Part 1. Overview Information

Key Dates

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.

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

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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions

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

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

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

SARS-CoV-2 Testing (also referred to as COVID-19 Testing ): Includes access to FDA-authorized/cleared/approved test kits and related supplies for polymerase chain reaction (PCR) and rapid (molecular or antigen) tests used to diagnose infection. PCR tests must be assayed in Clinical Laboratory Improvement Amendments (CLIA) certified laboratories (e.g., hospital, public health, or commercial) to administer the tests and return test results as quickly as possible. Rapid tests are conducted at or near the place where a specimen is collected, usually outside of a laboratory setting, and provide results to patients within minutes. The proposed (and implemented) COVID-19 testing must be fully FDA-Emergency Use Authorized/cleared/approved, and used solely for the specific, on-label purpose for which they were developed and authorized/approved/cleared. This includes sample collection, assays, and test performance. In the context of COVID-19, these tests are diagnostic tests that provide results to patients within minutes.

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

Community: For the purposes of this NOFO, community refers to a population that may be defined by geography, race, ethnicity, culture, gender, illness or other health condition, or to groups that have a common health-related interest or cause. Communities must include significant representation of one or more NIH-designated US populations with health disparities, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, sexual and gender minorities, socioeconomically disadvantaged populations and underserved rural populations.

Background

The RADx -UP initiative seeks to address COVID-19 morbidity and mortality disparities among underserved and vulnerable populations with disproportionate rates of SARS-CoV-2 and/or undue COVID-19 burden by understanding strategies and interventions to increase testing access, acceptability, and uptake. To date, more than 135 projects are engaging participants in all US states as well as American Samoa, the District of Columbia, Guam, the Northern Mariana Islands, Puerto Rico, and the US Virgin Islands.

Research conducted through RADx-UP funded projects, as well as through other COVID-19 research efforts, include interventions evaluated in multiple settings to reduce COVID-19 disparities among underserved and vulnerable populations and address scientific questions on interventions to increase access to and uptake of COVID-19 testing, including testing linked to active treatment of an infection (i.e., test to treat paradigms). As testing protocols and requirements have evolved and become less common, this NOFO will support D&I research on how evidence-based practices, interventions, and policies are effectively translated to and used in real-world settings such as residential care facilities and other congregate settings, clinical settings, schools, rural areas, and remote communities. These new projects will expand the evaluation of the effectiveness of COVID-19 interventions with a focus on sustainability. This is important given that the end of the COVID-19 national emergency and public health emergency declarations on May 11 may affect the implementation of evidence-based COVID-19 testing interventions. The overarching goal is to ensure that successful interventions in the RADx-UP and other programs carry forward to dissemination and implementation.

Dissemination and implementation (D&I) research intends to bridge the gap between research, practice, and policy by building a knowledge base about how health information, effective interventions, and new health-related practices, guidelines, and policies are communicated and integrated for public health and health care service use in specific settings. For the purpose of this NOFO, "dissemination research" and "implementation research" are defined as follows:

Dissemination research the scientific study of the targeted distribution of information and intervention materials to a specific public health, clinical practice, or policy audience. The intent is to understand how best to communicate and integrate knowledge around the associated evidence-based and community engaged interventions. We are currently missing critical information about how, when, by whom, and under what circumstances scientific knowledge and evidence spreads and is understood throughout communities, organizations, front line workers, and consumers of public health and clinical services. Needed is an understanding of how and why information on COVID-19 testing may or may not reach individuals/groups or motivate uptake, as well as the processes supporting the creation, transmission, and reception of information on evidence-based COVID-19 testing interventions.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health. Implementation research seeks to understand the behavior of practitioners and support staff, organizations, consumers, family members, and policymakers in context as key influences on the adoption, implementation, and sustainability of evidence-based COVID-19 testing interventions. Implementation studies should not assume that effective COVID-19 interventions can be integrated into any service setting and for consumer groups and populations without attention to local context, nor that a unidirectional flow of information is sufficient to achieve uptake and adoption.

