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Notice Special Interest NOSI): Understanding Sudden Death the Young Through Research Notice Number: NOT-HL-20-787 Key Dates Release Date: June 29, 2020 First Available Due Date: October 05, 2020 Expiration Date: January 08, 2023 Related Announcements PA-20-185 - NIH Research Project Grant Parent R01 Clinical Trial Allowed) Issued National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) Purpose Notice Special Interest NOSI) highlights interest receiving grant applications focused mechanistic, genetic, other studies evaluate causes consequences and risk factors sudden death the young. Studies required use data DNA samples, associated sequence data the NIH/CDC Sudden Death the Young SDY) Case Registry foundations their research. Results such studies expected be disseminated widely to provide evidence base advance discussions screening prevention SDY. sudden, unexpected loss a child a tragic event significant impact families communities. Sudden Death the Young SDY) Case Registry sdyregistry.org) a unique collaboration between National Institutes Health NHLBI NINDS) the Centers Disease Control Prevention CDC). was designed address critical knowledge gaps the epidemiology causes SDY to develop resource research will enhance evidence base inform prevention efforts. Fundamental gaps knowledge incidence, mechanisms, risk factors SDY limit identification effective prevention efforts. the majority SDY cases, after autopsy investigation, cause cannot identified. deaths where cause be identified, sudden, unexpected, non-injury-related infant child deaths often due cardiac causes myocarditis, cardiomyopathy, coronary artery anomalies, ion channelopathies), respiratory causes asthma, pneumonia), sudden unexpected death epilepsy SUDEP), various infections, neurological, hematologic, gastrointestinal catastrophes. Because the high number unexplained deaths the lack evidence regarding cause(s), is disagreement the best approach prevent SDY. SDY Case Registry the associated research efforts should help close knowledge gaps provide foundation data can used inform targeted prevention efforts. SDY Case Registry first funded 2013 address critical knowledge gaps the epidemiology etiologies SDY. CDC leading population-based surveillance efforts identify 100% cases SDY funded states/jurisdictions the SDY Case Registry. do this, provide technical assistance states/jurisdictions increase case ascertainment ensure consistent categorization cases. Support NHLBI NINDS focused developing resource research SDY ensuring collection a comprehensive battery phenotypic data elements collection DNA samples enable genomic analysis. Detailed phenotyping performed cases sudden cardiac death the young SCDY), unexplained infant child death, sudden unexpected death epilepsy SUDEP), limited data gathered other explained SDY cases. SDY Case Registry one the largest population-based cohorts children have died suddenly the US, including over 3000 SDY cases date. SDY Case Registry’s 13 states/jurisdictions include approximately 20% SDYs the US. population infants children the states/jurisdictions funded the SDY Case Registry 23% black. Ethnicity data not available all jurisdictions, the funded states include 14% Hispanic/Latino infants children. Data be used explore causes SCDY well SUDEP, sudden unexpected infant death SUID), other causes pediatric sudden death. Inclusion criteria infants children to age 20 die suddenly unexpectedly. Homicide, suicide, intentional overdose obvious injury-related deaths excluded. Data gathered symptoms, activity/exercise, previous diagnoses, medications, treatments, seizures, family history, resuscitation. Cases categorized cause state/local experts cardiology, neurology pathology, and, after informed consent surviving family members, blood/tissue collected DNA extraction stored the biorepository the University Michigan enable research. consent allows use the child’s DNA sample research, access the autopsy report, re-contact return results discussions future research opportunities. addition, families given option consent re-contact investigators the purposes obtaining additional information returning clinically actionable results. Consent been obtained research approximately 250 cases date, whole genome sequencing been performed 200 cases thus far. Sequence data be available investigators through NIH data repositories dbGAP). Controls not included the Registry must sought elsewhere. State public health agencies their bona fide agents) participating the SDY Case Registry proprietary rights over data enter the Registry; however, under specific agreement, data individual states combined a single de-identified dataset. SDY Case Registry’s Data Coordinating Center the Michigan Public Health Institute facilitate initiation data agreements between investigators state public health agencies access dataset. SDY Case Registry’s Data Coordinating Center DCC) the Michigan Public Health Institute funded separately via contract an Interagency Agreement between NIH CDC. DCC provides administrative support the SDY Case Registry, creates case report forms phenotypic data, develops consent forms participation the Registry, maintains SDY database, subcontracts a biorepository the University Michigan DNA extraction storage samples. DCC works closely research teams establish data agreements the SDY Case Registry data collection sites state public health agencies their bona fide agents) access phenotypic data DNA samples study. DCC does provide statistical support conduct data analysis each funded research project. Rather, facilitate access the data act liaisons between investigators the jurisdictions collect data. Selected Research Examples Research questions interest include, are limited the following: is prevalence ion channel mutations other candidate genes known be associated arrhythmias cases compared controls? is prevalence ion channel mutations other candidate genes known be associated the epilepsies cases compared controls, compared cases sudden cardiac death the young? do ion channel mutations differ between SUID cases cases sudden death older children? competitive athletics risk factor sudden cardiac death the young? there diurnal variations sudden cardiac death the young, is case some cardiovascular conditions adults? there risk factors SUDEP are associated the sleep setting and/or time death? there significant environmental contextual differences between cases controls, such socioeconomic status, history drug exposure, serum toxicology screens, family history, other factors? is yield molecular autopsy defined postmortem molecular, typically genetic diagnosis) autopsy-negative cases SDY? machine learning complex genetic models used identified novel SDY risk genes? Applications seek determine incidence SDY outside scope this NOSI, be considered non-responsive, will be considered under NOSI. CDC, NHLBI, NINDS SDY Case Registry Steering Committee be responsible evaluating incidence. Application Submission Information notice applies due dates or after October 5, 2020 subsequent receipt dates through January 8, 2023. Submit applications this initiative using following funding opportunity announcement FOA) any reissues this announcement through expiration date this notice PA-20-185 NIH Research Project Grant Parent R01 Clinical Trial Allowed) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-HL-20-787” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive terms this NOSI will not 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) Kristin M. Burns, MD National Heart, Lung, Blood Institute Telephone: 301-594-6859 Email: kristin.burns@nih.gov Vicky Whittemore, PhD National Institute Neurological Disorders Stroke Telephone: 301-594-8909 Email: vicky.whittemore@nih.gov Peer Review Contact(s) Examine eRA Commons account review assignment contact information information appears weeks after submission due date). Financial/Grants Management Contact(s) Judy Sint National Heart, Lung, Blood Institute Telephone: 301-480-1307 Email: sintj@mail.nih.gov

This funding opportunity announcement (FOA), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, aims to support early stage development of entirely new noninvasive imaging methods or unusually bold approaches for existing noninvasive imaging methods that will lead to transformative advances in our understanding of the function and connectivity of the human brain. The FOA solicits small-scale projects to prove exceptionally innovative, original and/or unconventional concepts.

