Find Funding Opportunities

Find Funding Opportunities

Subscribe to Find Funding OpportunitiesRSS
Returning 1448 results

Notice of Special Interest: Alzheimers-focused administrative supplements for NIH grants that are not focused on Alzheimers disease

Notice of Special Interest
Wednesday, September 9, 2020
Saturday, October 17, 2020
333
NOT-AG-20-034

Funding Opportunity Purpose

The participating Institutes and Centers (ICs) are inviting applications to expand existing awards that are not currently focused on Alzheimers disease and its related dementias - Frontotemporal dementia, Lewy Body dementia, Vascular Cognitive Impairment with Dementia and multiple etiology dementias - to allow the research to develop such a focus.

Emergency Awards: Chemosensory Testing as a COVID-19 Screening Tool (U01 Clinical Trial Optional)

RFA
Thursday, August 6, 2020
Wednesday, September 16, 2020
U01
RFA-OD-20-022

Funding Opportunity Purpose

NIH is issuing this RFA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency NOSI from the NIH provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. The goal of RADx-rad initiative is to encourage the development of novel, non-traditional approaches to identify the current SARS-CoV-2 virus or other markers of the COVID-19 disease that can be used in future outbreaks of COVID-19 and that could be applicable to other, as yet unknown, viruses. Specifically, the goal of this RFA is to solicit proposals to enhance the utility of chemosensory testing as a COVID-19 screening tool by using objective tests to examine the onset and prognostic value of chemosensory loss and to encourage the development and/or deployment of home-based and on-site chemosensory tests. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Chemosensory Testing as a COVID-19 Screening Tool

Notice of Special Interest
Thursday, August 6, 2020
Wednesday, September 16, 2020
333
NOT-OD-20-152

Funding Opportunity Purpose

Notice Special Interest NOSI): Availability Emergency Competitive Revisions Chemosensory Testing a COVID-19 Screening Tool Notice Number: NOT-OD-20-152 Key Dates Release Date: August 6, 2020 First Available Due Date: September 01, 2020 Expiration Date: September 16, 2020 Related Announcements PA-20-135 - Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) NOT-OD-20-144 - Notice Intent Publish Funding Opportunity Announcements the RADx-rad Initiative RFA-OD-20-022 - Chemosensory Testing a COVID-19 Screening Tool U01 Clinical Trial Optional) RFA-OD-20-019 - Emergency Awards: RADx-rad Data Coordination Center DCC) U24 Clinical Trial Allowed) Issued Office The Director, National Institutes Health OD) National Institute Aging NIA) 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 Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Research Women's Health ORWH) Purpose Purpose NIH issuing NOSI response the declared public health emergency issued the Secretary, HHS, 2019 Novel Coronavirus COVID-19). emergency NOSI the National Institutes Health NIH) provides expedited funding mechanism part the Rapid Acceleration Diagnostics-Radical RADx-rad) initiative. goal the RADx-rad initiative to encourage development novel, non-traditional approaches identify current SARS-CoV-2 virus other markers the COVID-19 disease can used future outbreaks COVID-19 that be applicable other, yet unknown, viruses. Specifically, goal this NOSI to solicit proposals enhance utility chemosensory testing a COVID-19 screening tool using objective tests examine onset prognostic value chemosensory loss to encourage development and/or deployment home-based on-site chemosensory tests. funding this initiative provided the Paycheck Protection Program Health Care Enhancement Act, 2020. Background SARS-CoV-2 a novel coronavirus has recently identified the causative agent COVID-19, respiratory disease exhibits wide range clinical outcomes asymptomatic mild disease severe viral pneumonia, Acute Respiratory Distress Syndrome ARDS), Multisystem Inflammatory Syndrome Children MIS-C), acute kidney injury, thrombotic disorders, chemosensory dysfunction, serious cardiac, cerebrovascular vascular complications. March 11, SARS-CoV-2 outbreak classified a pandemic the WHO. Research an important component the public health emergency response before, during after emergency. United States Food Drug Administration FDA)-authorized COVID-19 diagnostic testing critical slowing spread the virus preventing future outbreaks. Given this, is urgent public health need the National Institutes Health NIH) support development a variety approaches testing. Expanding capacity, throughput, regional placement existing technologies accelerating development new technologies contribute significantly the current national efforts curb COVID-19 pandemic. help meet need, NIH launched Rapid Acceleration Diagnostics RADx) initiative speed innovation the development, commercialization, implementation technologies COVID-19 testing. RADx initiative a national call scientists organizations bring innovative ideas new COVID-19 testing approaches strategies. a part this initiative, NIH developed RADx Radical RADx-rad) project. RADx-rad support new, non-traditional approaches, including unconventional screening, biological physiological markers, new platforms, point-of-care devices, address current gaps COVID-19 testing. program also support new non-traditional applications existing approaches enhance usability, accessibility, and/or accuracy. Despite variety activities included, overall RADx-rad effort be centrally aligned coordinated harmonize data collection, storage, management, providing opportunity further explore identify additional approaches understand novel virus. Beyond current crisis, is anticipated the technologies advanced through RADx-rad also applicable other, yet unknown, infectious agents. “Sudden loss smell taste” formally recognized one the hallmarks COVID-19 the CDC has emerged the main neurological manifestation the disease as as 80% patients infected SARS-CoV-2 reporting chemosensory dysfunction. fact, recent observational studies indicate the loss smell taste one the most common symptoms COVID-19 more predictive all symptoms, including fatigue, fever, cough. Most studies date used self-report rather objective chemosensory testing, leading the possibility the prevalence chemosensory loss be even higher among patients COVID-19 previously reported. findings highlight need objective chemosensory tests COVID-19 screening, yield immediate results are validated across lifespan, easy self-administer, quantitative graded allow determination diminished well profound sensory loss. initiative aims support further development, commercialization, implementation technologies chemosensory testing screen patients COVID-19 to complement current temperature screening procedures. Research Objectives NOSI fund competitive revisions existing NIH awards support chemosensory testing a COVID-19 screening tool using objective tests examine onset prognostic value chemosensory loss to encourage development and/or deployment home-based on-site chemosensory tests. Areas interest include: Development deployment standardized validated over counter testing kits tests utilize common household items remote, home-based screening through telemedicine mild moderately affected individuals. Modification existing test platforms e.g. NIH Toolbox®) improve efficiency administration, data collection evaluation using mobile phone apps telemedicine. Development innovative chemosensory platforms can implemented testing large, risk populations, example, health care workers, pregnant women, older adults caretakers residing/working nursing homes long-term care facilities. Establishment appropriate odorants, optimal odorant concentrations, standardized delivery systems protocols the development onsite, group testing stations those working living high-density, high risks environments. Analysis test results determine specificity chemosensory testing respect COVID-19 versus influenza, onset chemosensory dysfunction, the prognostic value chemosensory testing predicting neurological other manifestations. maximize research rapidly implement approaches address COVID-19 pandemic, comparisons across datasets studies data integration essential collaboration. Projects funded through FOA strongly encouraged use following resources applicable: 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. 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. Recipients expected work the RADx-rad Data Coordinating Center DCC) submit common evaluation metrics COVID-19 testing-related outcomes implementation the DCC. Recipients should identify dedicated unit responsible these data reporting activities. NIH expects all projects funded under NOSI actively coordinate, collaborate, share data the RADx-rad Data Coordinating Center, allowed, with considerations under tribal IRB processes, appropriate. Researchers applying this funding opportunity strongly encouraged review Data Coordinating Center DCC) funding opportunity. NIH Expects, data acquisition, collection, curation strategies be coordinated the DCC guidance annotation benchmarking data, including obtaining 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/). order maximize progress successful outcomes, recipientsare expected participate DCC-organized activities, including regular e.g., monthly) progress meetings individual subsets awardees, twice annual meetings all RADx-rad awardees. Applications must include timeline completion. timeline must include plans regular reports progress be submitted the DCC. Projects must include evaluation plan demonstrating the proposed COVID-19 diagnostic strategies/activities be assessed effectiveness impact. Recipientsare 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. Recipients must include measures reporting relevant testing implementation outcomes, inform future community, local, state, federal policies. 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 DCC DSMB activities. Recipients expected disaggregate study results sex gender; race ethnicity; age other relevant demographic factors, to consider intersectionality appropriate Accuracy, sensitivity, specificity, accessibility affordability key considerations chemosensory tests. Odor taste assessment delivery tools should follow FDA guidelines including performance testing demonstrate reliability detection loss chemosensory function be considered “Generally Recognized Safe” GRAS). Non-responsive Projects do have infrastructure rapidly report study findings impact the DCC. Projects have limited testing capacity, do include FDA-authorized/approved testing strategies present plan incorporate approved testing strategies Review Process Applications be evaluated scientific technical merit an appropriate internal review panel convened NIH staff, 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 detection SARS-CoV-2 COVID-19) infection related pathogenic processes? Research strategy: 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? the emergency time frame appropriate feasible support aims goals the study? Investigators: the PD/PIs, collaborators, other researchers well suited appropriate carry the project? Outcomes: outcomes products proposed impact improve acceptability, accessibility, effectiveness COVID-19 testing? 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)?  Data Sharing Plan: the proposed research generate unique resources data may impact public health response medical countermeasure development, does resource sharing plan adequately address rapid dissemination data, results, analyses the broader scientific community, using existing public repositories whenever possible not limited Tribal data sharing policy, a foundation further study? Coordination plans:How feasible appropriate the plans submit data, data collection instruments, outcomes/products the DCC? Pre-Award costs Pre-award costs be incurred January 20, 2020 through public health emergency period prior the date the federal award. Reporting 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 Application due date: September 15, 2020 5:00 PM local time applicant organization. Submit applications this initiative response the following funding opportunity announcement FOA) the subsequent reissued equivalent through expiration date this notice: PA-20-135- Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) Eligibility Active research resource grants, cooperative agreements small business grants SBIR STTRs). NRSA training fellowship grants not eligible apply funding. Product development, validation, scale-up activities supporting commercialization all within scope this NOSI. 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. Grants currently a no-cost extension eligible apply. instructions the SF424 R&R) Application Guide the parent funding opportunity announcement must followed, the following additions: funding consideration, applicants must include “NOT-OD-20-152” 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 non-responsive terms this NOSI be be considered. Requests expected to exceed 250,000 total direct costs. Total direct costs requested not exceed direct cost amount the current year’s award. Maximum direct costs exclusive consortium/contractual Facilities Administrative F&A) costs. Requests limited one year support. Regardless the grant mechanism the parent award, Research Strategy section the application limited 6 pages. Where applicable, provide details appropriate biohazard management plans commensurate the level risk https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html). Applications conducting research the SARS-CoV-2 virus specimens possible SARS-CoV-2 infection must address protections against potential biohazards, including details access special facilities, e.g., Biosafety Level 3/4 BSL3/4) laboratories. Potential applicants strongly encouraged contact Program Official listed the Notice Grant Award the parent project discuss responsiveness appropriate mechanism before submission to facilitate efficient processing the request. Inquiries Please direct inquiries one the following contacts: Susan Sullivan, Ph.D. National Institute Deafness Other Communication Disorders NIDCD): 301-451-3841 sullivas@nidcd.nih.gov Amanda Melillo, Ph.D. National Institute Dental Craniofacial Research NIDCR 301-312-9037 amanda.melillo@nih.gov Coryse St. Hillaire-Clarke, Ph.D. National Institute Aging NIA) 301-827-6944 sthillaireclacn@mail.nih.gov Nahida Chakhtoura, Ph.D. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) 301-435-6872 nahida.chakhtoura@nih.gov Jim Gnadt, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-9964 gnadtjw@ninds.nih.gov Michelle Hamlet National Institute Nursing Research NINR) 301-496-9623 hamletm@mail.nih.gov Rajasri Roy Office Research Women's Health ORWH) 301-451-0993 rajasri.roy@nih.gov

Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional)

RFA
Wednesday, July 29, 2020
Tuesday, October 20, 2020
P50
RFA-AR-21-008

Funding Opportunity Purpose

Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers

The NINDS Human Biospecimen and Data Repository (U24 Clinical Trial Not Allowed)

RFA
Tuesday, July 28, 2020
Wednesday, October 21, 2020
U24
RFA-NS-20-031

Funding Opportunity Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) is soliciting applications for a Human Biospecimen and Data Repository for Biomarkers Research ("Biomarkers Repository") in Neurological Disorders. Collaborative teams combining expertise in neuroscience, biomarkers, biospecimen handling, and data management are encouraged. Experience in biomarker research, such as evaluation of batch effects, protocol development, and analyte quality control measures, is expected. Successful applications will include a detailed description of 1) Administrative Structure, 2) Research and Resource Plan, and 3) Data Management and Web-Based activities.

NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls (P20 Clinical Trial Optional)

RFA
Wednesday, July 15, 2020
Tuesday, September 29, 2020
P20
RFA-NS-21-002

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) requests Exploratory Grant (P20) applications for the planning and initiation of collaborative activities to advance Parkinson's Disease (PD) research. The goal of this FOA is to convene new transdisciplinary research consortia and formalize the multi-institutional organizational and investigational structure necessary to resolve an essential challenge in Parkinson's disease (PD) through a subsequent NINDS Udall Center without Walls (CWOW) approach. The most compelling applications will: (i) identify a fundamental PD research priority; (ii) build an exemplary research consortium; (iii) gather supportive preliminary data; and (iv) demonstrate exceptional potential to pursue a targeted strategy to remove a critical impediment blocking advancement of the understanding and treatment of PD. The stated challenge and related research feasibility projects will inform the etiology, pathogenesis or treatment of PD; investigations on related synucleinopathies may be included if such studies directly address the central PD research challenge. To foster the development of innovative research collaborations, this FOA will provide support for new research consortia only; continuation of established projects and teams will not be supported. Proposed consortia must include the optimal combination of specialized expertise required to resolve the stated challenge using a goal-driven approach. The Program Director/Principal Investigator (PD/PI) must be eminently qualified to provide visionary scientific leadership and effective oversight of consortium administrative activities. Participating investigators should be recognized as world-class experts in their fields. Teams must be anchored by at least one PD researcher. To maximize potential for new insights and incorporation of cutting-edge approaches, consortia will actively integrate at least one investigator with primary expertise in another, complementary research area. The applicant inst

Notice of Correction to NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section

Notice of Special Interest
Tuesday, June 30, 2020
Heal
Wednesday, September 9, 2020
NOT-OD-20-138

Funding Opportunity Purpose

The purpose of this notice is to inform potential applicants of correction to the Eligibility section of: NOT-OD-20-119 "Notice of Special Interest (NOSI): Emergency Competitive Revisions for Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing among Underserved and/or Vulnerable Populations" NOT-OD-20-120 "Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations" NOT-OD-20-121 "Notice of Special Interest (NOSI): Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations" These Notices of Special Interest have been modified as follows: Eligibility Added: "Competitive revision applications to this NOSI may not propose new foreign components and may not request additional funding for existing foreign components.” Furthermore, in NOT-OD-20-121 "Notice of Special Interest (NOSI): Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations",NIDA corrects the list of eligible grant programs to add "Coordinating Center to Support NIDA Rural Opioid HIV and Comorbidity Initiative (RFA-DA-19-004)", and to correct the listed FOAs for "Limited Competition Cohort Studies of HIV/AIDS and Substance Abuse" adding RFA-DA-17-019; PAS-DA-12-222, and for "NIDA Research Center of Excellence Grant Program" to include PAR-19-259; PAR-18-224; PAR-16-009. Currently reads: “NIDA Eligible Grants are funded under the following Funding Opportunity Announcements: HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States: Building Systems for Prevention, Treatment and Control (RFA-DA-17-014) Hepatitis C Virus (HCV) Advanced Molecular Detection in Support of Systems for Prevention, Treatment and Control of HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States (RFA-DA-17-023) Limited Competition Cohort Studies of HIV/AIDS and Substance Abuse (RFA-DA-20-005; RFA-DA-18-011) NIDA Core “Center of Excellence” Grant Program (PAR-17-121; PAR-14-186) HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN): Methodology and Advanced Analytics Resource Center (RFA-DA-19-023); Clinical Research Centers (RFA-DA-19-025); Coordination and Translation Center (RFA-DA-19-024) HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) (RFA-DA-19-035); Coordinating Center (RFA-DA-19-034) HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (RFA-DA-19-036, RFA-DA-19-029) HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis: Research Sites (RFA-DA-19-016); Data Coordinating Center (RFA-DA-19-017) Limited Competition for Adolescent Brain Cognitive Development (ABCD) Study – Linked Research Project Sites (RFA-DA-20-002); Data Analysis, Informatics and Resource Center (RFA-DA-20-003); Coordinating Center (RFA-DA-20-004) The National Drug Abuse Treatment Clinical Trials Network (RFA-DA-20-024; RFA-DA-15-008) NIDA Research Center of Excellence Grant Program (PAR-18-224; PAR-18-224)” Modified to read: “NIDA Eligible Grants are funded under the following Funding Opportunity Announcements: HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States: Building Systems for Prevention, Treatment and Control? (RFA-DA-17-014) Hepatitis C Virus (HCV) Advanced Molecular Detection in Support of Systems for Prevention, Treatment and Control of HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States (RFA-DA-17-023) Coordinating Center to Support NIDA Rural Opioid HIV and Comorbidity Initiative (RFA-DA-19-004) Limited Competition Cohort Studies of HIV/AIDS and Substance Abuse (RFA-DA-20-005; RFA-DA-18-011; RFA-DA-17-019; PAS-DA-12-222) NIDA Core “Center of Excellence” Grant Program (PAR-17-121; PAR-14-186) HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN): Methodology and Advanced Analytics Resource Center (RFA-DA-19-023); Clinical Research Centers (RFA-DA-19-025); Coordination and Translation Center (RFA-DA-19-024) HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) (RFA-DA-19-035); Coordinating Center (RFA-DA-19-034) HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (RFA-DA-19-036, RFA-DA-19-029) HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis: Research Sites (RFA-DA-19-016); Data Coordinating Center (RFA-DA-19-017) Limited Competition for Adolescent Brain Cognitive Development (ABCD) Study – Linked Research Project Sites (RFA-DA-20-002); Data Analysis, Informatics and Resource Center (RFA-DA-20-003); Coordinating Center (RFA-DA-20-004) The National Drug Abuse Treatment Clinical Trials Network (RFA-DA-20-024; RFA-DA-15-008) NIDA Research Center of Excellence Grant Program (PAR-19-259; PAR-18-224; PAR-16-009)” All other aspects of the FOAs remain unchanged.

