Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

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 Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Cancer Institute (NCI)

Funding Opportunity Title
Emergency Award: RADx-UP Community-Engaged Research on Rapid SARS-CoV-2 Testing among Underserved and Vulnerable Populations (U01 Clinical Trial Optional)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
New
Related Notices

  • April 6, 2022 - Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed). See Notice RFA-OD-22-011
  • March 2, 2022 - Notice of Pre-application Webinar for Phase III of the RADx-UP® Initiative. See Notice NOT-OD-22-080.

Funding Opportunity Announcement (FOA) Number
RFA-OD-22-006
Companion Funding Opportunity
RFA-OD-22-005 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.867, 93.837, 93.838, 93.233, 93.839, 93.840, 93.113, 93.143, 93.361, 93.866, 93.279, 93.394, 93.395, 93.396, 93.399, 93.853, 93.393, 93.350, 93.172, 93.855, 93.865, 93.173, 93.273, 93.307, 93.859, 93.213, 93.286, 93.242, 93.121, 93.846, 93.847
Funding Opportunity Purpose

The goals of this funding opportunity announcement (FOA) are to implement and rigorously evaluate SARS-CoV-2 rapid testing strategies in communities experiencing COVID-19 health disparities. These two-year Rapid Testing Research Projects will evaluate (1) rapid testing interventions to prevent and control COVID-19 transmission among underserved and vulnerable populations and (2) partnership-driven research to implement and evaluate rapid testing and reduce COVID-19 disparities. The funding for this program is provided from the American Rescue Plan Act of 2021, PL 117-2.

Key Dates

Posted Date
Open Date (Earliest Submission Date)
April 04, 2022
Letter of Intent Due Date(s)

Not applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 02, 2022 Not Applicable Not Applicable July 2022 Not Applicable December 2022

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
May 03, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The National Institutes of Health (NIH) is issuing this Funding Opportunity Announcement (FOA) in response to the declared public health emergency issued by the Secretary, HHS, for the Novel Coronavirus 2019 (COVID-19). This FOA provides an expedited funding mechanism to support Phase III of the Rapid Acceleration of Diagnostics – Underserved Populations (RADx®-UP) initiative. This FOA highlights the urgent need to leverage rapid SARS-CoV-2 testing, which is often self-administered or administered outside of healthcare settings, to understand and address COVID-19 morbidity and mortality disparities among underserved and vulnerable populations across the United States. These two-year, community-engaged Rapid Testing Research Projects will examine SARS-CoV-2 infection patterns and interventions to increase access to and uptake of diagnostic methods through the RADx®-UP initiative. Successful applications will pose novel and adaptable scientific questions given new variants and the availability of SARS-CoV-2 vaccines.

The Office of the Director (OD) is issuing this FOA to address the objectives described below.

Key Definitions

This FOA is applicable to those populations who 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 vulnerable” elsewhere in this FOA):

Underserved: NIH-designated populations with health disparities 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.

Rapid SARS-CoV-2 Diagnostic Testing (also referred to as “rapid testing” or “rapid diagnostic testing” below): Rapid tests are molecular or antigen tests used to diagnose infection performed at or near the place where a specimen is collected, usually outside of a laboratory setting. In the context of COVID-19, these tests are diagnostic tests that provide results to patients within minutes. They might be used to diagnose SARS-CoV-2 infections in various settings, including at home, community health clinics, schools, the workplace, or other locations where the rapid determination of SARS-CoV-2 infection status could lead to the reduction of COVID-19 cases in the community.

For the purposes of this FOA it will be understood that the term "rapid SARS-CoV-2 diagnostic testing" (see above) refers to the use of FDA Emergency Use Authorized (EUA) or Approved or Cleared tests for the specific, on-label purpose for which they were developed and authorized/approved/cleared.

Point-of-Care Testing: Medical testing done at or near the point of care that involves performing a diagnostic test.

Background

The overarching goal of the RADx®-UP initiative, as seen in the Phase I and II funded projects, is to understand and address COVID-19 morbidity and mortality 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. Implementing effective strategies for testing, contact tracing, surveillance, and mitigation requires individuals and communities to avail themselves of testing when offered, adhere to isolation and quarantine restrictions if they test positive, and not lessen their adherence to mitigation strategies if they test negative. Public health officials, policymakers and communicators are hampered by limited evidence on individual, community, and population-level interventions to optimize testing and mitigation adherence. This is also of concern among groups (including persons with mental illness, autism, developmental disabilities) who have not been consistently identified as vulnerable in the pandemic and/or may have considerable barriers to testing and mitigation adherence (e.g., unable to miss work to self-isolate after a positive test or exposure to an individual who has tested positive). In school and childcare settings, better understanding of effective new testing models such as “Test-to-Stay” (i.e., close contacts who continue to test negative remain in the classroom instead of quarantining at home) and other testing implementation strategies are important for keeping children, household members, and school staff safe during in-person instruction. Precisely quantifying and addressing the benefits, risks, and efficacy of testing and mitigation strategies at multiple levels and rapidly evaluating individual, community, and population level interventions (e.g., via pragmatic trials) to optimize testing, vaccination, and mitigation adherence is a crucial component of any successful national strategy for testing, contact tracing, vaccination, surveillance, and mitigation implementation.

