Part 1. Overview Information

Key Dates

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 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/).
• In order to maximize progress and successful outcomes, recipients 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.

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:

• Data Harmonization for Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).

• A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.

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.

• Use of existing technologies (e.g., geospatial data, city-wide statistical reports) to inform and optimize sample collection.
• Assessing the needed granularity of testing at community- or neighborhood-level to detect and mitigate spread of the virus.
• Integration of existing epidemiological data on COVID-19 morbidity within specific populations inform an efficient and optimized sample-collection

Demonstration and optimization of wastewater sample analysis approaches.

• Optimization of protocols to ensure safety of people conducting the analyses (i.e., inactivation of virus and other pathogens present in sample prior to analysis).
• Assessment of the impact of key variables, such as water temperature, average in-sewer travel time, and per-capita water use on virus detection.
• Comparative analysis of specific existing technologies often used for WBT (such as LC-MS) for efficiency and timeliness of COVID-19 detection.
• Combined analysis of MS based WBT with other complementary approaches (e.g., high-throughput metagenomic sequencing) that can be readily deployed to detect broader spectrum and possible mutations of the COVID-19 virus.
• Development of methods for quantitative measures of the targeted viral concentration and pathogenicity in wastewater.
• Development and optimization of rapid field-based assays be optimized from point-of-care tests for use in environmental virus detection (e.g., microfluidics, nanomaterials, biosensors, and aptamers)
• Implementation and development of optimized approaches to extrapolate estimation of population-level data within the community.
• Assessment of key variables (e.g., viral load in human waste, density in wastewater, population density, volumetric wastewater flow rates, wastewater treatment regimens) affect pre-capita estimation of disease prevalence based on a specific sample collection and analysis.
• Application of algorithms (e.g., artificial-intelligence approaches based on machine-learning) to optimize accuracy of predictive models for virus spread among neighborhoods and communities.

Development of optimized intervention strategies.

• Application of data provided to improve short-term intervention practices, (e.g., neighborhood or dormitory quarantine efforts based on wastewater estimations of prevalence)
• Development of long-term prevention strategies at the municipal level in areas with low confirmed prevalence of COVID-19.
• Development of an early warning system based on WBT analysis of viral load and spread.

Incorporation of computational, statistical, and mathematical models.

• Use of models developed by the team to inform study design and for subsequent integration and analysis of complimentary data sets such as wastewater based environmental, geospatial, and socio-economic data to enhance impact of the models.
• Leverage ongoing infectious disease modeling efforts such as the Models of Infectious Disease Agent Study (MIDAS) network (https://midasnetwork.us) to incorporate the SARS-COV-2 wastewater detection data into existing and future studies.

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.

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 FOA.

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 Governments

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

Other

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

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. In the case of Emergency awards, if the applicant is unable to comply with the requirement to complete and maintain SAM registration at the time of application submission, contact the agency immediately.
  • 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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:

Leonardo Angelone, Ph.D.
Telephone: 301-827-5946
Email: [email protected]

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.

R&R or Modular 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.

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:

• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan

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.

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.

Foreign Institutions

Not applicable

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.

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 [email protected] 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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

For this particular announcement, note the following:

• This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, preliminary data is not explicitly required in the application.
• Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.
• This FOA is for the optimization of existing technologies and approaches. As proof-of-concept is required prior to entry, innovation will in part be evaluated by having a clear, comprehensive, and credible path towards transitioning an existing technology to broad and routine practice.

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?

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?

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.

2. Review and Selection Process

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please 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 further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. 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.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please 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 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:

• Supporting the Key Component Activities, including determining approaches, designing, and setting project milestones and implementing the project plan;
• Coordinating the development, adoption and implementation of the agreed-upon policies;
• Coordinating knowledge and experience sharing with respect to various tools and approaches utilized in conducting research in community and health care settings, including their strengths and weaknesses;
• Coordinating the communication of issues related to data quality, data management, data biases and errors, query quality and sampling challenges, and pitfalls in utilization of testing and health care data for research;
• Coordinating the communication of study designs, methods, protocols, tools, and strategies;
• Participating in group activities, including program-wide Work Group(s) and Steering Committee meetings;
• Cooperating with other awardees in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources;
• Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand and apply to their research projects with minimal assistance;
• Providing expertise and leadership in addressing issues of broad applicability, such as data sharing standards, analysis methodology, and dissemination
• Work with the RADx-rad Data Coordinating Center (DCC) to submit common evaluation metrics on COVID-19 testing-related outcomes and implementation to the DCC. Identify a dedicated unit responsible for these data reporting activities. Actively coordinate, collaborate, and share data with the RADx-rad Data Coordinating Center, as allowed, and with considerations under tribal IRB processes, as appropriate. To the extent possible, coordinate the data acquisition, collection, and curation strategies with the DCC guidance for annotation and benchmarking of data;
• 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;
• Providing information to the NIH Program Officer(s) and Project Scientist(s) concerning progress
• Awardees will retain custody and having primary rights to the data and software at the awardee institution developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and goals of this program, when not limited by Tribal data sharing policy.

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:

• Serving as a liaison, helping to coordinate activities, including acting as a liaison to other NIH Institutes/Centers, and as an information resource for the awardees;
• Providing advice in the management and technical performance of the award;
• Assisting in coordinating activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new resources and methodologies;
• Assisting in promoting the availability of the data and related resources developed by the award program to the scientific community at large;
• Participating with the applicants in addressing issues that arise with planning, operation, assessment, and data analysis;
• Participating in data analyses, interpretations, and where warranted, co-authorship of the publication of results of studies conducted through the program;
• Reviewing and commenting on critical stages in the program implementation;
• Assisting in the interaction between the awardee and investigators at other institutions to promote collaborations;
• Assisting in coordinating access to other resources available through statewide, regional, or national specialized technology project;
• Convening meetings/workshops to address emerging areas of high priority;
• Retaining the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
• Retaining the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget;
• Reporting periodically on progress to the Program Officer.
• Other NIH staff may assist the awardee as designated by the Program Official.

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:

• Prior to funding an application, the Program Official will contact the applicant to discuss the proposed milestones and any changes suggested by NIH staff or the NIH review panel. The Program Official will negotiate with the applicant and agree on a final set of approved milestones which will be specified in the Notice of Award;
• Determine if the awardee has met the milestones required for each year of funding;
• Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
• Assist in enforcing general statutory, regulatory or administrative assistance policy requirements;
• Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer reviewed funding mechanisms;
• Provide assistance in reviewing and commenting on all major transitional changes prior to implementation to ensure consistency with the goals of this FOA;
• Monitor institutional commitments and resources to ensure that the project receives the maximum chance of stabilization and success;
• Assist with financial oversight of the Program

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.

3. Reporting

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.

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: 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: [email protected] (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: [email protected]

National Institute on Drug Abuse (NIDA):

Leonardo Angelone, Ph.D.
301-827-5946
[email protected]

National Library of Medicine (NLM):

Valerie Florance, Ph.D.
301-496-4621
[email protected]

National Institute of Environmental Health Sciences (NIEHS):

David Balshaw, Ph.D.
984-287-3234
[email protected]

National Institute of General Medical Sciences (NIGMS):

Julia Barthold, M.D.
301-435-0832
[email protected]

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: [email protected]

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.