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 Institute on Minority Health and Health Disparities (NIMHD)

National Institute on Aging (NIA)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute 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 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 Nursing Research (NINR)

National Library of Medicine (NLM)

Fogarty International Center (FIC)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Neurological Disorders and Stroke (NINDS)

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


Sexual and Gender Minority Research Office (SGMRO)

Tribal Health Research Office (THRO)

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

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Environmental Influences on Child Health Outcomes (ECHO)

The FOA will be administered by theNational Institute on Minority Health and Health Disparities on behalf of the NIH.

Funding Opportunity Title
Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • July 24, 2020 - Notice of NHLBI Participation in NOT-OD-20-119 . See Notice NOT-HL-20-803.
  • June 26, 2020 - Notice of Corrections to RFA-OD-20-013. See Notice NOT-OD-20-140.
  • June 19, 2020 - Notice of Pre-Application Webinar for the RADx-UP Initiative. See Notice NOT-OD-20-131.
    NOT-OD-20-119
    NOT-OD-20-120
    NOT-OD-20-121
    Funding Opportunity Announcement (FOA) Number
    RFA-OD-20-013
    Companion Funding Opportunity

    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

    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

    Number of Applications

    Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

    Catalog of Federal Domestic Assistance (CFDA) Number(s)

    93.310, 93.865, 93.989, 93.393, 93.394, 93.395, 93.396, 93.399, 93.350, 93.213, 93.867, 93.837, 93.838, 93.839, 93.840, 93.233, 93.846, 93.286, 93.121, 93.113, 93.143, 93.859, 93.172, 93.242, 93.853, 93.361, 93.866, 93.173, 93.279, 93.307, 93.313, 93.879, 93.310, 93.865, 93.855, 93.847, 93.273, 93.853

    Funding Opportunity Purpose

    NIH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency cooperative agreement funding opportunity announcement (FOA) from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) initiative, a consortium of community-engaged research projects to understand factors that have led to disproportionate burden of the pandemic on the underserved and/or vulnerable populations so that interventions can be implemented to decrease these disparities. This FOA seeks to fund a single Coordination and Data Collection Center (CDCC) as an integral part of the consortium. The funding for this supplement is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

    The Office of the Director (OD) is therefore supporting a new cooperative agreement addressing the objectives described below. This FOA is therefore released in parallel with three companion emergency Notices of Special Interest (NOSIs)

    • NOT-OD-20-121 encourages community-engaged Testing Research Projects to supplement large scale networks, consortia, or centers, will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods.

    • NOT-OD-20-120 encourages community-engaged Testing Research Projects, but shifts the pool of eligible grants for supplementation to individual research awards that include community collaboration or partnership, generally targeting specific populations.

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

    The CDCC will serve as a national resource, working with NIH scientific staff and consortium members to coordinate and facilitate research activities. The CDCC will also serve as a spoke in the larger NIH initiatives by providing deidentified individual data to an NIH-based data center. The RADx-UP CDCC will provide overarching support and guidance in the following four domains: (1) Administrative Operations and Logistics, (2) COVID-19 Testing Technology, (3) Community and Health System Engagement and (4) Data Collection, Integration and Sharing. The CDCC will facilitate RADx-UP collaborative research by providing organizational and analytical infrastructure and expertise, supporting data integration and analysis, and coordinating across RADx-UP projects and the NIH-supported RADx initiatives that are developing and validating new COVID-19 testing technologies.

    Key Dates

    Posted Date
    June 12, 2020
    Open Date (Earliest Submission Date)
    July 08, 2020
    Letter of Intent Due Date(s)

    July 8, 2020

    Application Due Date(s)

    August 7, 2020

    No late applications will be accepted for this Funding Opportunity Announcement..

    All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

    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.

    AIDS Application Due Date(s)

    Not Applicable.

    Scientific Merit Review

    August, 2020

    Advisory Council Review

    Not Applicable to this Emergency Initiative

    Earliest Start Date

    September, 2020

    Expiration Date
    August 08, 2020
    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

    PURPOSE

    NIH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency cooperative agreement funding opportunity announcement (FOA) from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) initiative, a consortium of community-engaged research projects to understand factors that have led to disproportionate burden of the pandemic on the underserved and/or vulnerable populations so that interventions can be implemented to decrease these disparities. This FOA seeks to fund a single Coordination and Data Collection Center (CDCC) as an integral part of the consortium. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

    The Office of the Director (OD) is therefore supporting a new cooperative agreement addressing the objectives described below. This FOA is therefore released in parallel with three companion emergency Notices of Special Interest (NOSIs)

    • NOT-OD-20-121 encourages community-engaged Testing Research Projects to supplement large scale networks, consortia, or centers, will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods.

    • NOT-OD-20-120) encourages community-engaged Testing Research Projects, but shifts the pool of eligible grants for supplementation to individual research awards that include community collaboration or partnership, generally targeting specific populations.

