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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The goal of this notice of funding opportunity (NOFO) is to establish Centers for Accelerating Phage Therapy to combat ESKAPE pathogens (CAPT-CEPs). The CAPT-CEPs will be dedicated to developing preclinical assays, tools, and models and conducting essential studies that facilitate robust phage therapeutics against ESKAPE pathogens, ultimately preparing therapeutic candidates for future clinical studies. Applications are expected to include translational research projects covering multidisciplinary sciences. These projects aim to fill the gaps in phage therapeutics research and development (R&D), contributing significantly to the fight against antibiotic resistance (AR).

Background

Globally, about five million deaths annually are associated with AR, which is mainly caused by overuse and misuse of antibiotics. Without new preventative solutions to combat this rise in AR, this number is expected to rise to 10 million annual deaths at a total cost of up to $100 trillion in lost economic output by 2050. ESKAPE pathogens--- Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter---are among the top ten pathogens attributed to AR deaths. They have been shortlisted as global priority pathogens by the World Health Organization due to their capability of developing multidrug resistance (MDR) to last-resort antibiotics and causing biofilm-associated infections, which withstand classical antibiotic-mediated killing. Subsequently, the limited effectiveness of antibiotics in treating ESKAPE pathogens requires immediate and expeditious action to establish alternative treatment options.

Phage therapy is a potentially promising alternative to treat infections caused by AR pathogens. The notable benefits of phage therapy include pathogen-specificity, which preserves beneficial microbiota; patient-specificity, enabling precision medicine; and a favorable safety profile with minimal adverse events. Despite several small, randomized clinical trials currently underway, the availability of new, efficacious phage therapeutic products remains a significant obstacle in their development and in bringing them forward for rigorous assessment of clinical efficacy.  Moreover, the existing tools and approaches currently used to develop phage therapeutics are the same as those used for traditional small molecule antibiotics, which fail to consider the unique characteristics of phages. For example, phages proliferate in the presence of bacterial pathogens and interact with the human immune system, potentially being cleared by an immune response. Accordingly, the current in vitro tests, such as the phage susceptibility test and transduction assay, do not correlate with phage’s in vivo activity against targeted bacteria in infection sites. The strategies to evaluate the pharmacokinetic/pharmacodynamic (PK/PD) dynamics of phages also have not yet been fully explored due to the lack of proper in vivo (e.g., animal) models for phage research.

With the right resources and collaborative efforts, we can develop and advance efficacious phage therapy for treating AR infections. This requires the development and validation of suitable assays, tools, and in vitro and in vivo models. These are crucial for understanding the PK/PD dynamics of phage in vivo, identifying appropriate phage dosages, and optimizing the delivery methods .

The CAPT-CEP will serve as a catalyst for phage therapeutics research, providing a unique platform for coordination and promotion within the science community. The goal of the CAPT-CEPs is to significantly enhance the quality and efficacy of phage therapeutic products, thereby unlocking this therapy's full potential to combat ESKAPE pathogens.

Research Objectives and Scope

The objective of this NOFO is to establish collaborative, multidisciplinary research groups that will implement phage therapeutic research and facilitate interactions within and among teams of researchers from diverse scientific fields. The major goals of the CAPT-CEPs will be to develop novel, high-throughput, and cutting-edge assays, tools, and models for phage therapy that can be applied to other phage R&D studies; and to perform essential studies to understand PK/PD and to evaluate optimal delivery systems and dosages of phages, which can be used in designing future clinical trials to combat ESKAPE pathogens.

Applications must focus on the preclinical development of phage therapies that target at least one of the ESKAPE pathogens listed above. Projects should focus on developing necessary assays, tools, and models and conducting essential studies for robust phage therapeutics R&D for treating infections due to ESKAPE pathogens.  Applications from academic institutions are encouraged to include a substantive investment and participation in the project by an industry participant to facilitate appropriate and validated product development activities.

