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

Required Application Instructions

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

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

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of the Native American Research Centers for Health (NARCH) initiative is to support health research projects prioritized by the tribal communities, work toward reducing health disparities in the AI/AN populations, enhance health research partnerships and reduce distrust of research by AI/AN communities, while promoting a cadre of scientists and health research professionals interested in AI/AN health research. The AI/AN Tribal nations and communities have long experienced disparities in health compared with other Americans. Health disparities of AI/ANs are related to a complex set of factors and the paucity of health research within these populations may contribute to the situation. One approach to reduce this distrust of research within the AI/AN communities is to ensure that Tribes and Tribal Organizations are the managing partners in research and career enhancement involving their communities. To that end, NIH in collaboration with IHS has issued the NARCH funding opportunity announcement in which Federally recognized AI/AN Tribes or Tribal organizations (including national and area Indian health boards, and Tribal colleges meeting the definition of a Tribal organization as defined by 25 U.S.C. 1603(14) or (26)) may partner with institutions that conduct intensive academic-level biomedical research to conduct research focused on AI/AN health disparities as well as promote research career enhancement for students and scientists interested in AI/AN health. Areas of research proposed in the application will be selected by the AI/AN tribes and communities.

While characterized by many strengths, the AI/AN population has long experienced a disparity in certain health conditions compared with other Americans. AI/AN have higher rates of disease across many areas of health such as: diabetes, HIV/AIDS, dental disease, certain cancers, mental health and substance use (http://www.cdc.gov/omhd/amh/dbrf.htm, and http://www.cancer.gov/cancertopics/factsheet/disparities/cancer-health-disparities). Unfamiliarity with health care options may adversely influence health status and also may reduce the acceptability of health research. Identifying and utilizing existing strengths in AI/AN communities may contribute to reducing the health disparities that exist within the community. The daunting tasks confronting Tribes, researchers, and health care and public health programs are to decrease the health disparities and improve overall health among the AI/AN populations, maintain and strengthen resiliency factors and develop a new generation of researchers and health care workers interested in research focused on AI/AN health needs.

Factors known to contribute to health status and disparities are complex, and include social and historical factors, ethnicity, culture, historical trauma, socioeconomic status, gender/sex, sexual orientation, age, geographical access to care, and levels of insurance as well as underlying biology, physiology, and genetics. Additional interacting factors known to contribute to health status and disparities include, but are not limited to:

• Family, home, and work environments;
• General or culturally specific health practices;
• Social support systems;
• Lack of access to culturally appropriate health care; and
• Attitudes toward health.

The NARCH program seeks to build upon strengths in the AI/AN communities in combating health disparities, support research alliances between AI/AN communities and research intensive partners and enhance the pool of trained scientists and research professionals interested in AI/AN health needs. Due to the complexity of factors contributing to the health and disease of AI/ANs, and to their health disparities compared with other Americans, the collaborative efforts of the agencies of the Department of Health and Human Services (HHS) and the collaboration of researchers and AI/AN communities are needed to achieve significant improvements in the health status of AI/AN people. To accomplish this goal, in addition to objectives set by the Tribe, Tribal organization or Indian health boards, the NARCH program will pursue the following program objectives:

• To gain a better understanding of strengths and resiliency factors: An understanding of how to enhance the strengths and resilience within the AI/AN communities and individuals may help reduce health disparities. While AI/AN communities have relied on health research and medical science to promote overall healthful behaviors, they have also relied on their own psychological, organizational, and cultural assets and strengths to survive major harms and disruptions over the centuries, and to rebound from insults to health.
• Strengthen partnerships and AI/AN community engagement in health research: Fully utilizing all cultural and scientific knowledge, strengths, and competencies, such partnerships can lead to better understanding of the biological, genetic, behavioral, psychological, cultural, social, and economic factors either promoting or hindering improved health status of AI/ANs, and generate the development and evaluation of interventions to improve their health status. Community distrust of research and researchers will be reduced by giving the Tribe greater control over the research process as well as providing the opportunity to set the priority areas of scientific research for their NARCH grant. Published work on community-based participatory research suggests that AI/AN communities should work collaboratively in partnership with health researchers to further the research needs of AI/ANs. Helpful guidelines for community leaders and health researchers conducting research within the AI/AN communities can be found at http://www.ncaiprc.org/research-curriculum-guide and http://www.ncaiprc.org/research-regulation.
• Promote the enhancement of student and/or faculty research scientists interested in addressing the health issues within the AI/AN communities: Opportunities are needed to enhance the cadre of scientists and health professionals engaged in health research focused on AI/AN health needs, and to conduct biomedical, clinical and behavioral research that is responsive to the needs of the AI/AN community and the goals of this initiative. Faculty/researchers and students at each proposed NARCH can develop investigator-initiated, scientifically meritorious research projects, including pilot research projects. Career enhancement projects may also be proposed to improve the research skills of investigators involved with AI/AN communities.

By involving people in the community in areas of health research, a better understanding of community health concerns and needs regarding health research is attained. The approach in which the community is empowered in the research is beneficial in both designing research relevant to the health needs of the communities and providing sustainability of addressing these needs with trained researchers concerned with the health needs of the Tribal communities. By involving the AI/AN community in the research agenda for the proposed NARCH application, NIH is not limiting proposed projects to only Community Based Participatory Research (CBPR) projects. Research projects ranging from basic science to clinical investigation are welcome and encouraged.

The following must be proposed in the NARCH application:

• Administrative Core (Required): An administrative core can provide oversight of the different proposed components and projects, coordination of communication among the different proposed components and projects and guidance in evaluation planning.

