Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
U01 Research Project – Cooperative Agreements
None
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from institutions or organizations to participate in a cooperative research group focused on transplantation immunology research in three priority areas: 1) microbiota; 2) intravital imaging; and 3) targeted therapeutic delivery. This FOA stimulates the formation of interdisciplinary collaborations and facilitates the application of new scientific developments and technologies to the field of transplant immunology. Applying these advances to transplantation science will provide novel insights into the nature of alloimmune responses and reveal new avenues to diagnose, treat and prevent allograft rejection or promote immunologic tolerance.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 03, 2021 | September 03, 2021 | Not Applicable | January 2022 | May 2022 | June 2022 |
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
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.
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from institutions/organizations to participate in a multi-disciplinary cooperative research program focused on the application of novel science and technologies to transplantation immunology in three areas: 1) microbiota, 2) intravital imaging, and/or 3) targeted therapeutic delivery. Research in these areas has provided exciting insights that advance our understanding and treatment of diseases such as autoimmunity, cancer, and obesity, but the application of these advances to transplantation has been limited. This FOA will help bridge that gap by taking advantage of approaches and technologies from other fields and facilitating their application to transplantation immunology research. This FOA will stimulate and support research in these three high-priority areas in order to enhance our fundamental understanding of alloimmune responses and explore novel approaches to diagnose and prevent rejection, promote immunologic tolerance, and prolong graft survival, with the ultimate goal of achieving better outcomes for transplant recipients.
Background
Organ transplantation is the preferred treatment for end-stage organ failure when other interventions have failed. Basic, preclinical, and clinical research have provided a wealth of knowledge about the immune response in transplantation and revealed new therapeutic opportunities. This research has contributed to significant improvements in average one-year graft survival rates, exceeding 97% for kidney recipients. Nevertheless, organ transplantation does not restore normal life expectancy: for recipients of deceased donor kidneys, the ten-year graft survival rate is 50%; and among those with a functioning kidney graft, 10-year patient survival is only about 75%, indicating that the morbidities of immunosuppression contribute substantially to reduced patient survival. Immune-mediated rejection remains the primary cause of both short- and long-term graft failure. In addition, long-term dependency on immunosuppressive medications is associated with undesirable side effects that contribute to transplant-associated mortality and morbidity.
Recent advances that enable more sensitive and precise imaging have enhanced our understanding of the immune system, while innovations in drug delivery have the potential to improve safety and efficacy of therapeutics for multiple conditions. In addition, a growing body of research suggests that the microbiota has numerous bidirectional interactions with the host, not only affecting metabolism, but also influencing the body's immune responses, most notably in the context of inflammation and infection. These findings have broad implications for biomedical science, yet the impact on transplantation immunology to date has been limited.
Microbiota and Transplantation
The microbiota is the collective term for the complex population of bacteria, viruses, fungi, and parasites that inhabit body surfaces exposed to the external world, including skin, airways, genito-urinary and gastro-intestinal tracts, and naso-oropharyngeal cavities. The microbiota plays an important role in host metabolism, prevents colonization by pathogenic microbes, shapes local and distal immune responses, and may influence susceptibility to diseases. While most studies to date are focused on bacterial populations of the intestine, the microbiota of other anatomical sites as well as other microbial communities, including fungi and viruses, also contribute to the host's overall fitness.
Little is known about the role of microbiota in alloimmune responses. Preliminary investigations have identified a correlation between specific changes in the gut or the graft microbiota with various transplant outcomes. Bone marrow transplantation studies suggest that alterations in the intestinal microbiota exacerbate inflammation associated with graft-versus-host disease (GVHD). Studies of intestinal transplants undergoing acute rejection revealed associated alterations in the microbiota of the intestinal lumen. New findings indicate a direct association between microbial metabolites, obesity, and allograft survival. Similarly, changes in the lung microbiota of lung transplant recipients were associated with an elevated risk of bronchiolitis obliterans syndrome (BOS). However, it is unclear whether the microbial alterations observed were due to the immune response to the graft or to therapeutic modalities, or whether the changes were a marker or a cause of rejection. Antibiotic treatment in transplant recipients, peri-operatively and throughout their lifetime, may result in alterations of microbiota that affect the immune response of the host, further confounding an interpretation of the microbiota's influence on transplantation outcomes. These and similar studies reveal a complex interplay between the donor and/or recipient microbiota and local and systemic alloimmune responses, and are important areas of investigation.
