RFA-AI-27-005-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)

Funding Opportunity Title

Clinical Research Network on Antimicrobial Resistance (UM1 Clinical Trial Required)

Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type

Reissue of

RFA-AI-18-036

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-AI-27-005

Companion Funding Opportunity

None

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.855

Funding Opportunity Purpose

The purpose of this notice of funding opportunity (NOFO) is to support a Clinical Research Network (CRN) on Antimicrobial Resistance (AMR). The program aims to design, implement, and manage clinical research that addresses pivotal clinical questions related to AMR through a coordinated and integrated CRN. The CRN will comprise four centers: the Scientific Leadership Center (SLC), the Clinical Operations Center (COC), the Laboratory Center (LC), and the Statistics and Data Coordination Center (SDCC).

Funding Opportunity Goal(s)

To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials. To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas. Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Key Dates

Posted Date

September 01, 2026

Open Date (Earliest Submission Date)

October 10, 2026

November 10, 2026

November 10, 2026

Not Applicable

July 2027

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

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date

November 11, 2026

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background Effective antibiotics are essential for modern medical procedures; however, antimicrobial resistance (AMR) has emerged as a major public health concern that severely restricts treatment options, particularly for patients with chronic conditions. These individuals experience recurrent infections requiring repeated antibiotic use, which exacerbates AMR, complicates care, and increases rates of morbidity, mortality, and disability. Addressing AMR requires comprehensive clinical research to develop effective treatments and strategies to identify new antimicrobial agents and optimize existing therapies.

Due to limited effective treatment options and rapid pathogen adaptation, continued efforts are needed to focus on targeted therapeutic approaches, including non-antibiotic treatments, combination therapies, and innovative diagnostics for enhanced detection and antibiotic stewardship. Developing reliable biomarkers and development of future AMR researchers are essential.

Research Objectives and Scientific Scope This Clinical Research Network (CRN) aims to advance clinical research, including trials, studies, and related activities to enhance the prevention, diagnosis, and treatment of AMR infections. The CRN is anticipated to prioritize clinical research that targets the most significant AMR threats posed by various bacterial and fungal pathogens, as identified by the Centers for Disease Control (CDC), encompassing both antibiotic- and antifungal resistant and -susceptible strains. The research will focus on areas where current therapies are insufficient or exacerbate AMR, addressing urgent infections such as healthcare-associated, bloodstream, urinary tract, and respiratory infections.

Potential areas of interest include:

Other areas of interest may include, but are not limited to, clinical informatics, molecular epidemiology to inform trial design, identification of non-invasive biomarkers to guide infection detection and treatment duration, and pharmacokinetic (PK) and pharmacodynamic (PD) studies of new and/or novel drug combinations, with potential involvement of private and public partnerships.

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

CRN Structure The CRN is comprised of the following Centers that work synergistically to support the CRN's complex, large-scale operations and achieve its clinical research objectives.

Scientific Leadership Center (SLC) The SLC will be responsible for providing comprehensive administrative and scientific leadership and governance for the CRN. This includes overseeing and evaluating all CRN activities, developing and refining the clinical research agenda, prioritizing research concepts and clinical projects in alignment with the NIAID mission, engaging with AMR communities, ensuring the timely publication and communication of results and offering advancement opportunities for investigators early in their career and those new to the field.

Clinical Operations Center (COC) The COC provides operational support, management, and oversight for the CRN's clinical studies and trials. The COC is responsible for leading protocol development and implementation and establishes efficient systems for resource distribution and reallocation in response to evolving priorities identified by the SLC. Additionally, the COC establishes processes to identify and approve protocol-specific clinical research sites and provides specialized training for clinical trials, applicable laboratory procedures, and data management.

Note: Due to the broad nature of CRN studies and required subject populations, it is expected that performance sites for implementation of the clinical research agenda may be located at the applicants' institutions, subcontracted to protocol-specific clinical research sites, or provided by other NIAID clinical sites.

Laboratory Center (LC) The LC contributes to the development of the CRN's clinical research agenda, and leads the development, implementation and evaluation of essential laboratory research. The LC manages and oversees relevant laboratory services. Additionally, the LC is responsible for laboratory quality management programs, monitoring and evaluating specialized laboratories within the CRN, and managing the sharing of specimens outside the CRN when necessary. The LC also ensures the provision of storage facilities, and fosters collaboration and harmonization of laboratory activities within the CRN.

Statistics and Data Coordination Center (SDCC) The SDCC provides leadership and support for biostatistics, study design, analysis, interpretation and development of innovative statistical methods in the field of AMR and coordinating with other NIAID-sponsored programs. For Non-Investigational New Drug [IND] or Investigational Device Exemption [IDE] (IND/IDE) studies and trials, the SDCC will ensure the integrity of study design, comprehensive data coordination and statistical analysis for all CRN studies and trials. It also provides training and education for staff on data coordination and specimen shipping/tracking systems, with its role in specimen tracking limited to the development and management of electronic systems and data processes; physical handling and logistics are managed by the COC and affiliated laboratories.