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

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

Funding Opportunity Purpose

Notice Special Interest NOSI): Emergency Competitive Revisions Social, Ethical, Behavioral Implications SEBI) Research COVID-19 Testing among Underserved and/or Vulnerable Populations Notice Number: NOT-OD-20-119 Key Dates Release Date: June 12, 2020 First Available Due Date: July 08, 2020 Expiration Date: September 09, 2020 Related Announcements NOT-OD-20-131 - Notice Pre-Application Webinar the RADx-UP Initiative PA-20-135 - Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) NOT-OD-20-121 - Notice Special Interest NOSI): Limited Competition Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations NOT-OD-20-120 - Notice Special Interest NOSI): Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations RFA-OD-20-013- Emergency Awards: RADx-UP Coordination Data Collection Center CDCC) U24 Clinical Trial Optional) NOT-OD-20-138 - Notice Correction NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section NOT-HL-20-803 - Notice NHLBI Participation NOT-OD-20-119 NOT-HL-20-804 Notice NHLBI Participation NOT-OD-20-120 NOT-HL-20-805 - Notice NHLBI Participation NOT-OD-20-121 NOT-OD-20-157 - Notice Clarify Correct Eligibility Notices Special Interest under Rapid Acceleration Diagnostics Underserved Populations RADx-UP) Program Issued Office The Director, National Institutes Health OD)National Institute Minority Health Health Disparities NIMHD) National Institute Aging NIA) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) National Cancer Institute NCI) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers.Sexual Gender Minority Research Office SGMRO) Tribal Health Research Office THRO) Office The Director, National Institutes Health OD) Division Program Coordination, Planning Strategic Initiatives, Office Disease Prevention ODP) Office Behavioral Social Sciences Research OBSSR) Office Research Women's Health ORWH) Environmental Influences Child Health Outcomes ECHO) of Us Research Program - New participating organization of 7/10/2020 due dates on/after 8/7/2020 Purpose Notice Special Interest NOSI) highlights urgent need understand social, ethical, behavioral implications SEBI) COVID-19 testing among underserved and/or vulnerable populations across United States through Rapid Acceleration Diagnostics Underserved Populations RADx-UP) initiative. overarching goal to understand factors have led disproportionate burden the pandemic these underserved populations that interventions be implemented decrease disparities. funding this supplement provided the Paycheck Protection Program Health Care Enhancement Act, 2020. Office the Director therefore offering Emergency Competitive Revisions active eligible grants cooperative agreements addressing objectives described below. NOSI one four related RADx-UP opportunities. purpose this SEBI NOSI to identify, analyze, address social, ethical, behavioral factors likely influence access uptake COVID-19 testing underserved and/or vulnerable populations. Single mixed methods approaches involving community partners inform development evaluation such testing programs. studies assess ethical, historical, healthcare, social contextual factors surrounding COVID-19 testing, well how cultural beliefs attitudes, perceived expectations, preferences influence ability willingness get tested participate follow-up evaluations. Findings be used develop interventions mitigate barriers access increase uptake testing. Studies focused unintended consequences COVID-19 testing these groups also interest related social ethical issues. related program initiatives include: NOT-OD-20-121which encourages community-engaged Testing Research Projects supplement large scale networks, consortia, centers, examine SARS-CoV-2 infection patterns efforts increase access effectiveness diagnostic methods. NOT-OD-20-120 a similar focus, shifts pool eligible grants supplementation individual research awards include community collaboration partnership, generally targeting specific populations. RFA-OD-20-013 is U24 Coordination Data Collection Center CDCC) a key component the consortium Collectively, projects funded under three NOSIs serve one consortium interlinked community-engaged research projects across United States understand COVID-19 health disparities, to deploy implementation strategies improve reach, acceptance, uptake, sustainability COVID-19 testing. NIH expects all supplements funded under NOSI the related NOSIs actively coordinate share data where allowed) other grantees, CDCC, other research supported the RADx-UP program. Research specifically develops implements novel COVID-19 testing programs the populations defined below under Key Definitions should submitted under either NOT-OD-20-120 NOT-OD-20-120instead this NOSI. Applicants this SEBI NOSI allowed, not required, apply the RADx-UP opportunities. Researchers applying this NOSI strongly encouraged read four these interrelated funding opportunities. Researchers applying this NOSI strongly encouraged read four these interrelated funding opportunities. Key Definitions NOSI applicable those populations are underserved well populations are COVID-19 vulnerable due medical, geographic, social factors, defined below referred as underserved and/or vulnerable elsewhere this NOSI): Underserved: NIH-designated health disparity populations and/or groups known experience barriers needed health care services, to inadequate health care coverage. full description be found https://www.nimhd.nih.gov/about/overview/. COVID-19 medically and/or socially vulnerable populations: Residents nursing homes assisted living facilities; community-dwelling older adults; individuals intellectual, developmental, sensory, physical disabilities, cognitive impairment dementia, communication disorders; homeless populations; individuals involved the criminal juvenile justice systems incarcerated under community supervision); individuals medical comorbidities known increase risk severe COVID-19, including heart failure related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant post-partum women; children adolescents; individuals living congregate housing such shelters residential treatment facilities; individuals overcrowded public housing; individuals substance disorders serious mental illness; detainees immigration detention centers; migrant immigrant communities; residents tribal lands reservations; communities exposed high rates air pollution other toxic exposures; rural remote communities. Background SARS-CoV-2 a novel coronavirus has recently identified the causative agent COVID-19, respiratory disease exhibits wide range clinical outcomes asymptomatic mild disease severe viral pneumonia, Acute Respiratory Distress Syndrome ARDS), Multisystem Inflammatory Syndrome Children MIS-C), acute kidney injury, thrombotic disorders serious cardiac, cerebrovascular vascular complications. United States Food Drug Administration FDA)-authorized COVID-19 diagnostic testing critical slowing spread the virus preventing future outbreaks. Growing evidence suggests underserved and/or vulnerable populations more susceptible COVID-19 infection, severe COVID-19 complications, associated death, well the social, behavioral economic impacts the pandemic. Over next six months, advances testing technology vaccine development anticipated. Strategies accelerate dissemination these improved tests vaccine trials underserved and/or vulnerable populations also must developed. However, populations experience multilevel barriers testing arising individual, interpersonal, institutional e.g., health care system), community, policy levels reduce access and acceptance COVID-19 testing. Similar concerns the potential limit uptake public health impact future vaccination trials implementation programs, dissemination effective therapeutics ambulatory care settings. Against backdrop, COVID-19 testing programs underserved and/or vulnerable populations must design communication strategies, consent materials, data governance plans, processes return results, informational referral resources are responsive the communities will serve. inform development evaluation such testing programs, studies solicited here focus assessing ethical, historical, healthcare, social, economic, contextual factors surrounding COVID-19 testing, well cultural beliefs attitudes, expectations, preferences testing test results influence groups ability willingness get tested. factors include are limited individual proximal environmental factors such normative beliefs, peer influence, incentive/disincentive structures the social community environment may influence testing uptake. SEBI studies also focus factors the interpersonal, institutional e.g., health system), community, policy levels affect access COVID-19 testing among underserved and/or vulnerable populations. Findings be used inform development intervention strategies tools increase access and acceptability testing specified populations. findings help guide design implementation strategies other domains the consortium see, NOSI NOT-OD-20-121 NOSI NOT-OD-20-120, respectively]) in Phase II the RADx-UP initiative be announced a later date), will address developments diagnostics vaccination. Studies supported under NOSI should work closely communities support depth examination social, ethical behavioral factors related COVID-19 testing vaccination research. Projects also expected specify strategies address social determinants health SDOH) present barriers participation testing follow-up. RADx-UP projects expected demonstrate ability leverage existing partnerships such with Tribal governments organizations, academic community medical centers health systems, safety-net health social service systems, grassroots organizations, public health departments, community faith-based organizations, schools child care settings) complete study aims. Applicants should provide evidence collaboration community organizations whom will work must describe roles all partners. Study budgets should include funds the community partners be fully engaged successfully participate research design implementation. address expected impacts COVID-19 the scientific workforce, projects also strongly encouraged support early stage investigators, specifically targeting ability enhance diversity their research workforce. Applicants strongly encouraged contact SEBI program officials prior developing application determine programmatic responsiveness the NOSI. Areas Research Interest Supported studies should address key questions more one level analysis e.g., individual, interpersonal, institutional e.g., health system], community, policy). Scientific questions interest include, are limited to: social, ethical behavioral facilitators barriers substantially influence decisions whether when offer seek COVID-19 testing? strategies mitigate barriers, increase access and acceptability testing repeat testing? are implications both positive negative COVID-19 diagnostic tests underserved and/or vulnerable groups, how they influence testing decisions downstream beliefs behaviors? are test results interpreted used these underserved and/or vulnerable communities? are risks benefits implementing new COVID-19 testing technologies underserved and/or vulnerable communities the perspectives those populations? population specific social, ethical, behavioral factors should addressed before deploying novel testing strategies? factors should addressed before vaccine trials be considered? strategies be developed tested increase acceptability vaccine trials vaccinations underserved and/or vulnerable populations? Applicants encouraged consider investigate: Social, economic, ethical, cultural, historical, contextual factors beliefs behaviors associated testing/diagnostic technologies Collection, storage, and public health reporting requirements COVID-19 test data, considering Tribal data sovereignty where appropriate Return results, repeat testing, implications and provision support negative positive test results under-resourced populations, individual patients, their families Availability tests referral networks follow-up care social services address basic needs related COVID-19 e.g., patient referral navigation services) Stigma, discrimination, financial burden associated accessing testing a positive test result follow-up care Implications contact tracing including mistrust privacy considerations Health-related beliefs behavior regarding willingness be vaccinated against SARS-CoV2 or an effective vaccine made available most effective community engagement strategies inform culturally sensitive implementation diagnostic testing underserved and/or vulnerable populations Where possible, applications should work towards outcomes products could used improve access and acceptability COVID-19 diagnostics. Examples possible study outcomes included below. However, researchers should address outcomes identified high priority the communities being studied. studies focus specific communities, yet should also consider extent which findings be generalized adapted implemented across underserved and/or vulnerable populations. Applications should briefly describe generalizability, where possible, study approaches findings broader populations include plans the development materials toolkits facilitate adaptation, dissemination, implementation. Applications should detail community-engaged methods assess barriers COVID-19 test access, uptake follow-up, develop evaluate strategies interventions address those barriers. Applications should include dissemination activities maintain bi-directional feedback loops community experts RADx-UP study findings. Development pre-testing potential interventions increase testing access, acceptability, feasibility, uptake be interest. However, should be primary aim the application. Potential applicants considering applications focused interventions increase access uptake COVID-19 diagnostics should consult additional opportunities. Applications propose studies using either single mixed methods. Proposed approaches include, are limited hypothesis-generating qualitative quantitative approaches, observational research, randomized efficacy studies, policy, economic normative analyses, other types analytical conceptual research methodologies, such those involving direct engagement stakeholders. Sample Research Topics Products Broad research topic areas listed below, followed examples specific issues within area. list research topics issues not exhaustive, the order listed does indicate relative priority. Also listed possible outcomes, products tools could used improve access uptake COVID-19 testing. Applicants should develop aims products appropriate the goals this NOSI, close collaboration community partners. Decision-Making COVID-19 Diagnostics Assess factors influencing ability willingness underserved and/or vulnerable communities access available diagnostic services follow-up care services following positive results. Enumerate key facilitators barriers, strategies harness facilitators mitigate barriers. Assess reasons testing decisions, including perceived/actual harms benefits different testing decisions. Assess these factors weighed determine is most/least likely get tested under various scenarios locations e.g., health status, family member test status, employment health insurance status, rural/urban). Examine perceived actual risks testing other parties including family members, traced contacts, broader communities, how those risks influence decision-making. Assess variations provider, health system, employer protocols COVID-19 test eligibility, how are influenced socio-contextual factors. Products Validated reliable assessment tools determine likelihood seeking COVID-19 testing Strategies acknowledge influence contextual/health-related beliefs attitudes testing Strategies make testing accessible acceptable communities interest Return COVID-19 Test Results Determine information community members want learn believe would need their COVID-19 status diagnostic tests. Assess perceived utility diagnostic test result information, how those perceptions influence uptake. Determine information resource needs the time return results, develop assess communication methods varied languages, literacy levels, modes delivery. Assess improve understanding, misunderstanding retention key information using multimodal resources delivery channels. Assess test recipients interpret act their results, including mitigation behaviors a result negative findings e.g., less vigilance social distancing, wearing mask public, handwashing, etc.), information-seeking resources lead referral at-risk contacts testing. Products Results templates toolkits designed collaboration communities Strategies resources increase and utility results accompanying information resources Strategies encourage testing at-risk contacts Strategies encourage repeat testing follow-up services, appropriate Data Stewardship, Data Sharing Privacy Explore community understanding, expectations, concerns preferences governance, privacy, security, and sharing participant COVID-19 data including sharing secondary users, such third-party payers, employers, housing managers authorities, public health departments, law enforcement, etc.). Determine specified communities view balance public health benefits sharing test results e.g. contact tracing) cultural norms personal opinions privacy; explore these views influence testing decisions. Develop transparent governance policies COVID-19 test data meet scientific public health goals, while addressing acknowledging community concerns limitations. Product Community-informed data governance policies Health Communication, Literacy, Language Increasing understanding COVID-19 testing vaccination precursors uptake. Approaches should use multiple formats channels address linguistic cultural barriers. Assess trust local, regional national sources COVID-19 data testing information among underserved and/or vulnerable populations. Test impacts information source(s) beliefs veracity theoretical antecedents e.g., motivation, agency, intentions) behavior. Examine role health literacy, including limited English language literacy, COVID-19 testing disparities. Assess address current sources content messaging leading key understanding, misunderstanding misrepresentation these communities COVID-19 testing, contact tracing, vaccination. Identify messaging targets help improve testing uptake vaccination acceptance available. Assess interpersonal e.g., healthcare provider) COVID-19 communications working underserved and/or vulnerable populations address social ethical implications. Develop test community culturally appropriate COVID-19 messages specific foci social ethical considerations Assess address