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Temporary Extension of Eligibility for the NINDS F32 Award Due the COVID-19 Pandemic

NOT
Thursday, April 29, 2021
Monday, January 1, 2024
NOT-NS-21-059

Funding Opportunity Purpose

The NINDS F32 is designed specifically to support postdoctoral fellows who are beginning their training period in a new laboratory or research environment. Applicants are only eligible to apply for the NINDS F32 either before beginning or within the first 12 months of joining the postdoctoral lab in which the fellowship will be active. Given this eligibility window, many applicants apply either before or within the first 3 months in the laboratory (~30% of applicants have been in the postdoctoral laboratory for less than 3 months). At the start of the COVID-19 pandemic many laboratories across the country shut down. This would have been particularly detrimental to those transitioning to their new positions, which in most cases required not only a change in research institution but a move to a different city and/or state. Clearly, for those starting a new postdoctoral position right as the pandemic hit, labs began to close down amid uncertainty and remote interactions were just beginning to be developed. Although pandemic-related delays were not unique to a specific cohort of trainees, the individuals who were just starting in new postdoctoral positions during the initial months of the pandemic were some of the hardest hit in terms of their ability to integrate into and begin research-related activities in new laboratories. Consequently, NINDS will provide a 1-receipt cycle extension of eligibility to individuals who started in their new laboratory between February 1 and May 30 of 2020. Ordinarily, the last NINDS F32 due date for these individuals would have been February, 2021. With this extension, these individuals will now be eligible to apply for the June, 2021 due date.

Request for Information (RFI): Use of Common Data Elements (CDEs) in NIH-funded research

NOT
Wednesday, February 3, 2021
Monday, January 1, 2024
NOT-LM-21-005

Funding Opportunity Purpose

The purpose of this Request for Information (RFI) is to solicit public comment on the use of Common Data Elements (CDEs) in NIH-funded research, particularly in the context of research on COVID-19.

Notice of Temporary Extension of Eligibility for the BRAIN Initiative Diversity K99/R00 Career Transition Award During the COVID-19 Pandemic

NOT
Wednesday, September 30, 2020
Monday, January 1, 2024
NOT-NS-21-004

Funding Opportunity Purpose

The purpose of this Notice is to inform the extramural community that as a result of disruptions caused by the COVID-19 pandemic, the BRAIN Initiative will be providing up to a two-receipt cycle extension (roughly eight additional months) of eligibility for prospective applicants meeting the requirements for submission of an application to the BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) through the February/March 2021 due dates.

Notice of Intent to Publish a Funding Opportunity Announcement for HEALthy Brain and Child Development Study

NOT
Friday, July 31, 2020
Heal
Wednesday, September 1, 2021
NOT-DA-20-069
Michelle Freund

Funding Opportunity Purpose

The purpose of this Notice is to alert the community that NIH plans to publish a set of Funding Opportunity Announcements (FOAs) as part of the Helping to End Addiction Long-termSM (HEAL) Initiative to support research project sites, a Data Coordinating Center, and a Consortium Administrative Core for the HEALthy Brain and Child Development (HBCD) Study. This Notice is being provided to allow potential applicants sufficient time to form meaningful collaborations and develop responsive applications. The primary objective of the HBCD Project is to conduct a large scale multi-site longitudinal study that can prospectively examine human brain, cognitive, behavioral, social, and emotional development beginning at birth and extending through middle childhood. The study will comprise a normative sample that represents the diversity of pregnant women in the US population, a cohort of women who have used opioids and other substances during pregnancy will also be recruited, and a comparison group from similar backgrounds/environments as the cohort of women who have used substances. The study is intended to create a well-characterized cohort of children in order to examine the developmental impact of pre/postnatal drug exposure and multiple other genetic and environmental factors that affect risk or resilience in various health and mental health domains. Anonymized data from this cohort will be made available to the broader research community during the course of the study to maximize their utility. The FOAs are expected to be published in Fall 2020 with an expected application due date in WINTER 2021. These FOAs will utilize the cooperative agreement (U) activity codes. Details of the planned FOAs are provided below. Research Initiative Details This Notice encourages investigators with expertise and insights in neurodevelopment to consider applying for these new FOAs. This project is expected to be a collaboration between researchers having wide ranging expertise. This includes expertise in areas such as: neuroimaging, neurodevelopment, cognitive and behavioral science, environmental science, gene/environment interactions, substance use, mental health, family dynamics, bioethics, data management and biostatistics; as well as recruitment and retention of vulnerable populations in long term studies. The goal of the HBCD Project is to collect data in multiple domains to provide knowledge about the multiplicity of factors that affect a child’s health, brain, and behavioral development, an essential first step toward designing policies and interventions that promote well-being and resilience in all children. Below are some of the overarching research objectives, which are inherently interdependent and mutually informative: What does normative brain development look like from birth through childhood, and how do various biological and environmental factors affect these development trajectories? How do genetic factors interact with environmental factors to influence neurodevelopmental and cognitive development? How does early life exposure to substances (alone or in combination) and/or adverse or protective environmental circumstances affect the developmental trajectories of children? Are there key developmental windows during which the impact of adverse environmental exposures (e.g., opioids, stress, COVID-19) influence later neurodevelopmental outcomes? Are there key developmental windows during which ameliorating influences (e.g, SUD treatment; social/economic support) are protective against the potential neurodevelopmental insults of early adverse exposures? It is expected that investigators, upon funding, will work together with federal staff at NIH Institutes, Centers and Offices to achieve project goals.

