Key Dates

Related Announcements

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

RFA-OD-21-008 - Emergency Awards: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations RADx-UP Phase II (U01 Clinical Trial Optional)

RFA-OD-21-009 - Emergency Award: RADx-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations (U01 Clinical Trials Optional)

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

NOT-OD-21-097 Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

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

NOT-OD-21-065 - Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

NOT-OD-21-072 - Notice of Correction to NOT-OD-21-065 "Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Required)" for Clinical Trial Requirements

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

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

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

NOT-OD-20-121- Notice of Special Interest (NOSI): Limited Competition for Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations

NOT-OD-20-120- Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations

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

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

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

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

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

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

NOT-OD-20-119 - Notice of Special Interest (NOSI): Emergency Competitive Revisions for Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 Testing among Underserved and/or Vulnerable Populations

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

NOT-OD-21-115- Notice of Pre-Application Webinar for Phase II of the RADxSM-UP Initiative

NOT-OD-21-125- Notice of Correction to NOT-OD-21-103

Issued by

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 Library of Medicine (NLM)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Cancer Institute (NCI)

Tribal Health Research Office (THRO)

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

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

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

Office of Behavioral and Social Sciences Research (OBSSR)

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Environmental Influences on Child Health Outcomes (ECHO)

Purpose

Purpose

The National Institutes of Health (NIH) are issuing this NOSI in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This NOSI provides an expedited funding mechanism to support Phase II of the Rapid Acceleration of Diagnostics Underserved Populations (RADx^SM-UP) initiative. These two-year Testing Research Projects will (1) expand the scope and reach of RADx^SM-UP testing interventions to reduce COVID-19 disparities among underserved and vulnerable populations and (2) address scientific questions on interventions to increase access and uptake of COVID-19 testing given the increasing availability of SARS-CoV-2 vaccines. The funding for RADx^SM-UP is provided from the American Rescue Plan Act of 2021.

The NIH Office of the Director (OD) is issuing this NOSI to request competitive revision applications addressing the objectives described below. This NOSI is one of four related RADx^SM-UP funding opportunities. This Testing Research Projects NOSI will support research teams with established community-engaged partnerships to address the scientific objectives described herein.

Related program initiatives include:

• RFA-OD-21-008- Emergency Award: Community-engaged COVID-19 Testing Interventions among Underserved and Vulnerable Populations - RADx^SM-UP Phase II (U01 Clinical Trial Optional)
• NOT-OD-21-101- Notice of Special Interest (NOSI): Administrative Supplements for Rapid Acceleration of Diagnostics-Underserved Populations (RADx^SM-UP) Phase I Projects to Address Vaccine Hesitancy and Uptake
• RFA-OD-21-009- Emergency Award: RADx^SM-UP -Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations (U01 Clinical Trial Optional)
• NOT-OD-21-097 Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)
  

Key Definitions

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

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

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

Background and Goals

SARS-CoV-2 is the novel coronavirus and causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe complications and death. COVID-19 diagnostic testing with emergency use authorization (EUA) or (eventually) approval from the United States (U.S.) Food and Drug Administration (FDA) remains critical for tracking and slowing the spread of the virus and preventing future outbreaks. NIH is committed to applying scientific methods to ensure that all populations have optimal access to and uptake of COVID-19 testing with the goal of reducing health disparities and to building enhanced point-of-care infrastructures that can be sustained beyond the current pandemic.

Phase I of the RADx^SM-UP initiative established a consortium of community-engaged research projects focused on increasing access to and uptake of COVID-19 testing as well as understanding the social, ethical, and behavioral implications of testing among U.S. underserved and vulnerable populations. The overarching goal is to understand the factors that have led to the disproportionate burden of the pandemic on underserved populations and to implement interventions to decrease these disparities.

