It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

Globally, Tuberculosis (TB) is a leading cause of death by an infectious disease. The World Health Organization (WHO) estimates that 10 million people became sick with TB in 2019, and 1.4 million people died of TB disease. Around one-quarter of the world’s population have latent TB and the United States (US) Centers for Disease Control and Prevention (CDC) estimates that as many as 13 million latently infected individuals reside in the US. To address this global pandemic, NIAID published the NIAID Strategic Plan for TB Research in 2018 which aligns with US government TB activities and is in support of The End TB Strategy published by the WHO. This NIAID Strategic Plan for TB includes a comprehensive research agenda to accelerate basic, translational, and clinical research to improve understanding of TB and expedite the development of innovative new tools and strategies for better diagnosis, prevention and treatment of TB.

To accomplish the ambitious research agenda laid out in the NIAID Strategic Plan for TB, it will be critical to recruit and mentor the next generation of TB investigators, attract investigators to the field of TB, and increase collaborative, multidisciplinary research efforts. The TB Research Advancement Centers (TRACs) will help accomplish this by:

• Providing scientific leadership and institutional infrastructure dedicated to TB research
• Fostering and enhancing multidisciplinary collaboration across all aspects of TB research
• Developing the next generation of scientific leaders in TB research through focused mentoring, career development and funding support for New Investigators ( NIs as defined by NIH) pursuing TB research and any investigator who wants to enter the TB research field.
• Providing shared research support for resources, services and training dedicated to TB
• Strengthening TB clinical research through international and/or domestic collaborations

To fulfill the needs of the program and achieve the Specific Objectives outlined, institutions will require a critical mass of both experienced TB investigators and NIs in the TB research field. Institutional commitment and support for the proposed TRAC is encouraged.

Added Value

TRACs are expected to add value to the applicant institution's TB research efforts by providing support for activities that cannot easily be obtained through standard research awards. The added value contribution that the proposed TRAC will make at the institution(s) should go beyond what TB resources, services and collaborations currently exist at the institution. TRACs should promote and encourage activities that enhance collaboration and coordination of TB research, build multidisciplinary research efforts and provide mentoring and support for the next generation of TB investigators.

Some examples of added value include evidence of:

• Increased collaborations, publications and multidisciplinary research especially among NIs pursing TB research and any investigators new to the field of TB
• Enhanced support of existing programs
• Mentorship of NIs pursuing TB research and facilitating their transition to independence
• Increased TB clinical research through international and/or domestic collaborations
• Increase in the number of NIH funded TB researchers supported by the TRAC
• Development and implementation of a cost recovery system for science cores

Scientific and Fiscal Flexibility

TRACs will use a strategic planning process to provide guidance and oversight of scientific and fiscal flexibility. TRACs are responsible for using their resources to meet the needs of their TB investigators and be inclusive of the full range of TB science funded at that institution(s). A TRAC has the authority to re-prioritize and re-allocate resources/funds according to TRAC operating policies and procedures proposed in the application, as long as these changes are within scope of the award s scientific priorities. TRACs can change the structure and funding of cores through additions or eliminations, as long as the minimum number of required cores are maintained; approval by NIAID staff is required when eliminating or adding a Core. TRACs may leverage other resources in support of TB research. TRAC Cores may be fully supported, or in part, by TRAC funds. Applicants are also encouraged to develop creative collaborations to improve utilization of existing resources.

The overall structure of the TRAC is designed to support TB researchers at the applicant institution in the conduct of their research projects, help mentor the next generation of TB investigators, attract new researchers to the TB field and create opportunities for collaborative, multidisciplinary research efforts. A TRAC must include an Administrative Core, a Developmental Core and a minimum of two Scientific Cores that can include any combination of Basic Science, Clinical Science or Additional Cores.

Administrative Core

The TRAC Administrative Core will be responsible for providing both administrative and scientific leadership for the center and will be responsible for coordinating communication between the TRAC components and between the TRAC and NIAID Program staff. The Administrative Core will manage, coordinate and oversee all the TRAC activities, monitor progress and ensure that the program milestones are being met and implemented effectively within the proposed timelines. The Administrative Core must provide both an organizational and administrative structure and optimize opportunities to promote multidisciplinary collaborations and interactions among the Cores.

Developmental Core

The TRAC Developmental Core will provide short-term funding to support NIs pursuing TB research and any investigator who wants to enter the TB research field. These projects may encompass research to obtain preliminary data for a NIH grant application, perform feasibility studies, support high risk/high impact multidisciplinary collaborative studies or explore novel approaches to TB research questions. The Developmental Core can also support NIs pursuing TB research and any investigators who want to enter the TB research field through specific mentoring programs designed to develop successful TB investigators. The Developmental Core will solicit, review, prioritize and manage the Core awards; all Developmental Core awards require prior approval by NIAID before award/initiation.

Basic Science Core(s)

The TRAC Basic Science Core(s) will provide resources, services and/or training to support basic TB research activities that cannot be easily funded through standard research projects. Examples include support for state-of-the-art emerging technologies, specialized scientific expertise and/or training, shared laboratory services and equipment, animal models and TB research activities in BSL-3 facilities. Standard services may be included if evidence can be provided that the services are in great demand and will be highly utilized based on the needs of TRAC members. The Core may coordinate access to services available at the institution(s), but strong justification should be provided on why this approach provides added value to TRAC members. A Basic Science Core should not substitute for resources that are obtainable commercially, or replace existing resources normally supported by individual research grants.

Clinical Science Core(s)

The TRAC Clinical Science Core(s) will provide resources, services and/or training to support translational TB research activities that cannot be easily funded through standard research projects and strengthen TB clinical research through international and/or domestic collaborations as applicable. Examples include services for investigators to develop appropriate study designs, study protocols, informed consents or other regulatory documents, access to clinical cohorts and training to enhance TB clinical research. The Core may coordinate access to services available at the institution(s), but strong justification should be provided on why this approach provides added value to TRAC members. Activities that will not be supported by a TRAC Clinical Science Core are standard patient care, including screening of clinical specimens, diagnosis, treatment, or rehabilitation, and establishment of new clinical cohorts.

Additional Core(s)

Additional Cores (E.g. Statistical Core) may be proposed if justified as necessary to advance the local TB research efforts. These Cores may be of a nature other than basic or clinical science. The Core may coordinate access to services available at the institution(s), but strong justification should be provided on why this approach provides added value to TRAC members.

Center Governance

An External Advisory Committee (EAC) should be formed in consultation with the NIAID after award, to evaluate and advise on scientific progress within the awarded center. The EAC will meet at least once a year to evaluate the progress of the TRAC. The EAC will make recommendations in writing, including changes if any that would benefit the program. A copy of the report should be provided to NIAID.

Non-Responsive Applications

Applications not specifically focused on providing resources, services, funding and/or training to address research relevant to Mycobacterium tuberculosis/TB will be considered non-responsive and will not be reviewed.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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)
• 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 Institutions) 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 allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• o 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

One TRAC award per institution

No institution may have more than one TRAC. An institution that is part of a multi-institutional TRAC award may not be listed as a multi-institutional participant in another TRAC award.

Multi-institutional TRAC

In some cases, two or more institutions that can demonstrate a credible plan for collaborative research networks using TRAC Cores may wish to submit an application for a single TRAC award. A multi-institutional TRAC application must designate a lead institution that will receive the award, should demonstrate sharing in leadership positions, and provide details of agreements regarding coordination and support of Cores and activities at other participating institutions. An institution can only be part of one multi-institutional TRAC application.

Cores outside of the TRAC institution

With appropriate justification, TRAC awards may support a Core at an institution that is not part of the TRAC, including a primate facility or a foreign institution that provides a unique resource such as a clinical and/or laboratory site.

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Yong Gao, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-669-5048
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	12 pages
Core (use for Developmental, Basic Science, Clinical Science, Additional)	12 pages each

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of one
• Developmental Core: required, maximum of one
• Core: required, minimum of two; any combination of Basic Science, Clinical Science and Additional Cores

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

Project Summary/Abstract: Applicants should clearly indicate in the abstract that the application is for a TRAC award.

Facilities and Other Resources: Information related to the Institution s commitment to the proposed TRAC should be included here. 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 Core staff, and purchase of equipment.

Other Attachments: Applicants must provide the following additional material specified below. The attachment should be uploaded as a separate PDF using the indicated filename.

TRAC Investigators at the institution(s): Must title this attachment All TRAC Researchers .

Applicants must include a table with names and expertise of all researchers who will participate in the TRAC. This includes experienced TB investigators, NIs in the TB field and investigators new to the field of TB.

Existing Core Facilities at the Institution Applying for a TRAC Award: Must title this attachment Other Core Facilities .

Provide a list of NIH-funded cores at the TRAC institution that would be considered as overlap or that the TRAC will leverage. Include information about the services offered.

Enter primary site only.

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

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

Specific Aims: Describe the specific aims of the overall TRAC and outline how the different Cores will contribute to these aims.

Research Strategy:

TRAC Purpose and Strategy:

• Succinctly summarize TB science at the institution(s) that justifies the need for TRAC support.
• Describe how the TRAC provides added value to NIH-funded TB research conducted at the institution(s). If the applicant institution has an existing TB center, describe how TRAC will synergize with this center.
• Describe the proposed Overall Research Strategy and the strategic planning process of the TRAC and how it will contribute to meeting the overarching goals and objectives. Specifically, define the impact that a TRAC could have on enhancing TB research at the applicant institution(s) and exerting a sustained influence on the TB research field.
• Describe overall rationale for selection of Basic Science, Clinical Science or Additional Cores and how it will meet the need to support new emerging science and strengthen capacity for TB clinical research through international and/or domestic collaborations as applicable.

TRAC Leadership:

Describe the leadership plan for the TRAC, including rationale for the leadership structure and how decisions are made within the leadership team. If needed include a TRAC organizational chart.

TRAC Management:

• Discuss and provide plans for the TRAC scientific planning and management process.
• Discuss planned strategies for fostering collaboration among TRAC investigators from divergent disciplines within the proposed TRAC.
• Describe overall planned strategies for developing the next generation of scientific leaders in TB research. Include plans to engage NIs pursuing TB research and any investigators who wants to enter the TB research field as well as investigators from underrepresented backgrounds, including those from groups that have been shown to be nationally underrepresented in health-related research.
• If applicable, provide plans for transportation of specimens, data and results among major locations, especially those located outside of the United States.
• Describe the scientific expertise required for the EAC members, and how the TRAC functions and success would benefit from the EAC input. NOTE: POTENTIAL EAC MEMBERS SHOULD NOT BE CONTACTED BEFORE THE REVIEW IS COMPLETED OR NAMED IN THE APPLICATION.

For applicants proposing a multi-institutional TRAC, please address the following:

• Demonstrate an exceptional need to establish collaboration among multiple investigators at each proposed institution.
• Provide plans to overcome potential scientific and management challenges associated with multi-institutional collaborations.
• Describe specific plans to address any anticipated budgetary challenges in the transfer of funds and resources among participating institutions.

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

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director 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 forms appropriate for the specific component will be included in the application package.

The Administrative Core budget may include equipment, supplies, support contracts, and other necessary expenses. Budget costs for administrative support must relate directly to the TRAC proposed work and be well justified; similarly, budget support of the TRAC Administrative Core Director must match the effort associated with the TRAC Administrative Core work. All items should be fully justified for allocation of TRAC funds within the Budget Justification.

Other administrative costs may include those necessary for the central administration and fiscal

management of the TRAC, including relevant and reasonable costs for reprints, graphics, and publications for Developmental Core users.

Applicants should include travel funds for the TRAC PD/PI(s), Administrative Core Director and Administrator/Program Manager (if included in the application) to attend the annual face-to-face TRACs Meeting organized by NIAID, to be held in the Bethesda/Rockville, MD area (2 days per annual meeting). Travel funds may also be requested for travel to the Center s Annual Meeting. This includes travel for members of the EAC as well as PD/PI and Core Directors for multi-institutional TRAC centers. Additional travel fund requests beyond attendance for the Annual TRACs Meeting and the Center’s Annual meeting must not exceed $20,000 (direct costs) annually. This includes funding for Core Directors to attend meetings that provide new information on technologies or approaches used within the Cores. Travel funds may not be used for travel to scientific meetings.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

Specific Aims: Describe the specific aims of the Administrative Core, and how the Core will coordinate and manage activities and monitor progress across the TRAC, provide scientific leadership and have an impact on the research infrastructure.

Research Strategy:

Purpose and Strategy:

• Describe the role of the Administrative Core in the TRAC as a whole and how the responsibilities of the Core advance the mission and purpose of the TRAC.
• Describe how the Administrative Core staff will ensure success of the primary functions of the Core, such as the overall TRAC program management, including budget and resource allocation and prioritization.
• Provide criteria and procedures for increasing, decreasing or maintaining resources/funding of these Cores, and the criteria and procedure for adding or deleting Cores during the course of the award.
• Describe the plans for soliciting ideas for TRAC-sponsored conferences, seminars, workshops, and other activities.
• Management:
• Provide a strategic plan for evaluating the progress and utilization of Cores including procedures for obtaining assessments from TB investigators about the Core’s ability to meet research needs.
• Provide a plan for how TB researchers will be informed of the Core services available and how
• the process for obtaining support will be articulated to the end user.
• Describe the communications plan for all TRAC activities to TRAC members and plans for communicating information between the Center and NIAID staff. For multi-institutional TRACs, provide a plan for communication between the institutions.

Provide a management and oversight plan for all Administrative Core functions and activities, including coordination and oversight of Human Subjects Protections and Animal Welfare Assurance for the TRAC.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director 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 forms appropriate for the specific component will be included in the application package.

The Developmental Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of TRAC funds within the Budget Justification. Any budget requested for support of the Developmental Core Director must match the effort associated with the Developmental Core work conducted by the Developmental Core Director. Applicants may request support for NI salary for scientific developmental projects.

Applicants may include travel funds to support NIs pursuing TB research or investigators new to the TB field, to attend a scientific meeting to present the results from their TRAC developmental project award. TRAC funds cannot be used to provide travel scholarships for investigators without a TRAC developmental project award.

Applicants should budget funds to support developmental project awards that support or stimulate TB

research. These funds may be used by NIs pursuing TB research or by any investigator who wants to enter the TB research field. Established TB investigators are not eligible for developmental project awards but can be included as collaborators. All awards must have prior approval from NIH Program Staff. Applicants may also use a portion of the funds to support NIs pursuing TB research and investigators who want to enter the TB research field, through specific mentoring programs.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

Specific Aims: Describe the specific aims of the Developmental Core and how the Core will enhance,

increase, improve or stimulate the TB research conducted at the institution(s) and how it will support the next generation of TB researchers.

Research Strategy:

Purpose and Strategy:

• Describe the role of the Developmental Core in the TRAC as a whole, and how the responsibilities of this Core advance the mission and purpose of the TRAC.
• Describe the extent to which the Developmental Core provides added value to NIH-funded TB research conducted at the institution(s).
• Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.
• Describe the policies and procedures for the proposed Developmental Core, including the strategic planning process and how the overall Core progress will be assessed.
• Describe the types of developmental awards that will be considered and how they will support new and emerging science in TB research and multidisciplinary collaborative studies.
• Describe the plans to support and mentor NIs pursuing TB research field and investigators who want to enter the TB research field. Include the activities that will be undertaken by the Core (including working with other TRAC Cores), to enhance their ability to secure independent funding for their research and transition to independence.

Management:

• Describe how applications will be solicited, reviewed, prioritized for funding, awarded, administered, and evaluated for progress and outcomes.
• Describe how the Developmental Core will monitor and ensure compliance of all developmental projects involving human or animal subjects, and obtain the appropriate approvals (i.e., IRB approvals, FWA, IACUC, human subjects research training, etc. in domestic and foreign institutions).

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director 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 forms appropriate for the specific component will be included in the application package.

The Basic Science Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of TRAC funds within the Budget Justification. Any budget requested for support of the Basic Science Director must match the effort associated with the management of the Basic Science Core. The TRAC may support technical staff to provide TRAC services in Core facilities.

If the Basic Science Core includes a site not at the Applicant Institution, travel funds may be requested for the Core Director and other users to travel to the site. Travel funds may not be used for travel to scientific meetings.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

Specific Aims: Describe the specific aims of the Basic Science Core and how the Core services provided will enhance, increase, improve or stimulate the TB research conducted at the institution(s) and meet the needs to support new emerging science.

Research Strategy:

Purpose and Strategy:

• Describe the role of the Basic Science Core within the TRAC as a whole, the number of investigators expected to use the Core service and how the responsibilities of this Core advance the mission and purpose of the TRAC.
• Describe the extent to which the Basic Science Core provides added value to NIH-funded TB research conducted at the institution(s).
• For Cores with partial TRAC funding, indicate the extent to which the Core overlaps with or leverages existing Cores funded by the NIH at your institution. Provide a justification for your Core, based on the extent of overlap.
• Indicate how NIs pursuing TB research and investigators who want to enter the TB research field will benefit from Core services.
• Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.
• Describe how the Core will develop and/or incorporate state of the art, innovative technologies and resources to advance basic science research in the TB field.
• Describe the plans of the Basic Science Core to foster synergy with other TRAC Cores and enhance TB research collaborations.
• Management:
• Provide a management plan. This should include, for example, day-to-day operations, scientific communications, training as needed and efforts to monitor quality control, procedures, and safety.
• Describe the policies and procedures for the proposed Basic Science Core. Include processes for prioritizing workload and Core usage with respect to evolving scientific priorities at the applicant institution, procedures for assessment of overall Core progress and the process for reallocating funds within the Core as needed.
• Discuss potential problems, alternative strategies and benchmarks for success.
• Describe procedures to solicit feedback from TB investigators about the Core’s ability to meet their research needs.
• Describe plans to develop processes for a cost recovery system for the applicable Cores, wherein costs associated with this service Core are recovered using a proposed fee to the end user.
• Describe how the Basic Science Core will monitor and ensure Core User compliance with Human Subjects Protections and/or Animal Welfare Assurance in the processing of human or animal tissues, samples or other research data obtained through multiple sources, including ongoing funded trials or research.
• Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director 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 forms appropriate for the specific component will be included in the application package.

The Clinical Science Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of TRAC funds within the Budget Justification. Any budget requested for support of the Clinical Science Director must match the effort associated with the management of the Clinical Science Core. The TRAC may support technical staff to provide TRAC services in Core facilities.

If the Clinical Science Core includes a clinical site not at the Applicant Institution, travel funds may be requested for the Core Director and other users to travel to the clinical site. Travel funds may not be used for travel to scientific meetings.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

Specific Aims: Describe the specific aims of the Clinical Science Core and how the Core services provided will enhance, increase, improve or stimulate the TB research conducted at the institution(s) and meet the needs to support new emerging science.

Research Strategy:

Purpose and Strategy:

• Describe the role of the Clinical Science Core within the TRAC as a whole, the number of investigators expected to use the Core service and how the responsibilities of this Core advance the mission and purpose of the TRAC.
• Describe the extent to which the Clinical Science Core provides added value to NIH-funded TB research conducted at the institution(s).
• For Cores with partial TRAC funding, indicate the extent to which the Core overlaps with or leverages existing Cores funded by the NIH at your institution. Provide a justification for your Core, based on the extent of overlap.
• Indicate how NIs pursuing the TB research field and investigators who want to enter the TB research field will benefit from Core services, including guidance or training in the development of protocols and regulatory documents for clinical research projects.
• Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.
• Describe the plans to strengthen TB clinical research through international and/or domestic collaborations as applicable.
• Describe the plans of the Clinical Science Core to foster synergy with other TRAC Cores and enhance TB research collaborations.