Notice to Extend Eligibility for Submission of Diversity K22 Applications due to COVIDrelated Disruptions

NOT
Friday, June 26, 2020
Monday, January 1, 2024
NOT-NS-20-076

Funding Opportunity Purpose

Notice Extend Eligibility Submission Diversity K22 Applications due COVID–related Disruptions Notice Number: NOT-NS-20-076 Key Dates Release Date: June 26, 2020 Related Announcements PAR-18-469 - NINDS Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research K22-No Independent Clinical Trials) PAR-18-468 - NINDS Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research K22-Clinical Trial Required) Issued National Institute Neurological Disorders Stroke NINDS) Purpose Under normal circumstances, individuals must no than 5 years cumulative postdoctoral research experience i.e. research experience subsequent completion the doctorate) the relevant due date be eligible apply the NINDS K22 Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research. NINDS understands COVID-19 caused major disruption the ability many individuals make progress their research. Though subject future updates, NINDS will provide least 2-receipt cycle extension roughly 8 additional months) eligibility individuals whose eligibility apply the K22, under normal eligibility rules including resubmission policy defined NOT-OD-18-197), expiring between June/July 2020 February/March 2021 inclusive these dates). addition, those normally have eligible apply the June/July 2021 receipt date have 1-receipt cycle roughly 4 months) extension. Example 1: Under normal eligibility rules, final due date which individual apply the K22 June/July 12, 2020. individual now eligible apply the K22 June/July, 2020, October/November 2020 February/March 2021. Example 2: Under normal eligibility rules, final due date which individual apply the K99/R00 February/March 12, 2021. individual now eligible apply the K22 through October/November, 2021 due dates. Example 3: Under normal eligibility rules, final due date which individual apply the K22 June/July 12, 2021. individual now eligible apply the K22 through October/November, 2021 due dates. Example 4: Under normal eligibility rules, final due date which individual apply the K22 February/March 12, 2020. individual no longer eligible the K22. Example 5: individual applied the K22 the February/March, 2020 due date and, under normal eligibility rules, still within eligibility window the June/July, 2020 due date; however, summary statement this individual released after June/July due date. Because review this applicant’s initial submission not completed time the applicant resubmit the June/July 2020 due date, individual does receive extension eligibility is longer eligible apply the K22. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke NINDS)E-mail: NINDSDivesrityTraining@mail.nih.gov

Notice of Special Interest (NOSI) regarding the Availability of Urgent Competitive Revisions and Administrative Supplements for Research on Coronavirus Disease 2019 (COVID-19) in Individuals with Down Syndrome for the INCLUDE Project

Notice of Special Interest
Thursday, June 25, 2020
Tuesday, July 13, 2021
333
NOT-OD-20-129

