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
Mucosal Immunology Studies Team (MIST) (U01 Clinical Trial Not Allowed).
Activity Code
U01 Research Project – Cooperative Agreements
Announcement Type

Reissue of RFA-AI-15-023

Related Notices
July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128

August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137

Funding Opportunity Announcement (FOA) Number
RFA-AI-20-027
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 solicit applications from institutions/organizations to participate in a cooperative research group, the Mucosal Immunology Studies Team (MIST), focusing on immune mechanisms and immune regulation at mucosal surfaces of the respiratory, gastrointestinal and urogenital tracts. The main objective of this program is to break new ground in the understanding of basic mucosal immune mechanisms by introducing new ideas, approaches and technologies that address the difficult questions in mucosal immunology.

Key Dates

Posted Date

April 24, 2020

Open Date (Earliest Submission Date)
September 09, 2020
Letter of Intent Due Date(s)

September 9, 2020

Application Due Date(s)

October 9, 2020

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

February 2021

Advisory Council Review

May 2021

Earliest Start Date

June 2021

Expiration Date
October 10, 2020
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 from institutions to participate in a cooperative research group, the Mucosal Immunology Studies Team (MIST). The objective of MIST is to discover and define novel basic immune mechanisms, cells, mediators, and pathways that provide a more complete understanding of mucosal immune mechanisms; to explore innovative hypotheses; and to address difficult unsolved questions in mucosal immunity. The eventual goal is to develop the knowledge needed to facilitate future development of immunotherapies and vaccines to protect mucosal surfaces from infection and immune-mediated pathology/disease. Studies may use relevant animal models or human tissues to achieve this goal. This program is not intended to support development and/or evaluation of mucosal vaccines or therapies, or research primarily focused on pathogens.

Background

The mucosal immune system satisfies a range of diverse requirements from maintaining limited microbial burden in the lungs and upper reproductive tract to coexisting with many trillions of bacteria in the large intestine. An imbalanced mucosal immune response to food, allergens, microbial flora, or pathogens can lead to tissue damage or chronic inflammation. Therefore, responses at the mucosa require tight regulatory control. Recent studies have provided new clues about the strategies and cellular and molecular components used at different mucosal surfaces to detect and respond to pathogens and benign antigens without causing chronic inflammation, but much remains unknown.

With the goal of promoting a collaborative program to encourage basic and translational research focused on immunity at mucosal surfaces, the Mucosal Immunology Studies Team (MIST) was initiated in 2011 (RFA AI-10-008) and renewed in 2016 (RFA AI 15-023). The program has supported 21 U01 awards, 2 cores (imaging, animal models), and 43 pilot projects including early career awards, innovative collaborations, and translational projects. More information about these projects is available at the MIST website: https://mucosal.org.

Research Objectives and Scope

This FOA will support a cooperative study group, the Mucosal Immunology Studies Team (MIST), focused on research to define fundamental aspects of immunity at mucosal surfaces. This FOA intends to stimulate new basic and applied research that will contribute toward understanding broadly applicable mechanisms of mucosal immunology.

Areas of interest and research studies responsive to this FOA include but are not limited to those listed below. Many of the following areas of investigation are not new, but advances in recent years suggest that these areas have matured to a level where directed research efforts can have an impact. These and other research areas may be addressed in this FOA in the context of defining new mechanisms relevant to immune responses at the mucosa. If infectious organisms/vaccines/adjuvants or mucosal diseases are used for the proposed studies, they must be employed as model agents/diseases to probe host mucosal immune responses to discover new information about mechanisms of immunity. Studies may use relevant animal models or human tissues to achieve this goal.

Mucosal Epithelium: Barrier, Defense, Antigen Sampling, Immune Response Orchestration. Mucosal surfaces are lined by tightly joined epithelial cells, which form a physical barrier between the body and the microbial flora, thereby serving as a first line of immune defense against microbial invasion. Mucosal epithelial cells secrete a wide array of substances such as mucins, anti-microbial peptides, surfactant proteins, lipids, lysozyme, and nitric oxide, which non-specifically shield the mucosa from microbial damage. Mucosal epithelial cells are capable of innate recognition of microbial motifs via cell surface or cytosolic molecules, such as TLRs, NOD molecules, and RIG-I like molecules, which trigger the production of cytokines and chemokines that activate and mobilize immune cells. Specialized epithelium and epithelial cells (e.g., M cells, Paneth cells, goblet cells, tuft cells, follicle-associated epithelium) further contribute to immune responses by antigen/chemical recognition, transport of antigens across the mucosa, and presentation of antigens to dendritic cells (DC) or other immune cells within the mucosa. These mucosal epithelial cell types and their mediators serve to provide protection from pathogens, shape the microbiota, and influence host immune responses. How epithelial cells interact with and respond to luminal molecules and microbes is critical to orchestrating the balance of effector and regulatory responses needed to respond appropriately to pathogens. In addition, epithelial cells must maintain tolerance to innocuous antigens in air, food, and the microbial flora. The mechanisms, cells, and pathways governing epithelial barrier integrity, antigen recognition and acquisition, and presentation to DCs and immune cells to induce protection, ignorance or tolerance are important areas for further study.