Studies in the D&I field typically involve both interdisciplinary cooperation and transdisciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of scientific disciplines. Relevant fields include but are not limited to: health services research, information science, organizational and management theory, health economics, behavioral science, public health, business and public administration, statistics, anthropology, epidemiology, decision science, community-engagement science, community-engaged and community-based participatory research, systems science, engineering, and marketing. D&I research will often include significant and ongoing collaboration with stakeholders from multiple public health and/or clinical practice settings as well as communities of interest, consumers of services and their families/social networks. Wherever possible, studies of dissemination or implementation strategies should build knowledge both on the overall effectiveness of the strategies, as well as "how and why" they work. Data on mechanisms of action, moderators and mediators, and costs of dissemination and implementation strategies will greatly aid decision-making on which strategies work for which COVID-19 testing interventions, in which settings, and for what populations.

Resources to support community engaged research are available through the RADx-UP Coordination and Data Collection Center (CDCC) as well as the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities.

For additional resources on dissemination and implementation research visit: http://cancercontrol.cancer.gov/is/; and https://prevention.nih.gov/research-priorities/dissemination-implementation.

NOFO Goals:

This NOFO invites applications for D&I research project grants (R01s) to 1) develop and test D&I strategies for the equitable and effective adoption, adaptation, integration, scale-up, and sustainability of evidence-based COVID-19 testing interventions among underserved and vulnerable populations, or 2) understand circumstances that create a need to stop, reduce and/or replace ( de-implement ) the use of interventions related to COVID-19 testing that are ineffective, low-value or in-equitable, and identify optimal strategies to successfully de-implement such interventions.

D&I of COVID-19 testing interventions developed through RADx-UP are encouraged, but not required.

This NOFO will support rigorous study designs and methods including (but not limited to) observational, experimental, quasi-experimental, observational, hybrid effectiveness-implementation, configurational comparative, and simulation modeling that produce evidence on relevant outcomes (e.g., adoption, fidelity, penetration, sustainability), costs, and/or unanticipated consequences of D&I efforts. The goal is to conduct D&I studies utilizing research designs that are rigorous and measures that are contextually and culturally appropriate.

This NOFO encourages studies to test models, theories, and conceptual frameworks of the implementation process that move away from an exclusively "top-down" or reductionist approach to a greater emphasis on the resources of local care settings and the needs of multiple stakeholders, including approaches such as systems science, team science, community engaged research, participatory action research, citizen science, and related approaches that engage stakeholders and end-users throughout the research process.

Research Objectives:

The D&I research topics and questions of interest include, but are not limited to, the following areas:

What culturally and community specific D&I strategies can enhance the reach, adoption, effectiveness, integration and/or maintenance of COVID-19 testing interventions, including testing linked to active treatment of an infection (i.e., test to treat paradigms)?

How can D&I strategies for implementing evidence-based COVID-19 testing interventions be designed to optimally overcome barriers associated with structural racism and discrimination?

What are effective strategies to disseminate and implement multiple evidence-based COVID-19 testing interventions within community or clinical settings (including community clinics, Federally Qualified Health Centers [FQHCs], and primary care clinics) to meet the needs of underserved and vulnerable patients and diverse systems of care?

What are the critical barriers and facilitators that contribute to the adoption and sustainability of evidence-based COVID-19 testing interventions in public health, clinical practice, and school/academic environments, particularly in the context of evolving COVID-19 trajectories, experiences, perceptions, and policies?

What are the key determinants for understanding circumstances that create a need to stop or reduce ( de-implement ) the use of practices related to COVID-19 testing that are ineffective, low-value or in-equitable?

What are optimal context-specific strategies and considerations for successfully disseminating evidence relating to the need for de-implementation of practices related to COVID-19 testing that are ineffective low-value or in-equitable?

What are effective efforts to change behavior at multiple levels (individual, clinician, system, or policy level) related to COVID-19 testing and prevention to reduce health disparities and improve quality of care?

Key project requirements:

Testing

All projects funded by this NOFO must:

Use only SARS-CoV-2 tests (including rapid COVID-19 and other tests) that are FDA EUA/approved/cleared, including molecular and antigen tests. The term test covers any tests, laboratory procedures/process, measurements, or other applications, as well as those reagents, instruments, kits/devices, and systems used in the procedure, for the collection, preparation, and examination of human biological specimens, whether for diagnostic or research only purposes. Serology/Antibody and other adaptive immune response tests are not allowed for these projects.

