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Notice of Special Interest (NOSI): Understanding Sudden Death in the Young Through Research

Notice of Special Interest
Monday, June 29, 2020
Sunday, January 8, 2023
R01
NOT-HL-20-787

Funding Opportunity Purpose

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

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 Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s 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 tochromosome 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 Special Interest (NOSI): Common Fund ALS-related Transformative Research Award (R01 Clinical Trial Optional)

Notice of Special Interest
Wednesday, June 17, 2020
Sunday, January 1, 2023
R01
NOT-RM-20-019

Funding Opportunity Purpose

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 Director’s 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 Director’s 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 Director’s Transformative Research Award initiative receive review applications. initiative part the NIH Common Fund’s 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, Kennedy’s 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

Notice of Special Interest (NOSI): Emergency Competitive Revisions for Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing among Underserved and/or Vulnerable Populations

Notice of Special Interest
Friday, June 12, 2020
Wednesday, September 9, 2020
333
NOT-OD-20-119

Funding Opportunity Purpose

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) 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) 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 Women’s 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

Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations

Notice of Special Interest
Friday, June 12, 2020
Wednesday, September 9, 2020
333
NOT-OD-20-120

Funding Opportunity Purpose

Notice Special Interest NOSI): Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations Notice Number: NOT-OD-20-120 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-20-119 - Notice Special Interest NOSI): Emergency Competitive Revisions Social, Ethical, Behavioral Implications SEBI) 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) 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 Neurological Disorders Stroke NINDS) National Institute Mental Health NIMH) 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) Purpose Notice Special Interest NOSI) highlights urgent need understand address COVID-19 morbidity mortality disparities among underserved vulnerable populations across United States. two-year community-engaged Testing Research Projects examine SARS-CoV-2 infection patterns efforts increase access effectiveness diagnostic methods 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 program provided the Paycheck Protection Program Health Care Enhancement Act, 2020. Office the Director OD) therefore offering Emergency Competitive Revisions active eligible grants cooperative agreements addressing objectives described below. NOSI one four related RADx-UP funding opportunities. Testing Research Projects NOSI support supplements individual NIH research awards include community collaborations partnerships support COVID-19 testing have capacity ramp quickly) reach underserved and/or COVID-19 vulnerable populations. related program initiatives include: NOT-OD-20-121 a similar focus, shifts pool eligible grants supplementation those are part large-scale networks, consortia, centers other current programs have adequate capacity, infrastructure, established community-engaged relationships support large-scale testing. NOT-OD-20-119 seeks research understand Social, Ethical Behavioral Implications SEBI) COVID-19 testing these populations. RFA-OD-20-013 is U24 Coordination Data Collection Center CDCC) a key component the consortium. Collectively, projects funded under 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 competitive revisions funded under NOSI actively coordinate, collaborate, share data other Testing Research Projects, CDCC, other research supported the SEBI program, allowed, with considerations under tribal IRB processes. 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 accessing needed health care services have 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 housing; individuals substance disorders serious mental illness; migrant immigrant populations; residents tribal lands reservations; communities exposed high rates air pollution other toxic exposures; rural remote communities. Background Goals 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/approved COVID-19 diagnostic testing critical slowing spread the virus preventing future outbreaks. NIH committed applying scientific methods ensure all populations optimal access and uptake COVID-19 testing, to build enhanced point-of-care infrastructures advance the impending influenza season, requires swift action. overarching goal the RADx-UP initiative to understand factors associated COVID-19 morbidity mortality disparities to lay foundation reduce disparities those underserved vulnerable populations are disproportionately affected by, the highest infection rates of, and/or most risk adverse outcomes the COVID-19 pandemic. goal be accomplished strengthening available data disparities infection rates disease progression outcomes on differences testing access uptake patterns identifying strategies address disparities COVID-19 diagnostics related repeat testing, contact tracing, referrals). Testing Research Projects both enable targeted public health response COVID-19 build evidence-base approaches identify address disparities COVID 19 diagnostic testing uptake effectiveness underserved and/or vulnerable populations. maximize effectiveness, implementation approaches must include leverage culturally appropriate community partnerships strategies. Approaches increase COVID-19 testing apply knowledge effective interventions increasing access uptake other viral diagnostic tests, vaccines, therapeutics underserved vulnerable populations e.g., human immunodeficiency virus HIV], hepatitis B C testing). Best practices this work be applicable the ongoing COVID-19 public health efforts reach deliver evidence-based infection treatment for future vaccination implementation efforts particularly because testing strategies be essential accompany vaccine trials they advance). Applicants urged carefully consider cultural, ethical, social, behavioral, historical, economic implications associated testing/diagnostic technologies the collection, storage, dissemination health-related data these underserved populations. Key issues be considered addressed include, are limited to: barriers testing; returning test results; understanding implications a negative positive test result; stigma financial burden associated a positive test result follow-up care; feasibility effective self-isolation positive results; referrals contact tracing under-resourced communities, patients their families; privacy, confidentiality data sharing. Applicants should aware the possible discrimination faced these populations limited treatment resources available. Specific coordination federally funded services e.g., Tribal facilities, Federally Qualified Health Centers, Rural Health Clinics, etc.), state local health departments, community-based organizations can provide resources follow-up care public health mitigation, there a positive test, should specified the application. RADx-UP implementation occur two-phases, grants funded under NOSI collaborate part a Phase consortium led a CDCC RFA-OD-20-013). Phase Testing Research Projects supported under NOSI should work closely communities understand COVID-19 testing patterns, implement strategies interventions the potential rapidly i.e., within six months awards) increase reach, access, acceptance, uptake, sustainment FDA-authorized/approved diagnostics especially viral tests) among populations in geographic locations are underserved and/or vulnerable, See: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations, noting the contents these websites updated regularly applicants expected justify testing propose). Phase Testing Research Projects must established infrastructures community partnerships enable rapid measurable impact access uptake COVID-19 testing underserved and/or vulnerable populations. should also plan collaborate the RADx-UP Social, Ethical Behavioral Implications SEBI) program NOT-OD-20-119), where possible, support depth examination social, ethical behavioral implications related COVID-19 testing vaccination research. the significant investment developing validating new testing technologies particularly NIH-supported RADx initiatives), NIH anticipates significant changes the landscape testing diagnostic approaches, well shifts the pandemic itself over next 3 6 months. Phase II the RADx-UP initiative be released a later date will address such developments future community-engaged research. RADx-UP Testing Research Projects comprise community-engaged research studies linked a collaborative consortium) investigating variety COVID-19 diagnostic testing methods approaches improve understanding COVID-19-related health disparities enhance access effectiveness implementation vulnerable and/or underserved populations. consortium serve a resource COVID-19 diagnostic testing future public health pandemic outreach mitigation activities, such vaccine trials. overarching goal this program to understand factors have led disproportionate burden the pandemic these underserved vulnerable populations that interventions be implemented decrease disparities. Testing Research Projects address key questions, including not limited to: are rates testing characteristics testing contexts well rates COVID-19 morbidity mortality underserved and/or vulnerable populations? Based this background, implementation approaches strategies most effective increasing reach, access, uptake, sustainability COVID-19 testing these populations? can geographic information systems other innovative technologies such smart phone applications, etc.) used identify understand characteristics of, tailor testing access uptake approaches general especially defined testing deserts” i.e., geographic areas limited access COVID-19 testing sites low rates testing)? can evidence-based interventions have increased access uptake other viral screening tests e.g., human immunodeficiency virus HIV], hepatitis B C) adapted address diagnostic testing disparities COVID-19 among underserved and/or vulnerable populations communities? are approaches engaging clinical public health providers conducting referring persons testing recognize unique needs challenges underserved and/or vulnerable populations? can community stakeholders engaged efforts address testing-related barriers, provide health literacy support, provide patient navigation testing, increase appropriate referral follow-up care among underserved and/or vulnerable populations? community-driven research approaches effective reducing barriers testing uptake ameliorating stigma, distrust, fear, discrimination, mitigate effects exposure misinformation regarding COVID-19 testing? funding opportunity announcement encourages studies move away an exclusively top-down" approach emphasizing collaboration community partners, leaders, knowledge holders, leveraging community resources local service delivery settings address needs multiple stakeholders enhance COVD-19 testing. Approaches such team science, community engaged research, participatory action research, lay-person science, related frameworks should used engage stakeholders underserved and/or vulnerable populations throughout research process. RADx-UP testing intervention projects use rapid scale-up rigorous research strategies integrate data collected across sites maximize improvements public health control the pandemic. the extent possible, data acquisition, collection, curation strategies should coordinated the CDCC guidance annotation benchmarking data, including obtaining appropriate consent data sharing. Research designs include randomized controlled trials including group- cluster-randomized), pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, other dissemination implementation science methods including hybrid effectiveness/implementation designs). many these designs, special methods required analysis sample size estimation account correlation responses expected among responses participants measured treated the same cluster. Applicants need show their methods appropriate given plans assignment participants delivery interventions. Additional information available https://researchmethodsresources.nih.gov/. Applications should demonstrate history success recruiting retaining participants within specified target populations include sample size power calculations justify anticipated reach. Given RADx-UP goal population-level impact, applications should also delineate outcomes specify measures COVID-19 diagnostic testing impact other outcomes inform future maintenance, sustainability scale up. RADx-UP projects expected demonstrate ability leverage existing partnerships such with Tribal governments agencies, 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. Projects also expected specify strategies to: a) address individual structural social determinants health SDOH) present barriers participating testing, follow-up, retesting; b) create sustainable infrastructures support rapid deployment evidence-based approaches testing, testing follow-up, referral treatment delivery isolation systems; c) conduct effective outreach, communication, dissemination activities inform communities the project its findings. Applicants expected provide evidence partnerships community organizations whom will work include prior collaborations must describe roles all partners. Study budgets should include funds the community partners be fully engaged successfully participate research design implementation. Testing capacity includes access FDA-authorized/approved test kits related supplies, well access point-of-care testing and FDA-authorized/approved) certified laboratories e.g., hospital, public health, commercial) administer tests return test results quickly possible. Projects encouraged include active referral contact tracing through partnerships e.g., Tribal agencies health departments) where is possible. Repeat testing symptomatic asymptomatic persons, well individuals previous positive COVID-19 tests, encouraged help understand validity reliability tests underserved and/or vulnerable populations to help establish COVID-19 incidence rates these populations. Strategies maximize return test results, plans follow up, familial caregiver testing indicated) should consider literacy, health literacy, numeracy, cultural preferences, language barriers. Projects awarded under FOA be expected work collaboratively each other, the CDCC RFA-OD-20-013) with SEBI projects NOT-OD-20-119) related COVID-19 testing research. address expected impacts COVID-19 the scientific workforce, projects also strongly encouraged support early stage investigators, specifically targeting diversity their research workforce. Research Topics: Testing Research topics interest include, are limited to, following: Increasing reach, access, uptake, impact COVID-19 testing underserved and/or vulnerable populations Determine baseline rates testing use information evaluate innovative strategies increase testing access, uptake, sustainability environments such medical