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
A Multidisciplinary Approach to Study Vaccine-elicited Immunity and Efficacy against Malaria (U01 Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AI-20-064
Companion Funding Opportunity

None

Number of Applications

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

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

93.855

Funding Opportunity Purpose

The purpose of this initiative is to support research to advance understanding of the underlying immune mechanisms that contribute to malaria vaccine-elicited protection or vaccine hypo-responsiveness in endemic regions by capitalizing on recent research advances in systems vaccinology and systems immunology as well as emerging opportunities in data science and informatics. Multidisciplinary science and collaboration among investigators from the malaria vaccine research field and other relevant scientific areas are highly encouraged. The goal is to identify host signatures and mechanistic factors that influence malaria vaccine performance in endemic regions to guide and improve future vaccine design and evaluation.

Key Dates

Posted Date
October 07, 2020
Open Date (Earliest Submission Date)
January 08, 2021
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

February 8, 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

Not Applicable

 

 

Scientific Merit Review

June 2021

Advisory Council Review

October 2021

Earliest Start Date

February 2022

Expiration Date
February 09, 2021
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 initiative is to support research to advance understanding of the underlying immune mechanisms that contribute to malaria vaccine-elicited protection or vaccine hypo-responsiveness in endemic regions by capitalizing on recent research advances in systems vaccinology and systems immunology as well as emerging opportunities in data science and informatics. Multidisciplinary science and collaboration among investigators from the malaria vaccine research field and other relevant scientific areas are highly encouraged. The goal is to identify host signatures and mechanistic factors that influence malaria vaccine performance in endemic regions to guide and improve future vaccine design and evaluation.

Background

Development of a malaria vaccine with at least 75% protective efficacy is one of the Research and Development (R&D) targets initially identified in the Malaria Vaccine Technology Roadmap and adopted by the Global Vaccine Action Plan. After decades of malaria vaccine development efforts, one malaria vaccine, RTS,S/AS01E (Mosquirix ®) has emerged that conferred approximately 36% protection against clinical malaria in children in a Phase III trial. Under a World Health Organization (WHO)-coordinated pilot implementation program, this vaccine is currently being introduced in Ghana, Kenya, and Malawi to provide further evaluation of its performance in field deployment situations. Many others, including vaccines focusing on the pre-erythrocytic stage of malaria, are in preclinical development or clinical evaluation.

Historically, development of malaria vaccines has typically involved an initial assessment in a malaria-naïve population followed by assessment in populations in malaria-endemic areas including adults, children, and infants. It has been recognized that malaria vaccines are typically more immunogenic and efficacious in malaria-naïve populations than in malaria-exposed individuals (i.e., malaria vaccine hypo-responsiveness in endemic regions). Differential vaccine efficacies have also been observed among various age groups within endemic regions, and among target populations residing in regions with different transmission intensities or parasite population diversity. The underlying immune mechanisms that contribute to these differential vaccine efficacies are not fully understood.

After years of research attempting to elicit and define vaccine-induced protective immunity for malaria, many host immune responses have been associated with defined clinical outcomes post-vaccination; none, however, have provided a clear mechanistic explanation or consistently predicted vaccine efficacy. It is likely that multiple arms of the immune response are required for combating this disease with a complex pathogenesis. Many multi-faceted features and confounding variables, such as parasite diversity, levels of parasitemia, impact of co-infections, nutritional/metabolic status, disease manifestations as well as vaccine composition, immunization regimens, and timepoints of analysis, could impact vaccine efficacy in field settings. Therefore, innovative approaches and new research strategies are needed to overcome the deficits in understanding how protective immunity is conferred by various malaria vaccines, and the host and environmental factors that differentially impact on vaccine performance in endemic areas.

Systems immunology and systems vaccinology research has enabled detailed immune profiling and mechanistic studies of vaccine responsiveness and performance. These approaches include many emerging immunologic and -omics tools to collect systems level data, especially high dimensional data, such as CyTOF, EpiTOF, single-cell ATAC-seq, and other high-throughput (HTP) experimental technologies. Novel bioinformatics and computational tools permit data integration and analysis across different biological variables or technical platforms and facilitate discovery of new molecular networks and biomarkers. In addition to well-characterized unique human cohorts, cutting-edge biology research tools have become available for testing and validating mechanistic findings, such as novel organoid systems, newly generated animal models, or in vitro functional assays. Furthermore, new principles in biological data management and stewardship, such as FAIR (Findable, Accessible, Interoperable, Reusable) principles, are emerging and promoting an open science research environment. Many NIAID-supported research programs, established resources, and infrastructure facilitate access to tools and knowledge needed for acquisition, management, and further comprehensive analysis of world-wide malaria field data and malaria vaccine and immunology data. Examples include the Human Immunology Project Consortium (HIPC), the Systems Biology Consortium for Infectious Diseases, the International Centers of Excellence for Malaria Research (ICEMR), Bioinformatic Research Center (which includes PlasmoDB and VectorBase), ImmPort data repository, Immune Epitope Database and Analysis Resource, ImmuneSpace, and many other public data repositories.

