Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Interventions for Health Promotion and Disease prevention in Native American Populations (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-11-346

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-14-260

Companion Funding Opportunity

None

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

93.393, 93.399, 93,273, 93.121, 93.279, 93.113, 93.242, 93.361

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to develop, adapt, and test the effectiveness of health promotion and disease prevention interventions in Native American (NA) populations. NA populations are exposed to considerable risk factors that significantly increase their likelihood of chronic disease, substance abuse, mental illness, oral diseases, and HIV-infection. The intervention program should be culturally appropriate and promote the adoption of healthy lifestyles, improve behaviors and social conditions and/or improve environmental conditions related to chronic diseases, the consumption of tobacco, alcohol and other drugs, mental illness, oral disease, or HIV-infection. The intervention program should be designed so that it could be sustained within the entire community within existing resources, and, if successful, disseminated in other Native American communities. The long-term goal of this FOA is to reduce mortality and morbidity in NA communities. For the purposes of this FOA Native Americans include the following populations: Alaska Native, American Indian, and Native Hawaiian. The term ‘Native Hawaiian’ means any individual any of whose ancestors were natives, prior to 1778, of the area which now comprises the State of Hawaii.

Key Dates
Posted Date

June 16, 2014

Open Date (Earliest Submission Date)

April 12, 2015

Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

May 12, 2015; May 12, 2016; May 12, 2017, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

August 24, 2015; August 24, 2016, August 24, 2017, by 5:00 PM local time of applicant organization.

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

Scientific Merit Review

October 2015; October 2016; October 2017

Advisory Council Review

January 2016; January 2017; January 2018

Earliest Start Date

April 2016; April 2017; April 2018

Expiration Date

August 25, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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



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Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

The purpose of this funding opportunity announcement (FOA) is to develop, adapt, and test the effectiveness of health promotion and disease prevention interventions in Native American (NA) populations. NA populations are exposed to considerable risk factors that significantly increase their likelihood of chronic disease, substance abuse, mental illness, oral diseases, and HIV-infection. The intervention program should be culturally appropriate and promote the adoption of healthy lifestyles, improve behaviors and social conditions and/or improve environmental conditions related to chronic disease, the consumption of tobacco, alcohol and other drugs, mental illness, oral diseases, and HIV-infection. The intervention program should be designed so that it can be sustained within the entire community with existing resources, and, if successful, disseminated in other Native American communities. The long-term goal of this FOA is to reduce morbidity and mortality in NA communities. 

Tribes, communities, and organizations that do not have research experience are strongly encouraged to develop collaborations with research organizations. Involvement of Native researchers and other appropriate professionals also is strongly encouraged.

Background

Native Americans include the following populations: Alaska Native (AN), American Indian (AI), and Native Hawaiian (NH). The term ‘Native Hawaiian’ means any individual any of whose ancestors were natives, prior to 1778, of the area which now comprises the State of Hawaii. 

Investigators are encouraged to view the following website: http://cancercontrol.cancer.gov/nativeamericanintervention.html  and are encouraged to contact the relevant Scientific/Research Contact listed in Section VII. Agency Contacts before application submission. This website will have information related to Technical Assistance Workshops that are planned for this FOA.

Community/Structural Factors

Significant and worsening health issues among NA communities and individuals may be addressed by improved understanding of how to enhance the communities’ strengths and resiliencies, as well as to promote health literacy in the communities. Although NA communities have relied on health research and medical science to reduce health inequities, they also have relied on their own medical assets and strengths to survive major harms and disruptions over the centuries, and to rebound from insults to health.

NA people have an understanding of health that includes the entire family and their community. Geographic isolation has long led to limited access and utilization of prevention and screening facilities. Building sustainable family and community based prevention strategies that account for these structural challenges have been found to have a positive impact on health promotion and disease prevention.

NA communities often face disproportionate exposure to harmful environmental agents that may contribute to a variety of adverse health outcomes. For example, NA communities may experience increased exposure to heavy metals from abandoned mining and milling sites located on tribal land, persistent organic pollutants (POPs) and other chemicals that contaminate traditional food sources, and/or degraded indoor air quality from sources such as environmental tobacco smoke. 

Cultural Factors

NA people have a concept of health that is often broader than the definition of absence of disease. All four elements of life – the physical, emotional, mental, and spiritual – are intricately woven together and interact to support a strong and healthy person. In this holistic perspective, illness results from imbalance, be it external or internal to the body.

