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 Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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.
   
   



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling, and preventing diseases caused by virtually all infectious agents. In response to threats presented by emerging infectious diseases and bioterrorism, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established complementary research programs to facilitate development of medical countermeasures (MCMs) for certain pathogens and toxins.

This Notice of Funding Opportunity (NOFO) solicits applications to participate in the Centers of Excellence for Translational Research (CETR) program, comprising multi-disciplinary collaborations with diverse research communities in infectious diseases, microbiology, –omics, immunology, and vaccinology focused upon the development of MCMs and associated platforms/technologies targeting bacteria or fungi with known and emerging resistance to current therapies. For the purposes of this NOFO, "translational research" is defined as research and developmental activities focused on transforming basic science outcomes (knowledge, technologies, infrastructure, etc.) into new and innovative approaches for prevention, diagnosis, and treatment to combat known and emerging resistant bacterial and fungal pathogens. Emphasis will be placed on Centers that integrate current research knowledge and infrastructure with highly innovative and synergistic approaches to facilitate MCM development against drug resistant bacteria and/or fungi, and address related constraints, challenges or barriers to product development, licensure and usage.

Background

Antibiotic resistance is a growing global public health threat. In a recent report, the Centers for Disease Control and Prevention estimated that at least 2.8 million people develop an antibiotic-resistant or anti-fungal resistant infection and more than 35,000 people die from these infections yearly in the United States. These bacterial and fungal pathogens are described in CDC’s most recent report Antibiotic Resistance Threats in the United States, 2019. The potential for outbreaks involving infections in intensive care units, nursing homes, immunocompromised patients and other populations with limited treatment options is a significant public health burden. The seriousness of this situation has led to national and international efforts to address antibiotic resistance, including the United States Government’s National Strategy, and National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), as well as establishment of the Presidential Advisory Council on CARB. These efforts have consistently recognized the need for sustained support for research on pathogens with known or emerging resistance, and one of the key elements of these plans is to accelerate basic and applied research for development of new ways to reduce the threat posed by these infections. In addition to antimicrobial resistant (AMR) bacterial infections, resistant fungal infections have also increased, while therapeutic options for nonresistant fungal infections remain limited to only three classes of drugs that are in current use. Thus, development is needed of new antifungals that are broad spectrum and low toxicity.

The NIH and other agencies in the Department of Health and Human Services (HHS) support development of countermeasures to protect the public from infectious diseases. In 2002, the NIH advanced strategic plans to counter threats presented by emerging and re-emerging infectious diseases. A significant component of these plans was the NIAID Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) program, which enabled appropriate infrastructure and multifaceted research and development activities to provide scientific information and translational research capacity to facilitate discovery and development of the next generation of therapeutics, vaccines, and diagnostics. In 2014, NIAID transitioned the RCE program to the CETR program to facilitate innovative, interdisciplinary, translational research efforts focused on countermeasure and/or related platform development. The goal of the 2019 renewal of the CETR program has been to advance the discovery and/or development (or availability) of new and improved countermeasures or related technologies specific to select NIAID Emerging Infectious Diseases/Pathogens. This NOFO will solicit applications for new projects that will expand the pipeline of MCMs against bacteria and/or fungi with known and emerging antimicrobial resistance by supporting translational research activities for the purpose of advancing previously established basic discoveries into preclinical development and the product development pathway.

Research Objectives and Scope

The objective of this NOFO is to support a program of multi-project translational research Centers focused on advancing potential MCM candidates (therapeutics, immunotherapeutics, vaccines, vaccine technologies, and in vitro diagnostics) for known or emerging AMR bacteria and fungi beyond discovery through preclinical development.NIAID encourages Centers focused on development of MCMs that are effective against a variety of pathogens and toxins, technologies that can be widely applied to improve classes of products, and platforms that can reduce the time and cost of creating new products. For this NOFO, "preclinical development" is defined as all activities including hit-to-lead candidate identification through Investigational New Drug (IND) application enabling.

Each Center will be organized around a specific major objective, theme or program goal, that addresses development of MCMs for AMR bacteria and/or fungi. NIAID anticipates considerable variety among Center themes and objectives, which can range for example, from the development of countermeasures targeting a specific resistant pathogen or group of resistant pathogens, to the development of new technologies or platforms that target a wide array of these pathogens selected from the list below. Because FDA authorization of MCMs identified through these programs should be a long-term goal, each Center should consider and address anticipated regulatory barriers for the targeted countermeasure or technology, particularly for new classes of MCMs for which there are no precedents for FDA approval. Consistent with these goals, a Product Development Strategy, which should include Milestones and Product Development Plans, must be included in the Overall component of each application, with the exception of those focusing upon early translational studies in fungal pathogens.

Examples of translational Center themes could include, but are not limited to, the following areas:

• Evaluate single or multiple targets and MCM modalities (i.e., diagnostics, therapeutics and/or vaccines) to address a specific AMR pathogen;
• Develop new approaches for a known pathogen target (e.g., gyrase, cell wall, transcription/translation) to include broad-spectrum therapeutics with extended activity against more than one AMR pathogen;
• Develop potentiators that restore susceptibility to known therapeutic classes;
• Develop a monoclonal antibody (mAb), phage, or other technology approach to counter pathogen resistance;
• Use systems immunology and reverse vaccinology to design antigens/immunogens to be used in the development of vaccines, immunotherapeutics or diagnostics;
• Develop faster, direct-from-specimen pathogen identification (ID) tests to mitigate risk of progression to sepsis onset;
• Develop faster phenotypic antibacterial susceptibility test (AST) characterization for better antibiotic stewardship.

Note: Center themes supported by this program must target one or more of the AMR pathogens below with known and emerging resistance to current therapies. Though experiments with non-virulent forms of these pathogens are allowed, the virulent form must be targeted, and the use of clinical isolates is strongly encouraged.

Bacteria

• Acinetobacter baumannii
• Campylobacter spp.
• Clostridioides difficile
• Enterobacter spp.
• Enterococcus spp.
• Escherichia coli
• Klebsiella pneumoniae
• Neisseria gonorrhoeae
• Non-tuberculous mycobacteria (NTM)
• Nontyphoidal Salmonella spp.
• Pseudomonas aeruginosa
• Salmonella enterica serovar Typhi
• Shigella spp.
• Staphylococcus aureus
• Streptococcus pneumoniae

Fungi

• Aspergillus fumigatus
• Candida spp., in particular C. auris

Clinical studies (e.g., sample collection, strain isolation, etc.) may be involved. Utilization of human-derived material in pre-clinical studies is encouraged.

Applications must focus on translational activities towards development of one or more specific countermeasures described below:

Therapeutics

This NOFO will support translational efforts toward the development of novel drug candidates against one or more of the AMR pathogens listed above.  For AMR bacteria, applications should focus on therapeutic discovery projects in the lead optimization phase with existing lead candidates to support progression through pivotal nonclinical studies required for entry into clinical trials.  For AMR fungal pathogens listed above, earlier lead discovery efforts are of interest.

For example, this NOFO will support lead optimization programs that optimize a lead series by generation of new analogs with improved physicochemical properties, potency, efficacy, safety, and pharmacokinetics compatible with its Target Product Profile (TPP).

Studies that incorporate the following elements of a lead optimization program are strongly encouraged:

• Lead series verified to inhibit a defined target;
• Activity against resistant clinical isolates in a cell-based assay relevant to the target indication;
• Selective activity for the target pathogen type, for example, antibacterial agents should not exhibit antifungal activity and vice versa;
• Low cytotoxicity against a relevant human cell line;
• Physicochemical properties that support desirable exposure and distribution by the preferred route of administration;
• Demonstration of Structure-Activity-Relationships (SARs) that can be optimized through application of a focused medicinal chemistry plan appropriate for the phase of the project;
• Complete chemical structure of the most advanced lead and all entities for which experimental data is provided, or in the case of biologicals, a precise description of the product composition;
• Exploratory non-Good Laboratory Practices (non-GLP) in vivo toxicology aligned with the TPP;
• Demonstration of in vivo efficacy determination in animal models of diseases consistent with the TPP;
• Determination of pharmacokinetic/ pharmacodynamic (PK/PD) relationships to define efficacious exposure targets for further pre-clinical and clinical studies.

Therapeutic candidates of interest for this program include small molecule, biotherapeutic, monoclonal antibody, or phage candidates to be used as monotherapy, or in combination with other drugs, or as adjunctive therapy.Candidates with broad-spectrum activity are encouraged.However, therapeutic candidates with a narrow spectrum that target high-priority pathogens for which no standard clinical treatment exists or for which drug resistance poses a significant public health concern are also responsive.

Vaccines

Vaccines provide an important tool to combat infectious disease, yet the preclinical and clinical pipelines for vaccine candidates against the bacterial and fungal pathogens remain limited. This NOFO will support both antigen identification and development of vaccines against one or more of the AMR pathogens listed above.

Antigen Targets and Immunogen Design

Identification and validation of antigen targets and immunogen design should focus on systems vaccinology approaches and technologies including, but not limited to, multi-omics approaches, structural biology, and computational modeling and prediction that elucidate host responses to one or more of the AMR pathogens listed above. Immune signatures may be used to confirm antigen targets, identify epitopes, and refine immunogen designs, which will lead to an optimized vaccine candidate.