External Advisory Board (EAB) An External Advisory Board (EAB) will be established to review the progress in meeting the goals of the CRN and NIAID, and will make recommendations for the continuation or re-direction of all activities of the CRN.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed

New

Renewal

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIAID intends to commit $18 million in FY 2027 to fund 1 award.

Award Budget

Application budgets are not expected to exceed $12 million in direct costs per year and should reflect the actual needs of the proposed project.

Award Project Period

The project period must be 7 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Foreign Organizations/Foreign Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for 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 How to Apply - Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

Section IV. Application and Submission Information

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

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed, with the following additional instructions:

Within the Research Strategy, including the following sub-sections with the indicated page limits:

Subsection A. CRN Overview; one required, 6 pages Subsection B: Scientific Leadership Center (SLC); one required, 30 pages Subsection C: Clinical Operations Center (COC); one required, 30 pages Subsection D: Laboratory Center (LC); one required, 12 pages Subsection E: Statistics and Data Management Center (SDCC); one required, 12 pages

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

The Biographical Sketch Common Form should indicate experience with IND and IDE submissions, (s)IRB processes, and safety oversight reporting.

R&R Budget All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: List the Specific Aims of the CRN focusing on the clinical research agenda.

Research Strategy: The Research Strategy section should consist of Subsections A-E below.

Subsection A. CRN Overview Describe and discuss an overview of the proposed CRN. Include a description of the following:

Subsection B. Scientific Leadership Center (SLC) Describe the administrative and scientific leadership for the CRN, detailing the organizational structure and management plans that support effective oversight and evaluation of CRN activities, prioritization of research concepts, execution of projects, measurement of productivity, engagement of researchers, and timely publication and communication of results. Include a description of the following:

CRN Governance

Clinical Research Agenda/Scientific Priorities

Advancement Opportunities

Subsection C: Clinical Operations Center (COC) Describe the structure and function of the COC in implementing the clinical studies and clinical trials of CRN's clinical research agenda. Include a description of the following:

Management:

Budget Development:

The process for preparing budgets for protocol implementation.

Subsection D: Laboratory Center (LC) Provide an overview of the anticipated scientific contributions of the LC towards implementing the research agenda of the CRN. Include a description of the following:

Subsection E: Statistics and Data Coordination Center (SDCC) Provide an overview of the SDCC's role in implementing the clinical research agenda of the CRN and providing statistical and data coordination support for proposed clinical studies and trials. Include a description of the following:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The study will collect clinical data (including diagnostic results and physiological measurements such as chest imaging). De-identified data that can be shared are expected to be deposited in a publicly accessible repository no later than the time of an associated publication or the end of the performance period, whichever occurs first, with access provided according to NIH and institutional guidelines.

All investigators funded under this NOFO will be expected to share their data publicly through ImmPort or other public portals approved by NIAID. Therefore, the Data Management and Sharing Plan should include a summary of how the applicant will manage data submission and interactions with ImmPort.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Section 2 Study Population Characteristics

2.5 Recruitment and Retention Plan

Describe how the proposed recruitment and retention plan is designed to overcome obstacles to study participation. In addition to the primary plan for recruiting an appropriately representative research sample, provide alternative/back-up strategies to be used if enrollment significantly deviates (more than 20% of any category for each annual benchmarks/goals from the planned numbers. Please limit response to one page.

Section 3 Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

For clinical trials, upload an attachment that states: NIAID oversees the conduct of applicable clinical trials by convening appropriate Safety Oversight Committees, such as Data Safety and Monitoring Boards (DSMBs) or Safety Monitoring Committees (SMCs), and developing the monitoring plan as needed based on its clinical research policy. No other information should be provided.

3.5 Overall Structure of the Study Team

Please limit response to one page.

Section 4 Protocol Synopsis

4.1 Study Design

Significant development will be conducted with NIAID after award. Please limit response to one page.

4.3 Statistical Design and Power

Please limit response to one page.

4.5 Will the study use an FDA-regulated intervention?

4.5.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status Please limit response to one half page.

4.7 Dissemination Plan

Please limit response to one half page.

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 How to Apply - Application Guide must be followed.

Applicants may enter a delayed onset study record and must check box "Anticipated Clinical Trial?".

Study Title: use: "AMR Clinical Trial" This NOFO supports delayed onset studies. A proposed delayed onset study must provide a justification explaining why information on the clinical trial will not be available at the time of application.

PHS Assignment Request Form

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

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 How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH.