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 Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
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 General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Advancing Translational Sciences (NCATS)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Native American Research Centers for Health (NARCH)

Activity Code

S06 Research-Related Programs

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

PAR-12-182

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, 93.273, 93.933, 93.213,  93.846, 93.847, 93.279, 93.837, 93.242, 93.396, 93.398, 93.121, 93.856, 93.855, 93.350

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 8, 2012

Letter of Intent Due Date

June 10, 2012

Application Due Date(s)

July 10, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

July 2013

Expiration Date

July 11, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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.

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, enhance 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 combats this distrust is to ensure that Tribes and Tribal Organizations are the managing partners in research and training that involves them.  To that end, NIH in collaboration with IHS has issued the NARCH funding opportunity announcement 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. 

Background:

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

areas of health including, for example, diabetes, HIV/AIDS, 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). These rates of disparities in health mask sources of strength in AI/AN communities. Unfamiliarity with modern health care may adversely influence health status and also may reduce the acceptability of health research. The daunting tasks confronting Tribes, researchers, and health care and public health programs are to decrease the health disparities and overall disease rates among the AI/AN population, maintain and strengthen the resiliency factors and to 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 interwoven factors known to contribute to health status and disparities include:

    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.

Yet none of these alone, or in combination, accounts for all documented differences.

Research Objectives:

The NARCH program seeks to support development of AI/AN communities in research partnerships, build upon strengths in combating health disparities 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. 

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 Cancer Institute (NCI)

NCI leads the National Cancer Program to dramatically reduce the burden of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, and the development of new interventions including tobacco control and cessation; health promotion among cancer survivors; health services research; dissemination and implementation science; and cancer screening.

Center Health Disparities Research

The Center to Reduce Cancer Health Disparities (CRCHD) is committed to reducing cancer health disparities among AI/ANs. CRCHD welcomes investigations in basic, clinical, translational, and population-based research addressing cancer health disparities among AI/AN.

National Center for Complementary and Alternative Medicine (NCCAM)

NCCAM is interested in supporting research on traditional healing practices and its integration with conventional care for AI/AN communities. Details of NCCAM's research interests can be found at http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm

National Heart, Lung, and Blood Institute (NHLBI)

Cardiovascular and Respiratory Research

NHLBI is interested in supporting research in AI/AN communities that promotes the adoption of healthy lifestyles and/or improves behaviors related to cardiovascular risk, such as weight reduction, regular physical activity, and smoking cessation. Additional examples of NHLBI research interest can be found at http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Alcohol Research

NIAAA is committed to reducing the disproportionately high burden of illness associated with alcohol use, abuse, and dependence among AI/AN people.   Additional examples of NIAAA research interest can be found at http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm

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 Biomedical Imaging and Bioengineering (NIBIB)

Research in Technology for Health

NIBIB is committed to reducing health disparities through the development of new and affordable biomedical technologies. To this end, the NIBIB is interested in supporting the translation of biomedical technologies that target the health needs of AI/AN communities.  Additional examples of NIBIB's research interest can be found at be 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 more deatil regarding examples of NIDCR's research interest please see http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm

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 Instute of General medical Sciences (NIGMS)

Training, Workforce Development and Diversity

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

National Insitute of Mental Health (NIMH)

Research projects aimed at understanding the burden, treatment, intervention or prevention of mental

disorders and Human Immunodeficiency Virus (HIV)/AIDS in AI/AN populations.  Details regarding NIMH's areas of research interest can be found at http://www.nigms.nih.gov/Training/NARCH/NARCHInterestAreas.htm

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

Women’s Health and Sex Differences Research

The Office of Research on Women’s Health (ORWH) has developed several resources for interested researchers. The main one is the publication of the NIH Priorities on Women’s Health and Sex Differences Research, which can be found at: http://orwh.od.nih.gov/research/research_priorities.htm.

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

Application Types Allowed

New
Renewals of applications to RFA-GM-09-006 or RFA-GM-10-008
Resubmissions of applications to RFA- GM-10-008

The OER Glossary and the PHS398 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 per grant for fiscal year 2013. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are not limited, but need to reflect 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

Five 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 new or existing NARCH must be a working partnership of the eligible AI/AN organization and of the research intensive 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, 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 organization will define criteria and eligibility for participation in all aspects of the partnership, consistent with this announcement. 

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 PHS398 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 Program Directors/Principal Investigators (PD(s)/PI(s)) 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 least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s), 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 Principal Investigator may be, but is not required to be, the NARCH Program Coordinator or a Research Project Investigator. The NARCH PD/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 Investigator. The NARCH Program Coordinator may or may not have formal academic/research credentials, but if not, then the PD/PI must be so qualified.

