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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this notice of funding opportunity (NOFO) is to invite applications for the Centers for Research in Emerging Infectious Diseases (CREID) Network Research Centers (RCs). The CREID Network, comprised of all awards made under this NOFO and the companion NOFO [RFA-AI-24-016], serves to expand knowledge on re-emerging and emerging infectious diseases (re/EIDs) around the globe where outbreaks are most likely to occur while developing expertise, capacity, and readiness to address outbreak-related research. Multi- and interdisciplinary teams of domestic and international investigators will conduct innovative, collaborative, hypothesis-driven One Health (approach that recognizes the health of humans is interconnected with that of animal health and the shared environment) based research, will undertake outbreak-related research when necessary, in their geographical areas, and will work across the CREID Network in a coordinated, collaborative, and cooperative fashion.

Background

Core elements of NIAID’s mission include expanding the breadth and depth of knowledge in infectious diseases and developing flexible domestic and international research capacities to respond appropriately to emerging and re-emerging disease threats domestically and internationally. Recent emergences of viral, zoonotic origin infectious pathogens have demonstrated their ability to significantly impact human health and quality of life. As our environments and populations change, it is expected that re/EID events will increase in frequency and have significant potential to threaten global health. Many of these naturally occurring recent outbreaks have been caused by viral pathogens and characterized by their zoonotic reservoirs and/or arthropod vectors propagating transmission to humans. In many instances, re-emerging pathogens have circulated undetected or at low levels for several years before causing significant outbreaks with major public health concerns, and novel pathogens continue to emerge with the potential to cause world-wide pandemics. These prior outbreaks have revealed inefficiencies in communication, coordination, and collaboration between unlinked investigators or networks which made it difficult for NIAID to leverage quickly and efficiently for outbreak-related research efforts.

To address these challenges, NIAID established the Centers for Research in Emerging Infectious Diseases Network in 2020 which is currently comprised of ten Research Centers (RCs) and a single Coordination Center (CC). The CREID Network draws on skills from teams of multidisciplinary scientists, including for example, infectious disease clinicians, epidemiologists, virologists, clinical microbiologists, veterinarians, and entomologists to conduct innovative, collaborative, and coordinated One Health based research on re/EIDs that have the greatest potential of becoming pandemic threats (such as zoonotic and vector-borne viruses). Additionally, the multidisciplinary teams also strengthen and/or develop flexible domestic and international capacities and readiness to efficiently conduct research related to outbreaks and contribute to the development of the next generation of emerging infectious disease scientists and leaders globally. The CREID Network will provide continued support towards the broader NIAID strategy for pandemic preparedness by expanding our knowledge of re/EIDs and strengthening research infrastructure and scientific expertise in geographical regions of the world that are prone to re/EIDs.

Research Objectives and Scope

Each Research Center (RC), as part of the CREID Network, will be responsible for executing research that will expand our knowledge of re/EIDs while developing flexible domestic and international capacities, and strengthening research infrastructure and scientific expertise through development of the next generation of emerging infectious disease scientists and leaders globally. Each RC will develop multi- or interdisciplinary One Health based hypothesis driven research for re/EIDs. Each RC must incorporate both animal and human subjects elements to fulfill their One Health research goals and objectives, and other elements such as vectors or climate/environment may be incorporated towards the One Health approach. The human based elements of the research may include utilization of human subjects’ cohorts, either short-term (e.g., acute febrile illness, AFI) or long-term/longitudinal cohorts and use of archived clinical specimens. Research topics that may be supported include, for example: 

• pathogen discovery and characterization,
• pathogen surveillance in animals, vectors, and humans as it relates to assessment of prevalence, molecular epidemiology of specific pathogens in their geographic regions, and/or linked with another topic area listed here,
• evaluation of factors related to pathogen transmission, maintenance, emergence, adaptation, and evolution (including the role of climate change and/or social science elements) related to human infections,
• define the contemporary spectrum of clinical disease presentation and progression, pathophysiology, and clinical outcomes of infection in humans (including sequelae) and/or determinants of disease severity,
• human immunologic responses to the infection,
• modeling emergence risk,
• development of reagents, diagnostic/detection tools, and critical animal models,
• and research that is foundational or translatable to, or will enable, the further development of medical countermeasures (therapeutic and preventative) to important human health re/EIDs.

