Tuberculosis Research Advancement Centers (TRACs) (P30 Clinical Trial Not Allowed) is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) - NIH. The TRACs program aims to develop the next generation of TB researchers and catalyze multidisciplinary and innovative TB science by providing expertise and resources to facilitate basic and clinical TB research.

RFA-AI-27-016: Tuberculosis Research Advancement Centers (TRACs) (P30 Clinical Trial Not Allowed) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title Tuberculosis Research Advancement Centers (TRACs) (P30 Clinical Trial Not Allowed) Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Notice of Funding Opportunity Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Notice of Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to support applications for the Tuberculosis (TB) Research Advancement Centers (TRACs) program. The goal of the TRACs is to develop the next generation of TB researchers and to catalyze multidisciplinary and innovative TB science by providing expertise and resources to facilitate basic and clinical TB research.

Funding Opportunity Goal(s) To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials.

To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas.

Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions 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.

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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Part 1. Overview Information 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 Tuberculosis (TB) remains the leading cause of death from infectious diseases, with 1. 25 million global deaths in 2023.

TB cases have surged in the United States to their highest in 10 years with around 10,347 cases reported in 2024. Thirteen million Americans have latent TB and are at risk of developing future disease. Recent outbreaks of TB (including drug-resistant TB) in the American South, Midwest, and Pacific Northwest further underscore the critical need for sustained support for TB research.

The Tuberculosis Research Advancement Centers (TRACs), established in 2022, aim to meet this critical need through its support for multidisciplinary research and mentorship for emerging investigators.

Developing the next generation of scientific leaders in TB research through mentoring, career development and funding support for New Investigators (NIs as defined by NIH) and those entering the TB field Fostering multidisciplinary collaboration across all aspects of TB research Providing support for resources, services and training for TB basic research Strengthening TB clinical research through training and providing access to clinical samples and/or data Providing scientific leadership and organizational structure dedicated to TB research To fulfill the needs of the program and achieve the Research Objectives outlined above, institutions will require a critical mass of both experienced investigators and NIs in the TB field.

Institutional commitment to providing necessary resources ( e. g . , space, equipment, matching funds) and support for the proposed TRAC is strongly encouraged.

Due to the rise in nontuberculous mycobacteria (NTM) infections in the United States (U.S.) in recent years, the TRACs may, in addition, support research on NTMs. TRAC Organizational Structure Each TRAC must include an Administrative Core and a Developmental Core. A minimum of two additional Cores must be included to ensure the success of the overall goal(s) of the TRACs.

Examples of possible additional types of Cores include, but are not limited to, any combination of Basic Science Core(s), Clinical Science Core(s) or other Specialty Core(s). Core activities must not overlap with each other, or the activities of the required Administrative and Developmental Cores. Administrative Core (required) The TRAC Administrative Core will oversee operations and provide scientific leadership.

It will coordinate communication and collaborations among all the other Cores within the same TRAC and partnering institutions, and with other TRACs; provide fiscal oversight, foster synergy and collaborations and monitor progress. The TRAC Administrative Core will coordinate with NIAID staff. Annual Meetings: The TRACs will convene annually with NIAID staff to review and discuss progress.

Developmental pilot project recipients may have the opportunity to present their scientific findings during the meeting. Additionally, individual TRACs may have yearly programmatic meetings. Developmental Core (required) The TRAC Developmental Core will provide short-term funding to support NIs and researchers entering the TB field.

It will fund projects for preliminary data, feasibility studies, high-risk/high-impact collaborations, dissemination of information and novel research approaches to produce high quality research. It will evaluate, prioritize, and manage pilot projects, all of which require prior NIAID approval before initiation. It may also offer training and mentoring programs to develop successful biomedical scientists in the field of TB.

Priority for short-term funding eligibility will be given to NIs and investigators entering the TB field. Any combination of two or more of the following types of Cores, each Core with non-overlapping activities: The Basic Science Core(s) will offer resources, services and training to support TB research beyond standard grant support.

This may include emerging technologies, laboratory services, disease models, Biosafety Level (BSL)-3 activities, and training in replication and reproducibility. High-demand standard services and access to existing institutional resources may be included with appropriate justification but should not replace commercially available options.

The Clinical Science Core(s) will support translational TB research by providing resources, services, and training not covered by standard grants. This may include study design, development of new protocols, regulatory support, access to clinical data or cohorts, and clinical research training. It may coordinate institutional services, if beneficial, but should not provide routine clinical care or create new cohorts.

Specialty Core(s) ( e.g. , Statistical, Bioinformatics, Omics Core(s)) may be proposed if they are unique and essential for advancing local TB research. These Core(s) may leverage existing institutional services if they benefit TRAC members, with strong justification required. Following award, an External Advisory Board (EAB) will be established by each TRAC to evaluate the TRAC’s scientific progress.

The EAB will meet at least annually and generate a report, a copy of which will be provided to NIAID. Note : Applicants should not contact, recruit, or name potential EAB members prior to award. For renewal applications, provide the names of current and former EAB members, but do not recruit or name new members in the application prior to award.

Expected Characteristics of all TRACs TRACs should aim to strengthen TB research by supporting activities beyond standard grant funding and complement existing institutional resources (e.g. stimulate and support collaborations through networking, provide specialized training, expertise or services that researchers cannot easily access, create shared resources such as data platforms, etc.).