Phase II projects will apply scientific knowledge gained in 2020 and 2021 to develop and evaluate interventions with the goal of conducting testing to decrease disparities that contribute to the increased risk of COVID-19 infections, hospitalizations, and mortality. Projects will help to understand and address disparities in testing and the effects of testing combined with other mitigation strategies (e.g., contact tracing, testing combined with behavioral mitigation strategies, education programs, self-isolation after exposure) on infection rates, transmission, and outcomes. Even with the availability of SARS-CoV-2 vaccines, testing will remain an important tool in controlling community spread. Phase II projects are required to include COVID-19 test completion as a primary outcome but should consider that COVID-19 testing interventions will occur in environments with increasing vaccine availability, distribution, and uptake. Accordingly, funding opportunities may include scientific questions within the related topics of testing and vaccine uptake, focusing on interventions that have strong potential to reduce disparities in the real world. Successful Phase II awardees will propose innovative science to fill the gaps and address the new challenges that have arisen in the testing and virus mitigation landscape. Projects must have established research infrastructure and community-engaged partnerships to demonstrate measurable impact within 6 months post-award and across a two-year timeframe. Partnerships with locally relevant public health departments and health care organizations may also be desirable.

Applicants are encouraged to develop research or engagement partnerships with the Community Engagement Alliance (CEAL) Against COVID-19 Disparities initiative, where geographically appropriate (i.e., CEAL study sites are geographically co-located or near the applicant’s proposed study site). Phase II projects can be expansions of Phase I projects or new projects.

Research Objectives

Specific research objectives of Phase II studies will address key questions focused on underserved and vulnerable populations including, but not limited to:

• What testing interventions can be implemented and evaluated rapidly to decrease COVID-19 disparities as COVID-19 vaccines become increasingly available? For example, for those who are unable or unwilling to be vaccinated, how can testing support their health and safety?
• For those who are hesitant about getting vaccinated, would having testing available post-vaccination help reduce hesitancy and foster vaccine confidence?
• What COVID-19 diagnostic options are most acceptable and in what setting?
• What are the effective methods and interventions to incorporate testing and other strategies, such as genetic sequencing, to help identify and mitigate the transmission and population spread of existing or new variants of COVID-19?
• How can research on the social determinants of health (SDOH) help identify, understand, and address testing and vaccine access and uptake in low-resourced geographic areas or communities with high levels of social vulnerability?
• Does COVID-19 testing help address vaccine hesitancy and uptake, and if so, how?
• What community-driven interventions are effective to ameliorate stigma, bias, distrust, and fear regarding symptomatic and asymptomatic COVID-19 testing and vaccination?
• How does COVID-19 vaccine availability affect attitudes, beliefs, and behaviors related to testing intentions in specific communities and how can this information be applied to improve testing uptake?
• What is the role of frequent home testing with point-of-care methods in promotion of behavioral mitigation and vaccine uptake?
• What consent approach, testing method, testing frequency, and contact tracing methodologies are most effective to identify COVID-19 and prevent transmission in school or childcare settings?
• Are there existing prevention and health education programs in the school setting that can be adapted and scaled to promote COVID-19 safety measures, testing participation, testing literacy, and follow-up with health care providers at the child (across early childhood, elementary, middle and high school years), parent, and school staff levels? Could these programs be extended to address vaccine hesitancy and encourage vaccine uptake among adolescents?

Specific Areas of Research Interest

COVID-19 Testing Research Topics focused on underserved and vulnerable populations of interest include, but are not limited to, the following:

• Studies using rapid cycle designs to examine evolving COVID-19 testing technologies to improve uptake of testing, vaccination, and repeat testing of communities and individuals across the life span due to changes in the nature of the virus (variant presentation, infection risk, transmission rates)
• Interventions to improve implementation and adherence to Centers for Disease Control and Prevention (CDC) behavioral mitigation guidance (e.g., masks, hand washing, physical distancing, and limited indoor gatherings) in settings that serve vulnerable communities or (non-healthcare) frontline workplaces in combination with frequent testing to identify COVID-19, prevent transmission, and promote vaccine uptake
• Development and testing of implementation strategies that increase the reach, access, uptake, and sustainability of COVID-19testing in community-, workplace-, school-, or family-based settings (e.g., technology-based approaches, mobile health units)
• Pragmatic or theory driven behavioral intervention trials, including culturally adapted versions of evidence-based interventions, to increase motivation, and health literacy for testing and vaccination uptake in environments with known low testing and vaccination base rates
• Research to examine and address disparities in the availability, ease of use, and/or accessibility of at-home testing options, or other new FDA-authorized or approved point-of-care testing technologies
• Modeling and/or simulation studies using testing data, including that from RADx^SM-UP Phase I, to understand drivers of COVID-19disparities; to predict the impact of testing and contact tracing strategies and development of interventions based on modeling and simulation findings to reduce COVID-19disparities
• Multilevel interventions that address barriers, knowledge and attitudes, and testing and vaccine uptake at individual, interpersonal/family, and/or community levels
• Role of test distribution on health disparities, including the examination of access to healthcare and specific diagnostics and systems-level barriers and facilitators for equitable uptake
• Research on which types of distribution channels (or combinations of distribution channels) and supports (e.g., financial, informational, or technology) are needed to facilitate access to and uptake of COVID-19 self-testing kits
• Post-vaccination testing studies to understand the effect of vaccination on healthcare utilization for chronic medical conditions, mental health care, and antibody production
• Post-vaccination testing studies to understand the effect of vaccination on behavior (e.g., mitigation strategies) and subsequent infection and testing among individuals with and without prior infection
• Effective testing strategies implementable across a range of school/childcare reopening policies and protocols to inform in-person return or maintenance of in-person return to school/childcare settings
• Testing, mitigation, and follow-up protocols for safe school reopening efforts (early childhood education through grade 12), including comprehensive vaccination education programs in school-based settings (including special education settings)

Additional Requirements
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 Common Data Elements (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 authority).This data standardization will permit evaluation of the overall RADx^SM-UP consortium and impacts on COVID-19 disparities in specific populations, facilitate analysis of research questions and may inform policy at the local, community, and/or Tribal levels. Projects responding to this funding opportunity are required to collect the NIH RADx^SM-UP Tier 1 Common Data Elements. Permission from participants to collect and share these CDEs will be given through specific language in the Informed Consent Form (ICF).

Recipients will work closely with the CDCC on data sharing activities as part of the RADx^SM-UP consortium to advance the science of health disparities research in COVID-19 testing across the country. As an initiative that prioritizes community engagement, awardees will work with the CDCC to identify the scope of data sharing agreements that are acceptable to community partners, allow recruitment and retention of participants, and build trust, while contributing to consortium activities. The scope of data sharing may include the following: 1)?depositing de-identified data in the CDCC and NIH RADx^SM Data Hub, 2) sharing de-identified data with the CDCC and NIH for possible future scientific research, 3) sharing identifiable data to?permit re-contact of participants for future follow-up and participation in future research; and/or 4) sharing identifiable data to perform linkages with clinical and population data sets, to understand health outcomes of the COVID-19 pandemic among underserved and vulnerable populations.? Applicants are encouraged to discuss acceptability of one or more of these options for data sharing prior to application.

Any data collected as part of this funding announcement will be archived as de-identified data in the NIH RADx Data Hub and will enable authorized community members, health researchers, and scientists in the Federal government to understand the impact of the COVID-19 pandemic on the well-being, risk, resilience and disparities in underserved and vulnerable communities across the U.S. and the U.S. Territories. Funded projects will share study data collection instruments and other research products with other RADx^SM-UP funded projects through the CDCC.

Projects funded through this NOSI are strongly encouraged to use the following resources for the assessment of other constructs:

• Data Harmonization for Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (https://www.phenxtoolkit.org/collections/view/6).
• Existing COVID-19 survey items and investigator contact information are publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) https://dr2.nlm.nih.gov/and the PhenX Toolkit https://www.phenxtoolkit.org/index.php. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.

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

Additionally, researchers with funding through this NOSI must follow these requirements:

• Recipients are required to work with the RADx^SM-UP Coordinating and Data Collection Center (CDCC) to submit CDEs on COVID-19 testing-related outcomes and implementation to the CDCC. Recipients should identify a dedicated unit responsible for these data reporting activities and at least one dedicated staff member for coordinating and data sharing activities.
• Recipients are expected to obtain and retain personal identifiers on all research participants where it is not prohibited (e.g., Tribal data sovereignty) and where it is possible, for future longitudinal follow-up, to be leveraged for intervention research and for potential linkage to other sources of population health data. Data collected from this program will be protected by a Certificate of Confidentiality.
• Recipients are expected to use guidance provided by the CDCC for data acquisition, collection and curation (see CDEs above), including appropriate consent for data sharing and implementation of methods to enable data collected to be AI (artificial intelligence) ready.
• Recipients are expected to work with the RADx^SM-UP consortium members, as appropriate.
• Recipients must include measures and reporting of relevant testing implementation outcomes, to inform future community, local, state, and federal policies.
• Projects must include a description of sustainability of their infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts.
• Projects must include an evaluation plan demonstrating how the proposed COVID-19 diagnostic testing access and uptake strategies/activities will be assessed for effectiveness and impact.
• Applications must include milestones towards progress and a timeline for completion. The timeline must include plans for regular reports of progress to be submitted to the CDCC, as described above, and meetings with Community Advisory Boards. These reports will include both testing results and information regarding barriers and facilitators of COVID-19 testing, and vaccination where appropriate, and emerging challenges to implementation of the proposed research.
• As with all NIH supported research, details regarding human subjects research are expected, including data safety and monitoring plans and, if needed, plans for a Data Safety and Monitoring Board (DSMB). Studies that have a DSMB are expected to coordinate with CDCC (RFA-OD-20-013) for DSMB activities.
• Recipients are expected to disaggregate and analyze study results by sex/gender; race and ethnicity; age, a measure of socioeconomic status, birthplace, and other relevant demographic factors, and to consider intersectionality as appropriate.
• 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.).
• 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. If school or childcare settings are incorporated, recipients must provide letters of support from the school setting, school district or state Department of Education as applicable.

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

• Projects without a focus on one or more underserved and COVID-19 vulnerable populations
• Projects that have limited population reach (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 new foreign components; additional funding for existing foreign components; or COVID-19 testing or SEBI outside of the United States, its territories and possessions, the Commonwealth of Puerto Rico, or the Trust Territory of the Pacific Islands
• Projects that are exclusively qualitative (though mixed quantitative and qualitative are acceptable)
• Projects that do not have an infrastructure to rapidly report study findings and impact to the CDCC
• Project focusing exclusively on vaccination

Review Process

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

• Urgency and significance of research: How will successful completion of the aims contribute to or complement public health efforts for the control of SARS-CoV-2 (COVID-19) infection and related pathogenic processes? Does the proposed research fit within the mission of an emergency response to provide critical expertise, resources or activities?
• Research design: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? How feasible and appropriate are the overall research design elements (including power calculations) for demonstrating the effectiveness and impact of the proposed COVID-19 diagnostic testing and vaccination access and uptake strategies/activities? Is the emergency timeframe (with milestones) appropriate and feasible to support the aims and goals of the study? Is the management plan well-described and commensurate with the level of complexity required?
• Investigators: Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project?
• Community partners: Is there evidence of strong established research collaborations with proposed community partners? How feasible and appropriate are the plans for integrating community partners into the study?
• Data sharing plan: Are there timely plans to make results and data findable and accessible to the research community? In instances involving Tribal data sovereignty, is there documentation of Tribal agreement with adapted data sharing plans? Is the data-sharing plan concordant with CDCC requirements? 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)?
• Coordination plans: How feasible and appropriate are the plans to submit data, data collection instruments and outcomes/products to the CDCC (RFA-OD-20-013)? How feasible and appropriate are the plans for to collaborate with other RADx^SM-UP sites?
• Outcomes: Will outcomes or products proposed advance and improve acceptability, access, and uptake of COVID-19 testing and vaccination? How feasible and appropriate are the plans for measures and reporting of relevant outcomes, including assessment of testing implementation outcomes and population measures of COVID-19 related morbidity and mortality? Is there evidence that outcomes of interest to the community are included in outcomes measured and reported on and products? How will successful completion of the aims contribute to or complement public health efforts for the control of SARS-CoV-2 (COVID-19) infection and related pathogenic processes? Will successful completion of the aims reduce COVID related health disparities and enhance overall resilience of underserved populations? To what extent can the project contribute to the development and implementation of interventions that address factors associated with COVID-19 testing and vaccination in U.S. populations that experience health disparities?
• Sustainability: How feasible and appropriate are the plans for sustainability of project infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts?
• Testing: How feasible and appropriate are the plans for access to FDA-authorized/approved test kits and related activities (i.e., ability to process tests in a timely manner and return of test results as quickly as possible)? How feasible and appropriate are the plans to support follow up testing and contact tracing? Is the proposed approach dynamic and responsive to the evolving changes in COVID-19 diagnostics? Is there evidence of adequate support being provided to the community to understand and act on test results when they are returned to individuals and community members?
• Post-vaccination testing studies: How feasible and appropriate are the plans for assessing the effect(s) of vaccination?
• Evaluation: Is the evaluation plan feasible and appropriate? Will the evaluation assess the project activities/strategies and goals and determine overall impact? Is the evaluation informed by community input