Intravital Imaging in Transplantation
In recent years, researchers have used a variety of imaging technologies to visualize living cells and tissues in real-time, and to measure physiological or pathological changes in tissues of living organisms. Intravital imaging used to visualize and track immune cells in situ allows researchers to interrogate the location, function, and interactions of specific cells. This technology has similarly been used to track the dynamics of viral or bacterial infection, study tumor cells or cell therapies, and detect and visualize disease progression.
Investigators have tested various intravital imaging technologies in preclinical and clinical settings to visualize and evaluate the fate or function of allografts. However, the potential of this technology to address novel questions in transplantation immunology has not been fully explored and may require development of new probes and approaches to visualize allografts and/or draining lymph nodes in real time. Application of novel imaging technologies will allow researchers to study the immune response to the allograft, monitor the trafficking and fate of cellular therapies, and dynamically assess in situ graft responses to targeted immunomodulatory agents. Advances in this area may lead to development of novel non-surgical diagnostic and prognostic tools to monitor graft rejection or survival in the clinic.
Targeted Therapeutic Delivery in Transplantation
Successful organ transplantation is made possible by life-long, systemic pharmacologic immunosuppression. Such long-term immunosuppressive therapies often result in renal damage, cardiovascular morbidity, diabetes, and other undesirable outcomes. Additionally, non-specific immunosuppression increases the risk of infections and malignancies. Current approaches to drug delivery can be associated with unpredictable (toxic or sub-therapeutic) drug concentrations in the blood. Imperfect adherence to daily or more frequent dosing contributes to poor outcomes.
Targeted delivery of drugs or other therapeutics to the organ, tissue, or cells where their effects are desired may address some of these problems. Researchers have developed a plethora of targeted therapeutic delivery methods, some of which have Food and Drug Administration (FDA) approval for certain applications. These approaches include use of liposomes, nanoparticles, hydrogels, and antibody-conjugates to selectively treat cancers, autoimmune, and neurological diseases. Despite the progress made in other fields, transplantation has not yet benefited significantly from targeted delivery approaches.
Ideally, targeted delivery of therapeutics in transplantation would direct treatments to key sites of immune interactions to prevent rejection or promote tolerance, minimizing global immune suppression and its associated undesirable effects. Furthermore, targeted delivery strategies that increase drug half-life, bioavailability, and/or provide controlled and sustained payload release, could permit lower dosing without loss of efficacy, thereby increasing drug safety. These advantages would address significant challenges in the clinical treatment of transplant recipients.
Research Objective and Scope
This FOA will support studies that stimulate the application of emerging technologies and science in three priority areas to transplantation research: 1) microbiota, 2) intravital imaging, and/or 3) targeted therapeutic delivery. The objective is to promote a more precise understanding of factors contributing to allograft rejection or tolerance, the donor/recipient response to therapeutics, and the development of more specific, targeted treatments. Awardees will be expected to extensively interact with each other as a cooperative group. The cooperative group will stimulate research in transplantation immunology by fostering interdisciplinary collaborations, promoting the exchange of ideas and findings, building on developments in other fields, and facilitating the exchange of reagents and techniques.
Proposed studies must incorporate one or more of the three priority areas. All studies must be in the context of transplantation of an allogeneic solid organ, vascularized composite tissue graft, or of pancreatic islets. Studies may use animal models or human specimens relevant to transplantation. This initiative will not support clinical trials or research involving xenografts. Nonhuman primate (NHP) studies are permitted, if appropriately justified and within the stated budgetary restrictions.
