Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



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

Background

Tuberculosis (TB) is one of the leading infectious disease causes of mortality in the world. The World Health Organization (WHO) estimates that 10.6 million people became ill with TB and 1.3 million died of TB disease in 2022. There is a large global gap between the estimated number of people who fell ill with TB and the number of people newly diagnosed, with approximately 3.1 million people not diagnosed with the disease, or not officially reported to national authorities in 2022. Multi-drug and extensively drug-resistant TB (MDR-TB and XDR-TB) pose a growing threat. Early diagnosis of TB and universal drug-susceptibility testing (DST) are critical to identifying the most appropriate treatment for individual patients and to preventing the spread of disease.  Despite major advances in recent years, critical diagnostic needs are still unmet. There remains an urgent need for true point of care (POC) diagnostics, including rapid DST in decentralized settings, targeted pediatric diagnostics that include non-sputum-based diagnosis/technologies, and technologies to improve the diagnosis of TB among people in living with HIV (PLWH), including disseminated and paucibacillary TB.

Research Objectives

The purpose of this notice of funding opportunity (NOFO) is to support proof-of principle studies to evaluate novel, early-stage TB diagnostic tests assays and strategies, validate biomarkers, and provide feedback to diagnostic developers and policy makers on the performance of the technology and potential strategies for use in endemic settings. For the purpose of this NOFO, an "early-stage" diagnostic refers to a diagnostic that has advanced to the stage where a prototype is ready and available to be evaluated but is not currently used in clinical care and treatment decisions for TB.  Funding under this NOFO will establish a partnership of investigators and existing clinical study sites in TB endemic countries, coordinated and led by a leadership team. Clinical sites are encouraged to provide access to both adult and pediatric study populations with drug susceptible and drug resistant TB, including HIV-negative and PLWH. Additionally, applicants are encouraged to include sites that can demonstrate access to study populations with other common co-morbidities, such as type II diabetes.

Attaining the goals of the NOFO will require coordination with local and national TB programs and a demonstrated capacity to perform state-of-the-art diagnostic capabilities for TB including smear, culture, and approved molecular tests to allow comparison of new diagnostics to the standard of care in these settings.

Applicants must include one or more early-stage diagnostics ready for initial testing in the first year of performance (this should begin at the initiation of the project) and have detailed plans to evaluate additional diagnostics in subsequent years. Plans are anticipated to include mechanisms to identify and solicit novel diagnostics for testing and provide for requests from third party developers. Of particular interest are applications addressing:

• POC or near to care tests;
• diagnostics for use in underserved populations, including children and persons with disseminated and/or paucibacillary TB disease and PLWH;
• product candidates that identify TB using specimens other than sputum (e.g., blood, serum, urine, stool, breath, swabs) allowing identification of paucibacillary or extrapulmonary TB in adult and pediatric patients;
• diagnostics that may overcome limitations such as cost and infrastructure associated with current molecular diagnostic approaches;
• diagnostics that provide expanded rapid DST, including at the POC;
• studies to evaluate the performance of diagnostics or host biomarkers in PLWH and people who are not living with HIV and
• diagnostics that distinguish between vaccinated individuals and those who are infected with TB.

Diagnostics may be targeted to any type of TB disease, including identification of asymptomatic or subclinical disease, disseminated extra-pulmonary disease and paucibacillary disease. Also of interest is the evaluation of novel diagnostic strategies for TB in the context of existing clinical algorithms in TB endemic countries.

Applicants may consider conducting limited laboratory assessments of a diagnostic prototype(s) to ensure performance and feasibility for a clinical evaluation.

Information from experimental diagnostics may not be used to inform treatment decisions. Clinical trials are not allowed.

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

• Applications that propose establishment of new clinical infrastructure.
• Applications that propose to establish a public biorepository (i.e., a repository to maintain and distribute samples to requesting parties). Samples may be stored and used in studies addressing the goals of this NOFO by the study team.
• Applications that propose the development of a new diagnostic prototype.
• Applications that propose to conduct a clinical trial.

Program Infrastructure and Support

Administration and Leadership Team

The members of the Administration and Leadership Team, led by the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)), will be responsible for organizing, coordinating, and providing oversight for the implementation of studies to evaluate TB diagnostics.  This team will provide administrative oversight, coordinate the entire study, and serve to connect technology holders with clinicians in TB endemic countries to ensure diagnostic developers understand the needs of the primary users and patients.

Clinical Study Sites

The Clinical Study Site(s) should have established clinical facilities and laboratories capable of conducting clinical research studies to evaluate new TB diagnostics. It is expected that sites will have established relationships with local clinicians familiar with the current clinical algorithms for the diagnosis of TB. The Clinical Study Sites should include the facilities and personnel required to carry out study-specific laboratory testing in accordance with Good Clinical Laboratory Practice (GCLP) guidelines, storage of patient samples under appropriate conditions, as well as the ability to diagnose TB according to the current standard of care.

Clinical Study Sites must include at least one foreign clinical study site located in a TB-endemic country (as identified by the WHO annual Global Report, updated yearly). The program is expected to be flexible and to incorporate new clinical sites as needed to conduct the most effective studies.

