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 Aging (NIA)

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

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

National Library of Medicine (NLM)

Office of Data Science Strategy (ODSS)

Tribal Health Research Office (THRO)

Funding Opportunity Title
Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

April 29, 2022 - Notice of Pre-Application Technical Assistance Webinar for RFA-OD-22-011. See Notice NOT-MD-22-018

April 13, 2022 - Notice of Correction to RFA-OD-22-011: Clarification on Number of Applications an Organization Can Submit. See Notice NOT-OD-22-111.

RFA-OD-20-020 - Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (R44 Clinical Trial Not Allowed)

RFA-OD-20-022 - Emergency Awards: Chemosensory Testing as a COVID-19 Screening Tool (U01 Clinical Trial Optional)

RFA-OD-20-021 - Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (Fast-Track STTR Clinical Trial Not Allowed)

RFA-OD-20-014 - Emergency Awards: Automatic Detection and Tracing of SARS-CoV-2 (U01 Clinical Trial Not Allowed)

RFA-OD-20-018 - Emergency Awards: Exosome-based Non-traditional Technologies Towards Multi-Parametric and Integrated Approaches for SARS-CoV-2 (U18 Clinical Trial Not Allowed)

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

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

RFA-OD-20-016 - Emergency Awards: RADx-RAD Multimodal COVID-19 surveillance methods for high risk clustered populations (R01 Clinical Trial Optional)

RFA-OD-20-023 -Emergency Awards: RADx-rad Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and Artificial Intelligence (PreVAIL kIds) (R61/R33 Clinical Trial Optional)

RFA-OD-20-019 - Emergency Awards: RADx-rad Data Coordination Center (DCC) (U24 Clinical Trial Not Allowed)

RFA-OD-22-005 - Emergency Awards: RADx®-UP - Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing among Underserved and Vulnerable Populations (U01 Clinical Trial Optional)

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

RFA-OD-22-006 - Emergency Award: RADx-UP Community-Engaged Research on Rapid SARS-CoV-2 Testing among Underserved and Vulnerable Populations (U01 Clinical Trial Optional)

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

RFA-OD-20-017 - Emergency Awards RADx-RAD: Screening for COVID-19 by Electronic-Nose Technology (SCENT) (U18 Clinical Trial Not Allowed)

RFA-OD-20-015 - Emergency Awards: RADx-rad Wastewater Detection of SARS-COV-2 (COVID-19) (U01 - Clinical Trials Not Allowed)

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

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

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

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

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

NOT-OD-20-152 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Chemosensory Testing as a COVID-19 Screening Tool

NOT-OD-20-159 - Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for Wastewater Surveillance Research for Public Health Response to Coronavirus Disease 2019 (COVID-19).

OTA-21-004: Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

OTA-21-007: Notice of Intent to Publish a Research Opportunity Announcement for RADx-UP Return to School Diagnostic Testing Approaches (OT2 Clinical Trial Optional)

OTA-22-003: Notice of Intent to Publish Funding Opportunity Announcements for the RADx®-UP Initiative (Phase III

Funding Opportunity Announcement (FOA) Number
RFA-OD-22-011
Companion Funding Opportunity
None
Number of Applications

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

Assistance Listing Number(s)
93.310, 93.853, 93.242, 93.859, 93.879, 93.866, 93.113, 93.846
Funding Opportunity Purpose

The National Institutes of Health (NIH) Office of the Director intends to support a Rapid Acceleration of Diagnostics (RADx®) Tribal Data Repository (RADx TDR) in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency cooperative agreement FOA provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics (RADx®) initiative to accelerate innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. This FOA seeks to fund a single RADx Tribal Data Repository (RADx TDR). The RADx TDR is intended to be an independent research data repository governed under the principles and practices of tribal sovereignty. The RADx TDR will provide responsible data sharing and access to researchers and their collaborators who are generating or interested in working with RADx American Indian and Alaska Native (AI/AN) research data.