Scientific and Fiscal Flexibility Each TRAC has the flexibility to reallocate resources and adjust Core activities as priorities shift. NIAID approval is required to add or remove Cores. Each TRAC is also encouraged to leverage existing institutional resources ( e.g. , shared facilities, human and financial resources, research tools), and foster collaborations with other programs to maximize efficiency.

Investigators may either: submit a single TRAC application from their home institution, they may collaborate with other investigators from other institutions (as a sub-award) to submit a TRAC application. Applications including the following studies will be considered non-responsive and will not be reviewed: Applications not specifically focused on addressing research relevant to Mycobacterium tuberculosis /TB and/or other NTMs.

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIAID intends to commit $4,000,000 in FY27 to fund up to 5 awards.

Application budgets are not expected to exceed $600,000 direct costs per year and should reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is five years.

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 Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov 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. All PD(s)/PI(s) must be registered with ORCID .

The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator) 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.

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 . 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 Only one application per institution (normally identified by having a unique entity identifier (UEI) number or NIH IPF number) is allowed. 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 ). No institution may submit, or participate in (as a sub-award), more than one TRAC application. 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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ) 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.

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Component Type for Submission 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: Administrative Core: required, 1 Developmental Core: required, 1 Cores (any combination of Basic Science Core(s), Clinical Science Core(s), and/or Specialty Core(s)): required, minimum 2, no maximum 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) 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, with the following additional instructions: Facilities and Other Resources: Include information related to the Institution’s commitment to the proposed TRAC.

Examples of the types of institutional commitment include, but are not limited to, level of institutional funding for the proposed TRAC, space allocation, faculty commitments, salary for TRAC Core staff, and purchase of equipment.

Project/Performance Site Locations (Overall) 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.

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: Describe the specific aims of the overall TRAC and outline how the different Cores will contribute to these aims. Describe how TRAC provides added value and strengthens the institution’s NIH-funded TB research. If the institution(s) already has/have an existing center dedicated to TB research, describe how the TRAC will complement the efforts of the existing TB center, if applicable.

Summarize the current TB research within the proposed TRAC and justify the need for TRAC support. Justify the need for a TRAC by describing the categories and numbers of researchers or individuals who will benefit from, and utilize, TRAC services. Provide a leadership plan for the TRAC, including rationale for general management and scientific planning and how decisions will be made within the leadership team.

If needed, include a TRAC organizational chart. For applicants proposing collaborations across institutions within a single application, address the following items: Describe the necessity for establishing collaborations among multiple investigators at each proposed institution.

Provide shared leadership and communication strategies as well as plans to overcome potential administrative, scientific and management challenges across the institution(s), including across geographical distances. If applicable, provide evidence that an existing TRAC has been productive in increasing TB research at all participating institutions.

Describe the scientific expertise required for the EAB members, and how the TRAC will benefit from the EAB input. NOTE: Applicants should not contact, recruit, or name potential EAB members prior to award. For renewal applications, provide the names of current and former EAB members, but do not recruit or name new members in the application prior to award.

Letters of Support: If financial and other resource support for the TRAC will be provided by the applicant institution(s) ( e . g . , institutional matching funds), provide a letter(s) from the appropriate institutional official(s).

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide . All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data.

Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed.

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

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.

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: 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. 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.

Budgets may include central administration and fiscal management of the TRAC. Include travel funds for TRAC PD(s)/PI(s) and key personnel to attend the annual face-to-face TRACs meeting organized by NIAID (2 days per annual meeting in the Rockville, Maryland area), as well as the Center’s Annual Meeting.

PHS 398 Research Plan (Administrative Core) Specific Aims: Describe the role of the Administrative Core in the TRAC and how its work supports the TRAC’s overall goals and mission. Research Strategy: Describe how the Administrative Core will manage the TRAC’s organization, budget planning, resource allocation, and provide scientific leadership.

Describe how it will coordinate communication between TRAC Cores, partnering institutions, and NIAID staff. Describe how it will monitor TRAC activities, progress of the program, and how it will encourage collaborations. Provide criteria and processes for increasing, decreasing or maintaining resources/funding of the Cores, and the criteria and procedure for adding or deleting Cores.

Describe plans for soliciting ideas for TRAC-sponsored conferences, seminars, workshops, and other activities. Describe plans for expanding the membership of the TRAC and increasing the number of NIH funded TB researchers at the TRAC. Provide a plan for evaluating progress and utilization of Cores, including processes on how feedback will be collected from TB researchers on how well the Cores support their work.

Describe how researchers will be informed about available services and how they can request support. Describe how communication will be handled within a TRAC, among TRACs, and with NIAID staff. Describe how the Administrative Core will collaborate with other TRAC Cores to promote teamwork, efficiency and synergy.

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 . All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Do not include a Data Management and Sharing (DMS) Plan within this Component.

If a DMS Plan is required for this NOFO, it must be included within the Overall Component. 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.

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

’ All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. SF424 (R&R) Cover (Developmental Core) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Developmental Core) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental 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) (Developmental 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 (Developmental 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 (Developmental 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. Include funds to support developmental pilot projects aimed at stimulating TB research and supporting TB investigators.

Priority should be given to NIs or any researchers entering the TB field. Salary support can be requested. Budgets may