centers, community health clinics, Tribal facilities clinics, remote care settings, correctional facilities other congregant living facilities, testing locations outside health care settings e.g., pop-up sites, rotating sites, mobile units) Conduct comparative effectiveness studies test acceptance, uptake, effectiveness distinct COVID-19 test administration methods, such by medical staff, trained community health workers self-testing including supervised e.g., via telemedicine) unsupervised home-collection approaches Identify, track, increase testing access testing deserts” using novel methods, including geographic information systems policy implementation research Examine factors multiple levels including policies, community-level factors, interpersonal/family individual variables) maximize impact population morbidity mortality by: Increasing effective communication, reducing misinformation, promoting testing uptake, Increasing referral services, improving follow contact tracing Leverage community relationships cultural knowledge drive testing implementation strategies, specifically respect community entry, trust building, culturally appropriate ways engaging tapping community held knowledge best practices reduce testing barriers Employ strategies adoption adaptation effective communication, education, other engagement strategies enhance patient-clinician communication and implementation COVID-19 testing Examine implementation strategy effectiveness different organizations e.g., health care systems, schools, faith-based organizations, etc.) different components systems scale-up underserved and/or vulnerable communities examine long term sustainability Evaluate mechanisms mediators dissemination implementation strategies determine these strategies produce effects Create strategies widely disseminate up-to-date FDA-authorized/approved testing technology based detection viral nucleic acids consider viral detection point-of-care tests, including, antigen antibody tests emerge NIH-supported technology development programs) underserved and/or vulnerable populations Employ evidence-based innovative technologies the point-of-care such home-based self-testing kits, they become available, can limit contact allow continued isolation those significant comorbid conditions may more acceptable children families Integrate new technology techniques the testing model over time, particularly those emerging FDA authorization Apply innovative research methods such rapid cycle testing user centered design approaches use technology, Electronic Health Record other digital health modalities facilitate ordering tests this remains necessary), reporting results surveillance, contact tracing, long-term sustainability testing implementation strategies maximize consortium research rapidly implement approaches address COVID-19 pandemic, comparisons across datasets studies data integration essential collaboration. Projects 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, studies human participants 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. Additionally, researchers funding through NOSI be strongly encouragedto share survey items make public other researchers consider submitting surveys NIHCOVID19Measures@nih.gov. NIH also recognizes other federal agencies support research demonstration projects be strong collaborators these types research. NIH encourages collaboration investigators funded other agencies, appropriate, including, not limited those funded the Substance Abuse Mental Health Services Administration, Health Resources Services Administration, Administration Children Families, Administration Community Living its divisions, Centers Disease Control Prevention, Indian Health Service, Agency Health Research Quality, Office Minority Health, Department Defense, Department Agriculture, Department Education, Department Justice, Department Interior’s Bureau Indian Affairs, the Department Veterans Affairs. Additional Requirements NIH requiring data sharing all COVID-19 projects, where is prohibited i.e., Tribal data sovereignty). NIH expects supports timely release sharing final research data NIH-supported studies use other researchers expedite translation research results knowledge, products, procedures improve human health. Grantees expected work the RADx-UP Coordinating Data Collection Center CDCC, RFA-OD-20-013) submit common evaluation metrics COVID-19 testing-related outcomes implementation the CDCC. Grantees should identify dedicated unit responsible these data reporting activities. Grantees expected obtain retain personal identifiers all research participants where is prohibited i.e., Tribal data sovereignty) future longitudinal follow-up to leveraged intervention research. Data collected this program be protected a Certificate Confidentiality. Grantees expected use 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/). Grantees expected work the funded RADx-UP Social, Ethical Behavioral Implications program grantees SEBI, NOT-OD-20-119) other RADx-UP field sites support novel research social, ethical behavioral implications testing underserved and/or vulnerable populations, appropriate. Grantees encouraged identify dedicated staff member coordinating activities. Grantees must include measures reporting relevant testing implementation outcomes, inform future community, local, state, federal policies. Projects must include description sustainability their infrastructure partnerships may leveraged future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts. Projects must include evaluation plan demonstrating the proposed COVID-19 diagnostic testing access uptake strategies/activities be assessed effectiveness impact. Applications must include milestones towards progress a timeline completion. timeline must include plans regular reports progress be submitted the CDCC meetings Community Advisory Boards. reports include both testing results information regarding barriers facilitators COVID-19 testing emerging challenges implementation the proposed research. with NIH supported research, details regarding human subjects research expected, including data safety monitoring plans and, needed, plans a Data Safety Monitoring Board DSMB). Studies have DSMB expected coordinate CDCC RFA-OD-20-013) DSMB activities. Grantees expected disaggregate study results sex/gender; race ethnicity; age other relevant demographic factors, to consider intersectionality appropriate. Grantees expected participate CDCC-organized activities, including monthly cross-site meetings, cross-site working groups, dissemination activities effective implementation strategies, tools measures, etc.). Grantees expected demonstrate knowledge and comply federal, state, local, and/or Tribal requirements testing, reporting surveillance policies study protocols. Grantees must provide letters support the community partners should include community partners where possible) investigators NOT-OD-20-031). Budgets should reflect active participation community partners the extent possible. required, Tribal resolutions should included the application possible, before funds awarded all cases. Applications nonresponsive terms this NOSI not considered. following types projects generally be appropriate may deemed non-responsive: 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 relationship or engagement strategy the populations interest Projects involve COVID-19 testing interventions outside the United States Projects do address social, ethical, behavioral consequences their proposed design methods may exacerbate health disparities COVID-19 diagnostic testing 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/approved testing strategies present plan incorporate approved testing strategies Projects supplementing grants are eligible this NOSI Eligibility” section below under Application Submission Information) 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: Urgency significance research: will 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? Research design: the overall strategy, methodology, analyses well-reasoned appropriate accomplish specific aims the project? feasible appropriate the overall research design elements including power calculations) demonstrating effectiveness impact the proposed COVID-19 diagnostic testing uptake strategies/activities? the emergency timeframe milestones) appropriate feasible support aims goals the study? the management plan well-described commensurate the level complexity required? Investigators: the PD/PIs, collaborators, other researchers well suited appropriate carry the project? Community partners: there evidence strong established research collaborations proposed community partners? feasible appropriate the plans integrating community partners the study? Data sharing plan: there timely plans make results data findable accessible the research community? instances involving Tribal data sovereignty, there documentation Tribal agreement adapted data sharing plans? Coordination plans: feasible appropriate the plans submit data, data collection instruments outcomes/products the CDCC RFA-OD-20-013)? feasible appropriate the plans to collaborate other RADx-UP sites SEBI NOT-OD-20-119 LINK & COMPANION TESTING RESEARCH SITES NOT-OD-20-121)? Outcomes: outcomes products proposed advance improve acceptability uptake COVID-19 testing? feasible appropriate the plans measures reporting relevant outcomes, including assessment testing implementation outcomes population measures COVID-19 related morbidity mortality? there evidence outcomes interest the community included outcomes measured reported and products? Sustainability: feasible appropriate the plans sustainability project infrastructure partnerships may leveraged future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts? Testing: feasible appropriate the plans access FDA-authorized/approved test kits related activities i.e., ability process tests a timely manner return test results quickly possible)? feasible appropriate the plans support follow testing contact tracing? the proposed approach dynamic responsive the evolving changes COVID-19 diagnostics? there evidence adequate support being provided the community understand act test results they returned individuals community members? Evaluation: the evaluation plan feasible appropriate? the evaluation assess project activities/strategies goals determine overall impact? the evaluation informed community input? 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 following targeted funding opportunity its subsequent reissued equivalents: PA-20-135 Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) intended provide funds NIH grantees applying expand scope their active grant. funding instrument, activity code, be same the parent award. ORWH 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 700,000 direct costs the entire 2-year budget 75% the funds must allocated expenses the first year, reflect rapid ramp and outreach during first part the study. budget must reflect appropriate compensation community partners collaborating implementation testing interventions, test results return, development culturally appropriate dissemination research results i.e., publications other means dissemination). Given funds available, is anticipated up 30 awards be in FY2020 FY2021. Regardless the grant mechanism the parent award, Research Strategy section the application limited 6 pages must include: description specific milestones towards progress a timeline completion, taking account need rapid deployment testing protocols. Community Partner Program section demonstrate partnership community organizations, roles reach these partnerships, the organizational decision-making structure. Testing Capacity section demonstrate access FDA-authorized/approved test kits, personal protective equipment PPE), access certified laboratories e.g., hospital, institutional, public health, private commercial) process tests the ability store, transport return test results an appropriate manner as quickly possible. Consortium Data Reporting Unit demonstrate capability infrastructure the applicant report the number COVID-19 tests conducted, results, subsequent actions referrals, the overall study population relevant subpopulations. Unit must also disseminate effective implementation strategies rapid uptake across consortia relevant through CDCC. Human Subjects Unit works monitor ethical social implications human subjects concerns testing implementation. work essential monitoring implementation efforts not exacerbating health disparities underserved and/or vulnerable populations. Applications this FOA suggest possible collaborations the SEBI program NOT-OD-20-119). However, success work proposed applications this NOSI should depend those collaborations, since specifics those awards not known advance. Plans a Community Scientific Advisory Board includes target community representation scientists directly involved the project, well schedule structure inclusion the advisory board(s) required. Description contingency plans regarding ongoing potential future public health restrictions e.g., closures, physical distancing) might affect research approach, including online approaches where available appropriate. project period limited two years. Applicants request supplements budgets exceed parent grant. 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. Recipients 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. 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. IMPORTANT: funding consideration, applicants must designate NOT-OD-20-120"(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 applicationreceipt date better determine appropriateness interest therelevant Institute. Applicants also strongly encouraged notify Program staff listed this NOSI a request been submitted response this FOA order facilitate efficient processing the request. 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: Nadra Tyus, DrPH., MPH., 301-594-8065, nadra.tyus@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: April Oh, PhD., M.P.H., 240) 276-6709, april.oh@nih.gov LeeAnn Bailey, M.B.B.S, PhD., M.S. 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: Donald Everett, MA, 301) 451-2020, everettd@mail.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: Lucia Hindorff, PhD, MPH, 240-271-1509, hindorffl@mail.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:Pamela L. Thornton, PhD, 301-480-6476, pamela.thornton@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:Sheila A. Caldwell, PhD, 301-594-6115, caldwells@mail.nih.gov Grants Management Contact:Christy Leake, 301-594-7706, Christy.leake@nih.gov National Institute Mental Health NIMH): Scientific Program Contact:Gregory Greenwood, PhD, 240-669-5532, gregory.greenwood@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 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, MBAEunice Kennedy Shriver National Institute Child Health Human Development NICHD), 301-435-6975, clarkb1@mail.nih.gov National Institute Biomedical Imaging Bioengineering NIBIB) Grants Management Contact: Kwesi Wright, 301-451-4789, Kwesi.Wright@nih.gov Office Behavioral Social Science Research OBSSR): Scientific Program Contact: Dara Blachman-Denmer, PhD, 301-496-8522,dara.blachman-demner@nih.gov Office Disease Prevention ODP/DPCPSI/OD): Scientific Program Contact:Jacqueline Lloyd, PhD, MSW; 301-827-5559, lloydj2@nih.gov Office Research Women’s Health ORWH): Scientific Program Contact: Damiya S. Whitaker, Psy.D, M.A., 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