long-held beliefs attitudes science, government, health care public health enhance deter uptake testing vaccination. Products Create trusted local regional COVID-19 communication networks reach underserved and/or vulnerable populations; develop strategy aid similar partnership development other localities. Tested strategy improve quality, consistency quantity COVID-19 communication Tested materials approaches ameliorate distrust, fear, stigma discrimination surrounding COVID-19 Tested materials approaches address current misrepresentations misunderstandings inhibiting uptake COVID testing vaccination. Ensure products available readily adaptable other communities languages Vaccine Preparedness Underserved and/or Vulnerable Populations Understand population specific beliefs, attitudes, intentions towards future COVID-19 vaccination including individual, familial, community, economic, structural influences vaccine acceptability hesitancy. Assess misinformation the design countermeasures misinformation regarding vaccination Examine assess implementation strategies vaccine trial scale-up underserved and/or vulnerable communities, including roles organizations institutions the community. Develop culturally competent strategic communication COVID-19 vaccination averts stigma ensures effective exchange dissemination information. Develop methods ensure appropriate consent vaccine trials including approaches children parents/guardians other underserved and/or vulnerable populations Products: Resources strategies assess vaccine trial acceptability specified communities Resources strategies addressing community concerns regarding vaccine trials Resources community engagement collaboration vaccine trials Applications nonresponsive terms this NOSI not considered. following types projects generally be appropriate may deemed non-responsive: Projects primarily increasing delivery COVID-19 testing NOSINOT-OD-20-121 NOSI NOT-OD-20-120) Projects without focus one more underserved COVID-19 vulnerable populations Projects have limited population reach taking account size the target populations its COVID-19 epidemiologic profile) Projects do demonstrate equitable relationship engagement strategy the underserved and/or vulnerablepopulations interest Projects do include community engagement efforts Projects involve COVID-19 testingor SEBIoutside the United States Projects do address social, ethical, behavioral consequences their proposed design methods may exacerbate health disparities COVID-19 diagnostic testing Projects do consider than level analysis individual, interpersonal, institutional, community, policy) Projects are exclusively qualitative though mixed quantitative qualitative acceptable) Projects do have infrastructure rapidly report study findings impact the CDCC Projects have limited testing capacity, do include FDA-authorized testing strategies present plan incorporate approved testing strategies Projects supplementing grants are eligible this NOSI Eligibility section below under Application Submission Information maximize comparisons across datasets studies, facilitate data integration collaboration where appropriate study aims, researchers funded through NOSI strongly encouraged use following resources: Guidance provided the CDCC data acquisition, collection curation, including appropriate consent data sharing implementation the schemas proposed under ABOUT ML effort ( Annotation benchmarking understanding transparency machine learning lifecycles; available https://www.partnershiponai.org/about-ml/). Data Harmonization Social Determinants Health SDOH), COVID-19, other relevant measures via PhenX Toolkit: Investigators involved human-subject studies strongly encouraged employ common set tools resources will promote collection comparable data SDOH across studies. particular, human-subject studies should incorporate SDOH measures the Core Specialty collections are available the Social Determinants Health Collection the PhenX Toolkit www.phenxtoolkit.org). trans-NIH working group making existing COVID-19 survey items investigator contact information publicly available through NIH-supported platforms: NIH Public Health Emergency Disaster Research Response DR2) https://dr2.nlm.nih.gov/] the PhenX Toolkit https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based for clinical research, strongly encouraged consider COVID-19 specific survey item repositories select existing survey items protocol modules currently being fielded where address questions interest. Additionally, researchers funding through NOSI be required share survey items, data collection instruments methods other researchers consider submitting resources NIHCOVID19Measures@nih.gov. Review Process Applications be evaluated scientific technical merit an appropriate internal NIH staff review panel, accordance the review criteria specified PA-20-135 well these additional review criteria: there evidence strong established research collaborations proposed community partners? feasible appropriate the plans integrating community partners the study? Urgency significance research: successful completion the aims contribute or complement public health efforts the control SARS-CoV-2 COVID-19) infection related pathogenic processes? Does proposed research fit within mission an emergency response provide critical expertise, resources activities? Feasibility research: the overall strategy, methodology, analyses well-reasoned appropriate accomplish specific aims the project? the emergency time frame feasible the proposed research? the proposed approach dynamic responsive evolving changes COVID-19 diagnostics the United States? Outcomes: outcomes products result could used improve access, acceptability, uptake COVID-19 testing? the study contribute understanding diagnostic testing be clinically personally useful individuals, households communities? the proposed approaches likely yield important contributions applicable a range populations healthcare settings? the timeline milestones) appropriate feasible support aims goals the study? the PD/PIs, collaborators, other researchers well suited appropriate carry the project? feasible appropriate the plans sustainability project infrastructure partnerships may leveraged future engagement work surrounding public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts? Data sharing plan: there timely plans consistent the goals the program make instruments, products, results data findable accessible the research community, where limited Tribal data sovereignty? Coordination plans: feasible appropriate the plans submit data, data collection instruments outcomes/products the CDCC FOA RFA-OD-20-013)? feasible appropriate the plans collaborate the RADx-UP field sites NOSI NOT-OD-20-121 NOSI NOT-OD-20-120). the management plan well-described commensurate the level complexity required this NOSI? timely feasible remediation plans adverse outcomes included appropriate? Pre-award costs Pre-award costs be incurred January 20, 2020 through public health emergency period prior the date the federal award. Reporting OD plans make awards using funds provided the emergency supplemental appropriations COVID-19 coronavirus research: Paycheck Protection Program Health Care Enhancement Act, Public Law 116-139. Funds awarded using appropriations provided the Paycheck Protection Program Health Care Enhancement Act, Public Law 116-139 be issued unique subaccounts the HHS Payment Management System will require separate financial reporting any funds awarded. Application Submission Information Applications response this NOSI must submitted using Emergency Competitive Revision Existing NIH Awards Emergency Supplement Clinical Trial Optional) mechanism PA-20-135 https://grants.nih.gov/grants/guide/pa-files/PA-20-135.html), its subsequent reissued equivalents. Applications invited investigators representing wide range disciplines, including not limited ethics, health disparities research, health communication communication science, implementation science, clinical care, home community-based services, infectious disease, community-based participatory research, policy studies, public health, epidemiology, bioinformatics health information sciences, behavioral social sciences e.g., psychology, sociology, social work, anthropology, political science, economics, communication science). Notice supports collection multiple types data including qualitative quantitative methods, well reviews documents available data where appropriate. Where possible, primary alternate methods are robust unaffected shelter-in-place other restrictions research environments encouraged, although evidence availability acceptability communities individuals should provided, along the capacity maintain standards ethical research conduct. Applicants should describe the Research Strategy ideas working other SEBI RADx-UP sites accomplish project goals, their willingness adhere policies procedures determined cooperation the CDCC ( RFA-OD-20-013) Projects must focus and include or underserved and/or vulnerable populations identified above). Applicants should demonstrate successful record collaboration existing community partners. funding instrument, activity code, be same the parent award. NIH reminds applicants the appropriate consideration sex gender described NOT-OD-15-102 NIH policy a consideration NIH support. Eligibility Eligible existing grants can revised response this NOSI limited eligible non-fellowship active research resource grants cooperative agreements. Currently funded grantees apply work is related their funded project, whether within scope outside the scope the current project, regardless the time remaining the current project. Grants currently a no-cost extension eligible apply. instructions the SF424 R&R) Application Guide in target funding opportunity announcement PA-20-135) must followed, the following additions: Individual requests be more 400,000 direct costs per year up two years. Research Strategy section the application limited 12 pages. Applicants request supplements budgets exceed parent award. Budgets must reasonable reflect actual needs the project. be eligible a competing revision award under NOSI, parent award which revision application based must an active award including those a no-cost-extension period) managed one the participating institutes centers. Applicants should address whether how ongoing potential future public health restrictions e.g., closures, physical distancing, ability hold large meetings) might affect research approach and, so, include plan prevent mitigate any effect the proposed study. Applications be submitted beginning July 8, 2020 Application Due Dates August 7, 2020 5:00 PM local time the applicant organization) September 8, 2020 5:00 PM local time the applicant organization). Applications received after September 8, 2020 not considered. earliest start date applications received or before August 7, 2020 be September 2020, for applications received August 8, 2020 later be November, 2020. application submitted response this NOSI is received September 9, 2020 later be withdrawn. Specific applications target PA-20-135 Emergency Supplements): IMPORTANT: funding consideration, applicants must designate NOT-OD-20-119" without quotation marks) the Agency Routing Identifier field Box 4b) the SF424 R&R) Form. Applications without information Box 4b not considered this initiative. applications including those multi-project activity codes) must submitted electronically using single-project application form package Competitive revision applications PA-20-135 must the application form package the Competition ID contains FORMS-F-COMP-REV". Investigators planning submit application response this NOSI strongly encouraged contact discuss proposed research/aims Program staff listed this NOSI well advance the application receipt date better determine appropriateness interest the relevant Institute. Applicants also strongly encouraged notify Program staff listed this NOSI a request been submitted response this FOA order facilitate efficient processing the request. Office Behavioral Social Sciences OBSSR) does accept assignment applications manage awards are funded. Please contact of ICs listed below inquiries regarding suitability the proposed project the FOA the IC's research portfolio. Applications nonresponsive terms this NOSI be withdrawn consideration this initiative. Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: National Institute Minority Health Health Disparities NIMHD): Scientific Program Contact: Nancy Jones, PhD, 301.594.8945, nancy.jones@nih.gov Grants Management Contact: Priscilla Grant, JD, 301-594-8412, grantp@mail.nih.gov National Institute Aging NIA): Scientific Program Contact: Jonathan W. King, PhD., 301-496-3136, kingjo@nia.nih.gov Grants Management Contact: E. C. Melvin, 301-480-8991, e.melvin@nih.gov Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): Scientific Program Contact: Sonia Lee, PhD, 301-594-4783, leesonia@mail.nih.gov Grants Management Contact: Bonnie Jackson, 301-496-5482, jacksonbo@mail.nih.gov Fogarty International Center FIC): Program Contact: Marya Levintova, PhD, 301-496-1653, levintovam@mail.nih.gov Grants management Contact: Mollie Shea, 301-451-6830, Mollie.Shea@nih.gov National Cancer Institute NCI): Scientific Program Contact: LeeAnn Bailey, PhD, MS, 240-276-5337, leeann.bailey@nih.gov Grants Management Contact: Crystal Wolfrey, 240-276-6277, wolfreyc@mail.nih.gov National Center Advancing Translational Sciences NCATS): Scientific Program Contact: Xinzhi Zhang, MD, PhD, 301-827-9205, xinzhi.zhang@nih.gov Grants Management Contact: Esther Young, 301-402-7138, esther.young@nih.gov National Center Complementary Integrative Health NCCIH): Scientific Program Contact: Dave Clark, DrPH, 301-827-1916, Dave.Clark@nih.gov Grants Management Contact: Shelley Carow, 301-594-3788, carows@mail.nih.gov National Eye Institute NEI): Scientific Program Contact: Cheri Wiggs, PhD, 301-451-2020, cheri.wiggs@nih.gov Grants Management Contact: Karen Robinson Smith, 301-451-2020, Karen.Robinson.Smith@nei.nih.gov National Heart, Lung, Blood Institute NHLBI): Scientific Program Contact: Catherine M Stoney, PhD, 301-435-6670, catherine.stoney@nih.gov Grants Management Contact: Tracee Forster, 301-827-8030, tracee.foster@nih.gov National Human Genome Research Institute NHGRI): Scientific Program Contact: Dave Kaufman, PhD, 301-594-6907, dave.kaufman@nih.gov Grants Management Contact: Deanna Ingersoll, 301-435-7858, Deanna.Ingersoll@nih.gov National Institute Allergy Infectious Diseases NIAID): Scientific Program Contact: Ann Namkung, MPH, 240-627-3099, anamkung@niaid.nih.gov Grants Management Contact: Ann Devine, 240-669-2988, Ann.Devine@niaid.nih.gov National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Scientific Program Contact: Stephanie George, PhD, MPH, MA, 301) 594-4974, stephanie.george@nih.gov Grants Management Contact: Erik Edgerton, 301) 594-7760, edgertont@mail.nih.gov National Institute Biomedical Imaging Bioengineering NIBIB): Scientific Program Contact: Qi Duan, PhD, 301-827-4674, qi.duan@nih.gov National Institute Dental Craniofacial Research NIDCR): Scientific Program Contact: Elise Rice, PhD, 301-594-4814, elise.rice@nih.gov Grants Management Contact: Diana Rutberg, 301-594-4798, rutbergd@mail.nih.gov National Institute Diabetes Digestive Kidney Diseases NIDDK): Scientific Program Contact: Paul L. Kimmel, MD, MACP, 301-594-1409, paul.kimmel@nih.gov Grants Management Contact: Natasha Loveless, 301-594-8853, natasha.loveless@nih.gov National Institute Environmental Health Sciences NIEHS): Scientific Program Contact: Gwen W. Collman, PhD, 984-287-3249, collman@niehs.nih.gov Grants Management Contact: Jenny Greer, 984-287-3332, jenny.greer@nih.gov National Institute General Medical Sciences NIGMS): Scientific Program Contact: Dorit Zuk, PhD, 301-827-7616, dorit.zuk@nih.gov Grants Management Contact:Christy Leake, 301-594-7706, Christy.leake@nih.gov National Institute Mental Health NIMH): Scientific Program Contact:Crystal L. Barksdale, PhD, MPH, 301-443-7034, crystal.barksdale@nih.gov Grants Management Contact:Rita Sisco, 301-443-2805, siscor@mail.nih.gov National Institute Neurological Disorders Stroke NINDS): Scientific Program Contact:Richard T. Benson, MD, PhD, 301-827-9071, Richard.benson@nih.gov Grants Management Contact:Chief Grants Management Officer, ChiefGrantsManagementOfficer@ninds.nih.gov National Institute Nursing Research NINR): Scientific Program Contact:Jeri L. Miller, PhD, 301-594-6152, jmiller@mail.nih.gov Grants Management Contact: Brian Albertini, 301-594-6869, albertib@mail.nih.gov National Institute Alcohol Abuse Alcoholism NIAAA): Scientific Program Contact:Judith A. Arroyo, PhD, 301-402-0717, jarroyo@mail.nih.gov Grants Management Contact: Judy Fox, 301-443-4704, jfox@mail.nih.gov National Institute Deafness Other Communication Disorders NIDCD): Scientific Program Contact:Judith Cooper, PhD, 301-496-5061, cooperj@nidcd.nih.gov Grants Management Contact: Chris Myers, 301-435-0713, myersc@mail.nih.gov National Institute Drug Abuse NIDA): Scientific Program Contact:Richard A. Jenkins, PhD, 301.443.1923, jenkinsri@nida.nih.gov Grants Management Contact:Pam Fleming, 301.480.1159, pfleming@nida.nih.gov National Library Medicine NLM): Scientific Program Contact: Valerie Florance, PhD, 301-496-4621. florancev@mail.nih.gov Grants Management Contact:Samantha Tempchin, 301-496-4221, Tempchins@mail.nih.gov National Institute Biomedical Imaging Bioengineering NIBIB) Grants Management Contact: Kwesi Wright, 301-451-4789,Kwesi.Wright@nih.gov Office the Director, Environmental Influences Child Health Outcomes ECHO): Scientific Program Contact: Carol Blaisdell, MD, MEd, 301-435-5606, carol.blaisdell@nih.gov Grants Management Contact ECHO Cohorts): Donna Sullivan, 240-669-2979, dsullivan@niaid.nih.gov Grants Management ECHO ISPCTN) Contact: Bryan S. Clark, MBA Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), 301-435-6975, clarkb1@mail.nih.gov Office Behavioral Social Science Research OBSSR): Scientific Program Contact: Deborah Young-Hyman, PhD, 301-451-0721; deborah.young-hyman@nih.gov Office Disease Prevention ODP/DPCPSI/OD): Scientific Program Contact:Jacqueline Lloyd, PhD, MSW, 301.827.5559, lloydj2@nih.gov Office Research Womens Health ORWH): Scientific Program Contact: Damiya S. Whitaker, PsyD, MA, 301-451-8206, damiya.whitaker@nih.gov Sexual Gender Minority Research Office SGMRO): Scientific Program Contact:Christopher Barnhart, PhD, 301-594-8983, Christopher.barnhart@nih.gov Tribal Health Research Office THRO): Scientific Program Contact:Maria Jamela Revilleza, PhD, 301-451-0724, MariaJamela.Revilleza@nih.gov of Us Research Program: Sheri D. Schully, Ph.D., 301-827-1691, schullys@mail.nih.gov Kimberly Stanton, 301-827-8054, stantonk@nhlbi.nih.gov