Include specific plans to return individual test results to participants, if proposing COVID-19 surveillance. Surveillance with no plans to inform individuals of their test results is not allowed.

Include specific plans to address potential challenges associated with reduced access to and/or increase cost of testing kits.

Applications Not Responsive to this NOFO:

The following types of projects will be considered non-responsive and will not be reviewed:

Applications that do not focus on dissemination and implementation research. Proposals must contain a plan to implement, scale up an existing evidence-based COVID-19 testing intervention, or de-implement practices that are ineffective, low-value or in-equitable.

Projects without a focus on one or more underserved and COVID-19 vulnerable populations

Projects that have limited population reach (considering the size of the target populations and its COVID-19 epidemiologic profile)

Projects that do not demonstrate an existing relationship with or engagement strategy with the target community

Projects that involve COVID-19 testing interventions outside of the United States

Projects that do not address social, ethical, and behavioral consequences of their proposed design and methods and may exacerbate health disparities in COVID-19 diagnostic testing

Projects that are exclusively qualitative (though mixed quantitative and qualitative are acceptable)

Projects that do not include the use of FDA EUA/approved/cleared diagnostic tests and supplies that are utilized on-label (that is, in the way they are authorized/approved/cleared.) Note: All parts of study specimen collection, testing, assays, and processing of human specimens, including any requirements of CLIA certification, must be covered by FDA EUA/approval/clearance.

Projects proposing serology/antibody and other adaptive immune response tests or focusing exclusively on vaccination

Projects that are exclusively surveillance and do not include specific plans to return test results to individuals

Investigators planning to apply in response to this NOFO are encouraged to contact and discuss their proposed research/aims with Program staff listed on this NOFO well in advance of the application receipt date to better determine appropriateness and interest.

A pre-application webinar related to this funding opportunity will occur on May 24, 2023, at 1:30 PM. Registration is required. Please register here for the webinar. Questions can be pre-submitted at RADxInfo@nih.gov by 11:59pm local time on Friday, March 19^th, 2023, for the May 24^th, 2023, webinar.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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.

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. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 notice of funding opportunity 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 Emily.Foley@nih.gov

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

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

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

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

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

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

R&R or Modular Budget

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

A budget is required.

R&R Subaward Budget

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

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

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

All projects funded by this NOFO must:

Include milestones towards progress and a timeline for completion. Annual progress reports will include both testing results and information regarding barriers and facilitators of COVID-19 testing and emerging challenges to implementation of the proposed research.

Demonstrate a history of success recruiting and retaining participants within the specified target populations and where appropriate, include sample size and power calculations to justify the anticipated reach.

Include community-engaged/driven partnerships (such as public health departments, with Tribal governments and agencies, community medical centers or health systems, safety-net health or social service systems, pharmacies, grassroots organizations, community and faith-based organizations, schools, and childcare settings) and community partners as investigators, where possible. Study budgets should include funds to compensate community partners to participate in research design and implementation. Applicants may wish to leverage the resources available through the RADx-UP Coordination and Data Collection Center (CDCC) and the Community Engagement Alliance (CEAL) Against COVID-19 Disparities.

Provide letters of support from the community partners. When required, Tribal resolutions should be included with the application, if possible, but before funds are awarded in all cases.

Include a description of sustainability for their infrastructure and partnerships that may be leveraged for future public health pandemic mitigation efforts, including vaccine and/or therapeutic implementation efforts.

Specify strategies to address individual and structural social determinants of health (SDOH) that present barriers to the dissemination and implementation of COVID-19 testing interventions. Projects must use RADx-UP CDEs for measuring SDOH. For SDOH data elements not covered by the RADx-UP CDEs, projects are strongly encouraged to leverage relevant measures from the Core and Specialty SDOH collections that are available in the PhenX Toolkit.

In addition, all funded projects are expected to:

Propose scientific questions and methods that are forward-thinking with innovative and flexible research plans, procedures, and protocols that can be adapted as the trajectories of COVID-19 cases, variants, hospitalizations, and mortality, and related COVID-19 policies, change over time.

