Key Dates

Related Announcements

RFA-OD-22-011 - Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed).

NOT-OD-21-064 - Notice of Intent to Publish Funding Opportunity Announcements for the RADx-UP Initiative (Phase II)

NOT-HL-20-806 - NHLBI confirms participation in NOT-OD-20-119, NOT-OD-20-120, and NOT-OD-20-121 (Research on COVID-19 Testing among Underserved and/or Vulnerable Populations)

NOT-HL-20-803 - Notice of NHLBI Participation in NOT-OD-20-119

NOT-OD-20-131 - Notice of Pre-Application Webinar for the RADx-UP Initiative

PA-20-135 - Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)

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

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

RFA-OD-20-013 - Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)

NOT-OD-20-141 - Notice of Correction to NOT-OD-20-120 Eligibility Section for Budget Request Information

NOT-OD-20-138 - Notice of Correction to NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 Eligibility Section

NOT-HL-20-804 -Notice of NHLBI Participation in NOT-OD-20-120

NOT-HL-20-805 - Notice of NHLBI Participation in NOT-OD-20-121
NOT-OD-20-157 - Notice to Clarify and Correct Eligibility in Notices of Special Interest under the Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) Program

NOT-OD-21-038 - Updated Instructions on Interim Reporting and Carryover for RADx-UP Recipients

NOT-OD-21-103 - Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADx-UP Phase II (Emergency Supplement - Clinical Trial Optional)

NOT-OD-21-101 - Notice of Special Interest (NOSI): Administrative Supplements for Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) Phase I Projects to Address Vaccine Hesitancy and Uptake

Issued by

Office of The Director, National Institutes of Health (OD)

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute on Aging (NIA)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Library of Medicine (NLM)

Fogarty International Center (FIC)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Tribal Health Research Office (THRO)

Office of The Director, National Institutes of Health (OD)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Environmental Influences on Child Health Outcomes (ECHO)

All of Us Research Program - New participating organization as of 7/10/2020 for due dates on/after 8/7/2020

Purpose

This Notice of Special Interest (NOSI) highlights the urgent need to understand and address COVID-19 morbidity and mortality disparities among underserved and vulnerable populations across the United States. These two-year community-engaged Testing Research Projects will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods through the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) initiative. The overarching goal is to understand factors that have led to disproportionate burden of the pandemic on these underserved populations so that interventions can be implemented to decrease these disparities. The funding for this supplement program is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

The Office of the Director (OD) is therefore offering Emergency Competitive Revisions to active eligible grants and cooperative agreements addressing the objectives described below. This NOSI is one of four related RADx-UP funding opportunities. This Testing Research Projects NOSI will support supplements to individual NIH research awards that include community collaborations or partnerships to support COVID-19 testing (or have the capacity to ramp up quickly) to reach underserved and/or COVID-19 vulnerable populations.

The related program initiatives include:

• NOT-OD-20-121 with a similar focus, but shifts the pool of eligible grants for supplementation to those that are part of large-scale networks, consortia, centers and other current programs that have adequate capacity, infrastructure, and established community-engaged relationships to support large-scale testing.

• NOT-OD-20-119 which seeks research to understand the Social, Ethical and Behavioral Implications (SEBI) of COVID-19 testing in these populations.

• RFA-OD-20-013 which is a U24 Coordination and Data Collection Center (CDCC) as a key component of the consortium.

Collectively, projects funded under these NOSIs will serve as one consortium of interlinked community-engaged research projects across the United States to understand COVID-19 health disparities, and to deploy implementation strategies to improve the reach, acceptance, uptake, and sustainability of COVID-19 testing.

NIH expects that all competitive revisions funded under this NOSI will actively coordinate, collaborate, and share data with other Testing Research Projects, the CDCC, and other research supported by the SEBI program, as allowed, and with considerations under tribal IRB processes. Researchers applying to this NOSI are strongly encouraged to read all four of these interrelated funding opportunities.

