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Notice of Special Interest (NOSI): Understanding Sudden Death in the Young Through Research

Notice of Special Interest
Monday, June 29, 2020
Sunday, January 8, 2023
R01
NOT-HL-20-787
Vicky Whittemore

Funding Opportunity Purpose

Notice Special Interest NOSI): Understanding Sudden Death the Young Through Research Notice Number: NOT-HL-20-787 Key Dates Release Date: June 29, 2020 First Available Due Date: October 05, 2020 Expiration Date: January 08, 2023 Related Announcements PA-20-185 - NIH Research Project Grant Parent R01 Clinical Trial Allowed) Issued National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) Purpose Notice Special Interest NOSI) highlights interest receiving grant applications focused mechanistic, genetic, other studies evaluate causes consequences and risk factors sudden death the young. Studies required use data DNA samples, associated sequence data the NIH/CDC Sudden Death the Young SDY) Case Registry foundations their research. Results such studies expected be disseminated widely to provide evidence base advance discussions screening prevention SDY. sudden, unexpected loss a child a tragic event significant impact families communities. Sudden Death the Young SDY) Case Registry sdyregistry.org) a unique collaboration between National Institutes Health NHLBI NINDS) the Centers Disease Control Prevention CDC). was designed address critical knowledge gaps the epidemiology causes SDY to develop resource research will enhance evidence base inform prevention efforts. Fundamental gaps knowledge incidence, mechanisms, risk factors SDY limit identification effective prevention efforts. the majority SDY cases, after autopsy investigation, cause cannot identified. deaths where cause be identified, sudden, unexpected, non-injury-related infant child deaths often due cardiac causes myocarditis, cardiomyopathy, coronary artery anomalies, ion channelopathies), respiratory causes asthma, pneumonia), sudden unexpected death epilepsy SUDEP), various infections, neurological, hematologic, gastrointestinal catastrophes. Because the high number unexplained deaths the lack evidence regarding cause(s), is disagreement the best approach prevent SDY. SDY Case Registry the associated research efforts should help close knowledge gaps provide foundation data can used inform targeted prevention efforts. SDY Case Registry first funded 2013 address critical knowledge gaps the epidemiology etiologies SDY. CDC leading population-based surveillance efforts identify 100% cases SDY funded states/jurisdictions the SDY Case Registry. do this, provide technical assistance states/jurisdictions increase case ascertainment ensure consistent categorization cases. Support NHLBI NINDS focused developing resource research SDY ensuring collection a comprehensive battery phenotypic data elements collection DNA samples enable genomic analysis. Detailed phenotyping performed cases sudden cardiac death the young SCDY), unexplained infant child death, sudden unexpected death epilepsy SUDEP), limited data gathered other explained SDY cases. SDY Case Registry one the largest population-based cohorts children have died suddenly the US, including over 3000 SDY cases date. SDY Case Registry’s 13 states/jurisdictions include approximately 20% SDYs the US. population infants children the states/jurisdictions funded the SDY Case Registry 23% black. Ethnicity data not available all jurisdictions, the funded states include 14% Hispanic/Latino infants children. Data be used explore causes SCDY well SUDEP, sudden unexpected infant death SUID), other causes pediatric sudden death. Inclusion criteria infants children to age 20 die suddenly unexpectedly. Homicide, suicide, intentional overdose obvious injury-related deaths excluded. Data gathered symptoms, activity/exercise, previous diagnoses, medications, treatments, seizures, family history, resuscitation. Cases categorized cause state/local experts cardiology, neurology pathology, and, after informed consent surviving family members, blood/tissue collected DNA extraction stored the biorepository the University Michigan enable research. consent allows use the child’s DNA sample research, access the autopsy report, re-contact return results discussions future research opportunities. addition, families given option consent re-contact investigators the purposes obtaining additional information returning clinically actionable results. Consent been obtained research approximately 250 cases date, whole genome sequencing been performed 200 cases thus far. Sequence data be available investigators through NIH data repositories dbGAP). Controls not included the Registry must sought elsewhere. State public health agencies their bona fide agents) participating the SDY Case Registry proprietary rights over data enter the Registry; however, under specific agreement, data individual states combined a single de-identified dataset. SDY Case Registry’s Data Coordinating Center the Michigan Public Health Institute facilitate initiation data agreements between investigators state public health agencies access dataset. SDY Case Registry’s Data Coordinating Center DCC) the Michigan Public Health Institute funded separately via contract an Interagency Agreement between NIH CDC. DCC provides administrative support the SDY Case Registry, creates case report forms phenotypic data, develops consent forms participation the Registry, maintains SDY database, subcontracts a biorepository the University Michigan DNA extraction storage samples. DCC works closely research teams establish data agreements the SDY Case Registry data collection sites state public health agencies their bona fide agents) access phenotypic data DNA samples study. DCC does provide statistical support conduct data analysis each funded research project. Rather, facilitate access the data act liaisons between investigators the jurisdictions collect data. Selected Research Examples Research questions interest include, are limited the following: is prevalence ion channel mutations other candidate genes known be associated arrhythmias cases compared controls? is prevalence ion channel mutations other candidate genes known be associated the epilepsies cases compared controls, compared cases sudden cardiac death the young? do ion channel mutations differ between SUID cases cases sudden death older children? competitive athletics risk factor sudden cardiac death the young? there diurnal variations sudden cardiac death the young, is case some cardiovascular conditions adults? there risk factors SUDEP are associated the sleep setting and/or time death? there significant environmental contextual differences between cases controls, such socioeconomic status, history drug exposure, serum toxicology screens, family history, other factors? is yield molecular autopsy defined postmortem molecular, typically genetic diagnosis) autopsy-negative cases SDY? machine learning complex genetic models used identified novel SDY risk genes? Applications seek determine incidence SDY outside scope this NOSI, be considered non-responsive, will be considered under NOSI. CDC, NHLBI, NINDS SDY Case Registry Steering Committee be responsible evaluating incidence. Application Submission Information notice applies due dates or after October 5, 2020 subsequent receipt dates through January 8, 2023. Submit applications this initiative using following funding opportunity announcement FOA) any reissues this announcement through expiration date this notice PA-20-185 NIH Research Project Grant Parent R01 Clinical Trial Allowed) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-HL-20-787” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive terms this NOSI will not 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) Kristin M. Burns, MD National Heart, Lung, Blood Institute Telephone: 301-594-6859 Email: kristin.burns@nih.gov Vicky Whittemore, PhD National Institute Neurological Disorders Stroke Telephone: 301-594-8909 Email: vicky.whittemore@nih.gov Peer Review Contact(s) Examine eRA Commons account review assignment contact information information appears weeks after submission due date). Financial/Grants Management Contact(s) Judy Sint National Heart, Lung, Blood Institute Telephone: 301-480-1307 Email: sintj@mail.nih.gov

