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The objective of this FOA is to support the development of the Data Coordinating Center for the NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) project, which consists of the following components: a Data Portal Core, a Data Management Core, and an Administrative and Outreach Core. The goal of the web-based Data Portal is to accelerate discovery of etiology and biologic pathways underlying the comorbidities of Down syndrome by facilitating access to and querying of data from cohorts of individuals with Down syndrome. The Data Portal will facilitate access to aggregated and harmonized data to empower analyses among the Down syndrome research community, as well as the broader scientific community. The Data Management Core will work with INCLUDE investigators and other data generators to facilitate data collection, processing, and harmonization. The Administrative and Outreach Core will oversee administrative activities, work closely with a Steering Committee and INCLUDE program staff, and provide outreach and education to the research community on using the Data Portal.

Reissue of PAR-17-096. The Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences (JSPTPN) is an institutional program that supports broad and fundamental research training in the neurosciences. In addition to a broad education in the neurosciences, a key component will be a curriculum that provides a strong foundation in experimental design, statistical methodology and quantitative reasoning. JSPTPN programs are intended to be 2 years in duration and students may only be appointed to this training grant during the first 2 years of their graduate research training. The primary objective is to prepare students to be outstanding scientists equipped to pursue careers in neuroscience.

Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project Notice Number: NOT-OD-20-020 Key Dates Release Date: December 6, 2019 First Available Due Date: April 08, 2020 Expiration Date: January 08, 2022 Related Announcements NOT-OD-20-024 NOT-OD-20-023 NOT-OD-20-012Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-19-191Ruth L. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-192Ruth L. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-195Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Parent F31) PA-19-196Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Promote Diversity Health-Related Research Parent F31 - Diversity) PA-19-188Ruth L. Kirschstein National Research Service Award NRSA) Individual Postdoctoral Fellowship Parent F32) RFA-OD-20-004 RFA-OD-20-003 RFA-OD-20-005 RFA-OD-20-006 RFA-OD-20-007NOT-OD-20-025 NOT-OD-20-022 Issued Office The Director, National Institutes Health OD) National Cancer Institute NCI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases(NIAMS) Eunice Kennedy ShriverNational Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Purpose Background INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects werefundedin 2018 2019, well the INCLUDE ProjectResearch Plan?, available theINCLUDE Project website. Individuals DS face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives Notice Special Interest NOSI) announces NIH support the professional development trainees aiming establish career DS-related research. providing scientists training, resources, mentorship, NIH intends foster pipeline investigators DS other intellectual disabilities will lead future research improve understanding the biology DS support development new treatments health conditions experienced those DS. Investigators early their careers e.g., predoctoral candidates) well those advanced degrees e.g., PhD, MD) benefit mentorship established investigators professionals the DS research community basic science fields well clinical translational arenas. NIH issuing NOSI expand community investigators conducting research related DS encouraging scientists physicians early their research careers develop research projects related co-occurring conditions associated DS. Sharing resources effective communication outputs the broader communities a high priority theINCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3,NIH Strategic Plan Data Science). list ofFunding Priorities Institute Centerfor project available theINCLUDEwebsite. Applications response this NOSI should aligned the overall INCLUDE ProjectResearch Plan, consists three components: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Projects propose recruit subjects DS encouraged promote enrollment research subjects the DS patient registry supported NIH,DS-Connect. other data biospecimens human genetic non-genetic studies, awardees encouraged use biorepositories designated INCLUDE staff meet requirements broad sharing. NIH resource describingCommon Data Elementsmay helpful during planning phases a project considering ways optimize data collection order facilitate broad data sharing. Application Submission Information Notice applies due dates or after April 8, 2020 expires January 8, 2022. Applications response this NOSI must submitted using of following target funding opportunity Announcements FOAs) their reissued equivalents. Although all NIH components indicated above listed Participating Organizations all FOAs listed below, applications this special topic be accepted. PA-19-191RuthL. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-192Ruth L. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-195Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Parent F31) PA-19-196Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Promote Diversity Health-Related Research Parent F31 - Diversity) PA-19-188Ruth L. Kirschstein National Research Service Award NRSA) Individual Postdoctoral Fellowship Parent F32) instructions theSF424 R&R) Application Guideand listed funding opportunity announcements must followed, the following addition: funding consideration, applicants must includeNOT-OD-20-020in Agency Routing Identifier field box 4b) the SF424 R&R form.Applications without information box 4b not considered this initiative. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: list ofcontactsfor participating NIH Institute Center available theINCLUDEwebsite.

