EXPIRED
National Institutes of Health (NIH)
Office of The Director, National Institutes of Health (OD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Library of Medicine (NLM)
This Funding Opportunity Announcement will be administered by the National Institute on Drug Abuse (NIDA) on behalf of the NIH.
U01 Research Project Cooperative Agreements
New
NOT-OD-20-144 - Notice of Intent to Publish Funding Opportunity Announcements for the RADx-rad Initiative
RFA-OD-20-019 - U24 Resource-Related Research Projects Cooperative Agreements
93.310, 93.279, 93.113, 93.879, 93.859
The National Institutes of Health (NIH) is issuing this funding opportunity announcement (FOA) in response to the declared public health emergency issued by the Secretary, Department of Health and Human Services (DHHS), for the 2019 Novel Coronavirus (COVID-19). This emergency FOA provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. As one of the programs within the NIH Rapid Acceleration of Diagnostics-Radical (RADx-rad) program the RADx-rad Wastewater Detection of SARS-COV-2 (COVID-19) FOA will support wastewater-based testing (WBT) surveillance which can provide detailed mapping of the extent and spread of COVID-19. Wastewater testing has been shown to be orders of magnitude cheaper and faster than clinical screening, albeit serving as a complementary approach rather than substituting individual-level testing and screening. The purpose of this FOA is to solicit cooperative agreements both for field studies and for small business research and development projects in the field of WBT, to address topics such as: investigation and demonstration of specific approaches aiming to increase sensitivity and to inform and optimize sample collection; implementation and development of optimized approaches to extrapolate estimation of population-level data within the community; development of optimized intervention strategies, and incorporation of computational, statistical, and mathematical models.
The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.
August 15, 2020
September 15, 2020
No late applications will be accepted for this Funding Opportunity Announcement
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not applicable
October 2020
Not Applicable to this Emergency Initiative
December 1, 2020
Not Applicable
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.
NIH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).This emergency funding opportunity announcement (FOA) from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) project.
Research in response to this FOA can be proposed to address any aspect of wastewater-based testing, including but not limited to the following: 1) investigation of specific approaches aiming to inform and optimize wastewater sample collection, 2) demonstration and optimization of wastewater sample analysis approaches, 3) development of optimized intervention strategies, and 4) incorporation of computational, statistical, and mathematical models.
The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.
Background
SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. On March 11, the SARS-CoV-2 outbreak was classified as a pandemic by the WHO. Research is an important component of the public health emergency response before, during and after the emergency. The United States Food and Drug Administration (FDA)-authorized COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. Given this, there is an urgent public health need for the National Institutes of Health (NIH) to support the development of a variety of approaches to testing.
Expanding the capacity, throughput, and regional placement of existing technologies and accelerating the development of new technologies will contribute significantly to the current national efforts to curb the COVID-19 pandemic. To help meet this need, NIH launched the Rapid Acceleration of Diagnostics (RADx) program to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The RADx program is a national call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies.
As part of this program, the NIH developed the RADx Radical (RADx) initiative. RADx-rad will support new, or non-traditional applications of existing approaches, to enhance their usability, accessibility, and/or accuracy. RADx-rad will be centrally aligned and coordinated to harmonize the data collection, storage, and management, providing an opportunity to further explore and identify additional approaches to understand this novel virus. Beyond the current crisis, it is anticipated that the technologies advanced through RADx-rad may also be applicable to other, yet unknown, infectious agents.
To centrally align and coordinate RADx-rad projects to harmonize the data collection, storage, and management, the Data Coordination Center (DCC) will be established to serve as the hub in a hub-and spoke organizational framework within the funded RADx-rad research and development projects serving as spokes. In turn, the DCC will serve as a spoke in the larger NIH RADx initiative by providing de-identified data to an NIH-based data hub. NIH expects that all projects funded under this FOA will actively coordinate, collaborate, and share data with the RADx-rad Data Coordinating Center, as allowed, and with considerations under tribal IRB processes, as appropriate. The RADx-rad DCC will provide support and guidance to RADx-rad awardees in the following three areas: (1) Administrative Operations and Logistics, (2) Data Collection, Integration and Sharing, and (3) Data Management and Use. The DCC will develop (and revise as necessary) a framework for standards, metadata and common data elements that apply to all types of data gathered by RADx-rad awardees in order to maximize potential for longitudinal research, integration with other RADx data, and for evaluation of RADx-rad program impact. The DCC will assist awardees in identifying and obtaining data from public sources (e.g., Census data, Area Deprivation Index, etc.), electronic health records (EHR), administrative data, and others as needed. The DCC will coordinate quality control, data curation, and analyses, and provide tools to monitor progress, performance, and use of the curated data. The DCC will create a mechanism to support harmonizing with other large-scale COVID-19 research efforts and will participate in trans-NIH efforts to support scientific collaboration and data-sharing, evaluation of progress towards sustainable infrastructure, partnership and rapid dissemination of RADx findings.