Each RC may study any emerging pathogen (viral, bacterial or eukaryotic), however, the primary focus is expected to be on viral infectious pathogens that are most likely to emerge/reemerge in humans. Applicants are required to work on at least one viral pathogen from the NIAID list of Emerging Diseases including, but not limited to, members of viral families: Arenaviridae, Coronaviridae, Flaviviridae, Filoviridae, Hantaviridae, Nairoviridae, Paramyxoviridae, Peribunyaviridae, Phenuiviridae, Picornaviridae, and Togaviridae that are not already studied by other NIAID funded networks (e.g. HIV, influenza, malaria) and for which countermeasures are not developed or are suboptimal.

Each RC may propose to work in any region of the world that is considered a hotspot (known area of high viral biodiversity and/or area with frequent occurrences of outbreaks/epidemics) for re/EIDs. Applicants are encouraged to propose working in at least two geographic regions with at least one located within the tropical or subtropical regions of the world (Tropics: latitude between 23.5^o -Tropic of Cancer and Capricorn-Subtropics: between tropic and temperate zones (35-66.5^o N and’s of the equator) with the goal of establishing research sites in targeted areas of the globe such as South and Central America, Sub-Saharan Africa, and Southeast Asia. Each RC will complement and leverage existing NIAID international research efforts such as the Centers of Excellence for Influenza Research and Response (CEIRR), International Centers of Excellence for Malaria Research (ICEMR), Tropical Medicine Research Centers (TMRC), and Centers for AIDS Research (CFAR) and/or other US Government or internationally funded research infrastructure as needed to conduct the proposed research and exhibit the flexibility to pivot capacity or resources to address outbreak-related research needs in their geographic area, in consultation with NIAID. 

Coordination, Collaboration, and Cooperation:

Coordination, collaboration, and cooperation are key elements and priorities of the CREID Network. Each RC will be required to coordinate, collaborate, and cooperate with the other recipient RCs, the CC, NIAID, and relevant interest holders (a person, group, or organization with a vested interest in addressing re/EIDs, examples include other USG or international agencies or programs and/or other NIAID-funded programs) to maximize resource utilization, minimize duplication of efforts, strengthen scientific domestic and international relationships and trust, identify research gaps, translate research tools or products to downstream partners, and facilitate successful implementation and achievement of the research projects and goals of the CREID Network. To further support coordination, collaboration, and cooperation across the CREID Network, each RC will readily share information, data, specimens, diagnostics, reagents, models, tools, or any research products that arise from the award within the CREID Network, the greater scientific community, and other downstream partners or interest holders to aid in translational research or development of medical countermeasures and/or preventive interventions both before and during outbreak events. Additional highlighted areas of coordination, collaboration, and cooperation include but are not limited to: shared or complementary topic research projects, outbreak-related research, data stewardship, scientific working groups, publications, scientific expertise development and capacity strengthening, and annual CREID Network meetings. Each RC will participate and collaborate to help achieve interoperability amongst the CREID Network centers via processes and systems provided by the CC, for example governance structure, working groups, committees.

Capacity Strengthening:

To enable effective, global preparedness for and rapid outbreak-related research to re/EIDs threats, each RC will strengthen and build domestic and international capacities through their research and collaborations. Each RC will define their capacity building or strengthening goals and should design their research program or incorporate elements that will allow them to develop or strengthen scientific expertise, abilities, or infrastructure towards preparedness and readiness to undertake outbreak-related research at their domestic and international research sites. Additionally, a capacity strengthening, and pilot research program will be developed and managed by the CC and each RC may be asked to contribute expertise, mentorship, and guidance to the program as requested by the CC or in consultation with NIAID.

Opportunity Fund:

Each RC will develop and manage, in consultation with NIAID, an Opportunity Fund that is intended to strengthen the impact of the overall CREID Network, which may include enhancement of shared or complementary topic research within the CREID Network, preparedness and outbreak-related research and activities, and other activities or efforts that further the collaborative objectives and goals of the CREID Network .

