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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 Change Allowable Appendix Materials RFA-NS-19-038 NINDS Human Cell Data Repository U24 - Clinical Trial Allowed)" Notice Number: NOT-NS-20-006 Key Dates Release Date: September 16, 2019 Related Announcements RFA-NS-19-038 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change allowable Appendix Materials RFA-NS-19-038 NINDS Human Cell Data Repository U24-Clinical Trial Allowed)." Changes shown in Bold Italics below.  This notice be effective the October 22, 2019 receipt date. Appendix Currently Reads: Only limited Appendix materials allowed. Follow instructions the Appendix described the SF424 R&R) Application Guide. Modified Read: Only limited Appendix materials allowed.  Follow instructions the Appendix described the SF424 R&R) Application Guide. Standard Operational Procedures be included the appendix. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Christine Swanson-Fischer, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-5680 Email: christine.swanson-fischer@nih.gov Daniel Miller, PhD National Institute Neurological Disorders Stroke Telephone: 301-496-5680 Email: daniel.miller@nih.gov

Notice Intent Publish Funding Opportunity Announcement NIH Blueprint Program Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences R25 Clinical Trial Allowed) Notice Number: NOT-NS-20-009 Key Dates Release Date: September 16, 2019 Estimated Publication Date Funding Opportunity Announcement: October 10, 2019 First Estimated Application Due Date: February 19, 2020 Earliest Estimated Award Date: September 01, 2020 Earliest Estimated Start Date: December 01, 2020 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 Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Purpose National Institutes Health NIH) Blueprint Neuroscience Research intends reissue Funding Opportunity Announcement FOA) receipt new renewal applications its research education program neuroscience focused undergraduates. overall objective this funding opportunity be increase number undergraduate participants diverse groups successfully enter complete Ph.D. degree programs the neurosciences. accomplish goal, initiative support development collaborative research education partnerships increase participants’ awareness interest the neurosciences, develop participants’ scientific knowledge research skills would allow to progress transition more advanced neuroscience related research education training activities, establish working networks within existing Ph.D. degree granting NIH-supported predoctoral T32 neuroscience programs. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published late November 2019 an expected application due date February 2020. FOA utilize R25 activity code. Research Initiative Details overarching objective this funding opportunity to encourage individuals diverse backgrounds, including those groups underrepresented the biomedical, behavioral, clinical research workforce, pursue further studies careers neuroscience research. achieve goal, initiative support two-yearneuroscience research education programs comprised year-round authentic neuroscience research experiences, research career development, establishment professional networks, implemented through collaborative partnerships integrated across different educational institution types. future FOA expected continue overarching objective the 2019 NIH Blueprint R25 FOA: RFA-NS-19-007. Funding Information Estimated Total Funding TBD 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 Applications not being solicited this time.  Inquiries Please direct inquiries to: Michelle D. Jones-London, Ph.D.National Institute Neurological Disorders Stroke NINDS)301-451-7966jonesmiche@mail.nih.gov nbsp;