In addition, one or more of the following may be proposed:

• Student Enhancement Projects: Projects that work toward accomplishing the goals of the NARCH FOA in providing opportunities for enhancement of a cadre of researchers and health research professionals focused on addressing the health needs of the AI/AN communities.
• Faculty/Researcher Enhancement Projects: Discrete projects that work toward providing research skills, experiences and methodologies to investigators involved in research with AI/AN tribes/organizations.
• Capacity Building Projects: Capacity Building Projects build research infrastructure to foster health related research or opportunities to enhance the cadre of students and or faculty in health related fields by providing access to biomedical resources and strengthening the research capabilities of the communities and their research faculty.
• Pilot Projects: Pilot projects prioritized by the AI/AN communities are intended to provide a better understanding of basic biological processes as well as factors that promote or hinder the health status of AI/ANs, and to develop and evaluate interventions to improve their health status. Pilot projects are smaller in size compared with Research Projects and limited to $75,000 direct costs per year per project.
• Research Projects: Research projects prioritized by the AI/AN communities are intended to provide a better understanding of basic biological processes as well as factors that promote or hinder the health status of AI/ANs, and to develop and evaluate interventions to improve their health status.

NIH and IHS are vested in working toward eliminating health disparities in AI/AN communities while supporting an understanding of elements that contribute to health and well-being. Specifically, the mission of NIH is to acquire new knowledge that will lead to better health by understanding the processes underlying health and disease that in turn will help prevent, detect, diagnose, and treat disease and disability. In the Indian Health Care Improvement Act, Public Law 94 437 (as amended), IHS was legislatively mandated to improve the delivery of effective health care to AI/ANs. More recently an emphasis was placed on promoting and understanding preventive care by the President in The Affordable Care Act (http://www.healthcare.gov/news/factsheets/2010/07/preventive-care-background.html). In response to these priorities, NIH in collaboration with IHS continues to support the NARCH program, focused on addressing the health disparities of the AI/AN communities. The NARCH initiative works toward the overall mission of NIH by supporting research that discovers the interrelationships among the many factors that contribute to health and disease, and by promoting the enhancement of researchers with an interest in AI/AN health.. Below is a list of more explicit scientific areas of research interests expressed by NIH Institutes, Centers and Offices:

National Institute of General Medical Sciences (NIGMS)

NIGMS is committed to reducing health disparities that affect AI/AN populations, while supporting research opportunities for the enhancement of students, faculty and researchers concerned with AI/AN health. NIGMS also supports capacity/infrastructure building within AI/AN communities to ensure sustainability of biomedical research, and the ability to address pertinent health issues within the communities. Examples of NIGMS's research interest can be found at: https://www.nigms.nih.gov/about/overview/Pages/default.aspx.

National Institute on Minority Health and Health Disparities (NIMHD)

NIMHD leads scientific research to improve minority health and reduce health disparities, to realize an America in which all populations will have an equal opportunity to live long, healthy, and productive lives. To accomplish this, NIMHD raises national awareness about the prevalence and impact of health disparities and disseminates effective individual-, community-, and population-level interventions to reduce and encourage elimination of health disparities. NIMHD is interested in projects including, but not limited to, the following:

• Interventions derived from local culture in strategies, process, implementation and evaluation.
• Projects that directly address methodological issues inherent in research small populations such as those in many native communities.
• Culturally-leveraged community based interventions focused on existing practices that support strengths and resilience factors that may be applicable and useful in other communities.
• Projects that collect data to address risk factors for health disparities where aggregated data obscure disparities and data gaps.
• Projects that document efficacy and monetize traditional healing practices for coverage by insurance.
• Projects that develop innovative approaches to the provision of non-stigmatizing and resilience supportive prevention and treatment interventions.
• Projects that build community understanding and capacity for equal participation in health promotion and disease prevention research, including development of community health needs assessment, tribal health research review capacity, and tribal Institutional Review Board capacity.

The Office of Research on Women’s Health (ORWH)

ORWH is interested in applications that address issues associated with women’s health and/or sex and gender influences on health and disease. Please visit the NIH Strategic Plan for Women’s Health Research to determine if an application addresses the ORWH mission: http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf."

National Cancer Institute (NCI)

NCI is committed to supporting research to address the significant disparities and needs of the American Indian/Alaska Native (AI/AN) population in terms of cancer prevention and health promotion and treatment. NCI will support the NARCH initiative through its Center to Reduce Cancer Health Disparities (CRCHD) and Division of Cancer Control and Population Sciences (DCCPS).

Center to Reduce Cancer Health Disparities (CRCHD)

CRCHD is committed to the NCI's efforts to reduce the unequal burden of cancer in our society and train the next generation of competitive researchers from diverse populations in cancer and cancer health disparities research. As such, the CRCHD initiates, integrates, and engages in collaborative research studies with NCI divisions and NIH Institutes and Centers, and outside partners to promote research and training in cancer and cancer health disparities research and to identify new and innovative scientific opportunities to improve cancer outcomes in communities experiencing an excess burden of cancer.

The CRCHD will support scientifically meritorious projects that have direct relevance to the understanding of the basic, clinical, populations and translational sciences of cancer and cancer health disparities among AI/AN populations. CRCHD will assist in achieving these purposes by supporting projects developed by each NARCH partnership.

Division of Cancer Control and Population Sciences (DCCPS)

The mission of the DCCPS is alleviating the burden of cancer through research in epidemiology, behavioral and social sciences, health services, surveillance, and cancer survivorship. Cancer control research aims to generate basic knowledge about how to monitor and change individual and collective behavior, and to ensure that knowledge is translated into practice and policy rapidly, effectively, and efficiently. DCCPS also has been through other program announcements trying to enhance the research with Native American communities to address the challenges of cancer control and prevention.

DCCPS through the surveillance program has noted that Native American populations have the lowest 5-year cancer survival rate and highest percentage of disseminated and ill-defined cancers of any subpopulation in the U.S. Poorer cancer survival rates have been attributed to many factors, among them inadequate access to health care, geographic isolation, later stage of detection, underutilization of treatment, poverty, and social and cultural barriers.

