Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title
Development of Sample Sparing Assays for Monitoring Immune Responses (U24 Clinical Trial Not Allowed)
Activity Code
U24 Resource-Related Research Projects – Cooperative Agreements
Announcement Type

Reissue of RFA-AI-14-027

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-AI-19-017
Companion Funding Opportunity

None

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

93.855

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development and validation of sample sparing assays that can be applied for studying the human immune system in health and disease. Development of new, cutting-edge sample sparing assays will lead to maximum use of the human-derived specimens by significant reduction of sample volumes/amounts required or by simultaneous multi-parameter assessments of immune function.

Key Dates

Posted Date

March 27, 2019

Open Date (Earliest Submission Date)
June 30, 2019
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)
July 30, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)
July 30, 2019, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review
November 2019
Advisory Council Review
January 2020
Earliest Start Date
March 2020
Expiration Date
July 31, 2019
Due Dates for E.O. 12372

Not Applicable

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to develop cutting-edge assays that will enable complex immune monitoring from small volume samples derived from human subjects. Studies are sought to accelerate the development and validation of sample sparing assays that can be applied for studying the human immune system in health and disease. Development of sample sparing assays will lead to maximum use of the biological specimens by significant reduction of sample volumes/amounts required or by simultaneous multi-parameter assessments of immune function. By expanding the spectrum of parameters that can be measured on small samples derived from human subjects, assays developed in response to this announcement will be valuable for advancing the fundamental understanding of the immune system. Advances in this field will also be important for immune monitoring of healthy individuals and those with allergy, asthma, autoimmunity, primary immunodeficiency, transplantation, as well as in infectious diseases and vaccinology research.New sample sparing assays will have a major impact on clinical studies aimed at understanding immune functions in infants and young children where sample availability is most limited.

Background

The NIAID’s Division of Allergy, Immunology and Transplantation (DAIT) and Division of AIDS (DAIDS) support a wide range of research programs spanning basic immunology, translational and clinical research on HIV and immune-mediated diseases, including autoimmune and primary immunodeficiency diseases, allergic diseases, graft-versus host disease (GVHD) and allograft rejection in organ, tissue and cell transplantation. DAIT and DAIDS currently sponsor a wide variety of clinical trials that incorporate a strong emphasis on defining the underlying immunological mechanisms associated with the treatment and prevention of these diseases. Major constraints encountered in designing mechanism of action studies are related to limited quantity of biological specimens available for study and the paucity of robust, validated, miniaturized assays that can reliably and reproducibly assess immune function, disease state or effects of therapy. The restricted amounts of tissue, cells and fluids that can be collected from adult, pediatric or immunocompromised patients are often inadequate for the application of conventional assays that interrogate immune function. Novel, multi-parameter, sample sparing assays are needed to obtain maximal biologic information from limited amounts of biological materials. Emerging scientific technological advances such as microfluidic multiplexing, nanotechnology, mass cytometry, as well as high dimensional genomic, proteomic and transcriptional profiling, allow for simultaneous interrogation of an unprecedented number of parameters and provide opportunities for the development of novel, miniaturized, multi-parameter assays of immune function.

Combining these methods may best facilitate evaluation of a multiplicity of cell functions. For example, flow cytometry studies combined with assessments of cell function, such as cytokine secretion, mRNA profiling, or kinase activity, have revealed a high degree of heterogeneity within cell populations. In addition, for the first time, contemporary sequencing methods have enabled the study of heterogeneity within the adaptive arm of the immune system by interrogating antigen receptors on single B and/or T cells. Metabolomic and proteomic approaches have also enabled measurement of hundreds of analytes in serum and plasma, adding an additional level of complexity. Furthermore, development of microfluidic platforms has permitted studies on cell heterogeneity with significant cost reduction and enhanced precision.

