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Notice Special Interest NOSI): Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-024 Key Dates Release Date: December 18, 2019 First Available Due Date: March 23, 2020 Expiration Date: March 24, 2022 Related AnnouncementsNOT-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-20-022 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 PA-18-591,Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) NOT-OD-20-017,Notice Special Interest Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020 Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021 Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022 Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023 Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-025 Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005Transformative 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) Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) 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 Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose Office the Director the National Institutes Health NIH) announces opportunity investigators relevant active NIH-supported grants the participating Institutes listed above submit administrative supplement applications funded projects meet new NIH Down syndrome research objectives related the NIH INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project. Notice soliciting administrative supplements the following mechanismsONLY:R03,R21,R24,P01,P30,P40,P50,P51,U01,U10,U19,U24,U42,U54,UG1,UG3,UL1,U2C,K12, andT32. Background 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 were funded 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. 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). Supplement applications be eligible funding they address or of following components related the INCLUDE Project research objectives: 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 Applications be considered eligible funding they: within scope the active parent award focused DS Propose address of three components listed above likely stimulate additional activity leading progress DS Address priority the IC issued parent award below more information) Supplements existing clinical trials allowed. proposed research must within scope the parent clinical trial the parent clinical trial award must two more budget years remaining the current project period. addition a new clinical trial was a part the parent award not allowed. Supplement requests addressing INCLUDE Components 2 3 should encourage participants DS their caregivers register inDS-Connect: Down Syndrome Registry. INCLUDE website a list ofFunding Priorities Institute Center, well list ofcontactsfor participating NIH Institute Center. Before submitting supplement request, applicants strongly encouraged contact program officer the program contact the Institute Center IC) supporting parent award any questions to discuss whether proposed supplement within scope the parent award, focused the goals the INCLUDE Project consistent IC priorities. Award Project Period be eligible, parent award must active the current fiscal year i.e., parent award received funds the current fiscal year is in extension period), the research proposed the supplement should requested one year. awarding institute consider no-cost extension up an additional year the conclusion the first year. earliest anticipated start date August 2020, August 2021, August 2022. Budget Requests must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant cooperative agreement. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) submitted the awardee institution the parent award. Application Submission Information: Applications response this NOSI must submitted toPA-18-591Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) its subsequent reissued equivalent. instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: order ensure identification, tracking, appropriate review their applications, applicants MUST follow special instructions: Application Due Date(s) March 23, 2020, March 23, 2021, March 23, 2022 5:00 PM local time applicant organization. Applications must include NOT-OD-20-024 the Agency Routing Identifier field Box 4b) the SF424 R&R form. Applications without identifier NOT-OD-20-024) Box 4b not considered this initiative. process Streamlined Submissions using eRA Commons cannot used forPA-18-591. the form package theexistingNIH Grants and/or Cooperative Agreements. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response toNOT-OD-20-024in order facilitate efficient processing the request. Applicant organizations submit than application this NOSI. unique project titles each application ensure our systems treat application a distinct submission. Application budgets must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. application Abstract section should describe proposed supplement, the Research Strategy section should include summary abstract the funded parent award project. Research Strategy should state relevance the parent award the INCLUDE project, articulate component(s) any IC-specific priorities the supplement addressing. Page Limits:NIH consider supplements a Research Strategy ofno than 6 pages, addition the abstract. part the application investigators should submit abstract the proposed research shows relevance DS. Place abstract the Project Summary/Abstract section the SF424 R&R) Form. work include pilot projects resource development. Review Process:Each IC conduct administrative reviews applications their IC separately. Inquiries Please direct inquiries to: Investigators planning submit application response this NOSI strongly encouraged contact discuss proposed research/aims a Program Officer the appropriate Institute Center listed this NOSI well advance the grant receipt date better determine appropriateness interest the awarding ICO. Please direct inquiries the contact the Institute, Center Office supporting parent award indicated the funding page theINCLUDE Project website.