This Funding Opportunity Announcement (FOA) will support students at institutions without NIH-funded institutional predoctoral dual-degree training programs. The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and who intend careers as physician/clinician-scientists. Candidates must propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist. This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

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

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NINDS Neuroscience Development for Advancing the Careers of a Diverse Research Workforce R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce by (1) increasing the pool of current and future Ph.D.-level research scientists from diverse backgrounds underrepresented in biomedical neuroscience research; and (2) facilitating the career advancement/transition of the participants to the next step of their neuroscience careers. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on NINDS relevant research experiences, mentoring activities that enhance compentencies or leadership education and courses on skills development. Programs that target transitions and/or more than one career stage for neuroscience career advancement and progression are strongly encouraged. NINDS support for this R25 program relies equally on scientific merit and programmatic considerations. Consequently, we recommend that potential applicants contact Scientific/Research staff at NINDS before preparing an application. NINDS will not support projects if they do not fulfill current programmatic priorities at NINDS.

The NIH is coordinating efforts for establishing a developmental Genotype-Tissue Expression (dGTEx) project, to catalog and analyze transcriptional profiles from a wide variety of tissues obtained from neonates, children, and adolescents in a post-mortem setting. The purpose of this funding opportunity is for support of a Biospecimen Procurement Center (BPC) to enroll suitable pediatric donors and provide high quality tissue samples for analyses to the Laboratory, Data Analysis, and Coordinating Center (LDACC). The BPC will work closely with the LDACC to optimize tissue collection, preservation and transfer of specimens.

The National Human Genome Research Institute (NHGRI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development are coordinating efforts for establishing a Developmental Genotype-Tissue Expression (dGTEx) project, to catalog and analyze transcriptional profiles from a wide variety of tissues obtained from neonates, children, and adolescents in a post-mortem setting. The purpose of this FOA is to solicit applications to develop and implement a Laboratory, Data Analysis, and Coordinating Center (LDACC) for the Developmental Genotype-Tissue Expression (dGTEx) Project. The LDACC will perform 2 major functions: a molecular laboratory, and a data analysis and coordinating center. As a molecular laboratory, the LDACC will work with the Biospecimen Procurement Center (BPC) funded by NICHD to process tissue samples for sequencing and biobanking. Responsibilities as a data analysis and coordinating center include ensuring close coordination with the BPC, monitoring study progress and laboratory performance, performing basic analysis of data for gene expression analyses, and harmonizing and submitting datasets to be deposited in repositories such as the AnVIL ((Analysis, Visualization, and Informatics Lab-space) https://anvilproject.org/) or the GTEx portal (https://gtexportal.org/home/).

Notice Special Interest NOSI): Common Fund ALS-related Transformative Research Award R01 Clinical Trial Optional) Notice Number: NOT-RM-20-019 Key Dates Release Date: June 17, 2020 Related Announcements RFA-RM-20-013 - NIH Directors Transformative Research Awards R01 Clinical Trial Optional) Issued Office Strategic Coordination Common Fund) National Institute Aging NIA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the special interest the Office Strategic Coordination Common Fund), National Institute Neurological Disorders Stroke NINDS), National Institute Aging NIA), National Institute Environmental Health Sciences NIEHS), National Institute General Medical Sciences NIGMS) supporting exceptionally innovative research the basic biology Amyotrophic Lateral Sclerosis through NIH Directors Transformative Research Award initiative. Background: Amyotrophic lateral sclerosis ALS) a devastating disease no known cure. is neurodegenerative disease causes death motor neurons control voluntary muscles. results weakness ultimately loss voluntary muscle function. ALS rapidly progressive always fatal. people die within 3-5 years developing symptoms. cause ALS unknown likely involves combination genetic environmental risk factors. 5 10% cases familial the remaining cases considered be sporadic. Hampered the unknown etiology ALS despite extensive efforts, only drugs been developed are FDA approved these drugs extend life just few months do improve symptoms. Thus, development effective ALS therapeutics benefit tremendously investing basic ALS research tests highly novel concepts, brings together researchers different scientific perspectives, applies powerful emerging technologies a variety disciplines. Though such highly innovative research be inherently risky, potential payoff our understanding ALS warrant risk. solicit support such high-risk, high-reward ALS-related research, Accelerating Leading-edge Science ALS ALS2) being created. ALS2 use existing NIH Directors Transformative Research Award initiative receive review applications. initiative part the NIH Common Funds High-Risk, High-Reward Research HRHR) Program. HRHR program offers time-tested, powerful approach sparking innovation impact. Transformative Research Award initiative a particularly well-suited initiative within HRHR program supporting interdisciplinary teams scientists proposing combine expertise pursue highly innovative ideas. Transformative Research Award applications not require preliminary data a detailed experimental plan. Rather, emphases unusually high magnitude potential impact, exceptional degree innovation, a highly compelling logic the approach. note, anonymized review process the Transformative Research Award applications being piloted year help maintain focus these emphases. Large budgets exceeding 500,000 direct costs any given year) acceptable without pre-approval must commensurate the scope the project. Objective objective this Notice to advance dramatically our understanding the complex biology ALS. Thus, applications use or of following elements encouraged: Adapt emerging tools technologies neuroscience, cell