To properly address, mitigate, and navigate the ongoing effects of COVID-19, innovative and flexible research plans, procedures, and protocols are needed to expand the reach, scope, and effectiveness of rapid diagnostic tests for communities that are experiencing COVID-19 health disparities. Successful projects will accomplish this by developing scientific questions and methods that are forward-thinking and can be adapted as the trajectories of COVID-19 cases, variants, hospitalizations, and mortality change over time.

FOA Goals

The Office of the Director (OD) is requesting applications for cooperative agreements (U01s) addressing the objectives described below. Projects supported via this FOA will be part of the RADx®-UP initiative. This “Rapid Testing Research Projects” opportunity will support new cooperative agreements that have established community-engaged research and collaborations or partnerships to support SARS-CoV-2 (i.e., COVID-19) rapid testing at the point of care and/or for self-administration among underserved and vulnerable populations.

The U.S. Food and Drug Administration (FDA)-emergency use authorized (EUA) or Approved or Cleared (EUA/approved/cleared) SARS-CoV-2 testing options have expanded from laboratory-based diagnostics to include rapid tests administered in multiple settings, including outside of healthcare contexts (e.g., within homes, schools, and workplaces). Thus, there is a need for evidence-based optimization strategies that are responsive to community needs and that improve utilization of subsequent mitigation behaviors based on test results.

The goals of this FOA are to implement and evaluate interventions for underserved and vulnerable populations to increase access to, uptake of, and effective use of rapid diagnostic SARS-CoV-2 tests. “Effective use” indicates tests must be used for the specific, on-label purpose for which they were developed and authorized/approved/cleared (e.g., including serial administration of tests if part of the recommended approach) by the FDA.

Research Objectives:

This research will implement and evaluate SARS-CoV-2 rapid diagnostic testing in communities experiencing health disparities. Research projects will develop rapid testing implementation strategies among both unvaccinated and vaccinated individuals that leverage community relationships and cultural knowledge, specifically with respect to community entry, trust building, and culturally appropriate ways of engaging and tapping community held knowledge about best practices to reduce rapid testing barriers at various points-of-care and make best uses of test kits and results.

Rapid Testing Research topics of interest focused on underserved and vulnerable populations include, but are not limited to, the following areas:

Using Rapid Diagnostic Testing to Prevent and Control COVID-19 Transmission

  • Interventions to encourage and increase the uptake of SARS-CoV-2 rapid testing alone or in combination with other mitigation efforts, such as mask-wearing, physical distancing, frequent hand hygiene, and ongoing rapid testing even after vaccination
  • Rapid testing research to help assess, track, and reduce COVID-19 transmissions/infection in diverse settings and contexts, including large indoor gatherings (e.g., concerts, sporting events), day-to-day settings (e.g., workplaces, grocery stores, schools), and healthcare settings
  • Expanding and evaluating rapid testing strategies and new technologies to digitalize the return of results directly from participants in diverse settings and contexts, including large indoor gatherings (e.g., concerts, sporting events, etc.), day-to-day settings (e.g., workplaces, grocery stores, schools), and healthcare settings
  • Research to assess, track, and respond to increased transmission/infections associated with gatherings – such as concerts, cultural events, places of worship, sports events, political rallies, and day-to-day gatherings in places such as movie theaters, dining halls, schools, and workplaces – with services such as mobile clinics equipped with rapid testing and vaccination capacities
  • Implementing follow-up rapid testing of vaccinated individuals to understand the rate of infections in persons post initial vaccination and/or booster vaccination
  • Research to examine the effects of rapid testing interventions across states and localities with varying testing and vaccination mandates on COVID-19 transmission, new infections, moderate or severe illness, hospitalization, and mortality
  • Evaluating communication and technology-based strategies to increase access to rapid, at-home-testing kits and frequent testing of unvaccinated individuals
  • Interventions to increase rapid testing among asymptomatic persons, both vaccinated and unvaccinated, to reduce the spread of new infections in specific settings