NIAID anticipates considerable variety among the proposed CAPT-CEP themes and objectives. Overarching themes could include, but are not limited to:

• Developing assays, tools, and models, including in silico, in vitro, and in vivo, to help standardize phage therapy R&D
• Generating suitable in vitro and in vivo models for phage research against ESKAPE pathogens
• Understanding PK/PD relationships for phages
• Determining (poly)valency, delivery routes, and dosages of different phage products

CAPT-CEP multidisciplinary research projects contributing to a unifying theme could include, but are not limited to:

• Development of user-friendly and reproducible high-throughput assays, including phage in vitro and in vivo susceptibility tests, and in vivo phage transduction assays.
• Approaches to develop tools, including in silico models, to identify/isolate the most appropriate potential phage therapeutic candidates, including polyvalent phages, to treat ESKAPE bacterial infections.
• Strategies to develop ready-to-use (synthetic or bioengineered) phage therapeutics with broad host ranges.
• Development of in vitro organoids and in vivo animal models to study phage therapy. This includes chronic infection and inflammation models.
• Systems pharmacological studies to advance robust PK/PD models for phages, including applying Artificial Intelligence (AI) and machine learning technologies.
• Tools to evaluate and optimize (poly)valency, routes, and dosages of phage products.
• Approaches to minimize phage neutralization by the host immune response and to enhance stabilization of phage therapeutics.
• Novel methods to optimize phage cocktails to increase bacterial coverage and to prevent the selection of phage-resistant mutants without generating undesired cross-activity.
• Test-of-concept studies using developed assays and tools in appropriate in vivo models. These studies may include  efficacy studies in small animals, assessment of safety and toxicity, immunogenicity, resistance development, and evaluation of proper delivery routes, doses, and formulations.

Collaborative Multidisciplinary Teams

The scope of this work requires establishing multidisciplinary teams that pursue coordinated activities that can bridge and fill gaps in phage therapeutics R&D. The CAPT-CEP is expected to include researchers with unique and diverse scientific expertise in areas that will enhance the overall scientific partnerships to achieve stated goals. For example, the scientific disciplines may include but are not limited to phage biology, bacteriology, clinical microbiology, pharmacology, immunology, glycobiology, synthetic biology, omics, and computational biology.  The research teams may be located at one institution or may be formed through a consortium of different institutions.

Examples of CAPT-CEP:

The following are examples and do not reflect the full range of potential CAPT-CEPs:

• CAPT-CEP focused on developing rapid, standardized, high-throughput assays and tools, and validating tests with phage in vitro and in vivo models could bring together investigators with expertise in phage biology, bacteriology, genetics, in vitro and in vivo (including organoids) models, synthetic biology, omics, computational biology, and immunology.
• CAPT-CEP focused on performing systems pharmacological studies, advancing robust PK/PD models for phages, and evaluating optimal routes and dosages of different phage products could bring together investigators with expertise in phage biology, pharmacology, clinical microbiology, immunology, and AI and machine learning.
• CAPT-CEP focused on optimizing phage mixtures or developing polyvalent phages to increase bacterial coverage, prevent the selection of phage-resistant mutants, and minimize phage neutralization by the host immune system could bring together investigators with expertise in phage biology, immunology, glycobiology, bacteriology, synthetic biology, omics, computational biology, and immunology.

Applications proposing research in the areas listed below will be considered non-responsive and will not be reviewed: 

• Projects that do not target at least one ESKAPE pathogen---- Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter
• Basic science that does not support development of phage therapeutics
• Decolonization-focused studies
• Wound infection studies
• Mycobacteria or drug-resistant tuberculosis
• Clinical trials as defined by the NIH; however, use of existing clinical samples is permitted

Overall CAPT-CEP Structure

The CAPT-CEP should be organized around a common research theme and consist of an Administrative Core, Research Projects, and Scientific Core(s) (optional). The components of an application will include:

Administrative Core (Required):

The Administrative Core will be responsible for managing, coordinating, and monitoring overall progress and supervising the entire range of the CAPT-CEP's activities, including the Developmental Research Program (DRP), and ensuring distribution of CAPT-CEP specific content among and within CAPT-CEP recipients.  The Administrative Core will be responsible for implementation, oversight, and monitoring of the following activities:

• Data Stewardship and Content Dissemination among and within funded CAPT-CEPs:  

The CAPT-CEP will be responsible for developing and implementing procedures for the collection, oversight, and inventory of data, tools, and resources generated by the recipient, including, for example, harmonization, quality control, uniformity of data collection processes, troubleshooting data system problems, and developing solutions. Services will be provided for statistical, study design, and data analyses for the studies conducted under the award. Each CAPT-CEP recipient will be responsible for the exchange of data, information, tools, and resources generated by the recipient(s), among funded CAPT-CEPs. The CAPT-CEP will also provide expertise on study design planning and data analysis. This real-time dissemination activity among and between CAPT-CEP recipients is intended to further the goals of the overall CAPT-CEP effort to advance the development of phage therapies, and not meant to bypass Federally mandated data sharing requirements.  

• Development and Research Program (DRP):   

The CAPT-CEP will develop and manage a Development and Research Program (DRP) intended to test novel ideas, develop new technologies, strengthen collaborations among the CAPT-CEPs, and provide research-focused experiences in certain areas under investigation by the CAPT-CEP. The focus of the DRP awards is geared towards providing research experiences to scientist trainees, early-stage investigators, and/or investigators new to the phage research field.

Scientific Core(s) (Optional):

The CAPT-CEP may include up to two Scientific Core(s) to provide shared support services to the Research Projects. Cores must be well justified, provide support for at least two Research Projects, and be clearly non-duplicative of other services or facilities available to CAPT-CEP investigators. Examples of services provided by a shared Scientific Core include, for example, phage isolation and production, microbiology laboratory services, omics service, statistical support, or animal core.

Research Projects (Required):  

The CAPT-CEP must propose a minimum of two and no more than three Research Projects organized around a common theme. The collaborative projects should advance robust phage therapy R&D.

Scientific Advisory Board:

A Scientific Advisory Board (SAB) will serve as an independent, external advisory body for the funded CAPT-CEPs but will not be involved in the day-to-day activities of the CAPT-CEPs. The SAB will be composed of at least three outside experts recommended by recipients and approved by NIAID and will be constituted after award to review progress and make recommendations to investigators. Recipients will be required to attend an annual meeting with NIAID staff and the SAB to review progress, discuss problems encountered, plan future research activities, and establish priorities in following years. Do not contact, recruit, or name potential SAB members prior to completion of review activities.

Recipient Meetings:  

Kick-off meeting: All recipients of a CAPT-CEP and NIAID program staff will convene and participate in an in-person, one-day kick-off meeting in the Washington, DC metro area within three months following award to establish the major roles and functions of CAPT-CEPs and to facilitate collaborations.

Annual meeting: All recipients of a CAPT-CEP, along with key personnel, the SAB, and NIAID staff will convene and participate in an annual meeting in the  Washington, DC metro area or at another NIAID-approved site. These meetings will provide an opportunity  to present updates on research progress and discoveries, exchange scientific knowledge, and discuss potential collaborations.

Monthly virtual meetings: CAPT-CEP recipients are expected to attend monthly virtual meetings to facilitate communication and collaboration among funded CAPT-CEP recipients and NIAID staff. The Administrative Core will coordinate the meetings, including the agenda, which will be determined by PDs/PIs of the CAPT-CEPs and NIAID Program Official.

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

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 How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Soheyla Saadi, Ph.D.
Telephone: 240-669-5178
Email: [email protected] 

Page Limitations

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

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 Component

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

All instructions in the How to Apply - 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.

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.

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 CAPT-CEP. Concisely describe the hypotheses to be tested.

Research Strategy: This section summarizes the overall research strategy for the multi-project application. The multi-component, multi-disciplinary application should be viewed as an alliance 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 CAPT-CEP by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.

