Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
Indian Health Service (IHS)  

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

National Heart, Lung and Blood Institute (NHLBI) (Now Participating per NOT-AI-13-050)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (Now Participating per NOT-AI-13-050)
National Institute of Allergy and Infectious Diseases (NIAID) (Now Participating per NOT-AI-13-050)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS) (Now Participating per NOT-AI-13-050)
National Institute of Mental Health (NIMH) (Now Participating per NOT-AI-13-050)
National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Native American Research Centers for Health (NARCH) (S06)

Activity Code

S06 Research-Related Programs

Announcement Type

Reissue of PAR-12-182

Related Notices

  • June 14, 2013 - See Notice NOT-AI-13-050. Notice of Multiple Institutes' Participation.

Funding Opportunity Announcement (FOA) Number

PAR-13-239

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859, 93.846, 93.279, 93.121, 93.847, 93.213, 93.837, 93.838, 93.839, 93.233, 93.273, 93.855, 93.856, 93.113, 93.242

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to encourage grant applications for new or continued Native American Research Centers for Health (NARCH). The NARCH program supports opportunities for conducting research and research training to meet the needs of American Indian/Alaska Native (AI/AN) communities. This FOA is issued by the National Institute of General Medical Sciences in conjunction with the other Institutes/Centers of the National Institutes of Health (NIH) and the Indian Health Service (IHS).

Key Dates
Posted Date

May 31, 2013

Letter of Intent Due Date(s)

July 6, 2013

Application Due Date(s)

 August 6, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2013

Advisory Council Review

January 2014

Earliest Start Date

July 2014

Expiration Date

August 7, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Purpose

The purpose of the Native American Research Centers for Health (NARCH) initiative is to reduce health disparities, support health research projects prioritized by the tribal communities, enhance health research partnerships and reduce distrust of research by American Indian/Alaska Native (AI/AN) communities while developing a cadre of AI/AN scientists and health research professionals.  The AI/AN Tribal nations and communities have long experienced disparities in health compared with other Americans.  Health disparities of AI/ANs are related to a complex set of factors and the paucity of health research within these populations may contribute to the situation.  One approach that reduces this distrust of research within the AI/AN communities is to ensure that Tribes and Tribal Organizations are the managing partners in research and training involving them.  To that end, NIH, in collaboration with IHS, has issued the NARCH funding opportunity announcement (FOA) in which collaborations between 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(d) or (e)) and institutions that conduct intensive academic-level biomedical, behavioral and health services research will be supported to conduct research and training in AI/AN communities.  Areas of research proposed in the application will be selected by the AI/AN tribes and communities. 

Background

While characterized by many strengths, the AI/AN population has long experienced health status worse than that of other Americans.  AI/AN have higher rates of disease across many

areas of health such as: diabetes, HIV/AIDS, dental disease, certain cancers, mental health and substance use (http://www.cdc.gov/omhd/amh/dbrf.htm, and http://www.cancer.gov/cancertopics/factsheet/disparities/cancer-health-disparities).  Unfamiliarity with modern health care may adversely influence health status and also may reduce the acceptability of health research. These rates of disparities in health mask sources of strength in AI/AN communities. Identifying and utilyzing these strengths may contribute to reducing the health disparities that exist within the community.  The daunting tasks confronting Tribes, researchers, and health care and public health programs are to decrease the health disparities and improve overall health among the AI/AN populations, maintain and strengthen resiliency factors and train a new generation of researchers and health care workers from within the communities.

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

1. Family, home, and work environments;

2. General or culturally specific health practices;

3. Social support systems;

4. Lack of access to culturally appropriate health care; and

5. Attitudes toward health.

Research Objectives

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

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

The following can be proposed in the NARCH application:

Research Interests

NIH and IHS are vested in working toward eliminating health disparities while supporting an understanding of elements that contribute to health and well being.  Specifically, the mission of NIH is to acquire new knowledge that will lead to better health by understanding the processes underlying health and disease that in turn will help prevent, detect, diagnose, and treat disease and disability.  In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of under-represented minorities participating in biomedical, clinical, and behavioral research and the examination of the role of resiliency in the prevention and treatment of those conditions.  In the Indian Health Care Improvement Act, Public Law 94–437 (as amended), IHS was legislatively mandated to improve the delivery of effective health care to AI/ANs.  More recently an emphasis was placed on promoting and understanding preventive care by the President in the Affordable Care Act (http://www.healthcare.gov/news/factsheets/2010/07/preventive-care-background.html).    In response to these priorities, NIH in collaboration with IHS continues to support the NARCH program.  The NARCH initiative works toward the overall mission of NIH by supporting research that discovers the interrelationships among the many factors that contribute to health and disease, and by helping to train and promote AI/AN researchers and researchers concerned with AI/AN health. Below is a list of more explicit scientific areas of research interests expressed by NIH Institutes, Centers and Offices:

National Center for Complementary and Alternative Medicine (NCCAM)

NCCAM is particularly interested in supporting research projects in the following categories: 1) Utilization of systems of healing and health practices outside the conventional medical care by Native American/American Indian communities; 2) Extent and use of self-care and health practices,  integrative health practices, conventional medical care, or a combination of the two by Native American/American Indian communities. Specific areas of focus include symptoms management (Pain, HIV/AIDS), and special populations (older adults, military/veterans). All applications must be aligned to NCCAM’s mission, research priorities and strategic plan (http://nccam.nih.gov/). Applicants are encouraged to establish research collaborations with NCCAM-funded investigators as well as NCCAM’s Research Center Programs (http://nccam.nih.gov/research/centers). For the NARCH program, NCCAM will not consider applications proposing interventional clinical trials. 

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 training of underrepresented minority AI/AN researchers and ensuring inclusion of Native communities in clinical research studies. Details of NIAMS's research interests can be found at http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm.

National Institute of Dental and Craniofacial Research (NIDCR)

Oral Health Research

NIDCR is committed to reducing the disproportionate burden of oral diseases experienced by AI/ANs. The focus of NIDCR’s health disparities research is on improving oral health status and quality of life by understanding and addressing oral diseases that are prevalent in AI/AN communities, specifically caries (including early childhood caries), oral and pharyngeal cancer, and periodontal disease.  For research related to oral health, note that the NIDCR does not accept applications that include clinical trials in response to trans-NIH FOAs.  Applicants proposing a clinical trial should refer to the following NIDCR websites:  http://www.nidcr.nih.gov/clinicaltrials/

and http://grants.nih.gov/grants/guide/pa-files/PAR-11-338.html.

National Institute on Drug Abuse (NIDA)

Neuroscience and Drug Abuse Research

NIDA is committed to reducing health disparities in drug abuse and related health and social consequences among AI/AN. Further, the Institute supports methodologies required by the NARCH, expecting that studies be developed and implemented using community participatory approaches.  Details of NIDA's research interests can be found at http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm.

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

The National Institute of Diabetes and Digestive and Kidney Diseases (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.  Many of these chronic and costly diseases disproportionately afflict AI/AN communities; the Institute, therefore, supports basic, translational, and clinical research across a broad spectrum of research topics to reduce the health disparities especially as relates to the Native American communities.

NIDDK website: (http://www.niddk.nih.gov/)

National Instute of General Medical Sciences (NIGMS)

Training, Workforce Development and Diversity

NIGMS is committed to reducing health disparities that affect the AI/AN populations while supporting training and capacity building within these communities.  Examples of NIGMS's research interest can be found at http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm.

Participation by additional NIH Institutes will be announced in the NIH Guide.

A listing of grants recently funded by NIH may be found at Research Portfolio Online Reporting Tools (RePORT), a searchable database of Federally-funded biomedical research projects conducted at universities, hospitals, and other research institutions. It may be accessed at http://report.nih.gov/.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Resubmission

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH/IHS intends to fund an estimate of five to fifteen awards, corresponding to a total of $100,000-$1,100,000, for fiscal year 2014. Future year amounts will depend on annual appropriations.

FOA with multiple ICs/components (choice 1, preferred):

FOA with multiple ICs/components (choice 2, not preferred; use if ICs/components are not showing each contribution in the FOA)    

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project. A minimum of 30 percent of the grant funds must be budgeted in the application to remain with the eligible AI/AN organization(s); that is, no more than 70 percent of the application’s total budget may be contained in subcontract budgets of the non-eligible subcontracting partner institutions or organizations .

Award Project Period

Four Years 

Since awards will be issued and managed by IHS, HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

The proposed NARCH must be a working partnership of the eligible AI/AN tribes/organization and of the research institution.  The AI/AN applicant must be one of the following:

The Research-Intensive Partner must be an accredited public or private nonprofit university, academic medical center, or other institution that has an established record of conducting research into the health problems of AI/AN; has demonstrated a commitment to enhancing the capability of AI/AN faculty/researchers, students, investigators, and communities to engage in biomedical, behavioral, social, clinical and health services research; and has demonstrated a commitment to mentoring AI/AN faculty/researchers, students, and investigators.

As the grantee, the eligible AI/AN tribe/organization will define criteria and eligibility for participation in all aspects of the partnership, consistent with this announcement.

