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

Overview

The Infectious Diseases Clinical Trial Network (IDCTN) evaluates therapeutics, vaccines, biologics, diagnostics, and devices targeting infectious diseases, with the goal of treating, and ultimately preventing, emerging and chronic infectious diseases.

 The network consists of multiple Clinical Trial Evaluation Units (CTEUs) and only one CTEU with a Network Coordination Center (NCC). A CTEU provides critical domestic infrastructure to support timely conduct of clinical trials. The NCC, through its scientific leadership and clinical trial operational expertise, develops and refines the research agenda of the network, establishes priorities, and reviews concepts to ensure a balanced clinical research portfolio. Clinical trials performed at CTEUs originate from concepts developed by IDCTN.

Note: One (and only one) NCC will be awarded for the entire IDCTN; therefore, inclusion of an NCC within an application is optional. If an NCC is not awarded as part of one CTEU awarded under this notice of funding opportunity (NOFO), the IDCTN in its entirety will not be supported.
 

Research Areas and Scientific Areas of Interest

The scope of the clinical research priorities and clinical trial capabilities (Phase I - IV) across the IDCTN must span the National Institute of Allergy and Infectious Diseases (NIAID) clinical research areas of scientific interest. Each CTEU is not required to have capabilities to support all scientific areas of interest.

A feature of the IDCTN is the formation of multiple scientific working groups that provide expert input into the research areas of scientific interest to the IDCTN. These include:

• Malaria/neglected tropical diseases
• Sexually transmitted infections
• Respiratory infections, particularly influenza
• Enteric diseases
• Emerging infectious diseases and other infectious disease considerations

The clinical trial population scope includes people of varying ages and representative of the U.S. population: healthy volunteers, patients with common outpatient infections (e.g., sexually transmitted infections, respiratory viral infections), and people who are immunocompromised.

Examples of clinical research activities within the scope and scientific areas of interest include, and are not limited to:

• Evaluation of preventative candidates (including vaccines and monoclonal antibodies);
• Evaluation of therapeutic candidates (including live biotherapeutics);
• Development and utilization of controlled human infection models; and 
• Evaluation of tools for the diagnosis of infectious disease, including sexually transmitted infections.

Structure of the Clinical Trial Evaluation Unit (CTEU)

Each application must propose only one CTEU.

CTEU Administration (required) - The CTEU Administration develops clear governance structures for coordination and collaboration within the IDCTN and with NIAID for development and implementation of clinical trial protocols. It coordinates with NIAID and the NCC to ensure appropriate integration of NIAID-supported resources. The CTEU Administration also identifies and promotes opportunities for investigators at the CTEU that are early in their careers and/or those new to the field.

Clinical Trial Site (required) - The Clinical Trial Site encompasses the requisite infrastructure and personnel which enables the conduct of high-quality clinical research.

Clinic (required) - The CTEU Clinic provides and supports experienced researchers and location(s) for the enrollment of participants and the conduct of other protocol-specified clinical activities.

Clinical Laboratory (required) - The CTEU Clinical Laboratory provides for the conduct of protocol-specific clinical and safety laboratory testing and manages specimens.

Pharmacy (required) - The CTEU Pharmacy manages investigational study product(s) in accordance with applicable regulations and policies.

Research Laboratory (optional) - The CTEU Research Laboratory develops and conducts assays for the analysis of biospecimens for determination of clinical trial outcomes, or other clinical research activities.

IDCTN Collaboration (required) – The CTEU collaborates with the NCC and participates in: committees; annual meetings; and supports investigators early in their careers and/or those new to the field.

Structure of the Network Coordination Center (NCC) (optional)

NCC Administration (required if NCC is proposed) - The NCC Administration provides scientific leadership, establishes the operational framework and governance structures and coordinates meetings. It also supports opportunities for the next generation of clinical trialists in infectious disease by establishing a program for investigators early in their career and/or those new to the field.

