It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This FOA solicits applications for the Basic research program of the Autoimmunity Centers of Excellence (ACE). The companion FOA (RFA-AI-22-071) solicits applications to the Clinical research program of the ACE. The goal of the ACE is to conduct insightful analyses of human immunology as it applies to autoimmune disease(s) within and among collaborative Centers and especially in the context of Clinical Projects, i.e., clinical trials with integrated mechanistic studies. The members of the Basic and Clinical ACE will work together after award to design, develop, and conduct studies of autoimmunity and autoimmune diseases in humans. This approach is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating interventions used in therapy or tested in clinical trials.

The ACE program was founded to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE conducts cooperative clinical, mechanistic, and basic studies, fosters intellectual and material collaborations among scientists, and facilitates the study of clinical samples by research scientists. The ACE combines two research programs Basic and Clinical that align grant awards with responsibilities. The Clinical research program develops and conducts Clinical Projects (i.e., clinical trials with integrated mechanistic studies) as well as Collaborative Projects investigating fundamental human immunology. The Basic research program provides a solid scientific foundation and conducts advanced investigations into fundamental and applied human autoimmunity through innovative Principal, Pilot, and Collaborative Projects.  

The members of the Basic and Clinical programs will work closely together to fully develop and conduct the mechanistic studies in Clinical Projects and other studies of mechanism and pathogenesis. The ACE has conducted Clinical Projects in areas that include systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, Sj gren's Syndrome, ulcerative colitis, scleroderma, and pemphigus vulgaris (partial list: ClinicalTrials.gov). The collaborative ACE Research Plan and annual progress reports of the current ACE are available on the public ACE website.  

Collaborations among ACE basic and clinical scientists have been productive though challenging to initiate and maintain.  A 2005 Trans-NIH Autoimmune Diseases Research Plan advocated for clinical trials with integrated mechanistic studies that "utilize materials and data from clinical trials to elucidate underlying mechanisms of drug activity and immune response." This Plan also acknowledged that clinical trials are lengthy, risky, and expensive, conceding "many agents that show promising results in preclinical studies do not advance to clinical trials" and noting that new treatments are sometimes discovered "when practitioners identify new uses for medications originally approved for other conditions."  The importance of informative clinical trials in developing new therapies and evaluating existing therapies also was emphasized in a report from the Institute of Medicine, "Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary". Well-designed clinical studies can be fundamentally informative even if the intervention does not ultimately advance to licensure and clinical practice. 

The ACE responded to the COVID-19 pandemic by developing a clinical trial to test the serological response to vaccination in adults with autoimmune disease (ACV01: NCT05000216). Additional SARS-CoV2 studies were performed in these and other cohorts of adults and children with autoimmune disease (ACV02, PRISM: NCT04588363).

The objectives of the ACE are to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE program approaches these objectives by conducting cooperative basic, clinical, and mechanistic studies; fostering intellectual and material collaborations among basic and clinical scientists; and facilitating the study of clinical samples by basic research scientists.

Research Scope: All projects must investigate autoimmune disease in humans. 

Projects designed to test explicit hypotheses are preferred though 'data-driven' projects are permitted. The program is expected to advance our fundamental understanding of human autoimmunity, identify common and distinct mechanisms in the pathogenesis of autoimmune diseases, and clarify mechanisms of action of immune-modulating agents used in therapy or tested in clinical trials. 

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

• Large scale epidemiology.
• Research using animal models of human disease ("humanized" animals are not permitted).
• Clinical trials.
• Projects focused on primary immune deficiency or cancer (though studies of autoimmunity. including these patient populations are responsive).
• Projects focused on HIV/AIDS.
• Projects that do not investigate autoimmune disease in humans.

Program Components of the Basic Research ACE

A Basic ACE Research application must include the following:

• Administrative Core,
• ACE Funds Management Core,
• ACE Biorepository Core,
• Principal Project,
• Collaborative Project, and
• Pilot Project.

These components are described below.         

Administrative Core: The administrative core is responsible for providing overall leadership to the Center, including management, coordination, and oversight for the Center activities. 

ACE Funds Management Core (AFMC):  The AMFC will administer, on behalf of the entire ACE, two funds: the Clinical Project Fund for support of the Clinical Projects and the Collaborative Research Fund for support of the Collaborative Projects and additional studies required for achieving the aims of the ACE Research Agenda. One of the recipients will be selected by NIAID after award to administer the AFMC.

ACE Biorepository Core (ABC):  On behalf of the entire ACE, the ABC will help coordinate the collection and storage of samples from ACE clinical projects and provide them for use in mechanistic studies. One of the recipients, selected by NIAID based on reviews and other criteria, will be awarded the ABC.

Research Projects: Each ACE Basic Research Program must include three research projects: a Principal Project, a Pilot Project, and a Collaborative Project. The projects should be designed to advance our understanding of autoimmune disease in humans.

The Principal Project should incorporate the theme of the Center, exploit the applicant's expertise, and test hypotheses through Specific Aims that advance our mechanistic understanding of autoimmune diseases. 

The Collaborative Project should be designed to test at least one specific hypothesis on the nature of human autoimmunity, exploit particular strengths of the applicant, and engage other members of the ACE after award. The goals should exceed the reach of a single Center and produce a greater-than-additive return. It is recognized that applicants will NOT know in advance with whom they will be collaborating because the members of the ACE will not be known before award; therefore, applicants should make reasonable assumptions as to the types of collaborations that will be available and build flexibility into their research plans. Recent programs have demonstrated the importance of the Centers' themes in subsequent collaborations. The ACE will fully develop the Collaborative Projects after award, and they should be designed to become part of the ACE Research Agenda. Collaborative Projects may be expanded or reduced after award depending upon how well they are ultimately integrated within the ACE. Collaborative Projects will be supported for three years; support in years 4 and 5 will depend on progress and funds available. 

The Pilot Project should be designed as an innovative and exploratory investigation pursuing intriguing observations that may lead to discoveries or breakthroughs.  Pilot Projects are designed to be shorter duration (2 years) with benchmarks for evaluating progress part way through the project.  

Principal, Pilot, and Collaborative Projects: These Projects may use samples from previously completed clinical trials or studies, but they may not support a clinical trial. For these Projects, specific areas of interest include, but are not limited to:

• Pathogenesis of human autoimmune disease.
• Mechanisms of action of existing therapies for autoimmune disease.
• Biomarkers for autoimmune disease status, including diagnosis, disease progression, prediction of remission or relapse, therapeutic response, and stratification.
• Sex-based differences in autoimmune disease. 
• Mechanisms responsible for the initiation, maintenance, or loss of tolerance.
• Cellular diagnosis or cell therapy, including adult stem cells, regulatory B and T cells, and antigen-presenting cells.
• Single-cell or clonal analysis of genetic variation (including epigenetic) contributing to autoimmunity.
• Influence of histocompatibility genes (e.g., HLA) on autoimmunity.
• Novel mechanistic approaches to therapy applying advances in fundamental immunity and biology, such as gene therapy, regulating gene transcription (epigenetics, methylation, acetylation), RNA metabolism (splicing, stability, miRNA, RNAi), antigen receptors or Natural Killer (NK) inhibitor receptors (KIR), lymphocyte subsets, dendritic cells, cytokines, chemokines, proteins mediating signal transduction (immune synapse, intracellular pathways), imaging (3-dimensional, spatial transcriptomics, etc.), metabolomics and the microbiome.    

The ACE will coordinate the activities of the Clinical and Basic Research programs through the following elements: 

Steering Committee: A Steering Committee will be formed with the PDs/PIs of the Basic and Clinical Research programs. The Steering Committee will have responsibility for collaboratively formulating the ACE Research Agenda, and for helping develop, finalize, and implement Clinical and Collaborative Projects. The Steering Committee is also responsible for reviewing ACE Clinical Project budgets and publications reporting ACE clinical trial results.

ACE Research Agenda: The Steering Committee will formulate an ACE Research Agenda that includes overarching themes, goals, and approaches for the period of award. The Agenda will incorporate the best themes and goals from the individual Centers as well as the Clinical Projects and the Collaborative Projects.  The Research Agenda of the current ACE cycle and their annual progress reports are posted on the public ACE website. The ACE will be responsible for on-going "legacy" Clinical Projects. 

Plenary Meeting: The ACE will convene an annual plenary meeting, preceding one of the twice-annual face-to-face Steering Committee meetings, to exchange information and develop collaborations among the investigators.  All key personnel, including project leaders, are expected to attend and participate. The aims and status and highlights of all projects from all Centers will be presented in brief talks.   