Foreign Institutions

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 HHS Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Principal Investigators (PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

Eligible Individuals (Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Principal Investigator(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.

Additional Eligible requirements for the NARCH include:

The PI, the individual responsible for the administration (including fiscal management) of the overall project, must have his/her primary appointment with the AI/AN applicant organization. Special arrangements of employment, such as inter-organizational personnel agreements, are permissible. The PI may be, but is not required to be, the NARCH Program Coordinator or a Research Project Leader. The NARCH PI may or may not have formal academic/research credentials, but if not, then the NARCH Program Coordinator must be so qualified. 

The NARCH Program Coordinator is the individual responsible for the day-to-day leadership and management of the research and training programs within the proposed NARCH. The Program Coordinator may be, but is not required to be, the Student and Faculty/Researcher Development Director or a Research Project Leader. The NARCH Program Coordinator may or may not have formal academic/research credentials, but if not, then the PI must be so qualified.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH/IHS will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the HHS Grants Policy Statement), except for submission:

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

If a new Student and/or Faculty/Researcher Development Program is proposed in the current application, then that Development Project Leader is expected to be the NARCH Student and Faculty Development Director.  In order to be included as the Student and Faculty Development Director, the 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 mentor students and faculty/researchers and to generate and direct development and mentoring programs.  The Student and Faculty Development Director may be the proposed NARCH Program Coordinator.

Faculty/Researchers and Students should be supported in research education activities that improve their skills and abilities to be successful at the next stage of their professional development. To be included as a participant for faculty/researcher development in the proposed NARCH, the individual must have a faculty/researcher appointment at the research-intensive institution or equivalent appointment at the AI/AN organization or consortium partner.

In order to be included as 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.

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

The letter of intent should be sent to:

Sheila A. Caldwell, PhD
Division of Training, Workforce Development and Diversity
National Institute of General Medical Sciences
45 Center Drive, 2nd Floor
Bethesda, MD 20892-6200
Telephone: 301-594-6115
Email: caldwells@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, including appendices (3 CDs), in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Two additional paper copies of the application with Appendix files (2CDs) must be submitted for forwarding to IHS.  This is in addition to the original application with the appendix files submitted to CSR. Please send the additional copies to:

Sheila A. Caldwell, PhD
Division of Training, Workforce Development and Diversity
National Institute of General Medical Sciences
45 Center Drive, 2nd Floor
Bethesda, MD 20892-6200
Telephone: 301-594-6115
Email: caldwells@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition the following page limitations to the Research Strategy section of each component of the application.

Center Overview: 6 pages

Administrative Core: 6 page maximum

Student Development Projects: 6 pages

Faculty/Researcher Development Projects: 6 pages

Capacity Building Projects: 6 pages

Research/Pilot Projects: 6 pages

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Center Overview

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page ( Center Overview)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Center Overview)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description: Provide a succint but accurate description of the overall NARCH application addressing the major, overall aims and goals to be accomplished.

Project/Performance Sites: All sites proposed to be involved in the NARCH application should be listed in this section.

Senior/Key Personnel:  All key Personnel involved in the proposed NARCH application, including the individual components, should be included in this section.

Key personnel and key sites involved in individual projects and cores should be re-listed in those specific components in addition the overall section. 

Table of Contents (Center Overview)

All instructions in the PHS 398 Application Guide must be followed.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research/pilot or development project and core.  A page reference should be included for the budget for each project and each core.  Further, each research/pilot project should be identified by number (e.g. Project 1), title, and responsible Project Leader.  The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

Detailed Budget for Initial Budget Period (Center Overview)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Although each project should have an individualized budget, the center overall budget section should reflect a culmination of all the projects and cores porposed in the application.

Budget for Entire Proposed Period of Support (Center Overview)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The entire proposed budget section should again be a culmination of all individual projects or cores proposed in the grant application. Travel costs for the investigator(s) and staff are permitted to required meetings or when direct benefits to the program are expected, and when adequate justification is provided. Research project applications should also include costs associated with attendance for key personnel and presenters to the annual scientific meeting.  NARCH core and/or training budgets should include these travel costs for key NARCH personnel and trainees who are not associated with specific research projects.

Biographical Sketch (Center Overview)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Center Overview)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Thissection should provide information regarding all resources available in the individual components. 

Research Plan (Center Overview)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  The specific aims should briefly indicate the goals of the Center.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Administrative Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description: Provide a brief description of the role of the Administrative Core in addressing the major, overall aims and goals to be accomplished by the proposed NARCH.

Project/Performance Sites: List any sites proposed that will be involved in the Administrative functions of the proposed NARCH.

Senior/Key Personnel: In this section, list only Key Personnel that will be in the Administrative Core.