Rapid SARS-CoV-2 Diagnostic Testing in School and Childcare Settings

  • Research in school and childcare settings to determine appropriate and effective rapid testing implementation to identify testing cadence (e.g., “Test to Stay” or modified quarantine), close contacts, length of quarantine, and other mitigation strategies (e.g., masking, physical distancing, contact tracing, vaccination) to protect students, staff, and household members in the support of in-person instruction
  • Studies of effective implementation of timely return of rapid test results to the child and/or their parent(s) or guardian(s), as well as school communities and public health departments, understanding the implications of a negative or positive test result; and privacy, confidentiality, ethical implications, and data sharing of test results
  • Studies determining effective methods to incorporate rapid testing with other strategies, such as genetic sequencing, to help identify and mitigate in-school transmission and population spread of existing or new variants of COVID-19
  • Research to examine and address disparities in the availability, ease of use, and/or accessibility of new rapid testing technologies, including at-home testing options, to return and/or maintain in-person instruction

Partnership-Driven Research to Implement and Evaluate Rapid COVID-19 Diagnostic Testing

Of specific interest for these topics are projects conducted in partnership with public health departments, local/state/tribal stakeholders, various federal entities (Veterans Health Administration [VHA], Indian Health Service, military installations, and others), Federally Qualified Community Health Centers, and/or national organizations.

  • Evaluate rapid testing (home-testing kits, clinic, or community-based) among families or individuals in relation to vaccine status or uptake among unvaccinated individuals when offered through virtual or home visit services
  • Evaluate home visit programs for rapid testing, which may also be combined with vaccination (including boosters) and other mitigation strategies, especially among home-bound individuals, caregivers without back-up, older adults with cognitive impairment, persons of any age with disabilities, persons with visual impairment, and people with serious mental illnesses
  • Implement and evaluate rapid testing for variant emergence, or community-level sources of spread, home versus school versus worksite or others and communication of testing and infection rates
  • Evaluations of rapid testing and vaccination mandates among employers of frontline and healthcare workers who are over-represented among COVID-19 vulnerable populations
  • Evaluations of rapid testing and vaccination mandates on the uptake of rapid tests among private employers
  • Evaluate alternative strategies to support point-of-care or home-based rapid testing, including digital technologies, decision-making support tools, or innovative strategies (e.g., secondary distribution, or communications-based) to promote return of results, reporting or documentation of results, confirmatory or frequent testing, contact tracing and linkage to ongoing prevention, mitigation, or treatment services
  • Evaluate new rapid testing technology (e.g., software applications) or techniques in addition to contact tracing in settings with high transmission potential
  • Evaluate the use of rapid tests to promote effective contact tracing in underserved geographic locations with high community transmission
    • Studies that implement individual-level rapid testing and return of results to specifically identify SARS-CoV-2 variants among persons who test positive for the virus among populations with limited inclusion in variant surveillance systems
    • Studies that include rapid testing of asymptomatic individuals and return of individual results for infection control and transmission reduction in various settings such as health care settings and community

Key project considerations are listed below:

  • Projects funded through this activity will partner with state and local public health departments, and/or other community partners to evaluate the impact of increased on-site rapid testing efforts as variants and vaccination rates change.
  • Projects will test rapid testing interventions in settings such as homes, public health departments, healthcare systems, universities, K-12 schools, early childcare settings, defined neighborhoods, social service providers, the workplace, labor unions, social venues or large gatherings (e.g., concerts, sporting, religious or cultural events).
  • The Rapid Testing Research Projects will build upon the work of RADx-UP, the Community Engagement Alliance (CEAL) Against COVID-19 Disparities, the Social, Behavioral, and Economic (SBE) Research on COVID-19 in Vulnerable and Health Disparity Populations Consortium Initiative, and other NIH-supported COVID-19 focused projects. Successful applications will draw from initial research by funded RADx-UP projects to optimize and implement rapid testing programs that may also be combined with vaccination and mitigation adherence programs and study the implementation of these programs in close partnership with state and local public health testing programs.
  • This opportunity will complement the projects supported under a companion RADx®-UP funding opportunity (RFA-OD-22-005) that seeks to understand and address the social, ethical, and behavioral implications of COVID-19 testing, including mandates for testing and vaccination.
  • Projects must be capable of demonstrating measurable impact and the ability to adapt the research questions and methodology as the dynamics of the pandemic change across a two-year timeframe.
  • Research teams must also have established research infrastructure and community-engaged partnerships (such as public health departments, with Tribal governments and agencies, community medical centers or health systems, safety-net health or social service systems, pharmacies, grassroots organizations, community and faith-based organizations, schools, and childcare settings). Study budgets should include funds to compensate community partners to participate in research design and implementation.
  • Investigator teams submitting applications should demonstrate a history of success recruiting and retaining participants within the specified target populations and where appropriate, 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 FDA-EUA/cleared/approved rapid point-of-care or self-administered SARS-CoV-2 diagnostic testing and other outcomes to inform future maintenance, generalizability, sustainability and scale up.
  • Projects are expected to specify strategies to: a) address individual and structural social determinants of health (SDOH) that present barriers to participating in rapid testing, follow-up, and retesting; b) create and support sustainable infrastructures within existing public health, health care and/or community infrastructures that support rapid deployment of evidence-based approaches to rapid 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.
  • Data Harmonization for Social Determinants of Health (SDOH), COVID-19, and other relevant measures 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 SDOH across studies. In particular, human-subject studies 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).
  • Projects awarded under this FOA will be expected to work collaboratively with each other and with other projects related to SARS-CoV-2 testing research.
  • Results from these projects should be disseminated rapidly to ensure that communities disproportionately impacted by COVID-19 can alter or improve mitigation strategies using evidence-based information.
  • NIH requires that all studies funded under this FOA will actively coordinate, collaborate, and share all project data with the RADx-UP Coordination and Data Collection Center (CDCC) as allowed, and with considerations for Tribal sovereignty. Data transfer to the CDCC is to begin six months after the project’s start date with weekly transmission of RADx-UP common data elements (CDEs) and quarterly submission of all other project data. Recipients should identify a dedicated unit responsible for these data reporting activities. Note: this is separate from the requirement to comply with the NIH Data Sharing Policy and to submit a Data Sharing Plan as outlined in Section IV.
  • NIH is striving for consistency and high levels of rigor and reproducibility in all research, particularly in programs related to the COVID-19 pandemic. All researchers engaging human participants in their projects are required to use a set of CDEs to standardize the collection of data and ensure that data can be aggregated and compared across study populations and research topics (where not otherwise prohibited such as by Tribal sovereignty).This data standardization will permit evaluation of the overall RADx®-UP consortium and impacts on COVID-19 disparities in specific populations, facilitate analysis of research questions and may inform policy at the local, community, national and/or Tribal levels. Projects responding to this funding opportunity are required to collect all of the NIH RADx®-UP Tier 1 and Tier 2 Common Data Elements. Permission from participants to collect and share these CDEs and all research data for general research reuse will be given through specific language in the Informed Consent Form (ICF).

Projects are strongly encouraged to support early-stage investigators and diverse teams.

Design, Analysis, and Sample Size for Studies: RADx®-UP Phase III projects must demonstrate relevance of the scientific questions to COVID-19 testing among underserved and vulnerable populations. Projects should utilize rigorous research designs (e.g., randomized controlled trials, stepped wedge designs, multiphase optimization strategy (MOST) designs, pragmatic clinical trials, interrupted time series, dynamic wait list design, hybrid effectiveness-implementation designs, sequential multiple assignment trial (SMART) designs, and adaptive designs). Group and individual randomization may not be feasible in nor acceptable to participants in some community-engaged interventions among populations who experience health disparities or express research distrust. Applicants should use methods that are appropriate given their plans for assignment of participants and delivery of interventions. Projects must describe research strategies that will reflect the availability of COVID-19 vaccines. Projects must also demonstrate the ability to recruit and retain an adequate number of participants within the specified target populations and include sample size and power calculations. Given the RADx®-UP goal of population-level impact, projects should also delineate verified testing as the primary outcome (e.g., rapid COVID-19 test completion measured objectively versus self-report). Changes in testing access, effective use, vaccination uptake, and other psychosocial or behavioral variables would be acceptable as secondary outcomes. Additional information is available at https://researchmethodsresources.nih.gov/.

Additional Requirements

Testing:

  • For this FOA, only FDA EUA/approved/cleared rapid diagnostic tests, including molecular and antigen tests are allowed. Serology/antibody and other adaptive immune response tests are not allowed for these projects.
  • All studies that include collection and/or testing of human biological specimens, either for diagnostic or research only purposes, must be performed using tests that are FDA EUA/approved/cleared and must be used on-label (in the way authorized by the FDA). The term “test” covers any tests, laboratory procedures/process, measurements, or other applications, as well as those reagents, instruments, kits/devices, and systems used in the procedure, for the collection, preparation, and examination of human biological specimens.
  • Projects proposing COVID-19 surveillance must include specific plans to return individual test results to participants. Surveillance with no plans to inform individuals of their test results is not allowed.

