Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Allergy and Infectious Diseases (NIAID)
Reissue of RFA-AI-15-023
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
None
93.855
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.
April 24, 2020
September 9, 2020
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.
Not Applicable
February 2021
May 2021
June 2021
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.
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:
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:
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 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:
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.
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.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.
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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).
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.
The total project period submitted in response to this funding opportunity should be five (5) years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Sandip Bhattacharyya, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-0189
E-mail: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
, 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.
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.All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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:
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.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
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?
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
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.
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.
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:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Steering Committee
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.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.
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:[email protected](preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:[email protected]
Annette L. Rothermel, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3477
Email: [email protected]Sandip Bhattacharyya, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-0189
E-mail: [email protected]
Madeline Clarke
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7944
Email: [email protected]Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.