Vaccine Development Against Antimicrobial-Resistant Bacteria/Fungi

This NOFO will support development of vaccines (including immunoprophylactics) targeting one or more of the AMR pathogens listed above. Monovalent, multivalent, or broadly protective vaccines may also be considered. For this NOFO, "broadly protective vaccines” are defined as vaccines that provide protection against a group of taxonomically related pathogens, or two or more unrelated pathogens. Vaccines characterized by broad-spectrum activity in this class include cross-protective forms, which induce an immune response against conserved components of two or more microbes, and multiple component forms, which include elements that protect against microbes that are different and may or may not be related. Examples of this vaccine category would be a broadly protective Enterobacter species vaccine or a multivalent vaccine that protects against multiple Enterobacter strains.

Vaccine Technologies

This program will support innovative vaccine technologies including, but not limited to, the following: enhancing immune response, adjuvants, increasing stability, cold-chain minimization, and/or simplified vaccine delivery to patient populations. Of interest are vaccine formulations or technologies that achieve a rapid onset to protective immunity or minimal doses (two or fewer) to achieve protective immunity, as well as any technical improvement or enhancement that represents a significant advance for the field of vaccines. In addition, rapid production, characterization or formulation methodologies are encouraged. Proposed projects should pair the candidate technology with one or more appropriately mature, well-characterized antigen(s)/immunogen(s) for evaluation in appropriate animal models and assays.

Diagnostics

This NOFO will support coupled development of an integrated, sensitive, culture-independent, pathogen identification testing system with a phenotypic antibiotic or antifungal susceptibility testing system. For applications with a focus on diagnostics, a panel of targeted pathogens must comprise one or more of the AMR pathogens listed above. The phenotypic AST system should measure antimicrobial susceptibility against an FDA- or CLSI-recommended panel of antibiotics or antifungals. Proposed platforms should be intended for use in clinical settings, including hospital-based clinical microbiology or molecular diagnostic laboratories, and/or public health laboratories. These diagnostic systems should be developed to enable clinicians to prescribe more quickly the appropriate therapy or to de-escalate inappropriate therapy.

All diagnostics applications should be supported by sufficient proof-of-concept data to establish feasibility and reproducibility and should eventually exceed performance specifications of currently available instruments/systems for reduced turnaround time, breadth of antibiotic or anti-fungal test panels, and test performance as measured by CLSI guidelines. Additionally, applications should adequately describe design and development planning of instrument systems (e.g., assay and hardware prototype development, consumables development, sample preparation, sample processing, system integration, software development, manufacturing, and diagnostic validation).

The following performance goals for a developed diagnostics platform are strongly encouraged:

• Pathogen identification time of < 5 hr
• AST characterization in < 2 hr
• Ability to identify engineered or otherwise acquired genetic traits, such as patterns of antimicrobial resistance;
• Capability for deployment in non-traditional health care settings, including rural and urban community health care clinics and temporary health care clinics (e.g., those established in response to a natural or deliberate outbreak);
• Ease-of-use: Integrated, closed sample-to-answer system with automated data analyses or result presentation and with minimal operator training and expertise required;
• Cost-effective: Projected production and operating costs should be less than commonly used platforms for detecting infectious disease-causing pathogens;
• Random Access: The proposed platform should allow multiple samples to be run independently and concurrently;
• Adaptable: Capable of integrating new diagnostic assays for targets as required, including detection of modified or new targets, as well as addition of newly approved antibiotics to onboard phenotypic testing for resistance.

Applications that contain Research Projects including the following will be considered nonresponsive and will not be reviewed:

• Therapeutic projects targeting AMR bacterial pathogens focused on basic discovery (e.g., target identification);
• Viral pathogens;
• Bacterial strains: Mycobacterium tuberculosis, Group A/B Streptococcus, Bordetella pertussis and Mycoplasma genitalium;
• Clinical trials (all phases);
• Solely focused upon repurposing an FDA-approved drug(s);
• Development of surveillance/detection technologies;
• Activities other than translational activities towards the development of one or more of the following specific countermeasures: therapeutics, vaccines, diagnostics.

Applications that do not target one or more of the AMR pathogens listed above, or those that do not target a virulent form of these pathogens, will be considered nonresponsive and will not be reviewed.

Applications that do not contain a Product Development Strategy attachment in the Overall component, with the exception of applications solely proposing early translational studies in fungal pathogens, will be considered nonresponsive and will not be reviewed.

CETR STRUCTURE

Each Center in the CETR program will be organized around a chosen theme focused on preclinical development and/or use of one or more countermeasures and/or technologies that target specified pathogens with the objective of translating research results to product development. Each Center must include an Administrative Core, 3 or more Research Projects, and may include up to 3 Scientific Cores:

Administrative Core (required)

Each Center must include an Administrative Core, directed by the Program Director(s)/Principal Investigator(s) (PD[s]/PI[s]), under which all Center activities will be managed, coordinated, and supervised.  The Administrative Core will include a Scientific Advisory Board (SAB)that will participate in the development and management of the CETR and corresponding activities. Do not propose or contact any SAB members prior to award.