Reporting

• OD plans to make awards using funds provided in the emergency supplemental appropriations for COVID-19 and coronavirus research: American Rescue Plan Act of 2021Funds awarded using appropriations provided by the America 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

Application and Submission Information

Applications in response to this NOSI must be submitted using the following targeted funding opportunity or its subsequent reissued equivalents. Although not all NIH components indicated above are listed as Participating Organizations in all the FOA listed below, applications for this initiative will be accepted by the participating Institutes and Centers at NIH.

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

All instructions in the SF424 (R&R) Application Guideand the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-OD-21-103 in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will not be considered for this initiative.
• Revision applications must be submitted by the same project director/principal investigator (PD/PI), or Contact PD/PI for multi-PI grants, as listed on the current award.
• Select the Revision option in Box 8 of the SF424 R&R form to indicate TYPE OF APPLICATION, and option A Increase Award .
• Use the Project Summary/Abstract field to provide a succinct and accurate description of the work proposed for the revision. Do not use the abstract of the parent grant.
• Applicants must use the same budget format (i.e., R&R Budget Form or PHS 398 Modular Budget Form) as the current award.
• Use the Introduction to Application field of the PHS 398 Research Plan form to attach a one-page Introduction that describes the nature of the revision and how it will influence the specific aims, research design, and methods of the current grant.
• The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed revision in relation to the goals of the original application.
• Any budgetary changes for the remainder of the project period of the current grant should be discussed in the Budget Justification
• The project period is limited to two years.

• Individual requests can be no more than $750,000 in direct costs per year for each year of the 2-year award.
• Applicants may request supplements and budgets that exceed the parent grant. Budgets must be reasonable and reflect the actual needs of the project.
• The budget must reflect appropriate compensation to community partners collaborating in implementation of testing interventions, return of test results, and development of culturally appropriate dissemination of research results (i.e., publications and other means of dissemination).
• Regardless of the grant mechanism of the parent award, the Research Strategy section of the application is limited to 6 pages and must include:
  • A description of specific milestones towards progress and a timeline for completion, taking into account the need for rapid deployment of testing protocols.
  • A Community Partner Program section to demonstrate partnership with community organizations, roles and reach of these partnerships, and the organizational and decision-making structure.
  • A Testing Capacity section to demonstrate access to FDA-authorized/approved test kits, personal protective equipment (PPE), and access to Clinical Laboratory Improvement Amendments (CLIA) certified laboratories (e.g., hospital, public health, or commercial) to administer the tests and return test results as quickly as possible. The proposed (and implemented) COVID-19 testing must be fully FDA EUA or approved. This includes sample collection, assays, and test performance.
  • A Consortium Data Reporting Unit to demonstrate the capability and infrastructure of the applicant to report on the number of COVID-19 tests conducted, their results, and subsequent actions and referrals, for the overall study population and relevant subpopulations. The Unit must also disseminate effective implementation strategies for rapid uptake across consortia as relevant through the CDCC.
  • A Human Subjects Unit that works to monitor ethical and social implications and human subjects concerns in testing implementation. This work is essential in monitoring implementation efforts are not exacerbating health disparities in underserved and/or vulnerable populations. Applications to this NOSI can suggest collaborations with the SEBI program (NOT-OD-20-119). However, the success of work proposed in applications to this NOSI should not depend on those collaborations, since the specifics of those awards will not be known in advance.
  • Plans for a Community and Scientific Advisory Board that includes target community representation and scientists not directly involved in the project, as well as schedule and structure of inclusion of the advisory board(s) is required.
  • Description of contingency plans regarding ongoing or potential future public health restrictions (e.g., closures, physical distancing) that might affect the research approach, including online approaches where available and appropriate.
• To be eligible for a competitive competing revision award under this NOSI, the parent award on which the revision application is based must be an active award (including those in a no-cost-extension period) managed by one of the participating institutes or centers.
• Recipients may apply for work that expands the scope of their funded project, regardless of the time remaining on the current project. Grants currently in a no-cost extension are eligible to apply.
• Applications may be submitted beginning on May 1, 2021 for an Application Due Date of May 28, 2021 (5:00 PM local time of the applicant organization). Applications received after May 28, 2021 will not be considered. The earliest start date for applications received on or before May 28, 2021 will be September 2021. An application submitted in response to this NOSI that is received on May 29, 2021 or later will be withdrawn.