Examples of potential research studies in this area include, but are not limited to:

  • Signals that drive antigen-sampling epithelial cells at respiratory and other mucosal sites to become M cells
  • Molecular pathways involved in apical-to-basolateral translocation of luminal antigens
  • Regulation of goblet cell sentinel and antigen capture functions at diverse mucosal sites
  • Mechanism of sensing pathogens or allergens by chemosensory tuft cells in the airway
  • Relative contribution of specialized mucosal epithelial cells to mucosal surveillance, immunity, and tolerance
  • Epithelial factors influencing dendritic cell or T cell recruitment and differentiation
  • Functional consequences of MHC Class II expression on epithelial cells of the lung and intestine
  • Tissue-specific sites of presentation of antigens taken up in the lung, intestine, or urogenital tract; and influence of local conditions on resultant responses
  • Role of mucus in attenuating microbial virulence and in shaping immune responses

Mucosal Immunoglobulin and Mucosal B Cell Responses. IgA isotype antibodies predominate at the mucosal surface and are considered a first line of defense against microbial invasion through the mucosa. Particularly important functions of these antibodies are protection against infections and establishment of a healthy microbiota. Despite many recent discoveries that have provided a framework for understanding induction of IgA-producing B cells and transport of IgA, much remains unknown, for example, where and how B cells meet antigen, where IgM to IgA switching occurs, where long-term memory is established, and how responses to infection and commensal microbes differ at various mucosal sites. To facilitate mucosal vaccine development, more information is needed to understand where and how local IgA is produced and to identify the precise role for IgA and other mucosal immunoglobulins in protecting from infectious pathogens and maintaining a balance with commensal microbes.

Examples of research studies in this area include, but are not limited to:

  • Strategies to induce IgA at stratified epithelial mucosa, such as the lower female reproductive tract
  • Contribution of Peyer’s Patch CD4 T cell subsets to IgA B cell differentiation
  • Origin of T follicular helper T cells (Tfh) at mucosal locations
  • Role of FoxP3+ Tregs and follicular regulator cells (Tfr) in production of affinity-matured gut IgA antibodies
  • Epithelial, stromal, and dendritic cell mechanisms involved in development of IgA-producing B cells

Mucosal Immunity and Inflammation. The mucosal immune system is challenged to respond to harmful organisms while regulating the resultant influx of immune cells to prevent tissue injury due to inflammation. In the gut, several lines of evidence support the idea that the commensal flora exert an anti-inflammatory influence on the mucosa. Alterations in microbial flora may lead to inappropriate responses in which commensal microbes serve as surrogate pathogens and thus stimulate a chronic inflammatory response. In the relatively less colonized surfaces of the respiratory tract, failure to tightly control immune responses to pathogens or commensal microbiota can also lead to chronic inflammation and tissue destruction. To limit inflammatory responses, the airways, gut and other mucosal surfaces employ a range of complex physical, innate, and adaptive immune defenses. Alterations of any of these defenses could promote an uncontrolled inflammatory response that may lead to tissue injury, and also may promote pathology at distant non-mucosal sites, such as the central nervous system or the cardiovascular system. Complex mucosal systems to prevent responses to harmless antigens and limit inflammatory responses to pathogens are not well understood and represent an important area for further study.