The DCCPS is interested in applications that focus on both individual and community factors that affect cancer control and prevention. It is important that researchers consider the context in which people live (place, built environment, etc.) and develop programs that can improve overall health and result in improved health outcomes as they relate to cancer and cancer survivorship.

National Institute of Mental Health (NIMH)

Mental Disorders: The CDC Health Disparities and Inequalities Report United States, 2013, indicates that, when compared to the white population, American Indians and Alaska Natives (AI/AN), experience disproportionately higher rates of psychological distress, higher drug-related deaths and death by suicide. American Indian and Alaska Native youth, in particular, suffer disproportionately from suicide. From 2005-2009, AI/ANs between the ages of 15-34 had the highest rates of suicide of any racial or ethnic group. Multiple factors contribute to the high rates of suicide among AI/AN populations, including individual-level factors (e.g., alcohol and substance abuse and mental illness), family or peer-level factors (e.g., family disruption or suicidal behavior of others) and societal-level factors (e.g., poverty, unemployment, discrimination and historical trauma defined as the cumulative emotional and psychological wounding across generations). There is a paucity of empirical data on the incidence and prevalence of mental disorders, tools to pre-empt or prevent disorders, barriers to and facilitators of receipt of and retention in treatment and effective treatments for mental disorders among the various AI/AN populations, nationwide. NIMH encourages research projects that:

• Develop culturally congruent preventive interventions that reduce suicide;
• Develop strategies to enhance mental health service engagement across tribes and geographic regions, with cultural or other adaptations to existing evidence-based engagement approaches justified by empirical and theoretical evidence of the need for adaptation.
• Empirically determine the most effective strategies for the scale-up and implementation of evidenced-based interventions that treat, pre-empt or prevent mental disorders
• Identify and test the appropriate application of technology to extend mental health human resources in remote rural settings.
• Identify factors that may prevent mental disorders in AI/AN populations and could be target mechanisms for future intervention development research

NIMH strongly encourages the establishment of collaborative research partnerships which will provide the researchers of AI/AN mental health the capacity to investigate multiple units of analysis across domains/constructs that moderate intervention effects (e.g., stress, distress, cognition, social processes).

HIV/AIDS: Even though AI/AN HIV/AIDS cases comprise less than 1 percent of total cases in the United States, AI/AN communities are disproportionately impacted by the disease. American Indians and Alaska Natives have a 40 percent higher rate of AIDS than non-Hispanic white Americans, and the AIDS rate among Native women is 2.8 times that of non-Hispanic white women. American Indian and Alaska Native communities experience significant health disparities and face high rates of substance abuse and sexually transmitted infections, which increase the risk of HIV transmission. Several dimensions of the AIDS epidemic for AI/AN groups are especially concerning including rapid progression from HIV infection to AIDS-defining illness and low survival rates after AIDS diagnosis is made. Additionally, many AI/AN individuals, like other Americans, do not know that they are infected and are therefore more likely to spread the disease. Relevant factors that place these individuals at risk and present barriers to prevention include poverty, high rates of sexually transmitted diseases, substance abuse, violence, stigma, denial and concern about confidentiality in smaller reservation and rural communities.

Because HIV infection is a continuing health crisis in indigenous people, research on AI/ANs has been identified as one of the overarching research priorities of the FY 2016 Trans-NIH Plan for HIV-Related Research, section on Racial and Ethnic Populations in Areas of Special Interest (http://www.oar.nih.gov/strategicplan/fy2016/pdf/FY-2016-Trans-NIH-Plan-for-HIV-Related-Research.pdf). To reduce the impact of the HIV/AIDS epidemic among indigenous communities in the United States, NIMH/DAR-supported HIV/AIDS research in AI/AN communities should be responsive to high priority research as indicated in NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html. Proposed research should have the following objectives:

• Rapidly expand the HIV prevention intervention portfolio for gay men and other high-risk vulnerable individuals from indigenous communities.
• Address integrated continuum of care model (i.e., testing, linkage, retention, adherence, viral suppression) and identify mechanisms to explain differences in HIV-related disparities (e.g., factors like social/sexual networks, access to and quality of health care, characteristics of health biology).
• Develop and advance multilevel preventive intervention programs, address consequences of HIV and incorporate community-based participatory principles that ensure bidirectional benefit and investment of community and the research team.
• Examine utility of combination behavioral-biomedical interventions and treatment as prevention approaches.
• Explore operations research to focus on barriers, facilitating factors and outcomes of scaling-up HIV prevention interventions with known efficacy; improve uptake and effectiveness of efficacious interventions.

For these research objectives to be realized, it will be necessary to strengthen the workforce of HIV investigators through programs that develop a cadre of investigators in NIMH/DAR priorities, http://www.nimh.nih.gov/about/organization/dar/aids-research-centers-program/aids-research-centers-program.shtml.

NIMH recommends that both non-AIDS and AIDS applications that propose an adaptation to existing interventions provide an empirical rationale for the need for and focus of the adaptation, consistent with the NAMHC Workgroup Report recommendations on intervention adaptation, and in consultation with relevant Institute staff.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The NIAMS supports efforts to conduct research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of research progress to improve the public health. Goals specific to the AI/AN communities involve research addressing the career enhancement of researchers and ensuring inclusion of Native communities in clinical research studies. Details of NIAMS's research interests can be found at: http://niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/default.asp

National Institute on Drug Abuse (NIDA)

NIDA is interested in supporting research that will reduce health disparities in drug abuse and related health and social consequences among AI/AN. Studies should employ the methodologies required by the NARCH, including that studies be developed and implemented using community based participatory approaches. Details of NIDA's research interests can be found at https://www.nigms.nih.gov/Research/CRCB/NARCH/Pages/NARCHInterestAreas.aspx.

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

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

The applicant must be one of the following:

• A federally recognized AI/AN Tribe, as defined under 25 U.S.C. 1603(14); or
• A Tribal organization, as defined under 25 U.S.C. 1603(26), including Tribal colleges or health boards meeting this definition; or
• A consortium of two or more of those Tribes or Tribal organizations. Applicants other than Tribes must provide proof of non-profit status.