Research Objectives and Scope

The goal of this FOA is to accelerate development of robust, reliable, reproducible and multifunctional sample sparing assays for direct application in studies of the human immune system in healthy and diseased individuals. This FOA will support studies to develop novel assays for assessing human immune function in health and disease using biologic specimens that are available in limited sample volumes (e.g., blood, biologic fluids, tissue biopsies, etc.). It is expected that assays developed in response to this FOA will add valuable tools for immune-monitoring strategies leading to a better understanding of immune responses in general, as well as immunologic changes associated with disease prevention/remission/progression and responses to treatment. In addition, it is anticipated the new tools will ultimately facilitate development of improved clinical biomarkers of disease heterogeneity/severity. This initiative is not aimed at the discovery of new immune signaling pathways, nor the definition of new immune ligands and receptors, but rather at new ways to miniaturize or/and multiplex the measurement of biological markers related to immune status and function. The sample sparing assays developed through this FOA are intended to address challenges, gaps or unmet needs in the study of human immune responses and provide clear advantages over existing assays. The assay development must predominately use human cells, tissues, or fluids. When animal models are used validation with primary human cells, tissues or fluids is required. At the end of the award, the expectations are: 1) development of a novel or significantly improved, robust sample sparing assay, 2) assay validation studies in primary human cells or tissue, and 3) submission of Standard Operating Procedures (SOPs)/protocols and relevant data sets for the research community through ImmPort.

Applications that include multi-parametric measurements and/or technologies that integrate assessments of distinct aspects of human immune function are strongly encouraged.

Development of alternative approaches to visualize data generated from the proposed assay is encouraged if existing visualization approaches are inadequate.

Sample sparing immune assays of interest may include, but are not limited to, monitoring or assessments of the following:

  • Antigen-specific immune responses
  • Distinct immune cell (sub)populations
  • T-cell and B-cell regulatory networks
  • Innate immune responses
  • Markers of T-cell turnover and homing to organs and/or lymphoid tissue
  • Cytokine and signaling networks
  • Gene and protein expression and regulation
  • Mucosal inflammatory and innate immune responses
  • In vivo detection and functional characterization of immune cells infused for therapeutic purposes; e.g., T regulatory cells
  • Persistent HIV reservoirs in tissues of infected individuals on fully suppressive antiretroviral therapy

Technologies of interest may include, but are not limited to:

  • Microfluidic platforms
  • Novel cell-based assays
  • Multiplexed phenotypic imaging for various cell function studies
  • Multiplexed mass cytometry (CyToF) profiling
  • Multiplexed fluorescence/mass microscopy techniques
  • Highly multiplexed flow cytometry approaches (e.g., quantum dots, semiconducting polymer dots, imaging flow cytometry)
  • Nanotechnology-based biosensing platforms
  • New microarray technologies
  • Next generation sequencing technologies

Applications proposing studies in the following areas will not be supported by this FOA and will not be reviewed:

  • Clinical trials (Phases 1 – 3)
  • Identification of new biomarkers
  • Validation of biomarker candidates
  • Research projects that rely exclusively on animal studies and animal disease models. Animals may be used in assay development stages, but all assays must be validated using primary human samples (e.g., primary human cells, tissues or fluids)
  • Development of assays using established cell lines without validation in primary human samples (e.g., primary human cells, tissues or fluids)
  • Virus induced cancer studies
  • Studies that do not fall within the NIAID mission

Steering Committee

All PDs/PIs will be required to participate in a Steering Committee that will be formed after award to foster collaborations among awardees, accelerate assay development efforts and provide overall advice on future research directions. The steering committee will be composed at a minimum of PDs/PIs of each of the awards and a NIH Project Scientist serving as the representative of the NIH. The Steering Committee will also make recommendations regarding the use of the Infrastructure and Opportunities Fund.

Infrastructure and Opportunities Fund (IOF)

To capitalize on emerging opportunities consistent with the goals of the Development of Sample Sparing Assay (DSSA) program an Infrastructure and Opportunities Fund (IOF) will be made available to one institution chosen from successful applicants by NIH after award to manage for the entire DSSA program. This institution must agree to take responsibility for managing the IOF, and includes establishing an administrative structure, disbursement and tracking of funds, and reporting status. Examples of activities supported by the IOF may/could include collaborative and pilot/feasibility projects; resource development and sharing opportunities; translational projects; early stage investigator projects. IOF projects must be within the scope of this FOA and may be submitted by awardees or by outside investigators.

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

Section II. Award Information

Funding Instrument
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
Application Types Allowed
New

Renewal of RFA-AI-14-027

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $5M in FY 2020 to fund 8-10 awards and includes total costs of $0.5M annually to support an Infrastructure and Opportunities Fund (IOF).

Award Budget

For this funding opportunity, budgets may be requested up to $0.85M direct costs per year which includes a limit on the budget for the Infrastructure and Opportunity Fund of $0.5M direct costs per year, and a limit on the U24 research project of $0.35M direct costs per year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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)
  • 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
Foreign Institutions

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations

Applicant organizations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

 

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

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

 

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:

Priti Mehrotra, Ph.D.
Telephone: 240-669-5375
Email: PMehrotra@niaid.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments: The following attachment is required for this FOA. The filename "IOF.pdf" should be used.

