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Notice of Special Interest: Countermeasures Against Chemical Threats (CounterACT) U54 Centers of Excellence will only support targeted chemical threats of interest

Notice of Special Interest
Monday, January 6, 2020
Thursday, September 10, 2020
U54
NOT-NS-20-031

Funding Opportunity Purpose

Notice Special Interest: Countermeasures Against Chemical Threats CounterACT) U54 Centers Excellence only support targeted chemical threats interest Notice Number: NOT-NS-20-031 Key Dates Release Date: 01/06/2020 First Available Due Date: September 09, 2020 Expiration Date: September 10, 2020 Related Announcements PAR-18-657 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH Countermeasures Against Chemical Threats CounterACT) program supports research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. important component the CounterACT research network the U54 Research Centers Excellence. U54 Centers designed support three more projects scientific cores having unifying well-defined goal problem area research synergistically produce rigorous interdisciplinary research the highest quality. is expectation support interrelated projects collaborating investigators yield results beyond those achievable each project pursued separately without formal interaction among participating investigators. more information the CounterACT Program, please visit our website. view list currently funded projects, please visit our webpage, CounterACT Research Network Funded Investigators. NIH CounterACT program issuing NOSI provide chemical threat agents will supported grant applications the September 9, 2020 receipt date PAR-18-657 U54 Centers Excellence. only chemical agents will supported the U54 program are: Blood/Metabolic Agents: hydrogen cyanide, potassium cyanide sodium cyanide Organophosphorus OP) Chemical Warfare Agents Pesticides Opioids: carfentanil, fentanyl related analogs, NOT-NS-18-019 Pulmonary Agents: chlorine phosgene Vesicants: sulfur mustard lewisite Applicants strongly encouraged contact CounterACT Program Staff listed the parent funding opportunity announcement PAR-18-657) determine their proposed threat agent(s) of interest the NIH CounterACT program. Applications propose research chemical threats are listed above not considered funding. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. Application Submission Information Submit applications this initiative using following funding opportunity announcement through expiration date this notice. PAR-18-657 - Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) notice applies the September 9, 2020 due date PAR-18-657. instructions the SF424 R&R) Application Guide the funding opportunity announcement used submissionmust followed, the following additions funding consideration, applicants must include NOT-NS-20-031” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries the Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

Engineering Next-Generation Human Nervous System Microphysiological Systems (R01 Clinical Trials Not Allowed)

PAR
Friday, January 3, 2020
Sunday, January 8, 2023
R01
PAR-20-055

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages research grant applications directed toward developing next-generation human cell-derived microphysiological systems (MPS) and related assays that replicate complex nervous system architectures and physiology with improved fidelity over current capabilities. Supported projects will be expected to enable future studies of complex nervous system development, function and aging in healthy and disease states.

Engineering Next-Generation Human Nervous System Microphysiological Systems (R21 Clinical Trials Not Allowed)

PAR
Friday, January 3, 2020
Sunday, January 8, 2023
R21
PAR-20-082

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages research grant applications directed toward developing next-generation human cell-derived microphysiological systems (MPS) and related assays that replicate complex nervous system architectures and physiology with improved fidelity over current capabilities. Supported projects will be expected to enable future studies of complex nervous system development, function and aging in healthy and disease states.

BRAIN Initiative: Biology and Biophysics of Neural Stimulation and Recording Technologies (R01 Clinical Trials Optional)

RFA
Thursday, January 2, 2020
Tuesday, October 4, 2022
R01
RFA-NS-20-006

Funding Opportunity Purpose

A central goal of the BRAIN Initiative is to develop new and improved technologies suitable for recording from as well as controlling specified cell types and circuits to modulate and understand function in the central nervous system. In order to accomplish these goals, further information is needed to understand the function of current technologies used for recording or stimulating the nervous system. This RFA accepts grant applications in two related but distinct areas. The first is to systematically characterize, model, and validate the membrane, cellular, circuit, and adaptive-biological responses of neuronal and non-neuronal cells to various types of stimulation technologies. The second is to understand the biological and bioinformatic content of signals recorded from neuronal and non-neuronal cells and circuits. Development of new technologies, therapies and disease models, are outside the scope of this FOA. Activities related to enabling the simultaneous use of multiple recording or stimulation technologies are allowed.

Notice of Special Interest: Administrative Supplements to Promote Research Continuity and Retention of NIH Mentored Career Development (K) Award Recipients and Scholars

Notice of Special Interest
Thursday, January 2, 2020
Monday, March 6, 2023
333
NOT-OD-20-054