Governance (required if NCC is proposed) - The NCC establishes the IDCTN research agenda. A Governance Committee, comprised of CTEU PDs/PIs, and in collaboration with NIAID, regularly revises the IDCTN research agenda, identifies scientific priorities and evaluates the portfolio. The highest priority for clinical research is public health emergency declarations.

Scientific Working Groups (required if NCC is proposed) - The NCC is responsible for establishing processes (i.e., scientific working groups [SWGs]) to identify, solicit and review clinical concepts from experts in the field. The NCC also identifies knowledge gaps within specific disease or practice areas and defines corresponding research questions. NIAID subject matter experts, CTEU PDs/PIs, and CTEU key personnel will serve as members on SWGs to develop clinical concepts. Additional subject matter experts needed for concept review and development are identified and supported by the NCC (i.e., product developers, laboratory experts, and statisticians).

Clinical Oversight (required if NCC is proposed) - The NCC establishes processes to provide oversight of IDCTN clinical trials and to manage clinical trials implemented through the IDCTN.

Note: Clinical concepts will be evaluated by NIAID for provision of the appropriate Institute resources for protocol development and clinical trial implementation.

Investigators may contact the Scientific/Research Contact(s) listed in Section VII. Agency Contacts for more information regarding NIAID clinical research policies.

Non-Responsive Applications

The following will be considered non-responsive and will not be reviewed:

• Applications containing Clinical Trial Site facilities that are not a part of the applicant organization (except for Commercial Laboratories where a fee-for-service agreement is utilized).
• Applications proposing more than one CTEU.
• Applications that do not describe Registry/Screening and Specimen Sampling protocols.
• Applications in which all laboratories proposed as part of the Research Laboratory are not located within the applicant organization.
• Applications that do not propose any delayed onset clinical trials.

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.

At least one PD/PI must be a physician (M.D. or D.O. only). An investigator may serve as a PD/PI on only one application. A PD/PI may serve as a collaborator on another application(s) provided there is no scientific overlap.

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: 

Section 1: Clinical Trial Evaluation Unit (CTEU) – Each application must propose one CTEU (sub-sections 1A - 1H) 
Sub-section 1A. Overview of Clinical Trial Evaluation Unit - required - 6 pages 
Sub-section 1B. CTEU Administration - required - 12 pages 
Sub-section 1C. Clinical Trial Site - required - 12 pages 
Sub-section 1D. Clinic - required - 6 pages 
Sub-section 1E. Clinical Laboratory - required - 6 pages 
Sub-section 1F. Pharmacy - required - 6 pages 
Sub-section 1G. Research Laboratory - optional - 6 pages 
Sub-section 1H. IDCTN Collaboration - required - 12 pages

Section 2: Network Coordination Center (NCC) – Optional; all sub-sections are required in the application if an NCC is proposed - 30 pages maximum in total for sub-sections 2A – 2E 
Sub-section 2A. Overview of the Network Coordination Center 
Sub-section 2B. NCC Administration 
Sub-section 2C. Governance 
Sub-section 2D. Scientific Working Groups 
Sub-section 2E. Clinical Oversight 

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, with the following additional instructions:

Facilities & Other Resources: Describe each Clinical Trial Site facility identified within the application. All facilities (except Commercial laboratories utilizing a fee-for-service agreement) must be a part of the applicant organization. Describe any proposed laboratory space, which must be located within the applicant organization, within the Research Laboratory, if applicable. 

Describe the nature and categories of study product(s) the Pharmacy has experience managing. Include any specialized capabilities of the Pharmacy (e.g., compounding, over-encapsulation) and any certifications for pharmacy facilities. Include any certifications for laboratory facilities.  

SF424(R&R) Senior/Key Person Profile

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

Within the biosketches, highlight clinical trial expertise and experience that address the proposed scope and scientific areas of interest. Include in the description the type of study (observational, clinical trials, clinical trial under IND), the duration of the study (in years), and the number of subjects enrolled and retained.