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  

HEAL/NINDS Early Phase Pain Investigation Clinical Network EPPIC-Net): Opening applications non-addictive pain therapeutics Notice Number: NOT-NS-19-075 Key Dates Release Date: September 11, 2019 Related Announcements RFA-NS-19-023 RFA-NS-19-024 RFA-NS-19-025 RFA-NS-19-036 NOT-NS-19-043 Issued National Institute Neurological Disorders Stroke NINDS) Purpose April 2018, NIH launched HEAL Helping End Addiction Long-term) Initiative, aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. major goal the HEAL Initiative to spur development effective, non-addictive treatments reduce burden illness due pain to reduce risk addiction. Over past 2 years, NIH gathered input experts the U.S. Food Drug Administration FDA), academia, the private sector identify key gaps opportunities. sophisticated clinical trial network design execute innovative early phase trials promising non-addictive pain therapies well-characterized patient cohorts pain conditions high unmet need identified a high priority. response NIH establishing Early Phase Pain Investigation Clinical Network EPPIC-Net). mission EPPIC-Net to improve treatment acute chronic pain reduce reliance opioids. will accomplished accelerating early phase testing non-addictive pharmacologic device strategies alleviating pain submitted industry academic investigators. EPPIC-Net lower burden early phase clinical testing provide strong evidence guide decisions later phase trials therapeutics pain indications. a continually learning network, EPPIC-Net researchers provide needed knowledge pain conditions, biomarkers, innovative means testing therapies the research community the singular goal accelerating process making effective therapies pain available the public reducing reliance opioids. research infrastructure EPPIC-Net, established through previously published funding opportunities RFA-NS-19-023, RFA-NS-19-024, RFA-NS-19-025, RFA-NS-19-036) composed a Clinical Coordinating Center CCC), Data Coordinating Center DCC), Specialized Clinical Sites across USA. Centers Sites help EPPIC-Net Develop test innovative clinical trial paradigms establish best means testing pain therapies. Establish well-characterized patient cohorts specific pain conditions outcome measures utility phase 2 trials. Continuously learn experience engineer ever-improving early phase testing new pain therapies. Please note there no funding provided the asset holders applying have therapeutics studied within EPPIC-Net. Successful asset holders obtain access EPPIC-Net study their therapeutics. NIH Transaction funds conduct study awarded the EPPIC-Net CCC, administers funds other EPPIC-Net research components. HEAL Initiative, including EPPIC-Net, now reaching to industry academia potential phase 2-ready non-addictive pain therapeutics might tested EPPIC-Net. Additional information the Research Opportunity Announcement ROA) OTA-29-008 be found the EPPIC-Net website https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/NIND…. EPPIC-Net soliciting assets to: Test new treatments specific pain conditions early phase trials focused phase 2) using therapeutic candidates such drug, biologicals, device ldquo;assets”) Go/No-Go criteria inform decisions move toward Phase 3 trials. Test assets phase 2 trials help establish a specific therapeutic pathway holds promise a next generation device, small molecule biologic. to validate biomarkers utility tests target engagement proof-of-principle could used enable accelerate discovery, development, approval new, non-addictive pain therapies. Application Process Clinical Trials EPPIC-Net Application submission review: Applicants a potential pain therapeutic should submit EPPIC-Net preliminary application provides information their drug device asset, target condition population, available preclinical early phase clinical trial data proposed study design. application form information packet be found at https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/NIND…. EPPIC-Net open applications September 3, 2019. objective review process be used select highly meritorious applications. Those applicants then invited work an NIH contractor develop more detailed ldquo;dossier” information the asset proposed clinical trial. After dossier review, selected applicants proceed work the EPPIC-Net CCC, DCC, Specialized Clinical Sites develop clinical protocol. Clinical protocols be submitted the CCC final stage review. Highly meritorious protocols be selected implementation the asset clinical trial within EPPIC-Net, trial funding provided and managed the CCC distribution the Clinical Sites. Inquiries Please direct inquiries to: Barbara I. Karp, MDNational Institute Neurological Disorders StrokeTelephone: 301-496-0150Email: barbara.karp@nih.govRebecca Hommer, MDNational Institute Neurological Disorders StrokeTelephone: 301-827-2257Email: rebecca.hommer@nih.gov