Table of Contents (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Prepare a Table of Contents for the Administraive Core only for this section.

Detailed Budget for Initial Budget Period (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: A detailed Budget for the Administrative Core should only include budget items specific to the running of the Administrative Core.  The Administrative Core should include only budget items associated with the support and oversight of administrative functions, training or other items that are non-essential to the research projects.

Budget for Entire Proposed Period of Support (Administrative Core )

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Budget for the entire proposed period for the Administrative Core should include only budget items specific to the running of the Administrative Core. Travel costs for the investigator(s) and staff are permitted to required meetings or when direct benefits to the program are expected, and when adequate justification is provided. Research project applications should also include costs associated with attendance for key personnel and presenters to the annual scientific meeting.  NARCH core and/or training budgets should include these travel costs for key NARCH personnel and trainees who are not associated with specific research projects.

Biographical Sketch (Administrative Core )

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches should only include key personnel involved in the Administrative Core for the Administrative Core Section.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  The Administrative Core Section should include the goals of the core in coordinating functions among the different proposed NARCH projects in the grant application.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications: 

Student Development Project(s)

All instructions in the PHS398 Application Guide must be followed.

Face Page (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Student Development Leader/Director should be listed on the Face Page of the Student Development Project Section.  If multiple Student Development Projects are proposed then each should be submitted as a separate project.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  

Description: Provide a description (abstract) of the proposed Student Development Project. Included within the abstract, there should be a brief description of how the student development project will contribute towards the NARCH objectives.

Project/Performance Sites: List any proposed sites to be involved in each Student Development project proposed.

Senior/Key Personnel: In this section, include only key personnel involved in the proposed Student Development Project.

Table of Contents (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed with the following additional instructions: Prepare a Table of Contents for of the proposed the Student Development Projects.

Detailed Budget for Initial Budget Period (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: A detailed Budget for each Student Development Project proposed should be prepared, including only budget items specific to the proposed project.  Each subcontractor participating in each proposed project should submit its budget as part of that project’s budget, using appropriate form pages from the PHS 398. Each proposed project submission should include a set of budget pages from each of the institutional partners participating in that project. Each project budget should explicitly include that portion of the grantee’s indirect costs that are associated with activities under that project, including direction and oversight of the subcontracts. Each Project should have an individualized budget which can stand alone.

Budget for Entire Proposed Period of Support (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Prepare a budget for the entire proposed period for each Student Development Project proposed, including only budget items specific to the running of each Student Development Project. Travel costs for the investigator(s) and staff are permitted to required meetings or when direct benefits to the program are expected, and when adequate justification is provided. Research project applications should also include costs associated with attendance for key personnel and presenters to the annual scientific meeting.  

Biographical Sketch (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches should include only personnel involved in the proposed Student Development Project. 

Resources (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Only list the resources available for the Student Development Project in this section.

Research Plan (Student Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Provide the goals and objectivesof the project. 

Research Strategy:  The Student Development Project Section should describe:

Student Development 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. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Faculty/Researcher Development Project(s)

All instructions in the PHS398 Application Guide must be followed.

Face Page (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Faculty/Researcher Development Leader/Director should be listed as PI on the Face Page of the Faculty/Researcher Development Project Section.  If multiple Faculty/Researcher Development Projects are proposed,then each project should be submitted as an individual project.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description:  Provide a description (abstract) of the proposed Faculty/Researcher Development Project. Included within the abstract, there should be a brief description of how the Faculty/Researcher development project will contribute towards the NARCH objectives.

Project/Performance Sites: List any proposed sites to be involved in each Faculty/Researcher Development project proposed.

Senior/Key Personnel: In this section, include only key personnel involved in the proposed Faculty/Researcher Development Project.

Table of Contents (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Prepare a Table of Contents for the Student Development Project only for this section.

Detailed Budget for Initial Budget Period (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: A detailed Budget for each Faculty/Researcher Development Project proposed should be prepared, including only budget items specific to the proposed project. Each subcontractor participating in each proposed project should submit its budget as part of that project’s budget, using appropriate form pages from the PHS 398. Each proposed project submission should include a set of budget pages from each of the institutional partners participating in that project. Each project budget should explicitly include that portion of the grantee’s indirect costs that are associated with activities under that project, including direction and oversight of the subcontracts. Each Project should have an individualized budget which can stand alone.  

Budget for Entire Proposed Period of Support (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Budget for the entire proposed period for the Faculty/Researcher Development Project section should include only budget items specific to the running of the Faculty/Researcher Development Project. Travel costs for the investigator(s) and staff are permitted to required meetings or when direct benefits to the program are expected, and when adequate justification is provided. Research project applications should also include costs associated with attendance for key personnel and presenters to the annual scientific meeting.  