Resources Provided by NIAID

Statistical, Data Management, Site Monitoring, and Operations Support: NIAID will provide statistical, data collection and management, site monitoring, and clinical trial operations support through the separately funded Autoimmune Diseases-Statistical and Clinical Coordinating Center (AD-SCCC) contract as well as other trial support resources. NIAID provides information and guidance for NIH funded clinical research in Research Rules & Policies, which includes a Clinical Research Toolkit.  Guidance for the management and use of drugs is also provided within the Division of Allergy, Immunology and Transplantation's  DAIT Pharmacy Manual.

NIH s Interest in Diversity

NIH strongly encourages applicants to include a diverse group of scientists in their research programs, including individuals from underrepresented backgrounds (see NOT-OD-20-031, Notice of NIH’s Interest in Diversity and NOT-OD-22-019, Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

Link

For more information, please see FAQ here.

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

 

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

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

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.

• 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. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 individual may serve as PD/PI on an application to either this Basic ACE program FOA or the companion Clinical ACE program FOA (RFA-AI-22-071) but not both. An individual may serve as Project Leader or in another role (non-PD/PI) on applications to both FOAs. Note that the multiple PDs/PIs option may only be used for the overall Program Leader. NIAID does not support multiple Project/Core Leaders for individual Projects and Cores within a multi-project application.

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

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

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).

 

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

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

The letter of intent should be sent to:

James T. Snyder, Ph.D.
Telephone: 301-240-669-5060
Email: [email protected]

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

Available Components	Component Type for Submission	Page Limit	Required/Optional	Minimum	Maximum
Overall	Overall	12	Required	1	1
Admin Core	Admin Core	6	Required	1	1
Core (Use for ACE Funds Management Core & ACE Biorepository Core)	Core	6	Required	2	2
Project (Use for Principal Project & Collaborative Project)	Project	12	Required	2	2
Pilot Project	FOA-Specific Component Type	6	Required	1	1

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

The application should consist of the following components:

• Overall: required
• Administrative Core: required; 1 maximum
• ACE Funds Management Core (AFMC): required; 1 maximum
• ACE Biorepository Core (ABC): required; 1 maximum
• Principal Project: required, 1 maximum
• Collaborative Project: required, 1 maximum
• Pilot Project; required, 1 maximum

When preparing your application, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

The Biographical Sketch should include the following: Describe the experience of the PD(s)/PI(s) in developing and conducting collaborative research, highlight any participation in clinical studies with mechanistic studies and describe the synergies and collaborations that occurred.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

 

Specific Aims: Briefly introduce and describe the approach of the Center to autoimmune disease research and therapy, specifically including the following:

• Theme and overall goals of the Center,
• Most important questions in autoimmune disease research and therapy, and

How the questions will be answered (outline here, provide details in the projects).

Research Strategy: This narrative section summarizes the overall research strategy for the multi-project application and explains how the proposed Center satisfies the purpose and objectives of this FOA to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases.

Applicants should describe how the proposed Principal, Pilot, and Collaborative Projects are interrelated, synergistic, and fit under an overarching common theme and provide scientific gains beyond those achievable if each project were pursued independently. As the strategy develops, cite each project and core briefly as to its place in the overall scheme. Each project in this multi-project application must have its own scientific merit and complement the others. This section is an opportunity for the investigators to give conceptual wholeness to the overall program by stating the general problems and by presenting a comprehensive strategy for solving them. Include a description of the advantages the proposed Center will gain from participating in the ACE Program and what the Center will contribute to the overall group.

If the application is a renewal, in addition to discussing results from individual projects, describe the synergies and collaborations that occurred within the Center and with other Centers. Renewal applications may propose to renew and continue on-going Collaborative projects or else to begin entirely new research projects.

Advisory Committee (optional): For applicants proposing to appoint an advisory committee, describe the expertise and responsibilities of the potential committee members. For new applications, do not name, contact, or recruit potential members until review activities are completed. For renewal applications, provide the names of current and former members.