NIH requires that all projects funded under this FOA will actively coordinate, collaborate, and share data with the RADx-rad Data Coordinating Center (DCC), and with considerations under tribal IRB processes, as appropriate. Researchers applying to this funding opportunity are strongly encouraged to review the DCC funding opportunity (RFA-OD-20-019).
To maximize research and rapidly implement approaches to address the COVID-19 pandemic, comparisons across datasets or studies and data integration are essential to collaboration. Projects funded through this RFA are strongly encouraged to use the following resources as applicable:
Because traces of COVID-19 can be detected in human effluent, wastewater (i.e. sewage) sample testing can be an efficient and effective way to test defined population areas for the presence of COVID-19. Wastewater-based testing can be used alongside national and local data sources to provide cost-effective and objective measures of the presence of a specific compound (e.g., drug, virus). For over 20 years, wastewater-based testing (WBT), initially proposed by the U.S. Environmental Protection Agency, has been used in Europe, Australia, and the U.S. to test for the presence and extent of substance use in communities. Wastewater-based epidemiology (WBE) has also been successfully used as a surveillance tool for SARS, hepatitis A, and polio. Recent ongoing studies based on WBT with COVID-19 have provided an earlier prediction of an outbreak of COVID-19 cases, compared to data provided by individual-level testing, suggesting the possibility of using these data to inform early containment and mitigation measurements.
Historically, wastewater analysis approaches have focused on downstream sample collection, namely at the water treatment plants, which provides broad, city-level sampling that cannot be directly used to guide more localized estimates and related interventions. More recent novel approaches have focused on upstream sample collection, which allows for more granular, community- and neighborhood-level resolution. Advantages of such an approach, compared to individual-level testing, include the ability to capture a broader population size, the ability to be deployed in communities where individual-level testing may be difficult to implement, and anonymity of testing, which may reduce barriers to testing related to stigma. Community-level sampling can also be deployed in settings with a high risk of disease transmission (e.g., criminal justice facilities, assisted living/nursing home facilities, dormitories), within communities that are particularly vulnerable to COVID-19 due to underlying health conditions or other factors, and in areas with marginalized populations where access to or utilization of healthcare services, including individualized testing, may be limited. WBT-based surveillance can provide detailed mapping of the extent and spread of COVID-19 and has been shown to be orders of magnitude less expensive and faster than clinical screening, albeit serving as a complementary approach rather than substituting for individual-level testing and screening. Early engagement of communities in the identification of testing sites and implementation of testing, as well as dissemination of the data produced and reporting back to the community, may also improve compliance with community guidance aimed at preventing the spread of SARS-CoV-2, and mitigation strategies. Longer-term, the approaches developed for SARS-CoV-2 detection in wastewater could be leveraged to enable creation of early warning systems for future outbreaks of known and emerging pathogens.
Research in response to this FOA can be proposed to address any aspect of wastewater-based testing, including but not limited to the following:
Investigation of specific approaches aiming to inform and optimize wastewater sample collection.
Demonstration and optimization of wastewater sample analysis approaches.
Development of optimized intervention strategies.
Incorporation of computational, statistical, and mathematical models.
Projects that do not have an infrastructure to rapidly report study findings and impact to the Data Coordinating Center (DCC) will be considered non-responsive and will not be reviewed.
Leveraging Existing Research Resources: Applicants are strongly encouraged to leverage existing research resources for their studies whenever possible. NIH has developed innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public through programs such as: NCATS Clinical and Translational Science Awards (CTSA) Program, Research Evaluation and Commercialization Hubs (REACH), Small Business Education and Entrepreneurial Development (SEED) for assistance in proof of concept and commercialization of a marketable product. Applicants are encouraged to leverage all available internal (e.g., home institutional) and external (e.g., external institutional, NIH, and/or NIDCR and NCATS) resources to identify clinically relevant COVID-19 patient populations.