biology other disciplines identify causes ALS how disease progresses, forming basis new potential therapeutic strategies. Attract new talent a range scientific disciplines, including cell biology, bioengineering, chemistry, biophysics, environmental health sciences, computational science, initiate new interdisciplinary collaborations. Explore potential similarities between ALS other neurodegenerative disorders beyond, including, not limited to, frontotemporal dementia, chronic traumatic encephalopathy, Kennedys disease, spinal muscular atrophy, primary lateral sclerosis, aging-induced neuromuscular degeneration. Application, Review, Funding Information Applications must submitted response FOA RFA-RM-20-13. instructions the FOA must followed. addition, applications must indicate NOT-RM-20-019 without quotation marks) the Agency Routing Identifier field Box 4b) the SF424 R&R) Form. Applications without information Box 4b not considered support the ALS2 program. receipt date September 30, 2020. Applications be reviewed using same review process for other Transformative Research Award applications described RFA-RM-20-013. Funding applications submitted through Notice be considered separately other TRA applications will based the results peer review programmatic priorities. Inquiries Please direct inquiries to: Amelie K. Gubitz, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email:gubitza@ninds.nih.gov Ravi Basavappa Office the Director OD) Telephone: 301-435-7204 Email:Transformative_Awards@mail.nih.gov Lisa Opanashuk, Ph.D. National Institute Aging NIA) Telephone: 301-82705422 Email: lisa.opanashuk@nih.gov Jonathan A. Hollander, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 Email: jonathan.hollander@nih.gov Oleg Barski, Ph.D. National Institute General Medical Sciences NIGMS) Telephone: 301-496-1511 Email: oleg.barski@nih.gov

The purpose of this Funding Opportunity Announcement (FOA) is to address the problem of HIV persistence in people living with HIV treated with suppressive antiretroviral drug regimens. This FOA will support coordinated basic, clinical, and applied research focused on developing strategies to achieve an HIV cure, defined as either sustained viral remission or eradication of HIV infection. While some aspect of clinical research is required, unlike the previous iteration of this RFA, clinical trials will no longer be supported. The application must include at least one private sector entity to facilitate rapid translation of basic discovery research into therapeutic development and testing. Collaboratory research should be milestone-based and should be focused on specific innovative approaches to characterize and quantify persistent HIV-1 reservoirs and/or understand and predict post-treatment control of viral rebound, identify and test therapeutic strategies to control viral rebound after discontinuation of antiretroviral therapy, and identify and test strategies to eradicate or permanently inactivate rebound-competent HIV.

Notice Special Interest NOSI): Emergency Competitive Revisions Social, Ethical, Behavioral Implications SEBI) Research COVID-19 Testing among Underserved and/or Vulnerable Populations Notice Number: NOT-OD-20-119 Key Dates Release Date: June 12, 2020 First Available Due Date: July 08, 2020 Expiration Date: September 09, 2020 Related Announcements NOT-OD-20-131 - Notice Pre-Application Webinar the RADx-UP Initiative PA-20-135 - Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) NOT-OD-20-121 - Notice Special Interest NOSI): Limited Competition Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations NOT-OD-20-120 - Notice Special Interest NOSI): Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations RFA-OD-20-013- Emergency Awards: RADx-UP Coordination Data Collection Center CDCC) U24 Clinical Trial Optional) NOT-OD-20-138 - Notice Correction NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section NOT-HL-20-803 - Notice NHLBI Participation NOT-OD-20-119 NOT-HL-20-804 Notice NHLBI Participation NOT-OD-20-120 NOT-HL-20-805 - Notice NHLBI Participation NOT-OD-20-121 NOT-OD-20-157 - Notice Clarify Correct Eligibility Notices Special Interest under Rapid Acceleration Diagnostics Underserved Populations RADx-UP) Program Issued Office The Director, National Institutes Health OD)National Institute Minority Health Health Disparities NIMHD) National Institute Aging NIA) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) 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 Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) National Cancer Institute NCI) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers.Sexual Gender Minority Research Office SGMRO) Tribal Health Research Office THRO) Office The Director, National Institutes Health OD) Division Program Coordination, Planning Strategic Initiatives, Office Disease Prevention ODP) Office Behavioral Social Sciences Research OBSSR) Office Research Women's Health ORWH) Environmental Influences Child Health Outcomes ECHO) of Us Research Program - New participating organization of 7/10/2020 due dates on/after 8/7/2020 Purpose Notice Special Interest NOSI) highlights urgent need understand social, ethical, behavioral implications SEBI) COVID-19 testing among underserved and/or vulnerable populations across United States through Rapid Acceleration Diagnostics Underserved Populations RADx-UP) initiative. overarching goal to understand factors have led disproportionate burden the pandemic these underserved populations that interventions be implemented decrease disparities. funding this supplement provided the Paycheck Protection Program Health Care Enhancement Act, 2020. Office the Director therefore offering Emergency Competitive Revisions active eligible grants cooperative agreements addressing objectives described below. NOSI one four related RADx-UP opportunities. purpose this SEBI NOSI to identify, analyze, address social, ethical, behavioral factors likely influence access uptake COVID-19 testing underserved and/or vulnerable populations. Single mixed methods approaches involving community partners inform development evaluation such testing programs. studies assess ethical, historical, healthcare, social contextual factors surrounding COVID-19 testing, well how cultural beliefs attitudes, perceived expectations, preferences influence ability willingness get tested participate follow-up evaluations. Findings be used develop interventions mitigate barriers access increase uptake testing. Studies focused unintended consequences COVID-19 testing these groups also interest related social ethical issues. related program initiatives include: NOT-OD-20-121which