CREID Research Center Structure

Administration and Leadership Team

The RC Administration and Leadership Team (RC ALT), led by the Program Director(s)/Principal Investigator(s) (PD/PIs), will be responsible for organizing, coordinating, and providing oversight and supervision for the implementation and execution of all activities associated with the RC. The RC ALT will be responsible for developing, monitoring, and remediation/renegotiation with NIAID the milestones and timelines for all activities within each RC. The RC ALT will work with the Data Stewardship and Analysis Team (RC DSAT) to develop efficient & statistically powered study designs and provide support for the preliminary and final data analyses for the research. In addition, the RC ALT will ensure timely and coordinated communications within their RC and in relation to the CREID Network, and will lead their RC’s participation in strategic planning, readiness efforts, and outbreak-related research activities.

Data Stewardship and Analysis Team

The Data Stewardship and Analysis Team (RC DSAT) will be responsible for the range of activities related to data and information generated by the RC and exchanged among the CREID Network including: collection, management, distribution, analyses, quality assurance and standards, and development of statistically powered study designs for the RC. The RC DSAT will also collaborate and cooperate with the CC and other awarded RCs to facilitate implementation of data stewardship and analysis practices provided by the CC or adopted by the CREID Network. The RC DSAT will implement processes and procedures for receipt, storage, retrieval, and inventory of biological specimens, harmonization of specimens to clinical and experimental data (including metadata), tracking and monitoring of biological specimen use, storage, and/or distribution, and implementing of safety and security features for specimen storage and retrieval. This exchange of information generated by award recipients (CC and RC) to the CREID Network is intended to operationalize activities for achieving the goals of the program.The RC DSAT will also be responsible for executing data sharing agreements (DSAs) for exchange of data generated under the RC awards. Additionally, and separate from the RC DSAT, recipients are required to adhere to all applicable sharing policies.

Clinical Research Support Team

The Clinical Research Support Team (RC CRST) will be responsible for leading and coordinating the activities associated with human subjects’ research across the RC, including for example, multi-site coordination, pre-study community outreach, tracking and monitoring enrollment, recruitment, maintenance and status of regulatory documents with reporting to the CC, data collection and reporting, and compliance with human subjects’ research data and quality procedures. The RC CRST serves as the process and procedure hub for the clinical research sites and other functional work or project areas as needed by the RC.

External Advisory Committee (EAC)

One External Advisory Committee for the entire CREID Network, comprised of experts in the field outside the CREID Network, will be established by NIAID after award. The EAC will review progress of the CREID Network (including the role and progress of the RC) and share recommendations for the program with NIAID as part of the annual programmatic meeting. Note that applicants should not name EAC members in their application or contact potential EAC members until after the review is complete.

Annual Program Meetings

The RC will participate in one CREID Network kick-off meeting and thereafter, an annual CREID Network meeting. These meetings will serve to establish the major roles and functions of the CREID Network, facilitate collaborations, provide progress reports, seek new research directions and ideas, and update NIAID. These meetings will be attended by the RC PD(s)/PI(s) and Key Personnel, capacity strengthening and pilot research program recipients, the EAC, the NIAID Project Scientist and other NIAID personnel, and relevant interest holders.

Applications proposing any of the following topic areas or types of research projects will be considered nonresponsive and will not be reviewed:

• Applications that do not focus on at least one viral pathogen on the NIAID list of Emerging Diseases. 
• Pathogens already studied by other NIAID-funded networks, such as influenza, tuberculosis, malaria and antibiotic resistant bacteria.
• HIV, SIV or AIDS studies.
• Genome-wide association studies (GWAS).
• Projects where behavioral research is the primary focus.
• Projects that include product development research or advancement of vaccines or antivirals.
• Applications that propose a length of performance of less than 5 years in length.
• Clinical trials: Clinical research may be supported but not clinical trials, as defined by the NIH (https://grants.nih.gov/policy/clinical-trials/definition.htm).

For additional information about the Centers for Research in Emerging Infectious Diseases, see the "Frequently Asked Questions (FAQ)" link here.