The proposed NARCH may be a working partnership of the eligible AI/AN tribes/organization and of a research institution, with the federally recognized tribe/tribal organization being the grant applicant. The Research-Intensive partner must be an accredited public or private nonprofit university, academic medical center, or other institution that has an established record of conducting research into the health problems of AI/AN; has demonstrated a commitment to enhancing the capability of faculty/researchers, students, investigators, and communities to engage in biomedical, behavioral, and clinical research related to AI/AN health needs; and has demonstrated a commitment to enhancing the career of faculty/researchers, students, and investigators, including those engaged in or interested in AI/AN health research.

The grantee will determine the appropriate partners and partnerships for the proposed application.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) must have a primary appointment with the federally recognized AI/AN applicant organization. Special arrangements of employment, such as inter-organizational personnel agreements, are permissible. The PD/PI may be, but is not required to be, the NARCH Program Coordinator or a Research Project Leader.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. However, each organization may receive only one NARCH award.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

To be included as a participant for a faculty/researcher enhancement project in the proposed NARCH, the individual must have a faculty/researcher appointment at a research-intensive institution or equivalent appointment at an AI/AN organization or consortium partner.

In order to be a Research Project Leader in the NARCH, a prospective investigator must have a faculty appointment at the research-intensive institution or equivalent appointment at the AI/AN organization or other consortium partner.

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

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

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

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Sheila A. Caldwell, PhD
Telephone: 301-594-7800
Email: caldwells@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6 pages
Admin Core	6 pages
Career Enhancement (use for Faculty/Researcher Enhancement Project and Student Career Enhancement Project)	6 pages per project
Project (use for Research Projects and Pilot Projects)	6 pages per project
Capacity Building (use for Capacity Building Project)	6 pages per project

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of 1
• Faculty/Researcher Career Enhancement Project: optional
• Student Career Enhancement Project: optional
• Capacity Building Project: optional
• Research Project: optional; maximum = 5
• Pilot Project: optional; maximum = 5

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

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

Complete entire form.

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

Follow standard instructions.

Facilities and Other Resources: Provide a description of the current research enhancement opportunities at the proposed NARCH site and its institutional and community partners

Enter primary site only.

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

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

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

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

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

Specific Aims: The NARCH application overview should briefly explain each component of the application, and how the components help meet the purposes of the NARCH initiative.

Research Strategy: A description should be provided of the current state of the research enterprise at the proposed NARCH site and its institutional and community partners, including faculty/researcher and student profiles. Please provide the following information:

• Documentation should be provided to establish that the research intensive partner is an institution with a record of conducting research into the health of AI/ANs, and that it has a demonstrated commitment to the special encouragement of, and assistance to, faculty/researchers, students, investigators, and communities for enhancing their capacity to engage in biomedical, behavioral and health services research, including research related to AI/AN health needs.
• Documentation about the nature of the partnership itself should be included, such as: the process to develop the application and proposed NARCH itself, the past and future efforts to enhance the capacity of the partners to improve their partnership, and efforts to contribute to the success of the NARCH.

Letters of Support: A letter of Tribal Approval of the Application should be included to ensure research involving AI/AN Tribes has been approved by the Tribal governments with jurisdiction over the populations involved. This letter should address general support for the studies, separate from the tribal resolutions documenting approval of specific projects submitted in respective components.

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

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of 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 NARCH Program Coordinator is the individual responsible for the day-to-day leadership and management of the Center. The Program Coordinator may be, but is not required to be, the Student or Faculty/Researcher Enhancement Project Leader or a Research Project Leader. The NARCH Program Coordinator may or may not have formal academic/research credentials, but if not, then the PD/PI must be so qualified

Budget forms appropriate for the specific component will be included in the application package. The Administrative core budget may not exceed $65,000 direct costs per year. The Administrative Core should only include budget items pertaining to the oversight of the administrative functions and not items from other components.

PD/PIs should budget for and are expected to attend the NARCH PD/PI annual meeting. Costs for the PD/PI to travel to the NARCH PD/PI annual meeting should be included in the Administrative Core budget. Items pertaining to specific NARCH proposed projects in different projects should be included within the applicable projects' budget and not within the Administrative core budget.

Certain administrative costs for managing a comprehensive program are allowable and may vary, depending upon the size and complexity of the program’s activities. The costs budgeted for NARCH grants and subcontracts may not duplicate items already budgeted in other cost centers of the AI/AN, research-intensive, and subcontracted organizations and institutions, such as accounts which make up the Facilities and Administration (F&A) cost pool. The grantee organization receiving the award must be prepared to provide documentation showing the direct relationship of proposed costs to the program, and that costs of this type are charged in a uniform manner to all other grants at all institutions and organizations participating in the award. Limited salary support for secretarial or clerical help is allowable only when in direct support of the proposed NARCH project.

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

Specific Aims: Provide a description of the role of the core in the oversight of the proposed NARCH grant and how it will help to reach the major aims and goals of the NARCH grant.

Research Strategy: The Administrative Core component should include administrative functions that provide oversight to support the individual research, student/faculty or capacity building projects being proposed. Administrative functions may include responsibility for seeking out and dispersing information on potential research funding opportunities, providing information on resources on training and mentoring programs within the participating institutions, oversight of IRB or IACUC applications from NARCH researchers if applicable, coordination of communication among the different proposed projects within the application and guidance in evaluation planning.

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

Generally, Resource Sharing Plans are expected, but they are not applicable to this component.

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

PHS Inclusion Enrollment Report (Administrative Core)

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

When preparing your application in ASSIST, use Component Type Career Enhancement.

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

SF424 (R&R) Cover (Faculty/Researcher Career Enhancement Project)

Complete only the following fields:

• Applicant Information
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Faculty/Researcher Career Enhancement Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Faculty/Researcher Career Enhancement Project)

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

Facilities & Other Resources: Provide a description of resources available for the partnership. This could include allocation of space and facilities, opportunities for new projects and programs, as well as institutional resources for faculty development. Applications should also describe the experience, proposed commitment to the Faculty/Researcher Career Enhancement Project, and quality of the advisors or teachers, as well as their experience in providing guidance and advice to faculty/researchers, and in fostering the development of academic and community-based AI/AN research.

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) (Faculty/Researcher Career Enhancement Project)

List all performance sites that apply to the specific project.

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 (Faculty/Researcher Career Enhancement Project)

The Faculty/Researcher Enhancement Leader/Director should be listed as Project Lead and must have a faculty/researcher appointment at the research-intensive institution (or equivalent appointment at the AI/AN organization or other consortium partner) and must demonstrate that he/she has the knowledge, skills, and capabilities to direct a discrete research project that will provide him/her opportunities for the enhancement of faculty or research populations. A Faculty Enhancement Project Director may be the proposed NARCH Program Coordinator.

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

Budget (Faculty/Researcher Career Enhancement Project)

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

If a faculty/researcher project leader plans to attend the annual NARCH PI meeting or other scientific meeting then travel costs should be included in the Faculty/Researcher Development proposed budget.

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

PHS 398 Research Plan (Faculty/Researcher Career Enhancement Project)

Specific Aims: Provide a description of the proposed Faculty/Researcher Enhancement Project. Include the proposed goals and objectives of the Faculty/Researcher Enhancement Project and how these aims and goals will contribute towards the overall aims and goals of the NARCH.

Research Strategy: Applications should describe:

• the need for the project, the proposed activities, and anticipated outcomes. The project should describe how the faculty/researcher' research efforts and objectives will be advanced or broadened. Faculty/researcher enhancement projects might include, but do not need to include and are not limited to, short-term research experiences in the lab of an active NIH-extramurally-funded researcher; exposure to senior colleagues who will provide collegial support in advancing the faculty/researcher career and research goals; or attendance at workshops or courses or national meetings needed for acquiring specific skills or methodologies needed for prospective research.
• how the research education activities will improve their skills and abilities to be successful at the next stage of their professional evolution.
• how the project will fulfill the research and professional enhancement needs for faculty/researchers engaged in AI/AN health research, or will enhance of partnerships with the key institutions and groups in the application.

A Faculty/Researcher enhancement Project does not have to be tied in with other projects proposed in the application. The possibility exists that one project could be funded while another project is not funded.

Letters of Support: Tribal Resolution: For each specific project proposed, a tribal resolution letter from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project proposal. This means that the tribal resolution letter should specifically reference the tribal review and approval of those specific activities. Since the possibility exists that some of the projects proposed within an application may be funded while others may not be funded, this ensures that each discrete project has secured all necessary tribal permissions and approvals for that specific set of proposed activities, and can be considered and funded as a stand-alone project. If the current Tribal resolution under which a tribal organization operates would encompass the specific proposed activities, then a copy of the current resolution submitted with the discrete project proposal would be sufficient. The listed Tribes to be served by the project in the proposal must match the set of appended resolutions.

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

PHS Inclusion Enrollment Report (Faculty/Researcher Career Enhancement Project)

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

When preparing your application in ASSIST, use Component Type Career Enhancement.

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

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

Complete only the following fields:

• Applicant Information
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Student Career Enhancement Project)

Enter Human Embryonic Stem Cells in each relevant project.

Research & Related Other Project Information (Student 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 projects.

Project /Performance Site Location(s) (Student Career Enhancement Project)

List all performance sites that apply to the specific project.

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 (Student Career Enhancement Project)

The Student Enhancement Project Leader/Director should be listed as project lead and must have a faculty/researcher appointment at the research-intensive institution (or equivalent appointment at the AI/AN organization or other consortium partner) and must demonstrate that he/she has the knowledge, skills, and capabilities to advise students and to generate and direct programs to provide opportunities for the enhancement of student populations interested in or involved in research focused on AI/AN health. A Student Career Enhancement Project Director may be the proposed NARCH Program Coordinator.

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

Budget (Student Career Enhancement Project)

Budget forms appropriate for the specific project will be included in the application package. If a student enhancement project leader plans to attend the annual NARCH PD/PI meeting or travel students to a scientific meeting then travel costs should be included in the Student Enhancement proposed budget.

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

PHS 398 Research Plan (Student Career Enhancement Project)

Specific Aims: Provide a description of the proposed Student Career Enhancement Project. Include the proposed goals and objectives of the Student Career Enhancement Project and how these aims and goals will contribute towards the overall aims and goals of the NARCH.

Research Strategy: The application should describe:

• how the program will encourage and facilitate students to enter, advance, and remain in health research careers regarding AI/AN health. Projects might include, but do not need to include are not limited to: providing employment as research assistants in research projects of research-active advisors; providing workshops to improve technical or communication skills, responsible conduct of research and research integrity, teaching, and protection of human subjects; providing motivating seminars or journal clubs highlighting research problems of interest to students; providing contact with relevant career/science role models; and providing opportunities to travel to present results at national scientific meetings.
• the experience, proposed commitment, and quality of the advisors in providing guidance and advice to students (including advice about responsible conduct of research and research integrity, teaching, and protection of human subjects), and in fostering the development of academic and/or community-based AI/AN researchers.
• how the project will fulfill the career enhancement needs for the students involved in the proposed project and foster their research on the health issues in the AI/AN community.

A student in a NARCH Student Career Enhancement Project must be a full-time or part-time student officially enrolled in an educational program leading to an undergraduate or graduate degree, or in a post-doctoral educational program, or (if well justified) in late high school.

Student Career Enhancement research opportunities do not have to be tied in with other projects proposed in the application. The possibility exists that one project could be funded while another project is not funded.

Letters of Support: Tribal Resolution:

For each specific project proposed, a tribal resolution letter from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project proposal. This means that the tribal resolution letter should specifically reference the tribal review and approval of those specific activities. Since the possibility exists that some of the projects proposed within an application may be funded while others may not be funded, this ensures that each discrete project has secured all necessary tribal permissions and approvals for that specific set of proposed activities, and can be considered and funded as a stand-alone project. If the current Tribal resolution under which a tribal organization operates would encompass the specific proposed activities, then a copy of the current resolution submitted with the discrete project proposal would be sufficient. The listed Tribes to be served by the project in the proposal must match the set of appended resolutions.

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

PHS Inclusion Enrollment Report (Student Career Enhancement) Project

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

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

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• 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 project.

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 projects.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific project.

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 (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field. A Project Leader may not propose a pilot research project.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the project.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of projects in which they participate. When a Senior/Key person is listed in multiple projects, the Biographical Sketch can be included in any one project.
• If more than 100 Senior/Key persons are included in a project, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

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

If a research project leader plans to attend the annual NARCH PD/PI meeting or send key personnel to a scientific meeting as part of the proposed project, then travel costs should be included in the budget of the proposed research project.

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)

Specific Aims: Provide the objectives and goals of the project. Include how the goals and aims of the project will contribute towards the overall aims and goals of the NARCH.

Research Strategy: a Research Project may or may not have preliminary data, but may provide published work in other populations as support for the proposed research project.

• a Research Project does not have to be tied in with other projects proposed in the application. The possibility exists that one project could be funded while another project is not funded.
• the goals must clearly describe specific objectives and milestones which should include, but are not limited to, improving competitiveness in acquiring grant support. The applicant should describe how the proposed research project will provide research experiences and help develop the research skills of participating faculty/researchers.
• the proposed project must also describe the evaluation plan for the impact of the research project. The application must clearly describe how the research project will meet the needs of the community, as well as the goals of the FOA in either reducing health disparities, enhancing the career of health professionals and scientists interested or involved in AI/AN health or enhancing partnership between the groups in the application and the research intensive partners.

Letters of Support: Tribal Resolution: For each specific project proposed, a tribal resolution letter from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project proposal. This means that the tribal resolution letter should specifically reference the tribal review and approval of those specific activities. Since the possibility exists that some of the projects proposed within an application may be funded while others may not be funded, this ensures that each discrete project has secured all necessary tribal permissions and approvals for that specific set of proposed activities, and can be considered and funded as a stand-alone project. If the current Tribal resolution under which a tribal organization operates would encompass the specific proposed activities, then a copy of the current resolution submitted with the discrete project proposal would be sufficient. The listed Tribes to be served by the project in the proposal must match the set of appended resolutions.

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

PHS Inclusion Enrollment Report (Research Project)

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

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

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

SF424 (R&R) Cover (Pilot Project)

Complete only the following fields:

• Applicant Information
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot Project)

Enter Human Embryonic Stem Cells in each relevant project.

Research & Related Other Project Information (Pilot 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 project and applications will not receive an error if omitted in other projects.

Project /Performance Site Location(s) (Pilot Project)

List all performance sites that apply to the specific project.

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)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the project.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of projects in which they participate. When a Senior/Key person is listed in multiple projects, the Biographical Sketch can be included in any one project.
• If more than 100 Senior/Key persons are included in a project, the Additional Senior Key Person attachments should be used.
• The pilot project is intended for faculty/researchers without current Federal research support. Support for faculty/researchers participating in pilot research projects is preparatory to seeking more substantial funding from NIH research grant programs, as well as funding from other agencies and private sources. Academic Research Enhancement Award (AREA) grants (R15) as well as Federal or non-Federal funding whose purpose is to provide preliminary support in anticipation of a Research Project Grant (RPG) or Program Project Grant (PPG) such as exploratory/pilot project grants (such as NIH R03 and R21 awards), or mentored career development awards (such as NIH K01, and K08 awards) do not disqualify an investigator from being a pilot project leader.

Budget (Pilot Project)

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

If a pilot project leader plans to attend the annual NARCH PD/PI meeting or send key personnel to a scientific meeting as part of the proposed project, then travel costs should be included in the proposed project budget. Pilot projects are limited to a budget of no more than $75,000 direct costs per year for four years. Funds received from the proposed NARCH to support pilot research projects may not be used to supplement ongoing research projects.

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

PHS 398 Research Plan (Pilot Projects)

Specific Aims: Provide the objectives and goals of the project. Include how the goals and aims of the project will contribute towards the overall aims and goals of the NARCH.

Research Strategy: A pilot project is limited in scope and is not expected to have preliminary data. The proposed project must also describe the evaluation plan for the impact of the pilot project. The application must clearly describe how the research project will meet the needs of the community, as well as the goals of the FOA in either reducing health disparities, enhancing the career of health professionals and scientists involved or interested in AI/AN health research or enhancing partnership between the groups in the application and the research intensive partners.

A pilot project does not have to be tied in with other projects proposed in the application. The possibility exists that one project could be funded while another project is not funded.

Letters of Support: Tribal Resolution: For each specific project proposed, a tribal resolution letter from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project proposal. This means that the tribal resolution letter should specifically reference the tribal review and approval of those specific activities. Since the possibility exists that some of the projects proposed within an application may be funded while others may not be funded, this ensures that each discrete project has secured all necessary tribal permissions and approvals for that specific set of proposed activities, and can be considered and funded as a stand-alone project. If the current Tribal resolution under which a tribal organization operates would encompass the specific proposed activities, then a copy of the current resolution submitted with the discrete project proposal would be sufficient. The listed Tribes to be served by the project in the proposal must match the set of appended resolutions.

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

PHS Inclusion Enrollment Report (Pilot Projects)

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

When preparing your application in ASSIST, use Component Type Capacity Building.

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

SF424 (R&R) Cover (Capacity Building Project)

Complete only the following fields:

• Applicant Information
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Capacity Building Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Capacity Building 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 project and applications will not receive an error if omitted in other projects.

Other Attachments: If a plan is submitted for the creation of a research laboratory or conversion of an existing space for research purposes an architectural plan is required. Submit line drawings. (DO NOT SUBMIT BLUEPRINTS.). All floor plans must be legible, with the scale clearly indicated. The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. The floor plan should indicate the location of the proposed renovation area in the building. Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished.

Project /Performance Site Location(s) (Capacity Building Project)

List all performance sites that apply to the specific project.

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 (Capacity Building Project)

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

Budget (Capacity Building Project)

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

If a capacity building project leader plans to attend the annual NARCH PD/PI meeting or send key personnel to a scientific meeting as part of the proposed project, then travel costs should be included in the budget.

Alterations and renovations cannot exceed $60,000 in direct costs per proposed capacity building project.

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 (Capacity Building Project)

Specific Aims: Provide a description of the proposed Capacity Building Project. Include the proposed goals and objectives of the project and how these aims and goals will contribute towards the overall aims and goals of the NARCH.

Research Strategy: The application should describe:

• The need for the project, the proposed activity, and anticipated outcomes. A Capacity Building Project strengthens research capabilities within the communities they serve and provides access to biomedical resources by fostering research infrastructure and providing opportunities for research career enhancement and work experience in health care fields. A Capacity Building Project may include, but is not limited to, the conversion of existing space for research purposes, creation of a new health related research laboratory within the community, i.e. at the community serving Tribal Colleges and Universities (TCU).
• An evaluation plan for the Capacity Building Project. The description should include what is to be evaluated and how it will be evaluated. The application must clearly describe how the capacity building project will meet the needs of the community, as well as the goals of the FOA in either reducing health disparities, supporting the enhancement of faculty/researchers or students focused on AI/AN health research or enhancing partnerships between the groups in the application and the research intensive partners.

A Capacity Building Project does not have to be tied in with other projects proposed in the application. The possibility exists that one project could be funded while another project is not funded.

Letters of Support: Tribal Resolution: For each specific project proposed, a tribal resolution letter from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project proposal. This means that the tribal resolution letter should specifically reference the tribal review and approval of those specific activities. Since the possibility exists that some of the projects proposed within an application may be funded while others may not be funded, this ensures that each discrete project has secured all necessary tribal permissions and approvals for that specific set of proposed activities, and can be considered and funded as a stand-alone project. If the current Tribal resolution under which a tribal organization operates would encompass the specific proposed activities, then a copy of the current resolution submitted with the discrete project proposal would be sufficient. The listed Tribes to be served by the project in the proposal must match the set of appended resolutions.

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

Generally, Resource Sharing Plans are expected, but they are not applicable for this component.

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

PHS Inclusion Enrollment Report (Capacity Building Project)

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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

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

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

Important reminders:

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

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Each submitted project within the NARCH application must be budgeted so that it could stand on its own. That is, each project should be fundable under its own budget so that it could be completed even if no other proposed NARCH project is funded.

Applicants are required to follow our Post Submission Application Materials policy. Tribal Resolutions may be submitted as supplemental information at least 30 days prior to the review date.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

Does the program address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is this program supported by the community and does it address the needs of the community in which it is being proposed? Will opportunities be created for AI/AN health research that helps the applicable AI/AN communities address health issues pertinent to their communities? Will opportunities be created for faculty/researcher career enhancement or student career enhancement to benefit the health of AI/AN communities? Will research infrastructure be created to benefit the community and their research partnerships?

Although this is a multi-component mechanism, it is not expected that the NARCH application have a unified scientific theme. Rather the connection in the application among the projects should be based on accomplishing the FOA goals in fulfilling the research priorities of the AI/AN communities.

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

Is there a strong partnership between the PD/PI from the AI/AN tribes/organization and any partnering research institutions? Is there a demonstrated involvement of all the partners in the proposed NARCH program: i.e. intellectual and tangible contributions and activities of the partners in developing the application and the proposed NARCH; interactions of the partners in meetings (such as those to develop the application and proposed NARCH); past activities or future plans to enhance capacity among the involved partners?

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

Will the approaches bring new understanding or interventions to the AI/AN communities? Is the program likely to develop approaches to enhance opportunities in health research for faculty, postdoctoral fellows, graduate students, undergraduate students and community members and partnering institutions interested or involved in AI/AN health research? Will the program bring enhanced support of and involvement in health research by the community involved in the program?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Will the proposed program approach help to address health issues pertinent to the AI/AN community? Will the proposed program approach help to strengthen AI/AN tribal engagement in health research? Will the proposed program approach work toward the enhancement of scientists and health research professionals focused on AI/AN health? Is the plan for evaluating the impact of the proposed NARCH appropriate?

If the program involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the 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? Will the AI/AN tribal organizations and any NARCH partnerships support the enhancement of research and career opportunities of students, faculty and researchers? Is there support by the AI/AN tribes and the proposed partners in sustaining proposed NARCH projects or development of future projects?

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 core address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the core? If the aims of the core are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the Administrative Core support the individual proposed projects in completing the aims and goals of the NARCH?

Project Leader(s)

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

Innovation

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

Approach

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

Does the Administrative Core have a suitable plan for evaluation of the impact of the NARCH program and the proposed core? Are milestones for the NARCH program identified and are appropriate tools in place to measure success?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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 core proposed? Will the core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the Administrative Core have a supportive environment to assist the individual proposed projects in completing the aims and goals of the NARCH?

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.

Integration of Student and Faculty/Researcher Career Enhancement projects with other proposed NARCH projects within the application should not be considered as a factor. The possibility exists that one project in the grant application may be supported while another is not.

Significance

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

Is this project supported by the community and does it address the needs of the community in which it is being proposed? Will the anticipated outcome of the student or faculty/researcher career enhancement project make a difference relative to the current baseline data for the applicable community?