Biographical Sketch (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches should include only personnel involved in the proposed Faculty/Researcher Development Project. 

Resources (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Only resources available for each Faculty/Researcher Development Project should be addressed in this section.

Research Plan (Faculty/Researcher Development Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Provide the goals and objectives of the project. 

Research Strategy: The Faculty/Researcher Development Project Section should describe:

Faculty/Researcher development 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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Capacity Building Project

All instructions in the PHS398 Application Guide must be followed.

Face Page (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Capacity Building Project Leader should be listed as PI on the Face Page of each Capacity Building Project proposed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description: Provide a description (abstract) of the proposed Capacity Building project. Included within the abstract, there should be a brief description of how the Capacity Building Project will contribute towards the NARCH objectives.

Project/Performance Sites: List any proposed sites to be involved in each proposed Capacity Building Project.

Senior/Key Personnel: In this section, include only key personnel involved in each proposed Capacity Building Project.

Table of Contents (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Prepare a Table of Contents for each Capacity Building Project.

Detailed Budget for Initial Budget Period (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: A detailed Budget for each capacity Building project proposed should be prepared, including only budget items specific to the proposed project.  Each subcontractor participating in each proposed project should submit its budget as part of that project’s budget, using appropriate form pages from the PHS 398. Each proposed project submission should include a set of budget pages from each of the institutional partners participating in that project. Each project budget should explicitly include that portion of the grantee’s indirect costs that are associated with activities under that project, including direction and oversight of the subcontracts. Each Project should have an individualized budget which can stand alone. 

Budget for Entire Proposed Period of Support (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Budget for the entire proposed period for each Capacity Building project should include only budget items specific to the running of that Capacity Building Project. Travel costs for the investigator(s) and staff are permitted to required meetings or when direct benefits to the program are expected, and when adequate justification is provided. Research project applications should also include costs associated with attendance for key personnel and presenters to the annual scientific meeting.  

Biographical Sketch (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches should include only personnel involved in each proposed Capacity Building Project. 

Resources (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Only resources available for each Capacity Building Project should be addressed in this section.

Research Plan (Capacity Building Project)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: If a Capacity Building Project is proposed, provide the objectives and goals of the Capacity Building Project.

Research Strategy:  The Capacity Building Project should describe:

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.

If an  application is submitted for the creation of a research laboratory or conversion of an existing space for research purposes, an architectual plan is required.    

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Research/Pilot Projects

All instructions in the PHS398 Application Guide must be followed.

Face Page (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Research Project Leader should be listed as PI on the Face Page of each Research Project proposed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description: Provide a description (abstract) of each proposed Research project. Included within the abstract, there should be a brief description of how the Research project will contribute towards the NARCH objectives.

Project/Performance Sites: List any proposed sites to be involved in each proposed Research Project.

Senior/Key Personnel: In this section, include only key personnel involved in each proposed Research Project.

Table of Contents (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Prepare a Table of Contents for each Research Project.

Detailed Budget for Initial Budget Period (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  A detailed Budget for each Research/Pilot project proposed should be prepared, including only budget items specific to the proposed project.  Each subcontractor participating in each proposed project should submit its budget as part of that project’s budget, using appropriate form pages from the PHS 398. Each proposed project submission should include a set of budget pages from each of the institutional partners participating in that project. Each project budget should explicitly include that portion of the grantee’s indirect costs that are associated with activities under that project, including direction and oversight of the subcontracts. Each Project should have an individualized budget which can stand alone.

Budget for Entire Proposed Period of Support (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The Budget for the entire proposed period for each Research/Pilot Project should include only budget items specific to the running of that Project. Pilot projects are limited to a budget of no more than $75,000 direct costs per year for four years.  Travel costs for the investigator(s) and staff are permitted to required meetings or when direct benefits to the program are expected, and when adequate justification is provided. Research project applications should also include costs associated with attendance for key personnel and presenters to the annual scientific meeting.

Biographical Sketch (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Biographical Sketches should include only personnel involved in each proposed Research/Pilot Project. 

Resources (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Only resources available for the Research/Pilot Project should be addressed in this section.

Research Plan (Research/Pilot Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  If a Research/Pilot Project is proposed, provide the objectives and goals of the project. Clearly state if the proposed project is a research or pilot project (descriptions of research vs. pilot project are described below in the Research Strategy Section). 

Research Strategy:   A maximum of five (5) regular Research Projects and a maximum of five (5) Pilot Research Projects may be proposed in a NARCH application.  The application need not include both research projects and pilot research projects and may be submitted with only pilot projects or research projects.  Individual Project Leaders may propose either a research project or a pilot research project, but not both.    