If an NCC is proposed, within the biosketches, describe previous experience with implementation, oversight and overall management of complex projects of this scope. Expand on the specific skills that will contribute to scientific and operational success of the IDCTN.

R&R Budget

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

In the budget justification, provide a budget breakout for all activities under the following major headings: 

• CTEU Funds, for all costs related to the CTEU (including IDCTN Collaboration, maintenance of registry/screening and specimen sampling protocols, and travel for PD(s)/PI(s) and key personnel for kick-off and annual meetings), and 
• NCC Funds, as applicable, for all costs associated with the optional NCC (including travel for kick-off and annual meetings).  

CTEU and NCC funds are considered Core Funds. Do not request funds for support of specific clinical trial protocols (Protocol Funds) in response to this NOFO. Instead, Protocol Funds will be determined and provided as needed, based on the availability of funds.

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: Describe the specific aims of the CTEU with an emphasis on malaria/neglected tropical diseases, sexually transmitted infections, respiratory infections, enteric diseases, and/or emerging infectious diseases.

Research Strategy: The Research Strategy section should consist of Sub-sections 1A – 1H and Sub-sections 2A – 2E (as applicable).

Section 1: Clinical Trial Evaluation Unit (CTEU)

Sub-section 1A: Overview of Clinical Trial Evaluation Unit

• Discuss the overall structure of the CTEU and how the structure and established processes support timely engagement and the execution of high-quality clinical trials conducted under U.S. Food and Drug Administration (FDA) authority, and in compliance with Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), applicable U.S. regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and NIAID clinical research policies.
• Describe the scope and scientific areas of research that the CTEU will address.
• Summarize the overall functional role of the CTEU in the implementation of collaborative clinical research with the IDCTN and NIAID.

Sub-section 1B: CTEU Administration

• Describe the organizational structure, staffing, and governance plan supporting the CTEU. Do not duplicate information provided in the biosketches. Include Administration, Clinical Trial Site, Clinic, Clinical Laboratory, Pharmacy, and the optional Research Laboratory to demonstrate functional interactions, institutional workflows, roles and responsibilities of proposed personnel. Include all roles that will be supported by CTEU funds, and the staffing strategy for implementation of clinical trials.
• Describe the capabilities, processes and timelines for the implementation of clinical trials, including supporting a rapid response.
• Describe the role and processes for project management across the CTEU. Include project tracking, approaches to efficient utilization of resources and infrastructure, and continuous quality evaluation and improvement.
• Describe the structure and processes for financial management of the CTEU, including developing, tracking and reporting of clinical trial budgets and expenses.
• Describe the overall approach and processes for conducting internal Quality Control and Quality Assurance (QC/QA) for all research activities (e.g., clinical data, laboratory data, specimen management, communications with NIAID) consistent with NIAID clinical research policies. Include specific metrics and frequency for assessing operational performance and capacity of all components of the CTEU, as well as provision of these metrics to NCC and NIAID for oversight and management of the IDCTN program. Include plans for the development and implementation of risk management strategies throughout the CTEU.
• Describe plans for identifying and supporting investigators early in their career and those new to the field, incorporating them into the CTEU structure, and supporting them in clinical research opportunities, including funding modest secondary research (pilot) projects from data and/or specimens from NIAID-funded clinical trials.

Sub-section 1C: Clinical Trial Site (one site only)

• Without duplicating information in the biosketches, describe the composition of the clinical team supporting each area of scientific interest.
• Describe how the infrastructure (e.g., Administration, Clinic, Clinical Laboratory [including specimen processing and storage], and Pharmacy) will support each specific area of scientific interest.
• Describe how the processes supporting CTEU clinical activities, including safety oversight and reporting, protocol oversight, IRB approvals, clinical site monitoring, documentation of clinical staff training, data management/transfer of data to coordinating center, and timely publication and communication of research results, promote preparedness to conduct high quality clinical trials.
• Confirm all Clinical Trial Site facilities are within the applicant organization and under the oversight of one domestic Federal-wide Assurance (FWA).

