Part 1. Overview Information

Key Dates

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.

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.

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

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

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:

• Exploration and clinical evaluation of novel strategies including innovative antimicrobial treatments, drug combinations, and targeted interventions to effectively address AMR infections due to gram-negative (gram (-)) and gram-positive (gram (+)) bacterial pathogens as well as AMR fungal pathogens (e.g., Candida auris). Special emphasis could be placed on addressing gram (-) bacterial infections due to limited treatment options and complex resistance mechanisms, and on improving outcomes for difficult infections, including hospital-acquired or ventilator-associated pneumonia.
• Strategy trials to optimize the use of currently licensed antimicrobials aimed at minimizing the impact on native microbial communities.
• Investigations into diagnostic tests that refine treatment strategies and support appropriate use of antimicrobials, alongside studies supporting regulatory approval of new diagnostic tests.
• Advancing the next generation of clinical researchers specializing in AMR research.

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:

• Studies focused solely on infection control programs and/or broad antimicrobial stewardship interventions, without specific evaluation of targeted strategies to optimize antimicrobial use (such as prescribing practices, guideline implementation, audit and feedback, education, or policy interventions).
• Studies directed toward the following:
  • Parasitic, viral, mycobacteria infections (including tuberculous and non-tuberculous mycobacteria), and Streptococcus pneumoniae.
  • Pathogens that cause food- and water-borne illnesses, such as Salmonella Typhi, Campylobacter, nontyphoidal Salmonella, Shigella, certain Escherichia coli species, and Vibrio cholerae.
  • Microorganisms that are not mentioned in the CDC AMR threat lists.

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

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

Higher Education Institutions - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal 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.

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.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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:

• 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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

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

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

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:

• Provide a budget breakout for all planned activities under one of two major headings: 1. Core Funds, which covers all costs NOT related to clinical trials, and 2. Protocol Funds to cover all costs associated with proposed conduct of clinical trials. Budgetary requests are expected to vary in the proportion of funds going to activities in any given year. For example, Protocol Funds may fluctuate between 25% and 75% direct cost per year based on clinical trial implementation. Note: budget requests should align with activities in the clinical research agenda.
• Include travel funds for the PD(s)/PI(s), key personnel, and up to five External Advisory Board (EAB) Members (excluding NIAID staff if applicable) for the following required CRN meetings:
  • A one-day, in-person kickoff meeting to be held in the Washington, DC metro area within three months of award;
  • A one-day annual program progress meeting, to be held in the Washington, DC metro area or at another NIAID-approved site.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

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:

• The priority setting process including recent studies and current knowledge to support the planned approach as well as discussion of novel or innovative approaches.
• The rationale behind the proposed clinical research and how it relates to the clinical research agenda and explain how each clinical project might inform future studies.
• How future studies may emerge as a result of emphasizing innovative elements, novel approaches and tools. Provide a table or graphic representation of the combined timeline for all proposed clinical research
• The policies and procedures guiding CRN operations for effective research management and how the SLC, COC, LC, and SDCC staff will collaborate to achieve CRN goals, emphasizing the integrated structure of the CRN.

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

• The overall CRN structure. Tables, diagrams, flow charts and organizational charts are strongly recommended.
• The management plans consisting of approaches to decision-making, clear governance structures, effective communication plans, establishing committees, including a steering committee and, as appropriate, scientific working groups, achievement of goals and benchmarks, strategies for effective project management, innovative administrative approaches and strategies for dispute resolution and mitigation of potential and actual conflicts of interest, including financial conflicts. Describe strategies for coordination and collaboration with external partners, NIAID, other NIH-supported networks, and federal and private-sector clinical research programs, as well as policies for resource distribution. Describe any established or planned collaborations that will advance the CRN clinical research agenda and proposed CRN collaboration plans with other applicable companies and or agencies. Do not name or contact potential collaborators that are not already key personnel in the application until after review activities are completed.

Clinical Research Agenda/Scientific Priorities

• The comprehensive AMR clinical research agenda; discuss the process for determining the agenda and explain how the agenda will address key knowledge gaps and future opportunities in AMR clinical research, highlighting innovation; discuss the process used to prioritize research concepts and include a priority list of proposed clinical projects that are derived from these concepts and align with the clinical research agenda. Describe how the clinical research agenda will be developed and refined to clearly articulate the CRN's scientific priorities, establish a framework for initial and future projects, and align with NIAID's AMR research priorities. Include a discussion of responsive priority areas such as randomized clinical trials targeting Gram (-) negative bacterial infections, with a particular emphasis on difficult-to-treat cases; the evaluation of alternative therapies, including advanced bacteriophage strategies, monoclonal antibodies, and microbiome-based products (e.g., live biotherapeutic products); strategy trials to optimize the use of currently licensed antimicrobials (e.g., dose, duration, clinical algorithms, extending indications for use, and combinations); investigations of diagnostic tests to refine treatment strategies, support appropriate antimicrobial use, and support regulatory approval of new diagnostic tests; and the use of clinical informatics (e.g., big data mining, machine learning, Artificial Intelligence) and molecular epidemiology to inform trial design. For each proposed project, include preliminary data or information supporting feasibility.
• The goals and benchmarks for completing the key activities of the clinical research agenda.
• How the CRN structure will facilitate the achievement of the clinical research agenda's goals and ensure flexibility in responding to new AMR-related scientific opportunities.
• How additional clinical research concepts will be solicited from investigators both within and outside the CRN and how these concepts will be evaluated.
• How ancillary studies will be considered, approved, and integrated into the approved research concepts.
• The process and frequency for assessing and updating the clinical research agenda, including plans to obtain external assessments of the research and priorities.
• How the utility and continued need for decision-making committees will be evaluated and modified.

Advancement Opportunities

• The plans to incorporate clinical research advancement opportunities for investigators early in their career and those new to the field, including plans to advance the next generation of clinical researchers specializing in AMR research. Describe opportunities such as small research projects, clinical- or research project-related training, participation in CRN committees, and exposure to multiple aspects of AMR clinical research.
• How advancement opportunities will integrate perspectives from and collaborations with different fields and relevant disciplines (clinical bacteriology, infectious diseases, immunology, cutting edge technology [e.g., Artificial Intelligence/ Machine Learning, omics, etc.], pharmacology, epidemiology, public health).
• A comprehensive strategy to effectively and widely disseminate information about advancement opportunities to the research community.
• The mechanisms that will be used to coordinate and evaluate advancement opportunities, including regular progress reviews, feedback sessions, and performance assessments to monitor and enhance their effectiveness.
• The internal procedures that will be developed for responding to recommendations from the EAB. Note: The EAB will be constituted after award from recommendations put forward from the recipient in consultation with the NIAID Program Official. Do not name, recruit, or contact potential EAB member prior to award.

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:

• The organizational structure and lines of authority of the COC, including provisions for the fiscal management of CRN resources (financial management), the systems for tracking COC activities (activity tracking) and how plans will support timely expenditure of funds (use of visual aids such as tables, diagrams, flowcharts, and organizational charts to illustrate is recommended).
• The plans and procedures (excluding scientific rationale) for designing and executing clinical protocols and developing associated clinical documents.
• The processes and procedures to establish effective project management of COC activities, including management of both long-term and day-to-day study and trial activities, systems for tracking activities and monitoring progress, and development of project plans with realistic goals and benchmarks.
• The processes and practices to meet clinical study and trial timelines and benchmarks/goals, methods for performance assessment, and plans for remediation and follow up when established timelines are not met.
• The contingency plans for research continuity and the ability to redirect efforts as needed.
• Plans for coordination and execution of IND/IDE studies.
• Innovative approaches to oversight and/or management of complex clinical research efforts.
• Approaches to identifying obstacles or delays in study start up and assessing performance (include examples of specific metrics and, as applicable, examples for achieving study and trial goals [e.g., site selection, initiation]).
• The plans for communicating and coordinating within the CRN and with other applicable companies and/or agencies, including collaboration with NIAID and the clinical research sites to support successful completion of protocols.
• The approach to developing clinical research concepts into protocols and associated documents and the process for fast tracking development of high priority concepts and protocols.
• The criteria upon which protocol investigators, protocol project managers, and protocol teams will be selected and assembled.
• How protocol teams will access expertise in clinical site management, study product management, regulatory support (including for non-US regulatory agencies, where applicable), and industry liaisons, as appropriate.
• How project management plans will be developed, tracked, and monitored. Include a discussion of establishing realistic benchmarks/goals, activity tracking, evaluation of established plans, actual data, and future projections.
• The process for developing and maintaining essential documents to support the protocol, such as regulatory documents, the Manual of Operating Procedures, and Informed Consent Forms, policies, bylaws, standard operating procedures (SOPs), and communication plans.
• The plans, processes and communication strategies to meet the requirements of single Institutional Review Board (sIRB).
• How the training needs of CRN scientific staff will be identified and addressed. Explain the process for periodically reviewing and evaluating the value and effectiveness of the training conducted. Detail how necessary changes in training programs or approaches will be decided and implemented at the Clinical Research Sites.
• The process and approach for feasibility assessments; identifying, qualifying, selecting, and approving protocol-specific clinical research sites; safety oversight; receiving, labeling, storing and tracking study products and for monitoring storage conditions, and inventory control; classification, labeling, documentation, shipping and tracking of clinical specimens; access to a qualified affiliated laboratory and secure pharmacy facility; and collection, processing, analysis (if appropriate) and transmission of data to NIAID supported programs.
• How the COC will maintain protocols, informed consent forms (ICFs), Institutional Review Board (IRB)/single IRB (sIRB) documentation, Trial Master Files (TMFs), and other essential regulatory documents, while ensuring compliance with all applicable regulatory requirements.
• How the COC will oversee study product management and specimen handling at affiliated laboratories, including inventory, storage, and shipping, and how specimens requiring specialized testing, long-term storage, or external distribution will be transferred to the Laboratory Center (LC).