Occur in settings with high potential risk of COVID-19 transmission, including residential care facilities, correctional facilities, and other congregate settings, clinical settings, healthcare systems, universities, K-12 schools, early childcare settings, the workplace, social venues or large gatherings (e.g., concerts, sporting, religious or cultural events).

Conduct rapid and effective outreach, communication, and dissemination activities to inform communities about the project and its findings to increase COVID-19 prevention and control in communities that have been impacted disproportionately.

Disaggregate study results by sex; race and ethnicity; age and other relevant demographic factors, and to consider intersectionality as appropriate.

Demonstrate knowledge of and to comply with federal, state, local, and/or Tribal requirements on testing, reporting, and surveillance policies in study protocols.

Support early-stage investigators and diverse teams, including underrepresented investigators as well as community partner as investigators.

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

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.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Specific to this NOFO, projects will be required to:

Collect all NIH RADx -UP Tier 1 and Tier 2 Common Data Elements (CDE) to standardize the collection of data and ensure that data can be aggregated and compared across study populations and research topics (where not otherwise prohibited such as by Tribal sovereignty). Collected data should be deidentified and harmonized (possibly via the RADx-UP CDCC if the CDCC is still active at the time of data submission) and submitted to the RADx Data Hub. NIH RADx -UP CDEs are available at: https://radx-up.org/research/cdes/

Acquire permission from participants to collect and share research data for general research reuse, through specific language in the Informed Consent Form (ICF).

In addition, projects are encouraged to:

Obtain and retain personal identifiers on all research participants where it is not prohibited (e.g., Tribal data sovereignty) for future longitudinal follow-up and to be leveraged for intervention research. Data collected from this program will be protected by a Certificate of Confidentiality.

Coordinate and collaborate with the RADx -UP Coordination and Data Collection Center (CDCC) during its tenure (anticipated through 2025), including participating in CDCC-organized activities: monthly cross-site meetings, cross-site working groups, and dissemination activities (of effective implementation strategies, tools and measures, etc.).

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.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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.

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.

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 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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. No late applications will be accepted for this funding opportunity.

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:

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

In addition, for applications involving clinical trials

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

Specific to this NOFO:

If the aims of the proposed project are achieved, how impactful will the results be to the science of dissemination and implementation in underserved communities?

How broad a reach (to the population that will benefit from the knowledge/intervention) will be achieved and how equitable will reach and outcomes likely be through the knowledge/service delivery contexts selected?

How well have the resource requirements and costs of the implementation or de-implementation strategies been considered?

How well will potential adopters and organizations be able to determine the applicability of the results to their setting?

Investigator(s)

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

In addition, for applications involving clinical trials

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

Specific to this NOFO:

How appropriate is the expertise of the key personnel to conduct community engaged and dissemination and implementation research?

How well established and strong is the engagement and collaborations between the investigators and community? How well will these collaborations be able to support accomplishing the project aims?

Innovation

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

In addition, for applications involving clinical trials

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

Specific to this NOFO:

How much potential does the study proposed have to speed the translation of research into practice and/or produce novel and robust findings?

Approach

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

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

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?

Specific to this NOFO:

How able is the research team to adapt and respond quickly to the changing dynamics (e.g., variants, cases, hospitalizations, deaths, availability of tests and supplies, personal protective equipment, closures, public health guidance, population specific changes, etc.) of the COVID-19 pandemic?

How feasible and appropriate are the plans for integrating community partners into the study?

How well has the applicant justified the study design on the basis of the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation?

How appropriate are the partnerships and collaborations the applicant has established with the communities of interest?

How appropriate, relevant, practical, and rigorous are the research methods proposed to conduct the study? How relevant and appropriate to the problem and population of interest are the proposed dissemination or implementation approaches?

How appropriate are the procedures to assess and analyze the dissemination or implementation strategies appropriate?

How well aligned are the measurements and analysis plan linked to the study aims, and how appropriately does the analysis incorporate the best available data to track dissemination or implementation process and impact, including cost-effectiveness?

