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Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)

PAR
Tuesday, March 3, 2020
Monday, May 8, 2023
UG3/UH3
PAR-20-122
Charles Cywin

Funding Opportunity Purpose

Reissue of PAR-18-546. The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

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): 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-20-012 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.  

Clinical Trials Development for Co-Occurring Conditions in Individuals with Down syndrome: Phased Awards for INCLUDE (R61/R33 Clinical Trial Required)

RFA
Friday, December 13, 2019
Thursday, November 4, 2021
R61/R33
RFA-OD-20-003

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this FOA may not exceed five years. This FOA provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition of up to four years of expanded clinical trial support (R33), although the total duration of the award may not exceed five years. This FOA requires measurable R61 milestones.

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.    

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed

PAR
Monday, August 5, 2019
Wednesday, April 6, 2022
SB1
PAR-19-334

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts. This may include preparation of documents for a Food and Drug Administration (FDA) submission, development of an intellectual property strategy, and/or planning for a clinical trial. Although a significant amount of the work in a CRP award may be subcontracted to other organizations, the SBC is expected to maintain oversight and management of the R and D throughout the award. Clinical trials not accepted under this FOA.

Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed)

PAR
Monday, January 28, 2019
Saturday, January 8, 2022
UG3/UH3
PAR-19-171
Adam Hartman

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated comparative effectiveness research (CER) to the National Institute of Neurological Disorders and Stroke (NINDS). The study must address questions within the mission and research interests of the NINDS and may evaluate preventive strategies, diagnostic approaches, or interventions including drugs, biologics, and devices, or surgical, behavioral, and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (https://www.ninds.nih.gov/). Studies proposed should provide a cost-effective means of collecting data with a meaningful bearing on current clinical practice. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a observational study phase of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase for observational studies will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of data collection, storage, and planned analyses. Operational planning activities include, at a minimum, development of recruitment and retention strategies, case report forms, data management system and other tools for data and quality management. The UH3 phase of the award will support the conduct of investigator-initiated observational study.

Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial Not Allowed)

PA
Wednesday, October 17, 2018
Wednesday, February 3, 2021
333
PA-19-029

Funding Opportunity Purpose

This funding opportunity announcement (FOA) seeks to develop and nurture a national innovation ecosystem that builds upon biomedical research to develop technologies, products, and services that benefit society. Toward meeting this objective, the I-Corps program is being offered. The I-Corps at NIH program is focused on educating researchers and technologists on how to translate technologies from the lab into the marketplace. Under this FOA, participating NIH and CDC Institutes and Centers will continue providing administrative supplement awards to currently-funded SBIR and STTR Phase I grantees. The program is designed to provide three-member project teams with access to instruction and mentoring in order to accelerate the translation of technologies currently being developed with NIH and Centers for Disease Control and Prevention (CDC) SBIR and STTR funding. It is anticipated that outcomes for the I-Corps teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies. Prospective applicants are strongly encouraged to contact NIH or CDC Scientific/Research staff for more information about the program before applying.

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