Scientific Core(s) (optional)

Each Center may include development and maintenance of up to 3 scientific core resources and/or facilities that are essential for the activities of two or more Research Projects. Scientific Cores are intended to only serve the needs of Center project researchers and they may not conduct research independent of the served Research Projects.

Research Projects (required)

Each Center must include a minimum of 3 interdependent translational Research Projects focused upon development and advancement of a new or improved MCM and/or associated platform/technology described above and targeting one or more known or emerging resistant bacterial or fungal pathogens listed above. Each Research Project should clearly and directly contribute to the Center theme and objective(s). The PD(s)/PI(s) will monitor all Research Projects and actively promote efforts that foster integration, collaboration, and synergy across the projects. Research Project Leaders may be affiliated with either an academic organization or industry. For this NOFO, "industry" is defined as a large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, or chemical company, or a related non-profit entity.

Research Projects are expected to incorporate state-of-the-art technology and approaches and may include consortium arrangements for required activities. Applicants are encouraged to carefully consider the scope and range of research proposed and develop a Center that is coherent overall and consistent with available resources and personnel.

Examples of CETRs:

Center themes and objectives may range from development of single or multiple countermeasures targeting a specific group of pathogens to development of modern technologies or platforms that target a wide array of pathogens. To facilitate a product- focused approach, industrial participation (e.g., consultant, SAB member, co-investigator, or project PI) with each Center is anticipated.

As an example, a Center focused on development of new therapeutics that target antimicrobial-resistant Gram-negative bacterial pathogens might have the following structure:

• Administrative Core
• Scientific Core: Computational Chemistry Core
• Research Project 1: Optimization of small molecules targeting Drug Resistant Gram-negative Pathogens
• Research Project 2: Discovery of novel gene-encoded mAb candidates targeting Pseudomonas and Acinetobacter  
• Research Project 3: Optimization of gyrase inhibitor series and advancement of lead candidates through IND-enabling studies as a novel treatment option for Nontuberculous mycobacteria (NTM)
• Research Project 4: Development of novel diagnostics assays for simple and rapid detection of Pseudomonas and Acinetobacter to support narrow-spectrum therapeutics candidates

As a second example, a Center focused on diagnostics development for a panel of pathogens, must include one or more of the AMR pathogens listed above, and could also include other pathogens. Diagnostic development might include pathogen identification (bacterial or fungal) coupled with phenotypic AST, and might have the following structure:

• Administrative Core
• Research Project 1: Technology development for pathogen capture and enrichment direct from specimen
• Research Project 2: Platform development for pathogen identification direct from specimen
• Research Project 3: Development of phenotypic AST methods
• Research Project 4: Expanded AST assay development of panel testing
• Research Project 5: Bioinformatics effort to develop databases that are validated and curated to FDA standards

As a third example, a Center focused on structure-based development of a Klebsiella pneumoniae vaccine might have the following structure:

• Administrative Core
• Research Project 1: Antigen identification using computational Analysis and Prediction Research
• Research Project 2: Structure-Based Antigen/Immunogen Design and/or optimization
• Research Project 3: Screening and Down-selection of Protective Antigens/Immunogens
• Research Project 4: Preclinical Evaluation of Candidate Vaccines

Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. NIH encourages applicants to include a diverse group of scientists in their research programs, including individuals from underrepresented backgrounds (see NOT-OD-20-031, Notice of NIH’s Interest in Diversity and NOT-OD-22-019, Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

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 registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including individuals from 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 SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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:

Caitlin Brennan, Ph.D.
Telephone: 301-761-7792
Email: caitlin.brennan2@nih.gov  

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Scientific Core(s): optional, maximum 3, each Core must support at least two Research Projects
• Research Projects: required, minimum 3, no maximum 

Overall Component

When preparing the application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities & Other Resources: Describe the unique facilities and resources that will be leveraged by the CETR program. Examples of the types of leveraged resources might include level of institutional funding for the proposed support cores, space allocation, faculty commitments, salary for Core staff.

Existing Core Facilities: Provide a list of current NIH-funded research Cores at the applicant institution that the CETR program could leverage. Briefly describe the range of services offered by these Cores.

Other Attachments:

Product Development Strategy (required): Applications that do not include the Product Development Strategy will be deemed unresponsive and returned without review, with the exception of applications proposing early translational studies in fungal pathogens.

Include a single Product Development Strategy attachment, which must be no more than 12 pages total and covers all relevant product(s). The Product Development Strategy attachment should be in pdf format with a filename of "Product_Development_Strategy.pdf" and should include both a Milestones and Timeline section and a Product Development Plan. 