Funding Opportunity Purpose

Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project Notice Number: NOT-OD-20-129 Key Dates Release Date: June 25, 2020 First Available Due Date: July 13, 2020 Expiration Date: July 13, 2021 Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - 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 Nvestigation 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 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 Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose NIH issuing Notice Special Interest NOSI) highlight urgent need research Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Coronavirus Disease 2019 COVID-19) individuals Down syndrome conjunction the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project. Because people Down syndrome at increased risk having co-occurring medical conditions, such pulmonary disease, cardiac problems, obesity, diabetes, sleep apnea, altered immune function may predispose to severe infection SARS-CoV-2, may particularly vulnerable COVID-19 complications. Combined shared living situations, reduced access testing treatment services due disparities provision resources, impact COVID-19 infection people Down syndrome likely be elevated. overarching goal this NOSI to improve understanding treatment COVID-19 infection individuals Down syndrome reduce COVID-19 associated morbidity mortality this population, may disproportionately affected by, higher infection rates of, and/or at elevated risk adverse outcomes contracting virus. Background Investigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Consolidated Appropriations Acts, encouraged NIH expand current efforts Down syndrome common co-occurring conditions also seen the general population while increasing pipeline Down syndromeinvestigators. Information projects were funded 2018 2019, well the INCLUDE Project Research Plan, available the INCLUDE Project website. Individuals Down syndrome face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though Down syndrome the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, Down syndrome associate an increased prevalence autism epilepsy. 75% individuals Down syndrome experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals Down syndrome also high rates congenital heart defects, sleep apnea, pulmonary hypertension, obesity, gastrointestinal malformations, thyroid disease, diabetes, leukemia, other autoimmune immune dysregulation disorders. leading causes mortality individuals Down syndrome pneumonias, respiratory failure, dementia. particular, given many interferon receptor genes map chromosome 21, people Down syndrome three copies chromosome 21, result a hyperactive immune system elevated levels inflammatory markers results a baseline cytokine storm status may predispose to infection viruses such SARS-CoV-2, increasing risk severe respiratory tract involvement, respiratory failure mortality this virus. addition, may at increased risk contracting COVID-19 due residence congregate housing settings may experience severe illness death given increased mortality due the infection those IDD. also potential experience health disparities related access diagnostic testing, treatment, interventions. Understanding unique combination risk factors inform testing treatment those Down syndrome may contract COVID-19 infection. Research Objectives order rapidly improve our understanding SARS-CoV-2 COVID-19 infection, NIH encouraging submission applications administrative supplements urgent competitive revisions active NIH grants address pathology, prevention, diagnosis, sequelae, treatment COVID-19 people Down syndrome. funding opportunity intended support applications focus immediate needs help address COVID-19 pandemic a timely manner. Applications should address whether ongoing potential future public health restrictions e.g., closures, physical distancing) might affect research approach, if so, include plan prevent mitigate any effect the proposed study. General Objectives relevant more one Institute Center IC) NIH): Relationships individual factors, including co-existing conditions medications, resilient adverse outcomes SARS-CoV-2 exposure individuals Down syndrome. Studies pre-hospital, emergency, critical care settings improve screening, risk stratification, diagnostic testing, care delivery decisions, resource allocation, clinical outcomes those Down syndrome exposed SARS-CoV-2. Studies prevention practices hand washing, effectively covering cough, social distancing, etc.) factors influence adherence, including individual age differences social network effects populations cognitive impairment such Down syndrome. Evaluation pharmacological health care delivery intervention strategies those Down syndrome after exposure SARS-CoV-2 prevent mitigate morbidity and/or improve post-infection health function. Evaluating strategies used health systems reallocate resources, rapidly train practitioners, communicate preventative practices, maintain adherence public health clinical guidelines, a particular interest those serve high-risk groups e.g., group homes, nursing homes) resulting racial, ethnic, regional disparities access/care. Leveraging longitudinal studies elucidate COVID-19-related changes the social, economic, institutional, policy environments differentially impact health welfare people across life course in vulnerable social groups, such those Down syndrome; comparative studies regional national approaches encouraged. Areas specific interest participating Institutes, Centers, Offices include, are limited to, following: National Cancer Institute NCI): better understand impact SARS-CoV-2 infection its impact disease progression, response therapy, care delivery, survivorship infants children Down syndrome co-occurring cancer, such leukemia. particular interest studies take advantage unique cancer model systems analytical tools study consequences SARS-CoV-2 infection COVID-19 disease progression. Supported research expected inform future efforts diagnose, prevent, mitigate, treat viral infection children Down syndrome have leukemia transient myeloproliferative disorder pre-cancer), undergoing treatment cancer, are remission. National Heart, Lung, Blood Institute NHLBI): elucidate clinical trajectory cardio-respiratory illness, response therapy, outcomes individuals Down syndrome COVID-19, including, not limited to, sudden death, respiratory insufficiency progressing failure, arrhythmias, myocardial dysfunction, coagulation disorders including, not limited to, predisposition venous thromboembolism),and pulmonary hypertension; also individuals Down syndrome co-existing conditions such obstructive sleep apnea, obesity, congenital heart disease pre- post-surgery). assess refine approaches the management critically ill individuals Down syndrome COVID-19 including, not limited to, assessment optimization different ventilatory strategies acute respiratory distress syndrome ARDS), risks benefits prone positioning management these individuals considering habitus airways, their susceptibility and/ resilience end-organ damage a consequence profound hypoxemia. better understand pathogenesis pneumonia the basic mechanisms cytokine surge COVID-19 closely-coupled and/or specific Down syndrome, e.g., gamma-interferon mediated mechanisms, the goal identifying druggable biological pathways these mechanisms. understand effect COVID-19 central ventilatory control response hypoxemia individuals Down syndrome. assess clinical trajectory response therapies people Down Syndrome presenting the recently described Multisystem Inflammatory Syndrome Children MIS-C) left ventricular dysfunction