Notice Special Interest NOSI): NIH Research Project Grants Down Syndrome R01) the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-025 Key Dates Release Date: December 18, 2019 First Available Due Date: February 05, 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 ProjectNOT-OD-20-022 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-19-055Research Project Grant Parent R01 Clinical Trial Required) PA-19-056NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required NOT-OD-20-017Notice Special Interest NOSI) Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-024Notice Special Interest: Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project NOT-OD-20-025Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C) Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) 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 Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) 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 purpose this Notice Special Interest NOSI) to support research project grant R01) applications are focused Down syndrome that meet programmatic objectives the INCLUDE Project. Sharing resources effective communication outputs appropriate interest 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 Centeris 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 Down syndrome encouraged promote enrollment research subjects the Down syndrome 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. INCLUDE website a list ofFunding Priorities Institute Centerfor project, well list ofcontactsfor participating NIH Institute Center. Program Directors/Principal Investigators PD/PIs) planning submit applications response this NOSI strongly encouraged contact scientific contacts this NOSI prior submission be advised appropriateness the intended resource research plans this program, competitiveness a potential application, alignment program priorities the INCLUDE initiative. Application Submission Information Notice applies due dates or after February 5, 2020 subsequent receipt dates through September 7, 2022. following Funding Opportunity Announcements FOAs) their reissued equivalents must used submissions this initiative.Although all NIH components indicated above listed Participating Organizations all FOAs listed below, applications this initiative be accepted the participating Institutes Centers NIH. 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-19-091- NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) instructions theSF424 R&R) Application Guideand funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-20-025 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 withdrawn consideration this initiative. Inquiries Please direct inquiries to: 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): Development Animal Models Down Syndrome Related Biological Materials Part the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-017 Key Dates Release Date: December 18, 2019 First Available Due Date: January 27, 2020 Expiration Date: September 09, 2022 Related Announcements NOT-OD-20-024 NOT-OD-20-023 RFA-OD-19-027,Resource-Related Research Projects Development Animal Models Related Materials R24 Clinical Trials Not-Allowed)NOT-OD-20-025 PAR-19-369, Development Animal Models Related Biological Materials Research R21 Clinical Trial Allowed) NOT-OD-20-012, Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) ProjectNOT-OD-20-022 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/p 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 Issued National Institutes Health NIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) 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 common co-occurring conditions also seen the general population while increasing pipeline Down syndrome 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 purpose this Notice Special Interest NOSI) to foster development and improve access animal models Down syndrome related materials information will advance preclinical basic science studies related Down syndrome. Sharing resources effective communication outputs 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). Examples animal models related materials may developed include, are limited to: Animal models studying fundamental biological mechanisms underlying Down syndrome; Genetic resources, antibodies other reagents quantifying characterizing macromolecules cells animal models Down syndrome, systems biology approaches, informatics tools resources, including artificial intelligence, machine learning deep phenotyping tools, generating novel hypotheses improving value animal models Down syndrome research; Complementary approaches the of animals, such animal-tissue-on-chip models, can simulate physiological pathophysiological processes capture complex dynamics interacting molecules, cells, tissues organs outside the whole organism Down syndrome research. Comparison existing Down syndrome animal models best understand health conditions individuals Down Syndrome. While multiple useful animal models available the community, careful comparison their distinct phenotypes critical. example, the mouse strains presently use, penetrance particular phenotypes benefit qualitative quantitative validation. important comparisons include effect background strain colony maintenance the genotype phenotype over time. Development rat, non-rodent vertebrate, nonhuman primate models Down syndrome are better suited answer specific questions concerning complex neurological, behavioral, other phenotypes occur humans Down Syndrome currently available mouse models. INCLUDE project particularly interested development animal models relevance the multiple organ systems affected individuals Down syndrome co-occurring conditions, such neurodevelopment, immune system dysregulation, Alzheimers disease, cancer, cardiovascular disease, autism. Applications supporting R21 exploratory research projects R24 resource-related research projects should directly submitted response this NOSI. Applications R21 awards should describe projects distinct those supported through traditional R01 mechanism. Long-term projects, projects designed increase knowledge a well-established area, not appropriate R21 awards. R21 grant activity intended encourage exploratory research projects foster constant infusion new ideas, techniques, points view Down syndrome-related research. Such projects assess new experimental system propose innovative of existing methodology, system model enhance Down syndrome-related research. studies involve considerable risk may lead a breakthrough Down syndrome research through development novel techniques, reagents, methodologies models. Applications R24 awards should propose development animal models related resources would serve broad areas Down syndrome-related research. R24 grant activity intended encourage resource-related research projects support basic preclinical research providing substantial amount readily available animal-related resources. Animal-related resources include mutant transgenic animals; related biological materials, such nucleic acids, proteins, cell lines, tissues; knowledge an animals genome, life cycle, molecular, cellular physiological phenotypes, behaviors. Program Directors/Principal Investigators PD/PIs) planning submit applications response this NOSI strongly encouraged contact scientific contacts this NOSI prior submission be advised appropriateness the intended resource research plans this program, competitiveness a potential application, alignment program priorities the INCLUDE initiative. Application Submission Information Notice applies due dates or after January 27, 2020 expires September 9, 2022. following funding opportunity announcements FOAs) their reissued equivalents must used submissions this initiative. Activity Code FOA Number Title First Available Due Date R24 RFA-OD-19-027, Resource-Related Research Projects Development Animal Models Related Materials R24 Clinical Trials Not-Allowed) January 27, 2020 R21 PAR-19-369, Development Animal Models Related Biological Materials Research R21 Clinical Trial Allowed) February 16, 2020 instructions theSF424 R&R) Application Guideand funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must includeNOT-OD-20-017in Agency Routing Identifier field Box 4.b) the SF 424 R&R) Form. Applications without information Box 4.b not considered this initiative. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries to: Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: Scientific/Research Contact(s) Charlene Schramm, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301) 401-3793 Email:schrammc@nih.gov Sige Zou, PhD Office Research Infrastructure Programs ORIP) Telephone: 301) 435-0749 Email:zous@mail.nih.gov