Data Collection, Sharing, and Coordination:

  • NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (e.g., Tribal 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 (see above for required data-sharing cadence).
  • Recipients are required to obtain and retain personal identifiers on all research participants where it is not prohibited (e.g., 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.
  • Studies which require data safety monitoring board (DSMB) oversight are expected to coordinate with CDCC (RFA-OD-20-013) for DSMB activities.
  • Recipients are expected to disaggregate study results by sex/gender; race and ethnicity; age and other relevant demographic factors, and to consider intersectionality as appropriate.
  • Recipients are required 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/).
  • Recipients must include measures and reporting of relevant testing implementation outcomes to inform future community, local, state, tribal and federal policies.
  • Recipients 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.).

Research Plan:

  • Projects must include a description of sustainability for their infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including vaccine and/or therapeutic implementation efforts.
  • Projects must include an evaluation plan demonstrating how the proposed rapid 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 monthly (or at a frequency requested by the CDCC) reports of progress to be submitted to the CDCC. These reports will include both rapid testing results and information regarding barriers and facilitators of COVID-19 testing and emerging challenges to implementation of the proposed research.
  • Recipients 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.
  • Recipients must provide letters of support from the community partners and should include community partners (where possible) as investigators. 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 FOA 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/or COVID-19 vulnerable populations
  • Projects that have limited population reach (considering 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 rapid 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 share data and report study findings and impact to the CDCC
  • Projects that do not include the use of FDA EUA/approved/cleared rapid diagnostic tests and supplies that are utilized on-label (that is, in the way they are authorized/approved/cleared.) Note: All parts of study specimen collection, testing, assays, and processing of human specimens, including any requirements of CLIA certification, must be covered by FDA EUA/approval/clearance.
  • Projects proposing serology/antibody and other adaptive immune response tests or focusing exclusively on vaccination
  • Projects that are exclusively surveillance and do not include specific plans to return rapid test results to individuals

Investigators planning to submit an application in response to this FOA are encouraged to contact and discuss their proposed research/aims with Program staff listed on this FOA well in advance of the application receipt date to better determine appropriateness and interest. Applications are invited from investigators representing a wide range of disciplines, including but not limited to ethics, health disparities research, demography, health policy, health communication and communication science, implementation science, clinical care, home and community-based services, infectious disease, community-based participatory research, policy studies, public health, epidemiology, bioinformatics and health information sciences, behavioral and social sciences (e.g., psychology, sociology, social work, anthropology, nursing, political science, economics, communication science).

NIBIB Statement of Interest

The NIBIB supports technology development and translation of new or redesigned medical technologies that can have a significant impact on healthcare access and health outcomes for health disparate populations.

NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications". NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to commit $24 Million over 2 years to fund approximately 12 awards.

Award Budget

Application budgets are limited to $700,000 in direct costs per year and must reflect the actual needs of the proposed project.

Award Project Period

The maximum period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

In the biosketches, please outline the experience of the key personnel in community-engaged research and with community partners, including expertise such as years of work in the index community and successful delivery of health programs to underserved communities.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

.

Specific Aims

Concisely state the specific aims and include research to be conducted as well as actionable sources of disparities to be addressed.

Research Strategy

The Research Strategy should include details on methods, assumptions, research designs, data analysis plans, and any interdependencies of Aims, and justify major choices about populations, goals, outcomes, and methods. Please do not duplicate information already addressed in the Inclusion of Women and Minorities or Inclusion Across the Lifespan sections.

The potential of the proposed approach to yield important contributions applicable to a range of populations and settings, or to inform intervention and prevention strategies, should be addressed. Applications focusing on specific communities should describe how findings and products can be generalized or implemented across other underserved and vulnerable populations or to the same populations in other settings (rural/urban and regional differences). Briefly describe the generalizability of study approaches and findings to broader populations and include plans for the development and sharing of materials or toolkits to facilitate adaptation, dissemination, and implementation. Where vaccination uptake is included as a (secondary) topic, the study of vaccination must clearly add value to the application's aims regarding COVID-19 testing in underserved and minority populations. The proposed approach should be dynamic and able to be responsive to evolving changes in COVID-19 diagnostics, vaccination, and treatment. Where a network of subprojects are collaborating in a project, plans for each subproject should include agreement with the requirements to collect all NIH RADx-UP Tier 1 Common Data Elements, and adherence to sharing of all data where not prohibited by Tribal sovereignty in the required format and on the NIH-directed timetable.

Where applicable the Research Strategy should detail community- or stakeholder-engaged methods to assess barriers to rapid COVID-19 test and vaccination access, uptake and follow-up, and develop and evaluate strategies or interventions to address those barriers.