and/or coronary artery aneurysms. National Human Genome Research Institute NHGRI): Develop novel methods using genomic techniques identify signatures infection, prognosis, and/or severity disease individuals Down syndrome a medical setting. of electronic health information, other relevant clinical, environmental, demographic social determinants health data, accompanying genomic data, aid tracking understanding genetic epidemiology SARS-CoV-2, the individual susceptibility resistance infection disease severity those Down syndrome. Studies addressing ethical, legal, social implications the of genetic genomic information technologies diagnose, track, monitor, treat, triage SARS-CoV-2 COVID-19 infected individuals populations Down syndrome clinical public health settings. National Institute Aging NIA): Studies the role inflammation immune senescence adults Down syndrome increased susceptibility SARS-CoV-2 infection subsequent progression more severe disease, including lung pathology ARDS. Studies how host factors, including existing co-occurring conditions such respiratory, cardiac, other conditions, predispose older individuals Down syndrome acquire SARS-CoV-2 infections and/or develop severe COVID-19 disease, such ARDS. Studies mechanisms underlying SARS-CoV-2 neurological symptoms pathology older individuals Down syndrome COVID-19; research the role brain barriers preventing SARS-CoV-2 gaining access the neural tissues mechanisms through SARS-CoV-2 compromises such barriers propagates the central nervous system CNS); neuropathological studies COVID-19 the contribution brain tissue damage SARS-CoV-2 the morbidity mortality COVID-19 those Down syndrome. Studies neurological neurocognitive symptoms COVID-19 sequelae SARS-CoV-2 infection related the development aggravation such symptoms adults Down syndrome, e.g., delirium early alterations sensory function; studies the susceptibility people Down syndrome Alzheimer's disease Alzheimer's disease-related dementias AD/ADRD) COVID-19. Evaluation strategies minimize spread COVID-19 among adults Down syndrome their care providers, particularly within congregate housing facilities those cognitive impairment such group homes, including telemedicine remote medicine strategies. Studies how social distancing requirements impact care well-being vulnerable adult Down syndrome populations cognitive impairment and/or AD/ADRD, may dependent care providers. National Institute Allergy Infectious Diseases NIAID): Studies understand critical aspects viral infection pathogenesis individuals Down syndrome. development SARS-CoV-2 infection Down syndrome animal models suitable therapeutic candidate and/or pathogenesis studies. Identification evaluation the innate, cellular, humoral immune responses SARS-CoV-2 infection and/or candidate vaccines, individuals Down syndrome. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Research SARS-CoV-2 COVID-19 the Down syndrome population relevant the areas arthritic other rheumatic), musculoskeletal, skin anomalies disorders. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): Research whether children Down syndrome more susceptible Multisystem Inflammatory Syndrome Children MIS-C) associated COVID-19 infection. Studies understand whether infection SARS-CoV-2 more severe children Down syndrome underlying health conditions such congenital heart disease, pulmonary hypertension, frequent respiratory infections in those without such co-occurring conditions. Studies determine whether past infection vaccination, available, SARS-CoV-2 provides lasting immunity children Down syndrome. Research determine COVID-19 infection adolescents young adults impacts risk cognitive decline, behavioral mental health conditions, and/or regression. Incorporation COVID-19 elements existing registries the purpose tracking testing, diagnosis, and/or treatment the infection people Down syndrome. National Institute Deafness Other Communication Disorders NIDCD): Research SARS-CoV-2 COVID-19 the Down syndrome population relevant the areas hearing, balance, taste, smell, voice, speech, language. Specific impacts communication those Down syndrome the context a pandemic enforced social distancing, including impacts services interventions. National Institute Dental Craniofacial Research NIDCR): Topics would of immediate high impact protect ensure safety personnel dental practices their patients comprised individuals Down syndrome: Modifications dental practice and/or treatment space prevent aerosol droplet pathogen transmission Determination the extent which viral pathogens transmitted via aerosol droplet routes during treatment dental settings Design implementation strategies achieve Centers Disease Control Prevention CDC) second-tier Transmission-Based Precautions dental practice Implementation disinfection processes ensure treatment spaces equipment devoid transmissible viral pathogens Development interventions protect health care workers, front-line professionals, patients viral transmission Assessment the impact dental care delivery delays upon oral health needs access care, especially vulnerable Down syndrome populations those affected health disparities. Development implementation strategies triage manage those Down syndrome have oral care needs, including via remote virtual means. Examination the role oral/nasal microbiota ACE2 receptor SARS-CoV-2 infectivity carriage oral fluids nasal secretions the Down syndrome population, gateways the spread infection the respiratory tract via proof principle studies. Pilot testing existing therapeutic modulators oral microbiota may limit infectivity SARS-CoV-2 those Down syndrome. Performance research conducted within National Dental Practice-Based Research Network PBRN), supports clinical research studies dental practices dental practitioners their consenting patients well survey studies practitioners and/or patients include individuals Down syndrome. Potential applicants strongly encouraged review process potential grant applicants interact and utilize National Dental PBRN resources. Implementation FDA-approved detection screening tests SARS-CoV-2 virus antibodies improve triage early disease management strategies those Down syndrome. National Institute Minority Health Health Disparities NIMHD): Including individuals Down syndrome NIH-designated health disparity populations Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual gender minorities) existing clinical community-based studies sufficient number study: Intersectional stigma discrimination their impact health healthcare utilization. Coping strategies, social support, other protective factors related chronic disease risk outcomes. Access and quality healthcare, including primary, specialty, behavioral health care. Evaluating transition child adult healthcare other service systems. National Institute Neurological Disorders Stroke NINDS): Studies understand biologic effects SARS-CoV-2 infection the brain, spinal cord, nerves individuals Down syndrome. includes acute neurological symptoms, symptoms ranging the relatively mild anosmia dysgeusia) the extreme encephalitis, ataxia, seizures, cerebrovascular events such stroke). also includes potential delayed effects COVID-19, such post-viral complications e.g., acute disseminated encephalomyelitis Guillain-Barre syndrome). Establishment maintenance a database designed collect clinical information the neurological manifestations SARS-CoV-2 individuals Down syndrome. Such database should address objectives outlined NOT-NS-20-046 align centralized NINDS data collection efforts. Studies using telemedicine the diagnosis treatment neurological symptoms individuals