Notice of Special Interest (NOSI): Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations

Notice of Special Interest
Friday, June 12, 2020
Saturday, August 8, 2020
333
NOT-OD-20-121

Funding Opportunity Purpose

Notice Special Interest NOSI): Limited Competition Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations Notice Number: NOT-OD-20-121 Key Dates Release Date: June 12, 2020 First Available Due Date: August 07, 2020 Expiration Date: August 08, 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-20-120 - Notice Special Interest NOSI): Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations NOT-OD-20-119- Notice Special Interest NOSI): Emergency Competitive Revisions Social, Ethical, Behavioral Implications SEBI) 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) 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) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) 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) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) National Cancer Institute NCI) National Institute Biomedical Imaging Bioengineering ( NIBIB ) 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) Purpose Notice Special Interest NOSI) highlights urgent need understand address COVID-19 morbidity mortality disparities among underserved vulnerable populations across United States. two-year community-engaged Testing Research Projects examine SARS-CoV-2 infection patterns efforts increase access effectiveness diagnostic methods 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 program provided the Paycheck Protection Program Health Care Enhancement Act, 2020. Office the Director OD) therefore offering Emergency Competitive Revisions active eligible grants cooperative agreements addressing objectives described below. NOSI one four related RADx-UP funding opportunities. Testing Research Projects NOSI support supplements NIH grantees are part large-scale networks, consortia, centers other current programs have adequate capacity, infrastructure, established community-engaged relationships support large-scale testing. related program initiatives include: NOT-OD-20-120 a similar focus, shifts pool eligible grants supplementation individual research awards include community collaborations partnerships have capacity ramp quickly) reach underserved and/or COVID-19 vulnerable populations. NOT-OD-20-119 seeks research understand Social, Ethical Behavioral Implications SEBI) COVID-19 testing these populations. RFA-OD-20-013 is U24 Coordination Data Collection Center CDCC) a key component the consortium Collectively, projects funded under 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 competitive revisions funded under NOSI actively coordinate, collaborate, share data other Testing Research Projects, CDCC, other research supported the SEBI program, allowed, with considerations under tribal IRB processes. 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 accessing needed health care services have 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 housing; individuals substance disorders serious mental illness; migrant immigrant populations; residents tribal lands reservations; communities exposed high rates air pollution other toxic exposures; rural remote communities. Background Goals 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/approved COVID-19 diagnostic testing critical slowing spread the virus preventing future outbreaks. NIH committed applying scientific methods ensure all populations optimal access and uptake COVID-19 testing, to build enhanced point-of-care infrastructures advance the impending influenza season, requires swift action. overarching goal the RADx-UP initiative to understand factors associated COVID-19 morbidity mortality disparities to lay foundation reduce disparities those underserved vulnerable populations are disproportionately affected by, the highest infection rates of, and/or most risk adverse outcomes the COVID-19 pandemic. goal be accomplished strengthening available data disparities infection rates, disease progression outcomes, on differences testing access uptake patterns, identifying strategies address disparities COVID-19 diagnostics related repeat testing, contact tracing, referrals). Testing Research Projects both enable targeted public health response COVID-19 build evidence-base approaches identify address disparities COVID–19 diagnostic testing uptake effectiveness underserved and/or vulnerable populations. maximize effectiveness, implementation approaches must include leverage culturally appropriate community partnerships strategies. Approaches increase COVID-19 testing apply knowledge effective interventions increasing access uptake other viral diagnostic tests, vaccines, therapeutics underserved vulnerable populations e.g., human immunodeficiency virus HIV], hepatitis B C testing). Best practices this work be applicable the ongoing COVID-19 public health efforts reach deliver evidence-based infection treatment for future vaccination implementation efforts particularly because testing strategies be essential accompany vaccine trials they advance). Applicants urged carefully consider cultural, ethical, social, behavioral, historical, economic implications associated testing/diagnostic technologies the collection, storage, dissemination health-related data these underserved populations. Key issues be considered addressed include, are limited to: barriers testing; returning test results; understanding implications a negative positive test result; stigma financial burden associated a positive test result follow-up care; feasibility effective self-isolation positive results; referrals contact tracing under-resourced communities, patients their families; privacy, confidentiality data sharing. Applicants should aware the possible discrimination faced these populations limited treatment resources available. Specific coordination federally funded services e.g., Tribal facilities, Federally Qualified Health Centers, Rural Health Clinics, etc.), state local health departments, community-based organizations can provide resources follow-up care public health mitigation, there a positive test, should specified the application. RADx-UP implementation occur two-phases, grants funded under NOSI collaborate part a Phase consortium led a CDCC RFA-OD-20-013). Phase Testing Research Projects supported under NOSI should work closely communities understand COVID-19 testing patterns, implement strategies interventions the potential rapidly i.e., within six months awards) increase reach, access, acceptance, uptake, sustainment FDA-authorized/approved diagnostics especially viral tests) among populations in geographic locations are underserved and/or vulnerable See: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations, noting the contents these websites updated regularly applicants expected justify testing propose). Phase Testing Research Projects must established infrastructures community partnerships enable rapid measurable impact access uptake COVID-19 testing underserved and/or vulnerable populations. should also plan collaborate the RADx-UP Social, Ethical Behavioral Implications SEBI) program NOT-OD-20-119)), where possible, support depth examination social, ethical behavioral implications related COVID-19 testing vaccination research. Applicants this NOSI allowed, not required, apply these companion funding opportunities. the significant investment developing validating new testing technologies particularly NIH-supported RADx initiatives), NIH anticipates significant changes the landscape testing diagnostic approaches, well shifts the pandemic itself over next 3 6 months. Phase II the RADx-UP initiative be released a later date will address such developments future community-engaged research. RADx-UP Testing Research Projects comprise community-engaged research studies linked a collaborative consortium) investigating variety COVID-19 diagnostic testing methods approaches improve understanding COVID-19-related health disparities enhance access effectiveness implementation vulnerable and/or underserved populations. consortium serve a resource COVID-19 diagnostic testing future public health pandemic outreach mitigation activities, such vaccine trials. overarching goal this program to understand factors have led disproportionate burden the pandemic these underserved vulnerable populations that interventions be implemented decrease disparities. Testing Research Projects address key questions, including not limited to: are rates testing characteristics testing contexts well rates COVID-19 morbidity mortality underserved and/or vulnerable populations? Based this background, implementation approaches strategies most effective increasing reach, access, uptake, sustainability COVID-19 testing these populations? can geographic information systems other innovative technologies such smart phone applications, etc.) used identify understand characteristics of, tailor testing access uptake approaches general especially defined testing deserts” i.e., geographic areas limited access COVID-19 testing sites low rates testing)? can evidence-based interventions have increased access uptake other viral screening tests e.g., human immunodeficiency virus HIV], hepatitis B C) adapted address diagnostic testing disparities COVID-19 among underserved and/or vulnerable populations communities? are approaches engaging clinical public health providers conducting referring persons testing recognize unique needs challenges underserved and/or vulnerable populations? can community stakeholders engaged efforts address testing-related barriers, provide health literacy support, provide patient navigation testing, increase appropriate referral follow-up care among underserved and/or vulnerable populations? community-driven research approaches effective reducing barriers testing uptake ameliorating stigma, distrust, fear, discrimination, mitigate effects exposure misinformation regarding COVID-19 testing? NOSI