Notice Special Interest NOSI): Mentored Career Development Awards Foster Careers Investigators Pursuing Research Related Down syndrome Part the INCLUDE Project Notice Number: NOT-OD-20-021 Key Dates Release Date: December 6, 2019First Available Due Date:February 12, 2020 Expiration Date:January 08, 2022 Related Announcements NOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project NOT-OD-20-024 NOT-OD-20-023 NOT-OD-20-025 PA-19-126Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Allowed) PA-19-127Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Required) PA-19-084Mentored Research Scientist Development Award Parent K01 Independent Basic Experimental Studies Humans Required) PA-19-116Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Required) PA-19-117Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Allowed) PA-19-086Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Basic Experimental Studies Humans Required) PA-19-118Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Clinical Trial Required) PA-19-119Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Clinical Trial Allowed) PA-19-087Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Basic Experimental Studies Humans Required) PA-19-129NIH Pathway Independence Award Parent K99/R00 Independent Clinical Trial Required) PA-19-130NIH Pathway Independence Award Parent K99/R00 - Independent Clinical Trial Allowed) PA-19-090NIH Pathway Independence Award Parent K99/R00 Independent Basic Experimental Studies Humans Required) NOT-OD-20-012 Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project RFA-OD-20-004 - INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-005 - Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006 - Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007 - Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C Clinical Trial Allowed) NOT-OD-20-022 Issued Office The Director, National Institutes Health OD) National Cancer Institute NCI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy ShriverNational Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Purpose Background INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects werefundedin 2018 2019, well the INCLUDE ProjectResearch Plan, available theINCLUDE Project website. Individuals DS face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives Notice Special Interest NOSI) announces NIH support the professional development early career scientists aiming establish career DS-related research. providing scientists training, resources, mentorship, NIH intends foster pipeline investigators DS other intellectual disabilities will lead future research improve understanding the biology DS support development new treatments health conditions experienced those DS. NIH issuing NOSI expand community investigators conducting research related DS encouraging scientists physicians early their research careers develop research projects related co-occurring conditions associated DS. Sharing resources effective communication outputs the broader communities a high priority theINCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3,NIH Strategic Plan Data Science). list ofFunding Priorities Institute Centerfor project available theINCLUDEwebsite. Applications response this NOSI should aligned the overall INCLUDE ProjectResearch Plan, consists three components: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Projects propose recruit subjects DS encouraged promote enrollment research subjects the DS patient registry supported NIH,DS-Connect. other data biospecimens human genetic non-genetic studies, awardees encouraged use biorepositories designated INCLUDE staff meet requirements broad sharing. NIH resource describingCommon Data Elementsmay helpful during planning phases a project considering ways optimize data collection order facilitate broad data sharing.? Application Submission Information Notice applies due dates or after February 12, 2020 expires January 8, 2022. Applications response this NOSI must submitted using of following target Funding Opportunity Announcements FOAs) their reissued equivalents. Although all NIH components indicated above listed Participating Organizations all FOAs listed below, applications this special topic be accepted. Activity Code FOA First Available Due Date K01 PA-19-126Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Allowed) Feb 12, 2020 K01 PA-19-127Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Required) Feb 12, 2020 K01 PA-19-084Mentored Research Scientist Development Award Parent K01 Independent Basic Experimental Studies Humans Required) Feb 12, 2020 K08 PA-19-116Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Required) Feb 12, 2020 K08 PA-19-117Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Allowed) Feb 12, 2020 K08 PA-19-086Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Basic Experimental Studies Humans Required) Feb 12, 2020 K23 PA-19-118Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Clinical Trial Required) Feb 12, 2020 K23 PA-19-119Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Clinical Trial Allowed) Feb 12, 2020 K23 PA-19-087Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Basic Experimental Studies Humans Required) Feb 12, 2020 K99/R00 PA-19-129NIH Pathway Independence Award Parent K99/R00 Independent Clinical Trial Required) Feb 12, 2020 K99/R00 PA-19-130NIH Pathway Independence Award Parent K99/R00 - Independent Clinical Trial Allowed) Feb 12, 2020 K99/R00 PA-19-090NIH Pathway Independence Award Parent K99/R00 Independent Basic Experimental Studies Humans Required Feb 12, 2020 instructions theSF424 R&R) Application Guideand listed funding opportunity announcements must followed, the following additions: funding consideration, applicants must includeNOT-OD-20-021in Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive terms this NOSI be withdrawn consideration this initiative. Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: list ofcontactsfor participating NIH Institute Center available theINCLUDEwebsite.