Visiting the health care system, whether ill or not, is often not the first choice of those NA people who identify strongly with their tribal culture. Traditional native cultures often integrate several factors, such as an imbalance in the elements of life, as contributing to diseases such as cancer or other long-term conditions such as mental illness or HIV-infection. NA cultural norms regarding modesty, introversion, pragmatism, and fatalism can be barriers to chronic disease prevention and screening. Women who are more traditional in their behavior are less likely to be in compliance with Pap test recommendations; however, high levels of traditionalism are significantly associated with disease protective behaviors, such as practicing traditional activities such as dancing to keep healthy, and are inversely associated with disease risk factors such as tobacco, alcohol and drug abuse, and obesity. To be effective, interventions must demonstrate the immediate and long-term value of prevention and its importance to the balance of health. Additionally, it is noteworthy that the family structure is the most important social network in NA communities, as opposed to friends and faith-based organizations.

Individual Factors

The increasing morbidity and mortality in NA populations are likely the result of a combination of factors, but unique to NA people is cultural trauma from loss of land and heritage. This cultural trauma has resulted in the adoption of unhealthy lifestyles at the expense of healthier, traditional NA lifestyles. Tribal and cultural identity may have a significant impact on health outcomes and disease progression. With increasing numbers of NA in urban areas, issues such as cultural identity, linguistic preference, and health outcomes should be considered.

Unhealthy diets have had a significant impact on the health and disease progression among NA people. For example, the federal government’s food commodities program, introduced about 60 years ago to combat starvation on reservations, had the unintended consequence of introducing some unhealthy dietary changes. Traditional diets, by contrast, are generally very healthy, and consist largely of vegetables (e.g., corn, climbing beans, squash), lean game meats (e.g., bison, deer, turkey, fish), and gathered foods (e.g., wild rice, nuts, berries). Additionally, the traditional life promoted active lifestyles, such as hunting, gathering, canoeing, athletics, and traditional dancing.

Tobacco is a sacred plant in many AI cultures, and tobacco is used in prayer and in other customs. With the introduction of commercial sale of tobacco and mass-produced cigarettes, currently permissive attitudes toward cigarette smoking exist among AI people. This is in contrast to traditional AI cultures, in which smoking cigarettes is called “abusing” tobacco and is considered to be a sin against their culture. 

Poor mental, emotional, and spiritual health from intergenerational trauma has aggravated the above health issues, as well as suicide, risky sexual behaviors, abuse of alcohol and other drugs, and may contribute to non-adherence to dental care regimen.

Overall, traditional practices have not been consistently re-incorporated by the majority of NA communities, resulting in high prevalence of obesity, diabetes, high blood pressure, mental illness, HIV-infection, oral diseases, substance abuse, and cancer.

Specific Research Objectives and Scope

Each institute has specific areas of research interest.

National Cancer Institute (NCI)

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

The National Cancer Institute (NCI) is interested in applications that focus on both individual and community interventions relating to primary and secondary (screening) cancer prevention. It is important that researchers consider the context in which people live (place, built environment, etc.) and develop interventions that can improve overall health and result in improved health outcomes as they relate to cancer and cancer survivorship.

National Institute on Alcoholism and Alcohol Abuse (NIAAA)

When considering Native Americans as a whole, the epidemiologic data suggests a pattern of risky alcohol use including heavy, binging, and early onset drinking. The CDC reported that from 2001 to 2005, alcohol attributed deaths accounted for 11.7% of Native American deaths. The National Institute on Alcoholism and Alcohol Abuse (NIAAA) is interested in prevention interventions that seek to:

  • Reduce high risk drinking and alcohol use;
  • Promote moderate drinking;
  • Postpone onset of drinking among youth; and
  • Prevent any alcohol use among pregnant women

National Institute on Drug Abuse (NIDA)

The National Institute on Drug Abuse (NIDA) supports interventions to prevent the onset of drug use, prevent the escalation from drug use to abuse and dependence, and prevent the occurrence of drug-related HIV-risk behavior. Investigators should specifically aim to prevent drug use, drug abuse, and (as relevant) associated comorbid conditions including, but not limited to, HIV/sexually transmitted infections, child abuse and neglect, injuries, violence, and suicide. Drug abuse prevention research involving these outcomes and/or outcomes reflecting positive adjustment, such as educational achievement, is of interest to NIDA.