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

    The CDCC will serve as a national resource, working with NIH scientific staff and consortium members to coordinate and facilitate research activities. The CDCC will also serve as a spoke in the larger NIH initiatives by providing deidentified individual data to an NIH-based data center. The RADx-UP CDCC will provide overarching support and guidance in the following four domains: (1) Administrative Operations and Logistics, (2) COVID-19 Testing Technology, (3) Community and Health System Engagement and (4) Data Collection, Integration and Sharing. The CDCC will facilitate RADx-UP collaborative research by providing organizational and analytical infrastructure and expertise, supporting data integration and analysis, and coordinating across RADx-UP projects and the NIH-supported RADx initiatives that are developing and validating new COVID-19 testing technologies.

    Background

    SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. On March 11, the SARS-CoV-2 outbreak was classified as a pandemic by the WHO. Research is an important component of the public health emergency response before, during and after the emergency. United States Food and Drug Administration (FDA)-authorized COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. Given this, there is an urgent public health need for NIH to apply scientific methods to ensure that all populations have optimal access to and uptake of COVID-19 testing, and to build effective point-of-care infrastructures.

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

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

    Underserved: NIH-designated health disparity populations and/or other groups known to experience barriers to accessing health coverage and basic health care services. 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 or public 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.

    Implementation of the RADx-UP consortium will occur in two-phases. This four-year cooperative agreement will fund a single Coordination and Data Collection Center (CDCC) to support research activities in both phases of the initiative. The Phase I Testing Research Projects (NOT-OD-20-121 and NOT-OD-20-120 will work closely with communities to understand COVID-19 testing patterns, and implement interventions with the potential to rapidly (i.e., within six months of awards) increase reach, access, acceptance, uptake, and sustainment of FDA-approved diagnostics (especially viral tests) among populations and in geographic locations with identified need. A third NOSI seeks research to understand the Social, Ethical and Behavioral Implications (SEBI, NOT-OD-20-119) of COVID-19 testing and vaccination in these populations. Collectively, projects funded under these FOAs will serve as one consortium of interlinked community-engaged research projects across the United States to understand COVID-19 health disparities, and to deploy implementation strategies to improve the reach, acceptance, uptake, and sustainability of COVID-19 testing. The CDCC will serve as a key component of the consortium and it is expected that all RADx-UP projects will participate actively in coordinating and data submission activities of the CDCC. Researchers applying to this FOA are strongly encouraged to read all four of these interrelated funding announcements.

    With the significant investment in developing and validating new testing technologies (particularly the NIH-supported RADx initiatives), NIH anticipates significant changes in the landscape of testing and diagnostic approaches, as well as shifts in the pandemic itself over the next 3 to 6 months. Phase II of the RADx-UP initiative will be released at a later date and will address such developments for future community-based research.

    The CDCC will be the “hub” in a hub-and spoke organizational framework, and the spokes, in this framework, include the Testing Research Projects and the SEBI projects. The CDCC will also serve as a spoke in the larger NIH initiatives by providing deidentified individual data to an NIH-based data center. The CDCC, will provide management, direction, and overall coordination of the RADx-UP consortium. The CDCC will also serve as a liaison between the RADx-UP consortium and other NIH-supported RADx initiatives . The RADx-UP CDCC will provide support and guidance in the following four domains: (1) Administration and Coordination, (2) COVID-19 Testing Technology, (3) Community and Health System Engagement, and (4) Data Collection, Integration and Sharing. The CDCC will perform key functions such as coordinating efforts across up to 60 diverse research programs and the SEBI program. The CDCC will also develop (and revise when necessary) the procedures for standardized collection of individual sociodemographic, psychosocial, and clinical data (i.e., common data elements) to maximize comparability across the consortium for longitudinal research and evaluation of RADx-UP program impact. The CDCC will also assist research projects with linking these and other data to publicly available sources (e.g., Census data, Area Deprivation Index, etc.), electronic health records (EHR), administrative data, and others as needed. The CDCC, in collaboration with the testing projects, will perform quality control, data curation, and analyses, and provide data informatics tools to monitor consortium progress and performance, and exploration of the curated data. The CDCC will facilitate cross-site pooling of data, create a database across assessment modalities, and harmonize with existing large-scale COVID-19 research efforts. The CDCC will also collaborate with trans-NIH efforts to support scientific collaboration and data-sharing, enabling cross-consortium collaboration and evaluation of progress towards sustainable infrastructure, partnership and rapid dissemination of findings. This infrastructure is expected to support COVID-19 vaccination trials as they accelerate.