Key Definitions

This NOSI is applicable to those populations that are underserved as well as populations that are COVID-19 vulnerable due to medical, geographic and social factors, as defined below (referred to as underserved and/or vulnerable elsewhere in this NOSI):

Underserved: NIH-designated health disparity populations and/or other groups known to experience barriers to accessing needed health care services or have inadequate health care coverage. A full description can be found at https://www.nimhd.nih.gov/about/overview/.

COVID-19 medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities; community-dwelling older adults; individuals with intellectual, developmental, sensory, or physical disabilities, cognitive impairment or dementia, or communication disorders; homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); individuals with medical comorbidities known to increase risk of severe COVID-19, including heart failure and related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities; individuals in overcrowded housing; individuals with substance use disorders or serious mental illness; migrant and immigrant populations; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; and rural and remote communities.

Background and Goals
SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. United States Food and Drug Administration (FDA)-authorized/approved COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. NIH is committed to applying scientific methods to ensure that all populations have optimal access to and uptake of COVID-19 testing, and to build enhanced point-of-care infrastructures in advance of the impending influenza season, which requires swift action.

The overarching goal of the RADx-UP initiative is to understand the factors associated with COVID-19 morbidity and mortality disparities and to lay the foundation to reduce disparities for those underserved and vulnerable populations that are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from the COVID-19 pandemic. This goal will be accomplished by strengthening the available data on disparities in infection rates and disease progression and outcomes and on differences in testing access and uptake patterns and identifying strategies to address disparities in COVID-19 diagnostics (and related repeat testing, contact tracing, and referrals). Testing Research Projects will both enable a targeted public health response to COVID-19 and build the evidence-base of approaches to identify and address disparities in COVID 19 diagnostic testing uptake and effectiveness in underserved and/or vulnerable populations. To maximize effectiveness, implementation approaches must include and leverage culturally appropriate community partnerships and strategies.

Approaches to increase COVID-19 testing may apply knowledge from effective interventions for increasing access and uptake of other viral diagnostic tests, vaccines, and therapeutics in underserved and vulnerable populations (e.g., human immunodeficiency virus [HIV], hepatitis B and C testing). Best practices from this work could be applicable for the ongoing COVID-19 public health efforts to reach and deliver evidence-based infection treatment and for future vaccination implementation efforts (particularly because testing strategies will be essential to accompany vaccine trials as they advance).

Applicants are urged to carefully consider the cultural, ethical, social, behavioral, historical, and economic implications associated with testing/diagnostic technologies and the collection, storage, and dissemination of health-related data for these underserved populations. Key issues to be considered and addressed include, but are not limited to: barriers to testing; returning of test results; understanding the implications of a negative or positive test result; stigma and financial burden associated with a positive test result and follow-up care; feasibility of effective self-isolation for positive results; referrals for contact tracing for under-resourced communities, patients and their families; and privacy, confidentiality and data sharing. Applicants should be aware of the possible discrimination faced by these populations when limited treatment resources are available. Specific coordination with federally funded services (e.g., Tribal facilities, Federally Qualified Health Centers, Rural Health Clinics, etc.), state and local health departments, or community-based organizations that can provide resources for follow-up care and public health mitigation, if there is a positive test, should be specified in the application.

RADx-UP implementation will occur in two-phases, and grants funded under this NOSI will collaborate as part of a Phase I consortium led by a CDCC (RFA-OD-20-013). The Phase I Testing Research Projects supported under this NOSI should work closely with communities to understand COVID-19 testing patterns, and implement strategies or interventions with the potential to rapidly (i.e., within six months of awards) increase reach, access, acceptance, uptake, and sustainment of FDA-authorized/approved diagnostics (especially viral tests) among populations and in geographic locations who are underserved and/or vulnerable, (See: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations and https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations, noting that the contents of these websites are updated regularly and applicants are expected to justify the testing they propose). Phase I Testing Research Projects must have established infrastructures and community partnerships to enable rapid and measurable impact in access and uptake of COVID-19 testing by underserved and/or vulnerable populations. They should also plan to collaborate with the RADx-UP Social, Ethical and Behavioral Implications (SEBI) program (NOT-OD-20-119), where possible, to support in depth examination of social, ethical and behavioral implications related to COVID-19 testing and vaccination research. With the significant investment in developing and validating new testing technologies (particularly the NIH-supported RADx initiatives), NIH anticipates significant changes in the landscape of testing and diagnostic approaches, as well as shifts in the pandemic itself over the next 3 to 6 months. Phase II of the RADx-UP initiative will be released at a later date and will address such developments for future community-engaged research.

RADx-UP Testing Research Projects will comprise community-engaged research studies (linked as a collaborative consortium) investigating a variety of COVID-19 diagnostic testing methods and approaches to improve understanding of COVID-19-related health disparities and enhance access and effectiveness of implementation in vulnerable and/or underserved populations. This consortium will serve as a resource for COVID-19 diagnostic testing and future public health pandemic outreach and mitigation activities, such as vaccine trials. The overarching goal of this program is to understand factors that have led to disproportionate burden of the pandemic on these underserved and vulnerable populations so that interventions can be implemented to decrease these disparities. Testing Research Projects will address key questions, including but not limited to:

• What are the rates of testing and characteristics of testing contexts as well as rates of COVID-19 morbidity and mortality in underserved and/or vulnerable populations? Based on this background, what implementation approaches and strategies are most effective in increasing the reach, access, uptake, and sustainability of COVID-19 testing in these populations?
• How can geographic information systems and other innovative technologies (such as smart phone applications, etc.) be used to identify and understand the characteristics of, and tailor testing access and uptake approaches in general and especially in defined testing deserts (i.e., geographic areas with limited access to COVID-19 testing sites and low rates of testing)?
• How can evidence-based interventions that have increased access and uptake of other viral screening tests (e.g., human immunodeficiency virus [HIV], hepatitis B and C) be adapted to address diagnostic testing disparities for COVID-19 among underserved and/or vulnerable populations and communities?
• What are approaches for engaging clinical and public health providers in conducting or referring persons to testing that recognize the unique needs and challenges of underserved and/or vulnerable populations?
• How can community stakeholders be engaged in efforts to address testing-related barriers, provide health literacy support, provide patient navigation for testing, and increase appropriate referral for follow-up care among underserved and/or vulnerable populations?
• What community-driven research approaches are effective in reducing barriers to testing uptake and ameliorating stigma, distrust, fear, and discrimination, and mitigate the effects of exposure to misinformation regarding COVID-19 testing?

This funding opportunity announcement encourages studies that move away from an exclusively "top-down" approach by emphasizing collaboration with community partners, leaders, and knowledge holders, leveraging community resources and local service delivery settings to address the needs of multiple stakeholders to enhance COVD-19 testing. Approaches such as team science, community engaged research, participatory action research, lay-person science, and related frameworks should be used to engage stakeholders and underserved and/or vulnerable populations throughout the research process.

RADx-UP testing intervention projects will use rapid scale-up of rigorous research strategies and integrate data collected across the sites to maximize improvements in public health control of the pandemic. To the extent possible, data acquisition, collection, and curation strategies should be coordinated with the CDCC guidance for annotation and benchmarking of data, including obtaining appropriate consent for data sharing. Research designs may include randomized controlled trials (including group- or cluster-randomized), pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, and other dissemination and implementation science methods (including hybrid effectiveness/implementation designs). In many of these designs, special methods are required for analysis and sample size estimation to account for correlation of responses expected among responses from participants measured or treated in the same cluster. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

Applications should demonstrate a history of success in recruiting and retaining participants within the specified target populations and include sample size and power calculations to justify the anticipated reach. Given the RADx-UP goal of population-level impact, applications should also delineate outcomes and specify measures of COVID-19 diagnostic testing impact and other outcomes to inform future maintenance, sustainability and scale up.