National Institute on Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in applications relevant to preventive interventions in Native American communities in both non-AIDS and AIDS research areas.

Examples of specific areas of interest for NIMH are included below. NIMH recommends, for both non-AIDS and AIDS, that applications proposing an adaptation to existing interventions should provide an empirical rationale for the need for and focus of the adaptation, consistent with NAMHC Workgroup Report recommendations on intervention adaptation (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/fromdiscoverytocure.pdf) and consult with relevant Institute Program Staff. 

a) Non-AIDS-related Research Areas

  • Develop and test empirically informed preventive strategies and implementation approaches to support sustained use of science-based interventions;
  • Explore the expansion of science-based interventions that preempt or prevent mental disorders, including suicide;
  • Develop culturally appropriate interventions for increasing engagement in mental health services and linkage to care across Tribes and geographical regions;
  • Use mobile or IT interventions to increase use of evidence-based mental health care for individuals in hard-to-reach remote communities; 
  • Explore which factors promote resilience and prevent mental disorders in persons at extreme social disadvantage to develop preventive intervention targets.

b) AIDS-related Research Areas

  • Develop and test interventions to address the prevention, care and treatment needs for gay men, men who have sex with men (MSM) and other high-risk vulnerable individuals from indigenous communities;
  • Develop and test interventions based on the mechanisms that explain HIV-related disparities (e.g., factors like stigma, social/sexual networks, access to and quality of health care, characteristics of health biology);
  • Develop novel multilevel preventive interventions and/or combination biomedical-behavioral approaches to advance HIV prevention and care within those Tribal communities most impacted by HIV;
  • Explore operations research to focus on barriers, facilitating factors, and outcomes of scaling-up HIV prevention interventions with known efficacy; and improve uptake and effectiveness of efficacious interventions, particularly for individuals in hard-to-reach remote communities.

National Institute of Dental and Craniofacial Research (NIDCR)

The prevalence of oral disease in Native American populations is amongst the highest in the U.S. The National Institute of Dental and Craniofacial Research (NIDCR) is interested in interventions that focus on dental caries, periodontal disease, oral cancer, and untreated decay. Oral diseases share protective and risk factors with numerous other diseases and conditions making holistic approaches to health promotion and disease prevention particularly important. Determinants of oral health exist at individual, family, health care systems, community, organizational/institutional and policy levels. Reliable access to and use of sustainable preventive and telehealth approaches to oral health care; self-management strategies such as fluoridated toothpaste and water; healthful foods and beverages; and healthy tribal policy are examples. The NIDCR welcomes applications for studies that propose multi-level approaches to improve oral health status and reduce inequalities.

NOTE: NIDCR does not support the development or efficacy testing of clinical products with this FOA. Investigators interested in conducting such clinical trials should refer to http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm

National Institute of Nursing Research (NINR)

The National Institute on Nursing Research (NINR) is interested in research across the lifespan targeting wellness, management of illness related symptoms, enhancement of palliative and end-of-life care interventions, with an emphasis on individuals, families, communities, underserved, hard-to-reach, and vulnerable populations. Additional information on NINR’s research interests can be found at http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan. Specific topics of interest to the NINR include, but are not limited to:

  • Develop innovative behavioral interventions that promote health and prevent illness across the lifespan in diverse and underserved populations, (e.g., families with special needs, parents or caregivers of persons with chronic illness or developmental disabilities);
  • Elucidate mechanisms underlying health disparities and design interventions to eliminate them with particular attention to geographic and environmental issues, minority status, and persons whose chronic or temporary disabilities limit their access to care;
  • Assess behavioral, biological and genomic mechanisms (e.g., neurohumoral markers for differential responses to behavioral interventions);
  • Improve quality of life by promoting personalized health strategies (e.g., promoting healthy lifestyles, prevention of obesity; prevention of HIV/AIDS transmission);
  • Improve understanding of the complex issues and choices underlying palliative and end-of-life care (e.g., reducing physical and psychological burdens of caregivers) in underserved populations.

