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-HL-20-803 - Notice NHLBI Participation NOT-OD-20-119NOT-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) NOT-OD-20-141 - Notice Correction NOT-OD-20-120 Eligibility Section Budget Request Information NOT-OD-20-138 - Notice Correction NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section NOT-HL-20-804 Notice NHLBI Participation NOT-OD-20-120 NOT-HL-20-805 - Notice NHLBI Participation NOT-OD-20-121 NOT-OD-20-157 - Notice Clarify Correct Eligibility Notices Special Interest under Rapid Acceleration Diagnostics Underserved Populations RADx-UP) Program Issued Office The Director, National Institutes Health OD)National Institute Minority Health Health Disparities NIMHD) National Institute Aging NIA) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute 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) of Us Research Program - New participating organization of 7/10/2020 due dates on/after 8/7/2020 Purpose Notice Special Interest NOSI) highlights urgent need understand 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-device… https://www.fda.gov/medical-devices/emergency-situations-medical-device…, 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 Interiors 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 Womens 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 of Us Research Program: Sheri D. Schully, Ph.D., 301-827-1691, schullys@mail.nih.gov Kimberly Stanton, 301-827-8054, stantonk@nhlbi.nih.gov
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Expiration Date: Wednesday, September 9, 2020 NOFO Number: NOT-OD-20-120 Release Date: Friday, June 12, 2020 Notice Type: Notice of Special Interest
Expiration Date: Saturday, August 8, 2020 NOFO Number: NOT-OD-20-121 Release Date: Friday, June 12, 2020 Notice Type: Notice of Special Interest
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 RFA-OD-20-023 - Emergency Awards: RADx-rad Predicting Viral-Associated Inflammatory Disease Severity Children Laboratory Diagnostics Artificial Intelligence PreVAIL kIds) R61/R33 Clinical Trial Optional) 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) NOT-OD-20-138 - Notice Correction NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section NOT-HL-20-804 Notice NHLBI Participation NOT-OD-20-120 NOT-HL-20-805 - Notice NHLBI Participation NOT-OD-20-121 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) of Us Research Program - New participating organization of 7/10/2020 due dates on/after 8/7/2020 Purpose Notice Special Interest NOSI) highlights urgent need understand 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 COVID19 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-device… https://www.fda.gov/medical-devices/emergency-situations-medical-device…, 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 Interiors 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 Womens 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 of Us Research Program: Sheri D. Schully, Ph.D., 301-827-1691, schullys@mail.nih.gov Kimberly Stanton, 301-827-8054, stantonk@nhlbi.nih.gov
Expiration Date: Saturday, January 8, 2022 NOFO Number: NOT-MH-20-048 Release Date: Wednesday, June 3, 2020 Notice Type: Notice of Special Interest
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
Expiration Date: Saturday, October 3, 2020 NOFO Number: RFA-HL-21-003 Release Date: Tuesday, June 2, 2020 Notice Type: RFA
The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act.
Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials.
This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results.
Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ
Research Category: Workforce Diversity Expiration Date: Monday, November 30, 2020 NOFO Number: PA-20-222 Release Date: Friday, May 29, 2020 Notice Type: PA Contact: Michelle Jones-London
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.
Expiration Date: Monday, May 8, 2023 NOFO Number: PA-20-149 Release Date: Wednesday, May 13, 2020 Notice Type: PA
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.
Expiration Date: Monday, May 8, 2023 NOFO Number: PA-20-151 Release Date: Wednesday, May 13, 2020 Notice Type: PA
This Funding Opportunity Announcement (FOA) invites research grant applications studying mechanisms of HIV-1 persistence and eradication strategies specifically focused on the central nervous system (CNS) in the context of viral suppression. Basic and translational research in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged but not required
Research Category: Pain Expiration Date: Wednesday, May 8, 2024 NOFO Number: PA-20-201 Release Date: Tuesday, May 12, 2020 Notice Type: PA
The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.
Research Category: Clinical Trials Research Expiration Date: Saturday, August 15, 2020 NOFO Number: RFA-NS-20-030 Release Date: Tuesday, May 12, 2020 Notice Type: RFA
Reissue of RFA-NS-18-032. The purpose of the NINDS Research Program Award (RPA) is to provide longer-term support and increased flexibility to Program Directors (PDs) /Principal Investigators (PIs) whose records of research achievement demonstrate their ability to make major contributions to neuroscience. RPAs will support the overall research programs of NINDS-funded investigators for up to 8 years, at a level commensurate with a PD/PI's recent NINDS support (Part 2, Section II) This greater funding stability will provide eligible investigators at nearly all career stages increased freedom and flexibility, allowing them to be more adventurous in their research, take greater risks, embark upon research that breaks new ground, undertake research projects that require a longer timeframe, and/or extend previous discoveries in new directions. Research supported through the RPA must be within the scope of the NINDS mission (http://www.ninds.nih.gov/about_ninds/mission.htm). Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center will not be considered through this program. Other anticipated benefits of the RPA include: A more stable funding environment, facilitating the pursuit of longer-term research goals; Flexible funding, enabling investigators to pursue research opportunities as they arise, not tied to specific aims; Reduced time spent writing grant applications and managing multiple grant awards, thereby allowing investigators to spend more time conducting and overseeing research; and More time for PDs/PIsto mentor junior scientists. Eligibility to apply through this FOA is limited to investigators who currently have at least one active NINDS R01 or R01 equivalent grant (defined here as R00, R01, R37, R56, DP1 or DP2 awards), and who have had an active R01 equivalent grant from NINDS in each of the past 5 years, with no more than one of those years in a no cost extension.
Expiration Date: Wednesday, May 8, 2024 NOFO Number: PA-20-202 Release Date: Tuesday, May 12, 2020 Notice Type: PA
The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.