RADx-UP projects are expected to demonstrate their ability to leverage existing partnerships (such as with Tribal governments and agencies, academic and community medical centers or health systems, safety-net health or social service systems, grassroots organizations, public health departments, community and faith-based organizations, and schools or child care settings) to complete the study aims. Projects are also expected to specify strategies to: a) address individual and structural social determinants of health (SDOH) that present barriers to participating in testing, follow-up, and retesting; b) create sustainable infrastructures that support rapid deployment of evidence-based approaches to testing, testing follow-up, and referral to treatment delivery or isolation systems; and c) conduct effective outreach, communication, and dissemination activities to inform communities about the project and its findings. Applicants are expected to provide evidence of partnerships with community organizations with whom they will work that include prior collaborations and must describe the roles of all partners. Study budgets should include funds for the community partners to be fully engaged and successfully participate in research design and implementation.

Testing capacity includes access to FDA-authorized/approved test kits and related supplies, as well as access to point-of-care testing (if and when FDA-authorized/approved) or certified laboratories (e.g., hospital, public health, or commercial) to administer the tests and return of test results as quickly as possible. Projects are encouraged to include active referral and contact tracing through partnerships (e.g., Tribal agencies and health departments) where this is possible. Repeat testing of symptomatic and asymptomatic persons, as well as individuals with previous positive COVID-19 tests, is encouraged to help understand the validity and reliability of tests in underserved and/or vulnerable populations and to help establish COVID-19 incidence rates in these populations. Strategies to maximize return of test results, plans for follow up, and familial and caregiver testing (when indicated) should consider literacy, health literacy, numeracy, cultural preferences, and language barriers.

Projects awarded under this FOA will be expected to work collaboratively with each other, with the CDCC (RFA-OD-20-013) and with SEBI projects (NOT-OD-20-119) related to COVID-19 testing research.

To address expected impacts of COVID-19 on the scientific workforce, projects are also strongly encouraged to support early stage investigators, specifically targeting diversity in their research workforce.

Research Topics:

Testing Research topics of interest include, but are not limited to, the following:

• Increasing reach, access, uptake, and impact for COVID-19 testing in underserved and/or vulnerable populations
  • Determine baseline rates of testing and use this information to evaluate innovative strategies to increase testing access, uptake, and sustainability in environments such as medical centers, community health clinics, Tribal facilities and clinics, remote care settings, correctional facilities and other congregant living facilities, and testing locations outside of health care settings (e.g., pop-up sites, rotating sites, and mobile units)
  • Conduct comparative effectiveness studies to test acceptance, uptake, and effectiveness of distinct COVID-19 test administration methods, such as by medical staff, trained community health workers or self-testing including supervised (e.g., via telemedicine) or unsupervised home-collection approaches
  • Identify, track, and increase testing access in testing deserts using novel methods, including geographic information systems and policy implementation research
  • Examine factors at multiple levels (including policies, community-level factors, interpersonal/family and individual variables) that maximize the impact on population morbidity and mortality by:
    • Increasing effective communication, reducing misinformation, and promoting testing uptake, and
    • Increasing referral to services, and improving follow up contact tracing
  • Leverage community relationships and cultural knowledge to drive testing implementation strategies, specifically with respect to community entry, trust building, and culturally appropriate ways of engaging and tapping community held knowledge about best practices to reduce testing barriers
  • Employ strategies for adoption and adaptation of effective communication, education, or other engagement strategies to enhance patient-clinician communication on and implementation of COVID-19 testing
  • Examine implementation strategy effectiveness of different organizations (e.g., health care systems, schools, faith-based organizations, etc.) and different components of systems for scale-up in underserved and/or vulnerable communities and examine long term sustainability
  • Evaluate the mechanisms or mediators of dissemination and implementation strategies to determine how these strategies produce their effects

• Create strategies to widely disseminate up-to-date FDA-authorized/approved testing technology based on detection of viral nucleic acids and consider viral detection point-of-care tests, including, antigen and antibody tests that emerge from NIH-supported technology development programs) to underserved and/or vulnerable populations
  • Employ evidence-based innovative technologies at the point-of-care such as home-based self-testing kits, as they become available, that can limit contact and allow for continued isolation for those with significant comorbid conditions or may be more acceptable for children and families
  • Integrate new technology or techniques into the testing model over time, particularly those emerging from FDA authorization
  • Apply innovative research methods such as rapid cycle testing or user centered design approaches for use of technology, Electronic Health Record or other digital health modalities to facilitate ordering tests (if this remains necessary), reporting of results and surveillance, contact tracing, and long-term sustainability of testing implementation strategies

To maximize consortium research and rapidly implement approaches to address the COVID-19 pandemic, comparisons across datasets or studies and data integration are essential to collaboration. Projects funded through this NOSI are strongly encouraged to use the following resources:

• Data Harmonization for Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).
• A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.