National Institute of Environmental Health Sciences (NIEHS)

The National Institute of Environmental Health Sciences (NIEHS) is interested in interventions aimed to reduce the impact of environmental exposures on diseases and disorders among NA populations. In addition to testing impacts of interventions on exposure reduction, applicants also are encouraged to examine impacts on interim preclinical markers of disease when possible. Proposals may include, but are not limited to, projects focused on:

  • Development and testing of culturally-sensitive health promotion strategies and interventions designed to educate tribal leaders and tribal members about historical and emerging environmental hazards
  • Adaptation of proven strategies or existing risk messaging for specific targeted audiences, e.g., for specific age groups, for specific audiences such as health care providers and community health workers, or in formats and media that will be effective in low literacy/health literacy settings;
  • Development and testing of interventions that encourage behavior change to reduce or eliminate exposure;
  • Development and testing of existing low cost, sustainable methods that address indoor air pollution; or that provide safe alternatives to contaminated drinking water and food and/or remediation of contaminated water, air and/or soil;
  • Testing the impacts of policy-level decisions and interventions which are likely to influence environmental exposure levels and associated health outcomes;
  • Development and testing of programs to train and build the capacity of community health workers and local health care professionals to assist tribal members in identifying unhealthy environments and/or environmentally-induced illness and ways to intervene.

Developing Culturally Appropriate Interventions

Given the health inequities seen in NA populations and the relative paucity of studies and interventions in these communities, the primary research question to be addressed in these studies is: "Can culturally appropriate intervention programs in NA communities lead to sustained favorable changes in health outcomes for adults and children?" 

The research plan should be consistent with community attitudes and take into account their readiness for change. The following describes elements of the research and experimental approaches that are being sought to achieve the following Specific Research Objectives:

1. Community-based Participatory Research (CBPR). Given the long history and deep involvement of the family and the tribe in individual decisions on health and ultimately disease outcomes, projects to serve the NA communities should incorporate a community-based participatory research (CBPR) approach to adapt, develop, and test interventions, in which the tribes/communities are equal partners with academic/research institutions. Interventions should focus on community/cultural strengths and resiliencies.  

The CBPR endeavors should adopt an intervention approach that that seeks to target both individual behaviors and also seeks to intervene at the social and institutional levels (e.g., familial and tribal levels, respectively). These studies can design and implement community-based participatory prevention strategies to promote aggregate-level health by changing social and community environments (e.g., regulation of smoking in public places, institutional policies, access to safe/cleaner water, food, air, and soil). These interventions should be culturally sensitive, consistent with community values, and responsive to health literacy demands; they may include traditional health, medical, and/or cultural practices. It is recommended that an ecological approach to the design be considered, so that these interventions can be sustained over a long period of time.

Tribal-level approval and buy-in from the NA community is also critical to the implementation of these interventions. Thus, for the initial phase of the application researchers may choose to incorporate a mixed-model approach, with an initial qualitative data phase for intervention development, using talking circles, interviews, focus groups, and surveys.

2. Interventions. Interventions should be designed to engage the participants and be of sufficient intensity to affect change, because sustained behavior change is needed to reduce risk of disease, morbidity and mortality. Moreover, despite the efficacy of some treatments, such as combination HIV-related therapies, many people living with HIV in the U.S. and worldwide do not benefit from treatment because they are poorly engaged in medical care, and research is needed to promote factors contributing to engagement). Interventions should be directed both at the individual and familial/institutional/structural levels simultaneously. The proposed intervention in addition to behavior change should also incorporate familial/community/institutional changes so that these interventions can be sustained over time. However, the interventions should not be so intensive or time-consuming that they would exceed the resources of the participants/community to participate.

The interventions to be tested must be consistent with community values and may include traditional health, medical, and/or cultural practices. Proposed interventions proposed should account for community resilience in the health promotion and disease prevention projects. The term community resilience is often defined as the sustained ability to utilize available resources to respond to, cope, withstand and recover from with unexpected shocks or adverse situations. Resilient communities are those with a particular capacity to cope and respond to these adverse conditions. As a result, if ethics is not consciously considered at the inception of community-driven data projects, steps taken to increase community resilience and eliminate health inequities could in fact create more vulnerability and thus do harm.

It will be important for studies to consider the development of intervention manuals for primary and secondary prevention that can be disseminated if proven effective, to other NA communities.

The interventions should be delivered by individuals (e.g., behavioral professionals, community health workers, counselors, nutritionists, nurse practitioners, physician assistants, traditional healers) drawn from the community to the greatest extent possible.