• Summarize the overarching theme of the proposed CAPT-CEP and explain how, in the long term, the proposed research will address critical gaps and longstanding obstacles in the preclinical development of phage therapeutics against ESKAPE pathogens.
• Describe goals, relevant background, and a description of the impact of the science proposed in relation to the field. Include an explanation of how the work proposed is innovative and incorporates current and emerging technologies or methodologies in phage therapeutic development. Describe how the research represents a significant improvement to phage products.
• Describe the plan for integrating multidisciplinary investigations, novel technologies, and unique expertise to develop essential tools and assays and to conduct necessary studies for advancing robust phage therapy against ESKAPE pathogens.
• Describe how the proposed studies will foster a collaborative, multidisciplinary, diverse set of research activities. Explain how the individual Research Projects and Scientific Core(s) (if applicable) are strategically aligned with the CAPT-CEP's overall goals. Highlight how the combination of Research Projects and Scientific Core(s) (if applicable) provide a cohesive and synergistic whole that is more beneficial than pursuing each project independently.
• Explain the contributions of each component in the context of the whole CAPT-CEP. Include a graphic illustrating the relationship of the various Research Projects and Scientific Cores (if applicable) to one another and their place in the overall CAPT-CEP.
• Summarize the special features within the CAPT-CEP environment of the applicant and collaborator (if applicable) institutions, and the available resources that facilitate a multidisciplinary approach to phage R&D research.
• Without duplicating information in the biosketches, provide the rationale for specific scientific expertise and technical capabilities of the investigative team members.
• Discuss how the communication and collaboration plans among multi-disciplinary team members will contribute to the success of the proposed research.  

Letters of Support: PD(s)/PI(s) are encouraged to provide letters of support from private sector partners regarding their participation in the CAPT-CEP, plans for intellectual property, compliance with the dissemination of program-specific content among CAPT-CEP recipients and other legal matters that may arise during the period of the award. 

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

• Describe the plan for providing access to research tools, research approaches, and detailed protocol documents developed through this NOFO to the community, including dissemination through appropriate public databases and repositories.
• Investigators are encouraged to consult with the NIAID Program Official to determine specific locations to deposit research tools. Reagents, in vitro and in vivo models may be deposited at the BEI Resources Repository.

Other Plan(s): 

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

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

Appendix:

Only limited 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 How to Apply - 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 How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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 How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form (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 How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

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.

Budget (Administrative Core)

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

• Include expenses for the overall administrative efforts, including administrative roles and services, publications related to the operations, and communications within and among the CAPT-CEP(s).
• Travel costs should be included for the following meeting types and locations:
  • CAPT-CEP Kick-Off Meeting: In Year 01, include funds for the PD(s)/PI(s), Key Personnel, Research Project Leaders, and Core Leaders to travel and attend a kick-off meeting hosted by NIAID. The kick-off meeting will be held over 1 full day in the greater Washington, DC metro area.
  • Annual CAPT-CEP meetings: In Year 02 – 05, include funds for the PD(s)/PI(s), Key Personnel, SAB members, Research Project Leaders, Core Leaders, and DRP award recipients to travel to and participate in the annual meeting to be held over 1 full day in the greater Washington, DC metro area or at another NIAID-approved site for data presentation, progress evaluation and related activities.
• Development and Research Program (DRP):  Applicants are expected to budget $80,000 in direct costs for the DRP to fund up to 2 DRP awards per year for 1 year duration each, starting in Year 2.

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 objectives and goals of the proposed Core. In addition, state the Core's relationship to the CAPT-CEP's goals and how it relates to the individual Research Projects or other Scientific Cores in the application.

Research Strategy: Describe plans and procedures for establishing and managing an Administrative Core that provides the organizational capacity to ensure the following:

• Coordinating, supervising, and managing the day-to-day activities of the CAPT-CEP and providing a supportive structure sufficient to ensure the accomplishment of the CAPT-CEP goals.
• Monitoring progress, remediating delays, and providing project management oversight for administrative functions, as well as the various activities of the Research Projects and Science Core(s) (if applicable).
• Providing administrative and fiscal support to Research Project Leaders and Science Core(s) Leaders (if applicable), such as financial planning and prioritization of funds,  management of available resources and quality control, plans for conflict resolution, and ensuring compliance of Development and Research Projects recipients with project implementation monitoring.
• Developing a detailed plan for  communications within the CAPT-CEP, among funded CAPT-CEPs, with the DRP recipients and their institution, the SAB members, and the NIAID Program Official.
• In a clearly labeled section entitled "Data Stewardship and Content Dissemination” describe the range of activities necessary for developing and implementing procedures for the collection, oversight, and inventory of data, tools, and resources generated by the CAPT-CEP investigators, including, for example, harmonization, quality control, uniformity of data collection processes, troubleshooting data system problems, and eventual solutions. In addition, describe the range of study design, power calculations and statistical analyses offered in support of the Research Projects and Science Cores (if applicable) supported by the CAPT-CEP.  Discuss how the dissemination of data and content within and among the funded CAPT-CEPs will be used to advance the progress towards the CAPT-CEPs stated goals and objectives.  Note: do not address NIH Data Management and Sharing Policy activities within the “Data Stewardship and Content Dissemination” section.
• Management Plan (required): In a clearly labeled section named, “Management Plan,” address the following areas:
  • Describe the overall process related to coordination, integration, scientific and technical management of the proposed research.
  • Discuss the scientific oversight and management of the projects and associated staffing with respect to an evolving research field involving multiple science disciplines, novel technologies, and the development of novel tools and assays for resources for advancing robust phage therapy against ESKAPE pathogens.
  • Describe how the science conducted under the CAPT-CEP will be managed and tracked for progress towards the stated goals.
  • Describe the process for achieving routinely scheduled feedback on the projects including the process for troubleshooting problems and adjusting timelines to accommodate delays.
• Development and Research Program (DRP) Plan (required): In a clearly labeled section named, “Development and Research Program (DRP) Plan,” address the following: areas:
  • Describe the plan for the management and oversight of processes and procedures for implementation of the DRP, including selection, prioritization, development, and implementation of activities related to the use of the DRP.
  • Discuss how the research priorities within the CAPT-CEP will be incorporated in the DRP.
  • Discuss how collaborations among funded CAPT-CEPs may be utilized to capitalize on resources, expertise, application of new approaches in phage therapy research.
  • Describe how the impact of supported activities from the DRP will be evaluated over the life of the CAPT-CEP.
  • Describe how the DRP awards will benefit recipients to advance their careers, including trainees, early-stage investigators, or researchers new to this area of research.
  • Note: This section should only include information about the establishment and management of the DRP and should not include any DRP proposed research projects. 

Scientific Advisory Board (SAB): The SAB will be constituted after award from recommendations put forward from recipients in consultation with the NIAID Program Official. Describe the internal procedures that will be developed for responding to recommendations from the Scientific Advisory Board (SAB). Do not name, recruit, or contact potential SAB members until after the scientific review of the application.

Letters of Support:  Include letters of support, if applicable.

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Scientific Core (Optional)

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

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

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific 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) (Scientific 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 (Scientific 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.

Budget (Scientific Core)

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

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)

Specific Aims:  List, in priority order, the broad overarching long-range objectives and goals of the proposed Scientific Core.

Research Strategy:

• State the Scientific Core's relevance to the CAPT-CEP goals and how it relates to the individual Research Projects or other Scientific Cores (if applicable) in the application. Indicate which Research Project(s) are supported by the Science Core.
• Describe the specific services offered by the Core, and how these services will be managed, directed, scheduled, coordinated, and prioritized to meet the needs of the CAPT-CEP.
• Describe the methods, procedures, and approaches this Science Core will use to address the needs of research to accomplish the specific aims. Specifically describe the unique facilities, specialized resources, and dedicated environments necessary to conduct the proposed project(s).
• Discuss how the Core Leader and other professional staff associated with this Core will bring the necessary skills and knowledge to conduct the required science.

Letters of Support:  Include letters of support, if applicable.   

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Scientific 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 How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Research Projects

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

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

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.

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 Research Project. Describe the hypothesis or hypotheses to be tested.