encourages studies move away an exclusively top-down" approach emphasizing collaboration community partners, leaders knowledge holders, leveraging community resources local service delivery settings address needs multiple stakeholders enhance COVD-19 testing. Approaches such team science, community-engaged research, participatory action research, lay-person science, related frameworks should used engage stakeholders underserved and/or vulnerable populations throughout research process. RADx-UP testing intervention projects use rapid scale-up rigorous research strategies integrate data collected across sites maximize improvements public health control the pandemic. the extent possible, data acquisition, collection, curation strategies should coordinated the CDCC guidance annotation benchmarking data, including obtaining appropriate consent data sharing. Research designs include randomized controlled trials including group- cluster-randomized), pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, other dissemination implementation science methods including hybrid effectiveness/implementation designs). many these designs, special methods required analysis sample size estimation account correlation responses expected among responses participants measured treated the same cluster. Applicants need show their methods appropriate given plans assignment participants delivery interventions. Additional information available https://researchmethodsresources.nih.gov/. Applications should demonstrate history success recruiting retaining participants within specified target populations include sample size power calculations justify anticipated reach. Given RADx-UP goal population-level impact, applications should also delineate outcomes specify measures COVID-19 diagnostic testing impact other outcomes inform future maintenance, sustainability scale up. RADx-UP projects expected demonstrate ability leverage existing partnerships such with Tribal governments agencies, 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. Projects also expected specify strategies to: a) address individual structural social determinants health SDOH) present barriers participating testing, follow-up, retesting; b) create sustainable infrastructures support rapid deployment evidence-based approaches testing, testing follow-up, referral treatment delivery isolation systems; c) conduct effective outreach, communication, dissemination activities inform communities the project its findings. Applicants expected provide evidence partnerships community organizations whom will work include prior collaborations must describe roles all partners. Study budgets should include funds the community partners be fully engaged successfully participate research design implementation. Testing capacity includes access FDA-authorized/approved test kits related supplies, well access point-of-care testing and FDA-authorized/approved) certified laboratories e.g., hospital, public health, commercial) administer tests return test results quickly possible. Projects encouraged include active referral contact tracing through partnerships e.g., Tribal agencies health departments) where is possible. Repeat testing symptomatic asymptomatic persons, well individuals previous positive COVID-19 tests, encouraged help understand validity reliability tests underserved and/or vulnerable populations to help establish COVID-19 incidence rates these populations. Strategies maximize return test results, plans follow up, familial caregiver testing indicated) should consider literacy, health literacy, numeracy, cultural preferences, language barriers. Projects awarded under FOA be expected work collaboratively each other, the CDCC RFA-OD-20-013) with SEBI projects NOT-OD-20-119) related COVID-19 testing. address expected impacts COVID-19 the scientific workforce, projects also strongly encouraged support early stage investigators, specifically targeting diversity their research workforce. Research Topics: Testing Research topics interest include, are limited to, following: Increasing reach, access, uptake, impact COVID-19 testing underserved and/or vulnerable populations Determine baseline rates testing use information evaluate innovative strategies increase testing access, uptake, sustainability environments such medical centers, community health clinics, Tribal facilities clinics, remote care settings, correctional facilities other congregant living facilities, testing locations outside health care settings e.g., pop-up sites, rotating sites, mobile units) Conduct comparative effectiveness studies test acceptance, uptake, effectiveness distinct COVID-19 test administration methods, such by medical staff, trained community health workers self-testing including supervised e.g., via telemedicine) unsupervised home-collection approaches Identify, track, increase testing access testing deserts” using novel methods, including geographic information systems policy implementation research Examine factors multiple levels including policies, community-level factors, interpersonal/family individual variables) maximize impact population morbidity mortality by: Increasing effective communication, reducing misinformation, promoting testing uptake, Increasing referral services, improving follow contact tracing Leverage community relationships cultural knowledge drive testing implementation strategies, specifically respect community entry, trust building, culturally appropriate ways engaging tapping community held knowledge best practices reduce testing barriers Employ strategies adoption adaptation effective communication, education, other engagement strategies enhance patient-clinician communication and implementation COVID-19 testing Examine implementation strategy effectiveness different organizations e.g., health care systems, schools, faith-based organizations, etc.) different components systems scale-up underserved and/or vulnerable communities examine long term sustainability Evaluate mechanisms mediators dissemination implementation strategies determine these strategies produce effects Create strategies widely disseminate up-to-date FDA-authorized/approved testing technology based detection viral nucleic acids consider viral detection point-of-care tests, including, antigen antibody tests emerge NIH-supported technology development programs) underserved and/or vulnerable populations Employ evidence-based innovative technologies the point-of-care such home-based self-testing kits, they become available, can limit contact allow continued isolation those significant comorbid conditions may more acceptable children families Integrate new technology techniques the testing model over time, particularly those emerging FDA authorization Apply innovative research methods such rapid cycle testing user centered design approaches use technology, Electronic Health Record other digital health modalities facilitate ordering tests this remains necessary), reporting results surveillance, contact tracing, long-term sustainability testing implementation strategies maximize consortium research rapidly implement approaches address COVID-19 pandemic, comparisons across datasets studies data integration essential collaboration. Projects 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, studies human participants 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. Additionally, researchers funding through NOSI strongly encouragedto share survey items make public other researchers consider submitting surveys NIHCOVID19Measures@nih.gov. NIH also recognizes other federal agencies support research demonstration projects be strong collaborators these types research. NIH encourages collaboration investigators funded other agencies, appropriate, including, not limited those funded the Substance Abuse Mental Health Services Administration, Health Resources Services Administration, Administration Children Families, Administration Community Living its divisions, Centers Disease Control Prevention, Indian Health Service, Agency Health Research Quality, Office Minority Health, Department Defense, Department Agriculture, Department Education, Department Justice, Department Interior’s Bureau Indian Affairs, the Department Veterans Affairs. Additional Requirements NIH requiring data sharing all COVID-19 projects, where is prohibited i.e., Tribal data sovereignty). NIH expects supports timely release sharing final research data NIH-supported studies use other researchers expedite translation research results knowledge, products, procedures improve human health. Grantees expected work the RADx-UP Coordinating Data Collection Center CDCC, RFA-OD-20-013) submit common evaluation metrics COVID-19 testing-related outcomes implementation the CDCC. Grantees should identify dedicated unit responsible these data reporting activities. Grantees expected obtain retain personal identifiers all research participants where is prohibited i.e., Tribal data sovereignty) future longitudinal follow-up to leveraged intervention research. Data collected this program be protected a Certificate Confidentiality. Grantees expected use 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/). Grantees expected work the funded RADx-UP Social, Ethical Behavioral Implications program grantees SEBI, NOT-OD-20-119) other RADx-UP field sites support novel research social, ethical behavioral implications testing underserved and/or vulnerable populations, appropriate. Grantees encouraged identify dedicated staff member coordinating activities. Grantees must include measures reporting relevant testing implementation outcomes, inform future community, local, state, federal policies. Projects must include description sustainability their infrastructure partnerships may leveraged future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts. Projects must include evaluation plan demonstrating the proposed COVID-19 diagnostic testing access uptake strategies/activities be assessed effectiveness impact. Applications must