The traditional NIH research project grant consists of a single Principal Investigator (PI) working with a small group of subordinates on an independent research project. Although this model clearly continues to work well and encourages creativity and productivity, it does not always work well for multidisciplinary efforts and collaboration. Increasingly, health related research involves teams that vary in terms of size, hierarchy, location of participants, goals, disciplines, and structure. There is growing consensus that team science would be encouraged if more than one PI could be recognized on individual awards. The NIH has adopted a multiple-PI model, as recently directed by the Office of Science and Technology Policy. All agencies that have research and research-related programs must offer the multiple-PI model as an option. Note, it is only an option, not a requirement. The traditional NARCH division of roles between PI and Project Coordinator will usually address these issues to a satisfactory degree. For additional information regarding the new multiple-PI model, please click on the following website: http://grants.nih.gov/grants/multi_pi/index.htm.

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 will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

If a new Student and/or Faculty/Researcher Development Program is proposed in the current application, then the Principal Investigator of that project 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 NARCH Program Director. 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 Investigator 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.

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:

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 PHS398 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
Training, Workforce Development and Diversity
National Institute of General Medical Sciences
6701 Democracy Blvd
Suite 900
Bethesda, MD 20892
Telephone: 301-435-0760
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  five signed photocopies 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)

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Overview of the Proposed NARCH Center (6 page maximum)

NARCH components:

Administrative Core:

Student Development Projects:

Faculty/Researcher Development Projects:

Research Projects (including Pilot Projects):

For Resubmission or Renewal applications, also include an introduction:

Center Overview

The content of the application should briefly explain each component of the application, and how the components help meet the purposes of the NARCH initiative. A description should be provided of the current state of the research and research training enterprise at the proposed NARCH and its institutional and community partners, including faculty/researcher and student profiles. Please provide the following information regarding the environment:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

A proposed NARCH may include any or all of the following components:

Each component should clearly state the overall goals, specific measurable objectives, and anticipated milestones. A plan for assessment of the benfits of the activities by the proposed NARCH on specific, measurable outcomes identified in the application should be provided.  NIH and IHS recognize that Tribes, Tribally-based organizations, and research-intensive institutions are diverse in their missions, their health and economic status, and their cultures. Such an assessment for a new NARCH could include a self-study by the proposed NARCH and its partners, which focuses on fact-finding, program evaluation, and recommendations for improvement in key areas. Strategies for determining the initial and ongoing success of their efforts for organizational development should also be presented. It is expected that each proposed NARCH will develop its own set of strategies that best match its circumstances. Guidance and suggestions for program evaluation of a proposed NARCH can be obtained from http://www.ihs.gov/Research/index.cfm?module=narch.

The Administrative Core component should include administrative, training or other items that are non-essential to the research projects.  The administrative core should be responsible for the oversight of the different application components.  The core should also be responsible for seeking out and dispersing information on potential funding opportunities through NARCH or other resources for development of training and mentoring programs and/or research projects.   

If proposed, the Research Projects component may include a maximum of five (5) regular Research Projects and a maximum of five (5) Pilot Research Projects. Unlike regular research projects, a pilot research project is limited in scope and is not expected to have preliminary data. It is also limited to a budget of no more than $75,000 direct costs per year for four years. The pilot research 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, K, and R01 awards), as well as funding from other agencies and private sources. Funds received from the proposed NARCH to support pilot research projects may not be used to supplement ongoing research projects. A NARCH application need not include both research projects and pilot research projects. Applications for only pilot research projects or for only research projects may be submitted.

Individual Project Investigators may propose either a research project or a pilot research project, but not both.  Each research project or pilot research project  should follow the instructions provided in PHS 398 for preparing research grant applications. The professional development goals must clearly describe specific objectives and milestones which should include, but are not limited to, improving competitiveness in acquiring grant support. The applicant should describe how successful completion of the proposed research project will improve the research skills and will help develop the students and faculty/researchers, thus contributing to the overall goals and specific measurable objectives of the proposed NARCH.

Each research project or pilot research project must follow the IHS policy concerning Tribal approval, that all research involving AI/AN Tribes be approved by the Tribal governments with jurisdiction. That is, each grantee 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.

If Student Development Projects are proposed, the NARCH application should describe:

If Faculty/Researcher Development Projects are proposed, the NARCH application should describe:

For NARCH applicationsfrom multi-Tribal consortia with projects that involve only one or a few of the Tribes of the consortium, some description should be provided as to the process through which the particular Tribes were chosen to participate. Research projects (including pilot research projects) proposed under this initiative must be in research areas normally funded by NIH. Areas of research priorities for each NIH Institute, Center or Office can be found at http://www.nih.gov/icd/index.html.