See Section VIII. Other Information for award authorities and regulations.
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.
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.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIH intends to commit $19 Million to fund 5-10 awards.
Application budgets are limited to $2,000,000 per year in Direct Costs and need to reflect the actual needs of the proposed project.
The maximum period is 2 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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 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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Leonardo Angelone, Ph.D.
Telephone: 301-827-5946
Email: leonardo.angelone@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 FOA.
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.
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, with the following additional instructions:
The Specific Aims should be stated concisely and include activities for both the development of tools and technologies for SARS-CoV-2 wastewater analysis and field-work demonstrations of wastewater-based epidemiology (WBE) as outlined above. Aims should include hypothesis-driven experiments, and/or plans to reduce major barriers to approaches that currently are costly, difficult, or take too long to perform. Specific and measurable key milestones should be described.
The Research Strategy should include a description of the multidisciplinary approach to building and applying resources for WBE for SARS-CoV-2 through solution-oriented research. Additionally, how the sample collection and testing methodologies represent an improvement over current approaches with respect to usability, accessibility, sensitivity, specificity, and/or accuracy. Also, a description on how the proposed approach allows for rapid deployment of technologies and methodologies for optimal sample and epidemiological data collection, quantitative viral detection, and assurance of safety. Projects must include an evaluation plan demonstrating how the proposed COVID-19 diagnostic strategies/activities will be assessed for effectiveness and impact.
Optimization of existing technology is expected, as well as a research plan that includes a translational activity to apply the technologies in field work. Innovative approaches may include, but are not limited to, novel ways of extrapolating estimation of population-level data within the community or novel computational, statistical, and/or mathematical models.
While preliminary data is not explicitly required the application should clearly outline a solid rationale and conceptual framework to demonstrate the technical feasibility of the approach. In addition, applicants should outline their approach to research translation and the extension of novel tools and methods into field work. The potential of the proposed approach to yield important contributions applicable to a range of populations and settings, or to inform intervention and prevention strategies, should be addressed. A description of how the institutional environment will facilitate community engagement to identify sites, and facilitate testing implementation and dissemination of results, should be included. Partnership with a small business is encouraged but not required; such partnerships should include a commercialization plan for the resulting products of this research and letters of interest, additional funding commitments, and/or resources from the private sector that would enhance the likelihood for commercialization.
Project Milestones and Timeline: The Approach section should include specific, measurable milestones and a project timeline. For each milestone, details on methods, assumptions, experimental designs, data analysis plans, and interdependencies should be provided. Additionally, feasible and appropriate plans to submit data, data collection instruments, and outcomes/products to the DCC should be included.
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:
Only limited Appendix materials are allowed.
Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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.
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.
Not applicable
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.
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.
Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDA Referral Office by email at NIDAReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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.
Only the review criteria described below will be considered in the review process.
For this particular announcement, note the following:
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).
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?
Specific to this FOA: How well does the project propose investigation and demonstration of specific approaches that will optimize wastewater sample collection and SARS-CoV-2 analysis, leading to implementation of testing in appropriate populations? Do the proposed sample collection and testing methodologies represent an improvement over current approaches regarding usability, accessibility and/or accuracy? Will it serve to facilitate hypothesis-driven experiments, or reduce major barriers to approaches that currently are costly, difficult, or take too long to perform?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: Do the backgrounds, expertise, and commitments of the PD(s)/PI(s) and other key personnel demonstrate a record of accomplishment in the context of large networks or consortia; community engagement; testing; and data analysis? For applications involving multiple PDs/PIs, are their designated roles and responsibilities well defined, adequate, and complementary? How well do the proposed collaborations among the PD(s)/PI(s) and other key persons integrate to achieve the overarching research goals? Have the investigators demonstrated complementary expertise and an ongoing record of collaboration?? How well does the application describe how the investigative team will remain up to date on the changing landscape of SARS-CoV-2 testing in various settings?
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?
Specific to this FOA: To what extent does this application propose novel approaches to optimize wastewater sample collection SARS-CoV-2 testing? Do the proposed development and implementation strategies incorporate novel ways of extrapolating estimation of population-level data within the community? Are novel computational, statistical, and/or mathematical models proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA: Will the proposed approach allow for rapid deployment of technologies and methodologies for optimal sample and epidemiological data collection, quantitative viral detection, and assurance of safety? Does the application leverage existing computational models and/or other complementary methodologies to achieve these goals? Is the overall plan rigorous, well rationalized, and supported by clear milestones that are measurable and feasible? Is the proposed approach likely to yield important contributions applicable to a range of populations and settings, or to inform intervention and prevention strategies?