Key Dates

Posted Date
April 06, 2022
Open Date (Earliest Submission Date)
May 01, 2022
Letter of Intent Due Date(s)

May 1, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 31, 2022 Not Applicable Not Applicable July 2022 August 2022 September 2022

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

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

Expiration Date
June 01, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

PURPOSE

American Indian and Alaska Native (AI/AN) communities across the nation are disproportionately impacted by the COVID-19 pandemic. To address the disparities recognized in these communities, the NIH has focused on supporting research projects that can increase our overall understanding of COVID-19 and its effects on AI/AN communities. In response to the May 2020 Tribal Consultation for COVID-19 Research[https://dpcpsi.nih.gov/thro/tribal-consultations/covid-19]. NIH incorporated Tribal input into the design of the Rapid Acceleration of Diagnostics (RADx®) Initiative[https://www.nih.gov/research-training/medical-research-initiatives/radx] envisioned to accelerate the development, commercialization, and implementation of COVID-19 testing. Specifically, the RADx-Underserved Populations (RADx-UP)[https://radx-up.org] program focuses on understanding of COVID-19’s effect on communities who are experiencing health disparities and supporting research and approaches to improve health outcomes and reduce disparities. To provide curated and de-identified COVID-19 data for the RADx Initiative, the RADx Data Hub allows researchers to find, aggregate, and perform data analysis within an NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) cloud-enabled platform[https://datascience.nih.gov/strides]. The NIH RADx Data Hub works with RADx projects through the funded Coordination and Data Collection Center (CDCC) and the Data Collection Centers (DCC) to provide a data portal for researchers to find curated and de-identified data from additional NIH-supported COVID resources to integrate with related data from publicly available biomedical databases.

In funding the RADx Initiative and the resource to make RADx data available to the research community, the NIH believes that the RADx Data Hub does not meet the cultural, governance, sovereignty needs, or expectations to support and share de-identified AI/AN RADx research data.

To address this recognized challenge, the NIH envisaged the RADx Tribal Data Repository (RADx TDR), with input from Tribal Consultation, to further facilitate AI/AN participation in the RADx initiative.It is anticipated that data produced from this initiative will be provided back to the Tribes to contribute to their knowledge of COVID-19 and making health decisions for their communities.

The RADx TDR is intended to be an independent research data repository governed under principles and practices of tribal sovereignty for data sharing that will provide responsible data sharing and access to researchers and their collaborators who are generating or interested in working with RADx AI/AN research data[6]. The RADx initiative and the RADx Tribal Data Repository are independent from, and not associated with, other NIH projects, such as the All of Us Program or the National COVID Cohort Collaborative (N3C). The RADx TDR will collaborate with the RADx-UP Coordination and Data Collection Center (RADx-UP CDCC) [https://radx-up.org] and other data collection centers (DCC) funded through the RADx initiative. The RADx TDR will support and promote AI/AN researchers and other scientists working with AI/AN communities; help contribute toward a better understanding of COVID-19 impact; and provide data to allow for data informed decisions and policy development in addressing the COVID-19 pandemic and potential future pandemics.The RADx-UP projects are implementing community engaged interventions and there will be no biospecimens stored within the RADx TDR.

Key Definitions:

Common Data Elements (CDEs) are a type of health data standard that is commonly used and reused in both clinical and research settings. CDEs provide a way to standardize data collection—ensuring that data are collected consistently, and otherwise-avoidable variability is minimized. (https://nexus.od.nih.gov/all/2021/06/24/common-data-elements-increasing-fair-data-sharing/)

Data Use Agreements (DUAs) are contractual documents used for the transfer of nonpublic data that is subject to some restriction on its use.

Data Transfer Agreements (DTA) are a legal contract governing the transfer of non-human subject data or completely de-identified human subject data.

Artificial Intelligence is the theory and development of computer systems able to perform tasks that normally require human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages.

Data Ecosystem refers to the programming languages, packages, algorithms, cloud-computing services, and general infrastructure an organization uses to collect, store, analyze, and leverage data.

Hashing is taking a variable created for storing data and representing it as a value with a shorter string than the original.

Background

SARS-CoV-2 is a novel coronavirus identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical sequelae 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.

An overarching goal of the RADx Initiative is to reduce disparities in COVID-19 associated morbidity and mortality and establish a foundation to reduce disparities for underserved populations disproportionately affected by the highest infection rates and/or are most at risk for adverse outcomes from the COVID-19 pandemic. This goal will be accomplished by strengthening existing and newly collected data on infection rates, disease progression and outcomes, differences in testing access and uptake patterns, and identifying and developing strategies to address disparities in COVID-19 diagnostics (and related repeat testing, contact tracing, and referrals).