3. Standardization and Coordination. Although the studies supported by this initiative will not use a common study protocol, whenever possible, investigators are expected to meet after the awards are made and should, to the extent possible, collaborate and report in a standardized manner when they are measuring key common variables, such as social and environmental determinants of health, access to care, diet, physical activity, height and weight, oral disease status, and smoking status and rates. Investigators may also use different methods of measuring similar outcome variables when justified. Investigators may also collaborate in the development of formative assessment measures, such as survey instruments and focus group guidelines. Investigators are encouraged to collaborate for data archiving, such as selecting a single archive and archiving format, if that is acceptable to community collaborators.. Locations of semi-annual meetings will l vary depending on sites funded through the initiative. The meetings will provide a venue for presenting scientific findings from each of the funded studies and are intended to facilitate synergistic interactions among the projects within the evolving community of scientists. The investigators may form committees that would meet periodically by conference calls as needed. PDs/PIs will be expected to participate in these conference calls for planning purposes at monthly or other appropriate intervals. Other investigators should set time aside as needed to participate in cross-cutting “research interest groups” and other collaborative activities as a way of advancing transdisciplinary science in NA communities.

4. Outcome Measures. Potential outcome measures include, but are not limited to:

  • Increased availability of healthy foods;
  • Increased development of community-based programs, such as community physical activity programs;
  • Improved clinical practices that are culturally relevant and appropriate;
  • Verified screening rates;
  • Biochemical verification for smoking status;
  • Nutrient biomarkers as measures of dietary intake (e.g., urinary sodium as a measure of dietary sodium intake, urinary potassium as a measure of fruit and vegetable intake);
  • Body mass index or body weight for diet and physical activity;
  • Delayed initiation of drug and alcohol use or decreased frequency of use;
  • Reduction in high risk drinking and alcohol use;
  • Reduction in alcohol and drug use among women of childbearing age;
  • Improvement in HIV-related biological markers (CD4, VL); 
  • Reduction in HIV-related risk behaviors and in AIDS-associated co-morbidities;
  • Increase in pro-social behaviors;
  • Reductions in deaths due to suicide and/or number of persons who report a major depressive episode;
  • Increased use of mental health services;
  • Increased access to specialized mental health services through mobile devices, or telemedicine;
  • Decreased body burden of key environmental agents of interest;
  • Improved access to and use of sustainable preventive, telehealth and self-care strategies for oral health;

Adherence to recommendations, such as engaging in physical activity, diet, smoking cessation, moderate drinking, screening, oral disease preventive self-care, as well as improved quality of life, are of interest as indicators of success of the program(s). In addition to specifying the primary outcome, applicants should propose and justify secondary outcomes and measures. Although an extensive cost analysis is beyond the scope of this initiative, applicants should collect and consider limited analyses of cost data.

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
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) 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.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The project period is limited to five years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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

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

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) 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.

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Shobha Srinivasan, PhD
Telephone: 240-276-6938
Fax: 240-276-7908
Email: ss688k@nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed. Grantee organizations can be tribes, communities, research organizations, or institutions that are actively involved in the recruitment, evaluation, and treatment of study participants. Proposed studies may involve several tribes, communities, consortia, or sites. Partnerships with tribes and/or communities are mandatory if the tribe or community is not the grantee organization.

SF424(R&R) Other Project Information

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

Facilities and Other Resources: Awareness of Strain on Existing Resources: Investigators should be aware of the need to conduct this study without creating excessive strain on existing resources that are often functioning at, or above, capacity. These existing resources include medical facilities, personnel, and equipment, as well as community infrastructure. Applicants should propose using facilities or systems for which they have tribal, community, or Indian Health Service approval, as appropriate, and must provide written evidence thereof with their application.

SF424(R&R) Senior/Key Person Profile

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

Applicants are strongly encouraged to include Native researcher(s) as collaborators on the project. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Plans should be made and appropriate funds budgeted for the participation of investigators from each study to attend semi-annual grantee meetings throughout the duration of the award.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Applications should incorporate or address the following elements in the Research Strategy:

A. Pilot Data: Given that many NA communities are small and many members are dispersed across the US, it is not a requirement to provide pilot data from the community under study.  However, PD/PI(s) and collaborator(s) are encouraged to provide such data if they are available. Or else applicant(s) are encouraged to provide data on similar interventions that have been conducted in comparable (sub) populations or settings. Similarly, it may not be possible to generalize results from these studies to other (sub) populations.  However, applicant(s) should discuss the above factors in the application.

B. Recruitment of Individuals and Communities:  Applicants may propose to include one or more NA communities to achieve the necessary sample size or otherwise enhance the scientific value of the study sample. Applicants must provide evidence of community support and of their ability to recruit participants in each community involved in the study, to implement measurement and intervention protocols in the target population, to provide appropriate oversight, and to maintain high rates of retention throughout the intervention and follow-up period.