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements Promote Research Continuity Retention NIH Mentored Career Development K) Award Recipients Scholars Notice Number: NOT-OD-20-054 Key Dates Release Date: January 2, 2020 First Available Due Date: March 05, 2020 Expiration Date: March 06, 2023 Related Announcements PA-18-591 Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) 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) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose overarching goal this program to support transition retention investigators mentored career development research independence to minimize departures biomedical research workforce this critical juncture. supplement program intended ensure continuity research among recipients mentored career development K) awards providing supplemental research support help sustain investigator’s research during critical life events. supplement be used support additional personnel, computational services, supplies, equipment will promote continuity the career development research project during period which PD/PI experiences critical life events have potential impact research progress potential productivity. Administrative supplements must support work within scope the original project. the purposes this program, childbirth, adoption, primary caregiving responsibilities an ailing spouse, child, partner, a member the immediate family during project period critical life events would qualify consideration. Evidence the circumstance affect advancement the mentored career development award productivity must provided. circumstances which critical life event pending is expected occur during project period, supplement request be submitted advance the event. K awardees are late stage postdoctoral scientists, instructors, early stage faculty recipients the K awards referenced above encouraged apply. retention supplements support first-time NIH R01-Equivalent Awards, companion FOA Budget be eligible, parent award must able receive funds the time the award. administrative supplement budget limited 1 year. application budget cannot exceed maximum direct cost 50,000, applicable F & indirect) cost also requested. Flexible of supplemental funds highly encouraged support successful research within scope the parent project, including supported effort additional personnel, computational services, supplies equipment sustain research the PD/PI the individual K award during critical life event. Eligible Individuals Program Director/Principal Investigator) PD/PIs the following activity codes eligible the award: K01, K07, K08, K22, K23, K25, K38, K43, K76, K99/R00 the mentored K99 portion the K99/R00). Individual(s) must hold active grant, the research proposed the supplement must accomplished within competitive segment the active award. Individuals encouraged work their organizations develop applications support. Application Submission Information Supplement requests must submitted accordance the parent program announcement: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-591or subsequent reissued equivalent. Supplement requests should submitted electronically. process Streamlined Submissions using eRA Commons cannot used this initiative. instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions: Application Due Date(s) – Submission dates vary awarding IC. Table IC-Specific Information Requirements more details. funding consideration, applicants must include NOT-OD-20-054” without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4bwill be considered this initiative. PHS 398 Career Development Award Supplemental Form Candidate Information Goals Career Development attachment: Personal Statement the applicant, including long-term research objectives career goals, justification the supplemental support, a plan return full productivity the end the supplement period. Institutional Commitment Candidate’s Research Career Development attachment: Institutional letter commitment includes details resources mentoring be available the applicant ensure strong productivity the parent grant. letter should also detail institutional commitment the applicant’s return full productivity research career trajectory the end the supplement period. is strongly recommended the applicants contact respective program officers the NIH Institute/Center IC) supporting parent award confirm ahead time the supplement falls within scope the parent award. Further, applicants strongly encouraged notify program contact the IC supporting parent award Table IC-Specific Information Requirements)that request been submitted response this FOA order facilitate efficient processing the request. Administrative Review Process: IC conduct administrative reviews applications submitted their IC separately, will support most meritorious applications submitted consideration, based upon availability funds. Criteria: the work proposed within scope the parent mentored career development award? is progress date the parent mentored career development award? the administrative supplement increase preserve likelihood the project succeed assist K awardee appointee completing research project, transitioning the next career stage? there plan the PD/PI return full productivity the end the supplement period? there strong institutional commitment e.g., protected time, policies, programs, other strategies) ensure the PD/PI maintains his/her research project independent research trajectory? Inquiries Please direct inquiries to: Division Biomedical Research Workforce Office Extramural Research Website: https://researchtraining.nih.gov Email: NIHTrain@mail.nih.gov

White Matter Lesion Etiology of Dementia in the U.S. Including in Health Disparity Populations (U19 Clinical Trial not Allowed)

RFA
Monday, December 30, 2019
Wednesday, July 1, 2020
U19
RFA-NS-20-013

Funding Opportunity Purpose

Despite established associations between white matter lesions and cognitive impairment including dementia, the volume, anatomical location, and other key cellular and molecular characteristics of white matter lesions that are both necessary and sufficient are unknown, as are the comorbid clinical factors that may modify (including protect from) these effects. Therefore, this initiative will support one large prospective clinical research study in the U.S. studying individuals with white matter lesions at risk for cognitive decline to determine the magnitude and anatomical locations that are both necessary and sufficient to cause cognitive impairment and dementia. The study will include health disparities populations, and will examine additional clinical factors and comorbidities that may be effect modifiers of the relationship between white matter lesions and cognitive impairment, including dementia. Clinical trial-ready VCID biomarkers should be utilized, further developed, and/or subject to implementation research in this study. Secondary goals include: identifying clinical and mechanistic targets for future VCID interventional trials; determining interrelationships (cross-sectional and longitudinal) among white matter lesions, cerebro- and cardio-vascular disease and risk factors including dementia-relevant genes. Applicants are encouraged, when scientifically advantageous, to utilize existing resources for VCID and stroke research, e.g. MarkVCID, StrokeNet, Alzheimers Centers, and large NIH funded prospective cohort studies (e.g. Framingham, ARIC, CHS, NOMAS, etc.) as well as other dementia resources.

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 Announcements 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-20-022 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 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 AnnouncementsNOT-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 NOSI) 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 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 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 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 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. INCLUDE website a list of Funding Priorities Institute Center for project, well list of contacts for 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 the SF424 R&R) Application Guide and funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-20-025 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 of contacts for participating NIH Institute Center available the INCLUDE website.  

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