Notice Availability Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Administrative Supplement/ Clinical Trial Optional) Notice Number: NOT-OD-19-087 Key Dates Release Date: March 27, 2019 Related Announcements PA-18-591 NOT-OD-19-071NOT-OD-20-012> RFA-OD-19-015 RFA-OD-19-016 RFA-OD-19-018 Issued National Institutes Health NIH) National Cancer Institute NCI) National Eye Institute NEI) 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 Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Office Strategic Coordination Common Fund) Purpose National Institutes Health Office the Director announces opportunity investigators relevant active NIH-supported research project 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
https://www.nih.gov/include-project). notice soliciting administrative supplements the following mechanisms ONLY: Resource-Related Research Projects R24), Research Program Projects Centers P01, P30, P50) cooperative agreements U10, U19, U24, U54, UG1, UG3, UL1 ) Resource-Related Research Multi-Component Projects Centers Cooperative Agreements U2C), training programs T32). Down syndrome the most common genetic cause intellectual disability, most common autosomal trisomy, one the most visible universally recognized genetic syndromes. year are approximately 5300 babies born the United States Down syndrome. Within past 25 years, average lifespan a person Down syndrome doubled, 30 60 years. While people Down syndrome connected the common feature a complete partial copy chromosome 21 trisomy 21), are significant physical cognitive differences among them, indicating inter-individual variability exists. this notice, NIH continuing support a program research Down syndrome initiated FY2018 support research commonly co-occurring conditions individuals Down syndrome are also seen the general population, such Alzheimers disease/dementia, autism, cataracts, celiac disease, congenital heart disease diabetes. is known the INCLUDE Project (INvestigation Co-occurring conditions across Lifespan Understand Down syndromE). Information learned studying people Down syndrome also help us learn these conditions people without Down syndrome. Likewise, common complications aging, such coronary heart disease solid cancers, rarely seen individuals Down syndrome; warrants additional study. new research initiative expands of research objectives opportunities previously highlighted the 2014 Down Syndrome Directions: NIH Research Plan Down Syndrome. recent discoveries enhanced our understanding chromosome segregation chromosome silencing, identified certain proteins neurotropic factors involved brain development using mouse models, uncovered role interferons immune dysregulation, of have potential lead development novel therapies individuals Down syndrome, well broader applications. People Down syndrome often excluded clinical research, such trials potentially beneficial drugs therapeutics are used treat same condition the general population. is great value connecting people Down syndrome therapies could improve overall health quality life. there great interest the Down syndrome community participating clinical research, based experience NICHDs DS-Connect®: Down Syndrome Registry®,
https://DSConnect.nih.gov), online survey tool introduces individuals Down syndrome their families research opportunities. comprehensive clinical cohort study deep phenotyping exploration pan-omics permit identification biomarkers outcomes the co-occurring conditions Down syndrome. Coupled development a clinical trials readiness program, informed basic science discoveries, combination resources have great impact addressing health disparities exist people Down syndrome could also lead the development therapies improve outcomes those and without condition. Supplement applications be considered eligible funding they address or of following components related the INCLUDE Project research objectives: Component 1: Targeted, high risk-high reward, basic science studies Down syndrome: basic science studies, supplements should target areas science highest impact. Topics emphasis include: chromosome silencing, immune system dysregulation, epigenetic/metabolomic/transcriptomic profiling model organisms/iPSCs/brain organoids, development novel model systems, development a molecular atlas cardiac other specimens. Supplements also support projects will inform other components, namely cohort study a clinical trials network. Component 2: Molecular snapshot Down syndrome through cohort study: goal to add or expand existing Down syndrome cohort, data collected a shared database using common data elements building the DS-Connect® patient registry. Supplements add comprehensive molecular i.e., pan-omics) analyses existing Down syndrome cohorts support existing infrastructure sample neuroimaging collection the Down syndrome population. Component 3: Inclusive clinical research individuals Down syndrome: Supplement requests leverage existing clinical trials infrastructure expand extend existing DS cohort a currently funded trial build component(s) an existing clinical trials infrastructure includes Down syndrome could expanded accommodate additional Down syndrome clinical trials the future. Applications be considered eligible funding they: within scope the active parent award focused Down syndrome Propose address of components listed under Down syndrome research objectives likely stimulate additional activity leading progress Down syndrome Address priority the IC issued parent award applicable--see below) Investigators should submit applications responses the parent active administrative supplement PA, Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional):