Individuals recruited as part of a pre-existing non-intervention study may be proposed for inclusion in the proposed study. However, applicants must provide evidence that recruitment from an existing cohort will not unduly interfere with the goals of the existing study or that the cohort is no longer being studied. In addition, the application should include a justification for including such participants for the proposed protocol. Applicants including participants from an extant study must submit, prior to the review, a letter from the PD/PI or steering committee of the parent study approving their participation. 

C. Study Design: Applicants should choose rigorous study designs to test the effectiveness or efficacy of the proposed intervention. While randomized designs are ideal for reducing threats to internal validity, other research designs will be given consideration. The research approach is an important review criterion and investigators are encouraged to select a research design that will provide convincing evidence regarding the research questions. Thus application must address concerns related to the quality of the research such as outcome variables and anticipated magnitude of change, psychometrics for planned measures, expected attrition, power estimation, and statistical analyses planned. Applicants should also provide plans for assessing fidelity of implementation and other relevant process measures. Applicants are advised to consult with a methodologist and/or statistician when proposing a design with regard to its appropriateness for testing the proposed intervention, level of rigor, handling of missing data, and with regard to the data points needed for the planned analyses.

It is imperative that applicants describe and justify the nature of any comparison/control group, that is, whether the comparison group will receive, for example, usual care, information only, minimal treatment, or delayed intervention. Applicants should consult with collaborating communities to discuss the appropriateness of the selected approach to the comparison group, as tribal leaders and community members may believe that comparison group members should receive something more than usual care.

Awardees will have primary responsibility for collecting, editing, storing, and analyzing their data. Awardees should oversee testing of their interventions and adherence to their protocols, and assure that appropriate quality control procedures are in place. Each awardee will be responsible for training and certification of personnel.

D. Collaborations:  Collaborators should address issues of ownership, control, and storage of data and biological samples in the grant. However, NIH recognizes that communities may wish to retain ownership or control of data and biological samples. After award, partners should negotiate a formal and written data and biological sample agreement. This written agreement, once signed by all parties, should be submitted to NIH after award.

E. Community-based Participatory Research (CBPR): The community-researcher partnership must be documented in the grant application, and the community must be involved in the development, design, testing, and dissemination of the program. If this approach is used, the application must provide sufficient description of the intervention approach and its implementation for reviewers to assess its significance, innovation, and potential for public health impact. A Community Advisory Board should be implemented at the beginning of the study. Tribal resolutions or community letters of participation must accompany each application, as described in the Letters of Support section below. Tribal governments are legally sovereign nations, and potential partners should be informed that tribes may seek ownership or control of all data and all biological samples; therefore, universities and other partners should be prepared to negotiate data sharing and biological sample sharing agreements.

F. Community Support: Applications are expected to include evidence of: 1) strong scientific capabilities and 2) community involvement and support. Each NA organization that participates in the project must also submit such a letter of support.

Applications that represent collaborations between a tribe or community and a research organization should describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The application should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, procedures for resolving disagreements, and the relative contributions to the previous projects.

G. Standardization and Coordination: Investigators should indicate in their application their willingness to collaborate on the development and use of standardized measurement protocols, and coordination of formative assessment and possibly of intervention approaches.

Protection of Human Subjects: A Data and Safety Monitoring Board (DSMB) is required for multi-site, Phase II randomized controlled trials or other large proposed randomized intervention projects. If a DSMB is needed, the PD(s)/PI(s) of each study will establish a DSMB to monitor data and oversee participant safety in each study supported by this initiative. At the first meeting, the DSMB will review the awardee’s protocol. Subsequently, the DSMB will monitor and review recruitment, adverse events, data quality, outcome data, and overall awardee performance. The DSMB has the responsibility to review interim data and final data, and recommend whether the protocol should be modified, and, at each meeting, whether the study should be continued or should be terminated early. Thus, its ethical responsibilities, to the participants as well as to the integrity of the study, are of paramount importance to the National Institutes of Health. The DSMB will meet at least annually. Alternatively, the funding agencies may appoint a single DSMB for monitoring all or a subset of the funded projects. 

Applicants should not appoint DSMB members in advance of the peer review, or even inquire about the interest of possible DSMB members, because anyone so contacted would not be eligible to serve as a member of the peer reviewer committee that will evaluate the applications for scientific merit. 