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
• All investigators funded under this FOA will be expected to share their data publicly through ImmPort or other public portals approved by NIH. Therefore, the Data Sharing plan should include a summary of how the applicant will manage data submission and interactions with ImmPort, or other NIH-approved public portal.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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

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

When preparing your application, use Component Type Admin Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Administrative Core must be headed by the PD/PI or one of the PD/PIs on a multi-PD/PI application. Multiple Core Leaders are NOT permitted.

Budget forms appropriate for the specific component will be included in the application package.

Application budgets for the Administrative Core are not expected to exceed $50,000 in direct costs per year and should reflect the actual needs of the project. Applicants must request at least 1.2 person months effort by the PD/PI or 1.2 person months in total for multiple PDs/PIs. Funds must be budgeted for the PD(s)/PI(s) to attend the twice-yearly Steering Committee face-to-face meetings, one of which will overlap with the annual ACE plenary meeting, and for the PD(s)/PI(s) and all Project leaders to attend the annual ACE plenary meeting.  Both meetings will be held in the Bethesda/Rockville, MD area and each meeting is expected to be two days long.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the Specific Aims of the Administrative Core. Also state the core's relationship to the Program's goals and projects in the application.

Research Strategy:

• Provide a Staffing and Administrative Plan for the program that discusses the structure and roles of administrative and scientific staff, including the functions to be performed and how resources will be prioritized, allocated and managed.
• Provide overall milestones, timelines and performance objectives for the program which should include all Core activities. Provide a management plan for fiscal accountability and communication within the Center.
• Provide plans for coordination, problem identification and resolution, and establishment of a strong collaborative environment for the program.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If parts of the costs of the Core are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

When preparing your application, use Component Type Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The AFMC must be headed by the PD/PI or one of the PDs/PIs on a multi-PD/PI application. Multiple Core Leaders are NOT permitted. 

Budget forms appropriate for the specific component will be included in the application package.

The ACE Funds Management Core application budgets must include the following items:

• Application budgets for the AFMC are not expected to exceed $250,000 in direct costs per year and should reflect the actual needs of the project. Direct costs to include:
  • A minimum of 1.2 person months PD/PI effort as the AFMC Leader.
  • A minimum of 6 person months salary for an AFMC administrator and a maximum of 6 person months for Information Technology staff (if required by the AFMC) to be included in the Other Personnel category.
  • IT computing services, if required by the AFMC.
• The AFMC will support ongoing "legacy" Clinical Projects in addition to new Clinical Projects and Collaborative Projects.
• The AFMC should plan to issue consortium agreements with up to approximately $3,000,000 in direct costs annually for all costs related to Clinical Projects and Collaborative Projects. For the purpose of the application, assume 100 consortium agreements with 50 different sites. The costs may be included in the Other Expenses category because all consortium agreement expenses will be unknown to applicants.
• Travel for either the AFMC administrator or staff member to attend one of the two annual "face-to-face" Steering Committee meetings in the Bethesda/Rockville, Maryland area. Each meeting is expected to be two days long.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: List in priority order the Specific Aims of the AFMC. Also state the core's relationship to the Program's goals and projects in the application.

Research Strategy: List in priority order the proposed activities and services of the AFMC. The ACE Funds management plan must include:

• an administrative structure and plans for staffing.
• plans to negotiate, write, review, revise as needed, execute, and administer budgets and consortium agreements.
• a description of a draft template for Clinical Project consortium agreement budgets.
• plans to receive, review, revise as needed, approve and pay invoices in a timely manner.
• plans to identify and resolve problems.
• plans for accountability and communication with the Steering Committee and with NIAID.
• a description of a draft template of a quarterly report to NIAID on the status of the Clinical Project and Collaborative Project Funds.
• IT support for the maintenance and/or development of an internal website, if required.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If parts of the costs of the Core are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

1. Attach a file named "Clinical Trial Budget Template" showing a draft template for budgets supporting Clinical Projects.

2. Attach a file named "Quarterly Funds Report" showing a draft template for reporting the status of funds to NIAID.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

When preparing your application, use Component Type Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Multiple Core Leaders are not permitted. The ABC must be headed by the PD/PI or one of the PDs/PIs on a multi-PD/PI application.

Budget forms appropriate for the specific component will be included in the application package.