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

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

Funding Opportunity Purpose

Notice Special Interest NOSI): Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations Notice Number: NOT-OD-20-120 Key Dates Release Date: June 12, 2020 First Available Due Date: July 08, 2020 Expiration Date: September 09, 2020 Related Announcements NOT-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-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations, noting the contents these websites updated regularly applicants expected justify testing propose). Phase Testing Research Projects must established infrastructures community partnerships enable rapid measurable impact access uptake COVID-19 testing underserved and/or vulnerable populations. should also plan collaborate the RADx-UP Social, Ethical Behavioral Implications SEBI) program NOT-OD-20-119), where possible, support depth examination social, ethical behavioral implications related COVID-19 testing vaccination research. the significant investment developing validating new testing technologies particularly NIH-supported RADx initiatives), NIH anticipates significant changes the landscape testing diagnostic approaches, well shifts the pandemic itself over next 3 6 months. Phase II the RADx-UP initiative be released a later date will address such developments future community-engaged research. RADx-UP Testing Research Projects comprise community-engaged research studies linked a collaborative consortium) investigating variety COVID-19 diagnostic testing methods approaches improve understanding COVID-19-related health disparities enhance access effectiveness implementation vulnerable and/or underserved populations. consortium serve a resource COVID-19 diagnostic testing future public health pandemic outreach mitigation activities, such vaccine trials. overarching goal this program to understand factors have led disproportionate burden the pandemic these underserved vulnerable populations that interventions be implemented decrease disparities. Testing Research Projects address key questions, including not limited to: are rates testing characteristics testing contexts well rates COVID-19 morbidity mortality underserved and/or vulnerable populations? Based this background, implementation approaches strategies most effective increasing reach, access, uptake, sustainability COVID-19 testing these populations? can geographic information systems other innovative technologies such smart phone applications, etc.) used identify understand characteristics of, tailor testing access uptake approaches general especially defined testing deserts i.e., geographic areas limited access COVID-19 testing sites low rates testing)? can evidence-based interventions have increased access uptake other viral screening tests e.g., human immunodeficiency virus HIV], hepatitis B C) adapted address diagnostic testing disparities COVID-19 among underserved and/or vulnerable populations communities? are approaches engaging clinical public health providers conducting referring persons testing recognize unique needs challenges underserved and/or vulnerable populations? can community stakeholders engaged efforts address testing-related barriers, provide health literacy support, provide patient navigation testing, increase appropriate referral follow-up care among underserved and/or vulnerable populations? community-driven research approaches effective reducing barriers testing uptake ameliorating stigma, distrust, fear, discrimination, mitigate effects exposure misinformation regarding COVID-19 testing? funding opportunity announcement encourages studies move away an exclusively top-down" approach emphasizing collaboration community partners, leaders, knowledge holders, leveraging community resources local service delivery settings address needs multiple stakeholders enhance COVD-19 testing. Approaches such team science, community engaged research, participatory action research, lay-person science, related frameworks should used engage stakeholders underserved and/or vulnerable populations throughout research process. RADx-UP testing intervention projects use rapid scale-up rigorous research strategies integrate data collected across sites maximize improvements public health control the pandemic. the extent possible, data acquisition, collection, curation strategies should coordinated the CDCC guidance annotation benchmarking data, including obtaining appropriate consent data sharing. Research designs include randomized controlled trials including group- cluster-randomized), pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, other dissemination implementation science methods including hybrid effectiveness/implementation designs). many these designs, special methods required analysis sample size estimation account correlation responses expected among responses participants measured treated the same cluster. Applicants need show their methods appropriate given plans assignment participants delivery interventions. Additional information available https://researchmethodsresources.nih.gov/. Applications should demonstrate history success recruiting retaining participants within specified target populations include sample size power calculations justify anticipated reach. Given RADx-UP goal population-level impact, applications should also delineate outcomes specify measures COVID-19 diagnostic testing impact other outcomes inform future maintenance, sustainability scale up. RADx-UP projects expected demonstrate ability leverage existing partnerships such with Tribal governments agencies, academic community medical centers health systems, safety-net health social service systems, grassroots organizations, public health departments, community faith-based organizations, schools child care settings) complete study aims. Projects also expected specify strategies to: a) address individual structural social determinants health SDOH) present barriers participating testing, follow-up, retesting; b) create sustainable infrastructures support rapid deployment evidence-based approaches testing, testing follow-up, referral treatment delivery isolation systems; c) conduct effective outreach, communication, dissemination activities inform communities the project its findings. Applicants expected provide evidence partnerships community organizations whom will work include prior collaborations must describe roles all partners. Study budgets should include funds the community partners be fully engaged successfully participate research design implementation. Testing capacity includes access FDA-authorized/approved test kits related supplies, well access point-of-care testing and FDA-authorized/approved) certified laboratories e.g., hospital, public health, commercial) administer tests return test results quickly possible. Projects encouraged include active referral contact tracing through partnerships e.g., Tribal agencies health departments) where is possible. Repeat testing symptomatic asymptomatic persons, well individuals previous positive COVID-19 tests, encouraged help understand validity reliability tests underserved and/or vulnerable populations to help establish COVID-19 incidence rates these populations. Strategies maximize return test results, plans follow up, familial caregiver testing indicated) should consider literacy, health literacy, numeracy, cultural preferences, language barriers. Projects awarded under FOA be expected work collaboratively each other, the CDCC RFA-OD-20-013) with SEBI projects NOT-OD-20-119) related COVID-19 testing research. address expected impacts COVID-19 the scientific workforce, projects also strongly encouraged support early stage investigators, specifically targeting diversity their research workforce. Research Topics: Testing Research topics interest include, are limited to, following: Increasing reach, access, uptake, impact COVID-19 testing underserved and/or vulnerable populations Determine baseline rates testing use information evaluate innovative strategies increase testing access, uptake, sustainability environments such medical centers, community health clinics, Tribal facilities clinics, remote care settings, correctional facilities other congregant living facilities, testing locations outside health care settings e.g., pop-up sites, rotating sites, mobile units) Conduct comparative effectiveness studies test acceptance, uptake, effectiveness distinct COVID-19 test administration methods, such by medical staff, trained community health workers self-testing including supervised e.g., via telemedicine) unsupervised home-collection approaches Identify, track, increase testing access testing deserts using novel methods, including geographic information systems policy implementation research Examine factors multiple levels including policies, community-level factors, interpersonal/family individual variables) maximize impact population morbidity mortality by: Increasing effective communication, reducing misinformation, promoting testing uptake, Increasing referral services, improving follow contact tracing Leverage community relationships cultural knowledge drive testing implementation strategies, specifically respect community entry, trust building, culturally appropriate ways engaging tapping community held knowledge best practices reduce testing barriers Employ strategies adoption adaptation effective communication, education, other engagement strategies enhance patient-clinician communication and implementation COVID-19 testing Examine implementation strategy effectiveness different organizations e.g., health care systems, schools, faith-based organizations, etc.) different components systems scale-up underserved and/or vulnerable communities examine long term sustainability Evaluate mechanisms mediators dissemination implementation strategies determine these strategies produce effects Create strategies widely disseminate up-to-date FDA-authorized/approved testing technology based detection viral nucleic acids consider viral detection point-of-care tests, including, antigen antibody tests emerge NIH-supported technology development programs) underserved and/or vulnerable populations Employ evidence-based innovative technologies the point-of-care such home-based self-testing kits, they become available, can limit contact allow continued isolation those significant comorbid conditions may more acceptable children families Integrate new technology techniques the testing model over time, particularly those emerging FDA authorization Apply innovative research methods such rapid cycle testing user centered design approaches use technology, Electronic Health Record other digital health modalities facilitate ordering tests this remains necessary), reporting results surveillance, contact tracing, long-term sustainability testing implementation strategies maximize consortium research rapidly implement approaches address COVID-19 pandemic, comparisons across datasets studies data integration essential collaboration. Projects funded through NOSI strongly encouraged use following resources: Data Harmonization Social Determinants Health via PhenX Toolkit: Investigators involved human-subject studies strongly encouraged employ common set tools resources will promote collection comparable data social determinants health SDOH) across studies. particular, studies human participants should incorporate SDOH measures the Core Specialty collections are available the Social Determinants Health Collection the PhenX Toolkit www.phenxtoolkit.org). trans-NIH working group making existing COVID-19 survey items investigator contact information publicly available through NIH-supported platforms: NIH Public Health Emergency Disaster Research Response DR2) https://dr2.nlm.nih.gov/] the PhenX Toolkit https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based for clinical research, strongly encouraged consider COVID-19 specific survey item repositories select existing survey items protocol modules currently being fielded. Additionally, researchers funding through NOSI be strongly encouragedto share survey items make public other researchers consider submitting surveys NIHCOVID19Measures@nih.gov. NIH also recognizes other federal agencies support research demonstration projects be strong collaborators these types research. NIH encourages collaboration investigators funded other agencies, appropriate, including, not limited those funded the Substance Abuse Mental Health Services Administration, Health Resources Services Administration, Administration Children Families, Administration Community Living its divisions, Centers Disease Control Prevention, Indian Health Service, Agency Health Research Quality, Office Minority Health, Department Defense, Department Agriculture, Department Education, Department Justice, Department 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