    Specific Research Objectives

    1. Administration and Coordination

    The administrative functions include facilitating the work of the RADx-UP research consortium and NIH scientific staff in the overall program management of the initiative. Activities will include, but are not limited to:

    • Leadership and project management for the administrative, coordination, and data coordinating functions
    • Support collaboration and communication among the RADx-UP PIs, NIH program staff, the RADx-UP Governance Committee (NIH Institute and Center Directors), Data Safety Monitoring Board, Community-Scientific Advisory Board(s), and logistics and management support, such as organizing meetings, and maintaining documentation
    • Develop an organizational and administrative structure to promote collaboration, provide technical assistance, and facilitate interaction across the consortium, including maintaining a RADx-UP directory (consortium sites, partners, and stakeholders) and a web-portal to assist with information sharing (e.g., assessments and protocols, consent forms, recruitment and retention materials and strategies, best practices, interim findings, troubleshooting, etc.).
    • Establish, implement, and deliver a consortium program evaluation for the RADx-UP program, including a logic model and evaluation data collection and processes to specify, track, and assess testing milestones, including metrics of success for all Testing Research Projects and the SEBI projects
    • Provide expertise and assistance on data sharing, IRB and other human subject issues, including cross-consortium human subjects consent and assent procedures
    • Provide methodological and statistical consultation on cross consortium research design and analytics
    • Establish a CDCC Steering Committee to develop policies governing matters such as (e.g., authorship, communications, data sharing, etc.).
    • Prepare and distribute reports to the consortia members, NIH and regulatory agencies, including progress and data summaries, participant demographics, enrollment and COVID-19 testing data, Data Safety and Monitoring Board reports, interim findings, and scientific outputs such as publications and presentations
    1. COVID-19 Testing Technology

    The CDCC 1) provides expertise and disseminates emerging and new innovations on COVID-19 diagnostics and test modalities; 2) provides technical assistance to research teams related to selecting and implementing testing protocols in diverse populations and studies; and 3) administers a Rapid Pilot Studies Program. Activities include, but are not limited to:

    • Provide scientific expertise and technical assistance to consortium sites on selection and implementation of COVID-19 testing technologies, laboratory medicine, sample collection, and material transfers from study sites to testing laboratories. However, while common data elements will be required, testing projects are not expected to follow a master protocol for their testing due to variability in settings and needs for each specific population, community, and/or site.
    • Maintain up-to-date knowledge and expertise on new COVID-19 related diagnostics and provide frequent communication to the RADx-UP consortium about new testing approaches, FDA-authorization or approval status, testing supply availability, and considerations for the implementation of emerging testing protocols.
    • Coordinate and assist with vendor purchase discussions of FDA-authorized tests and supplies, technical support and coordination/negotiation for testing equipment to the RADx-UP Consortium for local procurements for the Testing Research Projects.
    • Develop model requirements or characteristics of successful tests, including the availability of automatic data capture as well as use of standard LOINC outputs, identity management, device identifiers, etc.
    • Develop, manage, and evaluate a Rapid Pilot Studies program. It is anticipated that new tests and testing modalities will become available over the course of the RADx-UP program. Supported pilot studies will coordinate with the NIH-supported RADx initiatives to assess the feasibility of integrating new technologies into RADx-UP.
      • The CDCC is expected to conduct four requests for proposals per year
      • The budget for the one-year Rapid Pilot Studies program cannot exceed $200,000 in direct costs, for up to $2,000,000 per year (total costs) exclusive of Facilities and Administrative (F&A) costs on sub-awards. Multi-year pilot projects are not encouraged and will require review and approval by the NIH.
    1. Community Engagement

    The CDCC will coordinate and support a community of partnership across the RADx-UP Consortium. Leveraging the expertise and experience across the consortium, the CDCC will provide support in convening and exchanging best practices across communities on recruitment approaches, communications, engagement and retention of study participants. The CDCC will also coordinate the dissemination of study findings from both the Testing Research Projects and SEBI projects. Activities must include at least the following:

    • Create and support a strong, vibrant community of practice among all healthcare systems and settings, community partners, community-based organizations, and other stakeholders to provide support and facilitate research activities
    • Develop and facilitate working groups on topics of specific interest to the work of the consortium
    • Collaborate with the SEBI program to share best practices and provide technical assistance for community engagement approaches to identify and address barriers to implementation, and facilitate strong community impact
    • Create and implement a mini-grant program to support the inclusion of additional community partners and stakeholder groups not included in the original grant (e.g., support community members to attend meetings, tailored campaign to improve COVID-19 testing uptake in specific groups, etc.). The mini-grants may total up to $50,000 (direct costs). The budget cannot exceed $750,000 per year (total costs) exclusive of Facilities and Administrative (F&A) costs on sub-awards. Multi-year pilot projects are not encouraged and will require review and approval by the NIH.
    • The CDCC will manage all aspects of this program, including the call for applications, review of applications, and awards to the community recipients.
    • Create community-facing communications materials (including social media) designed for study partners to promote and advertise the RADx-UP program, including a study logo with input from the stakeholders and a RADx-UP program newsletter (for research teams, communities, and participants), and coordinate with the programs funded by the Office of Minority Health, DHHS.
    1. Data Collection, Integration and Sharing