Management:

• Provide a management plan. This should include, for example, day-to-day operations, scientific communications, training as needed and efforts to monitor quality control, procedures, and safety.
• Describe the policies and procedures for the proposed Clinical Science Core. Include processes for prioritizing workload and Core usage with respect to evolving scientific priorities at the applicant institution, procedures for assessment of overall Core progress and the process for reallocating funds within the Core as needed.
• Discuss potential problems, alternative strategies and benchmarks for success.
• Describe procedures to solicit feedback from TB investigators about the Core’s ability to meet their research needs.
• Describe plans to develop processes for a cost recovery system for the applicable Cores, wherein costs associated with this service Core are recovered using a proposed fee to the end user.
• Describe how the Clinical Science Core will monitor and ensure Core User compliance with Human Subjects Protections in the processing of human tissues, samples or other research data obtained through multiple sources, including ongoing funded trials or research.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application, use Component Type Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director 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 forms appropriate for the specific component will be included in the application package.

The Core budget may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of TRAC funds within the Budget Justification. Any budget requested for support of the Clinical Science Director must match the effort associated with the management of the Additional Core. The TRAC may support technical staff to provide TRAC services in Core facilities.

If the Additional Core includes a site not at the Applicant Institution, travel funds may be requested for the Core Director and other users to travel to the site. Travel funds may not be used for travel to scientific meetings.

In the budget justification section, applicants may include any in-kind support the Core receives such as operating budgets provided by the institution, large gifts, dedicated space, direct support of infrastructure Core personnel, and dedicated equipment, including support for research infrastructure-related functions such as directing or managing the Core, and similar activities. This information may be presented in tabular form.

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.

Specific Aims: Describe the specific aims of the Core and how the Core services provided will enhance, increase, improve or stimulate the TB research conducted at the institution(s) and meet the needs to support new emerging science.

Research Strategy:

Purpose and Strategy:

• Describe the role of the Additional Core within the TRAC as a whole, the number of investigators expected to use the Core service and how the responsibilities of this Core advance the mission and purpose of the TRAC.
• Describe the extent to which the Core provides added value to NIH-funded TB research conducted at the institution(s).
• For Cores with partial TRAC funding, indicate the extent to which the Core overlaps with or leverages existing Cores funded by the NIH at your institution. Provide a justification for your Core, based on the extent of overlap.
• Indicate how NIs pursuing TB research field and investigators who want to enter the TB research field will benefit from Core services.
• Explain the general methods and approaches proposed to accomplish the specific aims, and the rationale for their selection.
• Describe the plans of the Additional Core to foster synergy with other TRAC Cores and enhance TB research collaborations.

Management:

• Provide a management plan. This should include, for example, day-to-day operations, scientific communications, training as needed and efforts to monitor quality control, procedures, and safety.
• Describe the policies and procedures for the proposed Additional Core. Include processes for prioritizing workload and Core usage with respect to evolving scientific priorities at the applicant institution, procedures for assessment of overall Core progress and the process for reallocating funds within the Core as needed.
• Discuss potential problems, alternative strategies and benchmarks for success.
• Describe procedures to solicit feedback from TB investigators about the Core’s ability to meet their research needs.
• Describe plans to develop processes for a cost recovery system for the applicable Cores, wherein costs associated with this service Core are recovered using a proposed fee to the end user.
• Describe how the Core will monitor and ensure Core User compliance with Human Subjects Protections and/or Animal Welfare Assurance in the processing of human or animal tissues, samples or other research data obtained through multiple sources, including ongoing funded trials or research.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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 SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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 TRAC 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 TRAC 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 TRAC that by its nature is not innovative may be essential to advance a field.