Milestones and Timeline: Provide detailed project performance and timeline objectives in a section entitled "Milestones and Timeline." This section should include:

• A clear description of all interim objectives (research and/or developmental milestones) to be achieved during the course of the project. Identify any impediments that could require a revision in the work plan or milestones with a discussion of alternative approaches.
• Detailed quantitative criteria by which milestone achievement will be assessed and factored into Go/No-Go decision-making.
• A detailed schedule or timeline for the anticipated attainment of each milestone and the overall goal(s).

Product Development Plan: Provide detailed development plans in a section entitled "Product Development Plan". The preparation of this plan should include the participation of consultants with expertise in technology transfer and the development of regulated products.

This section should include:

• A statement of the intended use/indication of the proposed product(s) and public health gap the product is intended to fill.
• A statement of the value of the project, including lay description of key technology objectives, innovation, and advantages compared to competing products, technologies, or services.
• A clear description of the goal(s) of the project, including one (or more) intermediate products (tools), final product(s) or stage(s) of product development to be completed during the award period. A specific final product profile that is intended for licensing indication is not required.
• Descriptions pertaining to preclinical product development activities for the product(s) proposed.
• Research activities that are justified by data and commensurate with project progress and product(s) readiness.

Discuss the following points as part of the Product Development Plan, based on the type of product proposed:

For Product Development Plans for therapeutic or vaccine projects, include the following:

• The performance specifications and features the product(s) should have to provide therapeutic and/or immunological benefit (i.e., target product profile)
• A description of the candidate product(s) or lead series as it is currently configured.
• A description and developmental status of the assays for product(s) release and characterization, including activity and efficacy.
• Data that support the characterization and selection of the candidate product(s) for further development.  For therapeutic and vaccine studies, include a summary of data that demonstrates efficacy in in vitro assays and/or in vivo models for one or more of the selected agent(s). This includes: a detailed description of the assays and animal models, the choice of pathogen challenge, strain and route, and a rationale for the choice of animal model, pathogen challenge, strain and route, as well as for the outcome/endpoints selected; documentation that the animal infection experiments were performed under well-controlled experimental conditions.
• Clearly defined goals, product development stages and product development activities.
• Criteria that will be used to support moving to the next stage of product(s) development.
• Discussions with the FDA, if any, that are relevant to development activities for the candidate product(s)/technology.

For Product Development Plans for diagnostics projects, include the following:

• With respect to performance specifications, the product(s) (diagnostic assay, method, technology, etc.) should demonstrate the equivalence or superiority to the gold standard for identifying the proposed agent(s), including clinical sensitivity in appropriate human samples, clinical specificity in appropriate human samples, analytical sensitivity (limit of detection), analytical reactivity (pathogen strains detected for each pathogen), analytical specificity (cross-reactivity), and analytical reproducibility (test replicates at different agent concentrations, at different sites, etc.). If no FDA-cleared test is available for the agent(s), the specifications should be equivalent to, or exceed performance specifications of FDA-cleared tests for similar types of agent(s).
• Data that support the selection of the candidate product(s) for further development, including an assessment of the present capacity of the diagnostic method, technology or assay to meet the performance specifications.
• Discussions with the FDA, if any, that are relevant to development activities for the candidate product(s).

When appropriate, and as part of the Product Development Plan, document compliance with guidelines that govern GLP, as defined by 21 CFR (58), and CGMP, as defined by 21 CFR (211), manufacturing and/or IND/IDE enabling studies that will be performed under the project award as they would be applicable to eventual product licensure in the U.S.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

Within the biosketches, highlight the following:

• The experience and scientific background of the PD(s)/PI(s) for development of an integrated and focused research program;
• The regulatory expertise of personnel, including previous experience with FDA submissions. 

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Center. Concisely describe the Center objectives.

Research Strategy: This narrative section summarizes the overall research plan for the multi-component application. The multi-component application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section, for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.

Clearly define the Center theme, the significance of the Center theme regarding the countermeasure(s) targeted for development, the public health need and benefit of a successful effort, and the range of activities being pursued. Discuss how the overall Center goals and significance focus on studies that increase knowledge needed to advance the translational activities of the Center. Additionally, detail the scientific merit of each Research Project and Scientific Core, and how each contributes to the Center theme of development of medical countermeasures against AMR bacteria and/or fungi, objectives and project interdependence. Outline expected synergies provided by the proposed Center. Discuss the scientific gains and synergy achieved by the multi-component Center beyond the gains achievable if each project were pursued independently. Describe the cohesion of the Center as a whole, and how the Research Projects and Scientific Cores relate to a single common theme demonstrating cohesion, multidisciplinary interactions, coordination, and synergy.