Research Strategy:

• Describe how the proposed research project will contribute to meeting the CAPT-CEP’s overall goals and indicate the Research Project's relevance to the primary theme of the overall application.
• Indicate how the project will rely on other components (e.g., Research Projects, Scientific Cores [if applicable]) of the CAPT-CEP in terms of leveraging specific resources, tools, analyses, or concepts.
• Describe the planned research including methods, procedures, analyses, and expected outcomes. Justify the rationale for selecting specific methods, procedures, and analyses, and discuss the potential difficulties and limitations of the proposed procedures with alternative approaches to achieve the end goal. Describe any new methodology and its advantage over existing methods.
• Describe the use of novel or cutting-edge technologies that may advance phage therapy research.
• Discuss how a multi-disciplinary team science approach, particularly with respect to the inclusion of scientific disciplines not normally part of this research area (e.g., pharmacology, glycobiology, immunology, synthetic biology, computational and in silico biology) will yield an outcome that can advance phage therapy research. 
• Describe the biological significance of the research project with respect to the development of efficacious phage therapeutics to combat ESKAPE pathogens.
• Discuss the potential impact of this research on the field of microbiology and infectious diseases.

Letters of Support:  Include letters of support, if applicable.   

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Research Project)

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 How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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 How to Apply - Application Guide.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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. 

See more tips for avoiding common errors.

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

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

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.

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: 

• How well does the application describe a single clearly defined and scientifically compelling program of research that supports the objective of the CAPT-CEP?
• To what degree does the CAPT-CEP focus on critical gaps to develop essential assays, tools, and models to conduct the necessary studies for developing effective and robust phage therapy against ESKAPE pathogens?

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: 

• To what extent does the application propose multi-disciplinary team science that incorporates scientific discipline(s) not typically associated with phage therapy research? 

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?

Specific to this NOFO:

• To what extent does the CAPT-CEP propose a unique and integrated strategy that incorporates current and emerging technologies, methodologies, concepts, or processes in developing assays, tools, and models to conduct essential studies to facilitate phage therapy development?

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 appropriate and adequate is the administrative and organizational structure of the CAPT-CEP to achieve the stated goals?
• How well do the individual Research Projects relate to the overall goals of the CAPT-CEP, resulting in a cohesive and synergistic whole?
• How effectively does the research approach address the specific challenges of advancing the development of assays, tools, and models for robust phage therapy?
• To what extent will the procedures related to collection, oversight, and inventory of data, tools, and resources generated by the CAPT-CEP investigators facilitate the exchange of data, information, tools, and resources among funded CAPT-CEPs?
• How well does the Management Plan describe the process and procedures related to scientific management and oversight for the integration of research across several unique multidisciplinary teams? Does the Management Plan adequately describe the process for problem identification and resolution, and promote a strong collaborative environment for the research undertaken by the CAPT-CEP?
• To what extent will the outcomes from the Development and Research Program (DRP) strengthen the impact of the CAPT-CEP contributing to the development of phage therapeutics?  How well does the DRP address the process and procedure for selection, prioritization, development, implementation, management, and oversight of future activities supported by the DRP?

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?

Specific to this NOFO:

• To what degree will the scientific environment at the participating institutions stimulate multi-disciplinary research collaborations?

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

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.

Scientific Core(s) (if applicable)

• To what degree are the stated Science Core services appropriate, justified, and relevant to the overall goals of the CAPT-CEP?
• To what degree is the plan for prioritization and efficient use of the Core services clearly articulated?
• To what extent are the Core Leader and planned professional staff associated with this Core well suited to conduct the proposed science?

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, Research Projects, Administrative Core, and Scientific Core(s) (if applicable)

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.
• Compliance with data stewardship and content dissemination within and among all CAPT-CEP recipients.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access 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

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

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

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

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.

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Not Applicable

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. 

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

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

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

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

Kyung Moon, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID) 
Telephone: 240-669-5515
Email: [email protected]

Soheyla Saadi, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID) 
Telephone: 240-669-5178
Email: [email protected] 

Dhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID) 
Telephone: 240-669-2966
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.