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

Specific for this FOA:

Does the applicant institution(s) have the necessary critical mass of TB investigators to warrant a TRAC? Do the TRAC structure and organization enhance proposed scientific collaboration, synergy, training efforts and mentoring? Does the proposed TRAC application provide plans to add value to the TB research community at the applicant institution(s) beyond what currently exists? For multi-institutional TRACs, are plans to address potential scientific and management challenges acceptable?

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

Specific for this FOA:

Does the proposed plan for TRAC leadership demonstrate sufficient scientific and managerial experience, leadership skills, and time commitment to achieve success of the Center?

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

Specific for this FOA:

Does the TRAC adequately describe innovative ways to integrate Cores and Core services, TB researchers and those wanting to enter the TB research field and advances in technology in order to achieve the scientific goals stated in the TRAC application? Will the TRAC strategic plans allow for changes in Core services that will meet the needs of TB investigators for new, emerging science?

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

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

1) the protection of human subjects from research risks, and

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

Specific for this FOA:

Is there a high likelihood of success for the proposed TRAC? Has the applicant provided a comprehensive strategy to support the NIH-funded researchers at the TRAC institution(s)? How robust is the plan to extend TRAC support and create opportunities for engagement of NIs pursuing TB research as well as investigators who want to enter the TB research field at the TRAC institution(s)? Does the approach also create opportunities for support of novel multidisciplinary research projects and to strengthen TB clinical research through international and domestic collaborations as applicable?

Has the applicant described the management and oversight of the TRAC in a manner that reflects an awareness of the Core services end user needs and the science to be conducted at the applicant institution?

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

Reviewers will consider the review criteria below in the determination of scientific merit and provide an overall impact score (a single numerical score) for each Core (i.e., Administrative Core, Developmental Core, Basic Science Core(s), Clinical Science Core(s), and optional Additional Core(s) of the TRAC.

All Cores

Are the Cores specifically targeted to TB research? Can the Cores support the research base, foster synergy, enhance TB research collaborations and provide added value?

Do the Core Director and other personnel have appropriate qualifications and time commitment to ensure success of the Core? If the Core Director is an Early Stage Investigator or in the early stages of independent career, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Are the leadership approach, governance and organizational structure appropriate for the Core?

Are potential problems, alternative strategies, and benchmarks for success presented? If the Core is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Are potential overlaps with existing services at the Institution adequately addressed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Are the Cores staffed appropriately to address the workload? Do the Core have plans for

prioritization of projects, services and allocation of resources?

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

Administrative Core

Are plans for coordinating and managing activities across the TRAC adequate? Are the

procedures appropriate for evaluating Cores, for reassigning priorities and for developing and utilizing outcome measurements? Is a plan to prioritize, allocate and manage fiscal resources adequate?

Developmental Core

Is the plan to solicit, review, prioritize, award, administer and evaluate all types of developmental awards adequate? Has the applicant provided adequate support and resources for supporting and mentoring NIs pursuing TB research and investigators who want to enter the TB research field? How well does the Developmental Core address the need for multidisciplinary research within the TB research field?

Basic Science, Clinical Science, and Additional Core(s)

Are the management and oversight of the Core(s) adequate to ensure support of the NIH-funded TB researchers at the TB institution(s)? Is there an adequate plan to engage NIs pursuing TB research or investigators who want to enter the TB research field? Are there clear plans for prioritizing Core utilization? Are procedures to solicit feedback from TB investigators about the Core’s ability to meet their research needs adequate and appropriate?

As applicable for the TRAC 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.

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

Not Applicable

Not Applicable

As applicable for the core 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.

Not Applicable

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by National Institute of Allergy and Infectious Diseases in accordance with NIH peer review policy and procedures, 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:

• 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.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that 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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Lakshmi Ramachandra, MSc, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-669-5061
Email: [email protected]

Yong Gao, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-669-5048
Email: [email protected]

Jordan Kindbom
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2983
Email: [email protected]

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 45 CFR Part 75.