Progress reports should not be submitted for existing Centers of Excellence for Translational Research.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

Reagents developed from these studies may be disseminated using NIH or NIAID repositories or existing public repositories whenever possible. Investigators are encouraged to consult with NIAID Program Officers to determine which reagents may be deposited at the BEI Resources Repository or other approved public repositories.

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

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.
• For Genomic Data Sharing, all pathogen and vector raw genome or metagenome data generated using sequencing approaches must be submitted to public repositories as rapidly as possible, and no later than 45 calendar days after quality control. Full or partial genome and metagenome assemblies and their annotations must be submitted to the appropriate database (e.g., GenBank), either as individual samples, or for defined cohorts of samples as rapidly as possible, and no later than 45 calendar days after being generated and validated. For infectious disease emergency response research, pathogen genomic information must be released as soon as possible to effectively inform public health and outbreak mitigation responses.
• Other data types, including expression data, immunological data, proteomic data, other omics data, unpublished primary and secondary data, and models and other digital work products, are expected to be released within nine months of generation and validation, upon publication, or the end of the project period, whichever comes first.
• A list of potential data repositories, including NIAD-specific ones can be found on the NIH Scientific Data Sharing website.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The PD/PI (or one of the PD(s)/PI(s) in the event of a multi-PD/PI application) must be the Core Lead of the Administrative Core.
• Within the biosketches, include an Administrative Core Associate who will be responsible for the daily administration and fiscal management of the Center.
• If appropriate, based on the maturity of the technology, within the biosketches, highlight the expertise of the staff in regulatory requirements and administrative expertise pertinent to emerging and re-emerging drug resistant bacterial or fungal strains.

Budget (Administrative Core)

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

The Administrative Core budget may not exceed 5% of total direct costs requested. The Core Lead must commit at least 0.6 person months effort per year to these Administrative Core responsibilities. It is recommended that the Administrative Core Associate devote a level of effort ranging from 3 to 6 person-months to the execution of the administrative details of the Center projects and to managing the day-to-day operations within the Center. Any additional Administrative Core personnel must be clearly justified. Regulatory expertise may be retained as defined effort or periodic consultation.

Include funds for the PD(s)/PI(s), Project Leaders, at least 3 external Scientific Advisory Board (SAB) members, and additional Center Key Personnel (at the discretion of the PD(s)/PI(s)) to attend mandatory semi-annual reverse site visits in Years 1-5 of the project period. One reverse site visit will be held at a location at/near Rockville, MD or at another NIAID-approved site, and the other site visit will be held virtually. Each meeting will last 0.5 to 1 day. In addition, include funds for the PD(s)/PI(s) from each Center to travel to 2 program-wide workshops (interim and final).

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

PHS 398 Research Plan (Administrative Core)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Administrative Core. In addition, state the Core's relationship to the Program's goals and how it relates to the individual Research Projects and other Cores in the application.       

Research Strategy: Include a Management Plan that identifies and discusses: the administrative and organizational structure of the Administrative Core; the roles of Administrative Core personnel; the composition and duties of the Scientific Advisory Board (see below); fiscal accountability of the program; and the facilitation of communications throughout the Center and with NIAID staff. Within the plan, address continual evaluation of research and development progress, coordination, establishment of a strong collaborative environment, group meetings and teleconferences, presentation and publication of data, resource and model sharing, transmission of information and reagents, the identification and proposed resolution of problems among Center staff and engagement of the NIAID staff, as appropriate. Describe how consortia (subcontracts) will be managed and include how communications, such as periodic meetings and conference calls, will be organized, managed and documented. In addition, detail how CETR- and research-related travel will be managed.

Each Administrative Core must include the following:

Scientific Advisory Board:

Upon award, each Center must establish a Scientific Advisory Board (SAB) that includes the PD(s)/PI(s) and at least 3 non-conflicted external advisors. For Centers engaged in preclinical product development activities, at least 1 of the external advisors must have demonstrated and relevant industry-level expertise. Note: Applicants must not contact or name external SAB members in their applications. SAB membership will be established in consultation with NIAID CETR program staff upon award.

Within the application, describe the areas of expertise to be represented on the SAB and how the SAB will be utilized to guide Center activities. Discuss the role of the SAB and the integration of its proposed expertise into the operations of the CETR. Describe procedures and approaches for obtaining SAB input via teleconferences, ad hoc and site visit meetings, review of written materials/data, etc. If preclinical and/or product development activities are proposed in the application the SAB must include relevant experience.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Scientific Core(s)

When preparing your application, use Component Type ‘Core.’

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

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

SF424 (R&R) Cover (Scientific Core(s))

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Scientific Core(s))

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Core(s))

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

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

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

Project /Performance Site Location(s) (Scientific Core(s))

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Scientific Core(s))

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific Core(s))

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

Each Scientific Core leader must commit at least 1.2 person-months effort to their Core per year.