    The CDCC will manage data collection, integration, and sharing for the RADx-UP consortium. It will facilitate data standardization, harmonization, integration, and analysis for RADx-UP projects. The CDCC is expected to have experience in clinical informatics and clinical research informatics managing a broad range of data, including harmonizing and merging data where feasible and working with latent variable structures and metanalytic strategies to create a data ecosystem for the RADx-UP consortia. The CDCC should also have expertise in the design and analytic methods appropriate for studies that evaluate community-engaged interventions. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, pragmatic clinical trials, rapid cycle testing, adaptive intervention methods, rigorous quasi-experiments, and other dissemination and implementation science methods (including hybrid effectiveness/implementation designs). In these studies, special methods are often required for analysis and sample size estimation. Additional information is available at https://researchmethodsresources.nih.gov/. Ability to bring scientific groups together to reach consensus around data collection and data sharing methods is essential, as is expertise in managing diverse data sets (e.g., qualitative, quantitative, EHR, geospatial, healthcare systems and settings, implementation data types), and preparation of de-identified data for public use, when applicable.

    The CDCC is expected to provide access to useful and practical administrative data systems that may assist research sites in identifying high-risk populations and subpopulations where increasing testing may be most useful. A centralized data warehouse with integrated data across the RADx-UP consortium and related administrative data should be available for secondary data analysis to the consortium research sites and the broader research and practice community.

    Activities may include, but are not limited to:

    • Support RADx-UP collaboration across the consortia by coordinating data sharing, management and security, and data use and access. Supervise and monitor these functions for fidelity.
    • Establish a secured, centralized, user-friendly data warehouse for RADx-UP that can accept individual participant data including unique participant IDs but does not contain personal identifiers. The data resource should be designed to promote and leverage standardization of data collection by identifying common data elements (CDEs) of COVID-19 and social determinants of health (SDOH) to be collected across the RADx-UP consortium; prepare and release data sets for consortia and public use in consultation with the CDCC Steering Committee in accordance with determined timelines and milestones
    • Build a CDCC data management model (i.e., RADx-UP hub) that serves as a repository for consortium projects (i.e., RADx-UP spokes), and that will also link deidentified data (through a third-party) to the hub for inclusion in larger NIH data integration model.
    • Develop a repository for data linked to personal identifiers for future re-contacting for follow-up evaluations and possible participation in prevention or therapeutic trials
    • Support and maintain a web-based tool for RADx-UP projects and community partners to access up to date COVID-19 diagnostic testing tools, data collection tools, testing related resources and materials. Promote engagement and adoption of technology along with testing to facilitate contact tracing and testing follow-up in community-based samples.
    • Select and provide access to essential data sets (e.g., CMS claims data and EHR and claims data from private vendors if available) to enable RADx-Up consortium sites to be rapidly responsive to emerging COVID-19 “hot spot” communities with high rates of infection or low rates of testing delivery in underserved and/or vulnerable populations, provide advice to the testing projects on sampling frame, and supplement primary data collection with testing and risk factor data, and provide linkages to medium and long term outcomes (e.g., linkage to National Death Index, claims and other administrative data).
    • Integrate different streams of data, including direct data collection of contextual, geographical, environmental and social determinants of health, with administrative data (e.g., EHR and claims data). Develop agreements about the structure of content used across projects to enable sharing and aggregation required by multiple projects. The use of standard vocabularies, CDEs and data dictionaries will support joint analyses and sharing.
    • The CDCC is strongly encouraged to use OMOP models (https://www.ohdsi.org/data-standardization/the-common-data-model/)[B[1] for that purpose when applicable.
    • Encourage adherence to federal health data standards including FHIR (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html) and USCDI (https://www.healthit.gov/isa/sites/isa/files/2020-03/USCDI-Version1-2020-Final-Standard.pdf)- which includes three NLM supported vocabulary standard for codes (and names) for drugs, tests diagnoses, symptoms, some social determinants of health, some psychologic scores and all of the Medicare/Medicaid assessments.
    • Communicate and provide technical assistance, as needed to encourage cross-consortium adherence to federal health data standards including FHIR (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html) and USCDI (https://www.healthit.gov/isa/sites/isa/files/2020-03/USCDI-Version1-2020-Final-Standard.pdf), where applicable and within scope.
    • Establish and manage a Data Safety Monitoring Board (DSMB) for the RADx-UP consortium.
    • Conduct quality assurance checks of data collected across RADx-UP consortium trials/studies, including but not limited to auditing RADx-UP test sites for adherence to data collection and testing protocol across multiple sites.
    • Provide consultation on harmonized existing social determinants of health (SDOH) and up-to-date utilization of COVID-19 instruments through two NIH-supported platforms:
      • 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, 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).
      • A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.
      • Additionally, CDCC is encouraged to share survey items and make them public for other researchers to consider by submitting their surveys toNIHCOVID19Measures@nih.gov

    Resources and Infrastructure

    The CDCC must have ready access to infrastructure and personnel (e.g., coordinating and contracting outside the institution) to accomplish CDCC activities and processes, including relevant support services, data management and analytic support, and real-time analytic capacity.

