PAR-27-056-Revised-Full-Announcement.html

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Limited Competition: Institutional Development Award (IDeA) for Clinical & Translational Research (CTR) (P30 - CT Optional)
Opportunity number
PAR-27-056
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This is a Notice of Funding Opportunity (NOFO) for the Limited Competition: Institutional Development Award (IDeA) for Clinical & Translational Research (CTR) program, issued by the National Institute of General Medical Sciences (NIGMS) under the Department of Health and Human Services. The program (FON PAR-27-056, Assistance Listing 93.859) develops biomedical research capacity in 23 IDeA-eligible states and Puerto Rico through two tracks: IDeA CTR Development (CTR-D) for organizations with limited clinical research capacity, and IDeA CTR Network (CTR-N) for statewide or multi-state networks of health research organizations. Applications are accepted as new, renewal, resubmission, or revision submissions through ASSIST or institutional system-to-system solutions. The earliest application submission date is September 15, 2026, with multiple deadline cycles through September 28, 2028. Award budgets are up to $1.0 million in year 1 and $1.75 million annually in years 2-5 for CTR-D (direct costs excluding F&A), and up to $3.0 million in year 1 and $3.5 million annually in years 2-5 for CTR-N (direct costs excluding F&A). The maximum project period is five years with an earliest start date of October 15, 2026, and the program expires May 31, 2029. Only one application per institution is permitted.

Eligible applicants include higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations, local and state governments, and Indian tribes, provided they are located in IDeA-eligible states and have externally-funded clinical and translational research (for lead organizations). Lead organizations must establish internal and external advisory committees, and the award requires five core components: Administrative Core, Professional Development Core, Community Engagement and Outreach Core, Research Design/Compliance/Data Management Core, and Health Research Core. The Health Research Core supports Research Preparation Phases (6-12 months, up to $150,000), Developmental Projects (2 years, $150,000), and for CTR-N only, Multi-Site Collaborative Projects (up to $500,000). All PD/PIs must register with eRA Commons and ORCID, and organizations must maintain active SAM and Grants.gov registrations. Applications undergo standard NIH peer review based on significance, investigator qualifications, innovation, and alignment with state health priorities, with no cost-sharing requirements. All registrations must be completed six weeks or more before submission.

PAR-27-056-Revised-Full-Announcement.html

Text of this file

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

Limited Competition: Institutional Development Award (IDeA) for Clinical & Translational Research (CTR) (P30 - CT Optional)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of

PAR-23-241

Reissue of

PAR-23-257

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.
January 23, 2026 - NIH Pause on New Submissions to the NIH Human Embryonic Stem Cell Registry and Request for Information on Reducing Reliance on Human Embryonic Stem Cells in NIH-Supported Research. See Notice, NOT-OD-26-031.

Funding Opportunity Number (FON)

PAR-27-056

Companion Notice of Funding Opportunity

None

Number of Applications

Only one application per applicant organization is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.859

Notice of Funding Opportunity Purpose

The Institutional Development Award (IDeA) program develops biomedical research capacity in states that have historically received low levels of NIH funding (IDeA states). The IDeA Clinical & Translational Research (CTR) program supports two programmatic tracks to build clinical and translational (C&T) research capacity to enable research on diseases and health challenges prevalent in IDeA states. IDeA CTR Development (CTR-D) awards focus on C&T research workforce development and infrastructure enhancement at health research organizations with limited clinical research capacity in IDeA states. IDeA CTR Network (CTR-N) awards support statewide (or multi-state) networks of health research organizations to expand existing infrastructure, develop the research workforce to enhance the network organization's ability to design and implement competitive C&T research programs, and coordinate clinical research activities state-wide and/or across IDeA states.

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered.

Funding Opportunity Goal(s)

To ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country.

Key Dates

Posted Date

August 19, 2026

Open Date (Earliest Submission Date)

September 15, 2026

Application Due Dates
Review and Award Cycles
New
Renewal / Resubmission / Revision (as allowed)
AIDS - New/Renewal/Resubmission/Revision, as allowed
Scientific Merit Review
Advisory Council Review
Earliest Start Date