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

Applicants may only serve as PD/PI or be part of a multi-PD/PI team for either the Centers for Research in Emerging Infectious Diseases (CREID) Network (U01 Clinical Trial Not Allowed) (RFA-AI-24-006; this NOFO) or the companion Centers for Research in Emerging Infectious Diseases (CREID) Network Coordination Center (U01 Clinical Trial Not Allowed) (RFA-AI-24-016), but not both. Additionally, applicants may only serve as PD/PI or be part of a multi-PD/PI team on one (1) RC. However, the PD/PI or member of a multi-PD/PI team may serve as a collaborator on more than one RC and/or CC application.    

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. 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Annie Walker-Abbey, PhD
Telephone: 240-627-3390
Email: [email protected]  

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:

For this specific NOFO, the Research Strategy is limited to 30 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, with the following additional instructions:

Facilities and Other Resources:

Provide the following information in the Facilities and Other Resources attachment.  Use separate sections to differentiate the requested information as indicated below:

• Within a section titled, "Information Technology Access and Resources,” briefly describe the features of the institutional environment that are relevant to the implementation of the proposed collaborations and/or research sites within the RC. Describe available Informational Technology (IT) resources with respect to access to computers, source and status of reliable, secure internet connections, and other communications.
• Within a section titled, "Biological Specimen Storage and Access,” briefly describe the facilities available to securely store, manage, and retrieve biological specimens for use by the PD/PI(s) and Key Personnel in the research projects.

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 Biosketch of the PD(s)/PI(s), under Personal Statement, describe the leadership approach and experience of the PD(s)/PI(s) with respect to developing and implementing multi- or interdisciplinary research program(s) of a similar size and nature, including multi-site/partner consortiums with domestic and/or international entities.
• Within the Biosketch of each Key Personnel, under Personal Statement, describe the administrative, technical, and management expertise in areas critical to the success of the application, including experience working productively in collaborative team environments, and the scientific expertise and experience working in geographic regions proposed. Demonstrate how specific expertise supports the multi- and/or interdisciplinary approach to guarantee a successful, integrated effort towards the goals of the research project.

R&R or Modular Budget

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

Within the relevant budget sections, include the following:

• Enter the ‘person months effort’ for the PD(s)/PI(s) and Key Personnel in the budget section based on the allocation of their respective roles on the project.
• Travel:
  • CREID Network Kick-Off Meeting: In Year 01, include funds for the RC PD(s)/PI(s) and Key Personnel to travel and attend a CREID Network kick-off meeting hosted by NIAID. The kickoff meeting will be held over 1 full day in the greater Washington, DC metro area.
  • Annual CREID Network meetings: In Year 02, 03 and 04, include funds for the RC PD(s)/PI(s) and Key Personnel to travel and attend the annual CREID Network meetings to be held over 3 full days in an international location. In Year 05, include funds for the RC PD(s)/PI(s) and Key Personnel to travel and attend the annual CREID Network meeting to be held over 3 full days in the greater Washington, DC metro area.
• Specimens: Include costs associated with biological specimen collection, processing, shipping, and storage as well as costs for depositing reagents and tools to NIAID-supported repositories (see listing of repositories here: https://www.niaid.nih.gov/research/resources).
• Opportunity Fund: Applicants are expected to budget $100,000 each year in direct costs for this fund.

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 in priority order, the broad, long-range objectives and goals of the proposed research and indicate how these goals will be accomplished.  Concisely describe the hypothesis or hypotheses to be tested and plans for incorporation of other emerging or re-emerging infectious disease pathogens, as needed.   

Research Strategy:   

• Describe the overall One Health strategy, procedures and approaches used to accomplish the RC research objectives and goals.
• Describe and justify the choice of targeted pathogen(s)/disease(s) to address the most relevant viral emerging pathogens.
• Describe how the outcomes from individual research activities are integrated into the aims of the RC.
• Discuss how the RC proposed research plans, procedures and approaches may be leveraged to address specific emerging/re-emerging disease outbreaks.
• Describe the rationale for the geographical regions in which the RC will operate.
• Describe how and to what extent the research and activities will be coordinated and synergized within the RC ensure achievement of its central objectives. 