    Large datasets procured under this program (e.g., claims or EHR data) should have provisions of re-use, including in data use agreements and Informed Consent and where permitted by Tribal data sharing policy, for NIH funded COVID or other NIH funded studies (intramural and extramural).

    The CDCC must plan for how it will preserve utility of resources for the future. Resources produced, coordinated, and shared through the CDCC should be transferable, such that other individuals or teams can continue development in the event that the original investigators are unwilling or unable to do so.

    Data and Resource Sharing

    The RADx-UP program requires sharing of resources, with broad availability of policies, practices, materials, protocols, and tools to facilitate collaboration across multiple programs as well as reuse and replication by a range of researchers and private entities when applicable. Developing creative approaches that foster the development of artificial-intelligence ready data sets (AI-Ready data sets) is highly desired. Applicants are required to provide an overarching data and resource sharing plan. The NIH expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals, with full understanding Data and Resource sharing may not be applicable for all research sites. The final Resources and Data Sharing Plan is expected to be developed in conjunction with RADx-UP research grantees post award.

    The CDCC must address how it will preserve utility of resources for the future. Resources produced, coordinated, and shared through the CDCC should be transferable, such that other individuals or teams can continue development in the event that the original investigators are unwilling or unable to do so.

    Applications which propose studies in vertebrate animals will be considered non-responsive to this funding opportunity and will be withdrawn without review.

    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?
    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIH intends to commit $7.5 Million in FY 2020 to fund one award.

    Award Budget

    Application budgets are limited to $5 Million in annual direct costs.

    Award Project Period

    The total project period may not exceed 4 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 Governments

    • 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

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • 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.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
    • 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.
      • In the case of Emergency awards, if the applicant is unable to comply with the requirement to complete and maintain SAM registration at the time of application submission, contact the agency immediately.
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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

     

    Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101)

    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 Guideexcept 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.

     

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    Dr. Thomas M. Vollberg, Sr.
    Telephone: 301-594-8770
    Email: vollbert@mail.nih.gov

    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.

     

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

    The central functions of (1) Administrative, (2) COVID-19 Testing Technology, (3) Community and Health System Engagement, and (4) Data Collection, Integration and Sharing are within this application. A single unified budget is expected.

    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:

    The application should explain the following central functions: (1) Administrative, (2) COVID-19 Testing Technology, (3) Community and Health System Engagement, and (4) Data Collection, Integration and Sharing. A single research plan narrative covers all the activities of the various central functions.

    Describe how the proposed studies will advance understanding of testing for and preventing the disparate effects of SARS-CoV-2 and/or COVID-19. If the proposed research relies on clinical samples (e.g. patient samples, isolates, etc.), describe how the investigators will have timely access to the samples in sufficient quantities to achieve the aims of the proposed research.

    Applicants must provide evidence that the infrastructure, resources, and institutional support needed to achieve the goals are available. Applications should include a plan that demonstrates they have ready access to infrastructure and personnel (e.g., coordinating and contracting outside the institution) to accomplish CDCC activities and processes, including relevant support services, data management and analytic support, and real-time analytic capacity. The plan should include provisions for reuse related to large datasets procured under this program (e.g., claims or EHR data), including in data use agreements and Informed Consent and where permitted by Tribal data sharing policy, for NIH funded COVID or other NIH funded studies (intramural and extramural). Plans must include how the CDCC will preserve utility of resources for the future. Resources produced, coordinated, and shared through the CDCC are to be transferable, such that another individuals or teams can continue development in the event that the original investigators are unwilling or unable to do so.

    Research Strategy

    Significance

    • Describe the specific research objectives of the proposed CDCC and how they will help accomplish the goals of the RADx-UP initiative.
    • Describe the specific strategies that will be implemented to support the Research Testing Projects and the SEBI studies in overall coordination, COVID-19 testing technology, community engagement, and data management and sharing.
    • Identify the specific problems or limitations funded projects might encounter that will be addressed by the proposed CDCC. Describe areas of opportunity that will be fulfilled by specific activities of the CDCC and across functional domains.