The ACE Biorepository Core (ABC) application budgets must include the following items:

• Application budgets for the ABC are not expected to exceed $250,000 in direct costs per year, and should reflect the actual needs of the project Direct costs to include:
  • A minimum of 0.6 person months PD/PI effort (total) as the ABC Leader.
  • A minimum of 6 person months' salary for an ABC administrator and a maximum of 6 person months for technical staff (if required) to be included in the Other Personnel category.
  • IT personnel and computing services, if required by the ABC
• The ABC should plan to help coordinate collection and storage of samples from new Clinical Projects and Collaborative Projects. For the purpose of the application, assume 5 new clinical trials with a total of 50 sites, each site providing samples of blood (20 ml) from 6 participant visits (amounting to 300 samples) per year. Budget only the costs of administration and infrastructure (e.g., robotics) for receipt, modest processing, aliquoting, storage, quality assessment); actual costs of assembling kits and collecting and shipping samples will be paid by the trial separately.
• Travel for either the ABC administrator or staff member to attend one of the two annual "face-to-face" Steering Committee meetings in the Bethesda/Rockville, Maryland area. Each meeting is expected to be two days long.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

 

Specific Aims: List in priority order the Specific Aims of the ABC. Also state the core's relationship to the Program's goals and projects in the application.

Research Strategy:

List in priority order the proposed activities and services of the ABC. The ABC plan must include:

• an administrative structure and plans for staffing.
• plans to help coordinate collection, shipment, receipt, processing, storage, retrieval, and provision of biological samples (an estimate of the anticipated capacity is provided in the budget section).
• plans to provide to the Steering Committee and NIAID up-to-date inventories of samples available.
• plans to identify and resolve problems.
• a description of the experience of the technical staff in biorepository management. 

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If parts of the costs of the Core are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

When preparing your application, use Component Type Project.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each Project must be led by one person. Co-leaders of projects are not allowed.

Budget forms appropriate for the specific component will be included in the application package.

Application budgets for Principal Projects are not expected to exceed $200,000 in direct annual costs per year for 5 years and should reflect the actual needs of the project. The Project Leader must commit at least 1.2 person months effort to the project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Introduce the hypothesis or hypotheses to be tested. Outline the approach to achieving the aim(s) and testing the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the theme of the application and how it relates to other projects.

Research Strategy: Use this section to describe and explain the strategy proposed to achieve the specific aims. Explain the rationale for selecting the methods proposed to achieve the specific aims.

Special Instructions for the Principal Project: This project should incorporate the theme of the Center, exploit the applicant's expertise, and test hypotheses through Specific Aims that advance our mechanistic understanding of autoimmune diseases. The Principal Project must include a 5-year research plan and benchmarks for evaluating progress.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If any costs are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

When preparing your application, use Component Type Project.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each Project must be led by one person. Co-leaders of projects are not allowed.

Budget forms appropriate for the specific component will be included in the application package.

Application budgets for Collaborative Projects are not expected to exceed $150,000 in direct costs per year for 5 years and should reflect the actual needs of the project. Funding levels will be determined post-award and will be guided by the final form of the ACE Research Agenda. Funds for the Collaborative Project will be provided by the AFMC, once that has been established.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Introduce the hypothesis or hypotheses to be tested. Outline the approach to achieving the aim(s) and testing the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the theme of the application and how it relates to other projects.

Research Strategy: Use this section to describe and explain the strategy proposed to achieve the specific aims. Explain the rationale for selecting the methods proposed to achieve the specific aims.

Special Instructions for the Collaborative Project: Describe and explain the strategy to test the proposed hypothesis or hypotheses for the Collaborative Project. Outline the approach and explain the rationale for selecting the methods proposed to test the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the primary theme of the applicant's proposed Center and how it relates to other projects. Since applicants will not know in advance what other ACE Centers may be funded, applicants may consider proposing projects that start from their own specific expertise and disease focus and later seek to generalize observations and mechanisms to other autoimmune diseases. This could be accomplished with collaborators who have complementary strengths and skills. The Collaborative Project must be coherent, but it may lack some details if they can be reasonably developed with additional ACE collaborators after award.

The Collaborative Project must include a research plan for the entire project period, including plans for formulating annual benchmarks for evaluating progress on the research project.

The ACE will fully develop the Collaborative Projects after award, and they should be designed to become part of the ACE Research Agenda. Collaborative Projects may be expanded or reduced after award, depending upon how well they are ultimately integrated within the ACE. Collaborative Projects will be supported for three years; support in years 4 and 5 will depend on progress and funds available.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If any costs are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

When preparing your application, use Component Type Project.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each Project must be led by one person. Co-leaders of projects are not allowed.