Access to the accumulated information and samples from malaria vaccine clinical trials or studies carried out over the past decade and to the associated metadata, derived from populations that vary in age, geography, intensity, and duration of prior exposure to malaria, now provide unprecedented opportunities to dissect out factors affecting clinical outcomes of vaccination. Building on the current knowledge of malaria vaccines and associated immunology, technological advances, and emergence of data science, this FOA solicits applications to systematically carry out immune profiling and comprehensive analyses of pre-erythrocytic malaria vaccine immunity, and the confounders that influence vaccine performance in endemic regions. This FOA especially encourages cross fertilization of new ideas and collaboration among investigators from different research fields to generate, test, and validate new hypotheses leading to identification of immune signatures or other biomarkers that explain or predict pre-erythrocytic malaria vaccination outcome.

Research Objectives and Scope

This initiative will support multi-disciplinary research that expands current understanding of malaria vaccine-induced protective immunity in humans as well as additional host and environmental factors that impact vaccination outcome in endemic regions, with a focus on pre-erythrocytic stage malaria vaccines.

This FOA will only support research topics related to pre-erythrocytic vaccines for Plasmodium parasites that cause human disease, especially P. falciparum and P. vivax. The goal is to gain a more mechanistic understanding of why endemic populations tend to be less responsive to malaria vaccination, and the challenges of achieving high level and durable protection conferred by pre-erythrocytic malaria vaccines in endemic areas. The successful outcome of this program is expected to guide future vaccine design and clinical evaluation that will more predictably accelerate translation of new candidates from the laboratory to the field.

The goal of this FOA is to enhance our understanding of malaria vaccine performance in endemic regions, including the level and/or durability of vaccine-induced immune protection, and to identify and validate host and environmental factors that impact on vaccination outcomes. Applications proposing research that will capitalize on recent scientific advances in systems immunology and vaccinology, as well as emerging opportunities in data science, informatics, and computational modeling are strongly encouraged. Applicants are encouraged to propose research efforts in one or more of the three major topic areas described below:

  • Baseline immune status: To characterize baseline human immune status and how it impacts or predicts malaria vaccine responsiveness, including the level or durability of protection. Applicants may propose to use data or samples from distinct cohorts from Controlled Human Malaria Infection (CHMI) studies or from other studies conducted in endemic areas to generate datasets for comprehensive analysis. Data or samples from malaria-naïve cohorts are acceptable as long as the study is linked to addressing malaria vaccine issues in endemic areas. Examples of studies of baseline immune status include, but are not limited to:
  • Comparative studies of baseline status across populations (i.e., involving two or more distinct populations) or within populations (i.e., among members within a defined population);
  • Subpopulation studies among non-, low-, or high-responders to malaria vaccination in endemic regions;
  • Characterization of how baseline status shapes malaria vaccine immunogenicity or efficacy;
  • Identification of baseline drivers of malaria vaccine hypo-responsiveness, including host or environmental factors, such as age, gender, genetic variation, microbiome, baseline inflammation, co-infection, nutrition, previous vaccinations and infections, Plasmodium exposure history and Plasmodium immune status;
  • Longitudinal epigenetic studies of innate or T/B cells in previously malaria exposed individuals;
  • Establishment of immunological signatures of baseline immunity that can be scaled for use in population studies.
  • Vaccine-elicited immunity and correlates of vaccine outcomes: To investigate vaccine-elicited immune responses, including innate, adaptive, and other cellular or molecular pathways, that are associated with vaccine immunogenicity and efficacy. Applicants may propose to acquire or generate large scale datasets (e.g., immune profiling) or other relevant data from vaccine clinical studies/trials and conduct integrated data analysis for hypothesis generation research. All datasets should include malaria vaccine and immunological data and other datasets that are relevant to achieving the proposed objectives. Hypothesis generation research should build on acquisition, generation, and analysis of immune profiling datasets, coupled with clinical metadata and vaccine end point assessment data. Analysis can also be performed by integration with other HTP datasets of systems biology studies. Data or samples can be from clinical cohorts residing in endemic areas or non-endemic areas (as long as the goal of the study is linked to vaccine outcome in endemic areas). Research that leads to the identification of correlates of protection or unique biosignatures that associate with or predict malaria vaccination outcomes are encouraged. Examples of studies on vaccine-elicited immunity or correlates of vaccine outcomes include, but are not limited to:
  • Immune profiling of human responses pre- and post-vaccination including characterization of B-and T-cell repertoires and antigen specificities in responders and non-responders;
  • Measurement of longitudinal dynamic changes in immune profiles to address vaccine duration topics;
  • Integrated analysis of multiple arms of immune responses (innate and adaptive immunity) to understand protective mechanisms and predict vaccine efficacy;
  • Studies to understand the role(s) of innate immunity (e.g., “trained immunity”) on pre-erythrocytic vaccine-induced immunity and efficacy;
  • Head-to-head comparison of different forms of pre-erythrocytic vaccines (i.e., different technology platforms, formulations, or regimens) with regards to their immunogenicity, functionality, or other derived “omics” or vaccine-related data;
  • Analysis of data combined from different studies/clinical trials to address the role of potential confounders on vaccine immunity, e.g., parasitemia asymptomatic malaria, or different regimens (same vaccine);
  • Analysis of novel correlates of vaccination outcome, including efficacy, duration, or disease risks, and identification of signatures that modify or predict vaccination outcome or vaccine hypo-responsiveness.
  • Mechanistic studies: To investigate factors that contribute to variation in baseline immune status or to vaccine-induced protective immunity and efficacy. Applicants may propose to prospectively test and substantiate the derived hypotheses of significance using additional data or samples from alternative cohorts, unique in vitro systems, such as primary human cells, organoids, or human immune mimics, or novel animal models. Applicants may propose mechanistic studies with strong and convincing scientific hypotheses derived from previous human immune profiling research projects. Examples of mechanistic research studies include, but are not limited to:
  • Dissection, identification, or validation of factors that contribute to baseline immune status or variation;
  • Dissection, identification, or validation of host biosignatures or mechanisms that contribute to a vaccine performance (level or duration of vaccine efficacy) or hypo-responsiveness;
  • Identification of novel approaches to restore abnormal baseline immune status (e.g., anti-malaria drug to eliminate parasitemia);
  • Discovery of new pre-vaccination interventions or novel approaches to overcome vaccine hypo-responsiveness or contribute to vaccine potency and durability (e.g., anti-inflammatory reagents, adjuvants, etc.) in endemic regions;
  • Discovery of vaccine-induced immune effector mechanisms that function in control and elimination of malaria.

Data Management and Analysis Research Focus

The purpose of the Data Management and Analysis Research Focus is to support the research in adopting and promoting data science principles. Applicants will need to identify a data repository for the relevant work, identify novel analytical tools and engage data science expertise to provide appropriate perspective for the research program. Applicants are expected to dedicate responsible personnel to work closely with staff from public portal designated by NIAID for data submission, analysis, presentation, and visualization.

Data Repository: Applications will utilize ongoing NIH/NIAID or other publicly available resources to house and analyze all the relevant data and information generated under the award. Applicants must adopt FAIR principles to better manage and share data with the wider scientific community to enhance the rigor and reproducibility of research results and secondary use of data per the NIAID Data Sharing Guidelines. Applicants shall provide a plan to delineate how to manage data sharing including timely data and information deposition, release, and dissemination. Applicants are encouraged to use NIH and NIAID supported open domain-specific repositories and knowledgebases especially NIAID ImmPort, VectorBase, or EuPathDB for broad sharing of domain-specific data, or generalist repositories or other publicly available data repositories as appropriate to achieve sharing and rapidly self-publish all useful and usable data that do not have a domain-specific repository, data underlying publication figures and tables, or useful data not associated with publications. Machine-readable/computable formats are strongly encouraged as opposed to PDF format data submissions.

Analytic Tools: Applicants are strongly encouraged to leverage novel analytical tools, such as natural language processing, machine learning, artificial intelligence (AI) technologies, novel bioinformatics, or computational modeling, to assist in management, analysis, and visualization of large datasets. Collaboration with experts from relevant research areas is highly encouraged. Secondary analysis or data mining of existing datasets to attain relevant scientific objectives will also be supported.