The RADx TDR is a four-year cooperative agreement for a single awardee to support data storage, access and monitored sharing of AI/AN RADx research data for COVID-19 testing and vaccination hesitancy research activities collected by RADx projects conducted in Tribal communities. The RADx TDR will:

  • Provide overall coordination of data collection and management guidance and support of RADx AI/AN data harmonization and de-identification with the RADx-UP CDCC and other RADx DCCs
  • Be the “hub” in a hub-and spoke organizational framework with the spokes, being RADx funded projects working with AI/AN communities. The RADx TDR will serve as a repository for data collected by RADx Initiative projects collecting AI/AN data
  • Negotiate and execute Data Transfer, Ownership, and Use Agreements (DTOUA) with Tribal Nations and communities contributing data to the RADx TDR
  • Support new and ongoing initiatives to oversee responsible sharing of de-identified AI/AN data to address scientific questions concerning testing and vaccination for COVID-19
  • Determine the process for review and approval for data access to deidentified individual AI/AN data for analysis based on the RADx TDR governed under principles and practices of tribal sovereignty and determine, in coordination with the RADx Data Hub, tribally appropriate data access processes
  • Provide data outcomes that inform the COVID-19 impact to Tribal Health Boards and/or Tribal Health Departments
  • Coordinate, when possible, with the RADx-UP CDCC for community engagement including access to and sharing of culturally responsive and community generated information and data generated by RADx projects through meetings, workshops, participation in publication and dissemination, among other activities
  • Conduct on-going discussions and involvement with Tribal Nation leadership and other designated representatives from projects of participating RADx Program AI/AN communities to be culturally responsive to governance and sovereignty issues regarding data, tools, and algorithms

Required Elements :

The RADx TDR will provide support and guidance in the following elements : (1) Administrative Operations and Logistics and (2) Data Collection, Integration and Data Sharing.

Descriptions of Required Elements

  1. Administrative Operations and Logistics

The administrative functions of the RADx TDR include implementing a governance structure under principles and practices of tribal sovereignty for data sharing and access in the overall data management of the RADx initiative AI/AN projects. The Administrative Operations and Logistics Core (The Core) will provide administrative, fiscal, and management oversight of the different proposed elements and the data access and sharing aspects of these projects, coordination of communication among the proposed elements and projects, and guidance in evaluation planning and implementation. Activities will include, but are not limited to:

  • Leadership and project management for the administrative, data sharing, access provision, regular weekly progress reporting, and evaluation functions
  • A governance plan under principles and practices of tribal sovereignty that includes ongoing Tribal involvement that encompassesTribal Nation representation (i.e., Tribal Official or their appointed designee) for those Tribal communities contributing data to the TDR for:
    • Guideline, policy development, and governance matters such as data sharing and access, data analyses and interpretation, publication and dissemination, and data ownership
    • Synergistic resources when possible with the RADx UP Program CDCC, including but not limited to community engagement activities and development, cultural adaptation and dissemination of COVID-19 relevant information, and linkage with IHS Tribal Epidemiology Center COVID-19 specific data
  • Logistics and management support, including but not limited to maintaining documentation of routine and scientific meeting minutes and workshops, webinars and report(s) (when applicable)
  • Develop administrative structures to provide technical assistance, and facilitate interaction across the RADx Initiative Programs-- RADx-Radical (RADx-rad), RADx-Digital Health (RADx-DH,) RADx-Technology (RADx-Tech), RADx-Underserved Populations (RADx-UP), and potentially other NIH COVID-19 activities
  • Information sharing including establishing and maintaining community resources such as a RADx TDR directory (e.g., tribal councils, partners, and stakeholders) a Web Portal (that connects with the RADx Initiative and Programs’ websites) catalogues and library (e.g., assessments and protocols, consent forms, data sharing plans,recruitment and retention materials and strategies, best practices, interim findings, troubleshooting)
  • Establish, implement, and deliver an evaluation of data integration processes to specify, track, and assess data submission, access advances, and document project progress on individual project recruitment, data deposition, and publication of results for all AI/AN engaged RADx projects
  • Provide expertise and assistance on data sharing and access policies, guidelines, and practices
  • Prepare and distribute reports to the NIH (e.g., RADx UP Co-Chairs) including progress of projects depositing data into the TDR and data summaries, participant demographics, enrollment and COVID-19 testing data, interim findings, and scientific outputs such as publications and presentations)
  1. Data Collection, Integration and Data Sharing

