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

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

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

The purpose of the Native American Research Centers for Health (NARCH) initiative is to:

• Work toward reducing health disparities and promoting wellness in AI/AN populations by allowing the AI/AN communities to select, control and prioritize health-related research and research career enhancement opportunities;
• Support research capacity and infrastructure building within AI/AN communities to promote their abilities to conduct important and sustainable biomedical research;
• Promote the development of biomedical research talent within AI/AN communities;
• 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. Additionally, AI/AN communities have experienced unethical and inappropriate research on their communities, leading to a general mistrust of both research and the researchers. One approach to reduce this distrust of research and promote research from within AI/AN communities is to ensure that Tribes and Tribal Organizations are the managing partners in biomedical research and career enhancement involving their communities. Additionally, supporting research capacity and infrastructure building within the tribal communities provides a path to creating a thriving and sustainable health-related AI/AN research enterprise developed and led by members of the tribal communities themselves. To that end, NIH, in collaboration with IHS, utilizes the NARCH funding opportunity announcement to support 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) (25) or (26)) who may partner with institutions that conduct intensive academic-level biomedical research to conduct research focused on AI/AN health priorities, support research capacity and infrastructure building, 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 and may range from basic science to clinical.

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 ((https://www.cdc.gov/mmwr/pdf/other/su6203.pdf) and http://www.cancer.gov/cancertopics/factsheet/disparities/cancer-health-disparities). Health disparities within the AI/AN communities may be influenced by unfamiliarity with health care options, coupled with a distrust of research due to prior unethical or inappropriate research conducted on AI/AN communities, which have led to a lack of representation of AI/AN populations in research that effects health care approaches and policies. Creating research opportunities which promote AI/AN inclusion can help provide pathways for research to address the health needs of the AI/AN communities. Additionally, identifying and utilizing existing strengths in AI/AN communities may contribute to reducing the health disparities and focusing on the health and research priorities within those communities. The daunting tasks confronting Tribes, researchers, and health care and public health programs are to decrease the health disparities and improve overall health among 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.

Several factors are known to contribute to health status of a person and the community, including: 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 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.

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 and promote wellness of AI/AN people. To accomplish this goal, the NARCH initiative 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 factors 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. By ensuring that the Tribe has greater control over the research process, the AI/AN communities can dictate the scientific agenda and research priorities. 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/AN. Helpful guidelines for community leaders and health researchers conducting research within the AI/AN communities can be found at https://dpcpsi.nih.gov/sites/default/files/Critical_Considerations_for_Reviewing_AIAN_Research_508.pdf and http://www.ncai.org/policy-research-center/initiatives/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 AI/AN communities 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.
• Encourage research infrastructure and capacity building within AI/AN communities, ensuring sustainability of research within AI/AN communities: Supporting the research infrastructure development and capacity building within the AI/AN communities provides tools to support research from within the communities, as well as the long-term maintenance and evolution of their research agenda.

By involving the community in health research and integrating the training of researchers the pool of investigators and the scientific knowledge of the communities can be increased. This approach benefits the communities in terms of research design and sustainability. By involving the AI/AN communities 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. Projects that do not focus on health disparities can be chosen as priorities for the proposed AI/AN populations.

The following must be proposed in the NARCH application:

• Administrative Core (Required): An administrative core should provide administrative, fiscal, and management 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 must be proposed:

• Student Enhancement Projects: Projects that work toward accomplishing the goals of the NARCH FOA in providing opportunities for the enhancement of a cadre of student researchers focused on addressing the health needs of the AI/AN communities.
• Faculty/Researcher Enhancement Project: Discrete projects that work toward providing research skills, experiences, and methodologies to investigators involved in research with AI/AN tribes/organizations.
• 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.
• 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.
• 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.

Sharing research resources among existing NIH-supported investigators is strongly encouraged. As much as practicable, applicants should seek to utilize existing equipment, instrumentation, and other core resources that are supported by other NIH awards. Projects proposed do not have to be related to other projects proposed within the application. The possibility exists that one project could be funded while another project is not funded.

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 seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness 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/AN. Below is a list of more explicit scientific areas of research interests expressed by participating NIH Institutes, Centers and Offices:

National Institute of General Medical Sciences (NIGMS)

NIGMS is committed to supporting research that is prioritized by the AI/AN populations, while encouraging 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 and research within the communities. Examples of NIGMS's research interest can be found at: https://www.nigms.nih.gov/research-areas.

National Cancer Institute (NCI)

NCI is committed to supporting research to address the significant disparities and needs of the 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).

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.

Data from the DCCPS Surveillance Research Program has shown 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, economic, and cultural barriers. DCCPS is interested in applications that focus on both individual and community factors that affect cancer control and prevention. Researchers and communities should 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.

Center to Reduce Cancer Health Disparities (CRCHD)

CRCHD is committed to the NCI's efforts to help reduce the unequal burden of cancer in our society by strengthening basic, clinical, translational, and population-based research addressing cancer health disparities; advising on strategic priorities, program direction, and leading NCI's efforts to enhance scientific workforce diversity through the training of underrepresented students and investigators. The CRCHD initiates, integrates, and engages with NCI divisions and NIH Institutes and Centers, and outside partners to promote research and training in cancer and cancer health disparities research.

The CRCHD will support scientifically meritorious projects with direct relevance to the training, education, and career development of AI/AN students and investigators and in the understanding of the basic, clinical, translational, or population factors of cancer and cancer health disparities among AI/AN populations. CRCHD will assist in achieving these purposes by supporting selected projects developed by NARCH partnerships.

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.

National Institute of Dental and Craniofacial Research (NIDCR)

The prevalence of oral diseases in AI/AN communities is amongst the highest in the U.S. The National Institute of Dental and Craniofacial Research (NIDCR) is interested in research that addresses dental caries, periodontal disease, and oral and pharyngeal cancer in AI/AN communities. Oral diseases share protective and risk factors with many other diseases and conditions, making holistic approaches to health promotion and disease prevention particularly important. Determinants of health exist at individual, family, health care systems, community, organizational/ institutional, and policy levels. Some examples of these determinants include: reliable access to oral health care, sustainable oral disease preventive approaches, availability and consumption of healthy foods and beverages, and policies that promote health. NIDCR welcomes applications for culturally appropriate research that propose multi-disciplinary approaches to improve oral health status and reduce inequities in AI/AN communities. Proposed research should not focus on oral health in isolation from general health.

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

The mission of the ORWH is to improve the quality of women s lives, reduce their disease burden across the life course, and address health disparities among populations of women in the United States. In support of this initiative, ORWH is interested in applications that address issues associated with women’s health and/or sex and gender influences on health and disease in AI/AN populations. There is a growing recognition that the quality and generalizability of biomedical research findings depend on the consideration of sex as a biological variable (SABV) to advance science for the health of women and men. The 2019-2023 Trans-NIH Strategic Plan for the Health of Women Advancing Science for the Health of Women identifies the guiding principles, research goals and objectives to advance the health of women. (https://www.nih.gov/women/strategicplan)

National Institute of Aging (NIA)

NIA promotes genetic, biological, clinical, behavioral, social, and economic research related to aging and life course health, including research on Alzheimer’s disease. A strategic priority of NIA is the understanding of health differences and development of strategies to improve the health status of older adults in diverse populations. NIA encourages comparisons between racial/ethnic groups, i.e., AI/AN versus other race/ethnic groups, and research on factors affecting health and longevity, such as cultural affiliation, socioeconomic and geographic inequality, gender differences, discrimination, and stress, among AI/AN groups. NIA interests in this area include, but are not limited to, the following:

• Understanding mechanisms that produce disparate life expectancy, morbidity or disability in AI/AN populations including stigma, bias, discrimination, racism, and inequity.
• Structural or institutional factors that mitigate or exacerbate disparities such as access to health care or services.
• Social, cultural and behavioral factors over the life course, such as early life adversity, education, employment, health behaviors (e.g., substance use and physical exercise/inactivity), and cultural beliefs, that may influence cognitive aging and dementia and explain the link between the aging process and morbidity and mortality.
• The development of data resources for studying disparities, including nationally representative samples with AI/AN group oversamples, and also smaller, more local samples that are targeted toward disparities questions.
• Approaches to enrolling and retaining samples of participants who represent AI/AN groups, as well as approaches to engaging systems that serve AI/AN groups but may be under-prepared to take part as research settings and collaborative partners.