Research Projects:

Pilot Projects:

Letters of Support: Each research project must follow the IHS policy concerning Tribal approval, in that all research involving AI/AN Tribes be approved by the Tribal governments with jurisdiction.  Each research project must include a resolution of approval from the Tribal government(s), or (if applicable) a letter of support signed by the Executive Director or CEO of the eligible AI/AN organization, or both (if applicable) for projects that involve people or community(ies) of an AI/AN Tribe, or an eligible Tribal organization.

Each pilot project must follow the IHS policy concerning Tribal approval, in that all research involving AI/AN Tribes be approved by the Tribal governments with jurisdiction.  Each pilot project must include a resolution of approval from the Tribal government(s), or (if applicable) a letter of support signed by the Executive Director or CEO of the eligible AI/AN organization, or both (if applicable) for projects that involve people or community(ies) of an AI/AN Tribe, or an eligible Tribal organization.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications:

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Tribal Approval of the Application: It is the policy of the IHS and since this is an NIH-IHS collaboration, it is required that all research involving AI/AN Tribes be approved by the Tribal governments with jurisdiction. Therefore, the following documentation is required as part of the application for new or existing centers or additional NARCH projects:

Tribal Resolution: If the applicant is a Tribal organization, a resolution supporting the project from the Tribal government of all Tribes to be served must accompany the application submission. Applications by Tribal organizations will not require resolutions if the current Tribal resolutions under which they operate would encompass the proposed activities. In this instance, a copy of the current resolution must accompany the application. The listed Tribes to be served by the project in the application must match the set of appended resolutions.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to terms and conditions, cost principles, and other considerations decribed in HHS Grants Policy Statement.

Pre-award costs are allowable pending prior approval from the awarding agency (i.e., IHS). However, in accordance with 45 CFR part 74, all pre-award costs are incurred at the applicants own risk and the IHS is under no obligation to reimburse such costs if for any reason the applicant does not receive an award or if the award is less than anticipated.

Indirect Costs

This section applies to all grant recipients that request reimbursement of indirect costs in their grant application. In accordance with HHS Grants Policy Statement, Part II-27, the IHS requires applicants to obtain a current indirect cost rate agreement prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable grant activities under the current award’s budget period. If the current rate is not on file with the DGM at the time of award, the indirect cost portion of the budget will be restricted. The restrictions will remain in place until the current rate is provided to the DGM.

Generally, indirect costs rates for IHS grantees are negotiated with the Division of Cost Allocation (http://rates.psc.gov/) and the Department of Interior National Business Center (http://www.aqd.nbc.gov/services/ICS.aspx). If your organization has questions regarding the indirect cost policy, please call the DGM at (301) 443-5204 to request assistance.

Administrative Costs

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. For guidance, applicants should refer to the OMB Circular appropriate for them (http://www.whitehouse.gov/omb/circulars_default), or should contact the Grants Management Officer listed under VII. Agency Contacts.

Evaluation

Costs for evaluation activities are allowable, as are costs for the Community and Scientific Advisory Council. All research project applications must include costs associated with one annual meeting per

year of the project Principal Investigators and their key scientific personnel.

Student Development Costs

Student (graduate, undergraduate, and high school if well justified) remuneration through salary/wages for participation in research experiences may be requested, provided all the following conditions are met:

Graduate Students

Graduate students, but not undergraduate students, are allowed tuition costs as part of a compensation package. When requesting support for a graduate student, the NARCH application should provide, in the budget justification section of the application, the basis for the compensation level (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-033.html).

Postdoctoral Students

Postdoctoral students should be compensated at a rate commensurate with that of other postdoctoral employees with similar degrees and experience at the research-intensive institution. It is the expectation of NIH and IHS that students who are enrolled in an accredited graduate program, as part of a proposed NARCH, will not be excluded from support from other non-Federal or Federal graduate training sources (such as loans and assistance under the Veterans’ Adjustment Benefit Act or Pell Grants) for which they are eligible.  However, graduate and postdoctoral students cannot concurrently hold other Federally-sponsored stipends or fellowship or any other Federal award that duplicates the NARCH support.

Faculty/Researcher Development Costs

Costs to support faculty/researcher development activities, such as workshops or courses, national meetings, or short-term research experiences in the laboratory of an active NIH-extramurally-funded researcher needed for acquiring specific skills or methodologies needed for prospective research, are allowable. Such costs might include tuition, travel and per diem costs, as well as salary support appropriate to the percent effort needed for the activity.