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

PHS 398 Research Plan (Scientific Core(s))

Specific Aims:

Describe the functions of the Scientific Core and how it supports the objectives of at least 2 Research Projects.

Research Strategy:

Within a section titled “Purpose and Strategy”, include the following information:

• Describe the role of this Scientific Core within the program as a whole. Discuss how the services provided by this Core will support at least 2 Research Projects and how the Core will help advance the overall goals and objectives of the program. Outline how the Core services will be used effectively.
• Describe the unique features of this Core that make it essential to the overall research area covered by the proposed Center.
• Describe the quality of the facilities or services to be provided by the Core, including procedures, techniques as well as overall quality control.
• Describe how the Core maintains up to date on the services offered by the Core and incorporates state-of-the-art, innovative technologies and resources to advance CETR research.
• If applicable, describe the plans for the Core to interact with other Scientific Cores within the program to enhance the outcomes of Center-relevant research collaborations.

Within a section titled “Management”, include the following information:

• Provide a management plan that describes the day-to-day operations, communications, safety measures, training of Core staff, as needed.
• Based on the services provided by this Core, as applicable, describe the plans to monitor quality control of the services offered, respond to problems as they arise, remediate issues of quality control and communicate these issues to the end users.   
• Describe the policies and procedures for prioritizing workload and individual Core usage with respect to evolving scientific priorities at the applicant institution, procedures for assessment of overall progress and the process for reallocating funds within the Core, as needed and in consultation with CETR leadership.
• Describe the communication plan to solicit feedback from end users regarding the Core services, functions and ability of the Core to meet Center research needs.

Letters of Support:

Provide Letters of Support from organizations or institutions that may provide biological specimens, reagents, assays, or equipment services that may not be available through host institution agreements.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Scientific Core(s))

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Research Projects

When preparing your application, use Component Type ‘Project.’

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

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

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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

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

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

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Projects)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Projects)

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

Each Research Project leader must commit at least 1.2 person-months effort to their Research Project per year.

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

PHS 398 Research Plan (Research Projects)

Specific Aims: List, in priority order, the broad long-range objectives and goals of the proposed project. Concisely describe the translational activities to be performed. In addition, state the individual Research Project's relationship to the Program's goals and how it relates to other Research Projects or Cores.

Research Strategy: Describe how the proposed research will contribute to meeting the Center's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. Indicate the project's relevance to the primary theme of the application.

For each Research Project, describe the research design conceptual procedures, and analyses to be used to accomplish the specific aims of the project. Provide a tentative sequence or timetable for the project. Describe how the Research Strategy is informed by an understanding of the regulatory process. Describe anticipated regulatory barriers and propose research and/or strategies to overcome these barriers.

For candidate products that may not be tested for efficacy in humans, identify and include animal models that are adequate to assess the ability of the product to induce a certain response and endpoints that will satisfy the Animal Rule.

Letters of Support: Provide Letters of Support from organizations or institutions that may provide biological specimens, reagents, assays, or other resources/services that may not be available through host institution agreements.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Program-generated novel reagents (e.g., expression vectors, mutant strains, libraries, protein clones), should be made available through NIAID-supported repositories, such as the NIAID BEI Resources, or in other repositories as identified by the SAB in consultation with the NIAID.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Research Projects)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

4. Submission Dates and Times

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

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.

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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: Applications proposing early translational studies in fungal pathogens are not required to contain a Product Development Strategy attachment.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO: To what extent does the application have a single clearly defined and scientifically justified program that supports the development of medical countermeasures against antimicrobial resistant bacteria and/or fungi? How justified is the: (1) scientific merit of each Research Project and Scientific Core, (2) the program as a whole; and (3) the significance of the overall Center goals? To what degree do the overall Center goals and significance focus on studies that increase knowledge needed to advance the translational activities of the Center?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this NOFO: How adequate is/are the experience and scientific background of the Program Director(s)/Principal Investigator(s) for development of an integrated and focused research program? How adequate is the regulatory expertise of the personnel, including experience with FDA submissions? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: How cohesive is the Center as a whole, and to what extent do the Research Projects and Scientific Cores relate to a single common theme demonstrating cohesion, multidisciplinary interactions, coordination, and synergy? To what extent are the scientific gains and synergy achieved by the multi-component Center beyond the gains achievable if each Research Project were pursued independently?

For all Centers except those focusing upon early translational studies in fungal pathogens:

• How well does the Product Development Plan address the goals of this NOFO?
• How feasible and appropriate is the Product Development Plan for proposed and future product development?
• How appropriate and feasible are the milestones?
• How timely, consistent and justified by data and candidate readiness are the product development activities?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Overall Impact - Individual Research Projects

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 five review criteria, and additional review criteria (as applicable for the project proposed).