Notice Special Interest NOSI): Competitive Supplements/Revisions R01) Available INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) Notice Number: NOT-OD-20-023 Key Dates Release Date: December 18, 2019 First Available Due Date: March 05, 2020 Expiration Date: September 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-20-022 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-19-055 Research Project Grant Parent R01 Clinical Trial Required) PA-19-056 NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091 NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) NOT-OD-20-017Notice Special Interest Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020 Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021 Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022 Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023 Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-024 Notice Special Interest: Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project NOT-OD-20-025 Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004 INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005Transformative 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) Issued Office The Director, National Institutes Health OD) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) 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 Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) National Cancer Institute NCI) 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 Down syndrome 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 availability competitive revision formerly known competitive supplement) applications grantees active Research Project Grants R01) wish either expand scope their grant project focused DS to expand scope a non-DS grant incorporate DS-related research. Sharing resources effective communication outputs the broader communities a high priority the INCLUDE 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 Centeris available theINCLUDE website. 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 Down syndrome encouraged promote enrollment research subjects the Down syndrome 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. further information INCLUDE priorities, resource sharing expectations, participating NIH Institutes Centers, seeFrequently Asked Questions. Application Submission Information Notice applies due dates or after March 5, 2020 subsequent receipt dates through September 7, 2022. Applications this initiative must submitted using of following funding opportunity announcements FOAs) their reissued equivalents.Although all NIH components indicated above listed Participating Organizations all FOAs listed below, applications this initiative be accepted the participating Institutes Centers NIH. 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-19-091 NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) instructions theSF424 R&R) Application Guideand funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must includeNOT-OD-20-023in Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Revision applications must submitted the same project director/principal investigator PD/PI), Contact PD/PI multi-PI grants, listed the current award. Select Revision option Box 8 the SF424 R&R form indicate TYPE APPLICATION, option Increase Award. the Project Summary/Abstract field provide succinct accurate description the work proposedfor revision. not the abstract the parent grant. Applicants must the same budget format i.e. R&R Budget Form PHS 398 Modular Budget Form) thecurrent award. the Introduction Application field the PHS 398 Research Plan form attach one-page Introduction describes nature the revision how will influence specific aims, research design, methods the current grant. body the application should contain sufficient information the original grant application allow evaluation the proposed revision relation the goals the original application. Any budgetary changes the remainder the project period the current grant should discussed the Budget Justification. Revisions not extend beyond term the current award period.Grants their final year the project period the time application receipt not eligible under Notice. 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: Scientific/Research Contact(s) list ofcontacts each participating NIH Institute Center available theINCLUDE website.

This Funding Opportunity Announcement (FOA) invites research applications to elucidate mechanisms of neuroimmune dysfunction caused by HIV-1 and to detect persistent/latent/reactivated HIV using novel imaging/neuroimaging approaches in the central nervous system from anti-retroviral therapy (ART) suppressed individuals. Applications testing a fully conceptualized and hypothesis-based solid premise founded with adequate preliminary data should consider applying to the companion R21 announcement, RFA MH-20-331 . Basic and preclinical research in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged but not required.

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

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.

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 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.

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.