Budget forms appropriate for the specific component will be included in the application package.

Application budgets for Pilot Projects are not expected to exceed $75,000 in direct costs per year for up to 2 years and should reflect the actual needs of the project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Introduce the hypothesis or hypotheses to be tested. Outline the approach to achieving the aim(s) and testing the hypothesis/hypotheses. In addition to stating the biological and clinical significance of the research, indicate the project's relevance to the primary theme of the application and how it relates to other projects. The theme of the Pilot Project must be related to the overarching goals of the applicant's proposed Center.

Research Strategy: Describe an innovative and exploratory Pilot Project that pursues intriguing observations that may lead to discoveries or breakthroughs. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for the Pilot Project; however, they may be included if available. The Pilot Project must include a 2-year research plan and benchmarks for evaluating progress at 18 months. The Pilot Project may be extended, expanded, or terminated after 2 years based on the Steering Committee's evaluation of progress and the availability of funds.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators. If any costs are to be borne by sources other than NIH, these contributions must be presented in detail as part of supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution. These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment of the Overall component in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of 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.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 NIAID, 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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 program 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 program that by its nature is not innovative may be essential to advance a field.

Does the program 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 program 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

• Is the Program scientifically compelling as a whole?

Are the overall Program goals significant and focused on studies that accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program? 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

• Have the applicants and collaborators made a significant contribution to the field of autoimmune diseases?
• Have the applicants and collaborators successfully developed and conducted collaborative research projects?

Do(es) the PD(s)/PI(s) have the scientific ability to develop an integrated and focused research Program?

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 program? Have 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 program 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 integration of the individual projects into a single Program provide synergy, i.e., more beneficial than pursuing each project independently?

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

Is there adequate evidence of sufficient institutional support for the PDs/PI(s) in terms of laboratory space, equipment, and other resources?

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 there a strong scientific premise for the project? 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

• Principal Project: Does the Principal project address key aspects of the Center's theme?
• Collaborative Project: Does the Collaborative Project address an aspect of the Center's theme? Does the Collaborative Project seek to answer broader questions beyond the capabilities of a single Center?
• Pilot Project: Does the Pilot Project address an aspect of the Center's theme?

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 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 children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA

Collaborative Project: Does the proposed Collaborative Project have a good probability of establishing useful, productive collaborative investigation?

Pilot Project: Is the 2-year Pilot Project research plan well-defined 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?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core 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 core proposed).

Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of merit and will give an overall impact score for each Core but will not give separate scores for each criterion.

• Is the Staffing and Administrative Plan appropriate for the objectives of the proposed Program?
• Are the experience, level of commitment, and availability of the Core Leader adequate to manage the overall Program?
• Are the plans for coordination, problem identification and resolution and the establishment of a strong collaborative environment for the program appropriate?
• Are the proposed timelines, milestones and performance objectives for the overall Program adequate?
• Is the management plan for fiscal accountability and communication within the Program appropriate?

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.

Are the administrative structure and plans for staffing appropriate to manage the program funds? Have adequate plans been made to receive, review, and implement budgets and execute consortium agreements? Have adequate plans been made to receive, review, pay invoices, and report status to NIAID in a timely manner? Are the clinical trial budget and quarterly reporting templates appropriate?

Are the administrative structure and plans for staffing appropriate to manage the program samples? Are the plans to coordinate sample collection, storage, and provision of biological samples appropriate? Did the applicant document their experience in successful biorepository management?   

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.

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

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

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

Not applicable

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

Not applicable

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

Not applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Allergy and Infectious Diseases in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see  https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.  