This FOA supports collection of multiple types of data including qualitative and quantitative methods, as well as reviews of documents and available data where appropriate. Where possible, primary or alternate methods that are robust or unaffected by shelter-in-place, and other restrictions on research environments, or by existing digital divides are encouraged, although evidence of availability and acceptability for communities and individuals should be provided, along with the capacity to maintain standards of ethical research conduct.

Applicants should address whether and how ongoing or potential future public health changes or restrictions (e.g., closures, physical distancing, ability to hold large meetings) might affect the research approach and, if so, include a plan to prevent or mitigate any effect on the proposed study.

While preliminary data are not explicitly required, the application should clearly outline a solid rationale and conceptual framework to demonstrate the feasibility of the approach and document through letters of support, joint publications, and other methods the length and strength of the research team’s engagement with the communities with whom the project intends to work.

A description of how the institutional environment will facilitate community or stakeholder engagement and facilitate implementation and dissemination of results to the community should be included where appropriate.

The Research Strategy section should include a project timeline.

.

Applicants should describe in the Research Strategy their ideas for working with other SEBI and RADx®-UP sites to accomplish project goals, and their willingness to adhere to policies and procedures determined in cooperation with the CDCC (RFA-OD-20-013).

Letters of Support

Letters of support from the community partners (e.g., Tribal leaders, or other key representatives with the authority to speak on behalf of the communities to be included in the study) that demonstrate established and robust collaborations of the investigators and the community partners as well as strong support for community involvement in the research project should be included with the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

  • All applications, regardless of the amount of direct costs requested for any one year, are required to address in detail in a Data Sharing Plan the available data collection and management infrastructure and resources (e.g., personnel, storage platforms) to facilitate the required data sharing across all partners, collaborators (e.g., health systems, public health departments, community organizations, pharmacies, etc.) via the CDCC, where not limited by tribal sovereignty.
  • Feasible and appropriate plans to submit data, data collection instruments, and outcomes/products to the CDCC on a quarterly basis, beginning six months after the project start date, where not limited by tribal sovereignty. Plans should include submission of CDEs on a weekly basis, beginning six months after the project start date.
  • Additionally, researchers with funding through this FOA will be required to share their survey items, data collection instruments and methods for other researchers via the CDCC and NIHCOVID19Measures@nih.gov.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to this emergency FOA will be evaluated for scientific and technical merit by objective review that will be conducted by the Center for Scientific Review.

For this particular announcement, note the following:

  • This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, preliminary data is not explicitly required in the application.
  • Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

Do the key personnel have appropriate expertise in community engaged research?

When considering experience of community engaged researchers and community partners, nontraditional indices of expertise such as years of work in the index community or successful delivery of health programs to underserved communities can be considered. This experience should be documented through letters of support from community stakeholders, Tribal leaders, or other key representatives of the community with the authority to speak to the collaboration and past accomplishments.

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

  • How feasible and appropriate are the plans to collaborate with the existing RADx-UP field sites and future RADx-UP field sites? Where a network of subprojects are collaborating in a project, does each subproject include agreement with the requirements to collect all NIH RADx-UP Tier 1 Common Data Elements, adhere to sharing of all data where not prohibited by Tribal sovereignty in the required format and on the NIH-directed timetable?
  • Does the research team have the capability to adapt and respond quickly to the changing dynamics (e.g., variants, cases, hospitalizations, deaths, availability of tests and supplies, personal protective equipment, closures, public health guidance, population specific changes, etc.) of the COVID-19 pandemic?
  • Where vaccination uptake is included as a topic, does the study of vaccination (within the context of rapid COVID-19 testing) clearly add value to the application's aims regarding rapid testing in underserved and vulnerable populations?
  • Is the proposed approach dynamic and able to be responsive to evolving changes in COVID-19 diagnostics, vaccination, and treatment?
  • How feasible and appropriate are the plans for integrating community partners into the study?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

 

Resource Sharing Plan

Is the resource sharing plan

timely and feasible? Does the plan make instruments, products, results, and data findable and accessible to the research and public health community, where not limited by Tribal data sovereignty? In instances involving Tribal data sovereignty, is there documentation of Tribal agreement with adapted data sharing plans? If school data are included, are there considerations of protections such as those included in the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99)?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit through an objective review process conducted by the Center for Scientific Review, using the stated review criteria.

As part of the objective review process, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique from reviewers.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial objective review, recommended applications will receive additional levels of review by the RADx-UP Governance Committee and the RADx Executive Committee, with final approval from the NIH Director or Acting NIH Director. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific objective review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the objective review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for objective review, , and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The Principal Investigator(s) will have the primary responsibility for:

  • Coordinating project activities technically, scientifically, and administratively at the recipient institution and coordinating project activities at other sites that may be supported by the award.
  • Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the award.
  • Ensuring that appropriate Institutional Review Board approvals and certifications for research involving human subjects for all participating sites, collaborators or partners are obtained.
  • Consulting with NIH to ensure compliance with relevant grant policies and regulations
  • Provision of information to the NIH Program Official and NIH Project Scientists.
  • Participating in the CDCC-organized activities and with RADx®-UP consortium members including monthly cross-site meetings, cross-site working groups, and dissemination activities (of effective implementation strategies, tools and measures, etc.).
  • Management of a dedicated unit responsible for data acquisition, collection, curation, and data reporting activities to the CDCC.
  • Implementing collection of data specified by the study protocol. For a multi-center study, each recipient/site is required to ensure that data will be submitted expeditiously to the CDCC. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
  • Establishing procedures for data quality, completeness, and security. Recipients are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. Submitting interim progress reports, when requested or agreed upon by both parties, to the Institute’s Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the Program Official may require additional information from individual recipients/sites. Such reports are in addition to the required bi-annual noncompeting continuation progress report.
  • Reporting of the study findings. Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The recipient must also be adherent to Study Publication and Presentation Policy. The Institute will have access to and may periodically review all data generated under an award. Institute staff may co-author publications of findings with recipients consistent with NIH and study policies.
  • Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/ Institute policies and procedures, and with written approval from Program staff. Any relevant proposed third-party agreements related to the network studies between recipient and third-party will be provided to the Program staff and Technology Advancement Office for review, comment, and approval to assure compliance with NIH/ Institute policies and network policies. Further, at the request of the Program staff, any other network-relevant third-party agreements must be shared with Program staff. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: “Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.”
  • Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network activities that includes access to any network generated resources (e.g., data and biosamples), or study results that are not publicly available, or using the name of the network or study or the name of the NIH or the Institute is permitted only after written permission by the Program staff who will consult with others at NIH and Technology Advancement Office.
  • Study investigators are required to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols, steering committee policies on publications, and the approved sharing plan.
  • Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the recipient is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH will assign a Program Official (see below) and Project Scientist(s) to the award. The Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination.

The Project Scientists(s) will:

  • Review and comment on critical stages in the program implementation;
  • Assist in the interaction between the recipient and investigators at other institutions to promote coordination with the CDCC;
  • Retain the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
  • Have the right to co-author manuscripts and other dissemination activities with the study investigators.

Additionally, the NIH program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The Program Official will:

  • Assist with the NIH’s monitoring of compliance of award-supported activities:
  • Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
  • Help ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer-reviewed funding mechanisms;
  • Provide assistance in reviewing and commenting on all major transitional changes of activities prior to implementation to ensure consistency with the goals of this FOA;
  • Assist with the NIH’s monitoring of financial oversight and compliance/exemption with all standard and program-specific study terms including but not limited to CDEs, data deposit and sharing, and identity management.

Areas of Joint Responsibility include:

  • Identifying and facilitating partnerships with other RADx®-UP award recipients or other relevant resources and expertise that could be leveraged to facilitate achievement of the FOA goals and objectives.
  • Organizing and participating in the CDCC activities.
  • We are mindful of the rapidly changing nature of the COVID-19 pandemic, the likelihood that new scientific questions will arise, and that RADx®-UP projects must be adaptable and responsive. To ensure continual relevance to the COVID-19 pandemic, at the time of award, and across the lifespan of the project the Program Official and PI(s) will meet with the project PIs, other Program Officers and Project Scientists assigned to RADx®-UP Projects and the CDCC Program Officers and Project Scientists monthly to ensure that the research questions and goals remain in scope while also reflecting the evolving medical, public health and behavioral landscape of COVID-19 disease testing and vaccination, and ensure alignment with NIH Executive and RADx®-UP Governance Committee guidance.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of theRADx®-UP consortium member chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

The NIH Office of the Director plans to make awards using funds provided in the emergency supplemental appropriations for COVID-19 and coronavirus research: “American Rescue Plan Act of 2021, Public Law 117-2".

Funds awarded using appropriations provided by the “American Rescue Plan Act of 2021, Public Law 117-2" will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Interim Reports

In addition to the annual RPPR, recipients are required to submit an interim progress report every six months outlining key milestones that have been met.

  • Recipients must upload the interim report using the Additional Materials tool (AM) in eRA. The Authorized Organization Official is required to submit interim reports to the Grants Management Official named on the Notice of Award using AM.
  • The interim progress report must outline for each award the following:
    • For each specific aim, a brief summary of major activities, significant results, and key outcomes or other achievements.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Elizabeth Walsh

NIH Office of the Director (OD)
Telephone: 301-480-8127
Email:

elizabeth.walsh@nih.gov

Kelly Anne King, Au.D., Ph.D.
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-402-3458
E-mail: kingke@mail.nih.gov

Dipanwita Basu, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
dipanwita.basu@nih.gov
240- 627-3469

Tammara Jenkins, MSN, RN, PCNS-BC, FCCM
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email: tjenkins@mail.nih.gov

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov

Ming Lei, PhD
National Institute of General Medical Sciences (NIGMS)
Email: leim@mail.nih.gov

Qi Duan
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-827-4674
E-mail: qi.duan@nih.gov

Hiroko Iida, DDS, MPH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7404
Email: hiroko.iida@nih.gov

Richard T. Benson, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Richard.benson@nih.gov
301-827-9071

Laura Elizabeth Kwako
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: 301-451-8507
E-mail: laura.kwako@nih.gov

Gregory Greenwood, PhD, MPH
National Institute of Mental Health (NIMH)
Telephone: 240-669-5532
Email: gregory.greenwood@nih.gov

April Oh, Ph.D, MPH
National Cancer Institute (NCI)
april.oh@nih.gov
240-276-6709

Yolanda Vallejo, Ph.D.
National Center for Advancing Translational Sciences (NCATS) 
yolanda.vallejo@nih.gov
301-451-1751

Ebony Madden
National Human Genome Research Institute (NHGRI)
ebony.madden@nih.gov   
301-503-5620

Rina Das, PhD
National Institutes on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: dasr2@mail.nih.gov

Cheri Wiggs, Ph.D
National Eye Institute (NEI)
cheri.wiggs@nih.gov
301-402-0276

Martha Lundberg
National Heart, Lung, and Blood Institute (NHLBI)
martha.lundberg@nih.gov
301-435-0513

Louis Vuga
National Heart, Lung, and Blood Institute (NHLBI)
louis.vuga@nih.gov
301-435-0233

Asif Rizwan
National Heart, Lung, and Blood Institute (NHLBI)
asif.rizwan@nih.gov
301-435-0070

Maliha Ilias, Ph.D
National Heart, Lung, and Blood Institute (NHLBI)
maliha.ilias@nih.gov
301-451-9921

Lindsey Martin, PH.D.
National Institute of Environmental Health Sciences (NIEHS) 
lindsey.martin@nih.gov
984-287-4036

Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR) 
dionne.godette@nih.gov
301-827-0095

Jonathan W. King, PHD
National Institute on Aging (NIA)
kingjo@nia.nih.gov
301-496-3136

Wilson Compton, M.D, M.P.E,
National Institute on Drug Abuse (NIDA)
wilson.compton@nih.gov
301-443-6480

Stephanie M George, PhD, MPH, MA
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: none
E-mail: stephanie.george@nih.gov

Raquel Greer,  M.D., MHS, FACP
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-402-0306
E-mail: raquel.greer@nih.gov


Jenna Norton, Ph.D, M.P.A.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-451-7314
E-mail: jenna.norton@nih.gov

 

Shavon Artis Dickerson, Dr.P.H., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-435-3055
E-mail: shavon.dickerson@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Christopher Myers
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-0713
E-mail: myersc@nidcd.nih.gov

Sam Ashe
National Institute of Allergy and Infectious Diseases (NIAID)
301-435-4799
Samuel.Ashe@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Christy Leake

National Institute of General Medical Sciences (NIGMS)

Email: christy.leake@nih.gov

 

Katie Ellis      
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone:  301-451-4791
Email: kellis@mail.nih.gov

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Judy Fox
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
240-276-6277
wolfreyc@mail.nih.gov

Matthew Zeback
National Center for Advancing Translational Sciences (NCATS) 
301-451-8309
matthew.zeback@nih.gov

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
301 -435 - 7858
deanna.ingersoll@mail.nih.gov

Priscilla Grant, JD
National Institutes on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Karen Robinson-Smith
National Eye Institute (NEI)
301-435-8178
karen.smith2@nih.gov

Tracee Foster
National Heart, Lung, and Blood Institute (NHLBI)
301-827-8030
tracee.foster@nih.gov

Jenny Greer
National Institute of Environmental Health Sciences (NIEHS) 
984-287-3332
jenny.greer@nih.gov

Brian Albertini
National Institute of Nursing Research (NINR) 
301-594-6869
albertib@mail.nih.gov

Ryan Blakeney
National Institute on Aging (NIA)
301-451-9802
blakeneyr@mail.nih.gov 

Pamela Fleming
National Institute on Drug Abuse (NIDA)
301-480-1159
pfleming@nida.nih.gov

Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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