Review Criteria - Individual Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit. 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.

Significance

Does the program project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the program project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO: To what extent is the project relevant to the primary theme of the Center?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program project? If Early-Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the program project involves human subjects and/or NIH-defined clinical research, are the plans to address: 1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: How adequately does the approach take into consideration the anticipated regulatory process and any anticipated regulatory barriers?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Overall Impact - Administrative Core, Scientific Core(s)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Core proposed).

Administrative Core

• How adequate and appropriate is the administrative and organizational structure to achieve the goals of the proposed Center?
• How appropriate is the Management Plan for fiscal accountability and communication within the Center and with NIAID staff?
• How adequate are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the Center?
• How skilled are the staff in regulatory requirements and administrative expertise pertinent to emerging and re-emerging drug resistant bacterial or fungal strains?

Scientific Core(s)

• How well is/are the Scientific Core(s) justified?
• How well does/do the Core(s) support at least two Research Projects?
• How connected is/are the Core(s) to the central focus of the overall program?
• How adequate is/are the quality of facilities or services provided by the Core(s) (including procedures, techniques, and quality control)?
• How effectively will the Core's/Cores’ services be used?

Additional Review Criteria - Overall, Administrative Core, Scientific Core(s), Research Projects

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall, Administrative Core, Scientific Core(s), Research Projects

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

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 their 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.

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

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

• Federal-wide 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 and 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 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.

n accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 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 45 CFR Part 75 and 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:

• Leadership, direction and oversight for all activities conducted within the program.
• Administrative oversight, financial accountability, and management of the program.
• Working closely with NIAID staff in the scientific, technical, and administrative management of the program.
• Adhering to established methods and procedures for assessment of progress and productivity of the work conducted under the program and implementing changes to optimize performance.
• Oversight and adherence to principles and practices associated with research regulations
• Organizing, participating, and chairing site visit and workshop activities.
• 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 NIAID Project Scientist will have significant programmatic involvement and will serve as an overall program coordinator. The main responsibilities of the NIAID Project Scientist include:

• Sharing information about other ongoing studies supported by NIAID with CETR leadership.
• Suggesting or recommending feedback on the design of research activities and advising in project management and technical performance.
• Providing technical input and suggest modifications to Research Projects as required to ensure research objectives are satisfactorily met.
• Facilitating interactions amongst the projects.
• Coordinating workshops and meetings among recipients and relevant stakeholders to share ideas and approaches on good practices.
• The NIAID Project Scientist will coordinate research approaches among all Programs funded through the NOFO and participate in the shaping of Research Projects or approaches.
• Coordinating NIAID staff assistance with regard to:
  
  
  • Oversight and monitoring of collaborative research
  • Feasibility of timely progress towards completion of planned activities
  • Plans for incorporation of new technologies or other resources
  • Facilitating collaborations with, and direct access to, other NIAID-supported research resources and services. 
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Scientific Advisory Board (SAB): The SAB will participate in the development and management of the CETR and corresponding activities. The SAB will attend CETR site visits to review Center activities and evaluate progress, adherence to milestones and timelines, and the continued relevance of each Research Project to the overall objective(s). The SAB will facilitate go/no go decision making, recommend new directions as appropriate and provide upon request of the PD(s)/PI(s) and NIAID Project Scientist a comprehensive written evaluation of the group's activities and the panel's recommendations.
• The NIAID Project Scientist and the PD(s)/PI(s) will coordinate to schedule two program-wide workshops to facilitate the achievement of program goals among the CETR Centers (interim and final). In the event that some members of the Centers develop common research interests, working groups may be formed to pursue collaborative activities.
• The NIAID Project Scientist and the PD(s)/PI(s) will coordinate meetings semi-annually, and/or teleconferences as needed to discuss program activities and progress and facilitate the achievement of program goals.

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. 

• For Genomic Data Sharing, all pathogen and vector raw genome or metagenome data generated using sequencing approaches must be submitted to public repositories as rapidly as possible, and no later than 45 calendar days after quality control. Full or partial genome and metagenome assemblies and their annotations must be submitted to the appropriate database (e.g., GenBank), either as individual samples, or for defined cohorts of samples as rapidly as possible, and no later than 45 calendar days after being generated and validated. For infectious disease emergency response research, pathogen genomic information must be released as soon as possible to effectively inform public health and outbreak mitigation responses.

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 (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 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: GrantsInfo@nih.gov (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: support@grants.gov

Candace Kerr, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6257
Email: candace.kerr@nih.gov 

Caitlin Brennan, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7792
Email: caitlin.brennan2@nih.gov  

Lindsey Pujanandez, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7830
Email: lindsey.pujanandez@nih.gov 

Sufiyan Saeed
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3761
Email: sufiyan.saeed@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.