encourages community-engaged Testing Research Projects supplement large scale networks, consortia, centers, examine SARS-CoV-2 infection patterns efforts increase access effectiveness diagnostic methods. NOT-OD-20-120 a similar focus, shifts pool eligible grants supplementation individual research awards include community collaboration partnership, generally targeting specific populations. RFA-OD-20-013 is U24 Coordination Data Collection Center CDCC) a key component the consortium Collectively, projects funded under three NOSIs serve one consortium interlinked community-engaged research projects across United States understand COVID-19 health disparities, to deploy implementation strategies improve reach, acceptance, uptake, sustainability COVID-19 testing. NIH expects all supplements funded under NOSI the related NOSIs actively coordinate share data where allowed) other grantees, CDCC, other research supported the RADx-UP program. Research specifically develops implements novel COVID-19 testing programs the populations defined below under Key Definitions should submitted under either NOT-OD-20-120 NOT-OD-20-120instead this NOSI. Applicants this SEBI NOSI allowed, not required, apply the RADx-UP opportunities. Researchers applying this NOSI strongly encouraged read four these interrelated funding opportunities. Researchers applying this NOSI strongly encouraged read four these interrelated funding opportunities. Key Definitions NOSI applicable those populations are underserved well populations are COVID-19 vulnerable due medical, geographic, social factors, defined below referred as underserved and/or vulnerable elsewhere this NOSI): Underserved: NIH-designated health disparity populations and/or groups known experience barriers needed health care services, to inadequate health care coverage. full description be found https://www.nimhd.nih.gov/about/overview/. COVID-19 medically and/or socially vulnerable populations: Residents nursing homes assisted living facilities; community-dwelling older adults; individuals intellectual, developmental, sensory, physical disabilities, cognitive impairment dementia, communication disorders; homeless populations; individuals involved the criminal juvenile justice systems incarcerated under community supervision); individuals medical comorbidities known increase risk severe COVID-19, including heart failure related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant post-partum women; children adolescents; individuals living congregate housing such shelters residential treatment facilities; individuals overcrowded public housing; individuals substance disorders serious mental illness; detainees immigration detention centers; migrant immigrant communities; residents tribal lands reservations; communities exposed high rates air pollution other toxic exposures; rural remote communities. Background SARS-CoV-2 a novel coronavirus has recently identified the causative agent COVID-19, respiratory disease exhibits wide range clinical outcomes asymptomatic mild disease severe viral pneumonia, Acute Respiratory Distress Syndrome ARDS), Multisystem Inflammatory Syndrome Children MIS-C), acute kidney injury, thrombotic disorders serious cardiac, cerebrovascular vascular complications. United States Food Drug Administration FDA)-authorized COVID-19 diagnostic testing critical slowing spread the virus preventing future outbreaks. Growing evidence suggests underserved and/or vulnerable populations more susceptible COVID-19 infection, severe COVID-19 complications, associated death, well the social, behavioral economic impacts the pandemic. Over next six months, advances testing technology vaccine development anticipated. Strategies accelerate dissemination these improved tests vaccine trials underserved and/or vulnerable populations also must developed. However, populations experience multilevel barriers testing arising individual, interpersonal, institutional e.g., health care system), community, policy levels reduce access and acceptance COVID-19 testing. Similar concerns the potential limit uptake public health impact future vaccination trials implementation programs, dissemination effective therapeutics ambulatory care settings. Against backdrop, COVID-19 testing programs underserved and/or vulnerable populations must design communication strategies, consent materials, data governance plans, processes return results, informational referral resources are responsive the communities will serve. inform development evaluation such testing programs, studies solicited here focus assessing ethical, historical, healthcare, social, economic, contextual factors surrounding COVID-19 testing, well cultural beliefs attitudes, expectations, preferences testing test results influence groups ability willingness get tested. factors include are limited individual proximal environmental factors such normative beliefs, peer influence, incentive/disincentive structures the social community environment may influence testing uptake. SEBI studies also focus factors the interpersonal, institutional e.g., health system), community, policy levels affect access COVID-19 testing among underserved and/or vulnerable populations. Findings be used inform development intervention strategies tools increase access and acceptability testing specified populations. findings help guide design implementation strategies other domains the consortium see, NOSI NOT-OD-20-121 NOSI NOT-OD-20-120, respectively]) in Phase II the RADx-UP initiative be announced a later date), will address developments diagnostics vaccination. Studies supported under NOSI should work closely communities support depth examination social, ethical behavioral factors related COVID-19 testing vaccination research. Projects also expected specify strategies address social determinants health SDOH) present barriers participation testing follow-up. RADx-UP projects expected demonstrate ability leverage existing partnerships such with Tribal governments organizations, academic community medical centers health systems, safety-net health social service systems, grassroots organizations, public health departments, community faith-based organizations, schools child care settings) complete study aims. Applicants should provide evidence collaboration community organizations whom will work must describe roles all partners. Study budgets should include funds the community partners be fully engaged successfully participate research design implementation. address expected impacts COVID-19 the scientific workforce, projects also strongly encouraged support early stage investigators, specifically targeting ability enhance diversity