include milestones towards progress a timeline completion. timeline must include plans regular reports progress be submitted the CDCC meetings Community Advisory Boards. reports include both testing results information regarding barriers facilitators COVID-19 testing emerging challenges implementation the proposed research. with NIH supported research, details regarding human subjects research expected, including data safety monitoring plans and, needed, plans a Data Safety Monitoring Board DSMB). Studies have DSMB expected coordinate CDCC RFA-OD-20-013) DSMB activities. Grantees expected disaggregate study results sex/gender; race ethnicity; age other relevant demographic factors, to consider intersectionality appropriate. Grantees expected participate CDCC-organized activities, including monthly cross-site meetings, cross-site working groups, dissemination activities effective implementation strategies, tools measures, etc.). Grantees expected demonstrate knowledge and comply federal, state, local, and/or Tribal requirements testing, reporting surveillance policies study protocols. Grantees must provide letters support the community partners should include community partners where possible) investigators RFA-OD-20-013). Budgets should reflect active participation community partners the extent possible. required, Tribal resolutions should included the application possible, before funds awarded all cases. Applications nonresponsive terms this NOSI not considered. following types projects generally be appropriate may deemed non-responsive: 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 relationship or engagement strategy the populations interest Projects involve COVID-19 testing interventions outside the United States Projects do address social, ethical, behavioral consequences their proposed design methods may exacerbate health disparities COVID-19 diagnostic testing 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/approved testing strategies present plan incorporate approved testing strategies Projects supplementing grants are eligible this NOSI Eligibility” section below under Application Submission Information”) 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, applicable: Urgency significance research: will 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? Research design: the overall strategy, methodology, analyses well-reasoned appropriate accomplish specific aims the project? feasible appropriate the overall research design elements including power calculations) demonstrating effectiveness impact the proposed COVID-19 diagnostic testing uptake strategies/activities? the emergency timeframe milestones) appropriate feasible support aims goals the study? the management plan well-described commensurate the level complexity required? Investigators: the PD/PIs, collaborators, other researchers well suited appropriate carry the project? Community partners: there evidence strong established research collaborations proposed community partners? feasible appropriate the plans integrating community partners the study? Data sharing plan: there timely plans make results data findable accessible the research community? instances involving Tribal data sovereignty, there documentation Tribal agreement adapted data sharing plans? Coordination plans: feasible appropriate the plans submit data, data collection instruments outcomes/products the CDCC RFA-OD-20-013)? feasible appropriate the plans to collaborate other RADx-UP sites SEBI NOT-OD-20-119 & COMPANION TESTING RESEARCH SITES NOT-OD-20-120)? Outcomes: outcomes products proposed advance improve acceptability uptake COVID-19 testing? feasible appropriate the plans measures reporting relevant outcomes, including assessment testing implementation outcomes population measures COVID-19 related morbidity mortality? there evidence outcomes interest the community included outcomes measured reported and products? Sustainability: feasible appropriate the plans sustainability project infrastructure partnerships may leveraged future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts? Testing: feasible appropriate the plans access FDA-authorized/approved test kits related activities i.e., ability process tests a timely manner return test results quickly possible)? feasible appropriate the plans support follow testing contact tracing? the proposed approach dynamic responsive the evolving changes COVID-19 diagnostics? there evidence adequate support being provided the community understand act test results they returned individuals community members? Evaluation: the evaluation plan feasible appropriate? the evaluation assess project activities/strategies goals determine overall impact? the evaluation informed community input? 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 following targeted funding opportunity its subsequent reissued equivalents: PA-20-135 Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) intended provide funds NIH grantees applying expand scope their active grant. funding instrument, activity code, be same the parent award. ORWH 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. list eligible NIH programs provided within section, below. NOTE: Grants funded each participating NIH IC can revised response this NOSI limited those eligible funded the programs participating NIH ICs listed. Note the same grant cannot submitted consideration under both NOSI the related NOSI individual studies NOT-OD-20-120). instructions the SF424 R&R) Application Guide in target funding opportunity announcement PA-20-135) must followed, the following additions: Individual requests be more 3,500,000 direct costs the entire 2-year budget to 5,000,000 Total Costs) 75% the funds must allocated expenses the first year, reflect rapid ramp and outreach during first part the study. budget must reflect appropriate compensation community partners collaborating implementation testing interventions, test results return, development culturally appropriate dissemination research results i.e., publications other means dissemination). Given funds available, is anticipated up 25 awards be in FY2020. Regardless the grant mechanism the parent award, Research Strategy section the application limited 12 pages must include: description specific milestones towards progress a timeline completion, taking account need rapid deployment testing protocols. Community Partner Program section demonstrate partnership community organizations, roles reach these partnerships, the organizational decision-making structure. Testing Capacity section demonstrate access FDA-authorized/approved test kits, personal protective equipment PPE), access laboratories e.g., hospital, institutional, public health, private commercial) process tests the ability store, transport return test results an appropriate manner as quickly possible. Consortium Data Reporting Unit demonstrate capability infrastructure the applicant report the number COVID-19 tests conducted, results, subsequent actions referrals, the overall study population relevant subpopulations. Unit must also disseminate effective implementation strategies rapid uptake across consortia relevant through CDCC. Human Subjects Unit works monitor ethical social implications human subjects concerns testing implementation. work essential monitoring implementation efforts not exacerbating health disparities underserved and/or vulnerable populations. Applications this NOSIcan suggest possible collaborations the SEBI program NOT-OD-20-119). However, success work proposed applications this NOSI should depend those collaborations, since specifics those awards not known advance. Plans a Community Scientific Advisory Board includes target community representation scientists directly involved the project, well schedule structure inclusion the advisory board(s) required. Description contingency plans regarding ongoing potential future public health restrictions e.g., closures, physical distancing) might affect research approach, including online approaches where available appropriate. project period limited two years. 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. Recipients 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. Applications be submitted beginning July 8, 2020 the Application Due Date August 7, 2020 5:00 PM local time the applicant organization). Applications received after time not considered. earliest start date be September, 2020.An application submitted response this NOSI is received August 8, 2020 later be withdrawn. . IMPORTANT: funding consideration, applicants must designate NOT-OD-20-121" 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. Only listed NIH programs participating Institutes Centers eligible this NOSI, follows: NIMHD Eligible Grants funded under following Funding Opportunity Announcements: Specialized Centers Excellence Minority Health Health Disparities RFA-MD-17-005) Research Centers Minority Institutions RFA-MD-17-003; RFA-MD-17-006; RFA-MD-18-012) Specialized Centers Excellence Environmental Health Disparities Research RFA-MD-20-001) Collaborative Minority Health Health Disparities Research Tribal Epidemiology Centers TEC) PAR-17-483 PAR-17-484) Transdisciplinary Collaborative Centers Health Disparities Research Focused Precision Medicine RFA-MD-15-013) Transdisciplinary Collaborative Centers Health Disparities Research Chronic Disease Prevention RFA-MD-15-014) NIA Eligible Grants funded under following Funding Opportunity Announcements: Resource Centers Minority Aging Research RFA-AG-18-002, RFA-AG-18-003) ADRD Health Care Research Systems Collaboratory RFA-AG-19-009) Claude D. Pepper Older Americans Independence Centers RFA-AG-20-019) NICHD Eligible Grants funded under following Funding Opportunity Announcements: INCLUDE Data Coordinating Center RFA-OD-20-007, RFA-OD-20-003;) National Longitudinal Study Adolescent Adult Health RFA-AG-21-008) Medical Rehabilitation Research Resource RFA-HD-20-004) Pediatric HIV/AIDS Cohort Study RFA-HD-15-027) Adolescent