Research projects addressing health disparities and the health priorities of the AI/AN partner are especially encouraged.

If the applicant is a federally recognized Tribe, Tribal organization, or a Tribal college, letters of support from the Chairman, President, Governor, or Tribal Health Director is required of all Tribes to be served to show their support of the grant project. Letters of support are intended to document that applicants have Tribal support for the specific grant for which they are applying. All letters of support must accompany the grant application.

Previous NARCH recepients need to provide additional information:

Prior NARCH grants cannot submit an application identical to their previous grant but can submit an application that demonstrates furtherance and progression of projects.  The new application needs to describe previous accomplishments and progress from the time of the initial NARCH award.  A specific and detailed list of accomplishments and assessment of the benefits from the previous NARCH grant(s) is required including:

The report should be included in the research strategy section.  The report and evaluation of the progress made under the previous NARCH grant(s) will be a key part of the application.

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 PHS398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

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 PHS398 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

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

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.

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 Investigator(s) and their key scientific personnel.

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.

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, 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).

Post-doctoral 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 a 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 post-doctoral 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 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. 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 postmarked on or before the due dates in Part I. Overview Information.

Each submitted project within the components must be budgeted so that it could stand on its own. That is, each project should be fundable under its own budget so that it could be completed even if none of the rest of the NARCH is funded. All things vital to each project should be included in the budget of that project and not included in the Administrative core. The NARCH core should include only administrative, training or other items that are non-essential to the research projects. The Administrative core should be budgeted as if it were an additional project and the total amounts requested on the face page of the NARCH application should represent the sum of the projects plus the Administrative core. Each subcontractor participating in each project (or core) should submit its budget as part of that project’s budget, using appropriate form pages from the PHS 398. Each 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. Only the main face page for the entire NARCH is required to have the signatures of the NARCH principal investigator and official signing for the applicant organization.

Each proposed project must have a checklist and face page for that project, abstract page (1 page), proposed project description/plan (maximum 6 page), proposed budget page, and biographical sketches of all key individuals involved in the project.

The main body of the application should be self contained and the Appendix must not be used to circumvent page limitations. Applicants must adhere to the guidelines described in the PHS 398 document instructions regarding the preparation and presentation of materials that can be included in the Appendix (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.) Lack of adherence to these guidelines may result in the application being considered as non-responsive and returned to the applicant.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. 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,

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.

Applications will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups convened by the CSR. The National Advisory General Medical Sciences Council will conduct the second level of review. 

The following section (composed of Overall Impact, Scored Review Criteria, Additional Review Criteria, and Additional Review Considerations) is for evaluation of the Overall Application.  Evaluation criteria and considerations for subprojects/cores should be placed at the end of this section.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

In reviewing the overall Center, the initial scientific review group will examine evidence of the partners’ commitment to the purposes of the NARCH initiative 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 intensive 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. The evidence will include:

Scored Review Criteria - Overall

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 project address an important problem or a critical barrier to progress in the field? 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?   

Investigator(s)

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

Innovation

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

Approach

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

Additional Review Criteria - Overall

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/priority score, but will not give separate scores for these items.

Review of Student and Faculty/Researcher Development Plans

The anticipated effectiveness 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:

Review of Research Projects

For NARCH applications, the five criteria listed in this announcement (Significance, Investigators, Innovation, Approach, , and Environment) will be used for the scientific review of research projects and pilot research projects. The review of research projects and pilot research projects will be the same except that applications for pilot studies may be smaller in scope and would not be expected to have preliminary data.  

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

For Renewals, the committee will consider the progress made in the last funding period.

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/priority 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. Review assignments 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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 Project Director 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:

C. Administrative Regulations for Grants:

D. Grants Policy:

E. Cost Principles:

F. Audit Requirements:

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting Requirements

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)
Phone: 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
Training, Workforce Development and Diversity
National Institute of General Medical Sciences
6701 Democracy Blvd, Suite 900
Bethesda, MD 20892
Telephone: 301-435-0760
Email: caldwells@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Grants (Business):

For specific grant-related and business management information:

Andrew Diggs
IHS Grants Management Specialist
801 Thompson Avenue, TMP Suite 360
Rockville, MD 20852
(301) 443-2262 or Andrew.Diggs@ihs.gov

Program (Programmatic/Technical):

For program-related and general information:

Alan Trachtenberg, M.D., M.P.H.
IHS Research Director (Acting)
801 Thompson Ave, TMP Suite 450
Rockville, MD 20852
(301) 443-0578 or narch@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 ofThe 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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