National Center for Complementary and Integrative Health (NCCIH)

The NCCIH is interested in supporting basic, mechanistic, and clinical research on complementary approaches for the following high-priority topic areas: symptom management particularly for chronic pain syndromes; reduction of prescription drug (opioid) use or abuse in patients with chronic pain; enhancement of medication adherence; treatment or prevention of post-traumatic stress (disorder), traumatic brain injury, sleep disorders or disturbances, anxiety, depression, obesity, and smoking; promotion of psychological resilience or well-being; and promotion of healthy eating and physical activity. Complementary approaches include natural or dietary products such as botanicals, probiotics/microbials, naturally derived peptides, dietary supplements, and special diets, as well as mind and body approaches delivering psychological and/or physical input, including AI/AN traditional medicine approaches. NCCIH will not fund research proposing efficacy or effectiveness clinical trials through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). Investigators are strongly encouraged to discuss their research plans with NCCIH program staff prior to submitting their application.

National Human Genome Research Institute (NHGRI)

NHGRI will support the development of resources, approaches, and technologies that will accelerate genomic research on the structure of genomes, the biology of genomes, and the biology of disease; that will use genomics to advance the science of medicine; and that will incorporate genomics to improve the effectiveness of healthcare. NHGRI will also support genomic research in several cross-cutting areas, including the ethical, legal and societal implications of genomics and genetics research, bioinformatics, technology development, and research training and workforce development. NHGRI is also committed to supporting genomics research that addresses health disparities.

In general, NHGRI supports studies that provide generalizable methods and knowledge. Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. NHGRI strongly encourages potential applicants to contact program staff in the early stages of developing your application.

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.

National Heart, Lung, and Blood Institute (NHLBI)

NHLBI has a strong history of supporting research to understand, document, prevent, and treat heart, lung, blood, and sleep (HLBS) disorders in AI/AN communities. The communities are disproportionally affected by heart disease, hypertension, and respiratory diseases. NHLBI s participation in NARCH will help advance research efforts, reduce risk factors, and promote the health of communities. NHLBI also recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical, and social science research workforce. NHLBI is interested in research projects including, but not limited to, the following:

• the prevention and reduction of cardiovascular disease morbidity and mortality and its risk factors (including psychosocial and behavioral risk factors)
• the causes, prevention, and treatment of lung diseases (such as asthma and COPD) and sleep disorders (such as insufficient sleep, poor sleep quality, and obstructive sleep apnea (OSA))
• the sustainable delivery of proven-effective, evidence-based interventions to improve overall health in tribal communities

NHLBI will also support capacity-building and career enhancement projects for faculty and students that can include opportunities for building research infrastructure, research training, and career development.

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 of Allergy and Infectious Diseases (NIAID)

NIAID supports basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases, with the goal of developing new therapies, vaccines, diagnostic tests, and other technologies. Research areas include microbiology and infectious diseases, AIDS and AIDS -related research, immunology, allergy, transplantation, and biodefense.

https://www.niaid.nih.gov/research/role

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIDDK conducts and supports medical research and research training and disseminates science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people s health and quality of life. The American Indian and Alaska Native communities suffer disproportionately from diseases in the mission area of NIDDK.

The Institute also believes that a wide range of skill sets and view points borne of diverse backgrounds is necessary. Therefore, we support efforts to bring new investigators from all backgrounds, including women, minority, and underrepresented populations, into biomedical research careers, ensure that new investigators can realize their potential to contribute to biomedical research and that today's generation of aspiring scientists will view research as a viable career. The Institute's research interests are many and broad and include:

Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM): DEM provides research funding and support for basic and clinical research in the areas of type 1 and type 2 diabetes and other metabolic disorders, including cystic fibrosis; endocrinology and endocrine disorders; obesity, neuroendocrinology, and energy balance; and development, metabolism, and basic biology of liver, fat, and endocrine tissues.

Division of Digestive Diseases and Nutrition (DDN): DDN supports research related to digestive diseases, including the alimentary tract, liver and pancreas, nutrition and obesity. The programs include basic, translational and clinical research, research training, and career development. DDN also promotes public awareness and education about digestive diseases and related conditions and oversees several national public awareness campaigns.

Division of Kidney, Urologic, and Hematologic Diseases (KUH): KUH provides research funding and support for basic, translational, and clinical research studies of the kidney, upper and lower urinary tract, and disorders of the blood and blood-forming organs.

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

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

The applicant institution must meet one of the following criteria:

• A federally recognized AI/AN Tribe, as defined under 25 U.S.C. 1603(14); or
• A Tribal organization, as defined under 25 U.S.C. 1603 (25) and (26), including Tribal colleges or health boards meeting this definition; or
• A consortium of two or more of those Tribes or Tribal organizations.

The proposed NARCH may be a working partnership between the eligible AI/AN tribes/organization and a research-intensive institution, but the federally recognized tribe/tribal organization must be the applicant institution. 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 concerns 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, interested in AI/AN health research.