In collaboration with the RADx-UP CDCC Data Core and other RADx DCCs, the RADx TDR will facilitate data standardization, harmonization, integration, and analysis for projects using RADx AI/AN data. The RADx TDR awardee is expected to have experience in research and clinical informatics, managing a broad range of data types, harmonizing and merging data where feasible, and working with latent variable structures and meta-analytic strategies to create a data ecosystem for the RADx initiative’s AI/AN data. The RADx TDR awardee should have expertise and experience in working with a wide breadth of data types and analytic methods, experience and ability to convene advisory Tribal Nation leadership (or designees), and other relevant tribal community-based groups as determined by the awardees’ governance structure.

The deidentified data governed by the RADx TDR should be available for secondary data use and analyses to the AI/AN and broader research and practice community that are consistent with conditions set forth in relevant data transfer and use agreements.

Activities may include, but are not limited to:

  • Establish a secure, centralized, user-friendly data repository that can accept individual participant data including unique participant IDs that do not contain Personal Identifying Information/Personal Health Information (PII/PHI)
  • Provide data storage, sharing, access, and stewardship
  • Support collection of required NIH RADx and RADx Program specific Common Data Elements
  • Hashing for data privacy/deidentification
  • Coordination and leverage resources and synergies with the RADx coordinating centers for RADx activities including data sharing and informed consent, data harmonization, data deposition, data transfer and use agreements, publication and dissemination policy and processes, access to and sharing of culturally responsive and community generated information and data generated by RADx projects through meetings, workshops, publication and other dissemination and community engagement activities, and data access for secondary analyses by the broader researcher community
  • Provide methodological and statistical consultation on design and analytics
  • Support RADx TDR collaboration and data use fidelity by monitoring data sharing, management and security, and data use and access
  • Prepare and release access to data sets to the broader research community consistent with the project in accordance with the RADx TDR governance determined timelines and milestones
  • Build a RADx TDR data management model that serves as a repository for AI/AN data from RADx Initiative program projects, that allows linkage of deidentified data to the RADx Data Hub for inclusion in larger NIH data integration models
  • Implement privacy preserving record linkage (PPRL) data to personal identifiers that will be held only by the Tribal Data Repository for future re-contacting for follow-up evaluations and possible participation in prevention or therapeutic trials. Any linkages to PPRL or plans for future contact will be determined by the proposed Tribal Data Repository governance structure
  • Provide capability to work with different data types (e.g., contextual, geographical, environmental, and social determinants of health, electronic health records, etc.).
  • The RADx TDR is strongly encouraged to use Observational Medical Outcomes Partnership (OMOP) models (https://www.ohdsi.org/data-standardization/the-common-data-Model/) when applicable
  • Encourage adherence to federal health data standards including Fast Healthcare Interoperability Resource (FHIR) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-122.html) and the United States Core Data for Interoperability (USCDI) (https://www.healthit.gov/isa/sites/isa/files/2020-03/USCDI-Version1-2020-Final-Standard.pdf) that includes three National Library of Medicine (NLM) supported vocabulary standard for codes (and names) for drugs, tests diagnoses, symptoms, some social determinants of health, some psychologic scores and all Medicare/Medicaid assessments
  • Communicate and provide technical assistance, as needed for adherence to Tribal sovereignty and governance expectations, where applicable and within scope
  • Collaborate with the RADx Data Safety Monitoring Board (DSMB) established through the RADx-UP CDCC to serve all RADx projects
  • Conduct quality assurance checks of RADx TDR AI/AN data

Resources and Infrastructure

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

Data and Resource Sharing

The RADx Initiative 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 is highly desired. Applicants are required to provide an overarching data and resource sharing plan. The NIH requires the awardee to implement a Resources and Data Sharing Plan consistent with achieving these program goals, that includes respecting and enforcing principles and practices of Tribal data sovereignty. The applicant is required to propose a data sharing plan that includes a description of how the RADx TDR will work with RADx project principal investigators (PI’s) and their sovereignty-based data management and sharing plans.

