FOA Title: 
Notice of Special Interest (NOSI): Administrative Supplements to NCATS CTSA Program KL2 Institutional Career Development Awards as part of the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndrome) Project
Grant Type: 
NOT-OD-20-022
Primary IC: 
NIH
Release Date: 
Dec 20 2019
Expiration Date: 
N/A
AC Source: 
N/A
Purpose: 
Notice Special Interest NOSI): Administrative Supplements NCATS CTSA Program KL2 Institutional Career Development Awards part the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project Notice Number: NOT-OD-20-022 Key Dates Release Date: December 19, 2019 First Available Due Date: March 02, 2020 Expiration Date: March 03, 2020 Related Announcements 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-20-024 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 Center Advancing Translational Sciences NCATS) 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 career development research experiences , 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 of appropriate interest to broader communities a high priority the INCLUDE Project. Applicants responding this NOSI are strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches(see Goal 3, NIH Strategic Plan Data Science). NIH issuing NOSI expand community investigators conducting research related DS encouraging CTSAs recruit scientists physicians early their research careers develop research projects related co-occurring conditions associated DS. This NOSI support additional scholar slots those KL2 grants currently approved under CTSA Program. 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 DS 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: 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: funding consideration, applicants must include NOT-OD-20-022 the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. supplement must comply all the parent FOA requirements the KL2 program. Requests be a minimum two years a maximum four years consecutive funding each scholar, consisting 12-month appointments depending the eligibility the parent award). Scholar appointment(s) must able be fulfilled the active parent project period. Only existing awardees KL2 active awards eligible apply. process Streamlined Submissions using eRA Commons cannot used for PA-18-591 Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response to NOT-OD-20-022 in order facilitate efficient processing the request. Applicant organizations submit than application this NOSI. application should include only named candidate the supplement. unique project titles each application ensure our systems treat application a distinct submission. Application budgets must reflect actual needs the proposed project. Instructions Electronic Application Submission through Grants.gov: Use Apply” button(s) Part of the PA-18-591 program announcement access application forms package posted Grants.gov. presented more one form package, the form package Competition ID FORMS-E-ADMINSUPP-K12-KL2-KM1-D43". Prepare applications using SF424 R&R) forms associated the chosen package. Please note some forms marked optional the application package required submission applications this announcement. Follow instructions the SF424 R&R) Application Guide to ensure complete appropriate required optional forms, the following additional guidance: Program Plan: (may exceed 12 pages) Background: Include summary abstract the funded parent award project. Provide rationale the proposed supplement program its alignment the main goals the INCLUDE Project accelerate development new therapies, while simultaneously bringing promising agents already development individuals DS quickly possible). Research Program Plan: proposed plan should align the missions the INCLUDE Project the NCATS CTSA Program. Describe the proposed project contribute the scholar's career goals path independence. Present timeline career development activities potential publications grant applications future support. Career Development Plan: Describe key activities the candidate scholar during supplement, included mentored team science activities, didactic coursework including formal degree programs appropriate), other activities. Describe the proposed career development activities experiences enhance candidate's clinical translational science skills prepare for independent research career. Mentoring Faculty: Provide information the program faculty will involved the supplement activities, including complementary expertise experiences, active research other scholarly activities which faculty engaged, well experience mentoring individuals the proposed career stages. any co-mentor not located the sponsoring institution, describe frequency type communication will used engage scholar Vertebrate Animals: Complete section the scholar design conduct own independent vertebrate animal research. Approval the Institutional Animal Care Use Committee IACUC) the grantee institution required prior award. Letters Support: Attach appropriate letters all individuals confirming roles the proposed supplement program. Include signed letter, institutional letterhead, describes applicant institution’s commitment the planned proposed research project. letter should provide assurance the candidate scholar be able devote minimum 9 person-months 75 percent full-time professional effort) the supplement project. letter should confirm the scholar be supported the KL2 the supplement funded. letter should also identify laboratories, centers, other specialized institutional facilities will made available the scholar the research project. Project/Performance Site Location form: Include primary site where proposed supplement activities be performed. a portion the proposed supplement activities be performed any site(s), identify locations the fields provided. Senior/Key Person form: List PD/PI the first person regardless their role the supplement activities). List Senior/Key Personnel will serving members the scholar's mentoring team. List scholar proposed be added through supplement. Scholars this supplement support must an eRA Commons account, the scholar's Commons Username must entered the Credential field. Biographical sketch Senior/Key Personnel: Include biographical sketch the KL2 PD/PI(s) of of individuals will compose scholar's mentoring team. personal statement each individual will serve the scholar's mentoring team should include description his/her specific role mentoring scholar, the mentoring occur e.g., frequency mode), how scholar's progress be monitored during supplement award period. Biographical sketch Scholar: personal statement the scholar's biographical sketch should include description his/her research objectives career goals, why experience qualifications them particularly well-suited receive INCLUDE / NCATS CTSA Program KL2 supplement award. Relevant factors include previous training research accomplishments complementary integrative health research any source(s) current funding. Budget forms: Using R&R budget form, only include funds requested the additional supplement activities. R&R Project Information form, Facilities Other Resources attachment:Describe the scientific environment which career development activities be done contributes the probability the scholar's success e.g., institutional support, physical resources, intellectual rapport). CTSA Program hub Training Resources, describe training resources are available the scholar. PHS Human Subjects Clinical Trials Information form:Complete section the scholar design conduct own independent human subjects research. Approval the human subjects Institutional Review Board IRB) the grantee institution required prior award. Adherence the NIH policy including women minorities clinical studies must also ensured, additional human subjects’ involvement planned the supplement component.   Inquiries Please direct inquiries to: Erica Rosemond, Ph.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8927 Email: Erica.Rosemond@nih.gov