Part 1. Overview Information

Key Dates

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

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   



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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The American Indian/Alaska Native (AI/AN) populations have long experienced disparities in health compared with other Americans. Multiple factors, including limited access to health care, the distrust of health-related research due to trauma inflicted on the AI/AN communities by past unethical and inappropriate research practices, and limited opportunities for AI/AN tribes to lead health research, have contributed to these disparities. The NARCH program was launched in 2000 to help reduce the distrust of health research by the AI/AN communities, promote AI/AN health research prioritized and led by eligible AI/AN tribal entities, and ultimately improve AI/AN health. To enhance the program’s efficacy in meeting its goals, NIGMS completed a comprehensive NARCH program evaluation culminating in a formal Tribal Consultation in 2021. Taking into account recommendations received through the Consultation, this Funding Opportunity Announcement (FOA) will strengthen NARCH’s support for health-related research, research career enhancement, and research infrastructure enhancement projects prioritized and led by eligible AI/AN tribal entities.

Program Description

A NARCH award supports health-related research, research career enhancement, and/or research infrastructure enhancement projects at one or more eligible AI/AN tribal entities (See Part II. Section III. Eligibility Information. An applicant organization must be one of the eligible AI/AN tribal entities, and must be committed to supporting a NARCH and its goals. The applicant organizations should also have the research administrative infrastructure to manage the multiple-component grant. An applicant organization (see Section III, Eligibility Information), may partner with other eligible AI/AN tribal entities as well as additional non-AI/AN organizations. In such cases, 60% or more of requested funds must remain with the eligible AI/AN tribal entities.

A NARCH supports an Administrative Core and one or more of the following components:

• Research Projects (RPs)
• Pilot Project Program (PPP)
• Career Enhancement Projects (CEPs)
• Research Infrastructure Enhancement Projects (RIEPs)

Each proposed component must contribute toward the overall goals of the NARCH. Each proposed component should be led by an individual with relevant expertise and experience. The PD(s)/PI(s) of the NARCH award may lead other proposed components in addition to the Administrative Core. Each proposed component will be reviewed on its own merit and may be selected for funding even if other components in the same application are not.

Administrative Core (Required): The Administrative Core (AC) manages the NARCH award and coordinates the Center’s activities. Its responsibilities include, but are not limited to, managing the NARCH's budget, preparing and submitting accurate and timely program and financial reports, ensuring all activities supported by the award are compliant with federal regulations, organizing and coordinating Center-wide activities such as seminars and workshops for research and career development, and coordinating activities of the proposed components. The AC is located within the applicant organization, led by a PD/PI, and supported by a staff needed to carry out the responsibilities. The AC should work closely with relevant components of the grantee organization, such as the Sponsored Programs Administration or Grants and Contracts Office, as well as those at any sub-contracting organizations, in order to carry out its functions.

Research Projects (RPs): RPs support innovative and culturally appropriate health-related research prioritized by the applicant organization and partner organizations that are eligible AI/AN tribal entities , if applicable. The research project(s) should focus on issues related to AI/AN health including strengths and resiliency factors contributing to and conditions hindering AI/AN health, mechanisms underlying diseases or conditions that are prevalent in AI/AN communities, and/or the development, implementation, and evaluation of interventions that address health challenges faced by the AI/AN communities. The scope of a project should be appropriate for 5 years of funding concurrent with the NARCH award. The RP Leader (RPL) should have expertise in the subject area. If the research involves human subjects, gaps in the RPL’s scientific and regulatory knowledge relevant to the study must be adequately addressed through mentorship, collaboration, and training. A NARCH may support up to three RPs. A RPL may not lead another RP or a pilot project supported by NARCH grants awarded to the same grantee organization simultaneously .

Pilot Project Program (PPP): A NARCH award may support a PPP to fund exploratory and/or preparatory research as Pilot Projects (PPs). PPs should be limited in scope compared to RPs but with the potential to develop into RPs. Each PP may have up to two years of support and should be led by Early Stage Investigators (ESIs) or New Investigators as defined by NIH. The PPP Director (PPPD) should have experience in mentoring, health-related research, and knowledge in culturally appropriate research approaches. The PPPD manages the solicitation and review of PP applications, and selection of meritorious projects for funding. The PPPD also assumes oversight responsibilities of funded PPs, including those with human subjects. A PP Leader (PPL) may not lead more than one PP nor a RP supported by NARCH grants awarded to the same grantee organization simultaneously . The PPPD is ineligible to receive a PP from the NARCH.