In a clearly labeled section entitled “Administrative Plan”:

• Describe the role of the RC ALT in oversight and management of the administrative plan.
• Describe the plan for overall administration of the RC, including the organizational structure, governance, staffing plan, lines of authority, the process for tracking and monitoring progress, the fiscal management plan, and other administrative procedures to ensure progress in meeting the goals and objectives of the RC.
• Describe the communication plan for the RC, including the various methods for bidirectional and unidirectional communications within the RC Teams (ALT, DSAT, CRST), across the like-named Network Teams (e.g., RC ALT with CC ALT), and broadly to all staff of the RC. As part of this plan, describe the plans for communicating with the CREID Network, NIAID, and relevant interest holders.
• Describe how the RC will manage their domestic and international research sites.
• Describe the plans for collaboration, cooperation, and coordination with all CREID RCs and CC. Discuss the overall process, including how the management, oversight, and assigned responsibilities will be planned, articulated, implemented, and monitored for progress of a shared goal.

In a clearly labeled section entitled "Data Stewardship and Analysis Plan” applicants should address the range of data stewardship and analysis activities within the RC related to data and information generated by the RC and exchanged amongst the CREID Network award recipients (RC and CC) Specifically: 

• Describe the role and approach of the RC DSAT in oversight, implementation, and management of the data stewardship plan across all RC’s research sites.
• Describe the general approaches of the RC DSAT in cooperating with the CC DSAT to develop and/or implement CREID Network data stewardship standards and practices.
• Describe the systems or procedures that will be utilized to harmonize the acquisition, curation, management, inventory and storage of data, information, and biological specimens within the RC.
• Describe how the statistical analysis plan will be developed and implemented for the research proposed within the RC.  Discuss the method for updating the statistical analysis plan including the individuals (roles) that will take the lead for this activity. Note: do not duplicate information provided within the Biosketch.
• Describe the training that will be provided for staff at all RC research sites with respect to data, information, and biological specimen collection and use of electronic data capture systems.
• Describe the approach of the RC DSAT to ensure all generated data, information, and biological specimens of the RC is of high quality and discuss how quality issues will be identified and resolved. Describe the timelines related to the quality procedures, including verification of data remediation following a quality breech.
• Describe approaches that the RC DSAT will take to ensure timely and complete response to data, information, and resource inquiries from the CC or NIAID.
• Describe the approach for timely execution of data sharing agreements.

Note: do not address NIH sharing policies within the “Data Stewardship and Analysis Plan.”

In a clearly labeled section entitled "Clinical Management Plan":

Note: if the proposed research includes a clinical study, specific information for that study will be entered using the PHS Human Subjects and Clinical Trials Information and should not be duplicated in the Research Strategy.

• Describe the role of the RC CRST in oversight, implementation, and management of the clinical management plan.   
• Describe plans for clinical research site selection including feasibility, capacity, and capabilities, and study development, conduct, and oversight.
• Describe the process and/or methods for adding new clinical research sites or establishing new human cohorts, with various scientific areas of research as needed, in response to an outbreak or newly emerging infectious disease. Describe how the clinical research sites or human cohorts may be leveraged for new emerging pathogens or outbreak-related research.
• Describe strategies for oversight and implementation of standardized approaches in the recruitment and clinical characterization of adequate numbers of relevant human subject populations. Discuss the process to ensure the prompt screening, enrollment, retention, and completion of studies.  Describe novel approaches and solutions to study enrollment.
• Describe the plans for comprehensively training clinical research site staff to ensure timely execution or completion of the research and compliance with all necessary regulations, policies, or laws. Describe or discuss how the staff at each enrollment/collection location will be trained regarding quality standards for data and specimen collection and compliance with any RC standardized procedures. 
• Provide general approaches to identification of the types of human cohorts needed to fulfill the goals of the research projects. Discuss types of clinical human cohorts and clinical assessments that will be utilized to study natural history and pathophysiology of disease, including characteristics of the cohort, site for recruitment, types of specimens collected and how they can be used for disease surveillance or provide the basis for discovery of novel pathogens, along with a detailed description on how specimens can be utilized for studying immunologic responses, pathogenesis, and development of reagent and/or diagnostic assays.
• Describe methods that might be applied to either elucidate a zoonotic source or a vector of transmission to humans.
• Describe capacity for and approaches to clinical, immunologic and biologic data and specimen collection.