    Approach

    • Describe without duplicating information in the biosketches the applicant’s team and level of experience in coordinating large-scale and diverse research consortia, including a description of previous projects, number of funded centers or sites, management and administrative processes, degree of scientific emphasis on underserved and/or vulnerable populations, and community engagement activities
    • Describe an overall strategy for addressing the aims of the CDCC. Describe how the proposed CDCC and will interact with projects funded in the RADx-UPprogram to accomplish the goals of the CDCC. Develop a logic model including metrics that will be used to assess progress toward specific goals. Provide timelines and an organizational chart.
    • Describe the organizational structure of the CDCC, including a leadership body that will have primary responsibility for overseeing the CDCC. This leadership body is in addition to the Steering Committee and External Advisory Board. Describe plans for day-to-day operations overseen by the leadership body, such as the following:
      • Coordination across multiple research objectives and program management
      • Allocation and review of resource utilization across all research objectives
      • Convening of an External Advisory Board and other panels as appropriate
      • Coordination of any joint research opportunities with RADx-UP investigators
      • Quality assurance of tasks coordinated by the CDCC (including data center) and across the RADx-UP consortium
      • Facilitating access to resources and data in the coordinating center
      • Preparation and submission of administrative documents related to the U24 award
      • Plans for modification of budget if necessary
    • Describe how the CDCC shall support various scientific and administrative meetings
    • Describe the existing infrastructure at the applicant’s institution(s), current capacity, research activities, data platforms, and how it will support and expand rapid scaling of COVID-19 testing and SEBI projects.
    • For each domain of CDCC functions, describe specific activities that will meet and expand the goals of RADx-UP, how the various domains and activities will interact/intersect, and how they will interact with existing and newly awarded projects within RADx-UP, or other NIH components (if applicable).
    • Describe the applicant’s experience with biomedical testing and supply chains for medical conditions, and specify procedures and available expertise to assist with the identification of FDA-authorized COVID-19 tests, reagents, supplies, and specimen transport to CLIA certified laboratories
    • Describe the applicant’s experience working with and coordinating data from under-represented groups or studies.
    • Describe the research goals of the Rapid Pilot Studies and mini-grant programs. Elucidate plans for establishing, implementing, and evaluating these pilot programs, including the types of projects that will be supported and how the CDCC will attract applicants for national competitions to meet the goals of each program. Provide a plan describing processes for solicitation, review, selection, monitoring, and evaluation of each pilot program.
    • Develop guidance provided 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/).
    • Describe plans for monitoring progress of the RADx-UP program, and CDCC functions. Briefly describe how the CDCC will adapt or eliminate processes based on the needs of RADx-UP investigators and community stakeholders.

    Innovation

    • Describe how the proposed RADx-UP CDCC will provide dynamic guidance to RADx-UP funded investigators as current testing landscape changes and future research or clinical practice paradigms for tests availability change, through use of novel concepts, approaches, data, or methodologies.

    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.

    The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • It is expected that awardees will rapidly disseminate data, results, and analyses to the broader scientific community, using existing public repositories whenever possible when not limited by Tribal data sharing policy, as a foundation for further study.
    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-definedclinical 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.

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

    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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides 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.

    In order to expedite review, applicants are requested to notify the NIMHD Referral Office by email at NIMHD_Referral_Group@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

    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 the NIH in support of the NIH mission are evaluated for scientific and technical merit through an administrativereview .

    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

    For this particular announcement, note the following:

    The CDCC, that by its nature is not innovative, may be essential to advance one field, but the overall CDCC structure must have administrative, technology testing, community engagement, and data expertise and collaboratively work with multiple smaller projects to make an overall impact on testing and eventual health outcomes.

    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.

     

    Does the proposed CDCC address the needs of the RADx-UP research consortium that it will coordinate? Is the scope of activities proposed for the CDCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the RADx-UP initiatives?If fully successful, is the CDCC likely to provide national leadership and engage multiple stakeholders in advancing policies and practices that enhance the broad participation of researchers, communities, and health care systems and settings in research to improve COVID-19 testing and capturing long-term health outcomes? If the aims of the CDCC are achieved, how will clinical research, translation of research into practice, and participation by communities and health care delivery organizations in research be improved? How will successful completion of the coordination across areas change the capability, methods, and technologies used in addressing research important to effect health improvement via COVID-19 testing?

    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?

     

    Are the PD(s)/PI(s) and other personnel well suited to their roles in the CDCC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing complex team science research across a vulnerable and/or underrepresented population? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? Do the project team members have relevant expertise in administration of complex consortia, community engagement expertise, testing expertise, and data science expertise to manage all activities of the CDCC? If the CDCC is multi-PD/PI, do the investigators have complementary and integrated expertise and skills? Is their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the CDCC? Does the applicant have experience overseeing selection and management of multiple subawards, if needed? Does the applicant have experience in coordinating multiple research teams?

    Specific to this FOA:

    Are the proposed leadership approach, staffing, governance and organizational structure appropriate for the project? Have the research team members demonstrated an ongoing record of accomplishment in support of coordination, collaboration, and communication of large national-level inclusive networks or consortia? Are the investigators able to collaborate with RADx-UP funded awardees, and other NIH-funded COVID-19 activities as appropriate? How well does the application describe how the investigative team will remain up to date on the changing landscape of COVID-19 testing in various communities and in health care systems and settings and research participant protection regulations?