Research Project Costs

Direct costs associated with research and pilot research projects are allowable when adequate justification is provided. These include faculty/researcher salaries, reimbursed according to percent effort. Summer salary support can be paid provided the institution’s academic schedule permits such release and when the institution approves. The maximum summer-salary support provided by the program cannot exceed the equivalent of three months at 100 percent effort, or time specified by the institution as its policy. Grant funds may not be used to increase or supplement faculty/researcher academic year salaries. Salary support for technical assistance and costs for consultants, if justified, are allowable. Costs for equipment to be used to carry out the proposed research are allowable.

Cost for Supplies

Costs for supplies, including costs for animals necessary to carry out the proposed research, may be included.

Travel Costs

Travel costs for the investigator(s) and staff are permitted to required meetings or when direct benefits to the program are expected, and when adequate justification is provided. Research project applications should also include costs associated with attendance for key personnel and presenters to the annual scientific meeting.

NARCH core and/or training budgets should include these travel costs for key NARCH personnel and trainees who are not associated with specific research projects.

Capacity Building

Alterations and renovations costs (up to $40,000) are allowable only when essential for conduct of the proposed research. Other permitted costs include animal maintenance (unit care costs and number of care days), donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, and service contracts.

Consortium and Contract Arrangements

Consortium arrangements that may involve personnel costs, supplies, and other allowable costs, including overhead costs; contractual costs for support services, such as the laboratory testing of biological materials, clinical services, data processing, or core administrative services, are allowable expenses. Consortia and contractual costs with Native health organizations, Tribes and/or research institutions in Canada or Mexico are allowable expenses.

Pilot Research Projects

The intent of pilot research projects is to lead to regular research projects funded as part of the center grant or as freestanding grants. For pilot research projects, applications may request support for up to $75,000 (direct costs) per year for up to four years. Pilot research investigators considering project periods of less than four years are encouraged to consider the fact that initiation of a new research activity in a new population often takes much longer than originally anticipated and that the creation of a trusting relationship between the investigator and the community is both vital and time consuming. NARCH pilot research support is non-renewable. However, NARCH research projects based on prior NARCH pilot research projects are encouraged.

Subcontracts

The grant recipient may issue subcontracts to other organizations (such as the research-intensive institution of the partnership), as long as a minimum of 30 percent of the grant funds are budgeted in the application to remain with the eligible AI/AN organization(s); that is, no more than 70 percent of the application’s total budget may be contained in subcontract budgets of the non-eligible subcontracting partner institutions or organizations.

Unallowable Costs

Unallowable costs for research projects (including for pilot projects) include costs for textbooks, journals, memberships, and Internet subscription costs, as well as other costs prohibited by OMB Circulars A–87 or A–122 as applicable. Employees of the applicant organization may not serve as paid consultants but may be paid. The pilot research project is intended for faculty/researcher without current Federal research support. Therefore, investigators with significant current support from other mechanisms such as the R01 and research funding from other extramural sources are not eligible, and the costs therefore are not allowable. Release time for preparing applications or mini-research projects, not submitted as pilot projects, is not allowed.   

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review. Applications that are incomplete will not be reviewed.  

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modification:

Section V. Application Review Information


1. Criteria

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

In reviewing the overall application, the initial scientific review group will examine evidence of the partners’ commitment to develop a cadre of AI/AN scientists and health professionals engaged in biomedical, clinical, behavioral and health services research that is competitive for Federal funding; to increase the capacity of both research institutions and AI/AN organizations to work in partnership to reduce distrust by AI/AN communities and people toward research; and to encourage competitive research linked to the health priorities of the AI/AN partner and to reducing health disparities. Although this is a multi-component activity code, it is not expected that the NARCH application have a unified scientific theme.  Rather the connection in the application among the projects should be based on accomplishing the FOA goals.  The evidence should include:

Overall Impact - Overall

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).

Scored Review Criteria - Overall and Administrative Core

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.

Significance

Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is this program supported by the community and does it address the needs of the community being proposed?    

Investigator(s)

Are PI, collaborators, and other researchers well suited to the program? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or -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 program likely to develop approaches to increase opportunities for faculty, postdoctoral fellows, graduate students and undergraduate students involved at the participating institutions?  Does the program support the research requests of the community involved in the project? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

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

Review Criteria for Components

Each of the following components of the application will be assessed and given a score.