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:

• A comprehensive overview of the LC, including the number and types of laboratories, the roles and significance of each laboratory with emphasis on synergistic interactions and innovative elements that enhance the overall functionality. Use visual aids such as tables, diagrams, flowcharts, and organizational charts to illustrate.
• The services provided, emphasizing proposed innovations and existing novel assays. Describe the decision-making process for selecting specialized assays, procedures (e.g., specimen characterization), and analyses (e.g., PK, bioanalysis) for protocol-specified testing. Summarize plans for developing new assays, the types of biological samples to be collected, and measures for processing, storage, and quality control. Describe the approach to ancillary studies using stored samples from CRN clinical trials.
• Laboratory quality management procedures, including general quality assurance (QA) and quality control (QC) measures. Outline requirements for external quality assurance (EQA), validations, reference range studies, and laboratory audits.
• The strategy for distributing specimens both internally and externally, specifying the criteria and procedures for external distribution once clinical specimens are collected and transferred by the COC. Describe how the LC will manage specialized testing, long-term storage, and external distribution in accordance with established protocols.
• Plans for engaging research communities about available specimen collections to ensure broad awareness and effective utilization.
• The procedures and interactions among laboratories, CRN centers, and clinical sites for performing routine non-specialized testing at affiliated laboratories, and shipping to one or more LC laboratories for specialized testing or to a repository for long-term storage.

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:

• The SDCC structure, emphasizing its role in advancing the CRN's objectives through effective statistics, data management, and IT integration, including its central role in standardizing and harmonizing statistical and data organization activities within the CRN and coordinating with other NIAID-sponsored programs, as necessary.
• The lines of authority (use visual aids such as tables, diagrams, flowcharts, and organizational charts to illustrate).
• How the SDCC's composition is strategically designed to support cutting-edge statistical analysis and robust data systems essential for AMR research.
• The synergistic interaction between statistics and data management staff within the SDCC, other CRN centers, and clinical research sites, focusing on protocol design, data analysis, and publication processes.
• The collaborative strategies with NIAID to ensure data integrity, consistency, and efficient analysis.
• The innovative statistical methodologies being implemented, including study design, control/comparison groups, sample size and power estimates, endpoints, and stratification/blocking methods, which aim to enhance AMR clinical research and facilitate the study of difficult-to-study infections.
• The development and adaptation of data collection systems, forms, and database structures to effectively meet the needs of the CRN and collaborators.
• The comprehensive process for preparing essential materials for clinical trials and studies (e.g., Case Report Forms [CRF], Laboratory Manuals, Pharmacy Manuals, and electronic CRF instructions).
• The procedures for planning and executing interim and final analyses, including safety analyses, with a focus on developing robust Statistical Analysis Plans.
• The establishment of a centralized system for participant randomization and strategies for maintaining blinding throughout the studies to ensure integrity and reliability.
• The study of randomization procedures, including systems such as web-based, touch-tone, and permuted block allocation, along with methods for verifying participant eligibility.
• The processes for data collection and management at clinical research sites, laboratories, and central CRN facilities, emphasizing the transmission, collation, reconciliation, and merging of datasets for accurate analysis.
• Approaches to data quality and validity (QA/QC), including timelines for resolving discrepancies and obtaining missing data.
• SDCC policies to ensure data security, confidentiality, and integrity during both internal handling and transmission to external systems, including NIAID programs.
• Measures to comply with U.S. regulatory standards and public laws (e.g., Clinical Data Interchange Standards Consortium [CDISC], 508 compliance, privacy impact assessment, and title 21 CFR part 11) for data coding activities.
• Plans for efficient data retrieval, timely report generation, statistical support for CRN publications, implementation of an electronic specimen tracking system, and training of site personnel on data system usage. The SDCC's role in specimen tracking is limited to electronic systems and data processes, while physical handling and logistics are managed by the COC and affiliated laboratories.