    Does the application provide evidence of how the planned collaboration will work among a team of diverse scientists and community stakeholders (administrative; large projects; community engagement; technology and data)?

    Will the proposed activities in this application bring together experienced administrators, community engagement expertise, testing expertise, along with data expertise, to manage all activities of the CDCC?

    Will the CDCC have adequate expertise to monitor the scientific rationale for various testing applications funded via the RADx-UP initiatives?

    In addition, for applications involving clinical studies

    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 CDCC and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For management ofmultisite studies, is the organizational structure appropriate and does the application identify an essentialgroup of potential CDCCinvestigators and staffing for a coordinating activity?

     

    Does the application propose novel organizational concepts, management strategies, for coordinating the RADx-UP research consortium? Are the concepts, strategies, or instrumentation novel to versatile research RADx-UP program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

    Does the application challenge and take into account current trends in COVID-19 testing research or clinical practice paradigms, and enlarge participation in clinical research by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools? Does the application challenge and seek to impact current COVID testing data management and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools? Is a refinement, improvement, or new application of approaches, concepts, or tools proposed for coordinating COVID testing and health outcomes follow up? Does the application include mechanisms for leveraging novel collaboration and communication strategies for coordinating timely COVID testing across multiple sites and research programs? Does the application indicate creativity and flexibility to innovate on an ongoing basis? Is the proposed approach dynamic and responsive to evolving changes in COVID-19 diagnostics in the United States? Is the applicant capable of adapting to testing and vaccine innovation landscape and lead the RADx-UP consortium

    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 to advance COVID-19 testing and outcomes knowledge?

     

    Are the overall strategies, methodologies, structures and systems proposed well-reasoned and appropriate to accomplish the specific aims of the CDCC? ?Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the RADx-UP program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the CDCC 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? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of human subjects?

    Specific to this FOA:

    Will the proposed approach allow for rapid deployment of administrative, community, technology and data coordination, and collaborative tools to enable coordination of COVID-19 testing and monitoring outcomes? Is the plan for administrative support across the CDCC facilitative of the proposed plan? How feasible and appropriate are the plans to coordinate data submission of data, data collection instruments and outcomes/products with RADx-UP funded studies (NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 )? How feasible and appropriate are CDCC plans to collaborate with the RADx-UP field sites (NOT-OD-20-119, NOT-OD-20-120, NOT-OD-20-121 ).

    Does the application demonstrate sufficient knowledge of approaches to create AI-Ready data sets, including acquisition, collection and curation, in a manner that could lead to effective guidance statements for use by all projects?

    Is the management plan well-described and commensurate with the level of complexity required for CDCC? Are the proposed approaches likely to yield important contributions applicable to a range of populations and healthcare settings for COVID testing?

    Does the CDCC provide adequate processes for coordinating with the broader NIH data hub/resource?

    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?Does the application demonstrate ability and expertise of the CDCC to assist with data analyses (e.g., CMS claims data or EHR data which will be managed by CDCC), replication analyses (when necessary), and statistical expertise for studies proposed across RADx-UP consortium? Are the procedures for data management and quality control of data adequate, as applicable? Will the CDCC have the ability to assist and provide consultation of methods for standardization of procedures for data management (when needed) to assess the effect of the COVID tests and quality control been addressed? Is there a plan to monitor RADx-UP studies and track data analysis within the proposed period for RADx-UP funded studies?

     

    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? Wil the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    Specific to this FOA:

    Will the proposed activities facilitate flexible, modular, and scalable policies, practices, algorithms, protocols, and tools to enable broad collaboration and participation among RADx-UP funded researchers? Will the proposed approach allow efficient management upkeep of a public website? Does the proposed approach account for dynamic change in work environment and how CDCC will coordinate meetings when in-person meetings may not be viable?

    Does the applicant propose an adequate plan to coordinate activities across areas, and across RADx-UP funded studies across multiple communities (i.e., not necessarily academic institutions)?

    Does the application adequately address the capability and ability to monitor RADx-UP study sites? Did the plans adequately address how CDCC will monitor addition, coordination (e.g merging complementary studies together to have adequate power) or drop enrollment sites, as needed, appropriate?

    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?

    Will the CDCC have the ability to coordinate with individual RADx-UP studies to: (1) track the proposed enrollment numbers; (2) adhere to the protocol (when appropriate); (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure of the CDCC and serve as the coordinating and monitoring institution for the RADx-UP program?

    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)?

     

    For research that involves human subjects but does not involve one of thecategories 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.

     

    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.

     

    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.

     

    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.

     

    Not Applicable.

     

    Not Applicable.

     

    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.

     

    Not Applicable.

     

    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).