their research workforce. Applicants strongly encouraged contact SEBI program officials prior developing application determine programmatic responsiveness the NOSI. Areas Research Interest Supported studies should address key questions more one level analysis e.g., individual, interpersonal, institutional e.g., health system], community, policy). Scientific questions interest include, are limited to: social, ethical behavioral facilitators barriers substantially influence decisions whether when offer seek COVID-19 testing? strategies mitigate barriers, increase access and acceptability testing repeat testing? are implications both positive negative COVID-19 diagnostic tests underserved and/or vulnerable groups, how they influence testing decisions downstream beliefs behaviors? are test results interpreted used these underserved and/or vulnerable communities? are risks benefits implementing new COVID-19 testing technologies underserved and/or vulnerable communities the perspectives those populations? population specific social, ethical, behavioral factors should addressed before deploying novel testing strategies? factors should addressed before vaccine trials be considered? strategies be developed tested increase acceptability vaccine trials vaccinations underserved and/or vulnerable populations? Applicants encouraged consider investigate: Social, economic, ethical, cultural, historical, contextual factors beliefs behaviors associated testing/diagnostic technologies Collection, storage, and public health reporting requirements COVID-19 test data, considering Tribal data sovereignty where appropriate Return results, repeat testing, implications and provision support negative positive test results under-resourced populations, individual patients, their families Availability tests referral networks follow-up care social services address basic needs related COVID-19 e.g., patient referral navigation services) Stigma, discrimination, financial burden associated accessing testing a positive test result follow-up care Implications contact tracing including mistrust privacy considerations Health-related beliefs behavior regarding willingness be vaccinated against SARS-CoV2 or an effective vaccine made available most effective community engagement strategies inform culturally sensitive implementation diagnostic testing underserved and/or vulnerable populations Where possible, applications should work towards outcomes products could used improve access and acceptability COVID-19 diagnostics. Examples possible study outcomes included below. However, researchers should address outcomes identified high priority the communities being studied. studies focus specific communities, yet should also consider extent which findings be generalized adapted implemented across underserved and/or vulnerable populations. Applications should briefly describe generalizability, where possible, study approaches findings broader populations include plans the development materials toolkits facilitate adaptation, dissemination, implementation. Applications should detail community-engaged methods assess barriers COVID-19 test access, uptake follow-up, develop evaluate strategies interventions address those barriers. Applications should include dissemination activities maintain bi-directional feedback loops community experts RADx-UP study findings. Development pre-testing potential interventions increase testing access, acceptability, feasibility, uptake be interest. However, should be primary aim the application. Potential applicants considering applications focused interventions increase access uptake COVID-19 diagnostics should consult additional opportunities. Applications propose studies using either single mixed methods. Proposed approaches include, are limited hypothesis-generating qualitative quantitative approaches, observational research, randomized efficacy studies, policy, economic normative analyses, other types analytical conceptual research methodologies, such those involving direct engagement stakeholders. Sample Research Topics Products Broad research topic areas listed below, followed examples specific issues within area. list research topics issues not exhaustive, the order listed does indicate relative priority. Also listed possible outcomes, products tools could used improve access uptake COVID-19 testing. Applicants should develop aims products appropriate the goals this NOSI, close collaboration community partners. Decision-Making COVID-19 Diagnostics Assess factors influencing ability willingness underserved and/or vulnerable communities access available diagnostic services follow-up care services following positive results. Enumerate key facilitators barriers, strategies harness facilitators mitigate barriers. Assess reasons testing decisions, including perceived/actual harms benefits different testing decisions. Assess these factors weighed determine is most/least likely get tested under various scenarios locations e.g., health status, family member test status, employment health insurance status, rural/urban). Examine perceived actual risks testing other parties including family members, traced contacts, broader communities, how those risks influence decision-making. Assess variations provider, health system, employer protocols COVID-19 test eligibility, how are influenced socio-contextual factors. Products Validated reliable assessment tools determine likelihood seeking COVID-19 testing Strategies acknowledge influence contextual/health-related beliefs attitudes testing Strategies make testing accessible acceptable communities interest Return COVID-19 Test Results Determine information community members want learn believe would need their COVID-19 status diagnostic tests. Assess perceived utility diagnostic test result information, how those perceptions influence uptake. Determine information resource needs the time return results, develop assess communication methods varied languages, literacy levels, modes delivery. Assess improve understanding, misunderstanding retention key information using multimodal resources delivery channels. Assess test recipients interpret act their results, including mitigation behaviors a result negative findings e.g., less vigilance social distancing, wearing mask public, handwashing, etc.), information-seeking resources lead referral at-risk contacts testing. Products Results templates toolkits designed collaboration communities Strategies resources increase and utility results accompanying information resources Strategies encourage testing at-risk contacts Strategies encourage repeat testing follow-up services, appropriate Data Stewardship, Data