Notice Increased Budget Limits NINDS Participation PAS-19-316 Advancing Research Alzheimer's Disease AD) Alzheimer's-Disease-Related Dementias ADRD) R43/R44 Clinical Trial Optional)" Notice Number: NOT-AG-19-040 Key Dates Release Date: September 5, 2019 Related Announcements PAS-19-316 Advancing Research Alzheimer's Disease AD) Alzheimer's-Disease-Related Dementias ADRD) R43/R44 Clinical Trial Optional) Issued National Institute Aging NIA)National Institute Neurological Disorders Stroke NINDS) Purpose Notice informs potential applicants new budget limits PAS-19-316 Advancing Research Alzheimer's Disease AD) Alzheimer's-Disease-Related Dementias ADRD) R41/R42 Clinical Trial Optional)". addition, National Institute Neurological Disorders Stroke NINDS) participate this funding opportunity announcement. notice be effective the January 5, 2020 receipt date subsequent due dates. following sections PAS-19-316 been updated shown bold italics) reflect changes. Currently Reads: Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) Catalog Federal Domestic Assistance CFDA) Number(s) 93.866 Section II. Award Information Funds Available Anticipated Number Awards NIA intends fund estimate 10 awards, corresponding a total 4 million fiscal year 2020. Future year amounts depend annual appropriations. Award Budget According statutory guidelines, total funding support direct costs, indirect costs, fee) normally not exceed 252,131 Phase awards 1,680,179 Phase II awards appropriate justification the applicant). However, NIH received waiver SBA, authorized statute, exceed 252,131 Phase or 1,680,179 Phase II specific topics. current list approved topics be found at https://sbir.nih.gov/funding#omni-sbir. Applications address approved waiver topics request total cost budgets to 300,000 Phase and 2,000,000 Phase II. Applicants strongly encouraged contact NIH program officials prior submitting any application excess the guidelines early the application planning process. all cases, applicants should propose budget is reasonable appropriate completion the research project. Phase IIB budgets must submitted accordance participating IC-specific budget limitations described the current SBIR/STTR Program Descriptions Research Topics of NIH, CDC FDA. Section VII. Agency Contacts Scientific/Research Contact(s): Zane Martin, Ph.D. National Institute Aging NIA) Division Neuroscience DN) Telephone: 301-827-7130 Email: zane.martni@nih.gov Michael-David ARR Kerns, M.M., M.S., Ph.D. National Institute Aging NIA) NIA SBIR-STTR Program Coordinator Telephone: 301-402-7713 Email: kernsmd@mail.nih.gov Financial/Grants Management Contact(s): Jessica Perez National Institute Aging NIA) Telephone: 301-403-7739 Email: jessi.perez@nih.gov Modified Read: Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.866, 93.853 Section II. Award Information Funds Available Anticipated Number Awards NIH intends fund estimate 11 awards, corresponding a total 4.4 million fiscal year 2020. Future year amounts depend annual appropriations. Award Budget According statutory guidelines, total funding support direct costs, indirect costs, fee) normally not exceed 252,131 Phase awards 1,680,179 Phase II awards appropriate justification the applicant). However, NIH received waiver SBA, authorized statute, exceed 252,131 Phase or 1,680,179 Phase II specific topics. current list approved topics be found http://sbir.nih.gov/funding#omni-sbir. Applications address approved waiver topics request total cost budgets to 500,000 Phase and 2,500,000 Phase II. Applicants strongly encouraged contact NIH program officials prior submitting any application excess the guidelines early the application planning process. all cases, applicants should propose budget is reasonable appropriate completion the research project. Phase IIB budgets must submitted accordance participating IC-specific budget limitations described the current SBIR/STTR Program Descriptions Research Topics of NIH, CDC FDA. Section VII. Agency Contacts Scientific/Research Contact(s): Zane Martin, Ph.D. National Institute Aging NIA) Division Neuroscience DN) Telephone: 301-827-7130 Email: zane.martni@nih.gov Michael-David ARR Kerns, M.M., M.S., Ph.D. National Institute Aging NIA) NIA SBIR-STTR Program Coordinator Telephone: 301-402-7713 Email: kernsmd@mail.nih.gov Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: fertigs@ninds.nih.gov Financial/Granst Management Contact(s): Jessica Perez National Institute Aging NIA) Telephone: 301-403-7739 Email: jessi.perez@nih.gov Tijuanna DeCoster, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9231 Email: decostert@mail.nih.gov addition the changes outlined above, NINDS adding following text Section I. Funding Opportunity Description: National Institute Neurological Disorders Stroke NINDS) National Institute Neurological Disorders Stroke NINDS) interested applications within NINDS mission. small business program NINDS used achieve mission the Institute supporting innovative ideas different stages development, including applied bench research, translational research, early stage clinical trials. NIA NINDS shared interest all areas AD/ADRD, NINDS the lead vascular contributions cognitive impairment dementia VCID), lewy body dementia LBD), frontotemporal lobar degeneration FTLD); NIA the lead applications focused Alzheimer’s Disease. those applications propose clinical trial use FDA-regulated intervention, NINDS give priority those applications a) protocol submitted under open IND the IND not under full partial hold. b) protocol submitted an original IDE as new study under open IDE, FDA fully approved IDE IDE supplement. c) protocol submitted under IND is full partial hold. d) protocol submitted an original IDE as new study under open IDE, FDA conditionally approved IDE IDE supplement. e) protocol exempt an IND. f) protocol either exempt the IDE regulations does require IDE approval because is determined be nonsignificant risk. NINDS decline funding any application includes human subjects programmatic administrative reasons. STTR applicants considering projects involving human subjects research strongly encouraged contact program staff early the process preparing submission. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 E-mail: fertigs@ninds.nih.gov