Applicants must provide: An Infrastructure and Opportunities Funds (IOF) Management Plan that describes how the IOF will operate to serve the DSSA program.

The IOF management plan must include:

  • an administrative structure;
  • plans for the logistics for solicitation, review, and award of pilot projects, including receipt of applications;
  • proposed procedures to support the Steering Committee in the timely award of consortium agreements, including the time interval for establishment and renewal of consortium agreements;
  • tracking and monitoring of timely submission and payment of invoices, and plans for handling consortium agreement administration delays;
  • plans for interacting with the institutions that will receive IOF funds;
  • reporting on the status of the funds and consortium agreements awarded;
  • plans to ensure regulatory compliance (e.g., IACUC approvals, human subjects reporting), and collection of materials for inclusion in the parent grant's annual progress reports.
  • Describe plans and procedures to ensure that all projects supported from the IOF will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in projects and appropriate ethical oversight.
This section should only include information about the management of the IOF and should NOT include any IOF proposed research projects.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
  • Provide information about the previous experience and qualifications of individuals in managing and administering an IOF Management Core, specifically issuing subaward agreements, tracking expenses, and submitting quarterly reports.
 

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

  • Include a budget for attendance of the PD(s)/PI(s) and one of the key personnel to an initial scientific meeting to be held soon after award, and annual face to face meetings (2-days per meeting each year) following the initial meeting. Meetings will be held in the Washington, D.C. metropolitan area.
  • Include costs related to data management and submission to ImmPort.
  • Applications must include a budget and justification for the $0.5M direct costs per year for the IOF. Within the justification applicants should justify the salary and effort of the IOF administrator and other personnel.
  • IOF application budgets must include the following costs:
  • A maximum of 1 calendar months' salary for the IOF Management Leader.
  • A minimum of 2 calendar months' salary for an IOF administrator to be included in the Other Personnel category.
  • Costs for pilot/feasibility projects per year to be included in the Other Direct Costs category for the remaining funds.
  • IOF travel for either the IOF administrator to attend the annual DSSA program Steering Committee meeting in the Bethesda/Rockville, Maryland area.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Describe the resources that will be provided to the research community.

Research Strategy: Include the following information:

  • A detailed description of the proposed plan for sample sparing assay(s) that includes an explanation of why the existing technology/methodology is inadequate;
  • A description of how the proposed assay is superior to, or significantly extends, currently available technologies and addresses an unmet need;
  • Details on the current development stage of the proposed technology;
  • Details on how the sensitivity or specificity of detection is increased or the sample size required for testing is reduced for small biologic samples;
  • A description of how the proposed technology introduces new multilevel analyses of cell function;
  • Details explaining the potential broad applicability of the proposed technology;
  • Preliminary data to demonstrate the feasibility of the approach and results clearly indicating what the new assay offers in terms of specificity, sensitivity or sample size reduction;
  • A description of the standardization/validation approaches and reproducibility assessments that will be used in the assay development phase;
  • Details of benchmark technology to which the new assay will be compared;
  • A discussion of the potential of the new technology to be widely used in basic and clinical human subjects research;
  • Plans for validation of the assay in human samples, if preliminary data are generated in animal models/cell lines;
  • Explain the significance of the specific technical approach with special emphasis on reproducibility and standardization.
  • Outline how Good Clinical Laboratory Practice (GCLP) standards will be utilized in assay development (see www.niaid.nih.gov/sites/default/files/gclp.pdf).

Provide the following plans for data submission to ImmPort:

Milestones

  • Outline detailed and quantitative annual milestones and Go/No-Go decision points for the project. These may be captured in a variety of tools, such as: Gantt charts, selection algorithms and decision trees. The milestones and Go/No-Go decision points should identify and quantify both success and failure of proposed activities at each development decision point. Do not restate the Specific Aims; include a quantitative description of what constitutes successful development. Discuss how the milestones will lead to the desired product properties and how the scientific and operational objectives will evolve as milestones are achieved. Discuss how the milestones support the potential for the overall program to advance the proposed technology.
  • Include planned timelines for executing tasks needed for completion of the work to be accomplished during the award.
  • Include a description of each stage of assay development, criteria for completing each stage and contingency plans if the milestones are not met.
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:

PD(s)/PI(s) are expected to share assay development and validation data along with developed SOPs with the general scientific community through NIAID’s Immunology Database and Analysis Portal (ImmPort). ImmPort is a contract supported by NIAID that provides support for handling and housing datasets along with developed SOPs in ImmPort (http://www.immport.org/immport-open/public/home/home), a data sharing platform. ImmPort has templates for data collection from various assays and established procedures for data exchanges that can be adapted by NIAID supported research programs. ImmPort also is charged with developing additional standards for data collection, curation, and exchange to meet the specific needs of NIAID-supported research programs.