Notice of Special Interest (NOSI): Availability of Administrative Supplements for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project

Notice of Special Interest
Wednesday, December 18, 2019
Thursday, March 24, 2022
333
NOT-OD-20-024

Funding Opportunity Purpose

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-20-004 INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) 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) 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 mechanisms ONLY: R03, R21, R24, P01, P30, P40, P50, P51, U01, U10, U19, U24, U42, U54, UG1, UG3, UL1, U2C, K12, and T32. 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 Project Research Plan, available the INCLUDE 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 Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s 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 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). 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 in DS-Connect®: Down Syndrome Registry. INCLUDE website a list of Funding Priorities Institute Center , well list of contacts for 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 to PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) its subsequent reissued equivalent. instructions the SF424 R&R) Application Guide and PA-18-591 must 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 for PA-18-591. the form package the existing NIH Grants and/or Cooperative Agreements. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response to NOT-OD-20-024 in 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 of no 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 the INCLUDE Project website.

Notice of Special Interest (NOSI): Competitive Supplements/Revisions (R01) Available for INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project (Competitive Supplement/Revision Clinical Trial Optional)

Notice of Special Interest
Wednesday, December 18, 2019
Thursday, September 8, 2022
R01
NOT-OD-20-023

Funding Opportunity Purpose

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-20-012 Notice 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-20-017 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-20-024 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-20-005 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) 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 were funded in 2018 2019, well the INCLUDE Project Research Plan, available the INCLUDE 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 Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s 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 of Funding Priorities Institute Center is available the INCLUDE website. Applications response this NOSI should aligned the overall INCLUDE Project Research 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 describing Common Data Elements may 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, see Frequently 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 the SF424 R&R) Application Guide and funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-20-023 in 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 proposed for revision. not the abstract the parent grant. Applicants must the same budget format i.e. R&R Budget Form PHS 398 Modular Budget Form) the current 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 of contacts each participating NIH Institute Center available the INCLUDE website.    