Notice Special Interest Encourage Eligible NIH BRAIN Initiative Awardees Apply PA-18-906 Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed) Notice Number: NOT-MH-19-038 Key Dates Release Date: September 4, 2019 First Available Due Date: October 5, 2019 Expiration Date: September 8, 2021 Related Announcements PA-18-906, Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed) Issued National Institute Mental Health NIMH) National Eye Institute NEI) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose Notice encourages eligible awardees the BRAIN Initiative community apply administrative supplements response to PA-18-906, Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed). NIH a strong interest the diversity the NIH-funded workforce see NOT-OD-18-210) encourages institutions diversify populations enhancing participation individuals groups identified underrepresented the biomedical, clinical, behavioral, social sciences. foundational BRAIN 2025 report states the BRAIN Initiative should a catalyst will drive outstanding young people enter area their most creative career stage." NIH diversity supplement offers opportunity BRAIN awardees request additional funds train mentor next generation researchers, including those underrepresented groups, will contribute advancing goals the BRAIN Initiative. Program Directors/Principal Investigators PDs/PIs) active BRAIN Initiative research program grants encouraged identify eligible individuals across career development pipeline high school students the faculty level) support scientific mentorship under auspices this administrative supplement. research activities proposed the supplement application must fall within scope the parent grant. Proposed career development activities should appropriate the career stage the supplement candidate should demonstrate both strong commitment the mentor a clear path forward the candidate. BRAIN Initiative PD/PIs strongly encouraged incorporate training activities will help prepare supplement candidate conduct research relevant the goals the BRAIN Initiative 2025 Report. Educational goals the NIH component the BRAIN Initiative see BRAIN 2025: Scientific Vision) include acquisition quantitative skills; appropriate and integration newly developed tools, technologies methods developed under BRAIN Initiative; consideration the ethical implications neuroscience research. Special emphasis placed training quantitative neuroscience i.e., theory statistics biologists) exposing physicists, engineers statisticians experimental neuroscience. BRAIN 2025 Report strongly encourages scientists cross traditional areas expertise conduct interdisciplinary research emphasizes need leverage perspectives quantitative disciplines e.g., statistics, computer science, physics, mathematics, engineering) address neuroscience questions. Application Submission Information: Notice applies due dates or after October 5, 2019 expires September 8, 2021. Applications this initiative must submitted using following opportunity its subsequent reissued equivalent PA-18-906 - Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed). instructions the SF424 R&R) Application Guide PA-18-906 must followed, the following additions: the first sentence the Research Strategy, applicants requested state the parent grant awarded a BRAIN Initiative award to identify specific FOA the parent grant e.g., RFA-NS-18-030) facilitate processing the supplement application. funding consideration, applicants must include NOT-MH-19-038" without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Only existing awardees BRAIN program eligible apply. Supplement applications be evaluated the BRAIN Initiative research training committee. process Streamlined Submissions using eRA Commons cannot used this initiative. Diversity supplement applications a parent grant is multiple-PD/PI MPI) BRAIN Initiative award a foreign institution permitted. Specifically, diversity supplement be submitted the supplement candidate meets eligibility criteria specified in PA-18-906 and work a subaward MPI a U.S. domestic institution. Potential applicants encouraged confirm eligibility the Program contact listed below. BRAIN diversity supplement awardees strongly encouraged participate annual PD/PI meetings in activities their mentors. Applicants request funds, addition the research costs specified in PA-18-906,to enable supplement candidate attend annual BRAIN Initiative PD/PI meeting the Washington, DC area. request additional funds should reasonable well justified the application. Potential applicants strongly encouraged review the supplemental guidance for BRAIN Initiative diversity supplement applications the NIH BRAIN Initiative web site. Consultation the Program Official the qualifying BRAIN award the individual named under Inquiries below highly recommended. Supplement applications be evaluated the BRAIN Initiative research training committee. Applications be considered according the following schedule: Application Due Date Funding Decision) October 5 – December 1 January) December 2 – February 15 March) February 16 – April 15 May) April 16 – June 15 July) tracking purposes, applicants encouraged inform Dr. James Churchill via email James.Churchill@nih.gov) a diversity supplement application submitted. Please include PD/PI name grant number the subject line this email. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries to: James Churchill, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: BRAIN.Initiative.Training@nih.gov

Notice Extend, PA-18-401 Research Autism Spectrum Disorders R01-Clinical Trial Optional)" Notice Number: NOT-MH-19-046 Key Dates Release Date: September 4, 2019 Related Announcements PA-18-401 Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) Purpose purpose this Notice to extend expiration date PA-18-401, Research Autism Spectrum Disorders R01-Clinical Trial Optional)". Current expiration date: September 8, 2019 Modified expiration date: January 8, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Lisa Gilotty, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3825 Email: gilottyl@mail.nih.gov

Notice Extend, PA-18-400 Research Autism Spectrum Disorders R21-Clinical Trial Optional)" Notice Number: NOT-MH-19-045 Key Dates Release Date: September 4, 2019 Related Announcements PA-18-400 Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) Purpose purpose this Notice to extend expiration date PA-18-400, Research Autism Spectrum Disorders R21-Clinical Trial Optional)". Current expiration date: September 8, 2019 Modified expiration date : January 8, 2021   Inquiries Please direct inquiries to: Lisa Gilotty, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3825 Email: gilottyl@mail.nih.gov