01, 2019 First Estimated Application Due Date: March 16, 2020 Earliest Estimated Award Date: September 16, 2020 Earliest Estimated Start Date: September 30, 2020 Related Announcements RFA-NS-20-007 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends promote new initiative publishing Request Applications RFA) solicit applications research will promote discovery / validation scientific clinically-relevant hypotheses secondary analysis existing clinical datasets samples, sourced two more multi-site clinical studies i.e., clinical trials, natural history studies, comparative effectiveness studies). Proposals within scope this announcement include projects focused clinical research areas are within NINDS mission go beyond scope the individual clinical studies being included harmonization, curation analyses. Notice being provided allow potential applicants sufficient time develop meaningful collaborations, confirm data accessibility, develop appropriate projects. RFA expected be published fall 2019 an expected application due date spring 2020. RFA utilize R61/R33 activity code. Details the planned RFA provided below. first phase R61) expected support initial harmonization curation the datasets the second phase R33) support analyses address proposed research objectives. Details the planned RFA provided below. Research Initiative Details RFA for secondary curation analysis existing datasets two more multi-site clinical studies’ datasets. Studies include datasets ongoing studies; however, RFA not support collection new data. RFA use R61/R33 phased mechanism provide multi-year funding both harmonization curation phase R61) the analyses phase R33). Applicants should provide sufficient information demonstrating feasibility obtaining access the datasets, taking consideration data sharing policies described the original studies, including scope the informed consents, local regional privacy regulations. this phased mechanism, funding the second phase R33) be dependent upon meeting Go/No-Go criteria the end the first phase. The Go/No-Go Criteria must describe clear quantitative curation standards necessary enable analyses the second phase R33). Notice encourages investigators form collaborative teams include clinical subject matter expertise, statisticians bioinformaticians/data scientists begin consider applying this new RFA. Teams must include investigators involved the original data acquisition part the investigative team as consultants. Trainees young investigators also highly encouraged be included the investigative team. Examples potential research topics include, are limited to: Validation diagnostic and/or prognostic models outcome Comparative effectiveness hypotheses Mediation analyses biological, cultural environmental factors affect treatment response course disease Evaluation biomarker validity including clinical outcome assessments COAs)), new populations and/or new context use Discovery validation multi-domain clinical and/or biological measures diagnosis, prognosis and/or treatment response using existing genetic biological samples along clinical physiological assessments Extended characterization validation natural history disease course Novel methods improving patient stratification Examples research this RFA not support include: Studies using non-human animal models Studies using data a single clinical research study Multiple single-site clinical research studies Studies harmonization, curation, analysis where primary data source Electronic Health Record EHR) data Studies harmonization, curation, analysis where primary data source metadata EHRs ensure maximal value the project, applicants this RFA be expected include open-source cataloging the processes tools used harmonization, curation, analysis, well data sharing plans include information any controlled-access requirements the curated datasets. Investigators strongly encouraged use open-source software, analytic tools, programming languages promote interoperability well reproducibility. Investigators encouraged make of existing resources, tools training the NIH’s BD2K Centers https://commonfund.nih.gov/bd2k/centers), such as: Center Expanded Data Annotation Retrieval CEDAR) provides computational ecosystem development, evaluation, use, refinement biomedical metadata; https://more.metadatacenter.org/tools-training Center Causal Discovery CCD) develops computational methods known causal discovery algorithms can used discover causal relationships a combination observational data, experimental data, prior knowledge; https://www.ccd.pitt.edu/tools/ Big Data Discovery Science BDDS) provides software tools data resources developed the management, manipulation, mining large-scale biomedical data along education training resources; https://bd2k.ini.usc.edu/tools/. Proposals expected include plans harmonize data available NINDS Common Data Elements CDEs; https://www.commondataelements.ninds.nih.gov/#page=Default) both outcome non-outcome variables. CDISC standards https://www.cdisc.org/) should also incorporated where applicable. Funding Information Estimated Total Funding 1,500,000 direct costs per year Expected Number Awards 3 Estimated Award Ceiling Applicants should propose budgets required conduct work proposed. 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) Indian/Native American Tribal Government Federally Recognized) Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) Applications not being solicited this time.  Inquiries Please direct inquiries to: Patrick S. Frost Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 psfb@mail.nih.gov Carol Taylor-Burds, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-1447 carol.taylor-burds@nih.gov