Career Enhancement Projects (CEPs): A CEP supports culturally appropriate career development programs to enhance knowledge and research skills of current and/or next generation participating health researchers. Participants of a CEP may be early career investigators, post-doctoral fellows, graduate students, undergraduate students, and/or high school students interested in AI/AN health-related research. Proposed program activities may include, but are not limited to, research internships, workshops, and courses. A CEP may support participants to attend career enhancement programs sponsored by organizations other than those supported by the NARCH award. A CEP Leader (CEPL) should be an investigator with experience in mentoring, career development, research, and knowledge of culturally appropriate research, mentoring and educational approaches. A NARCH can support up to two CEPs.

Research Infrastructure Enhancement Projects (RIEPs): RIEP projects aim to address a specific research infrastructural need of the NARCH. Examples of an RIEP can include, but are not limited to, support of technological or methodological cores that develop or strengthen technical capacity needed for health-related research at the applicant and partner organizations that are eligible AI/AN tribal entities; research resources such as a bio- or data-repository; or research administration infrastructure such as Tribal Institutional Review Boards (IRBs). An RIEP leader should have expertise in the appropriate area of scientific capacity building. A NARCH can support up to two RIEPs.

While NIGMS leads this FOA and will manage the NARCH awards, NIH Institutes, Centers, and Offices (ICOs) participating in the FOA are committed to fund meritorious components that align with their research interests. A description of the participating NIH ICO's areas of scientific interest for this FOA can be found at Research Interests of NIH Institutes, Centers, and Offices Participating in NARCH.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

The applicant organization must meet one of the following criteria:

• A federally recognized AI/AN tribe, as defined under 25 U.S.C. 1603(14); or
• A tribal college or university, a tribal health program, or a tribal organization as defined under 25 U.S.C. 1603 (24), (25), and (26), respectively; or
• A consortium of two or more of those tribal entities.

Specifically, an application may include foreign components only if one or more AI/AN tribes with ancestral catchment areas crossing the U. S. border will participate in the proposed NARCH.

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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) of the NARCH award assumes overall scientific and administrative leadership of the Center, including oversight responsibilities of research activities involving human subjects.The contact PD/PI must have a primary appointment with the applicant organization. For multi-PD/PI applications, a non-contact PD/PI's primary appointment may be with the applicant organization or a partner organization that is one of the eligible AI/AN tribal entities. PDs/PIs employed at eligible AI/AN tribal entities through special employment arrangements, such as inter-organizational personnel agreements among federally recognized AI/AN tribes, are allowable.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

An eligible AI/AN tribal entity that is not being supported by an active NARCH award may submit up to two applications in the same submission round, provided there are no overlapping components in the applications. An applicant organization that plans to submit two applications should discuss these plans with NIGMS Scientific/Research Contact listed in Section VII. Agency Contacts .

An eligible AI/AN tribal entity that is being supported by an active NARCH award, either as a recipient organization or a partner organization, is eligible to submit one more application, either as an applicant or a partner organization, provided there are no overlapping components between the application and the active award. An eligible AI/AN tribal entity that is currently supported by an active NARCH award (including No Cost Extension (NCE)) should discuss plans to submit a new application with the NIGMS Scientific/Research Contact listed in Section VII. Agency Contacts .

An eligible AI/AN tribal entity that is being supported by two active NARCH awards (including awards in a funded extension or in an NCE) either as a recipient organization and/or a partner organization, cannot receive a new NARCH award as the recipient/applicant organization or a partner organization. If such an organization submits applications in anticipation of expiration of one or both of its current NARCH awards, a new award can only be made after a current one is terminated.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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 organizations(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Crystal Richards, Ph.D.
National Institute of General Medical Sciences
Email:[email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

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 must consist of the following components:

• Overall
• Administrative Core

At least one of the following components is also required. If more than one of these components is proposed, any combination is allowable:

• Research Projects
• Pilot Project Program
• Career Enhancement Projects
• Research Infrastructure Enhancement Projects

Overall Component

When preparing your application, use Component Type Overall .

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

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 Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this 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, an Introduction to Application is required in the Overall component.

Specific Aims:. Provide specific aims for the overall Center.

Research Strategy: This section should describe:

• The goal of the proposed Center and its alignment with those of the NARCH program in advancing research, research career enhancement, and research infrastructure enhancement prioritized by the AI/AN community.
• The applicant organization's plans for advancing AI/AN health-related research and its commitment to support the proposed Center.
• The current state of the health-related research enterprise at the applicant organization and, if applicable, partner organizations that are eligible AI/AN tribal entities.
• The grants administration infrastructure of the applicant organization, including areas of weakness and plans to address them if the application is funded.
• The overall organization of the Center.
• How each proposed component contributes to the overall goals of the Center and will help advance the health of the AI/AN communities the Center will serve.
• How the Center will support the proposed projects' ability to incorporate and address cultural considerations in their approaches.
• For applications that include partner organizations, past collaborations with the partner organizations, accomplishments of these collaborations, and how the partner organizations will contribute to the proposed Center.
• Plans for ensuring that the research, career development and capacity building agendas are set by the Tribe(s) involved and that appropriate credit will be given for work conducted by Tribal members.

Letters of Support: Tribal Resolutions or Tribal Letters of Support for the application and any specific components should be included in this section and should include the proposed Center’s name, grant application title, and any relevant component or project title name. All projects proposed in the application should have the approval of the Tribal governments with jurisdiction over each AI/AN tribe involved in the Center.

If an application includes partner organizations, a letter (or resolution) of support from each of these organizations should also be included and should contain the title of the application and the name of the specific projects. The roles and commitments of the partner organization should be clearly described in the letter/resolution.

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

• NIH requires a consolidated DMS attachment which must include a plan for each research component. Please note, NIH recognizes Tribal sovereignty and the rights associated with Tribal sovereignty around data collection, data management and sharing of data and has published a supplemental Notice regarding the DMS Plan for AI/AN populations, NOT-OD-22-214.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

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 attachments 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 the 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.

A PD/PI is required to serve as the Administrative Core (AC) leader, being assisted by a staff needed to manage the grant and activities of the Center.

Budget (Administrative Core)

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

The AC budget may not exceed $100,000 direct costs (DC) per year, excluding consortium F&A.

Funds may be requested for:

• Compensation for the PD(s)/PI(s) effort devoted to the Center.
• Support of other staff critical to fulfilling the functions of the AC such as managing the Center’s budget, organizing workshops and retreats, and overseeing the Center’s project evaluations.
• Hiring advisors or consultants to provide counsel to the PD/PI on scientific and/or administrative matters.
• Covering costs of activities organized for the AC and Center staff, such as career and skills development workshops and seminars .
• PD/PI travel to Center relevant meetings .

Funds from the AC budget cannot be used for project leaders travel or expenses for non-AC activities.

An honorarium is not an allowable expense when the primary intent is to confer distinction on, or to symbolize respect, esteem, or admiration for, the recipient of the honorarium. A payment for services rendered, including a speaker's fee, is allowable.

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, an Introduction to Application is allowed for each component.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The AC assists the PD/PI in managing the award and coordinating proposed projects. This section should describe:

• A management plan for the Center, including descriptions of the structure of the Center and how the AC will work with leaders of proposed components to coordinate their activities and facilitate collaboration.
• If partner organizations are included in the application, a plan to develop effective partnerships between the applicant and partner organizations, including how resources will be allocated among partners and how activities at different organizations will be coordinated.
• A plan for the coordination of the components progress and financial reports.
• How information regarding the Center’s activities and projects progress will be communicated across the Center and with the participating AI/AN communities
• How information about other training and funding opportunities will be disseminated to Center personnel and AI/AN communities.
• A description of activities such as research and career development seminars or workshops the AC plans to organize.
• A plan for culturally-appropriate mentor training who will be involved in the Center's programs.
• A plan for coordinating the evaluations of the Center’s other components including metrics, benchmarks, and timelines to assess the overall success of the Center and its impact on the AI/AN community being served.
• If advisers or consultants are to be appointed to provide strategic counsel, the leadership qualities and expertise desired of the advisers/consultants, and a plan on how they will work with the PD/PI and the AC staff.

Letters of Support: No Letters of Support should be included here. Tribal Resolutions or Tribal Letters of Support for the Center are provided under the Overall section, and should be reviewed for support of the AC.

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Research Project

When preparing your application, use Component Type Project.

A RP should address one or more significant questions of health-related research prioritized by the participating organizations that are eligible AI/AN tribal entities. A project in the application may be selected for funding while other projects are not. Therefore, a RP does not have to be scientifically tied in with other projects proposed in the application. Preliminary data are neither required nor expected. A mentor for the RPL may be included.

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

SF424 (R&R) Cover (Research Project)

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 (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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) (Research Project)

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 attachments for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with the 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 (Research Project)

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

In general, a Research Project (RP) budget may not exceed $200,000 DC per year per project, excluding consortium F&A. Exceptions will be considered for RPs that include a clinical trial and are well justified.

RP budgets should be planned for 5 years and may include salary support for the project leader, postdoctoral research associates, graduate and undergraduate research assistants, and other research assistants for the level of effort devoted to the project.

Mentoring costs are allowable if a mentor for the Research Project Leader (RPL) is included.

In addition to personnel costs, the RP budget may include supply costs, acquisition of new equipment and modernization of existing instrumentation needed to complete the research project.

Funds may be used to develop or enhance appropriate community engagement, including Tribal Community Advisory Boards, recruitment and retention efforts, and validation of metrics.

A RPL may not receive simultaneous funding for another RP nor PP under the Center.

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 (Research Project)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The Research Strategy section should describe:

• The research question or questions to be addressed, relevant background information, and the overall goal of the project. Barriers to progress in the field and how cultural constructs and acceptability are considered in the research approach should also be described.
• The significance of the research, including its potential in enhancing scientific understanding and/or its potential impact on improving AI/AN health. Impact on the health of a specific tribe or study population is significant in this context. The study outcome does not need to be generalizable to other AI/AN communities or the broader population.
• A research plan that focuses on general strategies, approaches, timelines, and milestones, instead of specific experimental procedures or protocols. Culturally appropriate approaches and methodologies to the AI/AN communities are encouraged to be incorporated into the research plan.
• If the research involves human subjects, provide a plan to address any gap in the RPL’s scientific and regulatory knowledge base relevant to the study.
• A research workforce development plan including how researchers will attain needed research skills, and how the researchers will be mentored by the RPL and/or others available through the Center.
• If a mentor for the RPL is included, how the mentor will help the RPL advance the research project and RP's career.
• How the RP will help enhance the RPL’s career.
• A plan to disseminate the research results to the participating AI/AN communities and organizations, as well as the broader AI/AN and other communities.
• A plan to coordinate with the AC to share administrative capacity and resources.
• An evaluation plan including metrics and benchmarks.

Letters of Support: No Letters of Support should be included here. Tribal Resolutions or Tribal Letters of Support for the Center and all components are provided under the Overall section, and should be reviewed for support of the RP.

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Pilot Project Program

When preparing your application, use Component Type Project.

The PPP develops and manages an internal funding mechanism to support exploratory and/or preparatory PPs that are limited in scope and have the potential to produce preliminary results for future research awards. PPs may address any question in health-related research areas prioritized by the participating organization(s) that are eligible AI/AN tribal entities without being tied into those addressed by any RPs proposed in the application. Individual PPs should not be described in the application, as they are solicited, reviewed, and funded post-award.

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

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project 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 Project 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 Project Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with the 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 Project Program)

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

The Pilot Project Program (PPP) budget may not exceed $200,000 DC per year, excluding consortium F&A.

Each pilot project may be funded for up to $65,000 DC for 1 year and may be renewed once.

A salary appropriate for the PPP Director’s effort is allowable under the PPP budget.

Salaries for the Pilot Project Leader (PPL), postdoctoral research associates, graduate and undergraduate research assistants, and other research assistants efforts devoted to the project are allowable.

Costs for supplies, acquisition of new equipment and modernization of existing instrumentation needed to complete the project are allowable.

Funds may be used to develop or enhance appropriate community engagement, including Tribal Community Advisory Boards, recruitment and retention efforts, and validation of metrics.

A PPL may not receive simultaneous funding for another PP nor RP of the Center.

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 Project Program)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The research strategy section should describe :

• The goals of the PPP and the potential impact on the AI/AN communities and the careers of the PPLs.
• Eligibility criteria for PPLs, if any, beyond the requirement that they must be Early Stage Investigators (ESIs) or New Investigators as defined by NIH.
• Plans for solicitation, review, and selection of PP applications. Include information on how the program will maintain adherence to AI/AN research area prioritization and cultural acceptability.
• Plans for providing oversight of funded PPs, including specifics on providing timely and accurate progress and financial reports, and assuring full compliance by all PPs of applicable federal policies and guidelines for research involving human subjects, vertebrate animals, and/or biohazards.
• A plan for how PPLs will be mentored to enhance their pilot project and career development.
• A plan to coordinate with the AC to share administrative capacity and resources.
• A plan to encourage collaborations among PPs and with RPs and other components if applicable for research synergy and resource sharing.
• A plan to disseminate the research results to the participating AI/AN communities and the broader AI/AN and other communities.
• An evaluation plan for the PPP, including metrics and benchmarks.

Letters of Support: No Letters of Support should be included here. Tribal Resolutions or Tribal Letters of Support for the Center and all components are provided under the Overall section, and should be reviewed for support of the PPP.

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

Appendix: Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Career Enhancement Project

When preparing your application, use Component Type Career Enhancement.

A CEP supports the design and implementation of career development program(s) to enhance knowledge and research skills of current and/or future health-related researchers invested in AI/AN health. NIGMS encourages CEPs to incorporate development of participants' quantitative and computational skills as part of their planned activities. A CEP does not have to be tied in with or depend on other projects proposed in the application. A project in the application may be selected for funding while other projects are not.

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

SF424 (R&R) Cover (Career Enhancement Project)

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 (Career Enhancement Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Career Enhancement Project)

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) (Career Enhancement Project)

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 (Career Enhancement Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with the 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.

The biosketch for the CEP project leader should provide information about their mentoring experience.

Budget (Career Enhancement Project)

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

In general, a Career Enhancement Project (CEP) budget may not exceed $200,000 DC per year per project, excluding consortium F&A. Exceptions to the CEP budget cap will be considered, but must be well justified.

Costs for individuals to participate in CEPs, such as compensation for time involved in activities, travel and supplies, are allowable.

Costs for professional efforts in designing and/or delivering the curricula or program and mentoring participants are allowable.

Costs for supplies and travel for the CEP are allowable.

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 (Career Enhancement Project)

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

Specific Aims: The SF424 application Guide must be followed

Research Strategy: The research strategy section should describe:

• The goals of the CEP and how it will impact the participants engagement in biomedical and behavioral research.
• The design of the program, including:
  • its target participants
  • the health-related research area(s) that the program will focus on
  • an overview of the curriculum or program
  • venue and/or approaches of delivering the curriculum or program
  • project structure
  • plans to ensure a safe and supportive environment for participants
  • timeline
  • and anticipated outcomes

Culturally appropriate approaches, including any adaptations of current curriculum models or research exposure programs, should be described.

• The eligibility criteria of participants and a plan for the recruitment, selection, and support of participants.
• A plan to coordinate with the AC to share administrative capacity and resources.
• A plan to coordinate with other components of the Center, if applicable, to benefit from opportunities they may provide.
• An evaluation plan of the project, including metrics and benchmarks.

Letters of Support: No Letters of Support should be included here. Tribal Resolutions or Tribal Letters of Support for the Center and all components are provided under the Overall section, and should be reviewed for support of the CEP.

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

Appendix: Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Career Enhancement Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Research Infrastructure Enhancement Project

When preparing your application, use Component Type Capacity Building.

A Research Infrastructure Enhancement Project ( RIEP) aims to address a specific research infrastructural need within the participating organizations that are eligible AI/AN tribal entities. A RIEP does not have to be tied in with or dependent on other projects proposed in the application. A project in the application may be selected for funding while other projects are not.

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

SF424 (R&R) Cover (Research Infrastructure Enhancement Project)

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 (Research Infrastructure Enhancement Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Infrastructure Enhancement Project)

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) (Research Infrastructure Enhancement Project)

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 attachments for additional entries.

Research & Related Senior/Key Person Profile (Research Infrastructure Enhancement Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with the 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.

The biosketch for the RIEP project leader should provide information relevant to their ability to lead the proposed project.

Budget (Research Infrastructure Enhancement Project)

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

A Research Infrastructure Enhancement Project (RIEP) budget may not exceed $200,000 DC per project per year, excluding consortium F&A.

Funds may be requested for:

• Procuring appropriate equipment, software, service, and access to data management and cloud computing services.
• Establishing, maintaining, and/or improving facilities that are essential to support the RIEP. Additionally, costs for acquisition and modernization of instrumentation and supplies to support the RIEP may be requested.
• Development, enhancement or maintenance of necessary administrative services to support health-related research, including IRBs or sponsored programs administration functions.
• Covering costs incurred for training users of the RIEP.
• Providing salaries for key personnel’s professional efforts to support the RIEP.

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 (Research Infrastructure Enhancement Project)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The research strategy section should describe:

• The goals of the RIEP.
• The needs for the RIEP and how it will enhance the research capacity of the Center and the AI/AN communities it serves, as well as any potential career opportunities the RIEP may create.
• The design of the research infrastructure to be developed and/or strengthened, including overall structure and the primary technology or service to be provided. Include any cultural constructs and adaptations considered in the RIEP.
• The timeline with milestones of the project.
• A management plan for the operation of the RIEP and how service will be provided.
• A plan to coordinate with the AC to share administrative capacity and resources.
• A plan to coordinate with other components, if applicable, to maximize the impact of the research infrastructure.
• An evaluation plan of the RIEP, including metrics and benchmarks.

Letters of Support: No Letters of Support should be included here. Tribal Resolutions or Tribal Letters of Support for the Center and all components are provided under the Overall section, and should be reviewed for support of the RIEP.

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

Appendix: Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Infrastructure Enhancement Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

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

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Center demonstrate the potential to impact the health needs and advance health-related research, research careers, and/or research infrastructure prioritized by the AI/AN community?

Will implementation of the Center’s plans provide the AI/AN tribal entities with the ability to grow their research capacity or generate other research-related benefits?

Does the Center address AI/AN cultural considerations adequately?

If a partnership is proposed, how does the partnering organization contribute toward enhancing the Center?

Investigator(s)

Do the PD(s)/PI(s) have the skills and experience to lead the Center and provide adequate scientific and administrative oversight to components?

Do the PD(s)/PI(s) devote adequate effort to leading the Center?

Do other Key Personnel and collaborators (e.g., mentors, Research Project Leaders, Career Enhancement Project Leaders, Pilot Project Program Leaders, Research Infrastructure Enhancement Project Leaders) have the necessary skills and experience to carry out their roles successfully?

If a partnership is proposed, how do the partnering organization's associated staff provide skills and knowledge that will contribute toward the success of the Center?

Innovation

Will the Center be able to support components or projects with the potential to bring new understanding to current health interventions or develop new interventions specific for the health of the AI/AN community?

Will the Center encourage and support innovative approaches for, and innovations in, research, research career enhancement, or infrastructure enhancement?

If applicable, are innovative research approaches proposed?

If applicable, are the novel approaches proposed to enhance the research careers of participants reasonable?

If applicable, are the approaches to enhance the health research infrastructure innovative?

Are novel methods of incorporating culturally-appropriate research or career development approaches proposed?

If a partnership is proposed, how does the partnering organization bring knowledge and skills to enhance the innovation of the Center?

Approach

Does the Center have a well-designed structure to manage and support the components?

Does the application encourage and support culturally appropriate approaches?

Does the application demonstrate the potential to strengthen tribal engagement in health-related research by the involved AI/AN community?

If a partnership is proposed, does the partnering organization bring knowledge and skills to enhance or support the proposed approaches of the Center?

Are adequate plans in place to ensure tribal community members receive appropriate credit for their research activities supported by the Center?

Is it clear that the research agenda is being set by the AI/AN tribal entities involved?

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?

Are there adequate resources and infrastructure at the applicant organization to support the overall goals of the Center?

Does the applicant organization propose adequate plans or steps to improve on areas of infrastructure weakness?

Are the grant administration resources at the applicant organization adequate to manage the award?

Are the participating organizations' strategic priorities in line with the Center's goals?

If a partnership is proposed, how will the partnering organization contribute positively toward the success and sustainability of the proposed work?