https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html 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 components 2 3 should encourage participants Down syndrome their caregivers register DS-Connect®: Down Syndrome Registry
https://DSConnect.nih.gov). Before submitting supplement request, principal investigators strongly encouraged contact program officer the program contact the Institute, Center Office supporting parent award any questions to discuss whether proposed supplement within scope the parent award, focused the goals the INCLUDE Project consistent the priorities the IC supporting parent award. Award Project Period be eligible, parent award must active FY19 i.e., parent award received funds FY19 is in extension period), the research proposed the supplement should requested 1 year. awarding institute consider no-cost extension up an additional year the conclusion the first year. earliest anticipated start date August 1, 2019. Budget 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 listed below prior submission. Requests must reflect actual needs the proposed project. Modular categorical budgets permitted. 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. Submitting Application order ensure identification, tracking, appropriate review their applications, applicants MUST follow special instructions Applications must be submitted electronically through NIH ASSIST module, institutional system-to-system S2S) solution, Grants.gov Workspace, must include"NOT-OD-19-087" without quotation marks) the Agency Routing Identifier field Box 4B) the SF424 R&R form. Applications without identifier Box 4B not considered this special initiative. multi-component awards, administrative supplements should prepared a single project using FORMS-E-ADMINISUPP RESEARCH project. T32 awards should FORMS-E-ADMINISUPP TRAINING. addition, applicants strongly encouraged notify Program contact the Institute is supporting parent award list below) an application been submitted response this Notice order facilitate efficient processing the request. 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. additional information, the parent program announcement Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-591. Page Limits: NIH consider supplements a Research Strategy of no than 6 pages, addition the abstract. Requests must received 5:00 PM Pacific Daylight Time P.D.T.) May 24 , 2019 funding FY 2019. Frequently Asked Questions FAQs) listed the INCLUDE website information specific scientific priorities program contacts the NIH participating ICs
https://www.nih.gov/include-project). Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award: Malcolm A. Smith, MD, PhD National Cancer Institute NCI) Telephone: 240-276-6087 Email:
Malcolm.Smith@nih.gov Houmam Araj, PhD National Eye Institute NEI) Telephone: 301-451-2020 Email:
arajh@nei.nih.gov Charlene Schramm, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-402-3793 Email:
SchrammC@nhlbi.nih.gov Joy T. Boyer, BA National Human Genome Research Institute NHGRI) Telephone: 301-480-2247 Email:
jb40m@nih.gov Laurie M. Ryan, PhD National Institute Aging NIA) Telephone: 301-496-9350 Email:
ryanl@mail.nih.gov Frosso Voulgaropoulou, PhD National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3205 Email:
fvoulgaropoulou@niaid.nih.gov Marie Mancini, PhD National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email:
mancinim2@mail.nih.gov Melissa A. Parisi, MD, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6880 Email:
parisima@mail.nih.gov Kelly King, PhD National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-402-3458 Email:
kingke@nidcd.nih.gov Jonathan A. Hollander, PhD National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 Email:
jonathan.hollander@nih.gov Donna Krasnewich, MD, PhD National Institute General Medical Sciences NIGMS) Email:
dkras@nigms.nih.gov Robert Riddle, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email:
rr260c@nih.gov Rebekah S. Rasooly, PhD National Institute Nursing Research NINR) Telephone: 301-827-2599 Email:
rr185i@nih.gov Erica Rosemond, Ph.D National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8927 Email:
rosemonde@mail.nih.gov Robin Boineau, MD, MA National Center Complementary Integrative Health NCCIH) Telephone: 301-435-6286 Email:
Robin.Boineau@nih.gov Sige Zou, PhD Office Research Infrastructure Programs ORIP) Telephone: 301-435-0749 Email:
sige.zou@nih.gov Concepcion Marie) Nierras, PhD Office Strategic Coordination Common Fund) Telephone: 301-435-5840 Email:
concepcion.nierras@nih.gov