Sub-section 1D: Clinic

• Describe recruitment processes and the clinic location(s) to support the proposed scope and scientific areas of interest, including metrics associated with each recruitment/method.
• Describe innovative outreach, recruitment, retention and engagement activities with a population representative of the U.S. to support clinical trials in the proposed scope and scientific areas of interest. Discuss processes and practices facilitating retention of participants through all study visits. Discuss flexibilities that allow for accommodating increases and decreases in enrollment.
• Describe the screening/registry protocol and how it will support recruitment of the study populations within the proposed scope and scientific areas of interest. Provide plans for maintaining and updating the registry over the duration of the award.

Sub-section 1E: Clinical Laboratory

• Describe the overall Clinical Laboratory structure (including specific clinical laboratories and their capabilities), staffing plans, lines of authority, and how this structure will integrate within, and facilitate the conduct of clinical trials and clinical research activities at the CTEU. Do not repeat information provided in the biosketches.
• Describe the flow of specimens (from collection at the clinic, through the Clinical Laboratory, and ultimately to a long-term storage) and associated data (from the clinic and through to the NIAID designated statistics and data coordinating center) as governed by site SOPs. Include the process for collecting samples, the plan for labeling, preparation, storing, shipping, and tracking.
• Describe the processes for the management, storage, and sharing with the research community of biospecimens collected during the conduct of a clinical trial for the purpose of secondary research.
• Provide a table summarizing the nature and types of clinical specimens the Clinical Trial Site has collected during the conduct of infectious diseases clinical trials and that the Clinical Laboratory has processed previously.  Describe what, if any, Quality Assurance programs the Clinical Laboratory participates in and their performance.
• Describe the specimen sampling protocol: what specimens can be collected (e.g. blood for serum and peripheral blood mononuclear cells, and mucosal/epithelial swabs (i.e., oropharyngeal, genitourinary)); recruitment population (e.g., healthy volunteers, outpatient infections); the activities to be supported by the protocol (e.g., Quality Assurance programs, assay development); and processes for maintaining IRB approval.
• Describe oversight and quality processes for the Clinical Laboratory, QC processes, and process for developing, reviewing and implementing laboratory SOPs.

Sub-section 1F: Pharmacy

• Describe the overall Pharmacy structure (including specific pharmacy(ies) and their capabilities) and how this structure will integrate within and facilitate the conduct of clinical trials and clinical research activities at the CTEU.
• Describe the plan for pharmacy operations and communications, including lines of authority within the Pharmacy and within the overall CTEU structure. Describe oversight and quality processes for the Pharmacy, QC processes, and process for developing, reviewing and implementing pharmacy SOPs.
• Describe the plans for study product receipt, storage, preparation, identification and processing, labeling, dispensing, final disposition, record keeping and inventory. Also include any plans for providing participant counseling for specific study products.

Sub-section 1G: Research Laboratory (Optional)

If proposed, address the following, as applicable:

• Describe the overall Research Laboratory structure (including specific Research Laboratory(ies)) and how this structure is integrated into the CTEU to facilitate the conduct of clinical trials and clinical research activities within the proposed scope and scientific areas of interest. Include the plan for Research Laboratory operations, communications, and oversight by the CTEU administration, including lines of authority within the Research Laboratory and within the overall CTEU structure.
• Describe the types of assays that the Research Laboratory has conducted previously for the analysis of biospecimens collected during the conduct of a clinical trial for the determination of clinical protocol defined endpoints and outcomes. Indicate assays that supported clinical trials conducted under FDA authority and ICH guidelines.
• Describe the plans for research sample receipt, storage, preparation, processing, analysis, and disposition, including types of specimens/matrices. Also include process for the transfer of data from the Research Laboratory to the data coordinating center.
• Describe oversight and quality processes for the Research Laboratory, (including oversight by the CTEU Administration) QC processes, and process for developing, reviewing and implementing laboratory SOPs, and participation in any Quality Assurance programs.

