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This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in Down syndrome. The initiative seeks applications that are intended to facilitate Down syndrome research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for Down syndrome and its co-occurring conditions, and to increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with Down syndrome to enable the design of future clinical trials.

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.

Notice Special Interest: Administrative Supplements Research Sex/Gender Influences Admin Supp Clinical Trial Optional) Notice Number: NOT-OD-20-049 Key Dates Release Date: December 12, 2019 First Available Due Date:January 31, 2020 Expiration Date: January 26, 2021 Related Announcements PA-18-591: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued Office Research Women's Health ORWH) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) 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 Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Sexual Gender Minority Research Office SGMRO) Office The Director, National Institutes Health OD) National Cancer Institute NCI) Purpose Office Research Women's Health ORWH) announces availability administrative supplements support research highlighting impact sex gender influences human health illness. Sex gender important considerations many areas research, including basic biological, psychological, social, behavioral studies. continuous interaction between sex gender, human health determined both biology expression gender. most robust experimental designs include consideration both sex gender; therefore, applications proposing investigate influence both sex gender factors highly encouraged. proposed research must address least objective the five strategic goals the 2019-2023Trans-NIH Strategic Plan Women's Health Research"Advancing Science the Health Women". Background Women men characterized both sex gender, highlighted the Institute Medicine IOM) report, Exploring Biological Contributions Human Health: Does Sex Matter?"(IOM Report, 2001). this initiative, ORWH use IOM definitions describe sex gender-based studies: Sex-based studies:Sex the classification living things, generally male female according their reproductive organs functions assigned chromosomal complement. Gender-based studies:Gender refers a person's self-representation male female, how person responded by social institutions based the individual's gender presentation. Gender rooted biology shaped environment experience. Consideration these variables comparisons males females be critical the accurate interpretation, validation, generalization research findings. Sex gender also determine health disease processes differ among women, between women men, inform development testing preventive therapeutic interventions both sexes. Sex-based comparisons research also ensure findings applicable both women men. Specific Areas Research Interest broad range research be appropriate this initiative. Areas interest include study both male female subjects, the comparison their outcomes the following general areas: Preclinical research projects aimed increasing mechanistic understanding sex differences Comparative studies male female cells including stem cells), tissues, organs physiological systems Systems biology e.g., omics") approaches outcomes Bioengineering imaging studies structural and/or functional differences; medical device development implementation, including body armor, assistive exoskeletons, organs tissues chips vivo methods techniques identify fetal sex prior visualization gonads Computational models disease progression, transmission, prevention, treatment, relapse Prenatal, perinatal, postnatal development, both normal abnormal Assessment differences phenotypic characterization risk factors mental disorders; neurobehavioral mechanisms psychopathology; trajectories risk resilience. Neurobiological mechanisms relating alcohol other addictive drugs Sensitivity specificity biomarkers e.g. screening, predisposition/risk assessment, diagnostic, prognostic, predictive, therapeutic) Therapeutic interventions treatment prevention; development drugs/identification targets; Pharmacokinetic/Pharmacodynamic PK/PD) profiles. Examples Pain; Depression; Prescription drug abuse, addictive drugs; Atherothrombosis including coronary, cerebrovascular, peripheral artery diseases; Heart failure; Asthma; Myelodysplasia/myeloproliferative disorders; Insomnia- sleep-related fatigue, depression, stress, suicide; Sleep-disordered breathing. ORWH specifically interested supporting studies related the influence gender human health. Topics interest include, are limited to: influence gender disease incidence, prevention, treatment, relapse Gender roles influencing caretaking responsibilities, effects health, resilience, disease Research considering roles sex gender together the outcome human health Population study examining role gender different cultural, social, ethnic populations Eligibility Only PDs/PIs an active DP1, DP2, DP4, DP5, K08, K23, K76, P01, P20, P30, P40, P41, P50, P51, P60, PM1, R01, R03, R21, R21/R33, R24, R35, R37, R41, R41/R42, R42, R43, R43/R44, R44, RM1, U01, U10, U19, U42, U44, U54, U56, UG1, UG3/UH3, UH2, UH2/UH3, UH3, UM1, UM2 award NIH eligible apply. PDs/PIs encouraged apply electronically. PDs/PIs above-mentioned activity codes must also fulfill the following mandatory requirements, otherwise applications be deemed non-responsive this NOSI. parent peer-reviewed NIH funded grant must at least 16 months active grant support remaining the due date specified this NOSI. No-cost-extension not eligible. Only Sex/Gender Admin. Supp. award permitted a peer-reviewed NIH funded grant one grant cycle. least objective the five strategic goals the 2019-2023Trans-NIH Strategic Plan Women's Health Research"Advancing Science the Health Women"is proposed identified the application. least of threeSex/Gender-basedStudy Typesis proposed: Pre-Clinical ResearchincludesCell line, Primary culture animals, Animal model, Xenograft, non-human primates Clinical ResearchincludesHuman subjects, Human Biospecimens, Primary culture human subjects Both Pre-Clinical Clinical Researchincludesabove mentioned examples both study types, Patients derived xenografts least of threeSex/Gender-based ResearchApproachesis proposed: Add Opposite Sex/Gender:The addition animal human subjects, tissues cells the sex opposite those used the parent grant allow sex/gender-based comparisons.Applicants should discuss measures ensure comparability new data data already collected under parent grant. Increase Sample Size:The addition more animal human subjects, tissues cells a sample already includes both males females increase power a study analyze a sex/gender difference.Applicants should discuss methods used ensure control potential cohort differences related the new data compared data already collected. Analyze Existing Data:Comparative analyses existing samples/datasets/databases and/or data-mining investigate role sex/gender.Applicants should explain the proposed experiments analyses complement, without expanding scope the funded grant. Foreign Institutions: Non-domestic non-U.S.) Entities Foreign Institutions)are noteligible apply. Non-domestic non-U.S.) components U.S. Organizationsare noteligible apply. Foreign components, asdefined the NIH Grants Policy Statement,areallowed. Budget ORWH intends commit to 1 million per year award to 10 applications. Application budget limited one year only. Application budget cannot exceed maximum direct cost 100,000. addition the direct cost, applicable F&A indirect) cost also requested. Supplements provide support above dollar limits the funding opportunity announcement the parent grant award. Earliest start date July/August 2020 July/August 2021 Scientific Review Process NIH program staff conduct administrative reviews submitted applications will support most meritorious applications submitted consideration, pending availability funds. Application Submission Information process streamlined submissions using eRA Commons cannot used this initiative. Applications this initiative must submitted using following opportunity:PA-18-591- Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Continuous Submission not permitted. other words, late applications be accepted. instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: Application Due Date(s) - January 31, 2020 January 25, 2021, 5:00 PM local time applicant organization funding consideration, applicants must include NOT-OD-20-049 without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Research Strategy section the application limited parent application pages. is strongly recommended the applicant contact respective program officers the Institute supporting parent award confirm ahead time the supplement falls within scope the parent award. Following submission, applicants strongly encouraged notify program contact the IC supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Inquiries Please direct inquiries to: Rajeev K. Agarwal, Ph.D. Office Research Womens Health ORWH) Telephone: 301-451-7058 Email:Rajeev.Agarwal@nih.gov

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project Transformative Research Award supports individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research with the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies. Applications from individuals with diverse backgrounds and in any topic relevant to Down syndrome research are welcome. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in research related to Down syndrome.

This Funding Opportunity Announcement (FOA) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this FOA may not exceed five years. This FOA provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition of up to four years of expanded clinical trial support (R33), although the total duration of the award may not exceed five years. This FOA requires measurable R61 milestones.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This FOA is intended to support meritorious small research projects focused on analyses of genomic and other -omics datasets related to Down syndrome research, with an emphasis on elucidating the underlying etiologies of risk and resiliencies to co-occurring health conditions. Development of approaches, tools, or algorithms appropriate for analyzing data relevant to Down syndrome may also be proposed.