.

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

Technical Assistance Webinar

NIMHD will conduct a Technical Assistance webinar for prospective applicants. Information on the date and time of the webinar will be posted on the NIMHD website at www.nimhd.nih.gov.

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.

Funds Available and Anticipated Number of Awards

NIH intends to commit $3,000,000 in FY 2022 to fund one award.

Award Budget

Application budgets are limited to $2,000,000 direct costs annually not including consortia F&A.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 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
Foreign Institutions

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

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

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

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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:

Yujing Liu, Ph.D.

National Instiitute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815Email: liuyujing@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.

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

The application should explain the following elements: (1) Administrative Operations and Logistics and (2) Data Collection, Integration and Data Sharing within this application.

Research Strategy

Significance

  • Describe the specific research objectives of the proposed RADx TDR and how they will help accomplish the goals of the RADx initiative.
  • Describe how the proposed activities will advance responsible access to data collected from AI/AN communities for current and future research to understanding the disparate effects of SARS-CoV-2 and/or COVID-19.

Approach

  • Describe an overall strategy for addressing the aims of the RADx TDR, including governance under principles and practices of tribal sovereignty and how tribal data sovereignty will be exercised that will ensure accountability and decision making within the operational mission of the RADx TDR and the RADx Initiative.
  • Describe the organizational structure of the RADx TDR and implementation timelines, including leadership and leadership structures that will have responsibility for overseeing the RADx TDR including:
    • Implement quality assurance of tasks coordinated by the RADx TDR (including with the NIH RADx Data Hub and the RADx-UP CDCC) and across the RADx AI/AN projects.
    • Ensuring the security status of the proposed system and facilitating access to RADx TDR resources and RADx TDR research data.
    • Preserve utility of resources for the future.
    • Processes for continued development of the resources produced, coordinated, and shared through the RADx TDR in the event that the original investigators are unable to do so.
  • Describe processes for overall coordination of data collection and management guidance and support of RADx AI/AN data harmonization and de-identification with the RADx-UP CDCC to accomplish the goals of the RADx TDR.
  • Describe processes to develop guidance about data ownership, data uses, and publications.
  • Describe processes to develop criteria and procedures for reviewing and approving/rejecting data access requests for AI/AN data under principles and practices of tribal sovereignty.
  • Describe, without duplicating information in the biosketches, the applicant’s team experience in successfully engaging and collaborating with Tribal Nations or tribal-serving organizations related to data ownership, governance, data sharing, data repository establishment and management of controlled-access deidentified data (e.g., scientific emphasis on AI/AN populations, descriptions of previous projects, management and administrative processes, etc.)..
  • Describe a process for ongoing Tribal discussions and engagement with the AI/AN communities contributing data to the RADx projects.
  • Develop a model, including evaluation metrics, that will be used to assess progress toward specific goals.

Innovation

  • Describe how the proposed RADx TDR will provide dynamic guidance to RADx AI/AN community related projects funded investigators through use of novel concepts, approaches, data, or methodologies.

Environment

Describe the existing infrastructure at the applicant’s institution(s) that will be leveraged for the RADx TDR, current capacity, research activities, and data platforms.

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, are required submit a Data Sharing Plan that describes a process for providing access to and sharing of deidentified AI/AN data consistent with the principles and practices of Tribal sovereigty.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Clinical Trials are not responsive to this Funding Opportunity Announcement.

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The RADx TDR, by its nature, is innovative for its independent, governance under principles and practices of Tribal sovereignty, and data access and sharing. The overall RADx TDR structure must have administrative and coordination, technology testing, Tribal involvement and continued community engagement and dissemination, and data expertise and collaboratively work with RADx program Data Coordinating Centers (DCCs), specifically the RADx-UP CDCC, and multiple smaller projects to make an overall impact on testing and eventual health outcomes.

Overall Impact

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

Does the proposed RADx TDR address the needs of the AI/AN research projects that it will serve? Is the scope of activities proposed for the RADx TDR appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the RADx initiative research program?

Specific to this FOA:

To what extent will the proposed activities likely advance responsible access to data collected from AI/AN communities for current and future research to understanding the disparate effects of SARS-CoV-2 and/or COVID-19?