Eligibility

• Active research and resource grants, cooperative agreements, and small business grants (SBIR and STTRs) are eligible to apply. NRSA training and fellowship grants, and career development awards are not eligible to apply for funding. Currently funded recipients may apply regardless of the time remaining on the current project. Competitive revision applications to this NOSI may not propose new foreign components and may not request additional funding for existing foreign components or consultants. Grants currently in a no-cost extension are eligible to apply.

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 Governments

• 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.

Number of Applications

• Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
• Applications nonresponsive to terms of this NOSI will be not be considered.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Carol Blaisdell
Environmental Influences on Child Health Outcomes (ECHO)
Telephone: 301-435-5606
Email: [email protected]

Xinzhi Zhang
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-9205
Email: [email protected]

Wendy Weber
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: [email protected]

April Oh
National Cancer Institute (NCI)
Telephone: 240-276-6709
Email: [email protected]

Wen-Ying Sylvia Chou
National Cancer Institute (NCI)
Telephone: 240-276-6954
Email: [email protected]

Donald Everett
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Lucia Hindorff
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: [email protected]

Catherine (Kate) Stoney
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-6670
Email: [email protected]

Jonathan W. King, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: [email protected]

Laura Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: [email protected]

Ann Namkung Lee, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Division of AIDS (DAIDS)
Telephone: 240-627-3099
Email: [email protected]

Kristina T. Lu
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Microbiology and Infectious Diseases (DMID)
Telephone: 240-627-3307
Email: [email protected]

Paul S. Eder, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Microbiology and Infectious Diseases (DMID)
Telephone: 240-627-3252
Email: [email protected]

Stephanie M. George, PhD, MPH, MA
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-4974
Email: [email protected]

Qi Duan
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-827-4674
Email: [email protected]

Tammara Jenkins
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email: [email protected]

Richard Jenkins
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1923
Email: [email protected]

Kelly King
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: [email protected]

Dena Fischer
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 240-383-7204
Email: [email protected]

Pamela L. Thornton, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-6476
Email: [email protected]

Lindsey Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4036
Email: [email protected]

Ming Lei
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-827-7616
Email: [email protected]

Gregory Greenwood, PhD, MPH
National Institute of Mental Health (NIMH)
Telephone: 240-669-5532
Email: [email protected]

Priscah Mujuru
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9765
Email: [email protected]

Richard Benson
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]

Jeri L. Miller, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-6152
Email: [email protected]

Richard Palmer
National Library of Medicine (NLM)
Telephone: 301-496-4621
Email: [email protected]

Eilzabeth Walsh
Office of the Director (OD)
Telephone: 301-480-8127
Email: [email protected]

Jacqueline Lloyd
Office of Disease Prevention (ODP)
Telephone: 301-827-5559
Email: [email protected]

Miya Whitaker
Office of Research on Women's Health (ORWH)
Telephone: 301-451-8206
Email: [email protected]

Christopher Barnhart
Sexual and Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Juliana Blome
Tribal Health Research Office (THRO)
Telephone: 301-827-5857
Email: [email protected]

Peer Review Contact(s)

Nicholas Gaiano, PhD

National Institute of Mental Health

Phone: (301) 827-3420

Email: [email protected]

Financial/Grants Management Contact(s)

Please contact the Grants Management Contact(s) for the Parent Award.