In a clearly labeled section entitled, “Opportunity Fund”:

• Describe the Opportunity Fund plan to include management and oversight of the processes and procedures for selection, prioritization, development, and implementation of activities related to the use of the Opportunity Fund.
• Discuss initial RC priority activities for the utilization of the Opportunity Funds in service to the larger goals and objectives of the CREID Network.
• Within the Opportunity Fund plan, discuss how the impact of supported activities will be assessed over the life of the award.

In a clearly labeled section entitled, “Project Milestones and Timelines”:

• Describe specific goals and quantifiable milestones by annum and include annual timelines for the overall research project and for tracking progress from research sites, collaborators, and teams.  Milestones must specify the outcome(s) for each activity. Milestones should be quantifiable and scientifically justified, and include the completion of major research study activities, including, for example, protocol development, case report forms, scheduled clinical visits, obtaining clearances or approvals, study completion, and analysis of final data. Milestone criteria should not simply be a restatement of the specific aims.  The use of Gantt charts or an equivalent tool to demonstrate the timelines with associated outcomes for the research studies are encouraged.
• Discuss how in the event of an outbreak, above timelines and milestones would be altered/adjusted to address urgent needs.

Letters of Support: Include letters of support from consortium/site participants and research project collaborators. Letters of support are expected to address the nature and scope of the commitment to collaborate with the RC.

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.

• The RC will be required to annually share or deposit a limited number of contemporary or recently obtained viral isolates or residual PCR positive specimens with NIAID-supported repository resources to facilitate virus isolate access to the broader scientific community. All applicants will provide a plan for how to accomplish sharing of viral isolates, residual PCR-positive specimens, and other resources or tools with the CREID Network (with other awarded RCs or the CC), NIAID-supported repositories, and the broader research community.

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

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• Recipients are expected to share their data using NIH-supported open access data sharing repositories (https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html).  

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.

PHS Assignment Request Form

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

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply Application Guide.

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

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

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

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

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.

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 the National Institute of Allergy and Infectious Diseases, 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.

Appeals 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.

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

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

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

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. 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 addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 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.

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:

• Providing primary oversight, management and coordination of the proposed research and activities within the Research Center (RC).
• Engaging with NIH staff, at least quarterly, to discuss scientific and/or administrative progress (e.g., including NIH staff in RC meetings with PD(s)/PI(s) and key personnel).
• Complying with resource, data, and biospecimen sharing.
• Publishing of RC research results in peer-reviewed journals, presentation of RC research outcomes at professional meetings, and annual meetings.
• 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 scientific progress of the research, including recommending approval of changes in experimental approaches.
• Coordinating CREID Network activities.
• Advising RC recipient on the development and modification of milestone plans.
• Guiding program activities to address NIAID objectives that are consistent with the scope of the CREID Network.
• Advising on project or program modifications to ensure projects are compliant with NIH, HHS, and other relevant policies.
• Advising in the selection of and facilitating access to NIAID-supported resources and services.
• Assisting with prioritization of resources and implementation of data and resource sharing plans.
• Providing advice on scientific, operational, or administrative activities to facilitate progress and implementation of collaboration(s) related to outbreak research or overall goals and objectives of the CREID Network.
• Establishing the External Advisory Committee (EAC).
• 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:

• Reviewing the entirety of CREID Network and RC milestones annually and updating them based on recommendations from the EAC.
• Coordinating the overall objectives and progress at the annual meeting to facilitate the achievement of RC goals.
• Collaborating, communicating, and cooperating with NIAID, other NIAID-funded RCs and CC, USG and other international partners. 
• Reviewing and assisting in developing operating guidelines consistent with policies for dealing with situations that require coordinated action.

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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH 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.

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Sara E. Woodson, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6478
Email: [email protected] 

Annie Walker-Abbey, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3390
Email: [email protected] 

Marclyne Ceron
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301)761-7993 
Email: [email protected] 

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.