 

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

Are the PD(s)/PI(s) and other personnel well suited to their roles in the RADx TDR? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the RADx TDR? Does the applicant have experience overseeing selection and management of subawards, if needed?

 

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

Does the application propose novel organizational concepts and management strategies in coordinating the research data resource the RADx TDR will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of strategies proposed?

Specific to this FOA: To what extent does the applicant provide dynamic guidance to RADx AI/AN community related projects funded investigators through use of novel concepts, approaches, data, or methodologies?

 

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

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

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the RADx TDR will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this FOA:

To what extent will the overall strategy for addressing the aims of the RADx TDR including governance under principles and practices of tribal sovereignty and how tribal data sovereignty will be exercised likely ensure accountability and decision making within the operational mission of the RADx TDR and the RADx Initiative?

Are the processes for overall coordination of data collection and management guidance and support of RADx AI/AN data harmonization and de-identification with the RADx-UP CDCC to accomplish the goals of the RADx TDR well reasoned and appropriate?

To what extent are the processes proposed to develop guidance about data ownership, data uses, criteria and procedures for reviewing and approving/rejecting data access requests for AI/AN data appropriate and consistent with the principles and practices of tribal sovereignty?

To what extent does the applicant’s team have appropriate experience in successfully engaging and collaborating with Tribal Nations or tribal-serving organizations related to data ownership, governance, data sharing, data repository establishment and management of controlled-access deidentified data (e.g., scientific emphasis on AI/AN populations, descriptions of previous projects, management and administrative processes, etc.)?

Does the application propose a process for ongoing Tribal discussions and engagement with the AI/AN communities contributing data to the RADx projects?

Does the conceptual model developed including evaluation metrics, designed to appropriately assess progress toward the specific goals?

To what extent does the Data Sharing Plan adequately describe a process for providing access to and sharing of deidentified AI/AN data consistent with the principles and practices of Tribal sovereignty?

 

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

Will the institutional environment in which the RADx TDR will operate contribute to the probability of success in facilitating the current capacity, research activities, and creation of an AI/AN data platforms? Are the institutional support, equipment and other physical resources available to the investigators adequate for the RADx TDR proposed? Will the RADx TDR benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.

 

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 in collaboration with other RADx DCCs 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)? Does the application include in the study timeline activities concerning negotiation of Memoranda of Understanding and Data Use Agreements with Tribal Nations with respect for tribal sovereignty?

 

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

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

Does the application describe the ability to protect the identity of both individual study participants as well as Tribal nation and community identity?

 

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.

Vertebrate Animal research is non-responsive to this FOA.

 

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.

The collection of biospecimens is non-responsive to this FOA.

 

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. Collection of biospecimens, including model organisms and genomic data, is not permitted through this FOA.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

Not applicable.

 

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

 

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.

Not applicable

 

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 the review branch of the National Institute of Minority Health and Health Disparities, in accordance with NIH peer review policy and procedures, using the stated review criteria.

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

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

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

2. Administrative and National Policy Requirements

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, 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's 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 reside with the recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipientsand 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 Data Repository
  • Coordination of development, adoption, and implementation of the agreed-upon policies, including collaboration with the RADx-UP Coordination and Data Collection Center (CDCC) in preparation and dissemination of standardized consent forms to other NIH RADx funded projects, procedures, best practices, or other measures
  • Lead with other recipients in harmonizing and sharing 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 AI/AN communities 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 the utilization of testing and health care data for research
  • Coordinate with the RADx-UP CDCC sharing of study designs, methods, protocols, tools, and strategies
  • Participating in collaboration with NIH RADx supported DCCs particularly the RADx-UP CDCC in group activities, including program-wide Work Group(s) and Steering Committee meetings
  • Providing integrative, organizational, and logistical support for the NIH RADx funded projects focused on data collection in AI/AN communities program, including tracking, scheduling, and facilitating workgroup meetings, committee meetings, and conference calls, preparing concise minutes or summaries of meetings for distribution
  • Cooperating with other recipientsin 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 to research with AI/AN data, such as informed consent, data sharing standards, analysis methodology, and dissemination
  • Planning and hosting virtual and face to face meetings of the Work Groups, ongoing tribal guidance discussions, and any subcommittees meeting regularly on a monthly basis, 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 Tribal Sovereignty 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 Tribal Data Repository 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 and in alignment with the NIH Data Sharing Policy in the following Notices: NOT-OD-22-064 Request for Public Comments on DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/ Alaska Native Participant Data and NOT-OD-21-013– Final NIH Policy for Data Management and Sharing
  • Providing information to the NIH leadership, RADx leadership, Program Officer(s), and Project Scientist(s) concerning progress and reporting internal and external to NIH;
  • 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 recipients, and the sharing of information, data, and research materials, appropriate to tribal governance and with respect for Tribal Sovereignty