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?
Specific to this FOA: Will the institutional environment facilitate community engagement to identify sites, and facilitate testing implementation and dissemination of results?
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.
For Small Business Concerns: Does the proposed project have commercial potential to lead to a marketable product, process or service? To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector that would enhance the likelihood for commercialization?
Coordination plans: How feasible and appropriate are the plans to submit data, data collection instruments, and outcomes/products to the DCC?
Data Sharing Plan: If the proposed research will generate unique resources or data that may impact the public health response or medical countermeasure development, does the resource sharing plan adequately address the rapid dissemination of data, results, and analyses to the broader scientific community, using existing public repositories whenever possible when not limited by Tribal data sharing policy, as a foundation for further study?
Is there a convincing path towards a sustainable product for wide dissemination as appropriate and consistent with achieving the goals of the program? Reviewers should evaluate the resource sharing plan focusing on the following elements: a) Project management of resource sharing or dissemination; b) Description of the specific resources to be shared; c) Milestones with schedule for availability and for breadth of dissemination; d) Persons who will have access to the resources (written as broadly as possible to the extent consistent with applicable laws, regulations, rules, and policies); e) Plan for post award disposition of resources. It is expected that preference will be given towards eventual commercial manufacture, although plans with an end-goal of future dissemination capitalizing on existing NIH or alternate funding agency funding mechanisms will be considered.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not applicable
Renewals
Not applicable
Revisions
Not applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and () Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate internal NIH review group , using the stated review criteria.
As part of the scientific peer review:
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 review will not be accepted for applications submitted in response to this FOA.
The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (i.e., Tribal data sovereignty). The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products, and procedures to improve human health. Grantees are expected to work with the RADx-rad DCC to submit common evaluation metrics on COVID-19 testing-related outcomes and implementation to the DCC. Grantees should identify a dedicated unit responsible for these data reporting activities. NIH expects that all projects funded under this FOA will actively coordinate, collaborate, and share data with the RADx-rad DCC, as allowed, and with considerations under tribal IRB processes, as appropriate. Researchers applying to this funding opportunity are strongly encouraged to review the DCC funding opportunity. To the extent possible, data acquisition, collection, and curation strategies should be coordinated with the DCC guidance for annotation and benchmarking of data, including obtaining appropriate consent for data sharing and implementation of the schemas proposed under the ABOUT ML effort ( Annotation and benchmarking on understanding and transparency for machine learning lifecycles ; available at https://www.partnershiponai.org/about-ml/). Grantees are expected to participate in DCC-organized activities, including regular (e.g., monthly) progress meetings with individual or subsets of awardees, and twice annual meetings with all RADx-rad awardees.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 Parts 75 and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to each project.
NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
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:
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:
NIH reserves the right to withhold funding or curtail an award in the event of:
Substantive changes in the project, or failure to make sufficient progress toward the work scope with which NIH concurred
Ethical or conflict of interest issues
Collaborative Responsibilities
Areas of Joint Responsibility include close interaction among the participating investigators, as well as significant involvement from the NIH, to manage and assess the project. The awardees and the Project Scientist(s) will meet annually in person and monthly via conference calls to share information on methodologies, analytical tools, and preliminary results. PDs/PIs, key co-investigators and pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings.
The awardee agrees to work collaboratively to:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
Provide for secure, accurate and timely data submission.
Participate in presenting and publishing new processes and substantive findings
Assess and disseminate data and resources
Interact with other relevant NIH activities, as needed, to promote synergy and consistency among similar projects.
Funds awarded using appropriations provided by the Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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: 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
National Institute on Drug Abuse (NIDA):
Leonardo Angelone, Ph.D.
301-827-5946
leonardo.angelone@nih.gov
National Library of Medicine (NLM):
Valerie Florance, Ph.D.
301-496-4621
florancev@mail.nlm.nih.gov
National Institute of Environmental Health Sciences (NIEHS):
David Balshaw, Ph.D.
984-287-3234
david.balshaw@nih.gov
National Institute of General Medical Sciences (NIGMS):
Julia Barthold, M.D.
301-435-0832
julia.barthold@nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov
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.