Sharing Privacy Explore community understanding, expectations, concerns preferences governance, privacy, security, and sharing participant COVID-19 data including sharing secondary users, such third-party payers, employers, housing managers authorities, public health departments, law enforcement, etc.). Determine specified communities view balance public health benefits sharing test results e.g. contact tracing) cultural norms personal opinions privacy; explore these views influence testing decisions. Develop transparent governance policies COVID-19 test data meet scientific public health goals, while addressing acknowledging community concerns limitations. Product Community-informed data governance policies Health Communication, Literacy, Language Increasing understanding COVID-19 testing vaccination precursors uptake. Approaches should use multiple formats channels address linguistic cultural barriers. Assess trust local, regional national sources COVID-19 data testing information among underserved and/or vulnerable populations. Test impacts information source(s) beliefs veracity theoretical antecedents e.g., motivation, agency, intentions) behavior. Examine role health literacy, including limited English language literacy, COVID-19 testing disparities. Assess address current sources content messaging leading key understanding, misunderstanding misrepresentation these communities COVID-19 testing, contact tracing, vaccination. Identify messaging targets help improve testing uptake vaccination acceptance available. Assess interpersonal e.g., healthcare provider) COVID-19 communications working underserved and/or vulnerable populations address social ethical implications. Develop test community culturally appropriate COVID-19 messages specific foci social ethical considerations Assess address long-held beliefs attitudes science, government, health care public health enhance deter uptake testing vaccination. Products Create trusted local regional COVID-19 communication networks reach underserved and/or vulnerable populations; develop strategy aid similar partnership development other localities. Tested strategy improve quality, consistency quantity COVID-19 communication Tested materials approaches ameliorate distrust, fear, stigma discrimination surrounding COVID-19 Tested materials approaches address current misrepresentations misunderstandings inhibiting uptake COVID testing vaccination. Ensure products available readily adaptable other communities languages Vaccine Preparedness Underserved and/or Vulnerable Populations Understand population specific beliefs, attitudes, intentions towards future COVID-19 vaccination including individual, familial, community, economic, structural influences vaccine acceptability hesitancy. Assess misinformation the design countermeasures misinformation regarding vaccination Examine assess implementation strategies vaccine trial scale-up underserved and/or vulnerable communities, including roles organizations institutions the community. Develop culturally competent strategic communication COVID-19 vaccination averts stigma ensures effective exchange dissemination information. Develop methods ensure appropriate consent vaccine trials including approaches children parents/guardians other underserved and/or vulnerable populations Products: Resources strategies assess vaccine trial acceptability specified communities Resources strategies addressing community concerns regarding vaccine trials Resources community engagement collaboration vaccine trials Applications nonresponsive terms this NOSI not considered. following types projects generally be appropriate may deemed non-responsive: Projects primarily increasing delivery COVID-19 testing NOSINOT-OD-20-121 NOSI NOT-OD-20-120) Projects without focus one more underserved COVID-19 vulnerable populations Projects have limited population reach taking account size the target populations its COVID-19 epidemiologic profile) Projects do demonstrate equitable relationship engagement strategy the underserved and/or vulnerablepopulations interest Projects do include community engagement efforts Projects involve COVID-19 testingor SEBIoutside the United States Projects do address social, ethical, behavioral consequences their proposed design methods may exacerbate health disparities COVID-19 diagnostic testing Projects do consider than level analysis individual, interpersonal, institutional, community, policy) Projects are exclusively qualitative though mixed quantitative qualitative acceptable) Projects do have infrastructure rapidly report study findings impact the CDCC Projects have limited testing capacity, do include FDA-authorized testing strategies present plan incorporate approved testing strategies Projects supplementing grants are eligible this NOSI Eligibility section below under Application Submission Information maximize comparisons across datasets studies, facilitate data integration collaboration where appropriate study aims, researchers funded through NOSI strongly encouraged use following resources: Guidance provided the CDCC data acquisition, collection curation, including appropriate consent data sharing implementation the schemas proposed under ABOUT ML effort ( Annotation benchmarking understanding transparency machine learning lifecycles; available https://www.partnershiponai.org/about-ml/). Data Harmonization Social Determinants Health SDOH), COVID-19, other relevant measures via PhenX Toolkit: Investigators involved human-subject studies strongly encouraged employ common set tools resources will promote collection comparable data 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). 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 where address questions interest. Additionally, researchers funding through NOSI be required share survey items, data collection instruments methods other researchers consider submitting resources NIHCOVID19Measures@nih.gov. Review Process Applications be evaluated scientific technical merit an appropriate internal NIH staff review panel, accordance the review criteria specified PA-20-135 well these additional review criteria: there evidence strong established research collaborations proposed community partners? feasible appropriate the plans integrating community partners the study? Urgency significance research: successful completion the aims contribute or complement public health efforts the control SARS-CoV-2 COVID-19) infection related pathogenic processes? Does proposed research fit within mission an emergency response provide critical expertise, resources activities? Feasibility research: the overall strategy, methodology, analyses