Notice Special Interest: Alzheimer’s-focused administrative supplements NIH grants are focused Alzheimer’s disease Notice Number: NOT-AG-20-008 Key Dates Release Date: 12/04/2019 First Available Due Date: March 06, 2020 Expiration Date: March 07, 2020 Related Announcements NOT-CA-20-019 Notice Special Interest: Alzheimers-focused Administrative Supplements NIH/NCI Grants are focused Alzheimers Disease PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Institute Aging NIA) 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) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) 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) Purpose participating Institutes Centers ICs) inviting applications expand existing awards are currently focused Alzheimer’s disease its related dementias AD/ADRD)—frontotemporal dementia, Lewy body dementia, vascular cognitive impairment dementia, multiple etiology dementias—to allow research develop such focus. Active awards project end dates FY 2021 later eligible. award not in terminal cost extension going no cost extension FY 2020. Please note a few ICs limit cost extensions the final non-competing year an award. that reason, is important contact staff the Institute supporting award planning request. 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; biology neurodegeneration; genetics; imaging; computational methods; pain perception; biostatistical tools have application research AD/ADRD). NIA hosts website provides details how Alzheimer’s disease its related dementias defined provides examples currently supported research. Awardees expected seek competing support continue promising leads the research supported through supplement. Awards currently focus research Alzheimer’s disease on related dementias not eligible this program. an investigator uncertain whether project does carry Alzheimer’s focus defined NIH, the investigator contact appropriate program officer can check status. example, parent award be focusing cognitive change due chemotherapy cancer patients. Does research a current focus Alzheimer’s its related dementias? Contact program officer the award check status.) Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions: Application Due Date – March 6, 2020, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-AG-20-008” 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 electronic submissions be accepted this funding opportunity. one the methods described PA-18-591. Paper submissions applications submitted attachments be returned. Requests be one year support only. Individual requests be more 250,000 direct costs exclusive Facilities Administrative costs sub-contracts. Though supplement requests not limited one per award, will consider substantial additional funding an award beyond scope the funded award. process Streamlined Submissions using eRA Commons cannot used this initiative. Research Strategy section the application limited 6 pages. part the application, investigators should submit abstract the proposed research shows relevance Alzheimer’s disease and/or related dementias. Place abstract the Project Summary/Abstract section the SF424 R&R) form. work include pilot projects resource development. Institute-, Center-, Office-specific Instructions National Human Genome Research Institute: 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. Review Process IC conduct administrative reviews applications their IC separately. NIA make funds available at least ten awards each the participating ICs, provided sufficient funds available. Criteria: the work proposed within scope the active award? the work proposed focused Alzheimer’s disease its related dementias? the work likely stimulate additional activity leading progress any, all, these dementias? Inquiries Please direct inquiries to: Rene Etcheberrigaray National Institute Aging NIA) Telephone: 301-451-9798 Email: rene.etcheberrigaray@nih.gov Martha Flanders National Eye Institute NEI) Telephone: 301-451-2020 E-mail: Martha.flanders@nih.gov Jue Chen 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 National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3532 Email: minnicozzim@niaid.nih.gov Justine Buschman National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: justine.muschman@nih.gov Randy King National Institute Biomedical Imaging Bioengineering NIBIB) Telephone:301-451-4780 E-mail: randy.king@nih.gov Melissa Parisi Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-496-1383 Email: parisima@mail.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 Roger Little National Institute Drug Abuse NIDA) Telephone: 301-435-1315 Email: roger.little@nih.gov Jonathan Hollander National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 E-mail: jonathan.hollander@nih.gov Paula Flicker National Institute General Medical Sciences NIGMS) Telephone: 301-594-0574 Email: flickerp@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 Priscah Mujuru National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-9765 Email: mujurup@nih.gov Hua-Chuan Sim National Library Medicine NLM) Telephone: 301-594-4882 E-mail: simh@mail.nlm.nih.gov Kathleen Michels, Ph.D. Fogarty International Center FIC) Telephone: 301-435-6031 E-mail: michelsk@ficod.fic.nih.gov Dave Clark National Center Complementary Integrative Health NCCIH) Telephone: 301-827-1916 E-mail: dave.clark@nih.gov Oleg Mirochnitchenko Office Research Infrastructure Programs ORIP) Telephone: 301-435-0748 Email: oleg.mirochnitchenko@nih.gov