Engage Data Scientist Experts: Applicants are encouraged to include a data manager to be responsible for their site’s data management and information security services. The site should provide bioinformatics and data integration expertise and analysis support, including computational modeling if necessary, for the application. Although not required, the site may propose to modify or improve analytical technologies needed to achieve the proposed specific research objectives, such as innovative bioinformatics, new and enhanced computational algorithms, methods and tools, machine learning software, and statistical inference methods.

Milestones and Timelines

Applications must include measurable milestones and timelines to delineate research objectives, including data generation/acquisition, analysis, or testing, submission and sharing.

Annual Program Meetings

One kick off meeting and annual program meetings will be held to articulate and establish the major roles and functions of the program, facilitate collaborations, promote optimal research flexibility and efficiency, revisit project milestones and timelines, report on research progress and outcomes, seek new research directions and ideas, and update NIAID on issues of need. Meeting attendees will include PDs/PIs and key scientific staff from each award, the NIAID Program Official and other NIAID staff, in addition to members of the Scientific Advisory Group.

Scientific Advisory Group (SAG)

A SAG for the overall program will be established by NIAID post-award to monitor and evaluate ongoing projects and programs in terms of providing advice to the awardees on scientific progress and reported outcomes. Note that applicants should not name or contact potential SAG members.

Applications proposing any of the following topic areas will be considered nonresponsive and will not be reviewed:

  • Research areas related to malaria vaccines targeting to other life cycle stages of Plasmodium (e.g., asexual stage, sexual stage);
  • Research applications that involve blood stage or transmission stage immunity in human without a clear purpose of addressing pre-erythrocytic vaccine issues;
  • Applications addressing Plasmodium of animal species or immune profiling of animals for the purpose of animal Plasmodium parasite research without a focus on pre-erythrocytic stage human vaccines;
  • Studies that do not include an assessment of human immune profiles in response to pre-erythrocytic vaccines or human Plasmodium infection;
  • Studies to address malaria natural acquired immunity or malaria epidemiology that are not linked to pre-erythrocytic vaccine efficacy research;
  • Studies on baseline immunity or early response profiles without matching to malaria vaccine outcomes;
  • Studies solely using in vitro culture systems (transformed human cell lines or organoids, etc.) or animal models;
  • Systems immunology or systems biology studies that do not address pre-erythrocytic malaria vaccine issues;
  • Applications to conduct antigen or vaccine discovery research, preclinical process development, or production and testing of clinical trial materials;
  • Clinical trials (all phases), CHMI studies, malaria vaccine immunization program (Note: collecting data or samples from such studies that are implemented under other auspices will be supported).

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $5M in FY 2022 to fund 3-5 awards.

Award Budget

Application budgets are limited to $750,000 in direct costs per year and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

  • 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)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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

Number of Applications

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

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.

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:

Inka Sastalla, Ph.D.

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 301-761-6431

Email: sastallai@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.

SF424(R&R) Senior/Key Person Profile

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,

with the following additional instructions:

Within the budget section, applicants should include funds for the following specific costs:

  • Annual Meeting travel for the PDs/PIs, other key personnel, and up to two to-be-named SAG members to travel and attend annual one-day programmatic meetings to be held in Rockville, MD. Do not include costs associated with the organization and implementation of the meetings.
  • Support of submission of data, data analyses, and bioinformatics/computational tools to ImmPort, NIAID Bioinformatics Resources, or other databases designated by NIAID.
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:

Research Strategy:

  • Describe how the project will advance the understanding of immune mechanisms that contribute to malaria vaccine immunity and efficacy as well as variables that influence malaria vaccine responsiveness or has the potential of leading to the discovery of biosignatures that correlate or predict malaria vaccine performance.
  • Describe how the proposed research represents the best use of current knowledge or emerging technologies to acquire/generate, manage, and analyze data to achieve the specific objectives and aims, and how the project has the potential to contribute to future data science practice for the research community.
  • Discuss the overall approach to data generation or collection, and analyses that will address one or more of the three areas of interest, baseline immune status, vaccine-elicited immunity and correlates of vaccine outcomes, or mechanisms.
  • Discuss the composition of the multi-disciplinary investigative team with regard to the collective expertise that will lend support to the scope of the proposed research, including the scope of disciplines required to address compliance with data sharing and the use of NIAID or publicly available open data resources.
  • Describe and justify the source of the samples (either pre-existing or to-be-collected) and provide evidence that the samples are appropriate for use by the project. For example, the number of samples available, relevant sample metadata, expected quality and quantity of materials for the proposed studies, sample de-identification protocol, informed consent or plan for re-consenting for sample usage, etc. must be outlined.
  • Describe how the proposed research will address unbiased data acquisition. Include a justification for the datasets generated via systems biology including HTP experimental approaches, such as immunological, molecular, functional, epigenetics, or other high dimensional vaccinomics datasets. Discuss the rationale for the chosen datasets acquired from publicly available or other pre-existing datasets, generated from human samples that have been collected from previous malaria vaccine clinical trials, CHMI studies, or immunization programs. If proposed, describe the rationale for collecting additional clinical samples from relevant clinical cohort studies that are independently funded.
  • In a separate section labeled, Data Management and Analysis Research Focus, describe how the structure, functions and staffing of this research section will optimally support the goals of the proposed research.  Applicants must provide a plan to delineate how to manage data sharing including timely data and information deposition, release, and dissemination.
  • In a separate section labeled, Milestones and Timelines, state the interim objectives and detailed, quantitative annual milestones to be achieved during the project that define progress and success. Identify stepwise approaches for data acquisition or generation, analysis, deposition, and sharing. Provide a detailed timeline for the attainment of each goal.