well-reasoned appropriate accomplish specific aims the project? the emergency time frame feasible the proposed research? the proposed approach dynamic responsive evolving changes COVID-19 diagnostics the United States? Outcomes: outcomes products result could used improve access, acceptability, uptake COVID-19 testing? the study contribute understanding diagnostic testing be clinically personally useful individuals, households communities? the proposed approaches likely yield important contributions applicable a range populations healthcare settings? the timeline milestones) appropriate feasible support aims goals the study? the PD/PIs, collaborators, other researchers well suited appropriate carry the project? feasible appropriate the plans sustainability project infrastructure partnerships may leveraged future engagement work surrounding public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts? Data sharing plan: there timely plans consistent the goals the program make instruments, products, results data findable accessible the research community, where limited Tribal data sovereignty? Coordination plans: feasible appropriate the plans submit data, data collection instruments outcomes/products the CDCC FOA RFA-OD-20-013)? feasible appropriate the plans collaborate the RADx-UP field sites NOSI NOT-OD-20-121 NOSI NOT-OD-20-120). the management plan well-described commensurate the level complexity required this NOSI? timely feasible remediation plans adverse outcomes included appropriate? Pre-award costs Pre-award costs be incurred January 20, 2020 through public health emergency period prior the date the federal award. Reporting OD plans make awards using funds provided the emergency supplemental appropriations COVID-19 coronavirus research: Paycheck Protection Program Health Care Enhancement Act, Public Law 116-139. Funds awarded using appropriations provided the Paycheck Protection Program Health Care Enhancement Act, Public Law 116-139 be issued unique subaccounts the HHS Payment Management System will require separate financial reporting any funds awarded. Application Submission Information Applications response this NOSI must submitted using Emergency Competitive Revision Existing NIH Awards Emergency Supplement Clinical Trial Optional) mechanism PA-20-135 https://grants.nih.gov/grants/guide/pa-files/PA-20-135.html), its subsequent reissued equivalents. Applications invited investigators representing wide range disciplines, including not limited ethics, health disparities research, health communication communication science, implementation science, clinical care, home community-based services, infectious disease, community-based participatory research, policy studies, public health, epidemiology, bioinformatics health information sciences, behavioral social sciences e.g., psychology, sociology, social work, anthropology, political science, economics, communication science). Notice supports collection multiple types data including qualitative quantitative methods, well reviews documents available data where appropriate. Where possible, primary alternate methods are robust unaffected shelter-in-place other restrictions research environments encouraged, although evidence availability acceptability communities individuals should provided, along the capacity maintain standards ethical research conduct. Applicants should describe the Research Strategy ideas working other SEBI RADx-UP sites accomplish project goals, their willingness adhere policies procedures determined cooperation the CDCC ( RFA-OD-20-013) Projects must focus and include or underserved and/or vulnerable populations identified above). Applicants should demonstrate successful record collaboration existing community partners. funding instrument, activity code, be same the parent award. NIH reminds applicants the appropriate consideration sex gender described NOT-OD-15-102 NIH policy a consideration NIH support. Eligibility Eligible existing grants can revised response this NOSI limited eligible non-fellowship active research resource grants cooperative agreements. Currently funded grantees apply work is related their funded project, whether within scope outside the scope the current project, regardless the time remaining the current project. Grants currently a no-cost extension eligible apply. instructions the SF424 R&R) Application Guide in target funding opportunity announcement PA-20-135) must followed, the following additions: Individual requests be more 400,000 direct costs per year up two years. Research Strategy section the application limited 12 pages. Applicants request supplements budgets exceed parent award. Budgets must reasonable reflect actual needs the project. be eligible a competing revision award under NOSI, parent award which revision application based must an active award including those a no-cost-extension period) managed one the participating institutes centers. Applicants should address whether how ongoing potential future public health restrictions e.g., closures, physical distancing, ability hold large meetings) might affect research approach and, so, include plan prevent mitigate any effect the proposed study. Applications be submitted beginning July 8, 2020 Application Due Dates August 7, 2020 5:00 PM local time the applicant organization) September 8, 2020 5:00 PM local time the applicant organization). Applications received after September 8, 2020 not considered. earliest start date applications received or before August 7, 2020 be September 2020, for applications received August 8, 2020 later be November, 2020. application submitted response this NOSI is received September 9, 2020 later be withdrawn. Specific applications target PA-20-135 Emergency Supplements): IMPORTANT: funding consideration, applicants must designate NOT-OD-20-119" without quotation marks) the Agency Routing Identifier field Box 4b) the SF424 R&R) Form. Applications without information Box 4b not considered this initiative. applications including those multi-project activity codes) must submitted electronically using single-project application form package Competitive revision applications PA-20-135 must the application form package the Competition ID contains FORMS-F-COMP-REV". Investigators planning submit application response this NOSI strongly encouraged contact discuss proposed research/aims Program staff listed this NOSI well advance the application receipt date better determine appropriateness interest the relevant Institute. Applicants also strongly encouraged notify Program staff listed this NOSI a request been submitted response this FOA order facilitate efficient processing the request. Office Behavioral Social Sciences OBSSR) does accept assignment applications manage awards are funded. Please contact of ICs listed below inquiries regarding suitability the proposed project the FOA the IC's research portfolio. 