October 15, 2026

October 15, 2026

Not Applicable

March 2027
May 2027

July 2027

January 28, 2027

January 28, 2027

Not Applicable

July 2027
October 2027

December 2027

May 28, 2027

May 28, 2027

Not Applicable

November 2027
January 2028

April 2028

September 28, 2027

September 28, 2027

Not Applicable

March 2028
May 2028

July 2028

January 28, 2028

January 28, 2028

Not Applicable

July 2028
October 2028

December 2028

May 30, 2028

May 30, 2028

Not Applicable

November 2028
January 2029

April 2029

September 28, 2028

September 28, 2028

Not Applicable

March 2029
May 2029

July 2029

January 29, 2029

January 29, 2029

Not Applicable

July 2029
October 2029

December 2029

May 30, 2029

May 30, 2029

Not Applicable

November 2029
January 2030

April 2030

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

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

Expiration Date

May 31, 2029

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background This is a Notice of Funding Opportunity (NOFO) for a limited competition that invites applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Authorized by the U.S. Congress in 1993, the National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program to build biomedical research capacity in 23 U.S. states and Puerto Rico, which had historically low NIH grant funding success rates. IDeA programs support biomedical research in basic, clinical, behavioral, and translational science in IDeA-eligible states by developing faculty investigators, providing research opportunities to students, and enhancing research infrastructure.

One of the components of IDeA is the Clinical & Translational Research (IDeA-CTR) program. This program builds or expands clinical and translational (C&T) research capacity to enable research on diseases and health conditions which are prevalent in IDeA states and in alignment with the mission and priorities of the NIH. The program has two tracks:

IDeA Clinical and Translational Research Development (CTR-D) supports health research organizations with limited C&T research infrastructure to build and enhance their C&T research capacity and develop the necessary workforce to support C&T research.
IDeA Clinical and Translational Research Networks (CTR-N) expands existing C&T research infrastructure of statewide or multi-state networks of health research organizations, community clinics or Practice-Based Research Network (PBRN). The CTR-N will enable the networks to conduct complex observational studies and clinical trials (CTs) while continuing to develop the necessary workforce.

To ensure that organizations apply to the track that best fits their current level of development, applicants should clearly justify their choice of track.

Organizations that already receive IDeA-CTR, CTR-N, or CTR-D funding and choose to apply for the CTR-D track must explain:

Why a developmental-level award (CTR-D) is appropriate for their program, and
How a CTR-D will help them successfully apply for a network-level (CTR-N) award in the future

Current CTR-D award recipients who have made progress in building clinical and translational research capacity are encouraged to consider applying to the CTR-N track, if they meet eligibility requirements.

Program Overview Health research organizations located in an IDeA state and committed to the goals of building, developing or expanding C&T research capacity are encouraged to apply. Lead organization(s) should have a well-established research administration infrastructure to manage C&T research projects and identify the population health needs and the C&T research workforce gaps of the state(s). The proposed research areas should be sufficiently broad to address relevant diseases and health conditions in the state(s).

IDeA-CTR programs provide a vision for building or enhancing C&T research capacity in the state(s), and a coordinated plan to integrate activities of all the components and partner organizations as necessary, including community clinics and Practice Based Research Networks (PBRNs). CTR-N applications must include a nexus of community clinics and PBRNs to demonstrate active PBRN engagement as a required element of research capacity.

Developing a strong C&T research capacity often requires tailored strategies and realistic timelines.

CTR-Ds are to phase-in core activities to build research capacity. The Administrative, Professional Development, Community Engagement and Outreach, and Research Design, Compliance and Data Management cores are the foundational infrastructure that must be built first to enable the HR core to support rigorous science.
All CTR-N core activities may begin at the start of the award, provided the existing capacity is justified.

An IDeA-CTR consists of the following two committees and five required cores.

Committees:

Internal Advisory Committee (IAC) consists of PD(s)/PI(s) and senior organizational leaders from each partner organization. The IAC oversees all major program components and activities, including health research compliance, regulatory monitoring, and sustained organizational support for workforce participation in IDeA-CTR activities.
External Advisory Committee (EAC) consists of experts from outside the state or network and provides scientific and administrative guidance while overseeing integration of activities between the required cores.

Cores:

Administrative Core (AC) manages operations and ensures compliance with CTR award requirements. The AC will handle reporting and evaluation, administer the IDeA-CTR award, and work with the other cores to achieve the center's goals.
Professional Development (PD) Core oversees workforce training activities for the center. It organizes and sponsors the organization and/or network-wide professional and research development activities to meet the needs of the C&T workforce.
Community Engagement and Outreach (CEO) Core leads the center's engagement with community groups and state organizations. This engagement is necessary to identify health research needs, promote community participation in clinical research, and ensure the center's research priorities are guided by community health priorities.
Research Design, Compliance and Data Management (RDCD) Core supports center investigators across all stages of C&T research by providing methodological, biostatistical, and CT expertise. The RDCD core enhances the center's data infrastructure related to electronic health records or clinical datasets and improves C&T research efficiency.
Health Research (HR) Core advances all stages of investigator-initiated C&T research to address the IDeA state's health priorities through Health Research Projects (HRPs). HRPs are a central part of the IDeA-CTR award and serve as the main way the program supports and advances C&T research.Through the Health Research (HR) Core, projects move through a structured pathway:This pathway starts with the Research Preparation Phase (RPP), which provides short-term (6–12 months) support to help investigators develop strong, implementation-ready studies.
Promising projects then progress to HRPs, which support rigorous observational studies and early- to mid-phase clinical trials that address important health needs in IDeA states and position investigators for future NIH funding.
HRPs include two-year Developmental Projects for clinician fellows and early-career or independent investigators, with required mentoring and opportunities for exploratory or ancillary studies.
In the CTR-N track, the program may also support Multi-Site Collaborative Projects (MCPs)–larger, phased studies led by experienced investigators that involve multiple sites and focus on high-priority health conditions.

Together, these project types create a continuum that builds investigator capacity, produces publishable results, and strengthens the overall research enterprise in IDeA states.

Key Terms and Definitions in this NOFO

IDeA-eligible state, commonwealth, or jurisdiction (referred to as 'IDeA state' throughout this document): Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming
Lead Organization: Applicant health research organization that is responsible for administering the award.
Partner Organization: An organization that significantly contributes to the center's goals and activities, such as community clinics, PBRNs, hospitals, medical centers and state public health entities.
Multi-State Network/Multi-State Region: Formed when multiple IDeA states are linked as part of a single CTR.

Applications Not Responsive to this NOFO Applications with a narrow disease or population focus are not responsive to this NOFO and will not be accepted for review.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Renewal

Resubmission

Revision

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the number of meritorious applications submitted.

Award Budget

IDeA CTR Development Track: Applications may request up to $1.0 million in year 1 in direct costs, and up to $1.75 million in years 2 through 5 in annual direct costs, excluding consortium facilities and administrative (F&A) costs.

IDeA CTR Network Track: Application budgets may request up to $3.0 million in year 1 in direct costs, and up to $3.5 million in years 2 through 5 in annual direct costs, excluding consortium facilities and administrative (F&A) costs.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions - Includes all types
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Local Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Eligibility Criteria for Lead and Partner Organizations
Every organization in the application must be either a Lead or a Partner–no organization can be both.
Every organization in the application must be in an IDeA-eligible state.
There are strict limits to avoid overlap:Each IDeA-eligible state can only have one active IDeA-CTR-type (IDeA-CTR, CTR-N, or CTR-D) award at a time.
An organization can only be involved in one IDeA-CTR-type award at a time.
Organizations may not serve as a lead, partner or otherwise participate with an active Clinical and Translational Science Award (CTSA).

Organizations must meet all eligibility rules at the time of application submission and award.

Additional Eligibility Criteria for Lead Organizations To apply as the lead, the organization must:

Already have externally-funded clinical and translational (C&T) research.

Additional Eligibility Criteria for Partner Organizations To participate as a partner, the organization must Be in the same state or multi-state region as the lead organization.

Note:

Active awards include awards in no-cost extension (NCE).
An organization that currently leads an active IDeA-CTR-type award may submit a new application if substantial changes to the CTR are proposed.If the new application is funded, the current award will be administratively ended before the new award begins.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Unfunded foreign components are allowed with prior approval. An unfunded foreign component would be a collaboration with investigators at a foreign site anticipated to result in co-authorship but with no IDeA funds transferred to the institution(s) or investigator(s) in a foreign country. Please also see NOT-OD-26-084.

Foreign PIs or organizations may use center resources as a fee-for-service. In such cases, resulting publications cannot cite or acknowledge NIH grant support.

Required Registrations

Applicant organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks.

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

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

At the time of submission, the primary appointment of the contact PD/PI must be at the applicant organization. An IDeA-CTR PD/PI (including any MPIs) may not simultaneously lead an IDeA COBRE or INBRE award. Only PDs/PIs associated with the eligible applicant organizations as outlined above may apply.

NIGMS strongly encourages multiple PD/PI (MPI) applications, particularly given the complexities of C&T research and CTs. An established clinician scientist with a track record of leading externally funded C&T/CT research projects or programs is expected to lead the IDeA-CTR as the contact PD/PI. The PD/PI should have:

a demonstrated history of leadership experience.
mentoring experience in fostering the development of a C&T/CT research and workforce.
demonstrated success in working across organizational boundaries.

This expertise is important to unite the participating organizations into a cohesive network and to properly integrate the IDeA-CTR's components to maximize efficiency and effectiveness.

The MPI team should also include a PD/PI with relevant scientific expertise to guide the center.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Component
Component Type for Submission
Page Limit
Required/Optional
Minimum
Maximum
Overall
Overall
12

Required

1
1
Administrative Core
Admin Core
12

Required

Professional Development Core
Core
6

Required

Community Engagement and Outreach Core
Core
6

Required

Research Design, Compliance and Data Management Core
Additional Core
12

Required

Health Research Core
Additional Core
12

Required

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component When preparing the application, use Component Type 'Overall'.

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

SF424(R&R) Cover (Overall) Complete entire form.

The title of the application should indicate the CTR track in the format of "CTR-D: [Title]" or "CTR-N: [Title]"

PHS 398 Cover Page Supplement (Overall)

Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

Biographical Sketch: Each PD/PI should describe their leadership and administrative experience, as well as any prior and relevant experience for the IDeA-CTR track they are applying for in the Personal Statement of the NIH Biographical Sketch Supplement. The Biographical Sketch Common Form and NIH Biographical Sketch Supplement should provide evidence of the PD/PI's:
experience directing research centers and leading an efficient and effective C&T research program
history of clinical research involvement
administrative experience working across departments and with external collaborators
mentoring experience

Current & Pending Support: Attach a copy of the PD/PI's Current and Pending (Other) Support Common Form, which is critical information for determining the PD/PI's eligibility and suitability to lead the Center:

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall) The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

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

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Research Strategy: The IDeA-CTR aims to build or expand C&T research capacity. All cores must work together to provide shared, non-duplicative resources that strengthen infrastructure, expertise, and workforce development. Applicants should describe the major health challenges of the population in the state(s) served and how the center will build or expand C&T research capacity to address them.

Provide the Overall Plan for the IDeA-CTR, which must include the following sections:

A. Goals of the IDeA-CTR: Describe the goals of the IDeA-CTR and the roles of the lead organization and any partner organizations in meeting those objectives. Key elements to include are:

The overall vision of the IDeA-CTR, including how the center's goals align with the lead organization's strategic priorities, and how each organization will contribute to these overarching center goals.
Plans to address the state(s)' major health concerns through support for research, infrastructure, and workforce development.
Innovative approaches to overcome barriers and improve/strengthen C&T research at the involved organizations, including plans to:Increase interest among investigators in conducting C&T research on health concerns or health challenges that impact the population in the state(s).
Develop and/or strengthen collaborations across the partnering organizations to ensure the center performs effectively across organizational boundaries (applicable to the CTR-N track).
Develop novel C&T methodologies such as pragmatic or adaptive trials.
Enhance the use of innovative technologies/tools (for example, real-world data platforms or a mobile clinical trial unit).
Use C&T technologies and resources such as Fast Healthcare Interoperability Resources (FHIR) standard, EHR or other real-world data platforms, if applicable.
Connect researchers across disciplines to drive health research in support of precision and evidence-based medicine, if applicable.

Plans to leverage resources and infrastructure supported by other IDeA awards (such as INBRE, COBRE, and IDeA Clinical Research Resource Center) or those supported by other NIH-funded C&T programs.

B. Organizational Structure and Governance Model: The applicant should provide a clear organizational structure that illustrates the relationships among the lead organization, partner organizations, committees, and cores within the IDeA-CTR. Key elements to include are:

The available research administration infrastructure, including its:Capacity for administering the IDeA-CTR award
Ability to manage subcontracts
Experience in managing research involving human subjects, clinical trials, and vertebrate animals.
Clinical trial infrastructure, and centralized Institutional Review Board (IRB)
IRB approval processes that provide timely support to investigators conducting human subjects research and clinical trials
A list identifying the externally funded C&T research base (including participation in clinical trials), for the lead and partner organizations.
Areas of C&T research expertise among investigators and how their expertise will contribute to the goals of the IDeA-CTR.
A management plan for the IDeA-CTR, including a description of:How the IAC and EAC and the IDeA-CTR components will work together.
Interactions between the PD(s)/PI(s) and Core Leads, who will direct core operations by coordinating PIs and both advisory committees to standardize procedures, support investigators, and advance technology capabilities across all components.
How Core Leads will:Develop or improve standard operating procedures governing the utilization and management of core expertise and resources;
Disseminate information;
Ensure state-of-the-art technologies and knowledge capabilities will be gained and attained;
Recommend necessary technology and equipment to the IDeA-CTR PD(s)/PI(s).
How each organization or component will have input and participate in decision-making.
How ongoing communication channels will be maintained among components.
A succession plan in the event there is a change of PD(s)/PI(s).

A description of the required committees,their responsibilities, and how these commitees will assist the PD(s)/PI(s) in administering the award: Internal Advisory Committee (IAC): Committee composition: PD(s)/PI(s) The contact PD/PI serves as the chair

One senior organizational leader (President, Vice President, Provost, Dean or equivalent) from each lead and partner organization.
Ad hoc committee members as needed.
How the IAC will:Ensure the program stays aligned with IDeA-CTR goals.
Oversee all major program components and activities.
Give input on major program or network decisions.
Provide annual updates to the EAC through a progress report.
Organize the Health Research Compliance (HRC) sub-committee which is responsible for all aspects of research compliance including Federal, NIH and organizational research regulations, and requires the following experts:Clinical Research Program Coordinator.
Members of the CTR leadership team.
Regulatory Specialist/Research Navigators.
Research Compliance Officers.
Ensure the HRC will:Establish a plan for oversight during the entire duration of HRPs, and for making HRP funding recommendations and monitoring progress of the projects.
Ensure HRP applications submitted to the EAC include:IAC assessment.
The project's Individualized Action Plan.
Career development and mentoring plan for the investigator.
Report of Consultations and Outcomes (RCO).
Quarterly post-award monitoring plan.
Ensure that each Individualized Action Plan should cover the following topics:Quality assurance monitoring.
Expectations for the project investigator during the project period.
The investigator's experience.
Mentor's oversight of human subjects research.
Coordinator/Navigator involvement.
External Advisory Committee (EAC)Committee composition:PD(s)/PI(s)
At least 3 – 5 experts in C&T research from outside the state/network.
EAC chair appointed by the PD(s)/PI(s) in consultation with the IAC.
Additional members appointed by the PD(s)/PI(s)
Operating Plan:Process of filling EAC vacancies
Description of the qualities and scientific expertise desired for EAC members, without naming specific individuals or contacting them prior to receiving the Notice of Award for the application.
How the EAC will:Evaluate the program's annual progress report prepared by the IAC.
Give recommendations to help the PDs/PIs improve the center.
Assess all proposed HRPs before they are submitted to NIH for approval.
If a Multiple PD/PI application is submitted, a "Multiple PD/PI Leadership Plan" is required as a separate attachment and the information in that plan should not be duplicated here. This section should address:How the entire group will function to accomplish program objectives and vision
Strategies for building and maintaining group participation
Succession planning in the event of a change in PD(s)/PI(s).

C. Capacity for C&T Research:

To properly assess the baseline level of C&T research capacity in the organization or network, describe the current C&T research capacity of lead and partner organizations (use tables where appropriate). Key elements to include are:

Investigator research support and productivity:The current number and annual total dollar amount of C&T research grants held by investigators at the organizations or network organizations.
A summary of C&T related publications authored by investigators at the organization(s) or network organizations over the past five years.
A summary of the health conditions that are currently being studied.
If applicable, information on the progress and accomplishments from the current IDeA-CTR funding period including:The annual number of:C&T research projects supported.
Publications, research grant applications and awards resulting from research project support.
The annual number of research projects that were:Collaborative
Multidisciplinary
Multi-site or
CTs

A summary of non-research project C&T research supported by supplement awards and/or current IDeA-CTR cores.

Organization or Network Strength:Summarize the existing research collaborations among participating organizations and network investigators and other IDeA-supported programs.
Generate a synopsis of existing connections with community clinics/PBRN sites in the state(s).
Professional Development:Summarize the programs, seminars, workshops, mentoring activities provided to participating organizations or network investigators.
Indicate the activities that were developed during the current IDeA-CTR funding period, if applicable.
Letters of Support: The application must include a letter of support from a senior official from the lead (applicant) organization and each partner organization that demonstrates organizational commitment to the IDeA-CTR program. The letter must:
Commit the organization to the IDeA-CTR's goals and describe:How these goals align with the organization's strategic priorities.
Each partner organization's specific and actionable goals, not just formal endorsements.
Describe the commitment of specific resources, such as:Support for hiring new staff.
Investment in necessary infrastructure.
Specific commitments to cores or other components should be summarized in a table.