Sub-section 1H: IDCTN Collaboration

• Describe plans for CTEU personnel (not limited to key personnel) participation in the IDCTN and how they will contribute to the activities of the NCC, including: governance committee; scientific working groups; and the program for investigators early in their career (propose topics in clinical research that the CTEU will provide).
• Describe processes to foster collaborations with, and past partnerships between, product developers, and other external partners (e.g., industry partner, external investigator) within the ID/research community to solicit and generate clinical trial concepts.

Section 2: Network Coordination Center (NCC) (Optional) If proposed, address the following, as applicable:

Sub-section 2A: Overview of the Network Coordination Center

• Detail the specific aims of the NCC and the overall research agenda of the IDCTN.
• Describe the NCC's governance, scientific working group structures, and processes to set the clinical research agenda and scientific priorities, to achieve the goals of the IDCTN. Describe how these processes support generation of at least four prioritized clinical concepts per year.
• Describe the NCC leadership plan, including composition of the team, responsibilities, and integration into the overall structure. Describe how the team will work collaboratively to support the aims of the NCC. Do not duplicate information provided in the biosketches.

Sub-section 2B: NCC Administration

• Provide the governance plan and organizational structure of the NCC, including lines of authority and the administrative support for all proposed activities and committees.
• Describe the processes and frequency for assessing and updating the clinical research agenda and for setting the scientific priorities, through, for example, a landscape and/or gap analysis.
• Describe the overall approach and processes that will support and coordinate activities of the IDCTN, incorporating project management, fiscal management and quality review of all IDCTN activities and leveraging the network annual meeting.
• Describe how the NCC will engage with all CTEUs and the external research community. Include communication plans to highlight the goals of the IDCTN, promote awareness of the IDCTN, including soliciting concepts and its opportunities (e.g., secondary research specimens/data).
• Describe the aims and processes of a coordinated program for investigators early in their career and those new to the field. Describe how the program leverages the skills and expertise of all CTEUs to provide the next generation of clinical trialists opportunities in infectious diseases clinical research. Include processes for the oversight and evaluation of these activities and the program.

Sub-section 2C: Governance

• Describe the role and responsibilities of the governance structure, including how CTEU PDs/PIs and NIAID will be integrated into the governance structure.
• Describe process for concept prioritization, SOP development, resource management and allocation across the IDCTN, incorporating in continuous process improvement.
• Describe metrics for IDCTN activities and a process for routinely evaluating performance against those metrics to measure readiness and impact of the IDCTN.

Sub-section 2D: Scientific Working Groups

• Describe how the NCC will establish and run SWGs to review and develop enough clinical concepts so that the NCC can provide at least 4 prioritized clinical concepts per year that fully leverage the expertise and resources of the IDCTN to achieve the aims of the IDCTN.
• Describe the processes for generating, soliciting, reviewing, and refining clinical concepts that address scientific priorities of the IDCTN.
• Describe the strategy used to appoint CTEU personnel on SWGs.

Sub-section 2E: Clinical Oversight

• Describe how the NCC will conduct clinical oversight, including roles, responsibilities and staffing, and how it will scale to meet the IDCTN clinical trial pipeline.
• Describe the processes for the: development of clinical trial protocols; development and oversight of protocol budgets; site selection; operational support and oversight during clinical trial implementation.

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. 

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.

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, with the following additional instructions:

Applicants must enter at least one delayed onset study record and must check box "Anticipated Clinical Trial?".

Study Title: use: "CTEU Delayed Onset Clinical Trial"

All proposed delayed onset studies must provide a justification explaining why information on the clinical research projects will not be available at the time of application. Use the following justification: "Clinical trials supported through this NOFO will be developed and reviewed by the IDCTN, which will be established after award."