Additionally, researchers with funding through this NOSI will be strongly encouragedto share their survey items to make them public for other researchers to consider by submitting their surveys to [email protected].

The NIH also recognizes that other federal agencies who support research or demonstration projects may be strong collaborators for these types of research. NIH encourages collaboration with investigators funded by other agencies, as appropriate, including, but not limited to those funded by the Substance Abuse and Mental Health Services Administration, the Health Resources and Services Administration, the Administration for Children and Families, the Administration on Community Living and its divisions, the Centers for Disease Control and Prevention, the Indian Health Service, the Agency for Health Research and Quality, the Office on Minority Health, the Department of Defense, the Department of Agriculture, the Department of Education, the Department of Justice, the Department of Interior’s Bureau of Indian Affairs, and the Department of Veterans Affairs.

Additional Requirements

• NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (i.e., Tribal data sovereignty). The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products, and procedures to improve human health.
• Grantees are expected to work with the RADx-UP Coordinating and Data Collection Center (CDCC, RFA-OD-20-013) to submit common evaluation metrics on COVID-19 testing-related outcomes and implementation to the CDCC. Grantees should identify a dedicated unit responsible for these data reporting activities.
• Grantees are expected to obtain and retain personal identifiers on all research participants where it is not prohibited (i.e., Tribal data sovereignty) for future longitudinal follow-up and to be leveraged for intervention research. Data collected from this program will be protected by a Certificate of Confidentiality.
• Grantees are expected to use guidance provided by the CDCC for data acquisition, collection and curation, including appropriate consent for data sharing and implementation of the schemas proposed under the ABOUT ML effort ( Annotation and benchmarking on understanding and transparency for machine learning lifecycles ; available at https://www.partnershiponai.org/about-ml/).
• Grantees are expected to work with the funded RADx-UP Social, Ethical and Behavioral Implications program grantees (SEBI, NOT-OD-20-119) and other RADx-UP field sites to support novel research on social, ethical and behavioral implications of testing in underserved and/or vulnerable populations, as appropriate. Grantees are encouraged to identify a dedicated staff member for coordinating these activities.
• Grantees must include measures and reporting of relevant testing implementation outcomes, to inform future community, local, state, and federal policies.
• Projects must include a description of sustainability for their infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts.
• Projects must include an evaluation plan demonstrating how the proposed COVID-19 diagnostic testing access and uptake strategies/activities will be assessed for effectiveness and impact.
• Applications must include milestones towards progress and a timeline for completion. The timeline must include plans for regular reports of progress to be submitted to the CDCC and meetings with Community Advisory Boards. These reports will include both testing results and information regarding barriers and facilitators of COVID-19 testing and emerging challenges to implementation of the proposed research.
• As with all NIH supported research, details regarding human subjects research are expected, including data safety and monitoring plans and, if needed, plans for a Data Safety and Monitoring Board (DSMB). Studies that have a DSMB are expected to coordinate with CDCC (RFA-OD-20-013) for DSMB activities.
• Grantees are expected to disaggregate study results by sex/gender; race and ethnicity; age and other relevant demographic factors, and to consider intersectionality as appropriate.
• Grantees are expected to participate in CDCC-organized activities, including monthly cross-site meetings, cross-site working groups, and dissemination activities (of effective implementation strategies, tools and measures, etc.).
• Grantees are expected to demonstrate knowledge of and to comply with federal, state, local, and/or Tribal requirements on testing, reporting and surveillance policies in study protocols.
• Grantees must provide letters of support from the community partners and should include community partners (where possible) as investigators (See NOT-OD-20-031). Budgets should reflect active participation by community partners to the extent possible. When required, Tribal resolutions should be included with the application if possible, but before funds are awarded in all cases.

Applications nonresponsive to terms of this NOSI will not be considered. The following types of projects would generally not be appropriate and may be deemed non-responsive:

• Projects without a focus on one or more underserved and COVID-19 vulnerable populations
• Projects that have limited population reach (taking into account the size of the target populations and its COVID-19 epidemiologic profile)
• Projects that do not demonstrate a relationship with or engagement strategy with the populations of interest
• Projects that involve COVID-19 testing interventions outside of the United States
• Projects that do not address social, ethical, and behavioral consequences of their proposed design and methods and may exacerbate health disparities in COVID-19 diagnostic testing
• Projects that are exclusively qualitative (though mixed quantitative and qualitative are acceptable)
• Projects that do not have an infrastructure to rapidly report study findings and impact to the CDCC
• Projects that have limited testing capacity, that do not include FDA-authorized/approved testing strategies or present a plan to incorporate approved testing strategies
• Projects supplementing grants that are not eligible for this NOSI (see Eligibility section below under Application and Submission Information)

Review Process

Applications will be evaluated for scientific and technical merit by an appropriate internal NIH staff review panel, in accordance with the review criteria specified in PA-20-135 as well as these additional review criteria:

• Urgency and significance of research: How will successful completion of the aims contribute to or complement public health efforts for the control of SARS-CoV-2 (COVID-19) infection and related pathogenic processes? Does the proposed research fit within the mission of an emergency response to provide critical expertise, resources or activities?
• Research design: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? How feasible and appropriate are the overall research design elements (including power calculations) for demonstrating the effectiveness and impact of the proposed COVID-19 diagnostic testing uptake strategies/activities? Is the emergency timeframe (with milestones) appropriate and feasible to support the aims and goals of the study? Is the management plan well-described and commensurate with the level of complexity required?
• Investigators: Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project?
• Community partners: Is there evidence of strong established research collaborations with proposed community partners? How feasible and appropriate are the plans for integrating community partners into the study?
• Data sharing plan: Are there timely plans to make results and data findable and accessible to the research community? In instances involving Tribal data sovereignty, is there documentation of Tribal agreement with adapted data sharing plans?
• Coordination plans: How feasible and appropriate are the plans to submit data, data collection instruments and outcomes/products to the CDCC (RFA-OD-20-013)? How feasible and appropriate are the plans for to collaborate with other RADx-UP sites (SEBI NOT-OD-20-119 AND LINK & COMPANION TESTING RESEARCH SITES NOT-OD-20-121)?
• Outcomes: Will outcomes or products proposed advance and improve acceptability and uptake of COVID-19 testing? How feasible and appropriate are the plans for measures and reporting of relevant outcomes, including assessment of testing implementation outcomes and population measures of COVID-19 related morbidity and mortality? Is there evidence that outcomes of interest to the community are included in outcomes measured and reported on and products?
• Sustainability: How feasible and appropriate are the plans for sustainability of project infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts?
• Testing: How feasible and appropriate are the plans for access to FDA-authorized/approved test kits and related activities (i.e., ability to process tests in a timely manner and return of test results as quickly as possible)? How feasible and appropriate are the plans to support follow up testing and contact tracing? Is the proposed approach dynamic and responsive to the evolving changes in COVID-19 diagnostics? Is there evidence of adequate support being provided to the community to understand and act on test results when they are returned to individuals and community members?
• Evaluation: Is the evaluation plan feasible and appropriate? Will the evaluation assess the project activities/strategies and goals and determine overall impact? Is the evaluation informed by community input?

Pre-award costs

• Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

Reporting

• OD plans to make awards using funds provided in the emergency supplemental appropriations for COVID-19 and coronavirus research: Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 . Funds awarded using appropriations provided by the Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following targeted funding opportunity or its subsequent reissued equivalents:

• PA-20-135 Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional) is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
• The funding instrument, or activity code, will be the same as the parent award.
• ORWH reminds applicants that the appropriate consideration of sex and gender as described in NOT-OD-15-102 is NIH policy and a consideration for NIH support.