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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.

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

Section V. Application Review Information

1. Criteria

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

Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

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

Does the proposed assay have significant potential to achieve higher sensitivity or specificity over existing approaches for analyzing small biologic samples? Does the proposed assay introduce new multilevel analyses of cell function? Is the proposed technology broadly applicable?

 

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?

 

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?

 

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?

Do the preliminary data demonstrate feasibility? Are animal models appropriately validated in human samples? Are assay standardization and reproducibility assessments included in the assay development plan?

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?

 

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?

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

Milestones

Given the critical nature of the milestones to measure the success of program and development of sample sparing technologies, are the proposed milestones and Go/No-Go criteria well-defined with quantifiable measures that are appropriate for assessing success? Are the milestones appropriate, adequately described, feasible and achievable within the proposed time frame for the elements they support?

Do the proposed milestones lead to the desired product properties? Is it clear how the scientific and operational objectives will evolve as milestones are achieved? Given the potential benefits of the proposed research, do the milestones support the potential for the overall program to advance the proposed technology?

Is provision of the proposed IOF management services to the DSSA program described in sufficient detail? Is sufficient justification provided for the management methods proposed for the IOF? Are the personnel charged with managing the IOF appropriate?

 

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.

 

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

 

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

 

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

 

Not Applicable

 

For Renewals, the committee will consider the progress made in the last funding period.

 

Not Applicable

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

 

Not Applicable

 

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

 

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

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all 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.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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.

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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.

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.

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. HHS provides general 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/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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, 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:

  • Setting Project Milestones and timelines to achieve the proposed goals;
  • Develop a succession plan that addresses potential changes in leadership of the award;
  • Establish and implement mechanisms of quality control in data collection and management;
  • Develop and implement a plan for making the resources developed under this program available to the broad research community; and
  • Deposit final data and assay SOPs to ImmPort.

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

The NIH Project Scientist will:

  • Evaluate yearly Milestones and provide guidance to investigators regarding study implementation and design;
  • Participate as a non-voting member of the Steering Committee;
  • Help coordinate program activities through the Steering Committee;
  • Participate in the design of activities recommended by the Steering Committee;
  • Advise in the selection of sources or resources (e.g., determining where a resource may be found);
  • Assist in promoting and encouraging the sharing of unique research resources developed under this program;
  • Help to maintain the overall scientific balance on the program commensurate with emerging research opportunities; and
  • Assist awardees in refining and implementing the Sharing Unique Resources Plan.
  • Funding beyond the first year may be subject to downward negotiation depending on the progress.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Steering Committee

Infrastructure and Opportunities Fund (IOF): The NIH Project Scientist and PD(s)/PI(s) from the funded projects will establish a Steering Committee. The DSSA program Steering Committee will oversee the Infrastructure and Opportunities Fund, consistent with the goals of the program. The Steering Committee will devise and implement procedures, practices, and subcommittees as needed, for the IOF solicitation, receipt, review, development, evaluation, and recommendation of feasibility, pilot, resource development, or collaborative projects or potential resource sharing opportunities and other collaborative needs. The Steering Committee will also assess additional professional and administrative staffing needs beyond the administrative support provided as part of the requirements to manage the IOF budget and activities (e.g. for review activities or IT needs as required) and provide assessment to the NIH Project Scientist. In addition, the Steering Committee will be responsible for an annual report of progress of projects, status of funds, and other activities funded by the IOF program, including outcomes of all completed projects.

Results and research plans will be discussed, as determined by NIAID.

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 arbitration. An Arbitration 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
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.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Scientific/Research Contact(s)

Kasia Bourcier, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3482
Email: bourcierkd@niaid.nih.gov

Peer Review Contact(s)

Priti Mehrotra, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5375
Email: PMehtrotra@niaid.nih.gov

Financial/Grants Management Contact(s)

Kevin Lyons
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3513
Email: lyonskd@niaid.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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