This initiative will provide two years of support for planning activities necessary for initiating a Phase III clinical trial designed to validate VCID biomarkers and/or treat patients with VCID. The full spectrum of VCID is in scope, and the one or more VCID disorders(s) to be targeted in the trial must be clearly specified in the application, for example (but not limited to): vascular insults including clinical stroke, silent infarcts and microinfarcts, leukoaraiosis, cerebral amyloid angiopathy (CAA), transient ischemic attack (TIA), micro-bleeds, CADASIL, and vascular contributions to Alzheimers dementia. Planning activities may include identifying trial sites/collaborations, designing trial protocols and procedures, and addressing regulatory approvals.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIH Blueprint R25 program is to encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical, behavioral, and clinical research workforce, to pursue further studies or careers in research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on Courses for Skills Development, Research Experiences, and Mentoring Activities. The fully integrated educational activities should prepare undergraduate students from diverse backgrounds, including those from groups underrepresented in biomedical and behavioral sciences to enter Ph.D. degree programs in the neurosciences. To accomplish this goal, this initiative will provide institutional awards to develop neuroscience research education programs comprised of collaborative partnerships integrated across different educational institution types. Each partnership must include: a) one or more institutions that either: 1) have a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or 2) have a documented track record of recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers; b) a research-intensive institution that has an established neuroscience or neuroscience-related program; c) integrated

Notice Special Interest: Advancing Research Tickborne Diseases TBDs) Notice Number: NOT-AI-20-005 Key Dates Release Date: November 12, 2019 First Available Due Date: January 05, 2020 Expiration Date: January 08, 2023 Related Announcements PA-19-055 NIH Research Project Grant Parent R01 Clinical Trial Required) PA-19-056 NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-270 PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Allowed) PA-19-272 PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Allowed) PAR-19-134 Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Allowed) Issued National Institute Allergy Infectious Diseases NIAID ) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Mental Health NIMH ) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH ) Purpose purpose this Notice to announce the National Institute Allergy Infectious Diseases NIAID), National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), National Institute Mental Health NIMH), National Institute Neurological Disorders Stroke NINDS), the National Center Complementary Integrative Health NCCIH) encourage new applications advance research activities relevant the five strategic priorities identified the recently released NIH Strategic Plan Tickborne Disease Research: Improve fundamental knowledge TBDs to understand host, vector, pathogen factors drive TBD pathogenesis transmission. Elucidate host immune mechanisms response and exploited TBD pathogens. Advance research improve diagnosis TBDs using both host- pathogen-targeted approaches, including research rapid diagnostics multiplex platform approaches detect multiple tickborne pathogens. Accelerate research improve TBD prevention by supporting science design, develop, evaluate vaccines, vector control strategies, other prevention approaches. Promote research improve treatment all forms TBDs, including studies develop effective therapies treat symptoms persist after TBD treatment, therapies non-infectious TBDs, new antimicrobials. Support tools resources advance research understanding, preventing, diagnosing, treating TBDs, including repositories, genomic resources, animal models, preclinical services aid development assessment diagnostic, vaccine, therapeutic candidates. NIAID: NIAID support research the biology tickborne pathogens, vectors, animal reservoirs, human hosts, the interactions among elements they help understand underlying causes human disease. NIAID interested applications the basic science behind tickborne infections in applications seeking develop new approaches prevent, diagnose, treat those infections. NIAID also support research non-infectious TBDs, particularly alpha-gal syndrome. focus research this syndrome to understand pathogenesis develop improved diagnostics therapeutic approaches. NIAMS : NIAMS interested supporting research studies human immunity its role the initiation propagation Lyme arthritis. of systems biology approaches identify critical cellular molecular pathways involved pathogenesis encouraged. interests include studies the joint tissue remodeling pathways the cross-talk a wide range hematopoietic other cell types Lyme arthritis. Please note, NIAMS only accepts mechanistic studies meet NIH's definition a clinical trial PA-19-055. NIMH: As lead federal agency research mental disorders, NIMH interested the following areas: Basic mechanistic neuroscience