Notice Special Interest: Research the Health Women Understudied, Underrepresented Underreported U3) Populations Admin Supp Clinical Trial Optional) Notice Number: NOT-OD-20-048 Key Dates Release Date: December 13, 2019 First Available Due Date: January 28, 2020 Expiration Date: January 26, 2021 Related Announcements NOT-OD-20-156 PA-18-591: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued Office Research Women's Health ORWH) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) 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 Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Sexual Gender Minority Research Office SGMRO) Office The Director, National Institutes Health OD) National Cancer Institute NCI) National Institute Arthritis Musculoskeletal Skin ( NIAMS ) New participating organization of 06/082020 due dates on/after 06/08/2020 Purpose Office Research Women's Health ORWH) announces availability administrative supplements support research highlighting health disparities among women the US are underrepresented, understudied, underreported U3) biomedical research. proposed research must address least objective the strategic goals 1, 2, 3 the 2019-2023 Trans-NIH Strategic Plan Women's Health Research "Advancing Science the Health Women." Background NIH encourages supports biomedical research serves entirety the population women the US. However, is disproportionate burden disease exists a significant subpopulation women, including racial ethnic minorities, immigrants, those living poverty, those both rural urban areas. subpopulations diverse are mutually exclusive. Women girls these subpopulations bear disproportionate burden health risks conditions compared the general US population are often underrepresented understudied clinical biomedical research underreported surveillance data. Similarly, women physical, intellectual, developmental, sensory disabilities also often underrepresented biomedical research. women not well represented clinical research subsequent interventions not relevant the health women https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425923/ Understudied underreported subpopulations represent increasing percentage the US population bear disproportionate burden health risk, poorer health, disease prevalence. 2014 ORWH published Women Color Health Data Book, 4th edition" https://orwh.od.nih.gov/sites/orwh/files/docs/WoC-Databook-FINAL.pdf), consists US Government sourced, population-based health disease data highlights health disparities. Additionally, women a sexual minority including not limited transgender intersex women) often underrepresented biomedical research well in data reporting, failing unique opportunities learn about only differences among men women, also effects the hormonal milieu differs that expected based upon biologic sex alone. health women affected a multitude factors acting across life course. complex intersection these internal e.g., genetics) external e.g., social determinates) factors play crucial role the health status, disease presentations, treatment responses women well the effects diseases conditions women's quality life. Thus, consideration a multidimensional framework Schweinhart Clayton, 2018) needed improve quality women's lives, reduce disease burden across life course, address health disparities populations women most considerable risk certain diseases. Interdisciplinary research initiatives integrating perspectives multiple disciplines—as well researchers diverse skills, knowledge, experiences—are crucial capturing complex interplay various factors affecting health all women. Therefore, NOSI encourages research emerging topics include collaborations across range disciplines including not limited economics, medical anthropology, psychology, sociology, demography address areas the fuller context women's lives the underlying common root causes poorer health outcomes. Specific Areas Research Interest NOSI support projects highlight common sources disparities women's health. common pathways the manifestations ill health disease, differential risk, risk exposure, resilience, morbidity, mortality the individual, community, national levels areas particular research interest. NOSI provides following descriptions the applicants consider: Primary secondary data analysis reporting sex gender-based data, race ethnicity data, their intersection clinical research, including subgroup analyses existing data examine clinical differences among women diverse racial ethnic backgrounds, women sexual gender minority, women physical, intellectual developmental, and/or sensory disabilities. Identify evidence-based methods intervention reaching to women girls are under-represented the proposed study describe why selected methodology appropriate the project. Develop new effective statistical methods, sampling techniques small study sample include understudied underreported sub-population groups women, applicable. Identify process novel dissemination implementation approaches currently previously implemented the field identified the scientific literature. Areas scientific interest include are limited the study subjects U3 populations, the comparison their outcomes the following general areas: Sensitivity specificity biomarkers, screening, diagnosis