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 and Project Scientist(s) to the RADx TDR.

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, as permitted by governance under principles and practices of tribal sovereignty
  • Review and comment on critical stages in the program implementation
  • Assist in the interaction between the recipient 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 specific to NIMHD and in alignment with guidance from appropriate NIH leadership
  • 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 TDR activities prior to implementation to ensure consistency with the goals of this FOA
  • Link the approaches developed by the TDR independently and in collaboration with the NIH RADx-UP CDCC to other NIH and NIMHD supported networks to ensure that information is shared and utilized on the widest basis possible, where permissible by Tribal sovereignty
  • Monitor institutional commitments and resources to ensure that TDR receives the maximum chance of stabilization and success
  • Assist with financial oversight of the Program
  • Coordinate with Program Officers assigned to other RADx funded projects and Data Collection Centers for alignment with NIH RADx Executive Committee Guidance

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

Areas of Joint Responsibility include:

Recipients agree to governance, through voting and decision making, of the RADx TDR through governance under principles and practices of tribal sovereignty proposed by the applicant and should include at least one NIH-assigned Program staff.   Governance meetings will be held in the first year of the award with no less frequently than once a quarter, with monthly meetings preferred. One of these meetings must be an in-person meeting, travel conditions permitting, in Bethesda, MD. The frequency of meetings in succeeding years will be decided by the Governance Committee at the beginning of each budget period. Each member of the Governance Committee will have voting power as defined by the proposed governance policies of the successful applicant. The TDR leadership will be required to accept and implement policies approved by the Governance 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 Governance 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 recipient. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

Funds awarded using appropriations provided by the American Rescue Plan Act of 2021.  In alignment with other RADx funded projects, Interim Performance Progress Reports (IPPR) are required to be submitted every 6 months.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Dorothy Castille, Ph.D.
National Institute on Minority Health and Health Disparity (NIMHD)
Phone: 301-594-9411
Email: dorothy.castille@nih.gov

Sheila Caldwell, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: caldwells@mail.nih.gov
Phone: 301-594-6115

Vivian Ota Wang, Ph.D.
Office of Data Science Strategy (ODSS)
Phone: 240-276-5462
Email: otawangv@mail.nih.gov

Mose Herne, M.S., M.P.H.
Tribal Health Research Office (THRO)
Phone: 928-737-6010
Email: mose.herne@nih.gov

Sheila Caldwell
National Institute Of General Medical Sciences (NIGMS)
E-mail: caldwells@mail.nih.gov

Stephanie M George, PhD, MPH, MA
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-4974
E-mail: stephanie.george@nih.gov

Meryl Sufian, PhD
National Libary of Medicine (NLM)
301-496-4671
sufianm@mail.nih.gov

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

Dawn Morales Ph.D.
National Institutes of Mental Health (NIMH)
Telephone: 301-827-9668
Email: dawn.morales@nih.gov

Nina Silverberg, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: silverbergn@mail.nih.gov

Dorothy Castille, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Email:  dorothy.castille@nih.gov
Phone:  301-594-9411

Richard T. Benson, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
E-mail: richard.benson@nih.gov

Lindsey A. Martin, PhD?
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4036
Email: lindsey.martin@nih.gov?

Peer Review Contact(s)

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: liuyujin@mail.nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Sahar Rais-Danai
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5032
E-mail: sahar.rais-danai@nih.gov

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

Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: laneyr@mail.nih.gov

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

National Institute of Environmental Health Sciences (NIEHS) 
Telephone: 984-287-3332
Email: jenny.greer@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 and 2 CFR Part 200.

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