     

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS)

    Data Sharing Plan: If the proposed research will generate unique resources or data that may impact the public health response or medical countermeasure development, does the resource sharing plan adequately address the rapid dissemination of data, results, and analyses to the broader scientific community, using existing public repositories whenever possible when not limited by Tribal data sharing policy, as a foundation for further study?

     

    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.

     

    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 by (an) appropriate internal NIH reviewGroup(s), using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications will receive a written critique.

    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 peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    • Applications that include plans to rapidly make data available to the research community, when not limited by Tribal data sharing policy.

    3. Anticipated Announcement and Award Dates

    After the peer 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 peer review, advisory council 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 grantee’s business official.

    Awardees 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: Grantee 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 awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    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. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 “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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Supporting the Key Component Activities, including determining approaches, designing, and setting project milestones and implementing the project plan for the Collaboratory;
    • Coordination of development, adoption and implementation of the agreed-upon policies, including preparation and dissemination of standardized consent forms to other RADx UP funded projects, procedures, best practices, or other measures;
    • Lead with other awardees in harmonizing and sharing of tools, methods, and approaches within and between interventions, including providing guidance in adherence to security requirements and/or use of cloud infrastructure (FISMA-Moderate);
    • Coordination of knowledge and experience sharing with respect to various tools and approaches utilized in conducting research in community and health care settings, including their strengths and weaknesses;
    • Coordination of sharing issues related to data quality, data management, data biases and errors, query quality and sampling challenges, and pitfalls in utilization of testing and health care data for research;
    • Cooperating with both Testing Research Projects, and Social, Ethical and Behavioral Implications (SEBI) awardees in the development and testing of implementation plans;
    • Coordinate sharing of study designs, methods, protocols, tools, and strategies;
    • Participating in group activities, including program-wide Work Group(s) and Steering Committee meetings;
    • Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, and facilitating work group meetings, committee meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution;
    • Cooperating with other awardees in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources;
    • Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance;
    • Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination;
    • Planning and hosting virtual and face to face meetings of the Work Groups, Steering Committee, and any subcommittees as well as quarterly steering committee meetings, one of which is an annual face to face meeting, conditions permitting, in Bethesda, MD;
    • Retaining custody and having primary rights to the data and software at the awardee institution developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and goals of this program, when not limited by Tribal data sharing policy. It is expected the Collaboratory will have a Data Sharing plan which will protect human subjects and account for tribal sovereignty, and resources generated are expected to have broad availability through a public-facing website in order to facilitate collaboration, reuse, and replication, as appropriate and consistent with achieving the goals of the program
    • Providing information to the NIH Program Officer(s) and Project Scientist(s) concerning progress;
    • Participating in the overall coordination of NIMHD efforts in minority health and health disparities research; this participation may include collaboration and consultation with other research awardees, and the sharing of information, data and research materials.

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

    NIMHD will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to the CDCC.

    NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:

    • Assist in coordinating activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new clinically useful resources and methodologies;
    • Review and comment on critical stages in the program implementation;
    • assist in the interaction between the awardee and investigators at other institutions to promote collaborations;
    • Assist in coordinating access to other resources available through statewide, regional, or national specialized technology projects
    • 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;
    • Retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget;
    • Convene meetings/workshops to address emerging areas of high priority.

    An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The program official(s) will:

    • Assist in enforcing general statutory, regulatory or administrative assistance policy requirements;
    • 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;
    • 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 RRCN activities prior to implementation to ensure consistency with the goals of this FOA;
    • Link the approaches developed from CDCC to other NIMHD supported networks to ensure that information is shared and utilized on the widest basis possible;
    • Monitor institutional commitments and resources to ensure that CDCC receives the maximum chance of stabilization and success;
    • Assist with financial oversight of the Program.

    Additionally, the NIH Program Official(s) may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

    Areas of Joint Responsibility include:

    Awardees agree to governance, through voting and decision making, of the CDCC through a Steering Committee. Steering Committee voting membership shall consist of the Principal Investigator(s), NIMHD Program staff [ Project Scientist(s)]. Quarterly meetings of the Steering Committee will be held in the first year of the award. One of these meetings must be an in-person meeting, travel conditions permitting, in Bethesda, MD. Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period. Each member of the Steering Committee will have one vote. The CDCC leadership will be required to accept and implement policies approved by the Steering Committee.

    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 the Steering Committee 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, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    Funds awarded using appropriations provided by the Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

    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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare 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 threatensubmission 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)

    National Institute on Minority Health and Health Disparity (NIMHD)

    Dorothy Castille, 301-594-9411, dorothy.castille@nih.go

    Peer Review Contact(s)

    National Institute on Minority Health and Health Disparity (NIMHD)

    Maryline Laude-Sharp, 301.451.9536, maryline.laude-sharp@nih.gov

    Financial/Grants Management Contact(s)

    National Institute on Minority Health and Health Disparity (NIMHD)

    Priscilla Grant, 301-594-8412, pg38h@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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