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, should address a Data Sharing Plan.
  • Investigators must publicly share their data acquired in their U01-supported projects through ImmPort, ImmuneSpace, or other public portals designated by NIAID. The data sharing plans should describe procedures to be used to achieve this goal as appropriate.
  • All data should be submitted to ImmPort or other public portals within 9 months to 1 year of submission or upon publication, whichever comes first.
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 human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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.

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: To what extent will the anticipated results from the research adequately advance the understanding of the underlying immune mechanisms that contribute to malaria vaccine-elicited protection or vaccine hypo-responsiveness in endemic regions leading to the development of improved outcomes for humans?

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: Does the proposed research team leverage multi-disciplinary expertise to address the stated objectives? Are the designated personnel sufficient to enable compliance with the data- and other resource-sharing policy?

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: Does the research plan represent the best use of current or emerging knowledge and technologies to investigate and understand the underlying mechanisms accounted for malaria vaccine outcomes?

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:

  • Are the milestones/timelines provided well-justified and appropriate for the scope of the research project?
  • Within the Data Management and Analysis Research Focus, how well do the structure, functions and staffing plan for this research focus support the unique research questions addressed? Are there appropriate bioinformatics infrastructure(s) to support the proposed activities? Is there adequate support for the development and use of novel analytical tools? Is the plan for sharing, access and release and public dissemination of generated data and research resources adequate and reasonable?

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?

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.

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

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.

Applications from Foreign Organizations

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

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 (2)  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 Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases (NIAID), 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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned 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.
  • Compliance with data- and resource-sharing policies.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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:

  • Serving as the lead for scientific and administrative oversight for the proposed research, including overseeing, managing, and coordinating the overall Program.
  • Ensuring successful completion of the data- and other resource-sharing plans negotiated with NIAID.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

  • Providing input into the design of research activities and advise in project management and technical performance.
  • Coordinating NIAID staff assistance with regard to:
  • Oversight and monitoring of collaborative research
  • Feasibility of timely progress towards completion of planned activities
  • Plans for incorporation of new technologies or other resources
  • Evaluating the adequacy of data-sharing and other resource-sharing plans. NIAID program staff may require modifications of sharing plans with the applicant.
  • Facilitating collaborations with, and access to, other NIAID-supported research resources and services.
  • Serving as a liaison/facilitator among awardees and with the NIAID ImmPort or BRC knowledge based databased and other web portals.
  • Periodically reviewing data and access confidential data generated under this Cooperative Agreement for use in the preparation of internal reports on the activities of the awardees.
  • Establishing the Scientific Advisory Group.
  • 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:

  • NIAID program staff and the PDs/PIs will coordinate the scientific objectives and progress at the annual meeting to facilitate the achievement of program goals.
  • NIAID program staff and the PDs/PIs will collaborate to revise project milestones prior to initial or annual awards, based on peer review of the originally proposed milestones and/or PDs/PIs and/or NIAID program staff assessment of the proposed yearly milestones.

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.

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)

Annie Mo, Ph.D.
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3320
Email: moa@niaid.nih.gov

Joseph Breen, Ph.D.
Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4123
Email: jbreen@niaid.nih.gov

Peer Review Contact(s)

Inka Sastalla, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6431
Email: sastallai@niaid.nih.gov

Financial/Grants Management Contact(s)

Paula Acevedo
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-2860
Email: paula.acevedo@mail.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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