Tuberculosis Research Units (TBRUs)

Tuberculosis Research Units (TBRUs) is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-AI-25-027: Tuberculosis Research Units (P01 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. 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 Units (P01 Clinical Trial Optional) P01 Research Program Projects April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See 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 the establishment of multidisciplinary Tuberculosis (TB) Research Units (TBRUs) that will operate as a collaborative network to improve understanding of Mycobacterium tuberculosis (Mtb)-host interactions through characterizing the roles of bacterial and host heterogeneity on infection outcomes and disease progression, and defining bacterial and host determinants relevant to Mtb establishment, dissemination, and disease stage.

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) Letter of Intent Due Date(s) 30 days prior to application due 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. 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 The purpose of this notice of funding opportunity (NOFO) is to support the establishment of multidisciplinary Tuberculosis (TB) Research Units (TBRUs) that will operate as a collaborative network to improve understanding of Mycobacterium tuberculosis (Mtb)-host interactions through characterizing the roles of bacterial and host heterogeneity on infection outcomes and disease progression and defining bacterial and host determinants relevant to Mtb establishment, dissemination, and disease stage.

TB is the leading cause of death from an infectious disease, having killed 1. 25 million individuals in 2023. TB incidence rates in the United States are currently the highest in over a decade, with ~9,600 US TB cases in 2023 (a 15 percent increase over 2022 case numbers), including ~340 pediatric cases.

An estimated 13 million Americans live with latent TB and have a lifelong risk of developing TB disease, as triggered by poor nutrition, diabetes, aging, and immunosuppressive medications. Recent outbreaks of TB (including drug-resistant TB) in the American South, Midwest, and Pacific Northwest further highlight the need for continuing investments in understanding the factors that allow this chronic disease to persist and spread.

TB is caused by aerogenic transmission of the pathogen Mycobacterium tuberculosis (Mtb), which primarily infects the lung but can disseminate to extrapulmonary tissues.

Improved socioeconomic conditions, public health practices, and the use of effective drug treatment have reduced TB exposure and disease rates; however, global TB incidence remains stubbornly high, and—given the ubiquity of international travel—the persistence of drug resistant Mtb strains anywhere threatens every country’s ability to control TB, including the US. Globally, an estimated 400,000 new TB cases were drug resistant.

The HIV pandemic has further hampered TB control efforts, as people living with HIV are more likely to develop active TB and to relapse following chemotherapy, relative to those living without HIV. For these reasons, it is important to continue research into understanding the bacterial and host determinants that affect TB infection and disease progression in people living with and without HIV.

Heterogeneity at both pathogen and host levels influence the outcome of Mtb infection and progression to disease. At the pathogen level, there are differences in strain or lineage fitness, virulence, drug resistance, cell wall composition, ability to disseminate, and survive within an aerosol.

At the host level, there are differences in risk of infection and progression to disease, as influenced by lung function, immune profile, HIV status, and numerous comorbidities. Historically, TB had been categorized as either “active” or “latent” based on the presence or absence of symptoms, respectively, with active TB considered infectious and latent TB considered non-infectious.

A growing body of literature suggests, however, that TB is not bimodal but includes one or more “subclinical” states which may be infectious, analogous to other respiratory pathogens which can cause asymptomatic infections yet remain contagious (e.g., Streptococcus pneumoniae). Very little is known regarding the pathophysiology of subclinical TB.

Although we cannot control pathogen or host heterogeneity, by understanding their breadth and contributions to infection outcomes we can apply this knowledge to improve TB diagnostics, management, and treatment for greater numbers of people living with and without HIV.

Each TBRU will be established as part of a multi-disciplinary network of investigators and institutions with expertise in basic, pre-clinical and clinical research disciplines.

Each TBRU will be overseen by a Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) who will coordinate and oversee its multidisciplinary research and ensure that the individual research projects synergize to advance the goals of this NOFO to characterize bacterial and host determinants that are relevant during stages of infection, disease, and transmission, as well as the impact of bacterial and host heterogeneity on disease outcomes.