Student Development Plans

For NARCH applications, the five criteria listed in this announcement (Significance, Approach, Innovation, Investigators, and Environment) will be used for the scientific review of Student Development projects.  The anticipated impact of the proposed NARCH in making a difference relative to the current baseline data (based in part on previous experience of the NARCH if applicable) will be assessed. Factors to be considered include:

Faculty/Researcher Development Plans

For NARCH applications, the five criteria listed in this announcement (Significance, Approach, Innovation, Investigators, and Environment) will be used for the scientific review of Faculty Researcher Development projects.  The anticipated impact of the proposed NARCH in making a difference relative to the current baseline data (based in part on previous experience of the NARCH if applicable) will be assessed. Factors to be considered include:

Capacity Building Projects

Research Projects

Pilot Projects

Additional Review Criteria - Overall

As applicable for the projects 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.

Potential Regional or National Resource

The potential of the proposed NARCH to be a regional and national resource, including: Capacity to provide quality research training and mentoring for integrated promotion and development of AI/AN research careers from undergraduate (or if well justified, high school) through post-doctoral levels; attainment of quality research linked to health priorities of the AI/AN tribe/organization and to reducing health disparities; plans for research information dissemination and education activities; and plans for the development of research networks to support the scientific aims of the proposed NARCH.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable  

Revisions

Not Applicable  

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information


1. Award Notices

The Notice of Award (NoA) is a legally binding document, signed by the Grants Management Officer, and serves as the official notification of the grant award. The NoA will be initiated by the IHS Division of Grants Management (DGM) and will be emailed to each entity that is approved for funding under this announcement. The NoA is the authorizing document for which funds are disbursed to the approved entities and reflects the amount of Federal funds awarded, the purpose of the grant, the terms and conditions of the award, the effective date of the award, and the budget/project period.  Applicants who are approved but unfunded or disapproved will receive a copy of the NIH Summary Statement that identifies the strengths and weaknesses of the application submitted. Any correspondence other than the NoA announcing to the PI that an application was selected is not an authorization to begin performance.

2. Administrative and National Policy Requirements

Grants are administered in accordance with the following regulations, policies, and OMB cost principles:

A. The criteria as outlined in this Program Announcement.

B. Minority Biomedical Research Support (MBRS) Program regulations:

45 C.F.R. Part 52c (NIGMS) and USC title 42 part 241 (IHS).

C. Administrative Regulations for Grants:

45 C.F.R. Part 92, Uniform Administrative Requirements for Grants and Cooperative Agreements to State, Local and Tribal Governments.

45 C.F.R. Part 74, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and other Non-profit Organizations.

D. Grants Policy:

HHS Grants Policy Statement, Revised 01/07.

E. Cost Principles:

Title 2: Grant and Agreements, Part 225—Cost Principles for State, Local, and Indian Tribal Governments (OMB Circular A-87)."

Title 2: Grant and Agreements, Part 230—Cost Principles for Non-Profit Organizations (OMB Circular A-122).

F. Audit Requirements:

OMB Circular A-133, Audits of States, Local Governments, and Non-profit Organizations.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

Grantees must submit required reports consistent with the applicable deadlines. Per IHS policy, full instructions about completing and submitting required financial and progress reports will be provided to awardees in the Notice of Award.  Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following: (1) the imposition of special award provisions, or (2) the non-funding or non-award of other eligible projects or activities. This requirement applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports.

The reporting requirements for this program are noted below.

A. Progress Reports

Program progress reports are required to be submitted semi-annually, within 30 days after the budget period ends. These reports will include a brief comparison of actual accomplishments to the goals established for the period or, if applicable, provide sound justification for the lack of progress and other pertinent information as required. A final report must be submitted within 90 days of expiration of the budget/project period.

B. Financial Reports

SF-425 Federal Financial Report and Cash Transaction Reports are due at the end of every calendar quarter to the Division of Payment Management, Payment Management Branch, HHS at: www.dpm.psc.gov. It is recommended that a copy of the SF-425 report be sent to the Grants Management Specialist. Failure to submit timely reports may cause a disruption in payments to your organization.

Grantees are responsible and accountable for accurate information being reported on all required Progress and Federal Financial Reports.

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

Peer Review Contact(s)

Karyl Swartz, PhD
Division of AIDS Behavioral and Population Sciences
Center for Scientific Review (CSR)
Telephone: 301-435-1115
Email: karyl.swartz@nih.gov

Financial/Grants Management Contact(s)

Patience Musikikonga
Indian Health Service (IHS)
Telephone: 301-443-2059
Email: Patience.Musikikongo@ihs.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of The Snyder Act, 25 U.S.C. § 13; the Transfer Act, 42 U.S.C. § 2001(a); the Public Health Service Act, 42 U.S.C. § 241(a); and the Indian Health Care Improvement Act, as amended, 25 U.S.C. § 1621q(a).


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NIH Funding Opportunities and Notices



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