Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title
Nonhuman Primate Transplantation Tolerance Cooperative Study Group (U01 Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
Reissue of RFA-AI-16-007
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AI-22-002
Companion Funding Opportunity
RFA-AI-22-003 , U19 Research Program (Cooperative Agreement)
Assistance Listing Number(s)
93.855
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG), a multi-center, cooperative program dedicated to developing, optimizing, and evaluating approaches to induce and maintain immune tolerance to allogeneic transplants in nonhuman primate (NHP) models. The over-arching goal is to facilitate clinical translation of safe and effective tolerance-induction protocols for long-term graft survival.

Key Dates

Posted Date
January 18, 2022
Open Date (Earliest Submission Date)
April 13, 2022
Letter of Intent Due Date(s)

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
May 13, 2022 May 13, 2022 Not Applicable December 2022 January 2023 March 2023

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
May 14, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This FOA solicits applications from single institutions, or consortia of institutions, to participate in the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) program. The goals of the NHPCSG are to: (1) develop novel immune tolerance induction regimens; (2) evaluate the preclinical safety and efficacy of existing and newly developed candidate immune tolerance induction regimens; (3) develop and validate biomarkers for induction, maintenance and/or loss of immune tolerance or for prediction of graft rejection; and (4) elucidate mechanisms underlying induction, maintenance, and/or loss of tolerance in nonhuman primate (NHP) allograft models of kidney, pancreatic islet, heart, lung, liver, or intestinal transplantation.

Background

Organ transplantation is the preferred treatment for many end-stage organ diseases when other therapies have failed. While one-year graft survival rates now approach or exceed 90% for most organs, long-term graft and patient survival remains sub-optimal for all organ transplants. Immune-mediated graft injury is a leading cause of both short and long-term allograft failure. The current standard of care relies on life-long, non-specific immunosuppressive therapy that, while necessary to protect the allograft from immune injury, is associated with significant morbidity, including toxic side effects that contribute to late graft failure. Advances in induction of immune tolerance to donor organs, cells, or tissue through the development of new therapeutic strategies have the potential to eliminate the need for life-long immunosuppressive therapy, increase long-term graft survival and life expectancy, and improve health-related quality of life. The value of NHP transplant models is due, in large part, to the high degree of similarity between NHPs and humans in terms of physiology and immune system function. Thus, research supported by the NHPCSG paves the way for translation of basic discovery research and design of scientifically sound and ethically acceptable clinical trials in islet and organ transplantation, including regulatory Food and Drug Administration (FDA) approvals.

NIAID is strongly committed to developing safe and efficacious immune tolerance induction regimens that result in enhanced long-term graft survival and reduced morbidity in clinical transplantation. In 1998, NIAID convened an Expert Panel for Research on Immune Tolerance that endorsed the conceptual framework, scope, and timeliness of NIAID’s plan to accelerate research in this area. Two subsequent panels, the NIAID Expert Panel on Ethical Issues in Clinical Trials of Transplant Tolerance and the Expert Review Panel for NIAID's Extramural Transplantation Research Program, identified NHP tolerance research as an essential step to provide "...critical data on safety, toxicity and potential efficacy that cannot be obtained ethically in human clinical trials”. In response to these recommendations, a research program in NHP models of allogeneic kidney and islet transplantation was established in 1999. In 2004, the program expanded to include research in heart and lung models as well as an Infrastructure and Opportunities Fund. NIAID remains committed to the goals of this program and its direct relevance to the NIH mandate to translate basic discovery research to the clinic. NHPCSG-funded research has provided key supporting data for the design of multiple clinical trials, including several that are ongoing or in development.

Available Nonhuman Primate Resources

  • To facilitate NHPCSG research, NIAID supports breeding colonies of specific pathogen-free (SPF) cynomolgus macaques (Macaca fascicularis) and Indian-origin rhesus macaques (Macaca mulatta). NIAID animals are pedigreed and major histocompatibility complex (MHC)-typed to enable rigorous experimental design and data interpretation through knowledge of the degrees of relatedness and MHC disparity or identity between donors and recipients. While NIAID does not guarantee the availability of these animals for NHPCSG-supported studies, research-aged animals are prioritized for use in NHPCSG studies.
  • In addition, NIAID supports the NHP Reagent Resource,which develops, produces, and distributes immunologic reagents optimized for use in NHP research, including antibodies for NHP in vitro diagnostics, and immune-modulating reagents for in vivo administration. The NHPCSG has collaborated with the NHP Reagent Resource to develop and/or evaluate numerous reagents that are now in use by the wider researcher community.