disease risk, prognosis, benefit treatment. effect violence, including intimate partner violence across lifespan, including elder abuse, abuse during pregnancy, its subsequent impact upon infant/child. Evidence-based interventions improve outcomes women have experienced gender-based violence. role limited access health care care-seeking behavior outcomes geographically isolated populations understudied underrepresented women. Factors contributing disparities reproductive health and/or gynecologic conditions, their impact risk factors, diagnosis, treatments, health outcomes. Maternal morbidity mortality including effect maternal morbidities health conditions throughout women’s life course. Chronic diseases demonstrate health disparities specific communities women. Exposure assessments disease outcomes understudied women. Disparities economic hardship e.g., low socioeconomic status) its effect the risk disease e.g., epigenetic), disease development e.g., lack safe open spaces activity the development obesity; mental physical consequences early genital trauma), premature aging, increased morbidity mortality. Interdisciplinary transdisciplinary areas scientific interest include are limited to: Studies explore intersections social determinants such education, socioeconomic status, culture, built environment health outcomes, risk poor health outcomes diverse populations women; women suffering intellectual developmental disabilities. Studies will fill the gap focusing inclusion critical subpopulation women do reside households, e.g., homeless, institutionalized, incarcerated, ensure gaps surveillance addressed through research program. Studies encompass our understanding the mutable causes disparities HIV risk, presentation care, care engagement, linkage care, treatment adherence female, transgender, intersex individuals across lifespan. Studies foster our understanding the influence alone in combination exogenous factors such stigma, racism, classicism, residential segregation, historical trauma examples) risk disease, disease progression, health care engagement, retention, disease morbidity mortality. Eligibility Only PDs/PIs an active P01, P20, P30, P50, P60, P2C, S06, U10, U19, U2C, U54, UC2, UM2, R01, R15, R21, R24, R25, R33, R34, R35, RC4, S11, U01, UM1, UP5 award NIH eligible apply. PDs/PIs encouraged apply electronically. PDs/PIs the activity, mentioned above, must also fulfill the following mandatory requirements; otherwise, applications not responsive this NOSI. should 16 months remaining the project period the parent grant. no-cost extension not eligible. Only U3 Admin. Supp. Award permitted a peer-reviewed NIH funded grant one grant cycle. proposed research must address least objective the strategic goals 1, 2, 3 the 2019-2023 Trans-NIH Strategic Plan Women's Health Research "Advancing Science the Health Women." Foreign Institutions: Non-domestic non-U.S.) Entities Foreign Institutions) are not eligible apply. Non-domestic non-U.S.) components US Organizations are not eligible apply. Foreign components, as defined the NIH Grants Policy Statement, are allowed. Budget 2,000,000 expected be available annually funding program. budget should exceed 140,000 direct costs the administrative supplement per year. addition the direct cost, applicable F&A indirect) cost also requested. application budget limited one year only. Supplements provide support above dollar limits the funding opportunity announcement the parent grant award. Earliest start date – July/August 2020 July/August 2021 Scientific Review Process NIH program staff conduct administrative reviews submitted applications will support most meritorious applications submitted consideration, pending availability funds. Scope Support Administrative supplements be used meet increased costs are within scope the approved award, that unforeseen the new renewal application grant progress report non-competing continuation support submitted. Applicants should propose research that, successful, contribute a greater understanding the health wellbeing underrepresented, understudied, unreported women the US population. IC-Specific Considerations is strongly recommended the applicant contact respective program officers the Institute supporting parent award confirm ahead time the supplement falls within scope the parent award. Application Submission Information PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Application Due Date(s) – January 28, 2020, January 21, 2021, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-OD-20-048 the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests must for year support only. Research Strategy section the application limited 6 pages. process Streamlined Submissions using eRA Commons cannot used this initiative. Continuous submission not permitted. other words, late applications be accepted. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this NOSI facilitate efficient processing the application.   Inquiries Please direct inquiries to: Rajasri Roy Ph.D., MPH Office Research Women's Health ORWH) Telephone: 301-451-0993 Email: rajasri.roy@nih.gov

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): 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 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.