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

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

Funding Opportunity Purpose

Notice Special Interest NOSI): Limited Competition Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations Notice Number: NOT-OD-20-121 Key Dates Release Date: June 12, 2020 First Available Due Date: August 07, 2020 Expiration Date: August 08, 2020 Related Announcements NOT-OD-20-131 - Notice Pre-Application Webinar the RADx-UP Initiative PA-20-135 - Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) NOT-OD-20-120 - Notice Special Interest NOSI): Emergency Competitive Revisions Community-Engaged Research COVID-19 Testing among Underserved and/or Vulnerable Populations NOT-OD-20-119- Notice Special Interest NOSI): Emergency Competitive Revisions Social, Ethical, Behavioral Implications SEBI) Research COVID-19 Testing among Underserved and/or Vulnerable Populations RFA-OD-20-013 - Emergency Awards: RADx-UP Coordination Data Collection Center CDCC) U24 Clinical Trial Optional) 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 COVID–19 diagnostic testing uptake effectiveness underserved and/or vulnerable populations. maximize effectiveness, implementation approaches must include leverage culturally appropriate community partnerships strategies. Approaches increase COVID-19 testing apply knowledge effective interventions increasing access uptake other viral diagnostic tests, vaccines, therapeutics underserved vulnerable populations e.g., human immunodeficiency virus HIV], hepatitis B C testing). Best practices this work be applicable the ongoing COVID-19 public health efforts reach deliver evidence-based infection treatment for future vaccination implementation efforts particularly because testing strategies be essential accompany vaccine trials they advance). Applicants urged carefully consider cultural, ethical, social, behavioral, historical, economic implications associated testing/diagnostic technologies the collection, storage, dissemination health-related data these underserved populations. Key issues be considered addressed include, are limited to: barriers testing; returning test results; understanding implications a negative positive test result; stigma financial burden associated a positive test result follow-up care; feasibility effective self-isolation positive results; referrals contact tracing under-resourced communities, patients their families; privacy, confidentiality data sharing. Applicants should aware the possible discrimination faced these populations limited treatment resources available. Specific coordination federally funded services e.g., Tribal facilities, Federally Qualified Health Centers, Rural Health Clinics, etc.), state local health departments, community-based organizations can provide resources follow-up care public health mitigation, there a positive test, should specified the application. RADx-UP implementation occur two-phases, grants funded under NOSI collaborate part a Phase consortium led a CDCC RFA-OD-20-013). Phase Testing Research Projects supported under NOSI should work closely communities understand COVID-19 testing patterns, implement strategies interventions the potential rapidly i.e., within six months awards) increase reach, access, acceptance, uptake, sustainment FDA-authorized/approved diagnostics especially viral tests) among populations in geographic locations are underserved and/or vulnerable See: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations, noting the contents these websites updated regularly applicants expected justify testing propose). Phase Testing Research Projects must established infrastructures community partnerships enable rapid measurable impact access uptake COVID-19 testing underserved and/or vulnerable populations. should also plan collaborate the RADx-UP Social, Ethical Behavioral Implications SEBI) program NOT-OD-20-119)), where possible, support depth examination social, ethical behavioral implications related COVID-19 testing vaccination research. Applicants this NOSI allowed, not required, apply these companion funding opportunities. the significant investment developing validating new testing technologies particularly NIH-supported RADx initiatives), NIH anticipates significant changes the landscape testing diagnostic approaches, well shifts the pandemic itself over next 3 6 months. Phase II the RADx-UP initiative be released a later date will address such developments future community-engaged research. RADx-UP Testing Research Projects comprise community-engaged research studies linked a collaborative consortium) investigating variety COVID-19 diagnostic testing methods approaches improve understanding COVID-19-related health disparities enhance access effectiveness implementation vulnerable and/or underserved populations. consortium serve a resource COVID-19 diagnostic testing future public health pandemic outreach mitigation activities, such vaccine trials. overarching goal this program to understand factors have led disproportionate burden the pandemic these underserved vulnerable populations that interventions be implemented decrease disparities. Testing Research Projects address key questions, including not limited to: are rates testing characteristics testing contexts well rates COVID-19 morbidity mortality underserved and/or vulnerable populations? Based this background, implementation approaches strategies most effective increasing reach, access, uptake, sustainability COVID-19 testing these populations? can geographic information systems other innovative technologies such smart phone applications, etc.) used identify understand characteristics of, tailor testing access uptake approaches general especially defined testing deserts” i.e., geographic areas limited access COVID-19 testing sites low rates testing)? can evidence-based interventions have increased access uptake other viral screening tests e.g., human immunodeficiency virus HIV], hepatitis B C) adapted address diagnostic testing disparities COVID-19 among underserved and/or vulnerable populations communities? are approaches engaging clinical public health providers conducting referring persons testing recognize unique needs challenges underserved and/or vulnerable populations? can community stakeholders engaged efforts address testing-related barriers, provide health literacy support, provide patient navigation testing, increase appropriate referral follow-up care among underserved and/or vulnerable populations? community-driven research approaches effective reducing barriers testing uptake ameliorating stigma, distrust, fear, discrimination, mitigate effects exposure misinformation regarding COVID-19 testing? NOSI encourages studies move away an exclusively top-down" approach emphasizing collaboration community partners, leaders knowledge holders, leveraging community resources local service delivery settings address needs multiple stakeholders enhance COVD-19 testing. Approaches such team science, community-engaged research, participatory action research, lay-person science, related frameworks should used engage stakeholders underserved and/or vulnerable populations throughout research process. RADx-UP testing intervention projects use rapid scale-up rigorous research strategies integrate data collected across sites maximize improvements public health control the pandemic. the extent possible, data acquisition, collection, curation strategies should coordinated the CDCC guidance annotation benchmarking data, including obtaining appropriate consent data sharing. Research designs include randomized controlled trials including group- cluster-randomized), pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, other dissemination implementation science methods including hybrid effectiveness/implementation designs). many these designs, special methods required analysis sample size estimation account correlation responses expected among responses participants measured treated the same cluster. Applicants need show their methods appropriate given plans assignment participants delivery interventions. Additional information available https://researchmethodsresources.nih.gov/. Applications should demonstrate history success recruiting retaining participants within specified target populations include sample size power calculations justify anticipated reach. Given RADx-UP goal population-level impact, applications should also delineate outcomes specify measures COVID-19 diagnostic testing impact other outcomes inform future maintenance, sustainability scale up. RADx-UP projects expected demonstrate ability leverage existing partnerships such with Tribal governments agencies, academic community medical centers health systems, safety-net health social service systems, grassroots organizations, public health departments, community faith-based organizations, schools child care settings) complete study aims. Projects also expected specify strategies to: a) address individual structural social determinants health SDOH) present barriers participating testing, follow-up, retesting; b) create sustainable infrastructures support rapid deployment evidence-based approaches testing, testing follow-up, referral treatment delivery isolation systems; c) conduct effective outreach, communication, dissemination activities inform communities the project its findings. Applicants expected provide evidence partnerships community organizations whom will work include prior collaborations must describe roles all partners. Study budgets should include funds the community partners be fully engaged successfully participate research design implementation. Testing capacity includes access FDA-authorized/approved test kits related supplies, well access point-of-care testing and FDA-authorized/approved) certified laboratories e.g., hospital, public health, commercial) administer tests return test results quickly possible. Projects encouraged include active referral contact tracing through partnerships e.g., Tribal agencies health departments) where is possible. Repeat testing symptomatic asymptomatic persons, well individuals previous positive COVID-19 tests, encouraged help understand validity reliability tests underserved and/or vulnerable populations to help establish COVID-19 incidence rates these populations. Strategies maximize return test results, plans follow up, familial caregiver testing indicated) should consider literacy, health literacy, numeracy, cultural preferences, language barriers. Projects awarded under FOA be expected work collaboratively each other, the CDCC RFA-OD-20-013) with SEBI projects NOT-OD-20-119) related COVID-19 testing. address expected impacts COVID-19 the scientific workforce, projects also strongly encouraged support early stage investigators, specifically targeting diversity their research workforce. Research Topics: Testing Research topics interest include, are limited to, following: Increasing reach, access, uptake, impact COVID-19 testing underserved and/or vulnerable populations Determine baseline rates testing use information evaluate innovative strategies increase testing access, uptake, sustainability environments such medical centers, community health clinics, Tribal facilities clinics, remote care settings, correctional facilities other congregant living facilities, testing locations outside health care settings e.g., pop-up sites, rotating sites, mobile units) Conduct comparative effectiveness studies test acceptance, uptake, effectiveness distinct COVID-19 test administration methods, such by medical staff, trained community health workers self-testing including supervised e.g., via telemedicine) unsupervised home-collection approaches Identify, track, increase testing access testing deserts” using novel methods, including geographic information systems policy implementation research Examine factors multiple levels including policies, community-level factors, interpersonal/family individual variables) maximize impact population morbidity mortality by: Increasing effective communication, reducing misinformation, promoting testing uptake, Increasing referral services, improving follow contact tracing Leverage community relationships cultural knowledge drive testing implementation strategies, specifically respect community entry, trust building, culturally appropriate ways engaging tapping community held knowledge best practices reduce testing barriers Employ strategies adoption adaptation effective communication, education, other engagement strategies enhance patient-clinician communication and implementation COVID-19 testing Examine implementation strategy effectiveness different organizations e.g., health care systems, schools, faith-based organizations, etc.) different components systems scale-up underserved and/or vulnerable communities examine long term sustainability Evaluate mechanisms mediators dissemination implementation strategies determine these strategies produce effects Create strategies widely disseminate up-to-date FDA-authorized/approved testing technology based detection viral nucleic acids consider viral detection point-of-care tests, including, antigen antibody tests emerge NIH-supported technology development programs) underserved and/or vulnerable populations Employ evidence-based innovative technologies the point-of-care such home-based self-testing kits, they become available, can limit contact allow continued isolation those significant comorbid conditions may more acceptable children families Integrate new technology techniques the testing model over time, particularly those emerging FDA authorization Apply innovative research methods such rapid cycle testing user centered design approaches use technology, Electronic Health Record other digital health modalities facilitate ordering tests this remains necessary), reporting results surveillance, contact tracing, long-term sustainability testing implementation strategies maximize consortium research rapidly implement approaches address COVID-19 pandemic, comparisons across datasets studies data integration essential collaboration. Projects funded through NOSI strongly encouraged use following resources: Data Harmonization Social Determinants Health via PhenX Toolkit: Investigators involved human-subject studies strongly encouraged employ common set tools resources will promote collection comparable data social determinants health SDOH) across studies. particular, studies human participants should incorporate SDOH measures the Core Specialty collections are available the Social Determinants Health Collection the PhenX Toolkit www.phenxtoolkit.org). trans-NIH working group making existing COVID-19 survey items investigator contact information publicly available through