Down syndrome. National Center Complementary Integrative Health NCCIH): in vivo animal models Down syndrome, conduct assessments natural product therapeutic candidates repurposed existing candidate natural product therapeutics initially developed other indications against SARS-CoV-2, study mechanisms action the candidates treatment prevention COVID-19, such suppressing virus transmission, infection loading, entry, fusion), replication; and/or regulating innate, adaptive, cellular, humoral immune systems including immune-mediated pathologies host interactions molecular pathways, cytokine storms, free radicals, etc.). Office Research Infrastructure Programs ORIP): ORIP interested supporting projects aimed enhancing existing creating new animal models Down syndrome studying mechanisms underlying COVID-19 the context Down syndrome. Preference be given applications develop informative animal models demonstrate potential investigating multiple phenotypic features COVID-19 the context Down syndrome, rather focusing a specific phenotype the disease. Note ORIP only consider applications submitted under PA-18-591 subsequent reissued equivalents. Considerations maximize comparisons across datasets studies, facilitate data integration collaboration, researchers funded through NOSI strongly encouraged use following resources: Data Harmonization Social Determinants Health via PhenX Toolkit: Investigators involved human-subject studies strongly encouraged employ common set tools resources will promote collection comparable data social determinants health SDOH) across studies. particular, human-subject studies should incorporate SDOH measures the Core Specialty collections are available the Social Determinants Health Collection the PhenX Toolkit www.phenxtoolkit.org). NIH encouraging researchers explore use the HL7 FHIR Fast Healthcare Interoperability Resources) standard capture, integrate, exchange clinical data research purposes to enhance capabilities share research data NOT-OD-19-122). FHIR resources be particularly useful the development computational tools used COVID-19 research data sharing. Additional emerging data terminologies, ontologies, standards should considered describing semantic content data metadata COVID-19 research e.g., LOINC, SNOMED, ICD-10, others described here: https://covid.cd2h.org/forms_and_standards). trans-NIH working group making existing COVID-19 survey items investigator contact information publicly available through NIH-supported platforms: NIH Public Health Emergency Disaster Research Response DR2) https://dr2.nlm.nih.gov/] the PhenX Toolkit https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based for clinical research, strongly encouraged consider COVID-19 specific survey item repositories select existing survey items protocol modules currently being fielded. Additionally, researchers funding through NOSI be strongly encouraged share survey items make public other researchers consider submitting surveys NIHCOVID19Measures@nih.gov. 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. addition the review criteria described PA-18-591 PA-18-935, as applicable the project proposed, reviewers also evaluate: what extent does application address goals the INCLUDE Project? relevant the proposed research regard addressing key areas identified priorities COVID-19 research Down syndrome? likely it the investigators have immediate access the necessary resources e.g., patient samples, isolates, test kits, laboratory access, etc.) achieve aims the proposed research? strong the proposed plans the execution the proposed work laboratory access limited restricted due the COVID-19 pandemic? likely it the proposed research generate unique resources data could impact public health response? adequate the resource sharing plan? Review Selection Process: Applications both PA-18-591 PA-18-935 be evaluated scientific technical merit an appropriate internal review panel convened staff the NIH INCLUDE Project Team, accordance the stated review criteria any additional review criteria specified. Application Submission Information Application Due Dates: July 13, 2020, November 12, 2020, March 12, 2021, July 12, 2021 5:00 PM local time applicant organization. Applications this initiative must submitted electronically using of following target opportunities their subsequent reissued equivalents: PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) NIH anticipates most applications response this NOSI be expanding scope the parent award will submitted response PA-18-935. definition scope be found the NIH Grants Policy Statement. funding instrument, activity code, be same the parent award. Applicants must follow instructions the SF424 R&R) Application Guide in selected target funding opportunity announcement PA-18-591 PA-18-935), the following additions: Budget: applications targeting PA-18-591 Administrative Supplement), application budgets limited no than amount the current parent award 1,000,000 direct costs, whichever less, must reflect actual needs the proposed project. applications targeting PA-18-935 Urgent Competitive Revision), application budgets limited no than 1,000,000 direct costs, must reflect actual needs the proposed project. Exceptions these budget limits be with NIH pre-approval will only approved under very rare circumstances where work immediately impact public health. Project Period: Applicants request budget period only year support that year must align the existing parent award. parent award must active the supplement application submitted e.g. within originally reviewed approved project period), regardless the time remaining the current project. Abstract: Abstract section should describe proposed supplement. Research Strategy: Research Strategy section should provide summary abstract the funded parent award project describe relevance the proposed project the funded parent award the INCLUDE project. Describe component(s) any IC-specific priorities the supplement addressing. Research Strategy limited 6 pages Applicants should address whether ongoing potential future public health restrictions e.g., closures, physical distancing) might affect research approach and, so, include plan prevent mitigate any effect the proposed study. Administrative supplement applications PA-18-591must the application form package theCompetition ID contains FORMS-F-ADMINSUPP." addition, process forStreamlined Submissions using eRA Commons cannot used this initiative. Competitive revision applications PA-18-935 must the application form package the Competition ID contains FORMS-F-COMP-REV." applications including those multi-project activity codes) must submitted electronically using single-project application form package. funding consideration, applicants must include NOT-OD-20-129 the Agency Routing Identifier field Box 4.b) the SF 424 R&R) Form. Applications without information Box 4b not considered this initiative. Pre-award costs be incurred January 20, 2020 through public health emergency period prior the date the federal award. process Streamlined Submissions using eRA Commons cannot used this initiative. INCLUDE Program Office not consider applications fail meet terms this NOSI. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. NOSI expires July 13, 2021. application submitted response this NOSI is received on/after expiration date be withdrawn. Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award indicated the funding page the INCLUDE Project website. Financial/Grants Management Contact(s) Ryan Talesnik Eunice Kennedy Shriver National Institute Child Health Human Development Telephone: 301-435-6976 Email: talesnikr@mail.nih.gov