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 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. 
• Awards issued under this NOFO will be incrementally funded awards for project periods of up to seven years.
• 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.

For this particular NOFO, note the following:

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.

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).

Prior Approval of Pilot Projects

Recipient-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies. 

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:

• Defining the research agenda, approaches, and scientific priorities. Establishing policies and processes for evaluating and revising the research agenda and setting scientific priorities.
• Planning, coordinating, monitoring and executing the process by which clinical research concepts are solicited, proposed, refined, reviewed and prioritized to achieve the goals of the IDCTN, as needed.
• Overseeing administrative and operational framework of the Clinical Trial Evaluation Units (CTEU) to ensure performance standards of the Infectious Diseases Clinical Trials Network (IDCTN) are adhered to and high-quality clinical trials are conducted in a timely manner.
• Facilitating collaboration and communication within IDCTN and with NIAID, to accomplish the objectives of the CTEU and Network Coordination Center (NCC). Establishing or participating in NCC committees, as necessary. Each CTEU and the NCC shall have one vote on NCC committees. 
• Managing the relationship with and engagement of any third party (e.g., industry partner, external investigator) engaged in activities supported by this award (e.g., concept proposals, clinical trial implementation).
• Establishing and maintaining programs to support investigators early in their career and/or investigators new to field to provide hands-on and didactic clinical research opportunities.
• Establishing and adhering to policies and standard operating procedures, ensuring compliance with NIAID Clinical Research Policies. Providing policies, SOPs, and plans to NIAID.
• 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:

• The substantially involved NIH Project Scientist(s) and, as appropriate, other staff such as Medical Officer(s) (but not to include the Program Officer) will have the responsibility for:
  • Facilitating coordination among the NIAID- and NIH-supported clinical trials networks and research groups, clinical research support programs, and other U.S. Government agencies, promoting collaborations and facilitating information exchange.
  • Participating on scientific working groups and protocol teams, and as a voting member (sharing one vote) in NCC committees that are established by the recipient.
  • Conducting a periodic independent review of the constituent parts of the CTEU/NCC for reliability and compliance with clinical and regulatory requirements.
  • Determining appropriate institute resources for development of concepts into protocols and implementation of the clinical protocol (e.g., Clinical Research Operations Core (OpsCore), the Early Phase Clinical Trials Units (EPCTUs)). Each clinical study will be evaluated by NIAID on an individual basis for the need for NIAID-supported services including the need for an IND/IDE held by NIAID.
  • Providing clinical site monitoring, centralized data management and statistical analysis, primary research biospecimen storage and distribution, clinical agent management, medical monitoring, pharmacovigilance, resources to ensure consistent standards for the protection of human subjects, and safety oversight committees for clinical trials.
  • Providing scientific support during the accomplishment of the research by collaborating on the design of the activities, advising on 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.
• Additionally, an agency program official or IC program director (other than the Project Scientist(s)) 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 by PD(s)/PI(s) and NIH Project Scientist include:

• Ensuring that IDCTN research efforts are consistent with goals.
• Identifying scientific gaps and organizing meetings to facilitate exchange of scientific and regulatory information, including during IDCTN meetings.
• Planning, coordinating, monitoring and executing clinical trial protocols in accordance with applicable polices and regulations.
• Reviewing NCC and CTEU research agenda, activities, and progress at the annual meeting to facilitate achievement of IDCTN goals.
• Facilitating and evaluating the progress of clinical trials, including enrollment benchmarks, site quality, and data quality on an ongoing basis, jointly involving the CTEU, NCC and NIAID staff.
• Assessing the performance of the CTEUs in IDCTN activities in an ongoing manner, in conjunction with the NCC.
• Participating in the presentation of clinical research at scientific meetings, as well as publishing scientific papers.

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, 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: IDCTN_NOFO@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.