NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

NIH established the Institutional Development Award (IDeA) program in 1993 to enhance biomedical research activities in states that have had historically low NIH grant funding success rates. The program currently supports competitive research in 23 states and Puerto Rico through two major initiatives: Centers of Biomedical Research Excellence (COBRE) and IDeA Network of Biomedical Research Excellence (INBRE). Thus far, the COBRE and INBRE initiatives have enabled and continue to foster the development of capacity and infrastructure that allow many investigators in IDeA states to compete successfully for more traditional NIH funding, particularly in the areas of basic biomedical and behavioral research. While the progress achieved by IDeA investigators in basic research has been significant, tremendous challenges and opportunities remain for pursuing activities aligned with NIH’s growing interest and focus on clinical and translational research. Indeed, the proportion of research activities supported by the INBRE and COBRE initiatives focusing on clinical and translational research has been relatively small (about 15%). It is critical that the many advances in basic biomedical science research emerging from IDeA states be translated into better patient care and improved public health by fostering partnerships between basic and clinical scientists in IDeA institutions and among other NIH-funded programs. This funding opportunity announcement (FOA) encourages applications from IDeA states for the development of intra- and/or interstate network infrastructure for clinical and translational research.

The general objectives of the IDeA-CTR Program are the following:

• To support the development of infrastructure and human resources required to conduct clinical and translational research in IDeA-eligible states.
• To enhance the ability of IDeA institutions and investigators to develop competitive clinical and translational research programs.
• To foster and sustain collaboration and coordination of clinical and translational activities within and across IDeA institutions /organizations.

Goals of the IDeA-CTR Program include but are not limited to:

• The study of the underlying causes of diseases that affect the medically underserved and/or those diseases prevalent among populations in IDeA states.
• The development of approaches for the prevention, diagnosis, and treatment of diseases to improve health and health outcomes.
• The integration of basic, clinical, and translational research through collaborations among different disciplines and/or departments from different organizations within and across IDeA states.
• The provision of a core for professional development activities in clinical and translational research.

For the purposes of this initiative, the following definitions will apply:

• "Clinical research" comprises studies and trials in human subjects as defined by NIH Regulations and Policies (https://grants.nih.gov/grants/policy/hs/regulations.htm).
• in the PHS Supplemental Grant Application Instructions (see
• "Translational research" includes research that aims to convert basic research advances to practical applications in humans, and research aimed at the adoption of best practices in community healthcare.

The IDeA-CTR Program: General Outlines

IDeA-CTRs are expected to provide added value to the biomedical research efforts in the participating institutions through support of activities that cannot easily be provided through standard research grant awards. The proposed activities will provide the infrastructure and resources that will enhance the competitiveness of the investigators to obtain additional funding for clinical and translational research. The added value contributions that the proposed Center will make are anticipated to go beyond what would be expected from the pre-existing funded research at the partnering and collaborating institution(s). It should promote and encourage activities that enhance collaboration and coordination of clinical research (e.g. multi-site clinical studies on health concerns prevalent in the participating states) and/or promote cross-disciplinary translational research activities (i.e., basic scientists provide clinicians with new tools for use in patients and for assessment of their impact, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic investigations).

An IDeA-CTR application will provide details for supporting clinical and translational activities, particularly research focused on health concerns prevalent in the participating IDeA states. The IDeA-CTR must include infrastructure and/or activities that will support the following required Key Component Activities (KCAs):

• Professional Development Core
• Clinical Research Design, Epidemiology, and Biostatistics Core
• Pilot Projects Program
• Tracking and Evaluation Core

In addition to required KCAs, the applicant may also propose other KCAs to achieve the specific objectives of the IDeA-CTR. Optional KCAs that may be proposed include but are not limited to the following:

• Community Engagement and Outreach
• Clinical Research Resources and Facilities
• Biomedical Informatics and Cyberinfrastructure Enhancement Core
• Ethics, Regulatory Knowledge and Other Support Activities
• Technologies and Resources for Core Laboratories

The FOA provides funding through the cooperative agreements mechanism. As a cooperative agreement, implementation will involve participation of NIGMS IDeA Program staff in the planning and execution of the proposed activities.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

The applicant institution for an IDeA-CTR Program must be an Academic Health Center in an IDeA-eligible state. For the purposes of this FOA, an Academic Health Center is defined as a post-baccalaureate graduate degree-granting institution with ongoing funded research and academic programs in the biomedical clinical sciences (e.g., medicine and its related basic and clinical specialties, dentistry, public health, nursing, pharmacy, allied health clinical specialties).

The jurisdictions that are eligible for IDeA Program funding are currently restricted to the following:

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, Wyoming.

The following additional restrictions and considerations apply when submitting an application to this FOA:

• Institutions (normally identified by a unique NIH IPF number) that currently hold an active NIH-funded clinical and translational center award may not apply. However, these institutions are allowed to partner or collaborate with the lead applicant for an IDeA-CTR. For the purposes of this FOA, these awards include the following:
  • Clinical and Translational Science Award (CTSA) funded by the National Center for Advancing Translational Sciences (NCATS)
  • Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research (RCTR) funded by the National Institute on Minority Health and Health Disparities (NIMHD).
• Only one IDeA-CTR can be awarded per eligible IDeA state.

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 not 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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

The PD(s)/PI(s) must be full-time faculty at the applicant institution. He/she must be an established clinical investigator with active R01 or R01-equivalent clinical research award funded by NIH or other Federal or non-Federal funding entities.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

J. Rafael Gorospe, M.D., Ph.D.
Telephone: 301-435-0832
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	12
Core (use for each required and optional KCA)	12
Project (use for Pilot Project Program and Alterations and Renovations)	12

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
• Professional Development Core: required KCA
• Clinical Research Design, Epidemiology, and Biostatistics Core: required KCA
• Pilot Projects Program: required
• Tracking and Evaluation Core: required KCA
• Other KCA(s): optional

Alterations and Renovations: optional

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (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 & Related Senior/Key Person Profile (Overall)

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.

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 applications only, an Introduction to Application is required in the Overall component.

Specific Aims: Provide the Specific Aims for the Center.

Research Strategy: The application must provide details of the overall center organization that includes the following items:

Background and Organizational Structure

• The major health concerns in the participating state(s), the efforts that have been made to address these concerns, the biomedical research resources available in the/these state(s), and the areas in which a greater focus on clinical and translational activities would have a significant impact.
• As appropriate, a description of the impact of previous support from IDeA and other Federal and/or non-Federal sources for developing the infrastructure required to conduct multidisciplinary clinical and translational research.
• A brief history of the lead institution/organization, its mission, and a rationale for leading the IDeA-CTR; whether clinical and translational efforts are part of its priorities and whether the proposed IDeA-CTR will be an integral aspect of these priorities.
• The organizational structure of the Center and overall strategic plan for achieving the overall specific aims of the Center. Crucial to the effective operation of the Center is an Administrative Core that oversees the coordination and facilitation of all research and mentoring activities supported by the KCAs.
• The scientific opportunities that the Center intends to pursue over the next five years.
• Summary and justification for the Key Component Activities (KCAs) that will be supported.
• Innovative incentives and approaches to increase interest among IDeA-CTR investigators in conducting collaborative clinical and translational research on health concerns that disproportionately affect populations in the state or in the region.
• For renewal applications, justification for a second five-year period of support for the Center.

Partnerships and Collaborations

• An analysis of organizational, educational, and scientific strengths and weaknesses in the participating state(s) and a rationale for including each participant.
• Administrative and scientific relationships between the lead organization and collaborating partners within and across IDeA-eligible states
• Plans for facilitating or enhancing intra-institutional, inter-institutional, and multi- or interdisciplinary collaborations among basic, clinical and translational investigators
• Collaboration and synergy among the IDeA-CTR and other IDeA-funded programs within and/or outside the state [e.g. INBRE, COBRE(s), CTSA(s)]
• How cross-institutional, geographical, cross-disciplinary, regulatory and other hurdles related to collaborations will be addressed.

Progress and Accomplishments

For renewal applications, details on performance during the prior project period must be provided on the following:

• Impact of the IDeA-CTR award in developing the infrastructure for clinical and translational research at the institution(s). Describe the improvements to the clinical and translational research infrastructure relative to institutional baseline infrastructure in place at the onset of the prior project period.
• Impact of the IDeA-CTR in addressing the major health concerns in the state(s).
• Evidence of progress in conducting clinical and translational research enabled by the IDeA-CTR infrastructure including, but not limited to:
  • increase in the number of pre-clinical, clinical and translational research projects initiated, ongoing and/or completed utilizing IDeA-CTR activities and/or infrastructure
  • examples of multi-disciplinary research projects initiated as a result of IDeA-CTR activities and/or infrastructure
  • an increase in the number of multi-site or other collaborative research projects initiated, on-going or completed
  • examples of projects that were basic science but now as a result of IDeA-CTR activities, have pre-clinical applications and examples of clinical projects that now have practice or community relevance;
• Challenges encountered and solutions that were successfully implemented as well as improvements in institutional commitments to providing support for clinical and translational research.
• Evidence of overall research productivity attributed to and/or impacted by the IDeA-CTR award (other than lists submitted in the Progress Report Publication List) including, but not limited to:
  • presentations at major scientific meetings
  • workshops, seminars, community activities, technical assistance webinars and other capacity-building activities
  • numbers and types of research grant applications submitted and grants/contracts awarded (including funding source).
• Other metrics as defined by the applicant that demonstrate accomplishments during the prior project period.

Other details to be considered when completing the research strategy section for Overall: Each IDeA-CTR must have a well-delineated organizational structure and the requisite administrative mechanisms that foster interactions among investigators, accelerate the pace of clinical and translational research, and ensure a productive research effort. The applicant must demonstrate that all planned activities that comprise the IDeA-CTR are well integrated into a cohesive and coherent program and clearly indicate the roles of the participating institutions and organizations.

The applicant is required to identify one or more partners and collaborators within the state. The involvement of collaborators and partners from other IDeA states with shared goals and objectives is encouraged. The partners and collaborators may include Federal or non-Federal, public or private, and for profit or non-profit organizations, foundations, and/or community organizations as appropriate. The partners and collaborators will provide the manpower and sites for the conduct of clinical and translational research. The inclusion of minority-serving institutions is encouraged. The scientific and administrative management/organizational structure of the program must include individuals from diverse fields and backgrounds. Of particular importance, plans must be described for facilitating intra-institutional, inter-institutional, and multi- or interdisciplinary collaborations if not currently extant, or enhancing such activities if already in place. It is the responsibility of IDeA-CTR leadership to define effective partnership and collaboration among the participating states. The application must provide evidence and/or assurances that adequate cooperative arrangements are in place between participating institutions to ensure that the Center performs effectively as one cohesive and coherent program across institutional boundaries. Budgetary and administrative arrangements are to be negotiated between the partnering institutions.

The applicant must describe the major locations of Center activities, including those in collaborating institutions and discuss distances between locations; provide a chart or map illustrating the location and setting of the IDeA-CTR parent institution in relation to collaborating institutions, especially if there are KCAs/Cores that are located outside of the parent institutions; and describe the functional relationships.

Collaborations with recipients of other IDeA-supported initiatives (INBRE and COBRE) and/or other NIH-funded Clinical/Translational Programs (e.g. CTSAs, RCTRs) are strongly encouraged. When practical, the IDeA-CTR should seek to utilize existing resources and facilities supported by other programs of the NIH, other Federal, and/or non-Federal organizations.

All proposed clinical and translational research activities must employ applicable standards that are consistent with those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations.

Progress Report Publication List: All publications produced in the prior project period must be listed here. Also to be listed in this section are patents and inventions, videos, and other materials attributable to the IDeA-CTR KCAs/Cores.

Letters of Support: Applicants must provide letters from the appropriate high-ranking institutional official(s) from the lead institution and partnering institutions that:

• Commit the institution(s) to the IDeA-CTR goals, indicating that the program will be integral to their broad vision of clinical and translational research.
• Defines the position, authority, and reporting responsibility (on the institution's organizational chart) for the IDeA-CTR Director.
• Defines the financial and other resource support for the IDeA-CTR that will be provided by the applicant institution(s). There are no dollar requirements, but specific commitment is required. Some examples include financial support, adequate space, release time agreements, tenured or tenure-track positions for clinical/translational faculty, FTEs for clinical support or ancillary personnel, core consolidation and maintenance. Specific commitments to KCAs and other components can be summarized in a table.
• Defines the authority or influence that the IDeA-CTR (PD(s)/PI(s)) has/have, and/or will have over the different components of the Center, facilities and space, as well as decision-making authority for hiring and/or approving new faculty and support personnel.
• Commit to notify NIGMS of adverse events in all clinical studies supported by the IDeA-CTR that are serious, unexpected, and related to participation in research. A reiteration to notify NIGMS of all unanticipated problems as outlined in OHRP guidance (http:www.hhs.gov/ohrp/policy/advevntguid.html) on studies supported by IDeA-CTR resources would satisfy this requirement. These notifications include all adverse events as noted above as well as other reportable unanticipated problems.

Co-funding or matching funds from other sources (including industry) are encouraged, as long as these funds do not limit faculty research, communications, and implementation at any point and there are methods in place to ensure transparency, prevent misuse of federal funds, and ensure that NIH policies with respect to sharing of data and resources, academic freedom, and publication rights are not violated.

As appropriate, letters from the PD(s)/PI(s) of other NIH-funded centers (e.g. INBREs, COBREs, CTSAs, RCMIs, RCTRs) must be included indicating their program’s role in supporting the IDeA-CTR’s goals for clinical and translational activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

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

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

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The IDeA-CTR PD/PI must devote a minimum time commitment of 3.6 person months for the administrative oversight of the Center, serving as the Administrative Core Lead. A maximum of 6.0 person months effort may be supported. Each individual named as a Program Coordinator (PC) may devote 3.6 to 6.0 person months. The levels of effort specified for the PD/PI and the PC(s) are required whether or not salary support is requested.

The Administrative Core Lead (PD/PI) of the IDeA-CTR is not eligible for research support from the IDeA-CTR award, nor can he/she use IDeA-CTR funds to supplement research activities within his/her laboratory. Mentors may be compensated for up to 1 person month of effort.

Funds can be requested for activities related to the External Advisory Committee (EAC), including travel and consultant fees.

Funds cannot be used at collaborative institutions in non-IDeA states. However, funds may be used in other IDeA and non-IDeA states for fee-for-service activities that include activities such as learning new techniques, sample and data analysis, workshops, etc.

If items are requested as direct costs that are normally treated as F&A costs (for example, computers and general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Provide the Specific Aims for the Administrative Core.

Research Strategy: When completing the research strategy section for the Administrative Core, the following elements must be considered:

Governance

The IDeA-CTR Administrative Core will be responsible for managing, coordinating, and supervising the entire range of Center activities; realignment of institutional resources among the different components and partners as needed; and monitoring progress and ensuring that the Center milestones are being met and are being implemented effectively within the proposed timelines. The IDeA-CTR is expected to have scientific and fiscal flexibility. The leadership is responsible for the use of IDeA-CTR resources to meet the needs of partners and collaborators, including the authority to change allocation of resources according to the guidelines of the Center’s operating policies and procedures. An explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed must be provided.

The governance plan should include a discussion of the structure and roles of administrative staff and the functions to be performed and a discussion on how the Center will ensure effective and timely communications between the Center and partners, core leaders, investigators, and IDeA Program staff. The Administrative Core must provide both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among the participating institutions/organizations, KCAs/Cores and Center investigators. The application must include description of operational plans that will govern the center leadership's interactions with the proposed KCAs/Cores, advisory committees, and aligned investigators.

The Administrative Core should clearly identify personnel and resources needed to oversee the Center and ensure management of the KCAs/Cores and other related activities. If warranted, applicants should describe plans for recruiting and hiring additional research personnel that may be required to accomplish the goals of IDeA-CTR. This may include hiring of senior magnet clinical and translational investigators who have independent research support and will serve as mentors and role models to junior investigators. As appropriate, applicants must include a proposed timetable specifying the expected hiring date for each new faculty and/or staff member.

Policies and Procedures

The applicant must provide a clear and explicit discussion of the Policies and Procedures that will govern the management of the Center. Policies should be considered to be "a set of guiding principles of operation." Procedures should be considered to be a set of specific actions used to conduct the affairs of the IDeA-CTR. Procedures should specify how various tasks will be accomplished within the policy guidelines of the IDeA-CTR. Policies and procedures should describe:

• Proposed roles of the IDeA-CTR Director, KCA/Core Leads, IDeA-CTR investigators, advisory committees, and institutional officials in the decision-making process.
• The annual strategic planning process. Examples of issues that should be considered include:
  • how funds will be allocated to all KCAs/Cores and activities and procedures for changes in support of any cores
  • how Center-sponsored conferences, seminars, workshops, and other activities will be identified
  • how priorities for communication, outreach, and additional IDeA-CTR activities will be established
  • how Cores, Core Leads, leaders of additional IDeA-CTR activities, internal and external advisory committees will be selected and evaluated
  • the plans for leadership succession
  • the membership, authority, and responsibilities of advisory committees
  • how cores are selected and reports are developed, including the annual strategic plan and the noncompeting continuation application
  • the plans for conflict resolution.
  • process for informing IDeA Program staff of major changes in the Center.
• Policies and procedures for identifying new KCAs/Cores or Center activities, and eliminating KCAs/Cores or Center activities after they either have achieved independent sustainability or have been deemed unproductive.
• Other mechanisms used to determine research core needs at the participating institution(s), assigning priorities to potential cores, and selecting the Basic and Clinical KCAs to be included in the application.
• Plans for ensuring compliance with all regulatory guidelines pertaining to the protection of human subjects, and the care and welfare of vertebrate animals involved in research.

Leadership

When describing the leadership of the Administrative Core, the following elements must be considered and explicitly addressed.

The implementation of the activities detailed in the application is the ultimate responsibility of the IDeA-CTR CL. The application must demonstrate that the CL has sufficient authority and credibility to work across institutional boundaries and the requisite administrative experience and leadership skills to direct and integrate all components of this multi-faceted program. The responsibilities of the CL must be defined in establishing the appropriate administrative structure that will ensure efficient management of the facilities and resources across the institutions and organizations that participate in the IDeA-CTR program (e.g. overall management, staffing and resource allocation, and administration of the award in accordance with NIH policies).

The CL may be assisted by Program Coordinator(s) (PC(s)) from the same institution or at a partner institution. The PC(s) should also be experienced investigator(s) who have administrative skills and experience that complement those of the PD/PI. The application should describe involvement of the PC(s) in providing day-to-day operational and administrative oversight of assigned area(s) of responsibilities, and as appropriate, helping KCA/Core Leads set work priorities, and coordinating recommendations for major purchases of supplies, equipment upgrades, technical support staff, and assisting in the resolution of other budget issues with the core Leads and the PD/PI.

Steering Committee

The functions and responsibilities of the Steering Committee should be clearly defined. Each Center will be directed by a Steering Committee chaired by the PD/PI of the Center. The application should provide details of how the Steering Committee will establish guidelines to determine the most appropriate methods for providing access to the KCA/Core facilities and services and other strategic and operational plans, to maximize the impact of the Center on clinical and translational research within the network.

Internal and External Advisory Committees

Prior to submitting an application, an Internal Advisory Committee (IAC) that guides the IDeA-CTR PD/PI must have been constituted and named accordingly in the submission. The IAC may consist of six to eight members depending on the scope and complexity of the proposed IDeA-CTR. The application must provide functional and operational details of the duties and responsibilities of the group.

Each IDeA-CTR is also required to establish an External Advisory Committee (EAC) that will meet at least annually to review structure and progress of the IDeA-CTR and offer recommendations to the PD/PI. In order to maintain the largest possible reviewer pool for this FOA, the applicant should not contact potential EAC members or provide the names of potential EAC members during the preparation or review of the application. Renewal applications should name members of the EAC who will continue in that capacity, but not new members. The areas of expertise and requisite qualifications of (new) members who will be recruited for the EAC and their terms of service must be clearly defined and appropriately aligned with the objectives of the Center.

Plans must be included in the application for ensuring that the efforts and recommendations of the IAC and EAC are secured, considered and implemented by the IDeA-CTR leadership as appropriate. Official minutes of committee meetings must be kept on file with particular attention to documenting problems and special concerns, along with any recommendations for their mitigation or resolution. A summary of the issues discussed at each IAC and EAC meetings, recommendations made, and actions taken will have to be provided in yearly progress reports submitted to NIH. The EAC report must not be submitted directly by the EAC to NIH Program staff.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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 (Professional Development 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 (Professional Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Professional Development 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) (Professional Development 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 (Professional Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Professional Development Core)

Budget forms appropriate for the specific component will be included in the application package.

The Core Lead must devote a minimum of 2.4 person months annually to direct the Core.

Advisors may be compensated for up to 1 person month of effort. Advisors from non-IDeA states can be compensated as a consultant or fee for service. Funds cannot be used for graduate student or postdoctoral stipends. Funds cannot be used to compensate individuals for availing of professional development activities developed by the core.

If items are requested as direct costs that are normally treated as F&A costs (for example, computers and general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Professional Development Core)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Provide the specific aims for the Core.

Research Strategy: The Research Strategy for this Core must provide descriptions of the following elements:

• Core description, services, and operating procedures including plans for the integration and coordination of professional development activities within and across all participating institutions that form the Center network
• Operational plans for marketing resources, assisting users, and prioritizing projects
• For renewal applications, a description of major progress and accomplishments that includes:
  • impact of professional development activities on clinical and translational investigators supported in the prior project period and their current status
  • challenges encountered and solutions that were successfully implemented in facilitating the professional development of clinical and translational faculty
  • other metrics as defined by the applicant that demonstrate accomplishments during the prior project period.

Other details to be considered when completing the research strategy section for this core: The presence or absence of a Medical School in the applicant’s IDeA state or region may impact the types of professional development activities that can be proposed for individuals interested in clinical and translational work. Applicants that propose collaborations with existing CTSAs or RCTRs are encouraged to leverage the educational and training opportunities already in place at these sites.

If such opportunities are unavailable, applicants may propose to develop entirely new activities or programs to support research mentoring and professional development that specifically targets junior faculty from a variety of disciplines and clinical specialties (MD, DDS, PhD, Pharm D, RN); these can include short-term courses, curricula, seminars, workshops, sabbaticals, and visiting scholarships. The activities or programs proposed must address scientific/education areas and/or topics important to clinical and translational science in a variety of research areas. If no currently funded training program exists at any of the institutions in the participating states, applicants should also describe how the proposed IDeA-CTR activities will enhance their ability to apply for training awards, or partner with other institutions to leverage existing or proposed training activities.

Clear plans for the advancement and retention of investigators interested in pursuing clinical and translational science careers in IDeA states must be included in the application.

Letters of Support: Applicants can provide letters from the appropriate high-ranking institutional official(s) that details financial and other resources that will be provided by the institution specifically for the core. Examples may include funds for development of curriculum or other educational/mentoring activities, release time for the scholars and participating faculty, and commitment to providing didactic and mentoring experiences.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Professional Development Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Professional Development Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, 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 (Clinical Research Design, Epidemiology, and Biostatistics 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 (Clinical Research Design, Epidemiology, and Biostatistics Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Research Design, Epidemiology, and Biostatistics 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) (Clinical Research Design, Epidemiology, and Biostatistics 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 (Clinical Research Design, Epidemiology, and Biostatistics Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Clinical Research Design, Epidemiology, and Biostatistics Core)

Budget forms appropriate for the specific component will be included in the application package.

The Core Lead must devote a minimum of 2.4 person months annually to direct the Core. Staff members must be in sufficient number and have adequate training and effort to support the inter- and intra-institutional needs of the IDeA-CTR

If items are requested as direct costs that are normally treated as F&A costs (for example, computers and general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Clinical Research Design, Epidemiology, and Biostatistics Core)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Provide the specific aims for the Core.

Research Strategy: The Research Strategy for this Core must provide descriptions of the following elements:

• Services and resources that will be provided for the design and analysis of clinical and translational studies. The core is expected to provide expertise and assistance on, but not limited to, the following:
  • Developing, validating and integrating research designs and biostatistics methodologies essential to clinical and translational studies
  • Preventing bias in research methodology
  • Developing innovative methods of enhancing the power of studies
  • Capturing appropriate data
  • Developing design and analysis plans for studies of unique or vulnerable populations, and/or very small numbers of subjects.
• Plans for developing tools or methods in these areas
• Educational and mentoring activities that will be available to investigators
• Operational plans for marketing resources, assisting users, and prioritizing projects
• Existing Research Design, Epidemiology, and Biostatistics resources supported by other programs that are leveraged and utilized.
• Plans for the recruitment of appropriate personnel.
• For renewal applications, a description of major progress and accomplishments that includes:
  • summary of investigators and projects that were impacted by the resources provided by the Core
  • challenges encountered and solutions that were successfully implemented
  • evidence of overall research productivity attributed to and/or were impacted by the Core, other than lists submitted in the Progress Report Publication List other metrics as defined by the applicant that demonstrate accomplishments during the prior project period.

Progress Report Publication List (for renewal applications only). All publications attributable to this core produced in the prior project period must be listed here. Also to be listed in this section are patents and inventions, videos, and other materials.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Clinical Research Design, Epidemiology, and Biostatistics Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Clinical Research Design, Epidemiology, and Biostatistics Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Pilot Projects Program)

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 (Pilot Projects Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Projects Program)

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) (Pilot Projects Program)

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 (Pilot Projects Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot Projects Program)

Budget forms appropriate for the specific component will be included in the application package.

Funds cannot be used for graduate student or postdoctoral stipends. The PD/PI of the IDeA-CTR is not eligible for pilot project funding.

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 (Pilot Projects Program)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Provide the specific aims for the Program.

Research Strategy: The Research Strategy section for the Pilot Projects Program should include the following:

• A plan for the solicitation of proposals, prioritization of the projects, and the review of their methodology and research performance.
• Plans for constituting the review panel, their qualifications and expertise.
• The plans for defining the scope of the projects, eligibility requirements, the limit on the dollars available, and the number of years of support per project. Others important elements include:
  • One or more pilot projects that are funded per year must be "clinical research as defined above.
  • Pilot investigations on diseases that affect the medically underserved and/or diseases that disproportionately affect populations in the participating states should be prioritized.
  • Projects involving collaborative research between basic, clinical, and translational researchers from different disciplines, departments and/or programs within or across institutions should be encouraged.
• Governance and oversight procedures that include the EAC.
• The potential pool of qualified investigators from whom to solicit proposals.
• For renewal applications, data on the effectiveness of the program including the dissemination and review process, the number of applicants and awardees per cycle, outside grant applications submitted by pilot investigators and were funded, any scientific/technical breakthroughs, and other metrics as defined by the applicant demonstrating impact.
• Research plans for individual pilot projects should not be included in the application.
• Restrictions:
  • Leaders of pilot projects must hold a faculty appointment or equivalent at the time the pilot award commences. For the purposes of this FOA, these are individuals who can independently apply for Federal or non-Federal investigator-initiated peer-reviewed Research Project Grants (RPG). Individuals holding postdoctoral fellowships or other positions that lack independent status are not eligible to lead pilot projects.
  • The Project lead for Pilot projects may not concurrently have research funding from other IDeA Program award mechanisms (e.g. INBRE, COBRE).
  • Pilot projects may not overlap with ongoing funded projects.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot Projects Program)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Projects Program)

Not Applicable

When preparing your application in ASSIST, 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 (Tracking and Evaluation 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 (Tracking and Evaluation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Tracking and Evaluation 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) (Tracking and Evaluation 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 (Tracking and Evaluation Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Tracking and Evaluation Core)

Budget forms appropriate for the specific component will be included in the application package.

The Core Lead must devote a minimum of 2.4 person months annually to direct the Core. Staff members must be in sufficient number and have adequate training and effort to support the inter- and intra-institutional needs of the IDeA-CTR.

If items are requested as direct costs that are normally treated as F&A costs (for example, computers and general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Tracking and Evaluation Core)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Provide the specific aims for the Core.

Research Strategy: The application must include a Tracking and Evaluation Core that is tasked with overseeing an internal evaluation plan for assessing implementation of the short-term and long-term goals of the IDeA-CTR, including implementation of specific program activities. The applicant must describe how they will track the use, quality, and cost of the programs and resources and services provided by the Center and component KCAs/Cores; how the data will be assessed and programs, resources, and services modified to better meet researcher needs, increase efficiency and quality, and lower cost. Tracking and assessment of innovative new methods and practices in structuring, bundling, and delivery of programs, resources and services are encouraged.

The Research Strategy section for the Tracking and Evaluation Core should include the following:

• Plans for assessing progress in implementation of the short-term and long-term Center goals, including implementation of specific program activities (process); and plans for documenting the accomplishments anticipated for each budget period and within the total award period (outcomes). For each proposed activity or core, the plan should include the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources.
• Performance milestones for each KCA/Core, and the schedules and timelines that will be used to measure progress in each budget period towards the achievement of performance goals (e.g., Logic models and GANTT Charts).
• Plans for assessing demand, function, utilization, and effectiveness of the KCA/Core in providing the resources and expertise including, but not limited to, the following:
  • Assessment of budget implementation, allocation of resources, and leveraging of additional resources to achieve KCA/Core objectives
  • Assessment of effectiveness of resource sharing
  • Assessment of outreach, user training, and dissemination plans
• Anticipated impediments that could require revision of the milestones with a discussion of possible solutions.
• Plans for the recruitment of appropriate personnel.
• Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Tracking and Evaluation Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Tracking and Evaluation Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core for each proposed KCA.

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

PHS 398 Cover Page Supplement (Optional Key Component Activities)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Optional Key Component Activities)

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) (Optional Key Component Activities)

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 (Optional Key Component Activities)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Optional Key Component Activities)

Budget forms appropriate for the specific component will be included in the application package.

The Core Lead must devote a minimum of 2.4 person months annually to direct the Core.

If items are requested as direct costs that are normally treated as F&A costs (for example, computers and general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated activity. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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 (Optional Key Component Activities)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: Provide the specific aims for the Key Component Activity.

Research Strategy: The Research Strategy section for each proposed KCA/Core must provide details of the following:

• Core description and justification
• Roles and responsibilities of Core Lead and staff.
• Operating procedures of the KCA/Core:
  • Maintenance of state-of-the-art techniques and quality controls.
  • Mentoring and training of investigators in the capabilities of the core.
  • Allocation of core budgets.
  • Process for reviewing, prioritizing, and supporting projects. Resolution of disputes relating to core usage.
  • Fee-for-service arrangements and procedures for waiver.
• Plans for tracking utilization of core resources and for adapting to the needs of investigators.

When completing the research strategy section, the following elements must be considered for each proposed KCA/Core:

Resources and services

Each proposed KCA/Core must be well justified with the expectation that each will foster, facilitate, and enhance clinical and translational research capabilities of partners and collaborators. The aims of the KCA/Core and the services it provides should address the needs of clinical and translational investigators at the participating institutions and be inclusive of the full range of biomedical and biobehavioral sciences funded at these institutions. The application must show that the resources and services offered by each proposed KCA/Core are adequate to achieve the stated goals and objectives of the IDeA-CTR program, including capabilities to support intra- and inter-institutional operations and multi-disciplinary activities. Essential services for each KCA/Core will include dissemination of KCA/Core capabilities and mentoring in core technology and instrumentation, and providing scientific guidance in the design of research applications and experiments. Other core functions that must be defined include: (1) standard operating procedures governing the utilization and management of core expertise and resources, (2) maintenance of state-of-the-art technologies and knowledge capabilities as applicable, (3) recommending to the Center PD/PI and PC any updates and/or replacement of equipment or personnel, and (4).

Leveraging

Acknowledging that existing resources vary among applicant institutions, the support requested for each of the proposed components is expected to vary, reflecting current and projected needs. Where applicable, applicants are encouraged to develop creative collaborations to improve utilization of existing resources. Applicants must demonstrate synergy between the IDeA-CTR and other IDeA- or NIH-funded programs in the participating states, and not duplicate or substantially overlap with activities of these programs. Applicants should seek to utilize existing equipment and instrumentation supported by other COBRE or INBRE awards. Applicants should describe how cores with partial IDeA-CTR funding will be used to enhance ongoing and planned research. For example, a proposed IDeA-CTR KCA/Core supported by other funding (e.g., COBRE Bioinformatics Core, INBRE Community Outreach Core, or a CTSA Mentoring Core) may become more accessible to prospective clinical and translational investigators through leveraging of these existing resources by the Center. Requests that appear to be duplicative of existing equipment or instrumentation, including computational facilities and related bioinformatics resources, must be appropriately justified. Co-funding by the applicant organization or by outside sources is encouraged.

Descriptions of Potential Key Component Activities

1. Community Engagement and Outreach Core

If proposed, clear and detailed plans must be presented for identifying priority health issues and concerns of communities/populations within the participating state(s). Equally important to outline are plans for developing the capacity to respond to these issues/concerns. The core will provide support for investigators in conducting community engagement and outreach activities; this may include planning, implementing, evaluating, and disseminating effective preventions and interventions. Other appropriate activities could include cultural sensitivity training for institutional clinical and translational researchers, community and health care provider education and outreach, establishing community advisory boards, software development for facilitating collaboration with community practitioners, and developing/evaluating strategies for communicating with and promoting participation of diverse populations and community groups.

If proposed, applicants should describe:

• how the institution will involve the community in setting research priorities that directly affect patients
• innovative ways to engage community members in mentoring processes and collaborations in community-partnered clinical and translational research
• approaches to increase public trust in research and research participation
• recruitment methods to involve human subjects in clinical and translational research
• approaches for developing two-way communication with relevant community groups
• plans to involve community practitioners and approaches to integrate their participation in clinical and translational research
• plans for training IDeA-CTR researchers and scholars in community-based research, cultural sensitivity, and population and community-based research methods

2. Clinical Research Resources and Facilities

Applicants may propose a core that will oversee the recruitment and retention of research participants and the provision of necessary resources for cost-effective research participant interactions. Some examples of resources that may be requested include out-patient or community-based examination rooms, satellite research participant recruitment/enrollment sites at smaller institutions, research nurses, research coordinators and other support personnel, scheduling services, and services for research specimen collection and shipping. It is important that applicants describe a plan to familiarize investigators at all partner institutions/organizations and medical catchment areas of the available IDeA-CTR resources to support clinical translational research studies.

If proposed, applicants should describe:

• the resources that will be offered, with plans for their prioritization, availability, and management, and tracking of usage
• plans for familiarizing investigators at all partner institutions/organizations and medical catchment areas of the resources for human subject studies that are available through the IDeA-CTR
• methods to ensure that all studies utilizing these resources will meet the highest standards for quality of science, statistical rigor, ethical evaluation, robust design, participant safety, and strict implementation, analysis, and reporting
• how Good Clinical Practices (GCP) will be implemented
• how the institution(s) will anticipate and be responsive to changing needs of the clinical and translational research communities
• evaluation processes for justifying an investigator’s continued access to resources
• integration with similar resources at the partner institutions if these are currently available
• plans for cost recovery from funded investigators, where appropriate
• plans for obtaining required Office of Human Research Protections (OHRP) assurances, if not already in place
• plans for supporting clinical trial activities, if applicable

3. Biomedical Informatics and Cyberinfrastructure Enhancement Core

Applicants may propose a core for the organization and analysis of biological and related information, involving the use of computers to develop databases, retrieval mechanisms, and data analysis tools. Comprehensive supporting infrastructure may be proposed that integrates data-gathering facilities, computing hardware, data analysis and informatics tools, software and middleware, high-bandwidth network connectivity, and technical support. Resources that provide cyber access to rural areas and other hard to reach populations are strongly encouraged. Equally important are resources to enhance communications within the state(s) and with the rest of the world, including but not limited to library access to research journals and video-teleconferencing services. Applicants should consider both inter- and intra-institution communication platform(s) and external interoperability to allow for communication among the IDeA-CTR partners of clinical and translational investigators and other entities (e.g., government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers). Whenever available, bioinformatics resources already provided through other NIH-funded programs should be leveraged by the IDeA-CTR as it develops its own biomedical informatics infrastructure for clinical and translational activities. Biomedical informatics research activities should show innovation in the development of new tools, methods, and algorithms.

If proposed, applicants should describe:

• informatics resources for supporting operations, administration, and clinical/translational research activities of the IDeA-CTR
• plans to establish communication with relevant external organizations
• processes by which standards and other mechanisms will be developed and used to maximize interoperability among internal systems and systems in external organizations
• plans for inter- and intra-organizational sharing of data, technology, and best practices
• plans for increasing cyber access for and to rural areas and other hard to reach populations (e.g. access to research journals, video-teleconferencing services)
• plans for ensuring privacy and confidentiality of all human subjects data

4. Ethics and Regulatory Knowledge Core

Regulatory knowledge and support activities of the IDeA-CTR should promote the protection of human subjects and facilitate regulatory compliance. Best practices can be formulated that will reduce or remove institutional impediments to clinical and translational research. This KCA will develop the regulatory support interactions with the IRB and compliance office to facilitate research without loss of participant protections. A group that is independent of the institutional IRB or compliance office should be identified and will act as a sounding board for potential research participants, serve as their research subject advocate (RSA), and work with investigators to ensure that research involving human subjects places the highest priority for human subjects protections. Regulatory support provided through an IDeA-CTR may not take the place of an institutional compliance or enforcement office nor shall it be responsible for Institutional Review Board (IRB) activities. Instead, it should assist investigators in their documentation requirements for these offices. Other regulatory support activities can include the provision of integrated training, services, or tools for protocol and informed consent authoring and translation, adverse event reporting, and safety and regulatory management and compliance.

If proposed, applicants should describe:

• services to be provided, their selection, and implementation
• interaction with IRBs, IACUCs, and regulatory entities (e.g. FDA)
• operation of the human research subject advocacy resources
• plans for providing formal and informal instruction in scientific research integrity and the responsible conduct of research.
• plans for mitigating or removing institutional impediments to clinical and translational research

5. Technologies and Resources for Core Laboratories

If research resources core(s) are requested, these must be for multiple users and include infrastructure applicable to various disciplines (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering) and for the benefit of researchers and research projects across disease areas. The level of support requested must be justified by the projected use by clinical and translational researchers from among the partner institutions/organizations. The applicant should describe the standard operating procedures of the core, how state-of-the-art techniques will be maintained, how quality control will be managed, how disputes concerning core usage will be resolved, and how research investigators will be trained in the capabilities of the core and the techniques required. Where applicable, participation in national or international quality control and standardization efforts should be outlined. Examples of core resources that can be developed include those for biorepositories, 'omics' technologies (e.g., genomics, proteomics, metabolomics), and technologies for patient monitoring or examination. Activities aimed at reducing redundancy and using, enhancing, or improving existing core facilities rather than creating new cores are strongly encouraged. If applicants propose to acquire new technologies, the plans must be fully justified within the context of the overall proposed program goals. Core facilities supported through this FOA must not duplicate existing facilities within the participating states made available through other NIH funding mechanisms (e.g. INBREs, COBREs, CTSAs). Cost recovery for core support should be sought from funded investigators.

If proposed, applicants should describe:

• the resources that will be offered, plans for their prioritization, availability, applicability to various disciplines, management, user training, and tracking
• the integration of requested resources with similar resources at the institution and any affiliates
• how the institution(s) will anticipate and be responsive to changing needs of the clinical and translational research communities
• plans for participation in national or international quality control and standardization efforts
• plans for cost recovery from funded investigators, where appropriate

Letters of Support: Applicants can provide separate letters from the appropriate high-ranking institutional official(s) that details financial and other support that will be provided by the institution specifically for the KCA/Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Optional Key Component Activities)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Optional Key Component Activities)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Alterations and Renovations)

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 (Alterations and Renovations)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Alterations and Renovations)

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.

Other Attachments:

1. Line drawings should be submitted as described below:
   • Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS). All floor plans must be legible, with the scale clearly indicated.
   • The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.
   • The floor plan should indicate the location of the proposed renovation area in the building.
   • Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished.
   • Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.
   • Indicate the type(s) of new finishes to be applied to room surfaces.
2. Cost estimates including vendor quotes when available.

Project /Performance Site Location(s) (Alterations and Renovations)

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 (Alterations and Renovations)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

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

Budget (Alterations and Renovations)

Budget forms appropriate for the specific component will be included in the application package.

This FOA will provide up to $300,000 in direct costs in Year One of the award as one-time cost expenditure. Direct costs requested for A&R will not be subject to facilities and administrative costs (F&A) and will be in addition to the total costs requested for the applicant IDeA-CTR program.

Sufficient detail must be provided to estimate the cost and the suitability of the project. Failure to adequately justify an A&R request may result in its deletion from the requested budget.

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 (Alterations and Renovations)

Introduction to Application: For Resubmission applications only, an Introduction to Application is allowed for each component.

Specific Aims: The SF424 Application Guide must be followed.

Research Strategy: A&R projects must be relevant to the scope of the proposed research at the institution involved in the research network. Proposed A&R should not include new construction, including completion of shell space, or the purchase of movable research or clinical equipment/instrumentation or equipment intended for teaching or other non-research related purposes. A list of allowable fixed equipment can be found at http://dpcpsi.nih.gov/orip/diic/instru_fixed_equip_s10.aspx (refer to: Allowable as "Fixed Equipment" under C06/G20).

A narrative summary must:

• Relate the proposed renovations to planned activities by the Center. If renovations to animal facilities are proposed, they should be related to the projected animal populations (by species) in anticipated projects. If renovations to animal facilities are proposed, include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included.
• List the functional modules, including the size (dimensions) and square footage of each module (room, alcove, or cubicle) that will be directly affected by the renovation project.
• List engineering criteria applicable to each module (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.
• List appropriate architectural criteria (such as width of corridors and doors, surface finishes).
• List and justify all fixed equipment items requested for the renovated area.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Alterations and Renovations)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Alterations and Renovations)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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.

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: https://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 Applying Electronically.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 Center 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 Center proposed). The merit of each component will also be considered in assigning the Overall Impact Score.

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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?

Will the proposed IDeA-CTR benefit clinical and translational research activities in the partnering and collaborating institutions? Are the overall program vision and strategy adequate to facilitate and sustain clinical and translational research on health concerns prevalent in the target area(s)? Has the Center provided a vision and strategy that are conducive for enhancing and facilitating clinical and translational research efforts in the participating institutions? Will the proposed IDeA-CTR have potential to enhance the competitiveness of the investigators to obtain additional funding for clinical and translational research? Does the application provide strong evidence that the addition of the IDeA-CTR will provide resources that would not otherwise be possible?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or 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?

Leadership: Does/Do the PD/PI(s) have the experience and qualifications to provide scientific and administrative leadership and direction for the IDeA-CTR? Do the PD/PI(s) and PC(s) have the authority, and committed time to administer the proposed IDeA-CTR? Will the PD/PI(s) have sufficient authority and credibility in the institution to work across institutional boundaries? Has/Have the PD/PI(s) shown effective leadership and judgment in the selection of optional KCAs in terms of the KCAs being related to and consistent with the overall goals of the center? Do the program leadership and management team bring complementary and integrated expertise to the project? Does/Do the PC(s) have the requisite background and knowledge that complement those of the PD/PI(s) with respect to managing proposed resources and overall operations of the Center? Has he/she demonstrated an ability to oversee and coordinate research activities?

Innovation

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?

Is the IDeA-CTR positioned to develop new approaches to increasing the ease and efficiency of conducting clinical and translational research in the participating institutions that involve and engage investigators from different disciplines? Is there a well-designed and innovative plan for enhancing communication, coordination and collaboration among investigators, the required and proposed KCAs, and targeted populations?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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?

If the Center 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 children, justified in terms of the scientific goals and research strategy proposed?

Will the proposed IDeA-CTR have the organizational structure that is conducive for and will significantly strengthen clinical and translational research activities at the participating institutions? Do major resources facilitate the objectives of the IDeA-CTR? How well will the components of the Center be integrated with each other? Has the applicant demonstrated the need for all proposed optional KCAs and the effectiveness of these activities to enhance clinical and translational efforts in the participating institutions? Does the application identify key impediments to the performance of translational and clinical research and then propose plans or means to overcome these? Does the applicant indicate how the organization will be adapted to respond flexibly to changes in plans and priorities? Does the IDeA-CTR facilitate intra-institutional, inter-institutional, and multi- or interdisciplinary collaborations? Are plans included to address cross-institutional, geographical, cross-disciplinary, regulatory, and other hurdles? Is the governance plan appropriate for coordinating all proposed programmatic activities, fiscal administration, and personnel and property management? Will the resources be available to researchers in different disciplines? Are the operations and maintenance of resources and facilities appropriate and necessary for the functioning of the IDeA-CTR?

Environment

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?

Is the institutional environment supportive and conducive for achieving the objectives of the IDeA-CTR? Will the PD(s)/PI(s) and PC(s) have adequate support for managing the resources committed by the institution(s) for the IDeA-CTR? Are there adequate cooperative arrangements between participating institutions to ensure that the IDeA-CTR performs effectively as one activity across institutional boundaries? Are there effective lines of communication and cooperation among the IDeA-CTR leadership, KCA/Core Leads and staff, targeted investigators, and the Leadership at the applicant and partnering institutions?

In addition to the above criteria, the following aspects of the IDeA-CTR application will be scored independently AND will be considered in the determination of the overall impact/priority score for the whole application.

Administrative Core

Reviewers will consider the following criteria in the determination of an impact score for the Administrative Core, although scores for the individual criteria will not be provided.

Governance. Is the governance structure designed to ensure the optimal operations and accountability of all components that comprise the IDeA-CTR? Are the organization and administration lines appropriately structured for promoting the discipline of clinical and translational research? Are the lines of administrative responsibilities within the IDeA-CTR and the relationships between the PD(s)/PI(s), PC(s), and the KCA/Core Leads clearly delineated? Are appropriate and well-defined responsibilities described for the PD(s)/PI(s), PC(s), Advisory Committees, KCA/Core Leads, and other involved parties?

Communications. Are the proposed dissemination and communication plans adequate for reaching a wide range of investigators and promoting expansion of clinical and translational research efforts in the state(s)? Are there adequate plans for establishing communication lines between the COBRE leadership and the External Advisory Committee and Institutional Leaders?

Advisory Committees. Is the IDeA-CTR guided by an appropriately constituted Internal Advisory Committee? Does the Internal Advisory Committee include representation from various participating institutions? Has the applicant provided sufficient details of the areas of expertise and requisite qualifications of prospective members who will constitute the External Advisory Committee, and are these qualifications appropriately aligned with the objectives of the IDeA-CTR? Has the applicant provided details of the functional and operational duties and responsibilities of the IAC and EAC? Has the applicant provided appropriate plans for ensuring that the recommendations of the Steering and Advisory Committees will be integrated into the effective fiscal, personnel and scientific management of the IDeA-CTR over the course of the award?

Key Component Activities

Reviewers will consider the following criteria in the determination of an impact score for each KCA, although scores for the individual criteria will not be provided.

Operations and Programs. Are the resources and expertise provided by the KCA/Core adequate and appropriate for accomplishing the overall objectives of the IDeA-CTR and its other component activities? Will this resource be sufficient for intra- and inter-institutional operations? Does the KCA/Core provide appropriate programs, services, and plans for addressing scientific and educational areas important to clinical and translational science that specifically target postdoctoral level professionals and junior faculty from a variety of disciplines and clinical specialties (e.g. MD, DDS, Clinical PhD, Pharm D, RN)? Are there appropriate plans for marketing resources of the KCA/Core to target audience, assisting projected users, and prioritizing projects? Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators? Additional criteria:

• For the Professional Development Core only: Has the applicant provided clear plans for the advancement and retention of investigators interested in pursuing clinical and translational science careers?
• For Optional Key Component Activities: Is the proposed KCA/Core well justified?
• If a Community Engagement and Outreach Core is proposed: Will the resource(s) foster long-term bidirectional relationships between the IDeA-CTR institution(s) and the community for their mutual benefit?
• If an Ethics and Regulatory Knowledge Core is proposed: Are plans for establishing a group that will serve as a research subject advocate sound and appropriate?
• If a Biomedical Informatics and Cyberinfrastructure Enhancement Core is proposed: Are plans for ensuring data security and privacy sound and appropriate?

Personnel. Are the qualifications, experience, and commitment of the KCA/Core Lead and other core personnel appropriate for the functions of the core? Has the core leadership demonstrated appropriate expertise and experience in core capabilities? Are staff members of sufficient number and adequate training to support the needs of the projected pool of junior investigators?

Environment. Is there institutional commitment for this KCA/Core? Will resources, expertise, and support services already provided by existing programs funded by other Federal or non-Federal support be leveraged and utilized in standing up the KCA/Core?

• For Professional Development Core only: Is there a sufficient pool of senior clinical investigators who can serve as advisors to junior faculty?

Pilot Projects Program

Reviewers will consider the following criteria in the determination of an impact score for the Pilot Projects Program, although scores for the individual criteria will not be provided.

Significance: Is the Pilot Projects Program well integrated into the overall goals and objectives of the IDeA-CTR? Is the Pilot Projects Program configured to promote increased research interest and efforts in clinical and translational sciences? Is the Pilot Projects Program designed such that diseases that affect the medically underserved and/or diseases that disproportionately affect populations in the state(s) are prioritized?

Innovation: Is the program structured to allow the development of novel concepts, approaches, and methodologies? Does the program encourage new collaborative research efforts between basic, clinical, and translational researchers from different disciplines and/or programs within and across institutions?

Operation: Is there an adequate plan to solicit proposals, to prioritize the projects, and to review research performance? Are the plans for constituting the review panel, their qualifications and expertise, appropriate to evaluate pilot project applications? Has the applicant provided plans for governance, oversight, and evaluation of the program and supported pilot projects that involve the EAC? Is the program structured such that the required and optional KCAs are utilized and/or leveraged in the conduct of the pilot projects? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections, and to review their methodology?

Environment: Does the institution have a sufficient pool of qualified investigators from whom to solicit applications? Is there institutional commitment for the program?

Tracking and Evaluation Core

Reviewers will consider the following criteria in the determination of an impact score for the Tracking and Evaluation Core, although scores for the individual criteria will not be provided.

Personnel. Are the qualifications, experience, and commitment of the Core Lead and other core personnel appropriate for the functions of the core? Has the core leadership demonstrated appropriate expertise and experience in tracking and evaluation? Are staff members of sufficient number and adequate training to support the tracking and evaluation needs for all the components of the IDeA-CTR?

Approaches and Plans. Is there an evaluation plan that includes key milestones for the overall program and for each key component? Is the plan adequate to evaluate the short-term and long-term goals for each of the proposed key activities? Do the milestones and timelines provide feasible objectives, and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed? Are the measures valid for the program’s goals to be assessed and how accessible and practical are the available data sources? Are appropriate diagnostic, formative, and summative assessments provided for all key components?

Alterations and Renovations

Reviewers will consider the following criteria in the determination of an impact score for the Alterations and Renovations, although scores for the individual criteria will not be provided.

Scientific Need. Are requested alteration and renovation projects relevant to the scope of the proposed activities of the IDeA-CTR? Are the costs and suitability of the project justified? If renovations to animal facilities are proposed, do the proposed renovations relate to the projected animal populations (by species)? If renovations to animal facilities are proposed, are the lines of authority and responsibility for administering the institution's animal care and use program indicated?

Architectural Plans. Are the projected costs commensurate with the architectural plans for the proposed A&R? Are there lists of the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project? Are there appropriate descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is justification provided for all fixed equipment items requested for the renovated area?

Are legible line drawings provided for all floor plans with the scale clearly indicated? Are the line drawings of the proposed renovation drawn to a scale adequate to explain the project? Do the drawings indicate size (dimensions), function, and net and gross square feet of space for each room? Are the total net and gross square feet of space to be renovated provided? Does the plan indicate the location of the proposed renovation area in the building? Does the plan include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished? Do the plans indicate changes or additions to existing mechanical and electrical systems in notes made directly on the plan or attached to the plan? Do the plans indicate the type(s) of new finishes to be applied to room surfaces?

As applicable for the overall application and each component 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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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.

Inclusion of Women, Minorities, and Children

When the proposed project 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 children 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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period. Has the applicant provided justification for another 5 years of support? Has previous support allowed the Center to achieve specific benchmarks? Has the IDeA-CTR made or is starting to make an impact on some of the major health concerns prevalent in the state(s)? Is there evidence that a critical mass of clinical and translational investigators has been (or is being) established? Have new investigators been recruited to the Center and have these efforts been successful in increasing the clinical and translational research capacity of the institution? Is there evidence that the KCAs/Cores supported by Center were sufficiently utilized and were instrumental in enhancing clinical and translational research capabilities in the participating institutions?

Revisions

Not Applicable.

As applicable for the overall application and each component 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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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 NIGMS 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.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the NIGMS Advisory 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.

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.

Awardee-selected pilot projects require approval by NIH prior to initiation. The awardee institution will provide NIH with the following documents for review:

• Pilot research proposal.
• Funding recommendation by the IDeA-CTR External Advisory Committee.
• For pilot projects that involve human subjects:
  • Written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan, Part II Section 4 in the instructions must be completed as appropriate.
  • For clinical trials, provide specific plans for data and safety monitoring, and for notifying the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.
  • IRB approval.
  • Certificate of training on human subjects protections for all personnel involved in the project.
• For pilot project that involve vertebrate animals:
  • Written protocol addressing the 5 points as indicated above (Additional Review Criteria, Vertebrate Animals).
  • IACUC approval.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Program Director/Principal Investigator (PD/PI) and Program Coordinator (PC) will have the primary responsibility for:

• Oversight and management of all the Key Component Activities.
• Working towards developing, adopting and implementing the agreed on policies, procedures, best practices, or other measures for developing clinical and translational capabilities among the collaborating and partnering institutions.
• Providing the NIH Program Officer(s) annual written progress reports, and periodic supplementary reports upon request.
• Participating in the overall coordination of IDeA Program-wide efforts in clinical and translational research. This participation may include collaboration and consultation with other IDeA program awardees and/or other clinical and translational research awardees and the sharing of information, data, and research materials.
• In consultation with the Steering Committee, selecting the core leads, resolving disputes arising in the priority of usage of the KCA/core resources and facilities, and for final budget decisions.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH Program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIGMS will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to each IDeA-CTR.

An NIH Program Official will be responsible for the normal programmatic and scientific stewardship of the award and will be named in the award notice. The program official(s) will:

• enforce general statutory, regulatory, or administrative assistance policy requirements;
• evaluate progress by reviews of technical or fiscal reports or by staff visits, to determine that performance is consistent with objectives, terms, and conditions of the award;
• ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer reviewed funding mechanisms;
• interact with each IDeA-CTR, coordinate approaches between national programs, and contribute to the adjustment of projects, programs, or approaches as warranted;
• provide assistance in reviewing and commenting on all major transitional changes of individual IDeA-CTR activities prior to implementation to ensure consistency with the goals of this FOA;
• link the approaches developed from these partnerships to other IDeA-CTRs and, as appropriate, to other IDeA Program awardees (e.g. INBREs, COBREs) to ensure that information is shared and utilized on the widest basis possible;
• monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success;
• provide financial oversight of the Program.

NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:

• coordinate activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new clinically useful resources and methodologies;
• review and comment on critical stages in the program implementation;
• assist in the interaction between the awardee and investigators at other institutions to promote collaborations;
• coordinate access to other resources available through statewide, regional, or national specialized technology cores;
• retain the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
• retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget.

Additionally, the NIH Program Official may recommend the termination or curtailment of an investigator or KCA/Core in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility Include:

Awardees agree to governance, through voting and decision making, of the IDeA-CTR through a Steering Committee. Steering Committee voting membership shall consist of the Principal Investigator, Program Coordinator(s), a senior institutional official from the lead institution, and NIGMS Program staff [Project Scientist(s)]. The IDeA-CTR PD/PI will serve as chairperson of the steering committee. Quarterly meetings of the Steering Committee will ordinarily be held by telephone conference call in the first year of the award. Frequency of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period. In person meetings will be held once yearly in Bethesda, MD. Each member of the Steering Committee will have one vote. The IDeA-CTR leadership will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

J. Rafael Gorospe, M.D., Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-435-0832
Email: [email protected]

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-7706
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 Parts 74 and 92.