Notice of Change to Eligible Activity Codes for NOT-NS-20-051 "Notice of Special Interest: Availability of Urgent Competitive Revisions and Administrative Supplements For Research on Biological Effects of the 2019 Novel Coronavirus on the Nervous System"

NOT
Wednesday, May 27, 2020
Monday, January 1, 2024
NOT-NS-20-074

Funding Opportunity Purpose

Notice Change Eligible Activity Codes NOT-NS-20-051 Notice Special Interest: Availability Urgent Competitive Revisions Administrative Supplements Research Biological Effects the 2019 Novel Coronavirus the Nervous System" Notice Number: NOT-NS-20-074 Key Dates Release Date: 27, 2020 Related Announcements NOT-NS-20-051 - Notice Special Interest NOSI): Availability Urgent Competitive Revisions Administrative Supplements Research Biological Effects the 2019 Novel Coronavirus the Nervous System PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 - Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a change the eligible activity codes NOT-NS-20-051 "Notice Special Interest NOSI): Availability Urgent Competitive Revisions Administrative Supplements Research Biological Effects the 2019 Novel Coronavirus the Nervous System". Effective immediately,the RF1 activity codewill added an eligible activity codeto NOT-NS-20-051, applications submitted both, PA-18-591 "Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) " PA-18-935 "Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional)". changes below bold italics. Currently Reads: Purpose Application Submission Information Applications this initiative must submitted using of following opportunity announcements the subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 - Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) Applications research fall within scope an existing NINDS award should submitted through PA-18-591 Parent Admin Supp Clinical Trial Optional). Eligible activity codes limited the mechanisms listed PA-18-591. Applications research involve change the original scope an active award, still falls within mission the NINDS must apply through PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional). Eligible activity codes applications PA-18-935 limited the following mechanisms: P01, P50, R00, R01, R03, R15, R21, R33, R35, R41, R42, R43, R44, R61, U01, U19, U24, U44, U54, UG3, UH3). Modified Read: Purpose Application Submission Information Applications this initiative must submitted using of following opportunity announcements the subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 - Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) Applications research fall within scope an existing NINDS award should submitted through PA-18-591 Parent Admin Supp Clinical Trial Optional). Eligible activity codes limited the mechanisms listed PA-18-591, addition the RF1 mechanism. Applications research involve change the original scope an active award, still falls within mission the NINDS must apply through PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional). Eligible activity codes applications PA-18-935 limited the following mechanisms: P01, P50, RF1, R00, R01, R03, R15, R21, R33, R35, R41, R42, R43, R44, R61, U01, U19, U24, U44, U54, UG3, UH3) other aspects this Notice Special Interest remain unchanged. Inquiries Please direct inquiries to: Please contact program officer your active award.

Notice of Additional Due Date and Additional Areas of Focus Especially of Interest of PAR-19-373 and PAR-19-384, "Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01)"

NOT
Thursday, May 7, 2020
Monday, January 1, 2024
NOT-OD-20-103

Funding Opportunity Purpose

Notice Additional Due Date Additional Areas Focus Especially Interest” PAR-19-373 PAR-19-384, Research Biopsychosocial Factors Social Connectedness Isolation Health, Wellbeing, Illness, Recovery R01)" Notice Number: NOT-OD-20-103 Key Dates Release Date: 7, 2020 Related Announcements PAR-19-373 PAR-19-384 Issued NIH Basic Behavioral Social Science Opportunity Network OPPNET) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Purpose purpose this Notice to add third due date” additional areas focus especially interest” PAR-19-373 PAR-19-384 Research Biopsychosocial Factors Social Connectedness Isolation Health, Wellbeing, Illness, Recovery R01 Clinical Trials Allowed/Basic Experimental Studies Humans Required),” between two current due dates, March 17, 2020 March 17, 2021. Part 1 both PARs, under Key Dates, additional application due date June 8, 2020, added. I. Part 1 Key Dates PAR-19-373 PAR-19-384 Currently Reads: Application Due Date(s): March 17, 2020; March 17, 2021 applications due 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due the listed date(s). Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. II. Part 1 Key Dates PAR-19-373 PAR-19-384 Modified this Notice) Read italics): Application Due Date(s): March 17, 2020; June 8, 2020; March 17, 2021 Scientific Merit Review: June 2020, October 2020, June 2021 applications due 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due the listed date(s). Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review: June 2020, October 2020; June 2021 Advisory Council Review: August 2020, January 2021, August 2021 III. Part 1 Key Dates PAR-19-373 PAR-19-384 Remain Unmodified: Earliest Start Date September 2020 Expiration Date March 18, 2021 Part 1 both PARs, under Part 2, Section I. Funding Opportunity Description, of Three areas focus especially interest OppNet participating NIH ICO’s include, are limited to, those listed below” appear as, 1. Effects social connectedness, connection, isolation across lifespan Affective cognitive function during aging process Contextual factors increase mitigate impact disruption isolation different developmental time points, e.g., Caregivers people dementia, severe illness, end-of-life Chronic illness limited mobility Perceived strength quality extant social connections Recent diagnosis a serious medical illness Sleep changes across lifespan e.g. during adolescence, early parenthood, menopause) Molecular markers mechanisms e.g., epigenetic modifications, gene expression, microbiome alterations, telomere attrition) associated changes social connectedness Neurobiological developmental trajectories Protective and/or risk factors associated isolation connection disruption different times development over lifespan e.g., adolescence, death mate/parent, middle-age males, onset serious medical diagnosis) Aggressive behaviors and/or risky sexual activity associated connection trajectories Mechanisms connectedness, connection, isolation Neurobiological factors Impact structure function the nervous system central, peripheral, autonomic) Impact neuroimmune neuroendocrine systems Impact neural systems associated basic affective, cognitive, social processes Importance inter-individual neural synchrony mediating moderating effects relationship trajectories Neurobiological biosignatures predict sensitivity connection disruption isolation Neurobiological processes could targets ameliorate negative effects disruption isolation Neurophysiological consequences disruption isolation substance disorders SUDs) mental illness Behavioral environmental factors consequences perceived isolation e.g., loneliness) and/or objective/observed isolation behavioral clinical outcomes adolescence adulthood Connections between social disruption/isolation specific populations and/or health/illness contexts, e.g., Sex/gender differences; sexual gender minorities Racial/ethnic differences, acculturation/bicultural adaptations contributions social integration versus isolation Autism, HIV, mental illness, recovery status, substance disorder Whether source connection disruption leads different processes outcomes E.g., Self-induced isolation versus isolation others, sense undesired loneliness vs. sought solitude Modified this Notice) Read italics): 1. Effects social connectedness, connection, isolation across lifespan Affective cognitive function during aging process Contextual factors increase mitigate impact disruption isolation different developmental time points, e.g., Caregivers people COVID-19, dementia, severe illness, end-of-life Chronic illness limited mobility Perceived strength quality extant social connections Recent diagnosis a serious medical illness including, not limited to, COVID-19 Sleep changes across lifespan e.g. during adolescence, early parenthood, menopause) Molecular markers mechanisms e.g., epigenetic modifications, gene expression, microbiome alterations, telomere attrition) associated changes social connectedness Neurobiological developmental trajectories Protective and/or risk factors associated isolation connection disruption different times development over lifespan e.g., adolescence, death mate/parent, middle-age males, onset serious medical diagnosis) Aggressive behaviors and/or risky sexual activity associated connection trajectories Mechanisms connectedness, connection, isolation Neurobiological factors Impact structure function the nervous system central, peripheral, autonomic) Impact neuroimmune neuroendocrine systems Impact neural systems associated basic affective, cognitive, social processes Importance inter-individual neural synchrony mediating moderating effects relationship trajectories Neurobiological biosignatures predict sensitivity connection disruption isolation Neurobiological processes could targets ameliorate negative effects disruption isolation Neurophysiological consequences disruption isolation substance disorders SUDs) mental illness Behavioral environmental factors consequences perceived isolation e.g., loneliness) and/or objective/observed isolation behavioral clinical outcomes adolescence adulthood Connections between social disruption/isolation specific populations and/or health/illness contexts, e.g., Sex/gender differences; sexual gender minorities Racial/ethnic differences, acculturation/bicultural adaptations contributions social integration versus isolation Autism, COVID-19, HIV, mental illness, recovery status, substance disorder Whether source connection disruption leads different processes outcomes E.g., Self-induced isolation versus isolation others, sense undesired loneliness vs. sought solitude E.g., Isolation the result preventing COVID-19 a household, preventing COVID-19 infection within household NOTE: other aspects these funding opportunity announcements PAR-19-373 PAR-19-384) remain unchanged. Inquiries Please direct inquiries to: William Elwood, PhD Office Behavioral Social Sciences Research OBSSR) Telephone: 301-402-0116 Email: william.elwood@nih.gov