Trials Network RFA-HD-16-040, RFA-HAD-16-035) Obstetric-fetal Pharmacology Research Centers RFA-HD-14-013) Maternal Fetal Medicine Units RFA-HD-16-019) Intellectual Developmental Disabilities Research Centers RFA-HD-20-016) Autism Centers Excellence Program RFA-HD-17-008, RFA-HD-17-009) NCI Eligible Grants funded under following Funding Opportunity Announcements: Implementation Science Cancer Control: Advanced Centers Developing Centers RFA-CA-19-006, RFA-CA-19-005) Comprehensive Partnerships Advance Cancer Health Equity PAR-15-103, PAR-18-361, PAR-18-767) Cancer Center Support Grants CCSGs) NCI-designated Cancer Centers PAR-20-043, PAR-17-095, PAR-13-386) NCI Community Oncology Research Program Minority/Underserved Community Sites RFA-CA-18-017, RFA-CA-13-014) Prevention HPV-related Cancers HIV-infected individuals: United States-Latin American-Caribbean Clinical Trials Network: Partnership Centers RFA-CA-18-018) NCATS Eligible Grants funded under following Funding Opportunity Announcements: Clinical Translational Science Awards UL1 Component PAR-18-940, PAR-18-464, PAR-15-304, RFA-TR-14-009) NCCIH Eligible Grants funded under following Funding Opportunity Announcements: Health Care Systems Research Collaboratory Multiple Chronic Conditions RFA-RM-16-018, RFA-RM-16-019) NEI Eligible Grants funded under following Funding Opportunity Announcements: Pediatric Eye Disease Investigator Group PEDIG) Network PAR-18-523, PAR-14-098) Diabetic Retinopathy Clinical Research DRCR) Network PAR-18-523, PAR-14-098) NHLBI Eligible Grants funded under following Funding Opportunity Announcements: Sickle Cell Disease Implementation Consortium: Using Implementation Science Optimize Care Adolescents Adults Sickle Cell Disease RFA-16-011, RFA-HL-16-010) Asthma Empowerment Collaborations Reduce Childhood Asthma Disparities RFA-HL-17-001, RFA-HL-015-028) NHGRI Eligible Grants funded under following Funding Opportunity Announcements: Clinical Sequencing Evidence-Generating Research-Clinical Sites Enhanced Diversity RFA-HG-16-011) NIAID Eligible Grants funded under following Funding Opportunity Announcements: Centers AIDS Research PAR-17-237; PAR-20-106) IMPAACT Network UM1AI068632, UM1AI068616, UM1AI106716) Sexually Transmitted Infections STI) Cooperative Research Centers CRC): Vaccine Development, U19 RFA-AI-18-005) NIAMS Eligible Grants funded under following Funding Opportunity Announcements: Centers Research Translation RFA-AR-17-001) Core Centers Clinical Research RFA-AR-17-002) NIDCR Eligible Grants funded under following Funding Opportunity Announcements: Multidisciplinary Collaborative Research Consortium Reduce Oral Health Disparities Children: Multilevel Approach RFA-DE-15-006) NIDDK Eligible Grants funded under following Funding Opportunity Announcements: Prevention Lower Urinary Tract Symptoms RFA-DK-19-015) Centers Diabetes Translation Research RFA-DK-15-003, RFA-DK-20-002) Nutrition Obesity Research Centers RFA-DK-14-002, RFA-DK-16-006, RFA-DK-19-002) NIGMS Eligible Grants funded under following Funding Opportunity Announcements: Native American Research Centers Health PAR-16-297, PAR-13-239), IDeA-Clinical Translational Research Networks PAR-20-175, PAR-17-304, PAR-14-303) NIMH Eligible Grants funded under following Funding Opportunity Announcements: AIDS Research Center Mental Health HIV/AIDS PAR-15-197; PAR-18-832) Developmental AIDS Research Center Mental Health HIV/AIDS PAR-18-833) Advanced Laboratories Accelerating Reach Impact Treatments Youth Adults Mental Illness Research Centers PAR-16-354, PAR-18-701) Collaborative Hubs Reduce Burden Suicide among American Indian Alaska Native Youth RFA-MH-17-350) NINDS Eligible Grants funded under following Funding Opportunity Announcements: NIH Stroke Net Regional Coordinating Stroke Centers PAR-17-276) NINR Eligible Grants funded under following Funding Opportunity Announcements: Exploratory Research Centers RFA-NR-17-002) Core Centers/Centers Excellence RFA-NR-17-003) Palliative Care Research Cooperative RFA-NR-17-001) NIAAA Eligible Grants funded under following Funding Opportunity Announcements: Alcohol Hepatitis: Clinical Translational Network RFA-AA-18-005) Collaborative Study the Genetics Alcoholism COGA). RFA-AA-19-001) Collaborative Initiative Fetal Alcohol Spectrum Disorder CIFASD) RFA-AA-17-007) Comprehensive Alcohol-HIV/AIDS Research Center RFA-AA-19-003) Comprehensive Alcohol Research Center RFA-AA-17-002, RFA-AA-15-001, RFA-AA-20-002) Consortia HIV/AIDS Alcohol-Related Research Trials RFA-AA-16-001, RFA-AA-16-002, RFA-AA-003) NIDA Eligible Grants funded under following Funding Opportunity Announcements: HIV, HCV Related Comorbidities Rural Communities Affected Opioid Injection Drug Epidemics the United States: Building Systems Prevention, Treatment Control RFA-DA-17-014) Hepatitis C Virus HCV) Advanced Molecular Detection Support Systems Prevention, Treatment Control HIV, HCV Related Comorbidities Rural Communities Affected Opioid Injection Drug Epidemics the United States RFA-DA-17-023) Limited Competition Cohort Studies HIV/AIDS Substance Abuse RFA-DA-20-005; RFA-DA-18-011) NIDA Core Center Excellence” Grant Program PAR-17-121; PAR-14-186) HEAL Initiative: Justice Community Opioid Innovation Network JCOIN): Methodology Advanced Analytics Resource Center RFA-DA-19-023); Clinical Research Centers RFA-DA-19-025); Coordination Translation Center RFA-DA-19-024) HEAL Initiative: Preventing Opioid Disorder Older Adolescents Young Adults ages 16-30) RFA-DA-19-035); Coordinating Center RFA-DA-19-034) HEAL Initiative: HEALthy Brain Child Development Study HEALthy BCD) RFA-DA-19-036, RFA-DA-19-029) HEALing Communities Study: Developing Testing Integrated Approach Address Opioid Crisis: Research Sites RFA-DA-19-016); Data Coordinating Center RFA-DA-19-017) Limited Competition Adolescent Brain Cognitive Development ABCD) Study – Linked Research Project Sites RFA-DA-20-002); Data Analysis, Informatics Resource Center RFA-DA-20-003); Coordinating Center RFA-DA-20-004) National Drug Abuse Treatment Clinical Trials Network RFA-DA-20-024; RFA-DA-15-008) NIDA Research Center Excellence Grant Program PAR-18-224; PAR-18-224) NLM Eligible Grants funded under following Funding Opportunity Announcements: NLM University-based Biomedical Informatics Data Science Research Training RFA-LM-16-001) OD/ECHO Eligible Grants funded under following Funding Opportunity Announcements: Environmental Influences Child Health Outcomes RFA-OD-19-025, RFA-OD-19-026, RFA-OD-16-003, RFA-OD-16-005, RFA-OD-16-006, RFA-OD-16-004) NIBIB Eligible Grants funded under following Funding Opportunity Announcements: Point-of-Care Technologies Research Network PAR-17-453) NIBIB Biomedical Technology Resource Centers PAR-18-205, PAR-17-083, PAR-13-376, PAR-13-144, PAR-10-153) Centers Excellence Big Data Computing the Biomedical Sciences RFA-HG-13-009) Mobilizing Research: Research Resource Enhance mHealth Research RFA-OD-15-129)   NIEHS Eligible Grants funded under following Funding Opportunity Announcements: Superfund Hazardous Substance Research Training Program RFA-ES-12-003, RFA-ES-13-001, RFA-ES-14-007, RFA-ES-15-019, RFA-ES-18-002) Environmental Health Sciences Core Centers RFA-ES-13-012, RFA-ES-15-007, RFA-ES-16-001, RFA-ES-17-003, RFA-ES-18-003) Maintain Enrich Resource Infrastructure Existing Environmental Epidemiology Cohorts RFA-ES-16-004, RFA-ES-18-009) Centers Excellence Environmental Health Disparities Research RFA-ES-14-010) Hazardous Materials Worker Health Safety Training RFA-ES-14-008, RFA-ES-19-003) HAZMAT Training DOE Nuclear Weapons Complex RFA-ES 14-009, RFA-ES-19-004) 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:Nadra Tyus, DrPH., MPH., 301-594-8065, nadra.tyus@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 National Cancer Institute NCI): Scientific Program Contact: April Oh, PhD, M.P.H., 240-276-6709, april.oh@nih.gov LeeAnn Bailey, M.B.B.S, PhD, M.S. 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: Donald Everett, MA, 301-451-2020, everettd@mail.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:Lucia Hindorff, PhD, MPH, 240-271-1509, hindorffl@mail.nih.gov Grants Management Contact:Deanna Ingersoll, 301-435-7858 National Institute Allergy Infectious Diseases NIAID): Scientific Program Contact:Ann NamkungMPH, 240-627-3099,anamkung@niaid.nih.gov Grants Management Contact:Ann Devine, 240-669-2988, ADEVINE@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 Dental Craniofacial Research NIDCR): Scientific Program Contact: Darien Weatherspoon, DDS, 301-594-5394, darien.weatherspoon@nih.gov Grants Management Contact: Diana Rutberg, 301-594-4798, rutbergd@mail.nih.gov National Institute Diabetes Digestive Kidney Diseases NIDDK): Scientific Program Contact:Pamela L. Thornton, PhD, 301-480-6476, pamela.thornton@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:Ming Lei, PhD, 301-827-7616, leim@mail.nih.gov Grants Management Contact:Christy Leake, 301-594-7706, Christy.leake@nih.gov National Institute Mental Health NIMH): Scientific Program Contact:Gregory Greenwood, PhD, 240-669-5532, gregory.greenwood@nih.gov Grants Management Contact:Rita Sisco, 301-443-2805, siscor@mail.nih.gov National Institute Neurological Disorders Stroke NINDS): Scientific Program Contact:Scott Janis, PhD, 301-496-9135, Janiss@NINDS.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 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 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: Dara Blachman-Denmer, PhD, 301-496-8522, dara.blachman-demner@nih.gov Office Disease Prevention ODP/DPCPSI/OD): Scientific Program Contact:Jacqueline Lloyd, PhD, MSW; 301-827-5559, lloydj2@nih.gov Office Research Women’s Health ORWH): Scientific Program Contact: Damiya S. Whitaker, Psy.D, M.A., 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 National Institute Biomedical Imaging Bioengineering NIBIB): Scientific Program Contact:?Qi Duan, PhD, 301-827-4674, Qi.Duan@nih.gov Grants Management Contact: Kwesi Wright, 301-451-4789, Kwesi.Wright@nih.gov