Investigators are encouraged to develop pathogen specific tools and incorporate emerging technologies. To facilitate the understanding of the spectrum of TB infection and disease and enable the translation of research findings into clinical applications, each TBRU must include a minimum of two interdependent Research Projects that include animal research studies and clinical research studies.

This combination may help facilitate the development of more predictive, targeted, and interpretable animal models through back-translation of clinical findings. NIH-supported science should be replicable, reproducible and generalizable.

Examples of potential research areas include, but are not limited to: Pathophysiology and in-depth analysis of subclinical (asymptomatic) TB Understanding Mtb-host interactions and the effect of mycobacterial and host heterogeneity (individual and population levels) on TB outcome Metabolic adaptations of Mtb inside the host (persistence, resistance) Development of animal models that reflect human pathogenesis and development of applicable ex vivo systems to reduce the use of animals in research The role of comorbidities and/or coinfections on TB and treatment outcomes Studies to better understand the role of HIV on TB disease progression Applications proposing the following topics will be considered non-responsive and will not be reviewed: Applications that do not include both clinical and animal research studies Immune correlates of protection studies and analysis of immune responses to vaccine candidates Impact of substance abuse (e.g. opioids, cannabinoids, cocaine, methamphetamines, and alcohol) on TB transmission, progression and disease Research with a primary focus on epidemiologic studies Psychosocial or behavioral research Please note that it is expected that some animal models that are developed by the TBRUs will be suitable for product development and evaluation.

NIAID may request transfer of the protocols for these animal models to the NIAID Division of Microbiology and Infectious Diseases (DMID) preclinical services programs to be made available as a service to the community. Each TBRU must include an Administrative Core which is responsible for managing, coordinating, and supervising all TBRU activities.

The Administrative Core should include a Management Plan that will guide its operations and describe how data will be shared internally between projects and cores during the award. At least one Scientific Core is required as a resource for the entire TBRU, but up to four Scientific Cores are allowed if scientifically justified. Each shared Scientific Core must be utilized by two or more Research Projects within the TBRU.

Research activities should only be conducted in the Research Projects; Scientific Cores perform services and tasks, not research activities. Examples of services provided include, but are not limited to reagent production, specialized services (e.g. assays, “omics”, imaging, statistics, bioinformatics), animal core, or a clinically focused core.

Research Projects Each TRBU must include a minimum of two (maximum of four) interdependent Research Projects to meet the NOFO’s key goals of supporting cross disciplinary TB research engaging both clinical and animal model researchers. At least one Research Project must involve animal model studies, and at least one Research Project must involve clinical studies.

Alternatively, this requirement can also be met by proposing Research Projects that include both animal model studies and clinical studies, provided they are related through a common research hypothesis. For the purposes of this NOFO, clinical studies are defined as research using new or stored material and/or data of human origin (e.g. tissues, specimens, sequences, physiological measures) that are relevant to the research hypothesis.

If a clinical site(s) is part of either a Research Project or a Scientific Core, it must be present in a community where TB is prevalent or where TB is treated, and have an established infrastructure, including experienced local investigators capable of conducting human studies that meet US regulatory requirements for the protection of human subjects, adequate laboratory facilities and personnel to perform protocol-specific tests, access to patient populations that are suitable to study bacterial and host factors, as well as their relation to TB disease presentation and HIV status.

Research Projects may propose using experimental or licensed drugs and interventions to establish or test hypotheses. External Scientific Advisory Group (ESAG) : Each TBRU is strongly encouraged to form an ESAG, at the discretion of the PD(s)/PI(s), after award to evaluate and advise the PD(s)/PI(s) on scientific progress. Applicants should not name, recruit or contact potential ESAG members prior to award.

Programmatic Meetings : The PD/PI will organize an annual 1 to 2-day internal TBRU meeting at the PD/PI’s institution and will extend an invitation to the NIAID Program Official. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. 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 Renewal - Renewals of RFA-AI-20-020 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. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIAID intends to commit $10 million in FY 2026 to fund 4-5 awards. Application budgets are not expected to exceed $1.