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

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

Funding Opportunity Purpose

Notice Special Interest NOSI): Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-024 Key Dates Release Date: December 18, 2019 First Available Due Date: March 23, 2020 Expiration Date: March 24, 2022 Related AnnouncementsNOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project NOT-OD-20-022 NOT-OD-20-012, Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-18-591, Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) NOT-OD-20-017, Notice Special Interest Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020 Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021 Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022 Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023 Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-025 Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004 INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005 Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006 Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007 Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C) Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose Office the Director the National Institutes Health NIH) announces opportunity investigators relevant active NIH-supported grants the participating Institutes listed above submit administrative supplement applications funded projects meet new NIH Down syndrome research objectives related the NIH INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project. Notice soliciting administrative supplements the following mechanisms ONLY: R03, R21, R24, P01, P30, P40, P50, P51, U01, U10, U19, U24, U42, U54, UG1, UG3, UL1, U2C, K12, and T32. Background INCLUDE Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects were funded 2018 2019, well the INCLUDE Project Research Plan, available the INCLUDE Project website. Individuals DS face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives Notice Special Interest NOSI) announces NIH support the professional development early career scientists aiming establish career DS-related research. providing scientists training, resources, mentorship, NIH intends foster pipeline investigators DS other intellectual disabilities will lead future research improve understanding the biology DS support development new treatments health conditions experienced those DS. Sharing resources effective communication outputs the broader communities a high priority the INCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3, NIH Strategic Plan Data Science). Supplement applications be eligible funding they address or of following components related the INCLUDE Project research objectives: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down Syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Applications be considered eligible funding they: within scope the active parent award focused DS Propose address of three components listed above likely stimulate additional activity leading progress DS Address priority the IC issued parent award below more information) Supplements existing clinical trials allowed. proposed research must within scope the parent clinical trial the parent clinical trial award must two more budget years remaining the current project period. addition a new clinical trial was a part the parent award not allowed. Supplement requests addressing INCLUDE Components 2 3 should encourage participants DS their caregivers register in DS-Connect®: Down Syndrome Registry. INCLUDE website a list of Funding Priorities Institute Center , well list of contacts for participating NIH Institute Center. Before submitting supplement request, applicants strongly encouraged contact program officer the program contact the Institute Center IC) supporting parent award any questions to discuss whether proposed supplement within scope the parent award, focused the goals the INCLUDE Project consistent IC priorities. Award Project Period be eligible, parent award must active the current fiscal year i.e., parent award received funds the current fiscal year is in extension period), the research proposed the supplement should requested one year. awarding institute consider no-cost extension up an additional year the conclusion the first year. earliest anticipated start date August 2020, August 2021, August 2022. Budget Requests must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant cooperative agreement. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) submitted the awardee institution the parent award. Application Submission Information: Applications response this NOSI must submitted to PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) its subsequent reissued equivalent. instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: order ensure identification, tracking, appropriate review their applications, applicants MUST follow special instructions: Application Due Date(s) – March 23, 2020, March 23, 2021, March 23, 2022 5:00 PM local time applicant organization. Applications must include NOT-OD-20-024 the Agency Routing Identifier field Box 4b) the SF424 R&R form. Applications without identifier NOT-OD-20-024) Box 4b not considered this initiative. process Streamlined Submissions using eRA Commons cannot used for PA-18-591. the form package the existing NIH Grants and/or Cooperative Agreements. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response to NOT-OD-20-024 in order facilitate efficient processing the request. Applicant organizations submit than application this NOSI. unique project titles each application ensure our systems treat application a distinct submission. Application budgets must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. application Abstract section should describe proposed supplement, the Research Strategy section should include summary abstract the funded parent award project. Research Strategy should state relevance the parent award the INCLUDE project, articulate component(s) any IC-specific priorities the supplement addressing. Page Limits: NIH consider supplements a Research Strategy of no than 6 pages, addition the abstract. part the application investigators should submit abstract the proposed research shows relevance DS. Place abstract the Project Summary/Abstract section the SF424 R&R) Form. work include pilot projects resource development. Review Process: Each IC conduct administrative reviews applications their IC separately.   Inquiries Please direct inquiries to: Investigators planning submit application response this NOSI strongly encouraged contact discuss proposed research/aims a Program Officer the appropriate Institute Center listed this NOSI well advance the grant receipt date better determine appropriateness interest the awarding ICO. Please direct inquiries the contact the Institute, Center Office supporting parent award indicated the funding page the INCLUDE Project website.