NIH-supported platforms: NIH Public Health Emergency Disaster Research Response DR2) https://dr2.nlm.nih.gov/] the PhenX Toolkit https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based for clinical research, strongly encouraged consider COVID-19 specific survey item repositories select existing survey items protocol modules currently being fielded. Additionally, researchers funding through NOSI strongly encouragedto share survey items make public other researchers consider submitting surveys NIHCOVID19Measures@nih.gov. NIH also recognizes other federal agencies support research demonstration projects be strong collaborators these types research. NIH encourages collaboration investigators funded other agencies, appropriate, including, not limited those funded the Substance Abuse Mental Health Services Administration, Health Resources Services Administration, Administration Children Families, Administration Community Living its divisions, Centers Disease Control Prevention, Indian Health Service, Agency Health Research Quality, Office Minority Health, Department Defense, Department Agriculture, Department Education, Department Justice, Department Interior’s Bureau Indian Affairs, the Department Veterans Affairs. Additional Requirements NIH requiring data sharing all COVID-19 projects, where is prohibited i.e., Tribal data sovereignty). NIH expects supports timely release sharing final research data NIH-supported studies use other researchers expedite translation research results knowledge, products, procedures improve human health. Grantees expected work the RADx-UP Coordinating Data Collection Center CDCC, RFA-OD-20-013) submit common evaluation metrics COVID-19 testing-related outcomes implementation the CDCC. Grantees should identify dedicated unit responsible these data reporting activities. Grantees expected obtain retain personal identifiers all research participants where is prohibited i.e., Tribal data sovereignty) future longitudinal follow-up to leveraged intervention research. Data collected this program be protected a Certificate Confidentiality. Grantees expected use guidance provided the CDCC data acquisition, collection curation, including appropriate consent data sharing implementation the schemas proposed under ABOUT ML effort (“Annotation benchmarking understanding transparency machine learning lifecycles”; available https://www.partnershiponai.org/about-ml/). Grantees expected work the funded RADx-UP Social, Ethical Behavioral Implications program grantees SEBI, NOT-OD-20-119) other RADx-UP field sites support novel research social, ethical behavioral implications testing underserved and/or vulnerable populations, appropriate. Grantees encouraged identify dedicated staff member coordinating activities. Grantees must include measures reporting relevant testing implementation outcomes, inform future community, local, state, federal policies. Projects must include description sustainability their infrastructure partnerships may leveraged future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts. Projects must include evaluation plan demonstrating the proposed COVID-19 diagnostic testing access uptake strategies/activities be assessed effectiveness impact. Applications must include milestones towards progress a timeline completion. timeline must include plans regular reports progress be submitted the CDCC meetings Community Advisory Boards. reports include both testing results information regarding barriers facilitators COVID-19 testing emerging challenges implementation the proposed research. with NIH supported research, details regarding human subjects research expected, including data safety monitoring plans and, needed, plans a Data Safety Monitoring Board DSMB). Studies have DSMB expected coordinate CDCC RFA-OD-20-013) DSMB activities. Grantees expected disaggregate study results sex/gender; race ethnicity; age other relevant demographic factors, to consider intersectionality appropriate. Grantees expected participate CDCC-organized activities, including monthly cross-site meetings, cross-site working groups, dissemination activities effective implementation strategies, tools measures, etc.). Grantees expected demonstrate knowledge and comply federal, state, local, and/or Tribal requirements testing, reporting surveillance policies study protocols. Grantees must provide letters support the community partners should include community partners where possible) investigators RFA-OD-20-013). Budgets should reflect active participation community partners the extent possible. required, Tribal resolutions should included the application possible, before funds awarded all cases. Applications nonresponsive terms this NOSI not considered. following types projects generally be appropriate may deemed non-responsive: Projects without focus one more underserved COVID-19 vulnerable populations Projects have limited population reach taking account size the target populations its COVID-19 epidemiologic profile) Projects do demonstrate relationship or engagement strategy the populations interest Projects involve COVID-19 testing interventions outside the United States Projects do address social, ethical, behavioral consequences their proposed design methods may exacerbate health disparities COVID-19 diagnostic testing Projects are exclusively qualitative though mixed quantitative qualitative acceptable) Projects do have infrastructure rapidly report study findings impact the CDCC Projects have limited testing capacity, do include FDA-authorized/approved testing strategies present plan incorporate approved testing strategies Projects supplementing grants are eligible this NOSI Eligibility” section below under Application Submission Information”) Review Process Applications be evaluated scientific technical merit an appropriate internal NIH staff review panel, accordance the review criteria specified PA-20-135 well these additional review criteria, applicable: Urgency significance research: will successful completion the aims contribute or complement public health efforts the control SARS-CoV-2 COVID-19) infection related pathogenic processes? Does proposed research fit within mission an emergency response provide critical expertise, resources activities? Research design: the overall strategy, methodology, analyses well-reasoned appropriate accomplish specific aims the project? feasible appropriate the overall research design elements including power calculations) demonstrating effectiveness impact the proposed COVID-19 diagnostic testing uptake strategies/activities? the emergency timeframe milestones) appropriate feasible support aims goals the study? the management plan well-described commensurate the level complexity required? Investigators: the PD/PIs, collaborators, other researchers well suited appropriate carry the project? Community partners: there evidence strong established research collaborations proposed community partners? feasible appropriate the plans integrating community partners the study? Data sharing plan: there timely plans make results data findable accessible the research community? instances involving Tribal data sovereignty, there documentation Tribal agreement adapted data sharing plans? Coordination plans: feasible appropriate the plans submit data, data collection instruments outcomes/products the CDCC RFA-OD-20-013)? feasible appropriate the plans to collaborate other RADx-UP sites SEBI NOT-OD-20-119 & COMPANION TESTING RESEARCH SITES NOT-OD-20-120)? Outcomes: outcomes products proposed advance improve acceptability uptake COVID-19 testing? feasible appropriate the plans measures reporting relevant outcomes, including assessment testing implementation outcomes population measures COVID-19 related morbidity mortality? there evidence outcomes interest the community included outcomes measured reported and products? Sustainability: feasible appropriate the plans sustainability project infrastructure partnerships may leveraged future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts? Testing: feasible appropriate the plans access FDA-authorized/approved test kits related activities i.e., ability process tests a timely manner return test results quickly possible)? feasible appropriate the plans support follow testing contact tracing? the proposed approach dynamic responsive the evolving changes COVID-19 diagnostics? there evidence adequate support being provided the community understand act test results they returned individuals community members? Evaluation: the evaluation plan feasible appropriate? the evaluation assess project activities/strategies goals determine overall impact? the evaluation informed community input? Pre-Award costs Pre-award costs be incurred January 20, 2020 through public health emergency period prior the date the federal award. Reporting OD plans make awards using funds provided the emergency supplemental appropriations COVID-19 coronavirus research: Paycheck Protection Program Health Care Enhancement Act, Public Law 116-139”. Funds awarded using appropriations provided the Paycheck Protection Program Health Care Enhancement Act, Public Law 116-139” be issued unique subaccounts the HHS Payment Management System will require separate financial reporting any funds awarded Application Submission Information Applications response this NOSI must submitted using following targeted funding opportunity its subsequent reissued equivalents: PA-20-135 Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) intended provide funds NIH grantees applying expand scope their active grant. funding instrument, activity code, be same the parent award. ORWH reminds applicants the appropriate consideration sex gender described NOT-OD-15-102 NIH policy a consideration NIH support. Eligibility Eligible existing grants can revised response this NOSI limited. list eligible NIH programs provided within section, below. NOTE: Grants funded each participating NIH IC can revised response this NOSI limited those eligible funded the programs participating NIH ICs listed. Note the same grant cannot submitted consideration under both NOSI the related NOSI individual studies NOT-OD-20-120). instructions the SF424 R&R) Application Guide in target funding opportunity announcement PA-20-135) must followed, the following additions: Individual requests be more 3,500,000 direct costs the entire 2-year budget to 5,000,000 Total Costs) 75% the funds must allocated expenses the first year, reflect rapid ramp and outreach during first part the study. budget must reflect appropriate compensation community partners collaborating implementation testing interventions, test results return, development culturally appropriate dissemination research results i.e., publications other means dissemination). Given funds available, is anticipated up 25 awards be in FY2020. Regardless the grant mechanism the parent award, Research Strategy section the application limited 12 pages must include: description specific milestones towards progress a timeline completion, taking account need rapid deployment testing protocols. Community Partner Program section demonstrate partnership community organizations, roles reach these partnerships, the organizational decision-making structure. Testing Capacity section demonstrate access FDA-authorized/approved test kits, personal protective equipment PPE), access laboratories e.g., hospital, institutional, public health, private commercial) process tests the ability store, transport return test results an appropriate manner as quickly possible. Consortium Data Reporting Unit demonstrate capability infrastructure the applicant report the number COVID-19 tests conducted, results, subsequent actions referrals, the overall study population relevant subpopulations. Unit must also disseminate effective implementation strategies rapid uptake across consortia relevant through CDCC. Human Subjects Unit works monitor ethical social implications human subjects concerns testing implementation. work essential monitoring implementation efforts not exacerbating health disparities underserved and/or vulnerable populations. Applications this NOSIcan suggest possible collaborations the SEBI program NOT-OD-20-119). However, success work proposed applications this NOSI should depend those collaborations, since specifics those awards not known advance. Plans a Community Scientific Advisory Board includes target community representation scientists directly involved the project, well schedule structure inclusion the advisory board(s) required. Description contingency plans regarding ongoing potential future public health restrictions e.g., closures, physical distancing) might affect research approach, including online approaches where available appropriate. project period limited two years. Applicants request supplements budgets exceed parent award. Budgets must reasonable reflect actual needs the project. be eligible a competing revision award under NOSI, parent award which revision application based must an active award including those a no-cost-extension period) managed one the participating institutes centers. Recipients apply work is related their funded project, whether within scope outside the scope the current project, regardless the time remaining the current project. Grants currently a no-cost extension eligible apply. Applications be submitted beginning July 8, 2020 the Application Due Date August 7, 2020 5:00 PM local time the applicant organization). Applications received after time not considered. earliest start date be September, 2020.An application submitted response this NOSI is received August 8, 2020 later be withdrawn. . IMPORTANT: funding consideration, applicants must designate NOT-OD-20-121" without quotation marks) the Agency Routing Identifier field Box 4b) the SF424 R&R) Form. Applications without information Box 4b not considered this initiative. applications including those multi-project activity codes) must submitted electronically using single-project application form package. Competitive revision applications PA-20-135 must the application form package the Competition ID contains FORMS-F-COMP-REV”. Investigators planning submit application response this NOSI strongly encouraged contact discuss proposed research/aims Program staff listed this NOSI well advance the application receipt date better determine appropriateness interest the relevant Institute. Applicants also strongly encouraged notify Program staff listed this NOSI a request been submitted response this FOA order facilitate efficient processing the request. Only listed NIH programs participating Institutes Centers eligible this NOSI, follows: NIMHD Eligible Grants funded under following Funding Opportunity Announcements: Specialized Centers Excellence