Notice of Special Interest (NOSI): Chimerism in Marmosets and other New World Primates

Notice of Special Interest
Wednesday, June 3, 2020
Saturday, January 8, 2022
NOT-MH-20-048

Funding Opportunity Purpose

Notice Special Interest NOSI): Chimerism Marmosets other New World Primates Notice Number: NOT-MH-20-048 Key Dates Release Date: June 3, 2020 First Available Due Date: October 05, 2020 Expiration Date: January 08, 2022 Related Announcements PA-20-185 - NIH Research Project Grant Parent R01, Clinical Trial Allowed) PA-20-195 - NIH Exploratory/Developmental Research Grant Program Parent R21, Clinical Trial Allowed) Issued National Institute Mental Health NIMH) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institutes Health NIH) a special interest research project applications focusing understanding biological basis functional implications chimerism the common marmoset Callithrix jacchus) other callitrichid primates. interest applications focus the following areas: 1) stem cell exchange utero, extent molecular mechanisms associated the induction maintenance hematopoietic chimerism, the possibility somatic and/or germ line chimerism the adult animal; 2) development systems assays study cellular heterogeneity resulting chimerism potential intragenomic conflict within individual’s tissues; and, 3) understanding molecular cellular impact chimerism biological processes, including development, metabolism, cognition, social behavior, aging, immunological suppression reactivity, reproduction; well effects and mechanisms associated transplant tolerance. Background Nonhuman primates NHP) the closest evolutionary relatives humans, whom share anatomical, physiological, gene interaction features. common marmoset Callithrix jacchus) of increasing importance biomedical research worldwide, aided its small body size, shorter life span compared macaques, rapid reproductive maturation, making ideal genetic transgenerational research. New World primate also known cooperative social behavior, cognition, communication, potentially makes a good model organism contribute our understanding a wide range human biology diseases, are currently being extensively used study family interactions, hormonal development, reproduction, infectious diseases, neurodegenerative disorders age-related hearing loss. Marmosets obligate litter bearers most pregnancies resulting dizygotic twins show chimerism the blood other cells the hematopoietic lineage, a result in utero exchange stem cells through placental anastomoses during early development, process leads lifelong chimerism. Chimerism previously reported most marmoset tissues including skin, hair, brain, lung, blood, lymphatic tissues, muscle. However, recent quantitative studies indicate chimerism limited cells the hematopoietic lineage, that previous observation widespread tissue chimerism likely due blood lymphocyte infiltration those tissues, fibroblast cell lines chimeric individuals not chimeric. evolutionary functional consequences hematopoietic chimerism, is unique marmosets other callitrichid primates, currently unknown. is also known chimerism limits enhances use these animals models human physiology, health disorders. example, studies focused immune response the marmoset should cognizant the potential confounding effect chimeric lymphocytes. Therefore, this model reach full translational utility furthering our understanding human health diseases, is imperative we achieve better understanding the functional consequences chimerism its contributions health, behavior diseases New World primates. Research Objectives Applications response this NOSI should aligned the overall purpose, is improve our understanding the biological physiological significance chimerism this NHP model. Research areas include are limited to: stem cell exchange utero, extent molecular mechanisms/pathways associated the induction maintenance hematopoietic chimerism, mechanisms associated maintenance loss chimerism the bone marrow, blood, thymus, lymphoid tissues juveniles adults; the possibility somatic germ line chimerism the adult animal; development systems assays study cellular heterogeneity resulting chimerism; comparisons major histocompatibility complex genes proteins expressed dizygotic twin pairs; potential intragenomic conflict within individual’s tissues; understanding molecular cellular impact chimerism biological processes, including development, metabolism, cognition, social behavior, aging, immunological suppression reactivity, reproduction; medical interventions including organ cellular transplantation focus evaluation the immune response elicited a sibling twin third party donor organ e.g., kidney, heart, lung) cellular e.g., bone marrow islet) transplant mechanisms associated transplant tolerance rejection. Application Submission Information notice applies due dates or after October 5, 2020 subsequent receipt dates through January 8, 2022. Submit applications this initiative using of following funding opportunity announcements FOAs) any reissues these announcement through expiration date this notice PA-20-185: NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-20-195: NIH Exploratory/Developmental Research Grant Program Parent R21, 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-MH-20-048” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Although NIMH NINDS not listed a Participating Organization all FOAs listed above, applications this initiative be accepted. 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: Scientific/Research Contact(s) Abigail Soyombo, Ph.D., MBA National Institute Mental Health NIMH) Telephone: 301-827-7329 Email: abigail.soyombo@nih.gov Manuel Moro, DVM, Ph.D. National Institute Aging NIA) Telephone: 301-480-1796 Email: manuel.moro@nih.gov Julia Shaw, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3711 Email: julia.shaw@nih.gov Amy C. Lossie, PhD National Institute Drug Abuse NIDA) Telephone: 301) 827-6092 Email:amy.lossie@nih.gov James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email:gnadtjw@ninds.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) Theresa Jarosik National Institute Mental Health NIMH) Telephone: 301-443-3858 Email: tjarosik@mail.nih.gov

Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)

PA
Friday, May 29, 2020
Workforce Diversity
Monday, May 8, 2023
PA-20-222

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to enhance the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

HIV Infection of the Central Nervous System (R01 Clinical Trial Not Allowed)

PA
Wednesday, May 13, 2020
Monday, May 8, 2023
R01
PA-20-149

Funding Opportunity Purpose

The goals of this Funding Opportunity Announcement (FOA) are to stimulate further research on delineating the pathophysiology of HIV-1 associated CNS disease in the setting of chronic viral suppression and ART. In addition, FOA also encourages research studies to aid in the identification/ validation of biomarkers and pre-clinical targets with quantifiable readouts in domestic and international settings. Multidisciplinary research teams and collaborative alliances are encouraged but not required.

Notice of Special Interest: Administrative Supplements for the U.S.-Japan Brain Research Cooperative Program (BRCP) - U.S. Entity (Admin Supp)

Notice of Special Interest
Thursday, May 7, 2020
Thursday, September 8, 2022
333
NOT-NS-20-024