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.

• Describe the plan for providing access to tools developed through this NOFO to the community, including dissemination through appropriate public databases and repositories.
• Describe plans to collect samples (including biospecimens, e.g., microbiological isolates) under agreements that facilitate their distribution to the broader research community, ensuring that these resources can be utilized effectively to drive innovation and discovery.

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

All instructions in the How to Apply - Application Guide must be followed.

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.

• Awards issued under this NOFO will be incrementally funded awards for project periods of up to 7 years.
• Grants awarded under this NOFO will be excluded from automatic carryover; all carryover requests must be approved.
• Grants awarded under this NOFO will not be provided the authority to automatically extend the final budget period one time for up to 12 months beyond the original expiration date shown in the Notice of Award.
• Progress and financial reporting will be required and reviewed annually.
• All funds must be expended within the approved project period.

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. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.36.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

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 NOFO. 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: Investigational randomized controlled clinical trials for therapeutics, including non-traditional approaches, and diagnostics aimed at managing difficult-to-treat infections caused by Gram (-) pathogens.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 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 NIH as defined below.

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

• Maintaining primary responsibility for planning, directing, and executing the proposed scientific activities.
• Overseeing all aspects of studies including any modification of study design (which may require prior approval), conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators including industry.
• Facilitating collaboration and communication with the Scientific Leadership Center (SLC), Clinical Operations Center (COC), Laboratory Center (LC), and Statistics and Data Coordination Center (SDCC), to accomplish the objectives of the Clinical Research Network (CRN).
• Establishing all policies and procedures for decision-making and providing these to NIAID Program Staff, focusing on overall governance and management, and including, at a minimum, CRN governance, concept solicitation and review, and scientific working group plans.
• Ensuring that each clinical site, whether a single institution or a consortium of institutions, will follow the established procedures required by the protocol regarding study conduct and monitoring, volunteer management, data collection, data management, and quality control.
• Submitting a close-out plan of the collaborative decision that an awarded clinical study is no longer feasible. The plan must be approved and signed by the Authorized Official Representative and the PD/PI(s) listed on the award prior to submission.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• Monitoring the progress of the clinical trial, including each participating facility.
• Serving as a resource to provide scientific/programmatic support during the accomplishment of the research by advising to the design of the activities, advising the selection of sources or resources (e.g., determining where a particular reagent can be found), providing research resources and reagents available from NIAID recipients and contractors, or participating in the preparation of publications.
• Each clinical study will be evaluated by NIAID on an individual basis for the need for support services including the need for an IND/IDE held by NIAID.
• Assisting in the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the Food and Drug Administration, if applicable.
• Providing medical monitoring for clinical trials. Should a pharmaceutical or biotechnology company sponsoring a clinical trial choose to name its own Medical Monitor, then the NIAID Medical Officer will work with the company-assigned Medical Monitor.
• Monitoring the adequacy of adverse event management and reporting and having regular communications with the PD(s)/PI(s) and study team, which may include attendance at the safety monitoring (or DSMB) and related committee meetings.
• Participating in the development of study protocols, monitor compliance, enrollment targets, adherence to uniform data collection procedures, ongoing compliance with requirements and the timeliness and quality of data reporting.
• Comparing actual enrollment to the benchmarks and criteria identified in the application.
• NIAID reserves the right to terminate or curtail the study in the event of (a) failure to implement the study protocol, (b) a substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NIAID does not concur, (d) reaching a major study objective substantially before schedule with persuasive statistical evidence, or (e) human subject ethical issues that may dictate a premature termination.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Establishing an External Advisory Board (EAB) post-award for the CRN on AMR, which is expected to consist of investigators who are not current collaborators of the funded programs.
• Establishing a Clinical Quality Management Plan, developed in accordance with NIAID policy and to be approved by NIAID.
• Facilitating the conduct of the studies.
• Participating in a Steering Committee. The PD/PI or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee. The NIAID Project Scientist will serve as the voting member on behalf of NIH on the Steering Committee. Additional details and responsibilities of the Steering Committee will be negotiated at the time of award or post-award.

Dispute Resolution:

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

3. Data Management and Sharing

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. 

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR Part 200.301.

Section VII. Agency Contacts

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

National Institute of Allergy and Infectious Diseases (NIAID)
Email: AMRClinicalResearchNetworkContact@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

National Institute of Allergy and Infectious Diseases (NIAID)
Email: NIAIDFinancial-GrantsContact@mail.nih.gov

Section VIII. Other Information

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

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 2 CFR Part 200.