Research Objectives and Scope

The current renewal U01 FOA and companion U19 FOA (RFA-AI-22-003) will support research projects that use NHP models of allogeneic islet, kidney, heart, liver, intestine, or lung transplantation.

While individual approaches may vary significantly, the research objectives must incorporate both of the following:

1) One or more novel tolerogenic approaches

  • In vivo safety and efficacy assessment of immune tolerance induction regimens or refinements/modifications of existing regimens in NHP models, including development of immune-modulating agents, if required.

2) Accompanying mechanistic and/or biomarker studies

  • Elucidation of the underlying immunologic mechanisms responsible for or contributing to induction, maintenance, loss, and/or lack of immune tolerance achieved by the regimen tested in vivo.

And/or

  • Development, evaluation, and validation of biomarkers or other novel means for predicting or assessing the induction, maintenance, loss, and/or lack of immune tolerance and/or onset of acute or chronic graft rejection.

Additional objectives related to the tolerogenic approach or mechanistic studies may be proposed, such as alternative transplantation sites for pancreatic islets or measures to improve the safety and/or tolerability of the tolerogenic approaches tested as long as the primary focus of the application meets the above basic requirements.

Milestones

The research plan must include realistic, explicit, and quantitative annual milestones. These milestones will be used by NIAID program staff to assess annual progress and support funding decisions.

Infrastructure and Opportunities Fund

To capitalize on emerging opportunities consistent with the goals of the NHPCSG, specified funds will support pilot research projects and their administrative management through the Infrastructure and Opportunities Fund (IOF). Each application is required to submit an IOF Management Plan as an attachment. Post-award, one U01 or U19 (companion RFA-AI-22-003) awardee institution will be selected by NIAID to manage the NHPCSG IOF. Projects recommended for funding by the Steering Committee and approved by the NIAID Project Scientist will be funded as subawards/consortium agreements by the institution selected to manage the IOF.

In addition to the requirements above, note that:

  • Collaborations between NHP transplant model researchers and investigators outside this research community, including basic science immunologists and infectious disease experts, are encouraged.
  • Use of new technologies and approaches, including those that are minimally- or non-invasive, is encouraged.
  • Because the long-range goals of this FOA are to develop and evaluate candidate tolerogenic approaches for transplantation in humans, opportunities to interact with NIAID-funded clinical trials programs are possible and may include development of and participation in defined preclinical safety and efficacy studies.

Applications proposing the following will be considered non-responsive and will not be reviewed:

  • Studies in animal models other than NHPs, unless used solely as an in vivo assay to assess the NHP immune response;
  • Human subjects research, although use of human specimens in confirmatory or comparative assays is allowed;
  • Clinical trials (all phases);
  • Xenotransplantation;
  • Preliminary development of an NHP transplantation model (e.g., surgical techniques for reliable post-operative recovery and initial allograft function while on standard immunosuppression);
  • Studies with a primary focus on improving isolation, preservation, or supply of organs, tissues, or cells;
  • Hematopoietic cell transplantation unless proposed in the context of islet or organ transplantation (e.g., optimization of bone marrow chimerism approaches for tolerance induction);
  • Transplantation of any organs or tissues other than pancreatic islet, kidney, heart, lung, liver, or intestine, unless performed in the context of islet, kidney, heart, lung, liver, or intestinal transplantation (e.g., multivisceral transplantation or thymic tissue transplantation as a means of tolerance induction);
  • Studies of non-specific side effects of an immunomodulatory agent (e.g., drowsiness, fatigue, constipation);
  • Studies focused on HIV/AIDS-related research.

Applicants are advised to contact the Scientific/Research Contact with any questions they may have regarding the responsiveness of their application.

Steering Committee

All PDs/PIs of funded awards will serve on the NHPCSG Steering Committee, whose purpose is to coordinate and facilitate activities of the NHPCSG and promote optimal research flexibility, synergy, and efficiency through collaboration and sharing of reagents, samples, protocols, and experimental results. Steering Committee voting members will include the contact PD/PI from each U01 award and the contact PD/PI and one Project Leader from each U19 award (note: the Project Leader voting member may rotate annually). Non-voting members will include any additional Project Leaders from each U19 award, the non-contact PDs/PIs on multiple PD/PI awards, and the NIAID Project Scientist. Select scientists other than the awardees may serve as non-voting members when additional expertise is required for committee breadth and balance, to be determined by majority vote of the Steering Committee with NIAID approval. Voting members will elect a Chair by majority vote from among non-government Steering Committee members. In addition, the NIAID Project Scientist may appoint up to two external scientists to the Steering Committee as non-voting NIAID advisors. Subcommittees may be established as needed to facilitate the activities of the NHPCSG. Additional responsibilities of the Steering Committee members are described in section VI.2

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal - Renewal of RFA-AI-16-007

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $7.2 million to fund 4 to 6 awards; this includes any awards made under the companion U19 FOA (RFA-AI-22-003) and support for an Infrastructure and Opportunities Fund.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project. As a guide, the approximate average direct costs for previous NHPCSG U01 awardees was $570,000, excluding the Infrastructure and Opportunities Fund. Applicants may have valid requirements for exceeding this range and are encouraged to discuss such requirements prior to submission with the Scientific/Research Contact listed in Section VII.1 below.

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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

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

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

Required Registrations

Applicant organizations

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

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

  • An investigator may be a PD/PI, multiple PD/PI, or U19 Project Leader on ONLY ONE application submitted in response to either RFA-AI-22-002 or RFA-AI-22-003.
  • A PD/PI or multiple PD/PI may serve as a collaborator on another U01 or U19 Project or Core (see companion FOA RFA-AI-22-003) provided there is no scientific overlap between the applications.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Maggie Morris Fears, Ph.D.
Telephone: 301-761-5444
Email: maggie.morrisfears@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

For this specific FOA, the Infrastructure and Opportunities Fund Management Plan (submitted under Other Attachments) is limited to 6 pages.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments:

Infrastructure and Opportunities Fund (IOF) Management Plan

A PDF attachment that describes the IOF Management Plan is required for this FOA.

Use the filename "IOF.pdf" to facilitate consistent image bookmarking of the applications and reviewer access. Quotation marks should not be included in the filename.

The IOF Management Plan is limited to 6 pages and should include:

  • A list of the proposed activities and services of the IOF Management Plan and a concise description of how the IOF will function to further the goals of the NHPCSG.
  • A clear administrative structure and designated IOF administrator for coordinating activities between the IOF institution and the NIAID Project Scientist, IOF pilot project applicants and awardees, and an awardee-institution's grants management staff.
  • A description of administrative procedures designed to ensure:

1) timely award of Steering Committee-approved pilot projects via issuance of subawards/consortium agreements, including their establishment, renewal, and compliance with applicable Federal regulations, policies, and guidelines for research involving NHPs (if applicable), 2) accurate monitoring and prompt payment of invoices, and 3) efficient administrative and financial closeout of subawards/consortium agreements after project completion.

  • A communications plan for periodic reporting to the NIAID Project Scientist on the status of IOF funds, subawards/consortium agreements awarded, and any requests for changes in the subaward/consortium agreement budget period or project scope.
  • Information Technology (IT) support for the development (if needed) and maintenance of a secure, password-protected NHPCSG website for housing NHPCSG-specific documents and receipt and review of pilot project applications.
  • Statement of commitment from the PD/PI to serve as the IOF Management Leader and accept overall fiscal and administrative responsibility for the IOF, if selected by NIAID to receive designated IOF funds.

This section should only include information about the management of the IOF; do NOT include any proposed IOF research projects or plans for scientific review of IOF applications.

SF424(R&R) Senior/Key Person Profile

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

In the biographical sketch, describe relevant immunology expertise and/or experience in preclinical transplantation models.

R&R or Modular Budget

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

Each PD/PI or multiple PD/PI must commit a minimum of 1.8 person months per year to ensure success of the program.

Animal Purchase

  • NIAID animal resources may be inadequate to meet all research needs of the NHPCSG, therefore include all costs for NHP purchase, assuming they will come from sources other than the NIAID NHP colonies. In the budget justification, note the vendor/supplier and expected animal availability for the proposed studies.
  • When NHPs are provided from the NIAID colonies, costs for all shipping, handling, and special testing fees will be the responsibility of the awardee.In future years NIAID may implement a cost recovery program for provision of the NIAID animals such that a given award is decreased by the amount budgeted for purchase of NHPs when animals are supplied through the NIAID NHP colonies.
  • Note that if animals from the NIAID NHP colonies are available for a proposed study, they may not be available for shipment to non-US sites, depending on the country’s import regulations and cost considerations.

Travel

  • Budgets should include travel costs for the PD(s)/PI(s) and one additional investigator to attend the annual 1.5 day NHPCSG Steering Committee Meeting in Rockville, MD.

Infrastructure and Opportunities Fund (IOF)

  • Budget should include cost break-down and justification for the following:
  • IOF Management Leader (0.6 person months maximum)
  • IOF administrator (3.0 person months minimum)
  • IT staff for website administration (2.0 person months maximum)
  • IT computing supplies, if required
  • IOF Review Manager
  • Total of $200,000 for IOF pilot projects, included in the Other Direct Costs category.
  • Indirect costs for salary, supplies, and administration of pilot project subawards/consortium agreements (assume 2 new subawards per year) should be included in the total costs.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed project. Concisely describe the specific hypothesis or hypotheses to be tested.

Research Strategy:Use this section to summarize the research strategy, including the significance of the research, innovation involved and rationale for the approaches proposed (i.e., how will they help you accomplish your specific aims).

The application must include at least one tolerogenic approach as well as mechanistic and/or biomarker studies that are incorporated as either a separate aim or as integral parts of the study aims.

Compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), including completion of the Vertebrate Animals Section according to the criteria described below, is an absolute requirement. All institutions are also required to comply, as applicable, with the Animal Welfare Act, and other Federal statutes and regulations relating to animals. In addition to a detailed Vertebrate Animal Section, the Research Strategy should provide a description of, and rationale for, the acquisition and preparation methods used for procuring donor organs, tissues, or cells used for the studies, and the sources, methods, and numbers of donor and recipient samplings/biopsies proposed.

Provide a justification for the numbers of animals used per experiment, with a discussion of power calculations and statistical considerations for the proposed experiments within the bounds of limited resources and budgetary constraints.Describe conclusions that can be drawn using the specified number of animals proposed.

Treatment Protocols, Objectives, and Annual Milestones:

  • Clearly define experimental endpoints and provide a rationale for the proposed tolerance approach and relevance to human transplantation.
  • Include a synopsis and treatment diagram/timeline detailing the proposed treatment protocol(s).
  • State interim and long-term objectives and include realistic, explicit, and quantitative annual milestones and detailed timeline identifying critical decision points where a revised approach may be necessary.

Letters of Support:

  • Reagent Source(s)

Provide letters of commitment from reagent sources, where appropriate, documenting the availability, quantity, and anticipated timelines for supply of key reagents.

  • Non-NIAID Animal Source(s)

Provide letters verifying animal availability from other sources should the NIAID NHP colonies not be able to fully meet the application's NHP requirements or needs.

  • Infrastructure and Opportunities Fund Management Plan

Provide a letter from the PD's/PI's institutional signing official agreeing to take fiscal responsibility for the management of the Infrastructure and Opportunities Fund if chosen by NIAID to administer the funds.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Specific to this FOA: Would the project, as proposed, advance transplantation tolerance research? What is the likelihood that the results of the proposed studies will contribute to new approaches and knowledge that will inform future studies in NHP models and/or human transplantation?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Are the expertise and level of effort of those with NHP transplantation experience and basic transplantation investigators and/or immunologists appropriate to the work proposed? Does the PD/PI, or each PD/PI on a multiple PD/PI application, commit sufficient effort to ensure the success of the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Will the critical resources, reagents, or therapeutics needed be available for the study within the proposed time frame? Are the proposed tolerogenic approaches appropriate and ready for NHP research?Are approaches to study underlying mechanisms and/or biomarkers appropriate?Are the yearly milestones and timelines adequate, appropriate, and reasonably attainable?

Is the justification for the numbers of animals reasonable? Are the statistical considerations for the proposed experiments and the proposed conclusions that may be reached appropriate? Are the acquisition and preparation of the solid organs, tissues, or cells to be used in the studies and the proposed methods, source, and number of NHP samplings/biopsies appropriate?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA: Are appropriate and sufficient animal housing and care facilities available to the investigators to perform the studies proposed?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

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

Infrastructure and Opportunities Fund (IOF) Management Plan

Does the plan provide a clear administrative structure with a designated IOF administrator and IT support to enable adequate organization, communication, and budgetary oversight? Are the personnel charged with managing the IOF appropriate? Based on the above considerations, Reviewers will comment on whether the IOF Management Plan is acceptable or unacceptable.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Progress made under any current NHPCSG award, if applicable.
  • Availability of critical reagents and resources.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients 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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 2 CFR Part 200, 45 CFR Parts 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:

  • Determining and coordinating the scientific and administrative activities of the approved projects; setting project goals and timelines; accepting and implementing common guidelines approved by the Steering Committee;
  • Serving as a voting member on the Steering Committee; participating in Steering Committee activities, and accepting and implementing the policies and procedures developed by a majority vote of the Steering Committee;
  • Working closely with NIAID staff in the scientific, technical, and administrative management of this program;
  • Ensuring that all NHPs obtained from the NIAID breeding colonies are used only for the expressed purposes of the individual Cooperative Agreements funded under this FOA or the projects funded under the NHPCSG IOF RFA, as recommended by the Steering Committee and approved by NIAID.
  • Timely submission of manuscripts for publication that are (co)authored by members of the award and supported in part or in total by the NHPCSG and for adherence to all aspects of the collaborative group’s Publications Policy, to be determined by the NHPCSG Steering Committee and NIAID.
  • Making new information and materials, including research samples, tools, methods, reagents, and data developed under these awards known and available to the broader research community and members of this program through publications, presentations, web announcements, submission to public resources or databases, and reports to NIAID and/or the NHPCSG Steering Committee.