Examples of research studies in this area include, but are not limited to:

  • Mucosal immune mechanisms in pathogen and disease tolerance that limit tissue destruction or inflammation
  • Influence of circadian rhythms on immune cell/pathway functions in homeostasis, protective immunity, and inflammation
  • Mechanism and effects of “immune scarring” at the mucosa that lead to lasting mucosal changes evident long after or in the absence of pathogen infections (e.g., urothelial cell changes influencing recurrent bladder infection, recurrent enteric infections leading to an IBD-like syndrome, airway remodeling in airway disease)
  • Mechanisms of lung-gut cross-talk that affect mucosal immunity and mucosal inflammation
  • Role of trained innate immunity in mucosal infection and chronic inflammation
  • Identification and mechanisms of action of dietary factors, microbes, and microbial metabolites that influence mucosal immunity and inflammation
  • Role of innate lymphoid cells, MAIT cells, gamma delta T cells, resident T memory cells, and regulatory T cells in mucosal protection, inflammation, and tolerance
  • Defining correlates of mucosal protection or tolerance and predictors of inflammatory outcome in humans
  • Mechanisms by which mucosal responses differ between microbial infection of the upper vs. lower airways

Mucosal Immune System Cross-Talk with the Nervous System. Numerous connections among the microbiota, mucosal immune system, and nervous system have been identified, suggesting an interplay among the nervous and mucosal immune systems in detection and response to microbes and other molecules at mucosal surfaces. Tissues that are directly exposed to the external microbial flora such as mucosal surfaces of the digestive, lung, and urogenital tracts play a central role in immune surveillance. These sites are densely innervated by nervous system sensory cells, which recent pioneering studies have found to be important in regulating mucosal immune cells and responses, and barrier integrity. Effective communication between the mucosal immune and nervous systems shapes homeostasis of the GI and respiratory systems, can allow for more integrated detection and response to environmental insults and infectious agents, and may fine-tune responses to pathogens and tissue damage. Understanding how neuro-immune interactions shape responses to microbes, allergens, and other environmental stimuli is critical for identification of novel targets for development of future therapeutics for mucosal infections and inflammation, as well as disorders that may be initiated at mucosal surface, but manifest at non-mucosal sites such as the nervous system or cardiovascular system.

Examples of research studies in this area include, but are not limited to:

  • Mechanisms by which the enteric/respiratory nervous systems and central nervous system integrate with microbe-induced mucosal immune responses
  • Role of the nervous system in immune system development at mucosal sites
  • Mechanisms of cross-talk between mucosal neurons and glial cells, mucosal immune cells (e.g., mast cells, macrophages, ILCs, lymphocytes), and mucosal epithelial cells
  • Effects of the microbiota on enteric nervous system and how this influences development of the mucosal immune system
  • Immune consequences of innate lymphoid cell (ILC) interactions with neurons at mucosal sites
  • Nervous system involvement in restraining versus promoting immune responses

The MIST program is intended to support studies that break new ground in the understanding of mucosal defense and mucosal immunoregulation. Proposed studies may include a range of mucosal probes to gain new insights into mucosal immune defense mechanisms, such as microbes, pathogens, vaccines, adjuvants, infections, and mucosal inflammation.

Research areas NOT supported by this FOA are listed below. Applications containing research in these areas will be considered non-responsive and will not be reviewed.

  • Clinical trials; however, the use of samples obtained from human subjects in clinical trials funded through other mechanisms is allowed.
  • HIV/AIDS/SIV
  • Studies focused on skin or epidermis.
  • Studies focused primarily on specific microbes, infections, vaccines, or adjuvants that do not use these agents as probes to gain new insights about mucosal immune mechanisms; studies focused on non-immune mechanisms of pathogenesis.
  • Projects focused on autoimmune or inflammatory diseases (e.g., inflammatory bowel disease, celiac disease, cystic fibrosis, etc.), lung or intestinal transplantation, or asthma/allergy that do not use these diseases as probes to gain new insights about mucosal immune mechanisms.
  • Investigations that do not focus on the study of mucosal immune or immunoregulatory mechanisms, mucosal cells, mucosal molecules or mucosal pathways.

Steering Committee. A Steering Committee will be established to direct the overall efforts of the MIST program. The Steering Committee will be composed at a minimum of PD(s)/PI(s) of each of the awards and an NIH Project Scientist, who serves as a voting member of the Steering Committee. The Steering Committee will develop a "MIST Plan" that will articulate the goals of the MIST Program and will be used as a reference for making recommendations regarding use of the Infrastructure and Opportunities Fund (IOF) (see below). With regard to the IOF, the Steering Committee will be responsible organizing an annual competition for the IOF for high priority research aligned with the MIST research goals. The oversight of these activities will facilitate and enhance cooperative and collaborative efforts, among both MIST members and the research community at large, that are best suited to achieve the goals of the program and to advance understanding of immune mechanisms at the mucosa.