Eligibility

Eligible existing grants that can be revised in response to this NOSI are limited to eligible non-fellowship active research and resource grants and cooperative agreements. Currently funded grantees may apply for work that is related to their funded project, whether within the scope or outside of the scope of the current project, regardless of the time remaining on the current project. Grants currently in a no-cost extension are eligible to apply.

All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-20-135) must be followed, with the following additions:

• Individual requests can be no more than $700,000 in direct costs for the entire 2-year budget and 75% of the funds must be allocated to expenses in the first year, to reflect the rapid ramp up and outreach during the first part of the study.
• The budget must reflect appropriate compensation to community partners collaborating in implementation of testing interventions, test results return, and development of culturally appropriate dissemination of research results (i.e., publications and other means of dissemination).
• Given funds available, it is anticipated that up to 30 awards may be made in FY2020 or FY2021.
• Regardless of the grant mechanism of the parent award, the Research Strategy section of the application is limited to 6 pages and must include:
  • A description of specific milestones towards progress and a timeline for completion, taking into account the need for rapid deployment of testing protocols.
  • A Community Partner Program section to demonstrate partnership with community organizations, roles and reach of these partnerships, and the organizational and decision-making structure.
  • A Testing Capacity section to demonstrate access to FDA-authorized/approved test kits, personal protective equipment (PPE), and access to certified laboratories (e.g., hospital, institutional, public health, or private commercial) to process tests with the ability to store, transport and return of test results in an appropriate manner and as quickly as possible.
  • A Consortium Data Reporting Unit to demonstrate the capability and infrastructure of the applicant to report on the number of COVID-19 tests conducted, their results, and subsequent actions and referrals, for the overall study population and relevant subpopulations. The Unit must also disseminate effective implementation strategies for rapid uptake across consortia as relevant through the CDCC.
  • A Human Subjects Unit that works to monitor ethical and social implications and human subjects concerns in testing implementation. This work is essential in monitoring implementation efforts are not exacerbating health disparities in underserved and/or vulnerable populations. Applications to this FOA can suggest possible collaborations with the SEBI program (NOT-OD-20-119). However, the success of work proposed in applications to this NOSI should not depend on those collaborations, since the specifics of those awards will not be known in advance.
  • Plans for a Community and Scientific Advisory Board that includes target community representation and scientists not directly involved in the project, as well as schedule and structure of inclusion of the advisory board(s) is required.
  • Description of contingency plans regarding ongoing or potential future public health restrictions (e.g., closures, physical distancing) that might affect the research approach, including online approaches where available and appropriate.
• The project period is limited to two years.
• Applicants may request supplements and budgets that exceed the parent grant. Budgets must be reasonable and reflect the actual needs of the project.
• To be eligible for a competing revision award under this NOSI, the parent award on which the revision application is based must be an active award (including those in a no-cost-extension period) managed by one of the participating institutes or centers.
• Recipients may apply for work that is related to their funded project, whether within the scope or outside of the scope of the current project, regardless of the time remaining on the current project. Grants currently in a no-cost extension are eligible to apply.
• Applications may be submitted beginning on July 8, 2020 for Application Due Dates of August 7, 2020 (5:00 PM local time of the applicant organization) OR September 8, 2020 (5:00 PM local time of the applicant organization). Applications received after September 8, 2020 will not be considered. The earliest start date for applications received on or before August 7, 2020 will be September 2020, and for applications received on August 8, 2020 or later will be November, 2020. An application submitted in response to this NOSI that is received on September 9, 2020 or later will be withdrawn.
• IMPORTANT: For funding consideration, all applicants must designate "NOT-OD-20-120"(without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form. Applications without this information in Box 4b will not be considered for this initiative. All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package
• • Competitive revision applications to PA-20-135 must use the application form package with the Competition ID that contains FORMS-F-COMP-REV .

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program staff listed on this NOSI well in advance of the applicationreceipt date to better determine appropriateness and interest of therelevant Institute. Applicants are also strongly encouraged to notify the Program staff listed on this NOSI that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

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