Clinical Support Team

The members of the Clinical Support Team will be responsible for coordinating the functions at individual enrollment sites to facilitate multiple study procedures related to recruitment, enrollment, data and biological sample collection.

Data Stewardship and Analysis Team

The members of the Data Stewardship and Analysis Team will be responsible for developing and implementing procedures for the collection, oversight, and inventory of data and biological samples generated by the recipient, including, for example, harmonization, quality control, and uniformity of data collection processes, troubleshooting data system problems and developing solutions. Team members will also work with key personnel to provide statistical support for the study design and data analyses for the study. This team will be responsible for sharing data and information generated by the recipient and exchanged among recipient(s), as well as providing expertise on study design planning and data analysis. This exchange of information generated under the award and among the recipient(s) is intended to support efforts to further the goals of the FEND for TB program. Additionally, and separate from the Data Stewardship and Analysis Team, recipients are required to adhere to all applicable sharing policies.

External Advisory Committee (EAC) 

An EAC will be established by the PI(s))/PD(s) in consultation with the NIAID Program Officer for each project to review progress and share recommendations with NIAID as part of the annual programmatic meeting. The EAC will also make recommendations regarding the continuation or re-direction of the research program on an ongoing basis and in consultation with NIAID staff. The EAC will be established after award.

EAC members should not be contacted until the completion of all review activities.

Annual Programmatic Meetings

A kick-off meeting and annual program meetings will be held to articulate and establish the major roles and functions of the program and to facilitate collaborations, provide progress reporting, seek new research directions and ideas, and update NIAID on issues of need.  These meetings should be attended by the PD(s)/PI(s), key personnel, NIAID staff, and the EAC membership and will include all projects funded under this NOFO. These meetings will also allow coordination between multiple projects funded under this NOFO. Individual projects may also have an annual meeting limited to their project personnel with access offered to NIAID Program.

Quarterly Virtual Programmatic Meetings

It is anticipated multiple projects may be funded under this NOFO, which will require coordination and collaboration. Projects should participate in virtual quarterly meetings to discuss on-going and future activities to allow coordination between the funded centers and avoid duplication of efforts. These meetings will be attended by personnel designated by each project and can include the PD(s)/PI(s) as needed.

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

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

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

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. 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:

Patricia A. Gonzales Hurtado, Ph.D.
Telephone: 240-627-3556
Email: patricia.gonzales@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed, with the following additional instructions:

For this specific NOFO the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

• Applicants must include in the budget funds for the PD(s)/PI(s), other key personnel, and the members of the EAC to attend an annual in-person meeting in Rockville, Maryland. Applicants may also request funds for EAC members and key personal to travel for a project specific annual meeting at a location specific to the project needs.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed research, and indicate how these goals will be accomplished using the proposed structure and available clinical research sites.  Concisely describe the hypothesis or hypotheses to be tested. Indicate how the work proposed dovetails to address the overall goals and objectives of the research.

Research Strategy:

• Identify and clearly describe one or more novel, early-stage diagnostic test(s) that will be studied in the first year of performance, including a description of how these test(s) are novel and appropriate for a clinical evaluation.
• Provide a plan as to how additional diagnostics will be identified from third party diagnostic developers for testing during the later years of the grant period, including a process to submit a request for evaluation of an early-stage diagnostic, and the criteria and process by which these requests will be prioritized for testing by clinical sites.
• Describe how additional diagnostics studies will be developed and implemented for these future studies with these newly identified diagnostics.
• Discuss how the proposed initial study(ies) will be conducted to evaluate novel diagnostic tests and strategies, and how feedback will be provided to diagnostic developers on the performance of the technology(ies).
• Describe a strategy for how to use the diagnostics identified for the initial evaluation in an endemic setting and discuss the potential for novel diagnostics to improve the care cascade for both drug resistant and drug susceptible TB.
• Describe the current TB diagnostic capabilities and technologies at the clinical sites to be used as a benchmark for comparison including smear, culture and molecular methods.

In separate sections, using the suggested titles below, include the following:

Administration and Leadership Team Plan

• Describe the administrative and organizational structure of the research study team and the unique features of the organizational structure that serve to facilitate accomplishment of the long-range goals and objectives. Describe the overall management plan, including how resources will be managed, organized, and prioritized, and how subcontracts and consultants, if applicable, will be selected/funded and monitored. Describe how communications will be planned, implemented, and provided to collaborators, teams, or sites.
• Describe strategies for oversight and implementation of standardized approaches to ensure efficient cooperation, communication and coordination across the multiple sites and team structure.
• Describe how protocol specific training, including training on the use of novel diagnostic technologies for clinical staff will be determined and provided.
• Provide plans for communicating and coordinating with the clinical research sites and affiliated laboratories. Discuss plans to both ensure synergy among the clinical research sites and a flexible structure capable of responding to new scientific opportunities.
• Provide plans for coordinating and communicating with other diagnostic programs funded as part of this NOFO, including designating a representative to participate in quarterly calls for program coordination.
• Describe the experience of the investigative team (without duplicating information in the biosketches) in designing and developing protocols for human TB clinical studies, including the statistical design and analysis of TB clinical studies particularly for TB diagnostic studies and multi-national collaborative studies involving foreign sites in resource limited countries.
• Describe any existing relationships with the local TB control programs or ministry of health associated with the proposed clinical sites, including any established collaborations and provide proposed collaboration plans. Highlight collaborations with, plans for and process when coordinating with local and in country TB experts. Do not name or contact potential collaborators that are not already key personnel in the application.
• Describe the knowledge of TB diagnosis and diagnostic algorithms for the investigative team and their ability to serve as a resource to the TB community.