studies persistent effects Lyme disease brain signaling, circuits, proximal effects functional processes such cognition are impaired mental illnesses. Research illuminate mechanisms which tick-borne diseases lead specific psychiatric complications. Research understand neurobiological basis the impact tick-borne diseases specific domains functions relevant mental health, informed the Research Domain Criteria RDoC) approach. Research decrease burden acute chronic psychiatric complications Lyme disease other tick-borne diseases. Please note, NIMH only accepts mechanistic studies meet NIH's definition a clinical trial PA-19-055. NINDS : NINDS interested supporting research the basic biology mechanisms the neurological consequences tick-borne diseases. includes developing animal cell models will facilitate studying nervous system pathogenesis these diseases developing new approaches diagnose treat neurological complications. Please note, NINDS only accepts mechanistic studies meet NIH's definition a clinical trial PA-19-055. NCCIH: NCCIH support research the mechanisms which complementary integrative health approaches improve tick-borne disease TBD) treatment and/or post-TBD symptom care. Complementary integrative approaches include mind/brain-focused practices i.e., meditation, hypnosis), body-based approaches i.e., acupuncture, massage, spinal manipulation), meditative exercise i.e., yoga, tai chi, qi gong), natural products i.e., botanicals, dietary supplements, probiotics), isolation in combination conventional medical treatments. NCCIH not accept clinical trial measures efficacy effectiveness any intervention through NOSI. NCCIH only accepts mechanistic studies meet NIH's definition a clinical trial PA-19-055. Application Submission Information notice applies due dates or after January 5, 2020 subsequent receipt dates through January 8, 2023. Submit applications this initiative using of following funding opportunity announcements FOAs) any reissues these announcement through expiration date this notice. PA-19-055 NIH Research Project Grant Parent R01 Clinical Trial Required) PA-19-056 NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-270 PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Allowed) PA-19-272 PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Allowed) PAR-19-134 Research Enhancement Award Program REAP) Health Professional Schools Graduate Schools R15 Clinical Trial Allowed) instructions the SF424 R&R) Application Guide and funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include ldquo;NOT-AI-20-005” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries to: Samuel Perdue, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3341 E-mail: sperdue@nih.gov Yisong Wang, PhD. National Center Complementary Integrative Health NCCIH) Telephone: 301-480-9483 E-mail: yisong.wang@nih.gov Su-Yau Mao, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: maos2@mail.nih.gov Sarah H. Lisanby, M.D.. National Institute Mental Health NIMH) Telephone: 301-451-3029 Email: lisanbysh@mail.nih.gov Wong, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1431 Email: wongm@ninds.nih.gov

The purpose of the NINDS Postdoctoral Mentored Career Development Award is to support the ability of outstanding, mentored postdoctoral researchers to develop a potentially impactful research project with a comprehensive career development plan that will enable them to launch an independent research program. Candidates are encouraged to apply for support from this NINDS K01 any time between the second through fourth year of cumulative mentored postdoctoral research experience, and may be supported by this NINDS K01 within the first 6 years of cumulative postdoctoral research experience. Because the completion of a strong, well-planned, thorough career development plan, in addition to development of an impactful research project, is a critical aspect of this K01, applications are strongly encouraged early in the postdoctoral eligibility window. By the end of the proposed K01 award period, the candidate should be poised to begin an independent research career with a well-developed, impactful research project and the expertise required to become a leader in the field. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

The purpose of the NINDS Postdoctoral Mentored Career Development Award is to support the ability of outstanding, mentored postdoctoral researchers to develop a potentially impactful research project with a comprehensive career development plan that will enable them to launch an independent research program. Candidates are encouraged to apply for support from this NINDS K01 any time between the second through fourth year of cumulative mentored postdoctoral research experience, and may be supported by this NINDS K01 within the first 6 years of cumulative postdoctoral research experience. Because the completion of a strong, well-planned, thorough career development plan, in addition to development of an impactful research project, is a critical aspect of this K01, applications are strongly encouraged early in the postdoctoral eligibility window. By the end of the proposed K01 award period, the candidate should be poised to begin an independent research career with a well-developed, impactful research project and the expertise required to become a leader in the field. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development.