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements the U.S.-Japan Brain Research Cooperative Program BRCP) - U.S. Entity Admin Supp) Notice Number: NOT-NS-20-024 Key Dates Release Date: 05, 2020 First Available Due Date: September 07, 2020 Expiration Date:September 08, 2022 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Center Complementary Integrative Health NCCIH) Purpose National Institutes Health NIH) announces continuation the U.S. entity the U.S.-Japan Brain Research Cooperative Program BRCP). administrative supplement program provide funds currently active research grants are currently supported one the participating NIH Institutes Centers. Notice soliciting administrative supplements the following mechanisms ONLY: DP1, DP2, DP5, R01, R03, R21, R33, R34, R37, R61, U01, UH2, and UH3. purpose the BRCP to promote scientist exchange, training, collaborations basic, translational clinical research between neuroscientists the U.S. Japan. U.S. entity the BRCP supports following activities: 1) Visit U.S. scientists conduct collaborative research and/or acquire advanced research skills Japanese institutions, 2) Joint workshops exchange scientific information to foster collaborations. Background agreement ldquo;Cooperation Research Development Science Technology” signed the President the United States the Prime Minister Japan May 1, 1980, has subsequently renewed extended. Under umbrella this Agreement, National Institute Neurological Disorders Stroke NINDS) the National Institute Physiological Sciences NIPS), Okazaki National Research Institutes, Japan, signed Memorandum Understanding a Brain Research Cooperative Program BRCP) November 29, 2000. Since inception the U.S. BRCP 2002, NIH successfully supported U.S. neuroscientists’ collaborative activities Japanese institutions, joint workshops the neurosciences. Japanese entity the BRCP been active since 2001. Details the program available http://www.nips.ac.jp/jusnou/english/. Within funding guidelines the BRCP program, country supports own scientists participate the aforementioned activities. BRCP Activities Supported the NIH A. Collaborative Research Fund Collaborative Research Fund provides support the travel lodging expenses the U.S. scientist’s visit Japan. visit the institution Japan be performed the PD/PI, collaborators, postdoctoral fellows students work the collaborative project. Support the Collaborative Research Fund be used one multiple trips. duration the supplement one year. supplement be carried over the next fiscal year, prior approval NIH Program staff. B. Workshop Fund U.S. Workshop Fund provides partial support joint workshops. U.S. Japan funding agencies the BRCP provide parallel support joint-workshops. entity support travel lodging expenses the joint-workshop participants their own country. the joint workshop be held the U.S., U.S. entity the BRCP support logistical meeting expenses. the joint workshop be held Japan, Japan entity support logistical meeting expenses. proposed workshop should at least co-organizer the U.S. one Japan. Co-organizers encouraged work together develop workshop applications. U.S. co-organizer must an active grant a participating NIH Institute Center. Workshop applications U.S. co-organizers should submitted response this FOA. Similarly, co-organizers Japan should submit application the NIPS. See: http://www.nips.ac.jp/jusnou/eng/ Applicants encouraged use Workshop Fund compensate travel lodging individuals groups are underrepresented the biomedical, clinical, behavioral social sciences encourage participation, the planning implementation of, well participation in, proposed workshop. NOT-OD--20-031. support junior investigators, postdoctoral fellows, graduate students also encouraged. Areas research interests the participating NIH Institutes Centers NINDS supports basic, translational clinical research understand structure function the nervous system mechanisms underlying neurological disorders stroke. Awardees projects funded the NIH BRAIN Initiative braininitiative.nih.gov/) encouraged submit supplement requests collaborative efforts are within scope this FOA NIH’s goals the BRAIN Initiative, defined the strategic planning report, BRAIN 2025: Scientific Vision. Investigators encouraged contact potential collaborators participating related efforts led Japan such the Brain/MINDS project http://brainminds.jp/en/). Collaborations promote interdisciplinary approaches research questions within NINDS mission also strongly encouraged. NIA supports broad spectrum research training aimed a better understanding age-related normal pathological changes the structure function the nervous system how such changes affect behavior. addition, NIA encourages cross-country collaborations research related the etiology, diagnosis, progression, treatment Alzheimer’s Disease AD). mission includes basic clinical studies the nervous system, clinical trials interventions therapeutic modalities, epidemiological research identify risk factors to establish prevalence incidence estimates pathologic conditions aging AD. mission NIBIB to improve human health leading development accelerating application biomedical technologies. NIBIB encourages submission applications support development bioengineering biomedical imaging technologies. NIDA supports basic, clinical, applied research the causes, consequences, prevention treatment drug abuse addiction. NIDCD encourages collaborative basic clinical biomedical bio-behavioral research the communication sciences hearing, balance, smell, taste, voice, speech language. NIDCR supports wide range basic, clinical translational research painful disorders the orofacial region including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain, other conditions; well chronic pain conditions co-morbid orofacial pain. NIEHS supports basic mechanistic human based studies the interplay environmental neurotoxicant exposure neuronal dysfunction across life span. includes influence prenatal exposure both childhood adult dysfunction/disease well adult exposures the aging brain. NIMH supports research transform understanding treatment mental illnesses through basic, translational, clinical, services research, paving way prevention, recovery, cure. NIMH encourages innovative thinking ensure a full array novel scientific perspectives used further discovery the evolving science brain, behavior, experience. NIMH now focusing an experimental medicine approach evaluating novel interventions mental illnesses. strategy designed increase value the public investment early clinical trials ensuring informed, data-driven decisions an early stage behavioral, device, pharmacologic studies. NCCIH supports rigorous scientific investigation, usefulness safety complementary integrative health approaches, their roles improving health health care. includes collaborations involving studying neurobiological mechanisms natural products such herbs, prebiotics, probiotics, dietary supplements) mind body interventions such acupuncture, meditation, manual therapy, yoga, Tai Chi, hypnosis, music art therapy, etc) their effects pain, sleep, stress, anxiety, emotional well-being, and/or behavioral changes. NCATS supports development disruptive innovative methods technologies will enhance development, testing implementation diagnostics therapeutics across wide range human diseases conditions. includes translational early stage clinical research rare neurologic brain conditions. 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 should accomplished within currently approved project period the existing parent award. awarding institute consider no-cost extension up an additional year the conclusion the first year. Award Budget Application budgets Collaborative Research Funds limited 25,000 direct cost. to 2,500 be used research supplies. Funds the BRCP not used salary support the PD/PI, collaborators, postdoctoral fellows, students collaborators. Travel costs associated Collaborative Research Fund requests should exceed U.S. Government Foreign Per Diem Rates Japan. See: http://aoprals.state.gov/content.asp?content_id=184&menu_id=81/ Application budgets Workshop Funds limited 35,000 direct cost. support travel lodging expenses should exceed U.S. Government Per Diem Rates http://www.gsa.gov/portal/content/101518 ; or http://aoprals.state.gov/content.asp?content_id=184&menu_id=81/ ). honorarium allowed. is recommended investigators secure additional funding support other sources, needed. announcement for supplements existing projects. research proposed the NIH grantee the supplement application must within original scope the NIH-supported grant award. Similarly, scope the proposed collaborative research activities workshops should well aligned the aims the parent award. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant award one the participating NIH Institutes Centers. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) must submitted the awardee institution the parent award. New early stage investigators encouraged apply, well established neuroscientists. Individuals diverse backgrounds, including underrepresented racial ethnic groups, individuals disabilities, women always encouraged apply NIH support. Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Application Due Date(s) – September 7, 2020, September 7, 2021, September 7, 2022, 5:00 PM local time applicant organization. funding consideration, applicants must include ldquo;NOT-IC-20-024” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. Only existing awardees a participating Institute Center eligible apply. Administrative supplement applications to PA-18-591 must the application form package the Competition ID contains ldquo;FORMS-F-ADMINSUPP”. addition, process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Page Limits: NIH consider supplements a Research Strategy no than 6 pages, addition the abstract. Research Strategies Collaborative Research Fund Submitted applications collaboration/training must include: Description the goals the collaboration/training how will enhance research the NIH-supported parent grant Details the supplement's specific aims, research design, methods data analysis Background significance the proposed research/training its relevance the goals the BRCP the mission the participating NIH Institutes Centers unique opportunities offered this collaboration/training, the reciprocal U.S. Japan) entity the project should clearly delineated Description the qualifications the Japanese host the research facilities resources the host institution Submitted applications collaboration/training must include letter invitation biosketch the Japanese host(s). Workshop Fund Submitted applications joint workshops must include: Description the importance the proposed workshop investigators the field the larger neuroscience community Relevance the workshop the goals the BRCP the mission the participating NIH Institutes Centers Background anticipated outcomes Description the meeting content, including topics, sessions, a tentative agenda Plans foster potential collaborations between U.S. Japanese participants Justification the proposed workshop location duration Composition role the organizing committee, the name credentials key participants i.e., presenters, moderators) Plans disseminate information generated the proposed workshop the larger scientific community. Plans the inclusion junior investigators, women, racial/ethnic minorities, persons disabilities. Review Process: Administrative supplement requests undergo administrative evaluation NIH Program staff the participating Institutes Centers. Reporting: Reporting requirements be specified the terms conditions award applicable the supplemental activities. most non-competing continuation applications, progress report budget the supplement must included with, clearly delineated from, progress report budget the parent award. progress report must include information the activities supported the supplement even support future years not requested. Final Report Within month the completion all collaborative research/training efforts workshops, U.S. BRCP supported investigators required submit final report the NIH, detailing following information: Project objectives Significance Results/findings including list publications, presentations, dissemination material research grant applications resulting the collaboration/training workshop Outcome collaboration/training workshop how benefits NIH supported research plans continued collaboration the Japanese investigator(s) Inquiries Please direct inquiries to: Scientific/Research Contact(s) Stacey D. ChambersNational Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-0690 Email: chambers@ninds.nih.go Coryse St. Hillaire-Clarke, Ph.D.National Institute Aging NIA)Telephone: 301-827-6944Email: sthillaireclacn@mail.nih.gov Shumin Wang, Ph.D.National Institute Biomedical Imaging Bioengineering NIBIB)Telephone: 301-594-9001Email: shumin.wang@nih.gov Da-Yu Wu, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-443-1887 Email: wudy@nida.nih.gov Susan L. Sullivan, Ph.D.National Institute Deafness amp; Communication Disorders NIDCD)Telephone: 301-451-3841Email: sullivaS@nidcd.nih.gov Yolanda F. Vallejo, Ph.D.National Institute Dental Craniofacial Research NIDCR)Telephone: 301-827-4655Email: Yolanda.Vallejo@nih.gov Jonathan A. Hollander, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-9467 Email: jonathan.hollander@nih.gov Miri Gitik, Ph.D. National Institute Mental Health NIMH) Telephone: 301-827-3523 Email: miri.gitik@nih.gov Inna Belfer, M.D., Ph.D. National Center Complementary Integrative Health NCCIH) Telephone: 301-435-1573 Email: inna.belfer@nih.gov Danilo A. Tagle, Ph.D., M.S. National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8064 Email: danilo.tagle@nih.gov Financial/Grants Management Contact(s) Chief Grants Management Officer National Institute Neurological Disorders Stroke NINDS) Email: ChiefGrantsManagementOfficer@ninds.nih.gov Jennifer Edwards National Institute Aging NIA) Telephone: 301-827-6689 Email: edwardsj@mail.nih.gov James Huff National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4786 Email: huffj@mail.nih.gov Cheryl Nathaniel National Institute Drug Abuse NIDA) Telephone: 202-526-0108 Email: nathanic@nida.nih.gov Christopher MyersNational Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-402-0909 Email: myersc@mail.nih.gov Dede Rutberg National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-4798 Email: rutbergd@mail.nih.gov James R. Williams National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-1403 Email: james.williams3@nih.gov Tamara KeesNational Institute Mental Health NIMH)Telephone: 301-443-8811Email: tkees@mail.nih.gov Shelley M. CarowNational Center Complementary Integrative Health NCCIH)Telephone: 301-594-3788Email: carows@mail.nih.gov Karen BrummettNational Center Advancing Translational Sciences NCATS)Telephone: 301-594-6268Email: Karen.Brummett@nih.gov

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