Minority Health Health Disparities RFA-MD-17-005) Research Centers Minority Institutions RFA-MD-17-003; RFA-MD-17-006; RFA-MD-18-012) Specialized Centers Excellence Environmental Health Disparities Research RFA-MD-20-001) Collaborative Minority Health Health Disparities Research Tribal Epidemiology Centers TEC) PAR-17-483 PAR-17-484) Transdisciplinary Collaborative Centers Health Disparities Research Focused Precision Medicine RFA-MD-15-013) Transdisciplinary Collaborative Centers Health Disparities Research Chronic Disease Prevention RFA-MD-15-014) NIA Eligible Grants funded under following Funding Opportunity Announcements: Resource Centers Minority Aging Research RFA-AG-18-002, RFA-AG-18-003) ADRD Health Care Research Systems Collaboratory RFA-AG-19-009) Claude D. Pepper Older Americans Independence Centers RFA-AG-20-019) NICHD Eligible Grants funded under following Funding Opportunity Announcements: INCLUDE Data Coordinating Center RFA-OD-20-007, RFA-OD-20-003;) National Longitudinal Study Adolescent Adult Health RFA-AG-21-008) Medical Rehabilitation Research Resource RFA-HD-20-004) Pediatric HIV/AIDS Cohort Study RFA-HD-15-027) Adolescent Trials Network RFA-HD-16-040, RFA-HAD-16-035) Obstetric-fetal Pharmacology Research Centers RFA-HD-14-013) Maternal Fetal Medicine Units RFA-HD-16-019) Intellectual Developmental Disabilities Research Centers RFA-HD-20-016) Autism Centers Excellence Program RFA-HD-17-008, RFA-HD-17-009) NCI Eligible Grants funded under following Funding Opportunity Announcements: Implementation Science Cancer Control: Advanced Centers Developing Centers RFA-CA-19-006, RFA-CA-19-005) Comprehensive Partnerships Advance Cancer Health Equity PAR-15-103, PAR-18-361, PAR-18-767) Cancer Center Support Grants CCSGs) NCI-designated Cancer Centers PAR-20-043, PAR-17-095, PAR-13-386) NCI Community Oncology Research Program Minority/Underserved Community Sites RFA-CA-18-017, RFA-CA-13-014) Prevention HPV-related Cancers HIV-infected individuals: United States-Latin American-Caribbean Clinical Trials Network: Partnership Centers RFA-CA-18-018) NCATS Eligible Grants funded under following Funding Opportunity Announcements: Clinical Translational Science Awards UL1 Component PAR-18-940, PAR-18-464, PAR-15-304, RFA-TR-14-009) NCCIH Eligible Grants funded under following Funding Opportunity Announcements: Health Care Systems Research Collaboratory Multiple Chronic Conditions RFA-RM-16-018, RFA-RM-16-019) NEI Eligible Grants funded under following Funding Opportunity Announcements: Pediatric Eye Disease Investigator Group PEDIG) Network PAR-18-523, PAR-14-098) Diabetic Retinopathy Clinical Research DRCR) Network PAR-18-523, PAR-14-098) NHLBI Eligible Grants funded under following Funding Opportunity Announcements: Sickle Cell Disease Implementation Consortium: Using Implementation Science Optimize Care Adolescents Adults Sickle Cell Disease RFA-16-011, RFA-HL-16-010) Asthma Empowerment Collaborations Reduce Childhood Asthma Disparities RFA-HL-17-001, RFA-HL-015-028) NHGRI Eligible Grants funded under following Funding Opportunity Announcements: Clinical Sequencing Evidence-Generating Research-Clinical Sites Enhanced Diversity RFA-HG-16-011) NIAID Eligible Grants funded under following Funding Opportunity Announcements: Centers AIDS Research PAR-17-237; PAR-20-106) IMPAACT Network UM1AI068632, UM1AI068616, UM1AI106716) Sexually Transmitted Infections STI) Cooperative Research Centers CRC): Vaccine Development, U19 RFA-AI-18-005) NIAMS Eligible Grants funded under following Funding Opportunity Announcements: Centers Research Translation RFA-AR-17-001) Core Centers Clinical Research RFA-AR-17-002) NIDCR Eligible Grants funded under following Funding Opportunity Announcements: Multidisciplinary Collaborative Research Consortium Reduce Oral Health Disparities Children: Multilevel Approach RFA-DE-15-006) NIDDK Eligible Grants funded under following Funding Opportunity Announcements: Prevention Lower Urinary Tract Symptoms RFA-DK-19-015) Centers Diabetes Translation Research RFA-DK-15-003, RFA-DK-20-002) Nutrition Obesity Research Centers RFA-DK-14-002, RFA-DK-16-006, RFA-DK-19-002) NIGMS Eligible Grants funded under following Funding Opportunity Announcements: Native American Research Centers Health PAR-16-297, PAR-13-239), IDeA-Clinical Translational Research Networks PAR-20-175, PAR-17-304, PAR-14-303) NIMH Eligible Grants funded under following Funding Opportunity Announcements: AIDS Research Center Mental Health HIV/AIDS PAR-15-197; PAR-18-832) Developmental AIDS Research Center Mental Health HIV/AIDS PAR-18-833) Advanced Laboratories Accelerating Reach Impact Treatments Youth Adults Mental Illness Research Centers PAR-16-354, PAR-18-701) Collaborative Hubs Reduce Burden Suicide among American Indian Alaska Native Youth RFA-MH-17-350) NINDS Eligible Grants funded under following Funding Opportunity Announcements: NIH Stroke Net Regional Coordinating Stroke Centers PAR-17-276) NINR Eligible Grants funded under following Funding Opportunity Announcements: Exploratory Research Centers RFA-NR-17-002) Core Centers/Centers Excellence RFA-NR-17-003) Palliative Care Research Cooperative RFA-NR-17-001) NIAAA Eligible Grants funded under following Funding Opportunity Announcements: Alcohol Hepatitis: Clinical Translational Network RFA-AA-18-005) Collaborative Study the Genetics Alcoholism COGA). RFA-AA-19-001) Collaborative Initiative Fetal Alcohol Spectrum Disorder CIFASD) RFA-AA-17-007) Comprehensive Alcohol-HIV/AIDS Research Center RFA-AA-19-003) Comprehensive Alcohol Research Center RFA-AA-17-002, RFA-AA-15-001, RFA-AA-20-002) Consortia HIV/AIDS Alcohol-Related Research Trials RFA-AA-16-001, RFA-AA-16-002, RFA-AA-003) NIDA Eligible Grants funded under following Funding Opportunity Announcements: HIV, HCV Related Comorbidities Rural Communities Affected Opioid Injection Drug Epidemics the United States: Building Systems Prevention, Treatment Control RFA-DA-17-014) Hepatitis C Virus HCV) Advanced Molecular Detection Support Systems Prevention, Treatment Control HIV, HCV Related Comorbidities Rural Communities Affected Opioid Injection Drug Epidemics the United States RFA-DA-17-023) Limited Competition Cohort Studies HIV/AIDS Substance Abuse RFA-DA-20-005; RFA-DA-18-011) NIDA Core Center Excellence” Grant Program PAR-17-121; PAR-14-186) HEAL Initiative: Justice Community Opioid Innovation Network JCOIN): Methodology Advanced Analytics Resource Center RFA-DA-19-023); Clinical Research Centers RFA-DA-19-025); Coordination Translation Center RFA-DA-19-024) HEAL Initiative: Preventing Opioid Disorder Older Adolescents Young Adults ages 16-30) RFA-DA-19-035); Coordinating Center RFA-DA-19-034) HEAL Initiative: HEALthy Brain Child Development Study HEALthy BCD) RFA-DA-19-036, RFA-DA-19-029) HEALing Communities Study: Developing Testing Integrated Approach Address Opioid Crisis: Research Sites RFA-DA-19-016); Data Coordinating Center RFA-DA-19-017) Limited Competition Adolescent Brain Cognitive Development ABCD) Study – Linked Research Project Sites RFA-DA-20-002); Data Analysis, Informatics Resource Center RFA-DA-20-003); Coordinating Center RFA-DA-20-004) National Drug Abuse Treatment Clinical Trials Network RFA-DA-20-024; RFA-DA-15-008) NIDA Research Center Excellence Grant Program PAR-18-224; PAR-18-224) NLM Eligible Grants funded under following Funding Opportunity Announcements: NLM University-based Biomedical Informatics Data Science Research Training RFA-LM-16-001) OD/ECHO Eligible Grants funded under following Funding Opportunity Announcements: Environmental Influences Child Health Outcomes RFA-OD-19-025, RFA-OD-19-026, RFA-OD-16-003, RFA-OD-16-005, RFA-OD-16-006, RFA-OD-16-004) NIBIB Eligible Grants funded under following Funding Opportunity Announcements: Point-of-Care Technologies Research Network PAR-17-453) NIBIB Biomedical Technology Resource Centers PAR-18-205, PAR-17-083, PAR-13-376, PAR-13-144, PAR-10-153) Centers Excellence Big Data Computing the Biomedical Sciences RFA-HG-13-009) Mobilizing Research: Research Resource Enhance mHealth Research RFA-OD-15-129)   NIEHS Eligible Grants funded under following Funding Opportunity Announcements: Superfund Hazardous Substance Research Training Program RFA-ES-12-003, RFA-ES-13-001, RFA-ES-14-007, RFA-ES-15-019, RFA-ES-18-002) Environmental Health Sciences Core Centers RFA-ES-13-012, RFA-ES-15-007, RFA-ES-16-001, RFA-ES-17-003, RFA-ES-18-003) Maintain Enrich Resource Infrastructure Existing Environmental Epidemiology Cohorts RFA-ES-16-004, RFA-ES-18-009) Centers Excellence Environmental Health Disparities Research RFA-ES-14-010) Hazardous Materials Worker Health Safety Training RFA-ES-14-008, RFA-ES-19-003) HAZMAT Training DOE Nuclear Weapons Complex RFA-ES 14-009, RFA-ES-19-004) Applications nonresponsive terms this NOSI be withdrawn consideration this initiative. Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: National Institute Minority Health Health Disparities NIMHD): Scientific Program Contact:Nadra Tyus, DrPH., MPH., 301-594-8065, nadra.tyus@nih.gov Grants Management Contact: Priscilla Grant, JD, 301-594-8412, grantp@mail.nih.gov National Institute Aging NIA): Scientific Program Contact:Jonathan W. King, PhD, 301-496-3136, kingjo@nia.nih.gov Grants Management Contact:E. C. Melvin, 301-480-8991, e.melvin@nih.gov Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): Scientific Program Contact:Sonia Lee, PhD, 301-594-4783, leesonia@mail.nih.gov Grants Management Contact: Bonnie Jackson, 301-496-5482, jacksonbo@mail.nih.gov National Cancer Institute NCI): Scientific Program Contact: April Oh, PhD, M.P.H., 240-276-6709, april.oh@nih.gov LeeAnn Bailey, M.B.B.S, PhD, M.S. 240) 276-5337,leeann.bailey@nih.gov Grants Management Contact:Crystal Wolfrey, 240) 276-6277, wolfreyc@mail.nih.gov National Center Advancing Translational Sciences NCATS): Scientific Program Contact:Xinzhi Zhang, MD, PhD, 301-827-9205, xinzhi.zhang@nih.gov Grants Management Contact:Esther Young, 301-402-7138, esther.young@nih.gov National Center Complementary Integrative Health NCCIH): Scientific Program Contact:Dave Clark, DrPH, 301-827-1916, Dave.Clark@nih.gov Grants Management Contact:Shelley Carow, 301-594-3788, carows@mail.nih.gov National Eye Institute NEI): Scientific Program Contact: Donald Everett, MA, 301-451-2020, everettd@mail.nih.gov Grants Management Contact: Karen Robinson Smith, 301-451-2020, Karen.Robinson.Smith@nei.nih.gov National Heart, Lung, Blood Institute NHLBI): Scientific Program Contact:Catherine M Stoney, PhD, 301-435-6670, catherine.stoney@nih.gov Grants Management Contact:Tracee Forster, 301-827-8030, tracee.foster@nih.gov National Human Genome Research Institute NHGRI): Scientific Program Contact:Lucia Hindorff, PhD, MPH, 240-271-1509, hindorffl@mail.nih.gov Grants Management Contact:Deanna Ingersoll, 301-435-7858 National Institute Allergy Infectious Diseases NIAID): Scientific Program Contact:Ann NamkungMPH, 240-627-3099,anamkung@niaid.nih.gov Grants Management Contact:Ann Devine, 240-669-2988, ADEVINE@niaid.nih.gov National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Scientific Program Contact:Stephanie George, PhD, MPH, MA, 301-594-4974, stephanie.george@nih.gov Grants Management Contact: Erik Edgerton, 301-594-7760, edgertont@mail.nih.gov National Institute Dental Craniofacial Research NIDCR): Scientific Program Contact: Darien Weatherspoon, DDS, 301-594-5394, darien.weatherspoon@nih.gov Grants Management Contact: Diana Rutberg, 301-594-4798, rutbergd@mail.nih.gov National Institute Diabetes Digestive Kidney Diseases NIDDK): Scientific Program Contact:Pamela L. Thornton, PhD, 301-480-6476, pamela.thornton@nih.gov Grants Management Contact:Natasha Loveless, 301-594-8853, natasha.loveless@nih.gov National Institute Environmental Health Sciences NIEHS): Scientific Program Contact:Gwen W. Collman, PhD, 984-287-3249, collman@niehs.nih.gov Grants Management Contact:Jenny Greer, 984-287-3332, jenny.greer@nih.gov National Institute General Medical Sciences NIGMS): Scientific Program Contact:Ming Lei, PhD, 301-827-7616, leim@mail.nih.gov Grants Management Contact:Christy Leake, 301-594-7706, Christy.leake@nih.gov National Institute Mental Health NIMH): Scientific Program Contact:Gregory Greenwood, PhD, 240-669-5532, gregory.greenwood@nih.gov Grants Management Contact:Rita Sisco, 301-443-2805, siscor@mail.nih.gov National Institute Neurological Disorders Stroke NINDS): Scientific Program Contact:Scott Janis, PhD, 301-496-9135, Janiss@NINDS.NIH.gov Grants Management Contact:Chief Grants Management Officer, ChiefGrantsManagementOfficer@ninds.nih.gov National Institute Nursing Research NINR): Scientific Program Contact:Jeri L. Miller, PhD, 301-594-6152, jmiller@mail.nih.gov Grants Management Contact: Brian Albertini, 301-594-6869, albertib@mail.nih.gov National Institute Alcohol Abuse Alcoholism NIAAA): Scientific Program Contact:Judith A. Arroyo, PhD, 301-402-0717, jarroyo@mail.nih.gov Grants Management Contact:Judy Fox, 301-443-4704, jfox@mail.nih.gov National Institute Drug Abuse NIDA): Scientific Program Contact:Richard A. Jenkins, PhD, 301.443.1923, jenkinsri@nida.nih.gov Grants Management Contact:Pam Fleming, 301.480.1159, pfleming@nida.nih.gov National Library Medicine NLM): Scientific Program Contact: Valerie Florance, PhD, 301-496-4621, florancev@mail.nih.gov Grants Management Contact:Samantha Tempchin, 301-496-4221, Tempchins@mail.nih.gov Office the Director, Environmental Influences Child Health Outcomes ECHO): Scientific Program Contact: Carol Blaisdell, MD, MEd, 301-435-5606, carol.blaisdell@nih.gov Grants Management Contact ECHO Cohorts): Donna Sullivan, 240-669-2979, dsullivan@niaid.nih.gov Grants Management ECHO ISPCTN) Contact: Bryan S. Clark, MBA, Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), 301-435-6975, clarkb1@mail.nih.gov Office Behavioral Social Science Research OBSSR): Scientific Program Contact: Dara Blachman-Denmer, PhD, 301-496-8522, dara.blachman-demner@nih.gov Office Disease Prevention ODP/DPCPSI/OD): Scientific Program Contact: Jacqueline Lloyd, PhD, MSW; 301-827-5559, lloydj2@nih.gov Office Research Women’s Health ORWH): Scientific Program Contact: Damiya S. Whitaker, Psy.D, M.A., 301-451-8206, damiya.whitaker@nih.gov Sexual Gender Minority Research Office SGMRO): Scientific Program Contact: Christopher Barnhart, PhD, 301-594-8983, Christopher.barnhart@nih.gov Tribal Health Research Office THRO): Scientific Program Contact: Maria Jamela Revilleza, PhD, 301-451-0724, MariaJamela.Revilleza@nih.gov National Institute Biomedical Imaging Bioengineering NIBIB): Scientific Program Contact: Qi Duan, PhD, 301-827-4674, Qi.Duan@nih.gov Grants Management Contact: Kwesi Wright, 301-451-4789, Kwesi.Wright@nih.gov 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

Pages