Infrastructure and Opportunities Fund (IOF). To capitalize on emerging opportunities and sharing of resources and expertise consistent with the goals of MIST, an IOF will be made available. Examples of activities supported by the current IOF include development and management of a website for MIST activities; collaborative and pilot/feasibility projects among MIST members; translational projects; early stage investigator projects; and imaging and animal model development cores. IOF projects must be within the scope of this FOA and may be submitted by members of MIST or by outside investigators.

IOF Management. One institution will be chosen by NIH after award from the successful applicants to manage the IOF for the entire MIST. This institution must agree to take responsibility for managing the IOF, including establishing an administrative structure for disbursement and tracking funds, and under the advice of the Steering Committee establishing procedures for reporting status of IOF projects to NIH and the Steering Committee.
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 to RFA-AI-15-023

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 $5.45M in FY 2021 to fund 8-10 awards, which includes $1.0M for an Infrastructure and Opportunities Fund (IOF).

Award Budget

Application budgets are limited to $350,000 in direct costs per year, excluding the IOF budget, and need to reflect the actual needs of the proposed project.

Award Project Period

The total project period submitted in response to this funding opportunity should be five (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)

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
  • 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

 

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 Guideexcept 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:

Sandip Bhattacharyya, PhD

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 240-292-0189

E-mail: sandip.bhattacharyya@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.

, with the following additional instructions:

Other Attachments: The following attachment is required for this FOA and must be included as a separate pdf attachment.

Infrastructure and Opportunities Fund (IOF) Management Plan: The filename “IOF.pdf” should be used and will be reflected in the final image bookmarking for easy access for reviewers.

Applicants must include a plan for administering the IOF to include coordination, communication, and management of the proposed IOF, proposed measures and procedures for disbursement, reporting and monitoring of expenditures, and plans for soliciting, evaluating, and selecting projects. Applicants should NOT include or propose specific projects to be funded from the IOF; these decisions will be made in conjunction with the steering committee after award.

SF424(R&R) Senior/Key Person Profile

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

 

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

, with the following additional instructions:

In the budget section, applicants should include funds for travel to the Rockville, Maryland area for two Steering Committee meetings within the first 12 months, and usually once annually thereafter, for the PD(s)/PI(s). For multi-PD/PI applications, the budget should include travel funds sufficient for all PD(s)/PI(s) to attend the Steering Committee meetings

All applicants must propose an IOF Budget. One (1) IOF budget of up to $1.0M total costs will be awarded to one recipient organization, which will be selected by NIAID post-award to manage the fund. Each applicant should propose Direct Costs as a single line item in the Other Direct Costs Category of the Budget. Direct Costs proposed for the overall administration and oversight of the IOF may be requested and must comply with NIH Grants Policy. Direct Costs for the research projects using IOF funds should be estimated at 5-10 pilot projects per year. F&A costs will be applied in accordance with NIH Grants Policy.
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: List the broad, long range objectives and goals of the proposed project and describe the work to be completed.

Research Strategy: Within the research strategy, applicants must include the following:

A clear and detailed description of how the proposed studies contribute knowledge critical to achieving the goal of advancing understanding of mucosal immune mechanisms or addressing difficult unsolved questions in mucosal immunity.

If approaches including infectious organisms/vaccines/adjuvants or mucosal diseases are proposed, describe how these model agents/diseases will advance research towards discovery of new information about basic mechanisms of mucosal immunity (e.g., cells, mediators, pathways).

Describe in detail the rationale behind the choice of any proposed animal models or human tissues and how their use will advance the research strategy.

Letter of Support: Infrastructure and Opportunities Fund Management - All applicants should include a letter from the PD(s)/PI(s) and the Institution's Signing Official agreeing to take fiscal responsibility for the management of the IOF, if chosen by NIAID to do so.

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.
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-definedclinical 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 (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.

 

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: Will the proposed studies explore original and creative hypotheses related to immunity at mucosal surfaces, and/or identify and or define basic mucosal immune mechanisms, cells, mediators, and pathways?

 

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?

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: If approaches including infectious organisms/vaccines/adjuvants or mucosal diseases are proposed, does the description of these model agents/diseases support their use to advance research towards discovery of new information about basic mechanisms of mucosal immunity (e.g., cells, mediators, pathways) beyond the current level of understanding?

 

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.

 

For research that involves human subjects but does not involve one of thecategories 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.