Microbiota and Transplantation
To better understand the interaction between the microbiota and transplantation outcomes, potential research topics include, but are not limited to, the identification and/or elucidation of:
Applications including the following types of studies will be considered non-responsive and will not be reviewed:
Intravital Imaging in Transplantation
To accelerate the application of intravital imaging technologies to transplantation, potential research topics include, but are not limited to:
Applications including the following types of studies will be considered non-responsive and will not be reviewed:
Targeted Therapeutic Delivery in Transplantation
To advance the development of targeted therapeutic delivery in transplantation, potential research topics include, but are not limited to leveraging existing or developing novel targeted delivery vehicles, materials, methods, or platforms to:
Applications including the following types of studies will be considered non-responsive and will not be reviewed:
Applicants are strongly encouraged to contact the Scientific Research Contacts well in advance of the application submission deadline to discuss the proposed research program.
Steering Committee
Program Directors/Principal Investigators (PD/PIs) from awards funded under this program will form a Steering Committee after award. The Steering Committee will serve as the main governing body for the cooperative group. Among other responsibilities, it will identify scientific opportunities, emerging needs and impediments, ensure the timely release of data through publications and/or public databases, and develop guidelines for the publication of collaborative research project results.
See Section VIII. Other Information for award authorities and regulations.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NIAID intends to commit $2.0M in FY 2022 to fund 4-6 awards.
Application budgets are limited to $250,000 per year (direct costs). If studies in nonhuman primates are proposed, application budgets are limited to $300,000 per year (direct costs).
The project period is 5 years. The scope of the project must be appropriate to a 5-year project period.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Vanitha S. Raman, Ph.D.
Telephone: 301-761-7949
Email: vanitha.raman@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PD(s)/PI(s) must commit a minimum of 0.8 calendar months per year.
Include appropriate travel budgets to accommodate travel by the PD(s)/PI(s) to the annual Steering Committee meeting in Bethesda, MD.
Support for clinical costs, research coordinators, and/or data centers is not permitted under 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:
Research Strategy:
Letters of Support: If the application includes samples not currently in the possession of the PD/PI, include a letter of support from the person or institution controlling the samples indicating that the samples and associated clinical/phenotypic data will be made available to the applicant.
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-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 project advance transplantation research in one or more of the following areas: 1) intravital imaging, 2) microbiota, and/or 3) targeted therapeutic delivery?
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 applicable, was documentation shown to demonstrate the availability of specimens and their associated clinical/phenotypic data?
Are the milestones and timelines reasonable and appropriate?
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.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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 will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council . The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 recipient'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: Recipient 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, Recipients, 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 OMB administrative guidelines, HHS 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:
The NIAID Project Collaborator(s) and the PD(s)/PI(s) will coordinate the scientific objectives and progress to facilitate the achievement of program goals.
The NIAID Project Collaborator(s) and the PD(s)/PI(s) will collaborate to revise project milestones prior to initial or annual awards, based on peer review of the originally proposed milestones and/or the PD(s)/PI(s) and/or the NIAID Project Collaborator(s) assessment of the proposed yearly milestones.
Steering Committee: The Steering Committee will coordinate and facilitate research activities for the overall program; facilitate compliance with the data- and other resource-sharing policies; and promote optimal research flexibility, synergy, and efficiency. The Steering Committee will include one PD/PI from each awarded U01 as a voting member and the NIAID Program Official(s) as non-voting members. The NIAID Project Collaborator(s) may appoint, in coordination with the Steering Committee, other investigators as consultants or subject matter experts to provide additional perspectives. Awardees will be expected to collaborate, share reagents, assays, animal models, human samples, and experimental results that would facilitate the research activities of other members. Subcommittees of the Steering Committee may be established as needed to make recommendations on other activities of the cooperative research group.
The Steering Committee will:
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.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: 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
For applications that focus on Microbiome and/or Intravital Imaging, please contact:
Nasrin Nabavi, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3538
Email: nnabavi@mail.nih.gov
For applications that focus on Targeted Therapeutic Delivery, please contact:
Monica Zamisch, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-706-4417
Email: monica.zamisch@nih.gov
Vanitha S. Raman, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7949
Email: vanitha.raman@nih.gov
Carissa Reilly-Weedon
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5468
Email: Carissa.Reilly-Weedon@nih.gov
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.
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