Optional Letters of Support (10-page maximum): The application may include additional letters

From the PD(s)/PI(s) of other NIH IDeA awards describing how their programs will significantly support the IDeA-CTR and its goals.
That address important and specific needs of the IDeA-CTR may also be included, as applicable, but must not exceed the 10-page maximum.

Letters of support that repeat material or do not add new content should not be included in the application.

Resource Sharing Plan:

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

Other Plan(s):

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

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

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

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Administrative Core The Administrative Core administers the IDeA-CTR award. The contact PD/PI is expected to lead the AC. The AC administers the IDeA-CTR award and works closely with the other cores and organizational leadership to develop and implement plans that will meet the strategic goals of the organization(s) to support C&T research and synergize existing strengths and resources. The AC assesses the C&T/CT research capacity building needs of the organization(s) and develops and executes plans needed to meet those needs.

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.

SF424 (R&R) Cover (Administrative Core) Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core) Follow standard instructions.

Research & Related Other Project Information (Administrative Core) Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core) In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field. The Core Lead should be the PD/PI or contact PD/PI for multi-PI applications.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core) Budget forms appropriate for the specific component will be included in the application package.

A maximum annual level-of-effort of 6.0 person-months may be requested for all PDs/PIs, collectively. For multi-PI applications, no more than 2 PD(s)/PI(s) are allowed and the minimum level of effort for each PD/PI is 3.0 person-months.

A PD/PI may not use IDeA-CTR funds to supplement research activities for his or her own research projects or research team.
A PD/PI is not eligible to serve as a project lead on another IDeA-CTR award.
Funds may be requested:To support staff to manage the budget and conduct annual IDeA-CTR program evaluations.
For the EAC and IAC, including travel costs and compensation to members as consultants via a fee-for-service arrangement, if applicable.
For consulting services that assist in strategic planning.
To assist with the recruitment of additional faculty or staff to provide C&T research expertise. These funds are limited to $200,000 in annual direct costs and may be used for salary, supplies, and/or equipment costs.
To help defray the costs for the PD(s)/PI(s) and other key personnel funded through this NOFO to attend the National Symposium of Biomedical Research Excellence (NISBRE) biennial meetings.

Funds cannot be used by or for collaborators at organizations in non-IDeA states or at foreign sites. However, funds may be used in IDeA and non-IDeA states for fee-for-service activities such as learning new techniques (for example, biostatistics or clinical research design courses), sample and data analysis, attending workshops, or obtaining scientific, methodological or biostatistical advising/consulting/mentoring.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core) Research Strategy:

This section should describe how the Core will:

Manage and oversee the entire IDeA-CTR program, including coordinating and integrating all activities.
Ensure clear and timely communication among relevant staff.
Coordinate and support the activities of the two required committees – IAC and EAC.
Coordinate activities across center components.
Manage finances.
Provide accurate and timely progress reports to the NIH.
Annually monitor and evaluate performance of each core component.
Track usage of core components and adapt cores to the needs of investigators.
Provide the annual evaluation report to the EAC.

Letters of Support: Not allowed. Organizational Letters of Support, including support for the Administrative Core, should be included in the Overall Component.

PHS Human Subjects and Clinical Trials Information (Admin Core) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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.

Professional Development (PD) Core The PD Core oversees workforce development for the IDeA-CTR and organizes professional development activities. These activities should be tailored to the needs of the IDeA-CTR's C&T research workforce, including investigators eligible for HR Core funding and members of their research teams. The PD Core is expected to collaborate with other IDeA-CTR cores to identify needs for additional expertise and to ensure training in research regulations, mentoring, and the ability to provide scientific and technical review of post-award applications.

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.

SF424 (R&R) Cover (PD Core) Complete only the following fields:

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

PHS 398 Cover Page Supplement (PD Core) Follow standard instructions.

Research & Related Other Project Information (PD Core) Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (PD Core) List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (PD Core)

In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch Common Form and NIH Biographical Sketch Supplement for 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 (PD Core) Budget forms appropriate for the specific component will be included in the application package.

Each Core Lead must devote a minimum of 1 person-months annually to direct the core.

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