Administrative Core (AC)

Does the AC have the potential to manage the Center’s budget, and submit accurate and timely financial reports and progress reports in conjunction with the appropriate administrative components of the applicant organization(s) such as sponsored programs or grants and contracts offices?

Does the AC have a sound plan to support the Center’s components and facilitate collaboration among them?

Are the roles and responsibilities of the PD/PI and other key personnel in the AC well-thought-out and clearly described?

Does the AC offer quality Center-wide activities such as seminars and workshops that help develop the research environment of the Center and provide skills and knowledge to staff that will contribute toward building the capacity of the participating organizations?

Is the proposed mentor training program effective and culturally appropriate?

Does the AC have a sound plan to coordinate evaluation of the components?

Research Project (RP)

Will the RP address important health-related issues and have the potential to positively impact the involved AI/AN community, including enhancing support of, and involvement in, health-related research?

Is the research plan culturally appropriate and will the research methodologies incorporate the cultural expectations of the participating AI/AN community?

Will the RP contribute to the development of biomedical scientists and health-related research professionals focused on AI/AN health?

Will the RP facilitate the research career development of the project leader?

Will the RP have the potential to enhance the research capacity of the AI/AN tribal entities and grow their research enterprise?

Are the infrastructure and resources adequate to support the RP or if new infrastructure and resources are proposed to strengthen support of the RP, are they adequate?

Is the Research Project Leader (RPL) well suited to lead the project? If certain expertise is lacking, is there a sound plan to provide support to the RPL?

Does the RPL demonstrate competency to work with the participating AI/AN community or are key personnel and/or mentors included who have knowledge and experience working within the AI/AN community?

Is there a sound plan to evaluate the impact of the RP on the AI/AN community and the RPL?

If a partnership including non-AI/AN organizations is proposed, how will the non-AI/AN partnering organization(s) bring expertise to help and enhance the AI/AN organization's effort on the RP ?

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and interventions that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?

With regard to the proposed leadership for the project, do the RPL and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multi-center trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Does the application adequately address the following, if applicable:

• Study Design
  • Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? Is the prior preclinical and/or clinical research that serves as the key support for the proposed project rigorous? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
  • Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
  • Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
• Data Management and Statistical Analysis
  • Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
  • If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Pilot Project Program (PPP)

Are the goals of the PPP well-thought-out, clearly described, and aligned with the overall goal of the Center?

Is there a well-designed and clearly described management plan for the PPP?

Does the plan to solicit, review, and select pilot projects inspire confidence in achieving the PPP goals?

Does the PPP have a clear emphasis on the importance of A I/AN cultural acceptability of research and have plans to accommodate cultural expectations of the participating AI/AN communities?

Will the PPP have the potential to address health issues pertinent to and prioritized by the AI/AN community involved?

Will the PPP have the potential to contribute to the development of biomedical scientists and health research professionals focused on AI/AN health?

Will the PPP have the potential to enhance the research capacity of the AI/AN tribal entities and sustain or grow its research enterprise?

Is the PPP Director well suited to lead the PPP, including providing mentorship to PPPLs if the proposed activities involve human subjects and/or clinical trials? If the PPP Director is lacking certain expertise, are key personnel involved to provide support to the PPP Director?

Is there a sound plan to evaluate the PPP, including benchmarks and metrics of the program?

If a partnership including non-AI/AN organizations is proposed, how will the non-AI/AN partnering organization(s)bring expertise to help and enhance the AI/AN tribal entity's effort in leading the PPP ?

Career Enhancement Project (CEP)

Does the CEP adopt culturally-appropriate approaches tailored to the career development needs of professionals, students or other program participants invested in AI/AN health?

Does the overall design and proposed curriculum and/or programs of the CEP inspire confidence in achieving its goals?

Does the CEP provide adequate training on conducting culturally appropriate health-related research?

Is the CEP likely to contribute significantly to the participants' career development?

Does the CEP leader have the scientific and career development expertise and cultural knowledge to lead the CEP?

Does the management plan of the CEP support effective operation and collaboration with the AC and other components of the Center?

Is there a sound plan to evaluate the impact of the CEP, including benchmarks and metrics?

If a partnership including non-AI/AN organizations is proposed, how will the non-AI/AN partnering organization(s)bring expertise to help and enhance the AI/AN organization's effort in leading the CEP ?

Research Infrastructure Enhancement Project (RIEP)

Will the RIEP build research infrastructure that addresses important needs of the AI/AN tribal entities involved ?

Will the research infrastructure create research and career opportunities that benefit the involved AI/AN tribal entities?

Are the plans for enhancing the infrastructure well conceived?

Does the RIEP leader have the scientific expertise and cultural knowledge to lead the RIEP?

Does the management plan of the RIEP inspire confidence in efficient and effective operation of the infrastructure?

Is there a sound plan to evaluate the impact of the RIEP, including benchmarks and metrics?

If a partnership including non-AI/AN organizations is proposed, how will the non-AI/AN partnering organization(s) bring expertise to help and enhance the AI/AN tribal entity's effort in leading the RIEP ?

As applicable for the proposed Center, 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Not Applicable

Revisions

Not Applicable

As applicable for the proposed center, 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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions consistent with applicable law:

• 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.
• Breadth of the Institute's portfolio, including number of organizations supported and geographic distribution of awards.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Post Award Program Requirements

The Project Leads are key personnel named on the Notice of Award.

If a Project Leader leaves the Center, the grantee must notify NIGMS immediately and not wait until a replacement Project Leader has been identified.

If a Pilot Project Program is proposed, prior approval by NIGMS is required before a new Pilot Project can begin.

Prior Approval of Pilot Projects

The following documentation for each Pilot Project (PP) and Replacement Pilot Project (RPP) must be submitted to NIGMS staff for administrative review:

Using PHS398 forms and instructions, only the following sections need to be submitted:

• Face Page (PP and RPP, signed by institutional signing official)
• Project Summary (PP and RPP)
• Research Strategy Section (PP and RPP)
• Updated Other Support (PP and RPP)
• Biographical Sketch (PP and RPP)
• Detailed budget and budget justification (PP and RPP)
• Checklist Format Page with F&A cost breakdown (PP and RPP)
• Letter of Support from participating Tribal government (PP and RPP).

If the proposed study involves human biospecimens or data, include:

• Current PHS Human Subjects and Clinical Trials Information Form

If the proposed study involves Human Subjects, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Tribal Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt)

If the proposed project involves Clinical Trials, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Tribal Institutional Review Board (IRB) approval
• Documentation of Investigational New Drug (IND)/Investigational Device Exemption (IDE) status for studies that are subject to FDA regulation
• Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification
• For all clinical trials, in addition to the information requested in Section 3.3 of the PHS Human Subjects and Clinical Trials Information form, the awardee institution will provide NIGMS with a statement detailing the risks to study participants, the frequency of monitoring of clinical trial data and participant safety, and the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and clinicaltrials.gov registration and results reporting.

Note: For Human Subjects or Clinical Trials, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval.

If the proposed project involves Vertebrate Animals, include:

• IACUC approval
• Vertebrate Animal Section

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, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

NIH requires a Data Management and Sharing (DMS) Plan for this NOFO, NOT-OD-21-013. Please note, NIH recognizes Tribal sovereignty and the rights associated with Tribal sovereignty around data collection, data management and sharing of data and has published a supplemental notice regarding the DMS Plan for AI/AN populations, NOT-OD-22-214.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOA’s outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the NARCH program, employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes. The overall evaluation of the program will be based on metrics, when applicable, including but are not limited to:

- Indicators of center/institutional/investigator capacity building, such as:

• Development of faculty
• Improved access to scientific research infrastructure
• Subsequent submission of peer-reviewed grant proposals
• Subsequent external funding obtained by participants in the program

- Characteristics of the applicant and awardee pool for the program, such as:

• Scientific areas of focus

- Indicators of scientific productivity and impact among grantees and their participants /partners, such as:

• Peer-reviewed research publications and citations
• Presentations, including scientific conferences/meetings, Tribal Council meetings, and community gatherings/meetings.
• Clinical trials

- Outcome measures for educational/student activities such as:

• Curriculum development and courses offered for enhanced scientific skills development
  • Research experiences obtained by students
  • Mentoring activities conducted with students
• Subsequent participation of students in the biomedical research workforce

- Levels of community engagement and outreach such as:

• Evidence of outreach activities to inform the public and enhance scientific literacy.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Crystal Richards, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Center for Scientific Review (CSR)
[email protected]

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email:[email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.