Where applicable, how well does the proposed plan for analysis take into account hierarchical relationships among multiple levels of outcomes (e.g., patient, provider, system)?

Environment

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

In addition, for applications involving clinical trials

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

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

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

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

Specific to this NOFO:

How well-positioned are the applicants to influence large or influential networks capable of taking the results of the proposed study to scale to achieve public health impact?

How well will the proposed approaches be able to take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements?

How well will institutional supports be able to sustain dissemination or implementation strategies once the research funding ends?

Additional Review Criteria

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons. No late applications will be accepted.

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 NOFO.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the RADx-UP Governance Committee and the RADx Executive Committee. 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.
• Compliance with data management and sharing policies

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. 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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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.

NIH may make awards using funds, if available, provided in the emergency supplemental appropriations for COVID-19 and coronavirus research: American Rescue Plan Act of 2021 . If funds are awarded using appropriations provided by the American Rescue Plan Act of 2021 , funds will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Interim Reports

In addition to the annual RPPR, recipients of awards funded with supplemental appropriations for COVID-19 and coronavirus research are required to submit an interim progress report every six months outlining key milestones that have been met.

• Recipients of awards made with supplemental appropriations for COVID-19 and coronavirus research must upload the interim report using the Additional Materials (AM) tool in eRA. The Authorized Organization Official is required to submit interim reports to the Grants Management Official named on the Notice of Award using AM.
• The interim progress report must outline for each award the following:
  • For each specific aim, a brief summary of major activities, significant results, and key outcomes or other achievements.

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75 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 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.

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: https://www.era.nih.gov/need-help (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: 301-480-7075

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

Elizabeth Walsh, PhD
National Institutes of Health, Office of the Director (OD)
Telephone: 301-480-8127
Email: RADxInfo@nih.gov

Cheri Wiggs, PhD
National Eye Institute (NEI)
Telephone: (301) 402-0276
Email: wiggsc@mail.nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov

Jonathan W. King, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Division of Behavioral and Social Research
Phone: (301) 402-4156
E-mail: kingjo@mail.nih.gov

Jarrett A. Johnson, DrPH
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-827-6919
Email: johnsonjara@mail.nih.gov

Changhai Cui, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-1678
Email: changhai.cui@nih.gov

Lori Ducharme
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-827-6331
E-mail: lori.ducharme@nih.gov

Lindsey Ann Martin, PhD
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984-287-4036
E-mail: lindsey.martin@nih.gov

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

Maliha Ilias, PhD
National Heart, Lung, and Blood Institute
Telephone: 301-451-9921
Email: maliha.ilias@nih.gov

Jenna Norton, Ph.D., MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-928-5509
Email: jenna.norton@nih.gov

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

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

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

Wen-Ying Sylvia Chou, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6954
Email: chouws@mail.nih.gov

Michele McGuirl, Ph.D.
NIGMS
Email: michele.mcguirl@nih.gov

Yanli Wang
NLM
Phone: 301-827-7092
Email: yanli.wang@nih.gov

Paul S. Eder, Ph.D.
NIAID
Phone: 240-627-3252
Email: paul.eder@nih.gov

Collene Lawhorn, Ph.D.
National Institute of Mental Health (NIMH)
phone: 301-828-7186
Emai: collene.lawhorn@nih.gov

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

Ryan Blakeney
NIA - NATIONAL INSTITUTE ON AGING
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
Email: Karen.Robinson.Smith@nei.nih.gov

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Jenny L Greer
NIEHS - NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Phone: 984.287.3332
E-mail: jenny.greer@nih.gov

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

Anthony Agresti
National Heart, Lung, and Blood Institute
Telephone: 301-827-8014
Email: anthony.agresti@nih.gov

Charlette Kenley
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-8847
Email: charlette.kenley@nih.gov

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov

Christy Leake
NIGMS
Email: christy.leake@nih.gov

Samantha Tempchin
NLM
Phone: 301-496-4222
Email: tempchins@mail.nih.gov

Sam Ashe
NIAID
Phone: 301-435-4799
Email: Samuel.Ashe@nih.gov

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

Erin Davis
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-4238
Email: erin.davis@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.

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.