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: National Institute Minority Health Health Disparities NIMHD): Scientific Program Contact: Nancy Jones, PhD, 301.594.8945, nancy.jones@nih.gov Grants Management Contact: Priscilla Grant, JD, 301-594-8412, grantp@mail.nih.gov National Institute Aging NIA): Scientific Program Contact: Jonathan W. King, PhD., 301-496-3136, kingjo@nia.nih.gov Grants Management Contact: E. C. Melvin, 301-480-8991, e.melvin@nih.gov Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): Scientific Program Contact: Sonia Lee, PhD, 301-594-4783, leesonia@mail.nih.gov Grants Management Contact: Bonnie Jackson, 301-496-5482, jacksonbo@mail.nih.gov Fogarty International Center FIC): Program Contact: Marya Levintova, PhD, 301-496-1653, levintovam@mail.nih.gov Grants management Contact: Mollie Shea, 301-451-6830, Mollie.Shea@nih.gov National Cancer Institute NCI): Scientific Program Contact: LeeAnn Bailey, PhD, MS, 240-276-5337, leeann.bailey@nih.gov Grants Management Contact: Crystal Wolfrey, 240-276-6277, wolfreyc@mail.nih.gov National Center Advancing Translational Sciences NCATS): Scientific Program Contact: Xinzhi Zhang, MD, PhD, 301-827-9205, xinzhi.zhang@nih.gov Grants Management Contact: Esther Young, 301-402-7138, esther.young@nih.gov National Center Complementary Integrative Health NCCIH): Scientific Program Contact: Dave Clark, DrPH, 301-827-1916, Dave.Clark@nih.gov Grants Management Contact: Shelley Carow, 301-594-3788, carows@mail.nih.gov National Eye Institute NEI): Scientific Program Contact: Cheri Wiggs, PhD, 301-451-2020, cheri.wiggs@nih.gov Grants Management Contact: Karen Robinson Smith, 301-451-2020, Karen.Robinson.Smith@nei.nih.gov National Heart, Lung, Blood Institute NHLBI): Scientific Program Contact: Catherine M Stoney, PhD, 301-435-6670, catherine.stoney@nih.gov Grants Management Contact: Tracee Forster, 301-827-8030, tracee.foster@nih.gov National Human Genome Research Institute NHGRI): Scientific Program Contact: Dave Kaufman, PhD, 301-594-6907, dave.kaufman@nih.gov Grants Management Contact: Deanna Ingersoll, 301-435-7858, Deanna.Ingersoll@nih.gov National Institute Allergy Infectious Diseases NIAID): Scientific Program Contact: Ann Namkung, MPH, 240-627-3099, anamkung@niaid.nih.gov Grants Management Contact: Ann Devine, 240-669-2988, Ann.Devine@niaid.nih.gov National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Scientific Program Contact: Stephanie George, PhD, MPH, MA, 301) 594-4974, stephanie.george@nih.gov Grants Management Contact: Erik Edgerton, 301) 594-7760, edgertont@mail.nih.gov National Institute Biomedical Imaging Bioengineering NIBIB): Scientific Program Contact: Qi Duan, PhD, 301-827-4674, qi.duan@nih.gov National Institute Dental Craniofacial Research NIDCR): Scientific Program Contact: Elise Rice, PhD, 301-594-4814, elise.rice@nih.gov Grants Management Contact: Diana Rutberg, 301-594-4798, rutbergd@mail.nih.gov National Institute Diabetes Digestive Kidney Diseases NIDDK): Scientific Program Contact: Paul L. Kimmel, MD, MACP, 301-594-1409, paul.kimmel@nih.gov Grants Management Contact: Natasha Loveless, 301-594-8853, natasha.loveless@nih.gov National Institute Environmental Health Sciences NIEHS): Scientific Program Contact: Gwen W. Collman, PhD, 984-287-3249, collman@niehs.nih.gov Grants Management Contact: Jenny Greer, 984-287-3332, jenny.greer@nih.gov National Institute General Medical Sciences NIGMS): Scientific Program Contact: Dorit Zuk, PhD, 301-827-7616, dorit.zuk@nih.gov Grants Management Contact:Christy Leake, 301-594-7706, Christy.leake@nih.gov National Institute Mental Health NIMH): Scientific Program Contact:Crystal L. Barksdale, PhD, MPH, 301-443-7034, crystal.barksdale@nih.gov Grants Management Contact:Rita Sisco, 301-443-2805, siscor@mail.nih.gov National Institute Neurological Disorders Stroke NINDS): Scientific Program Contact:Richard T. Benson, MD, PhD, 301-827-9071, Richard.benson@nih.gov Grants Management Contact:Chief Grants Management Officer, ChiefGrantsManagementOfficer@ninds.nih.gov National Institute Nursing Research NINR): Scientific Program Contact:Jeri L. Miller, PhD, 301-594-6152, jmiller@mail.nih.gov Grants Management Contact: Brian Albertini, 301-594-6869, albertib@mail.nih.gov National Institute Alcohol Abuse Alcoholism NIAAA): Scientific Program Contact:Judith A. Arroyo, PhD, 301-402-0717, jarroyo@mail.nih.gov Grants Management Contact: Judy Fox, 301-443-4704, jfox@mail.nih.gov National Institute Deafness Other Communication Disorders NIDCD): Scientific Program Contact:Judith Cooper, PhD, 301-496-5061, cooperj@nidcd.nih.gov Grants Management Contact: Chris Myers, 301-435-0713, myersc@mail.nih.gov National Institute Drug Abuse NIDA): Scientific Program Contact:Richard A. Jenkins, PhD, 301.443.1923, jenkinsri@nida.nih.gov Grants Management Contact:Pam Fleming, 301.480.1159, pfleming@nida.nih.gov National Library Medicine NLM): Scientific Program Contact: Valerie Florance, PhD, 301-496-4621. florancev@mail.nih.gov Grants Management Contact:Samantha Tempchin, 301-496-4221, Tempchins@mail.nih.gov National Institute Biomedical Imaging Bioengineering NIBIB) Grants Management Contact: Kwesi Wright, 301-451-4789,Kwesi.Wright@nih.gov Office the Director, Environmental Influences Child Health Outcomes ECHO): Scientific Program Contact: Carol Blaisdell, MD, MEd, 301-435-5606, carol.blaisdell@nih.gov Grants Management Contact ECHO Cohorts): Donna Sullivan, 240-669-2979, dsullivan@niaid.nih.gov Grants Management ECHO ISPCTN) Contact: Bryan S. Clark, MBA Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), 301-435-6975, clarkb1@mail.nih.gov Office Behavioral Social Science Research OBSSR): Scientific Program Contact: Deborah Young-Hyman, PhD, 301-451-0721; deborah.young-hyman@nih.gov Office Disease Prevention ODP/DPCPSI/OD): Scientific Program Contact:Jacqueline Lloyd, PhD, MSW, 301.827.5559, lloydj2@nih.gov Office Research Womens Health ORWH): Scientific Program Contact: Damiya S. Whitaker, PsyD, MA, 301-451-8206, damiya.whitaker@nih.gov Sexual Gender Minority Research Office SGMRO): Scientific Program Contact:Christopher Barnhart, PhD, 301-594-8983, Christopher.barnhart@nih.gov Tribal Health Research Office THRO): Scientific Program Contact:Maria Jamela Revilleza, PhD, 301-451-0724, MariaJamela.Revilleza@nih.gov of Us Research Program: Sheri D. Schully, Ph.D., 301-827-1691, schullys@mail.nih.gov Kimberly Stanton, 301-827-8054, stantonk@nhlbi.nih.gov