Project Leader(s)

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

Does the project leader have the appropriate background and experience to support the project in completing the aims and goals of the NARCH program and project? Do the proposed advisors have the research experience and expertise to guide and advise the candidates?

Innovation

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

Is the project likely to develop approaches to enhance opportunities for faculty, postdoctoral fellows, graduate students and undergraduate students involved in the project? Will the approaches bring new understanding or interventions to the AI/AN communities?

Approach

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

Is the approach appropriate in supporting the development of opportunities for faculty, postdoctoral fellows, graduate students and undergraduate students involved in the project? Will the approach improve the ability of the student, faculty/researcher to conduct or understand biomedical research addressing the health needs of the AI/AN community? Are the phasing and duration of the proposed project appropriate to accomplish the aims of the project? Is the evaluation plan appropriate to assess the proposed outcome measures?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

Is the environment supportive of fostering student and/or faculty/researcher career enhancement in understanding and meeting the needs of AI/AN health research?

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.

Research projects are not required to have preliminary data, but may provide published data using similar proposed approaches in different populations as justification for investigating certain approaches or protocols in the AI/AN population. The results do not need to be generalizable to the general population.

Research projects should not be evaluated for their integration with other proposed NARCH projects within the application. The possibility exists that one project in the grant application may be funded while another is not.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is this project supported by the community and does it address the needs of the AI/AN community in which it is being proposed?

Investigator(s)

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

Innovation

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

Does the project support the research requests of the AI/AN community involved in the project? Will the approaches bring new understanding or interventions related to the health of AI/AN communities?

Approach

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

Will the project provide opportunities for faculty, postdoctoral fellows, graduate students and undergraduate students involved in the project? Is there a plan to disseminate the results of the research project to the AI/AN community? Is the evaluation plan appropriate to assess the proposed outcome measures?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

Pilot projects are not required to have preliminary data, but may provide published data using similar proposed approaches in different populations as justification for investigating certain approaches or protocols in the AI/AN population. The results do not need to be generalizable to the general population.

Pilot projects should not be evaluated for their integration with other proposed NARCH projects within the application. The possibility exists that one project in the grant application may be funded while another is not.

Significance

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

Is this project supported by the community and does it address the needs of the AI/AN community in which it is being proposed?

Investigator(s)

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

Innovation

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

Does the project support the research requests of the AI/AN community involved in the project? Will the pilot project provide preliminary data for research that will address health concerns pertinent to the AI/AN community? Will the approaches bring new understanding of or interventions in health to the AI/AN communities?

Approach

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

Will the project provide potential opportunities for faculty, postdoctoral fellows, graduate students and undergraduate students involved at the participating institutions and within the AI/AN communities? Is there a plan to disseminate the results of the research project to the AI/AN community? Is the evaluation plan appropriate to assess the proposed outcome measures?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

Integration of the Capacity Building project with other proposed NARCH projects within the application should not be considered as a factor. The possibility exists that one project in the grant application may be supported while another is not.

Significance

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

Is this project supported by the AI/AN community and does it address the needs of the AI/AN community in which it is being proposed? Will the project provide for sustainability of NARCH projects and programs? Will the capacity building project contribute towards helping the community and its members in the health research process? Will the project enhance or improve communication about research within the AI/AN community and/or research community?

Investigator(s)

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

Innovation

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

Is the project likely to develop an environment or opportunities to support future health research development and projects? Will the project contribute toward independent research capability for the AI/AN community and its research partnerships? Will new initiatives, ideas or collaborations be created? Does the project provide opportunities to support sustaining NARCH projects? Does the project have the potential to support the research requests of the AI/AN community involved in the NARCH?

Approach

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

Is the approach appropriate to enable the AI/AN community and its members to better understand the health research process? Is the approach appropriate to help enhance or improve communication about research within the AI/AN community and/or research community? Is the evaluation plan appropriate to assess the proposed outcome measures?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

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

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

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.

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned 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:

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

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

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-945-7573

Judith A. Arroyo, PhD
National Institute on Alcohol Abuse, and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: jarroyo@mail.nih.gov

Nina Silverberg, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: silverbergn@nih.gov

Sheila A. Caldwell, PhD
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: caldwells@mail.nih.gov

Ricardo Cibotti, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-5888
Email: ricardo.cibotti@nih.gov

Laura J. Hsu, DrPH
National Institute of Dental and Craniofacial Research (NIAMS)
Phone: 301-594-4807
Email: laura.hsu@nih.gov

Davyd W. Chung, PhD
National Cancer Institute (NCI)
Phone: 240-276-6921
Email: davyd.chung@nih.gov

Shobha Srinivasan, PhD
National Cancer Institute (NCI)
Phone: 240-276-6938
Email: sriniva2@mail.nih.gov

David M. Stoff, PhD
National Institute of Mental Health (NIMH)
HIV Prevention Branch
Telephone: 240-627-3876
Email: dstoff@mail.nih.gov

Catherine A. Roca, PhD
National Institute of Mental Health (NIMH)
Office of Research on Disparities & Global Mental Health
Telephone: 301-443-3945
Email: rocac@mail.nih.gov

Dorothy M. Castille, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9411
Email: dorothy.castille@nih.gov

Claudette E. Brooks, MD
Office of Research on Women's Health
Telephone: 301-402-1770
Email: claudette.brooks@nih.gov

Kathy Etz, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1749
Email: ketz@mail.nih.gov

Lawrence Y. Agodoa, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-1932
Email: agodoal@mail.nih.gov

Diane Adger-Johnson
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2924
Email: dadger@niaid.nih.gov

Symma Finn, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: finns@niehs.nih.gov

Della Brown White, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-2712
Email: whitede@mail.nih.gov

Gabriel B. Fosu, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: fosug@mail.nih.gov

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-7706
Email: cleake@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse, and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Ted Williams
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-326-6450
Email: williate@mail.nih.gov

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