Note: Recipientswill retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

A program official from the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as the NIAID Project Scientist for this program. The role of the Project Scientist will be to facilitate and not to direct NHPCSG activities. The Project Scientist will:

  • Serve as a non-voting member(s) of the Steering Committee and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies. It is anticipated that the majority of Steering Committee decisions will be reached by consensus and NIAID staff will be given the opportunity to offer input into this process, but the manner of reaching this consensus and the primary decision-making responsibility will rest with the Steering Committee, except where stated in this FOA.
  • Assist the Steering Committee Chair and subcommittee chairs in scheduling meetings of the NHPCSG Steering Committee and subcommittees and actively participate in agenda development as well as the organization and planning of a NHPCSG-hosted workshop.
  • Support project activities through technical assistance, advice, and coordination.
  • Advise in the selection of sources or resources (e.g., determining where a particular reagent may be found) and identification of potential collaborations to further the goals of the NHPCSG.
  • Coordinate NIH staff assistance and serve as a resource for scientific and policy information related to the goals of the awardee’s research.
  • Approve distribution of NHPs from the NIAID breeding colonies for individual research projects, based on overall availability and number of animals proposed in the peer-reviewed studies.
  • Review milestones prior to award and during the course of the project period, and request revised milestones, as needed.
  • Annually review progress towards achieving the goals of the project and previously agreed upon milestones to ensure successful completion of the project.
  • Approve redirection of research aims within the scope of the original award during the funding period, as needed. NIAID reserves the right to terminate or curtail a study/project in the event of a substantial failure to meet study milestones or other major deviation from the approved project's aims.

Note: A program official from the NIAID/DAIT will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The NIAID Project Scientist and the PD(s)/PI(s) will coordinate the scientific objectives and progress made on individual awards to facilitate the achievement of program goals. This may include pre-approved redirection of research aims within the scope of the original award, as needed, to ensure consistent progress.

The NIAID Project Scientist 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 Scientist assessment of the proposed yearly milestones.

Steering Committee:

The Steering Committee will:

  • Meet at least annually, but more often as needed, to carry-out its role as the main governing board for the NHPCSG.
  • Identify and advise the NIAID Project Scientist on scientific opportunities, emerging needs, and impediments to overall program success.
  • Develop a publications policy, including guidelines for publication of collaborative project results;
  • Coordinate timely preparation and provision of annual reports, if requested.
  • Provide guidance and recommendations to investigators regarding study design and implementation.
  • Advise the NIAID Project Scientist on ways to maximize the value of the NIAID NHP breeding colonies.
  • Oversee the general activities of NHPCSG IOF by providing recommendations for: 1) the procedures, policies, and subcommittees required for the solicitation, receipt, review, and evaluation of feasibility, pilot, resource development, or collaborative projects; 2) approving, disapproving, or discontinuing funding for individual IOF projects; and 3) website functionalities and resources to facilitate the goals of the NHPCSG.
  • Outline an Action Plan that includes the organization of at least one workshop to be held during the funding period. The workshop should include participants from outside the NHPCSG to ensure consistent engagement with the broader research community and to advance the broader goals of the NHPCSG through collaboration-building and the education of the next generation of transplant investigators.
  • If requested by the NIAID Project Scientist, the NHPCSG Steering Committee or a designated subcommittee will prepare a cumulative group progress report or ad hoc reports, as required, on NHPCSG activities, potentially including a summary of ongoing and newly-initiated studies (including any funded IOF projects); manuscripts published, in press, and in preparation; presentations given at regional, national, and international meetings; other notable NHPCSG endeavors; and future plans to be submitted at a time agreed upon by the NIAID Project Collaborator(s) and the Steering Committee Chair.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Scientific/Research Contact(s)

Julia Shaw, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3711
Email: julia.shaw@nih.gov

Peer Review Contact(s)

Maggie Morris Fears, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-5444
Email: maggie.morrisfears@nih.gov

Financial/Grants Management Contact(s)

Caleb Waller
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6643
Email: caleb.waller@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52 and 45 CFR Part 75.

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