Notice of Special Interest (NOSI): Development of Animal Models of Down Syndrome and Related Biological Materials as Part of the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project

Notice of Special Interest
Wednesday, December 18, 2019
Friday, September 9, 2022
NOT-OD-20-017

Funding Opportunity Purpose

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 were funded in 2018 2019, well the INCLUDE Project Research Plan, available the INCLUDE 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 Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s 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 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). 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, Alzheimer’s 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 animal’s 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 the SF424 R&R) Application Guide and funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-20-017 in 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 of Special Interest (NOSI): NIH Research Project Grants on Down Syndrome (R01) for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project

Notice of Special Interest
Wednesday, December 18, 2019
Saturday, January 8, 2022
R01
NOT-OD-20-025

Funding Opportunity Purpose

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 of Special Interest (NOSI): Mentored Career Development Awards to Foster the Careers of Investigators Pursuing Research Related to Down syndrome as Part of the INCLUDE Project

Notice of Special Interest
Friday, December 6, 2019
Saturday, January 8, 2022
NOT-OD-20-021

Funding Opportunity Purpose

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-19-126 Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Allowed) PA-19-127 Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Required) PA-19-084 Mentored Research Scientist Development Award Parent K01 Independent Basic Experimental Studies Humans Required) PA-19-116 Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Required) PA-19-117 Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Allowed) PA-19-086 Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Basic Experimental Studies Humans Required) PA-19-118 Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Clinical Trial Required) PA-19-119 Mentored Patient-Oriented Research Career Development Award Parent K23 – Independent Clinical Trial Allowed) PA-19-087 Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Basic Experimental Studies Humans Required) PA-19-129 NIH Pathway Independence Award Parent K99/R00 Independent Clinical Trial Required) PA-19-130 NIH Pathway Independence Award Parent K99/R00 - Independent Clinical Trial Allowed) PA-19-090 NIH 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 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 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 were funded in 2018 2019, well the INCLUDE Project Research Plan, available the INCLUDE 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 Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s 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 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 of Funding Priorities Institute Center for project available the INCLUDE website. Applications response this NOSI should aligned the overall INCLUDE Project Research 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 describing Common Data Elements may 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-19-126 Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Allowed) Feb 12, 2020 K01 PA-19-127 Mentored Research Scientist Development Award Parent K01 - Independent Clinical Trial Required) Feb 12, 2020 K01 PA-19-084 Mentored Research Scientist Development Award Parent K01 Independent Basic Experimental Studies Humans Required) Feb 12, 2020 K08 PA-19-116 Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Required) Feb 12, 2020 K08 PA-19-117 Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Clinical Trial Allowed) Feb 12, 2020 K08 PA-19-086 Mentored Clinical Scientist Research Career Development Award Parent K08 Independent Basic Experimental Studies Humans Required) Feb 12, 2020 K23 PA-19-118 Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Clinical Trial Required) Feb 12, 2020 K23 PA-19-119 Mentored Patient-Oriented Research Career Development Award Parent K23 – Independent Clinical Trial Allowed) Feb 12, 2020 K23 PA-19-087 Mentored Patient-Oriented Research Career Development Award Parent K23 Independent Basic Experimental Studies Humans Required) Feb 12, 2020 K99/R00 PA-19-129 NIH Pathway Independence Award Parent K99/R00 Independent Clinical Trial Required) Feb 12, 2020 K99/R00 PA-19-130 NIH Pathway Independence Award Parent K99/R00 - Independent Clinical Trial Allowed) Feb 12, 2020 K99/R00 PA-19-090 NIH Pathway Independence Award Parent K99/R00 Independent Basic Experimental Studies Humans Required Feb 12, 2020 instructions the SF424 R&R) Application Guide and listed funding opportunity announcements must followed, the following additions: funding consideration, applicants must include NOT-OD-20-021 in 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 of contacts for participating NIH Institute Center available the INCLUDE website.    

Notice of Special Interest (NOSI): Ruth L. Kirschstein National Research Service Award (NRSA) Fellowship Awards to Support Training in Research Related to Down Syndrome as Part of the INCLUDE Project

Notice of Special Interest
Friday, December 6, 2019
Saturday, January 8, 2022
NOT-OD-20-020

Funding Opportunity Purpose

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-20-012 Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-19-191 Ruth L. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-192 Ruth L. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-195 Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Parent F31) PA-19-196 Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Promote Diversity Health-Related Research Parent F31 - Diversity) PA-19-188 Ruth 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 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 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 were funded in 2018 2019, well the INCLUDE Project Research Plan?, available the INCLUDE 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 Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s 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 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 of Funding Priorities Institute Center for project available the INCLUDE website. Applications response this NOSI should aligned the overall INCLUDE Project Research 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 describing Common Data Elements may 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-19-191 Ruth L. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-192 Ruth L. Kirschstein National Research Service Award NRSA) Individual Fellowship Students Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs Parent F30) PA-19-195 Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Parent F31) PA-19-196 Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral Fellowship Promote Diversity Health-Related Research Parent F31 - Diversity) PA-19-188 Ruth L. Kirschstein National Research Service Award NRSA) Individual Postdoctoral Fellowship Parent F32) instructions the SF424 R&R) Application Guide and listed funding opportunity announcements must followed, the following addition: funding consideration, applicants must include NOT-OD-20-020 in 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 of contacts for participating NIH Institute Center available the INCLUDE website.