Letters of Support: If the applicant(s) is working with tribes/Tribal governments then Tribal/community resolutions of support, or equivalent documents, must accompany the application.

  • Applications that represent a partnership between a tribe or community and a research organization must include a resolution from the tribal or community government or equivalent document, specifying that the community or tribe agrees to participate as a partner in the project and will strongly support the project for its entire duration.
  • Applications that include more than one tribe or community must include a resolution of support, or equivalent document from each participating tribe and community.
  • If the application includes a consortium of tribes or communities, applicants must provide a resolution of support from each tribe or community of the consortium.
  • If the applicant is a tribally sanctioned non-profit tribal organization, specific tribal resolution(s) of support will not be required if the current tribal resolution(s) under which the organization operates encompasses activities proposed in the application. A copy of the current operational resolution(s) must be submitted with the application.

In recognizing that Tribal governments are legal sovereign nations, potential partners should be informed that tribes may seek ownership or control of all data and all biological samples; therefore, universities and other partners should be prepared to negotiate data sharing and biological sample sharing agreements with tribes/Tribal government(s). If such an agreement is in place the applicant(s) should provide the letter of such an agreement with the application.  Letters of Support should also explicitly stipulate that Tribes agree to respond expeditiously to requests for approval of the protocol, protocol modifications, approval of abstracts for presentation to scientific meetings, and approval of manuscripts for submission for publication in scientific journals. The time required for approving each of these (protocol, abstracts, manuscripts): 1) must be proposed and stated within the resolution of support, 2) may differ for each of these activities, 3) may be modified by study investigators only in consultation with the tribal/community leadership, and 4) should identify an individual or entity within the tribe or community to whom a request for waiver of the time requirement can be directed if circumstances arise. PD/PI(s) and tribes/communities are expected to publish scientific papers, present at scientific conferences/associations/meetings; and may also be expected to develop fact sheets/materials for dissemination to the tribe/community.

Because the application represents collaboration(s) between tribe(s)/community(ies) and research organization(s), the letters of support should also describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The letter(s) of support should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, and the relative contributions to the previous projects.

Tribal governments are legally sovereign nations, and potential partners should be informed that tribes may seek ownership or control of all data and all biological samples; therefore, universities and other partners should be prepared to negotiate data sharing and biological sample sharing agreements with tribes/Tribal government(s).

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 SF424 (R&R) Application Guide.with the following modifications

Dissemination Plan:  Intervention programs resulting in positive study outcomes may be disseminated to the communities in which the study was conducted, as well as other Native communities, and to NIH at the completion of the research. 

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

Overall Impact

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

Scored Review Criteria

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

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

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

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Institutional Review Boards (IRBs):  Applicants should obtain necessary clearance for their research protocols through all applicable IRBs, including their institutional IRB, the tribal or community IRB(s), if applicable, and the regional and national Indian Health Service IRB if their research involves Indian Health Service facilities or personnel. When requesting clearance for research protocols through all applicable IRBs, the IRB package should include descriptions of all intervention components for both the intervention group(s) and the comparison group and descriptions of all measurements. All required IRB approvals must be submitted to the NIH prior to the award of the grant.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Shobha Srinivasan, Ph.D. 
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: ss688k@nih.gov

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

Aria Davis Crump, Sc.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: acrump@nida.nih.gov

Ruth Nowjack-Raymer, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5394
Email: Ruth.Nowjack-Raymer@nih.gov

David M. Stoff, Ph.D. (AIDS applications)
National Institute of Mental Health (NIMH) 
Telephone: 301-443-4625 
Email: dstoff@nih.gov

Robert A. Mays Jr., Ph.D. (non-AIDS applications)
National Institute of Mental Health (NIMH)
Telephone:301-443-2847
Email: rmays@mail.nih.gov

Mary Roary, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-2154
Email: Mary.roary@nih.gov

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Connie Murphy
National Cancer Institute (NCI)
Telephone: 301-631-3008
Email: murphco@mail.nih.gov

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 302-443-4704
Email: jfox@mail.nih.gov

Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-774-3803
Email: mconnell@nida.nih.gov

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Joy R. Knipple
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: jk173@nih.gov

Lawrence Haller
National Institute of Nursing Research (NINR)
Telephone: 301-402-1878
Email: HALLERL@mail.nih.gov

Molly Puente, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: puentem@mail.nih.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 NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

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