5 million direct costs per year and should reflect the actual needs of the 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign Organizations/ International Collaborations NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors. 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 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.

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 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.

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: Center for Scientific 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 Scientific Core(s): required, minimum 1, maximum 4, each Core must support at least two Research Projects Research Projects: required, minimum 2, maximum 4 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.

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: List in priority order, the broad, overarching, long-range objectives and goals of the proposed TBRU. Concisely describe the hypothesis or hypotheses to be tested. Research Strategy: This section summarizes the overall research strategy for the proposed TBRU.

A multi-component, multidisciplinary application should be viewed as a confederation of interrelated Research Projects and Cores, each capable of standing on its own scientific merit, but complementary to one another. This is an important section and should provide the conceptual rationale of the TBRU and lay out a broad strategy for accomplishing the stated goals.

Summarize the overarching theme of the proposed TBRU, the significance of the theme in addressing research areas important for combating TB, the scientific challenges and opportunities being addressed, and the benefit of a successful effort.

Describe how the proposed TBRU incorporates a multidisciplinary yet interconnected set of research activities to achieve the TBRU goals and provide a compelling argument for the team-research approach. Describe how the individual Research Projects and Scientific Core(s) relate to the overall goals of the TBRU and form a cohesive, synergistic whole that is more beneficial than pursuing each project independently.

We encourage including a visual/graphic representation of the interactions between the various Research Projects and Scientific Core(s) and their place in the overall TBRU delineating the collaborative and synergistic potential of the proposed TBRU.

Without duplicating information in the Senior/Key Person Profile section, describe how the scientific and technical expertise of the research team and organization will interact to effectively design and conduct the proposed activities. Letters of Support: Include letters of support, if applicable.

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: 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. 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.

For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Lead. For institutions/organizations proposing multiple PD(s)/PI(s), the Contact PD/PI must serve as the Administrative Core Lead. Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package.

Include necessary expenses for the planning, implementation, and administration of the Data Management and Sharing Plan (DMSP). Include travel funds for the PD(s)/PI(s), Research Project Leaders and Core Leaders to attend the Kick-Off meeting, to be held within 6 months of award, in the Rockville, MD area (one and a half day meeting).

Include travel funds for the PD(s)/PI(s), Research Project Leaders, Core Leaders, and presenters (at the discretion of the PD/PI) to attend Annual Programmatic meetings, to be held annually beginning in Year 2, in the Rockville, MD area or in the location of one of the TBRUs (one and a half day meeting). Funds may be included in support travel for early-stage investigators to attend the Annual Programmatic meetings.

If appropriate, include travel funds for the External Scientific Advisory Group (ESAG) to attend the TBRU’s annual internal programmatic meeting. 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 Administrative Core. In addition, state the Core’s relationship to the TBRU's goals and how it relates to individual Research Projects or Scientific Core(s) 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 all TBRU activities. Providing a supportive structure sufficient to ensure the accomplishment of all research goals, administrative support, fiscal and project management, implementation and oversight of subawards.

Promoting collaboration and coordination among Research Project and Core Leaders. Promoting communication with other TBRUs regarding potential collaboration. Communicating and interacting with the NIAID Program Officer, or other staff.

Management Plan : Provide a Management Plan that describes the organization of the proposed TBRU and its management structure and how data will be shared internally between projects and cores. The Management Plan sections should be clearly indicated in the application.

The Management Plan should include: A description of the organizational structure and roles of administrative staff, including the functions to be performed; how fiscal and other resources will be prioritized, allocated and managed; and how communications will be facilitated.

An overview of how the Research Projects and Scientific Core(s) will be integrated and managed to form a cohesive, collaborative environment to answer the scientific questions and hypotheses proposed in the application. Plans for tracking of Research Project and Scientific Core progress, problem identification and resolution. Plans for sharing data internally between Research Projects and Cores.

External Scientific Advisory Group (ESAG): Each TBRU