Solicitation, Review and Prioritization of Proposals for Future Diagnostic Studies Plan

• Describe the plan for how new technologies will be identified for future clinical diagnostic studies.
• Describe the process that will be utilized to review and prioritize proposals for clinical evaluation studies.
• Describe how decisions will be made on where clinical evaluations will be conducted and how the TB diagnostic priorities in research sites are suitable for the proposed studies.

Clinical Study Sites Plan

• Discuss general plans to include clinical study site(s) with established clinical facilities and laboratories capable of conducting clinical studies to evaluate new TB diagnostics, as well as established, collaborative relationships with local clinicians familiar with the current clinical algorithms for the diagnosis of TB.
• Describe the overall approach and strategies for the Clinical Research Site Selection and Management activities to include:
  • conducting feasibility assessments, including how site capacity, capabilities, and needs will be assessed;
  • soliciting, reviewing, and selecting clinical research sites;
  • safety oversight for study participants and compliance with all safety guidelines and regulations at all clinical research sites;
  • receiving, labeling, storing, and tracking study products and for monitoring storage conditions, and inventory control; and
  • classification, labeling, documentation, shipping, and tracking of clinical specimens.
• Discuss general plans for access to adequate numbers of relevant patient populations to ensure the prompt screening, enrollment, and completion of clinical studies. Include overall plans to ensure access to adult and pediatric patient populations: TB patients with drug susceptible and/or drug resistant disease; adult and pediatric subjects presenting with TB related co-infections and co-morbid conditions, such as HIV/AIDS or Type II diabetes; underserved populations including children and persons with disseminated and/or paucibacillary TB disease and controls; and subjects who have received childhood vaccination with BCG.

Clinical Support Team Plan

• Without repeating information from individual biosketches, describe the team's experience with developing and testing diagnostics and past relevant accomplishments. Include staffing plans with diagrams and charts as needed.

Data Stewardship and Analysis Plan

Applicants should address the range of data stewardship and analysis activities related to data and information generated by and exchanged within the recipient(s). Specifically:

• The overall plan and approach for biostatistical support systems; for example: 1) preliminary data analyses, 2) estimates of power and sample size, 3) research study design and protocol development.  Describe plans to estimate and achieve adequate sample size to achieve the needs of the research program. Describe the plan to support the data analytics and design features unique to the research study.
• Internal data acquisition strategies to achieve harmonization of systems and procedures for data management, data quality, data analyses, and dissemination within the project network for data and data-related materials generated by the research studies.
• Within the plan, indicate the extent to which dedicated systems or procedures will be utilized to harmonize the acquisition, curation, management, inventory and storage of data and samples.  Describe how training for the data and sample collection, in terms of the use of electronic data capture systems, will be provided to all staff including those at enrollment sites.
• The quality control procedures for the data and biological specimens and how to identify and resolve issues with quality control that maintains integrity of data and specimens.

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

External Advisory Committee (EAC) Plans

• Describe an overall plan for nominating, vetting, and inviting membership on the EAC and for including the EAC recommendations in the overall research direction and progress towards milestones of the award. The EAC will be developed in consultation with NIAID after an award is made.
• Note that applicants should not name potential EAC members in their application or contact potential members prior to completion of all review activities.

Project Milestones and Timelines

• Describe specific quantifiable milestones by annum and include annual projections for the overall research study and for tracking progress from individual sites, collaborators, and Teams. Milestones must specify the outcome(s) for each activity. Milestones should be quantifiable and scientifically justified and include the completion of major research study activities. Milestone criteria should not simply be a restatement of the specific aims. Using a Gantt chart or equivalent tool, describe the associated timelines and identified outcomes for the research study.

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

Letters of Support: Provide a letter signed by the appropriate institutional official(s) from the applicant institution documenting specifics of institutional commitment for the duration of the award.

• Provide letters of support from people named as Key Personnel or whose support is necessary for the successful conduct of the scope of research.
• Provide a letter of support, if needed, to demonstrate access and permission to utilize any proprietary diagnostics in the research plan.
• Provide a letter from the applicant organization(s) in support of efficient and effective processes for the negotiation and execution of subcontracts and other legal agreements.

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

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

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Organizations

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

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

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

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

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 Institute of 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 management and sharing policies.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: 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:

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

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: 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

Karen Lacourciere, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3297
Email: lacourcierek@niaid.nih.gov 

Patricia A. Gonzales Hurtado, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3556
Email: patricia.gonzales@nih.gov   

Vandhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: khruanav@mail.nih.gov 

Section VIII. Other Information

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

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