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

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

Funding Opportunity Purpose

Notice Special Interest NOSI): Competitive Supplements/Revisions R01) Available INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) Notice Number: NOT-OD-20-023 Key Dates Release Date: December 18, 2019 First Available Due Date: March 05, 2020 Expiration Date: September 08, 2022 Related Announcements NOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project NOT-OD-20-022 NOT-OD-20-012 Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-19-055 Research Project Grant Parent R01 Clinical Trial Required) PA-19-056 NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091 NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) NOT-OD-20-017 Notice Special Interest Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020 Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021 Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022 Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023 Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-024 Notice Special Interest: Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project NOT-OD-20-025 Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004 INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005 Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006 Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007 Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C) Issued Office The Director, National Institutes Health OD) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) National Cancer Institute NCI) Purpose Background INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects were funded in 2018 2019, well the INCLUDE Project Research Plan, available the INCLUDE Project website. Individuals Down syndrome DS) face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives Notice Special Interest NOSI) announces availability competitive revision formerly known competitive supplement) applications grantees active Research Project Grants R01) wish either expand scope their grant project focused DS to expand scope a non-DS grant incorporate DS-related research. Sharing resources effective communication outputs the broader communities a high priority the INCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3, NIH Strategic Plan Data Science). list of Funding Priorities Institute Center is available the INCLUDE website. Applications response this NOSI should aligned the overall INCLUDE Project Research Plan, consists three components: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Projects propose recruit subjects Down syndrome encouraged promote enrollment research subjects the Down syndrome patient registry supported NIH, DS-Connect®. other data biospecimens human genetic non-genetic studies, awardees encouraged use biorepositories designated INCLUDE staff meet requirements broad sharing. NIH resource describing Common Data Elements may helpful during planning phases a project considering ways optimize data collection order facilitate broad data sharing. further information INCLUDE priorities, resource sharing expectations, participating NIH Institutes Centers, see Frequently Asked Questions. Application Submission Information Notice applies due dates or after March 5, 2020 subsequent receipt dates through September 7, 2022. Applications this initiative must submitted using of following funding opportunity announcements FOAs) their reissued equivalents. Although all NIH components indicated above listed Participating Organizations all FOAs listed below, applications this initiative be accepted the participating Institutes Centers NIH. PA-19-055 - NIH Research Project Grant Parent R01 Clinical Trial Required) PA-19-056 - NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091 – NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) instructions the SF424 R&R) Application Guide and funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-20-023 in Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Revision applications must submitted the same project director/principal investigator PD/PI), Contact PD/PI multi-PI grants, listed the current award. Select Revision” option Box 8 the SF424 R&R form indicate TYPE APPLICATION, option Increase Award”. the Project Summary/Abstract field provide succinct accurate description the work proposed for revision. not the abstract the parent grant. Applicants must the same budget format i.e. R&R Budget Form PHS 398 Modular Budget Form) the current award. the Introduction Application field the PHS 398 Research Plan form attach one-page Introduction describes nature the revision how will influence specific aims, research design, methods the current grant. body the application should contain sufficient information the original grant application allow evaluation the proposed revision relation the goals the original application. Any budgetary changes the remainder the project period the current grant should discussed the Budget Justification. Revisions not extend beyond term the current award period. Grants their final year the project period the time application receipt not eligible under Notice. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: Scientific/Research Contact(s) list of contacts each participating NIH Institute Center available the INCLUDE website.    

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