The applicant institution 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 allowed.

Applicant Organizations

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

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

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

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

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

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

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.

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

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

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

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

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

The letter of intent should be sent to:

Sheila A. Caldwell, PhD
Email: [email protected]

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

Required:

• Overall
• Administrative Core: maximum of 1

Any combination allowable, but at least one of the following components is required:

• Student Career Enhancement Project
• Faculty/Researcher Career Enhancement Project
• Research Project
• Pilot Project: maximum of 5
• Capacity Building Project

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

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 also provide the following information:

• A research strategy that describes the organization and proposed component functions, including how they will contribute to the overall center.
• Letter(s) of support from research intensive partner(s), if proposed, stating commitment to engagement with the AI/AN community and meeting the health priorities of the AI/AN community.
• Documentation about the nature of any partnerships proposed should be included, such as: the process to develop the relationship, 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. Each AI/AN Sovereign Nation may approach the support differently, hence a tribal letter of support or tribal resolution is acceptable.

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

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, Capacity Building 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(s)/PI(s) 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. Any budget items pertaining to specific proposed projects within the application, should be included within that proposed project 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.

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

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

Research Strategy: A description should be provided of how the Administrative Core will provide oversight to support the individual research, student/faculty, or capacity building projects being proposed.

The application should also provide the following information:

• A description of how information will be dispersed among the proposed NARCH components regarding potential funding opportunities.
• A plan for providing information on resources for training and mentoring programs for personnel involved in the proposed NARCH application.
• If applicable, how assistance will be provided in oversight of IRB and IACUC applications.
• A plan for establishing communication and collaboration among the different projects proposed, where applicable.
• A plan for providing guidance in evaluation of the proposed NARCH projects.

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:

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

PHS Human Subjects and Clinical Trials Information (Administrative Core)

Do not complete. Human subjects research is not allowed in the Administrative Core.

When preparing your application, 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
• Type of Applicant (optional)
• 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 project.

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.

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 project.

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)

Each Faculty/Researcher Enhancement Leader/Director should be listed as Project Lead. Each prospective director 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 faculty/researchers, and to generate and direct programs to provide 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.

A detailed budget should be prepared that includes only budget items specific to the proposed project. If for example, a faculty/researcher project leader plans to attend the annual NARCH PD/PI meeting or other scientific meeting, then travel costs should be included in the 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)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: Proposed Faculty/Researcher Career Enhancement Applications should describe:

• The need for the project, the proposed activities, and anticipated outcomes. The application should describe how the faculty/researchers' research efforts and objectives will be advanced or broadened. Faculty/researcher enhancement projects might include but 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.
• The experience, proposed commitment, and quality of the advisors and teachers proposed, or their experience in providing guidance and advice to faculty/researchers, and in fostering the development of academic and community-based AI/AN research.
• How the research and/or research education activities will improve their skills and abilities to be successful at the next stage of their professional evolution.
• How investigators will gain experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction.
• How the project will fulfill the research and professional enhancement needs for faculty/researchers engaged in AI/AN health research, or enhancement 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: For each specific project proposed, a tribal resolution or tribal letter of support from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project. Each AI/AN Sovereign Nation may approach the support differently, hence a tribal letter of support or tribal resolution is acceptable. The tribal resolution or letter should specifically reference the tribal 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 would be sufficient. The listed Tribes to be served by the project 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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

When preparing your application, 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
• Type of Applicant (optional)
• 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 project 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. Each prospective director 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.

A detailed budget should be prepared that includes only budget items specific to the proposed project. If for example, 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 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)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: Proposed Student Career Enhancement applications 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 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 the 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, 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: For each specific project proposed, a tribal resolution or tribal letter of support from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project. Each AI/AN Sovereign Nation may approach the support differently, hence a tribal letter of support or tribal resolution is acceptable. The tribal resolution or 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 would be sufficient. The listed Tribes to be served by the project 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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide,

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

When preparing your application, 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
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant 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 project 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 of a research project 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 lead 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)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: Proposed research project(s) may or may not have preliminary data but may provide published work in other populations as support for the proposed research project.

In addition, proposed research application(s) should include:

• The goals must clearly include specific objectives and milestones which should include, but are not limited to, improving competitiveness in acquiring grant support. The application should describe how the proposed research project will provide research experiences and help develop the research skills of participating faculty/researchers.
• The application 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.

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.

Letters of Support: For each specific project proposed, a tribal resolution or tribal letter of support from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project. Each AI/AN Sovereign Nation may approach the support differently, hence a tribal letter of support or tribal resolution is acceptable. The tribal resolution or 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 would be sufficient. The listed Tribes to be served by the project 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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

When preparing your application, 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
• Type of Applicant (optional)
• 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 (e.g., Academic Research Enhancement Award (R15), K, and R01 awards), 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 (for example, NIH R03 and R21 awards), or mentored career development awards (for example, NIH K01 and K08 awards) also 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 component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot Project)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: A pilot project is limited in scope and is not expected to have preliminary data. The research strategy for the proposed pilot project should include:

• a clear description of how the pilot project will meet the needs of the community, as well as the goals of the FOA.
• an evaluation plan for the impact of the pilot project.

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

Letters of Support: For each specific project proposed, a tribal resolution or tribal letter of support from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project. Each AI/AN Sovereign Nation may approach the support differently, hence a tribal letter of support or tribal resolution is acceptable. The tribal resolution or 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 would be sufficient. The listed Tribes to be served by the project 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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Pilot Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

When preparing your application, 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
• Type of Applicant (optional)
• 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 project.

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 per year.

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)

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

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The application should describe:

• The need for the project, the proposed activity, and anticipated outcomes. A Capacity Building Project strengthens research capabilities within the communities served 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) or the development of, or creation of, the steps to develop a tribal IRB.
• 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

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: For each specific project proposed, a tribal resolution or tribal letter of support from the Tribal government of all Tribes to be served by those proposed activities, should accompany that particular project. Each AI/AN Sovereign Nation may approach the support differently, hence a tribal letter of support or tribal resolution is acceptable. The tribal resolution or 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 would be sufficient. The listed Tribes to be served by the project 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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Capacity Building Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

For this particular announcement, note the following: Although this is a multi-component mechanism, it is not expected that the NARCH application will 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.

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 program 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 the prior research that serves as the key support for the proposed project rigorous? 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?

In addition, for this FOA: 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 or research projects prioritized by their communities? Will opportunities be created for faculty/researcher career enhancement or student career enhancement to benefit the health or research priorities of AI/AN communities? Will research infrastructure be created to benefit the community and their research partnerships?

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

In addition, for this FOA: 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?

In addition, for this FOA: Will the approaches bring new understanding to current interventions to the AI/AN communities? Will the approaches bring new 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 investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for this FOA: Will the approach of the proposed program help to address health issues pertinent to the AI/AN community or prioritized research interests? Will the approach of the proposed program help to strengthen AI/AN tribal engagement in health research? Will the approach of the proposed program work toward the enhancement of scientists and health research professionals focused on AI/AN health?

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

In addition, for this FOA: 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 the prior research that serves as the key support for the proposed project rigorous? 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?

Core Leader(s)

Are the core leaders, collaborators, and other researchers well suited to the core? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the 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 investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the 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 individuals of all ages (including children and older adults), 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 the prior research that serves as the key support for the proposed project rigorous? 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 those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-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 investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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 individuals of all ages (including children and older adults), 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.

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

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 the prior research that serves as the key support for the proposed project rigorous? 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?

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

Investigator(s)

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

In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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 of current interventions or new interventions related to the health of AI/AN communities?

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

Approach

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

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

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

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 the prior research that serves as the key support for the proposed project rigorous? 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?

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

Investigator(s)

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

In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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 a current intervention or new interventions in health to the AI/AN communities?

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

Approach

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

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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 the prior research that serves as the key support for the proposed project rigorous? 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 those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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

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 individuals of all ages (including children and older adults), 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.

Study Timeline

Specific to applications involving clinical trials

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

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

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

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

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

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

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

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

Not Applicable

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.

Not Applicable

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

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

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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 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.

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

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

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

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

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

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

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

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

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

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

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

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

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

Sheila A. Caldwell, PhD
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Lindsey Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-4036
Email: [email protected]

Juanita J. Chinn, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-4901
Email: [email protected]

Dawn Morales Ph.D.
National Institutes of Mental Health (NIMH)
Telephone: 301-827-9668
Email: [email protected]

Lynn S. Adams, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email: [email protected]

Laura Kwako, Ph.D.
National Institute on Alcohol Abuse, and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: [email protected]

Delia Olufokunbi Sam, PhD
Center for Scientific Review (CSR)
Email: [email protected]

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

Jenny Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]

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

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