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 award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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 recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have primary responsibility for:

• Advancing and coordinating the activities at their Center, scientifically and administratively.
• One PD/PI from each Center will attend meetings and serve as a voting member of the Steering Committee.
• Participating actively in the formulation and implementation of the ACE Research Agenda.
• Implementing policies approved by the Steering Committee or emplaced by NIAID.
• Participating in working groups, assigned to each new Clinical Project, charged with ensuring that timely, state-of-the-art approaches are taken in mechanistic studies addressing fundamental questions in autoimmunity.
• Sharing all data publicly through ImmPort or other public portals designated by NIAID, as appropriate and consistent with achieving the goals of the program. The PD/PI will establish procedures within the center to ensure that all members of that center, including any scientists added via AFMC support, conform to the data sharing and other resource-sharing plans.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

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

• A NIAID Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. NIAID staff assistance will be provided by DAIT Project Scientists along with other NIH staff. They will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination, including participation in periodic on-site monitoring with respect to compliance with Federal regulations, quality control, accuracy of data recording, sample accrual, etc.
• Facilitate collaborations with and access to other NIAID-supported research resources and services.
• Serve as liaison/facilitator among recipients and with the data portal ImmPort.
• Provide oversight for human subjects protections and provide monitoring for any studies that involve more than minimal risk for participants or that involve vulnerable populations.
• Provide assistance to the Steering Committee in the development of procedures for evaluating the performance of research studies and monitoring any Clinical Trials.
• Participate on the Steering Committee as a voting member and coordinate Steering Committee activities and implementation of its recommendations, decisions, and policies.
• Share information regarding promising new agents, strategies, and developments when appropriate.
• Identify scientific gaps and organize meetings to facilitate exchange of scientific and regulatory information, including during meetings.
• Oversee resources that:
  • provide statistical and data management support,
  • provide regulatory support services,
  • conduct external site monitoring, and
  • manage and distribute investigational agents.
• Participate in the presentation of research results, including publications.
• Oversee clinical site operations to include development of template informed consent documents as well as site specific consents for IRB submission, operational activation of ACE clinical sites, and review and evaluation of site monitoring reports.

Clinical Sample Access. NIAID owns all clinical samples collected. In conjunction with the ACE Biorepository Core (ABC), NIAID staff will facilitate and help coordinate collection, storage, and provision of clinical samples for subsequent studies.

Areas of Joint Responsibilities include:

Steering Committee

A Steering Committee will serve as the coordinating body for the ACE research program. It will be formed by a single PD/PI from each ACE Clinical and Basic Program recipient and representatives from the AD-SCCC and NIAID. It will be chaired by a PD/PI chosen by a majority vote of the Steering Committee, with terms determined by the committee. Each member of the Steering Committee will have one vote. The AD-SCCC representative and NIAID Project Scientist will be voting members but will not serve as the Chair of the Steering Committee. NIH staff with voting rights on the steering committee will collectively have one vote as permitted. All participants in the ACE program are bound by the policies and procedures developed by the Steering Committee.

The Steering Committee responsibilities include:

• Composing, within six months of award, an ACE Research Agenda establishing goals and priorities for the entire program term. The Agenda will be based on the Clinical and Collaborative Projects but may include additional plans in order to foster collaborations among all of the members of the ACE. The Agenda will include but is not limited to the following items:
  • Overall goals and Specific Aims,
  • Clinical and Collaborative Projects to be initiated within the coming year, and
  • Benchmarks and Timelines for accomplishing the work.
    
• Composing an annual collaborative group report and posting it along with the ACE Research Agenda on the public ACE website.
• Helping to fully develop and conduct the mechanistic studies in Clinical Projects and other studies of mechanism and pathogenesis including the associated mechanistic studies and the Collaborative Projects.
• Reviewing ACE Clinical Project budgets.
• Reviewing publications reporting ACE clinical trial results.
• Determining how data from multiple Centers collaborating on a study will be shared and analyzed: investigators wishing to perform their own analysis of local data or of single site studies must obtain approval for the planned analysis from the Steering Committee.
• Developing policies for use of the ACE Clinical Project Fund and the Collaborative Research Fund.
• Establishing procedures for reporting results of ACE trials/studies, including composing and approving a Publications Policy governing the initial public release of ACE clinical trial-related information.

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 arbitration. An Arbitration Panel composed of three members will be convened. The members shall be: (1) one designee of the Steering Committee chosen without NIH staff voting, (2) one NIH designee, and (3) one designee with expertise in the relevant area who is chosen by the other two members. In the case of individual disagreement, the first member may be chosen by the individual recipient. This special arbitration procedure in no way affects the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Stacy E. Ferguson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3504
Email: [email protected],gov

James T. Snyder, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5060
Email: [email protected]

Tiffany Johnson
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3563
Email: [email protected]

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

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