Infrastructure and Opportunities Fund (IOF) Plan

As described, does the IOF plan propose an adequate plan to successfully administer the funds to indicate a high potential for successful tracking, distribution and management of the funds? Does the IOF plan include adequate plans for soliciting, reviewing, and selecting projects?

 

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.

 

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 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.

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:

  • Acceptance and implementation of common guidelines approved by the MIST Steering Committee.
  • Timely publication of major findings; submission of manuscripts to the NIAID Program Officer promptly upon acceptance for publication.
  • Abiding by guidelines established by the Steering Committee with NIH assistance for publication of results of collaborative projects.
  • Making data generated using MIST support publicly available while safeguarding the privacy of participants and protecting confidential and proprietary information as appropriate and consistent with achieving the goals of the program. Data set definitions and timelines for deposition in private database areas and release to the public are expected to be negotiated with NIAID as part of the data-sharing plan.
  • Ensuring successful completion of the data- and other resource-sharing plans negotiated with NIAID as appropriate and consistent with achieving the goals of the program. Sharing plans represent a commitment by the applicant institution (and its subcontractors, if any) to support and abide by the plan.
  • Publication of findings linked to clinical trials (for example, mechanistic studies that utilize samples from a clinical trial) must adhere to the policies enacted by the governing body of the clinical trial and the sponsor of the trial.
  • 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:

  • NIAID staff assistance will be provided by a Program Official from the Autoimmunity and Mucosal Immunology Branch, Division of Allergy, Immunology and Transplantation, NIAID, who will serve as the NIH Project Scientist. The role of the NIH Project Scientist will be to facilitate, and not to direct, the activities of MIST. The NIH Project Scientist will serve as a voting member of the Steering Committee.
  • The NIH Project Scientist will support MIST activities through technical assistance, advice and coordination of MIST activities. Support may be through selection of resources and identification of potential collaborations to further the goals of the program; acting as a liaison to other mucosal immunity-related NIH programs; recruiting external advisors from the international mucosal immunity research community and soliciting their advice and attendance at MIST Steering Committee meetings; and participating in the preparation of publications for collaborative projects, as appropriate.
  • NIH may appoint up to two external scientists or additional NIH staff to the Steering Committee as non-voting members.
  • 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

  • A Steering Committee will serve as the governing body of MIST. All MIST investigators and recipients of IOF funding will be required to accept and implement common guidelines and procedures approved by the Steering Committee.
  • All U01 PD(s)/PIs will serve as Steering Committee members. For multi-PD(s)/PI(s) awards, each PD/PI will serve on the steering committee, but each U01 will have only vote.
  • Each Steering Committee member will be expected to participate in all Steering Committee activities necessary to accomplish the work of MIST.
  • The Steering Committee may appoint additional non-voting members by majority vote.
  • A chairperson will be selected from among the non-federal Steering Committee members.
  • Subcommittees of the Steering Committee may be established as necessary.
  • The Steering Committee will:
  • Identify scientific opportunities, emerging needs, and impediments.
  • Develop a MIST Plan that outlines an overall agenda for MIST activities to produce maximum progress in the field of mucosal immunology. The initial MIST Plan will outline critical areas to be addressed through collaborative, coordinated, and/or pilot projects as described above, and will be submitted to the NIH Project Scientist. As part of the Steering Committee’s annual review of all MIST projects and activities, the MIST Plan will also be reviewed and modified as necessary to address new opportunities and problems in the field.
  • Ensure that the activities of MIST are coordinated, productive, collaborative when appropriate, and directed toward the goals expressed in the MIST Plan.
  • Provide guidance and recommendations to investigators regarding study implementation and conduct.
  • Develop guidelines and policies for publication of collaborative project results.
  • Compile reports of the MIST program accomplishments, as requested by the NIH Program Officer.
  • Establish definitions and data collection standards for collaborative projects, as needed.
  • Establish subcommittees as needed to provide recommendations on shared aspects of the cooperative research group, including but not limited to the activities listed above.
  • Additional details and responsibilities of the Steering Committee will be negotiated at the time of award or post-award.

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 agreementsare 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 threatensubmission 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)

Annette L. Rothermel, PhD

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 240-627-3477

Email: arothermel@niaid.nih.gov
Peer Review Contact(s)

Sandip Bhattacharyya, PhD

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 240-292-0189

E-mail: sandip.bhattacharyya@nih.gov

Financial/Grants Management Contact(s)

Madeline Clarke

National Institute of Allergy and Infectious Diseases (NIAID)

Telephone: 301-761-7944

Email: Madeline.Clarke@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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