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 Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute for Nursing Research (NINR)
National Institute of Environmental Health Sciences (NIEHS)
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

New

Related Notices

  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • February 11, 2013 - See Notice NOT-OD-13-037. Notice of Participation of the Office of Behavioral and Social Sciences Research (OBSSR).

Funding Opportunity Announcement (FOA) Number

PAR-11-346

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.393, 93.394, 93.395, 93.399, 93.837, 93,273, 93.279, 93.242, 93.361, 93.113

FOA 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, 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 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

September 22, 2011

Open Date (Earliest Submission Date)

April 15, 2012

Letter of Intent Due Date

April 15, 2012; April 15, 2013; April 15, 2014

Application Due Date(s)

May 15, 2012; May 15, 2013; May 15, 2014

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2012; October 2013; October 2014

Advisory Council Review

January 2013; January 2014; January 2015

Earliest Start Date(s)

April 2013; April 2014; April 2015

Expiration Date

May 16, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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, 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 and 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. 

Background

Native Americans include the following populations: Alaska Native, American Indian (AI), 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. 

Each institute has specific areas of research interest.  Investigators are required to view the following website http://cancercontrol.cancer.gov/nativeamericanintervention.html to identify topics of interest to each institute and encouraged to contact the program director before submission.  This website also has 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. (For research about resiliencies, see http://www.nida.nih.gov/ResilandRiskWG/ResilandRiskWG.html.)

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 based prevention strategies that account for these structural challenges have been found to have a positive impact on health promotion and disease prevention.    

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 anathema to 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 Hopi activities 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 the importance to the balance of health.  Additionally, it is important to note that the family structure is the most important social network in Native American communities, as opposed to friends and faith-based organizations.

Individual Factors

Increasing morbidity and mortality in NA populations are likely the result of a combination of factors. Adopting unhealthy lifestyles at the expense of healthier, traditional NA lifestyles, and cultural trauma from loss of land and heritage are possibly the most significant, overarching factors.  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 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 by the Europeans, 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, and abuse of alcohol and other drugs.

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. 

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, cardiovascular disease, mental illness, HIV-infection, substance abuse, and cancer.  

Specific Research Objectives and Scope

Each institute has specific areas of research interest.  Investigators are encouraged to view the following website http://cancercontrol.cancer.gov/nativeamericanintervention.html to identify topics of interest to each institute and encouraged to contact the program director before submission.  A brief summary of each institute’s interest is below.

National Cancer Institute

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 and develop interventions that can improve overall health and result in better health outcomes as they relate to cancer.

National Heart, Lung, and Blood Institute

The National Heart, Lung, and Blood Institute (NHLBI) is interested in applications that evaluate interventions of health risk factors that contribute to cardiovascular and pulmonary morbidity and mortality including smoking, poor dietary intake, sedentary behavior, hypertension, dyslipidemia (elevated LDL, total cholesterol, and/or triglycerides), sleep disorder, and chronic obstructive pulmonary disease or COPD.  Primordial, primary and secondary prevention of cardiovascular disease and evaluation of interventions that address multiple cardiovascular risk factors in a comprehensive program, especially in those at risk for cardiovascular disease, are particularly encouraged. 

National Institute on Alcoholism and Alcohol Abuse

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:

National Institute on Drug Abuse

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

The National Institute of Mental Health (NIMH) is interested in applications relevant to preventive interventions in Native American communities in both nonAIDS 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. 

nonAIDS

AIDS

National Institute of Nursing Research

The National Institute of Nursing Research (NINR) is interested in interventions that promote and improve the health of individuals, families, communities, and populations. Specific topics that would be appropriate to this FOA and of interest to the NINR include, but are not limited to:

Elucidate mechanisms underlying health disparities and design interventions to eliminate them, with particular attention to issues of geography (rural and remote settings), minority status, underserved populations, and persons whose chronic or temporary disabilities limit their access to care.

National Institute of Environmental Health Sciences

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:

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. The community-researcher partnership must be documented in the grant application, and the community must be involved in the design, testing, and dissemination of the program.  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 Community Support section below. Tribal governments are legally sovereign nations, and potential partners should be informed via the Funding Opportunity Announcement (FOA) 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.  Interventions should focus on community/cultural strengths and resiliencies.

The CBPR endeavors should adopt a multilevel intervention design 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, researchers may want to use a mixed-model approach, with an initial qualitative data phase for intervention development, using talking circles, interviews, focus groups, and surveys. If this approach is used, the application must describe what the intervention is expected to include and how it will be conducted.

2. Study Design. Applicants should choose rigorous study designs to test the effectiveness or efficacy of the proposed intervention, while reducing threats to internal validity.  The randomized controlled trial (RCT) is often the most appropriate selection for tests of intervention effects because of the ability to minimize threats to internal validity through this method.  Applicants who elect to conduct an RCT may select either an individually or family randomized design, or, alternatively, a cluster-randomized design with community, clinic, hospital, or school randomization.  Alternative study designs are appropriate if they are rigorous enough to support causal inferences.  All selected research designs must include a comparison or control condition and must provide a scientific justification for the selection.  In addition, the chosen design must significantly minimize threats to internal validity, for example, as with the interrupted time series/multiple baseline with comparison design.  The approach to the research will be considered as a factor in reviewing the applications, and applicants 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. In no cases will a one group before-after design be appropriate for this FOA.

It is imperative that applicants describe and justify the nature of their 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.   

3. Interventions. Interventions should be designed to engage the participants and to 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 (http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-12-060.html).  Interventions should be directed both at the individual/familial and the institutional/structural levels simultaneously.  The proposed intervention should be multilevel, and, in addition to behavior change, should also incorporate 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 to participate.  Because the targeted health behaviors tend to cluster, applicants are strongly encouraged to propose intervention components targeted at two or more behaviors (e.g., dietary change and increased physical activity). 

The interventions to be tested will be consistent with community values and may include traditional health, medical, and/or cultural practices.  For example, in the non-randomized trial, some clinics, hospitals, or schools already have a program in place, whereas others do not, and randomization is not possible.  Enrolling a number of units in each condition is important in order to control for as many sources of variance as possible.  Examples include: smoking cessation programs, obesity prevention programs, drug abuse prevention programs, cancer screening programs, and culturally-tailored food and drinking water advisory campaigns.

4. 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, 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 consistent with the communities’ desires.  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.

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

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

Research Project Grant applications that are appropriate to this FOA are encouraged to incorporate or address the following elements in the Research Strategy:

A. 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 principal investigator or steering committee of the parent study approving their participation. 

B. Collaborations. 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.  Applicants are strongly encouraged to include a Native researcher as a co-investigator on this project in their application. 

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.

C. 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.

D. Dissemination Plan. A critical feature of this project is the development of interventions with the potential to be incorporated into the medical care systems, public-health system, and/or community structure of NA communities, if the results demonstrate effectiveness.  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. 

E. Study Components. Grantee organizations will 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.

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.

F. Data and Safety Monitoring Board (DSMB): The Program Director(s)/Principal Investigator(s) 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. 

In addition to the annual DSMB meetings, a meeting will be held with the Project Officers from the funding organizations and the investigators from each site at least semi-annually.  The investigators may form committees that would meet periodically by conference calls as needed.  Annual meetings will be held in the Washington, D.C. area, alternating among the grantee’s home institutions or in conjunction with scientific meetings.

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

Letters of support and/or resolutions must be appended to the grant application (in PHS 398 Research Plan Component, Section 14: Letters of Support), and referenced in the body of the application, where the organizational structure is discussed.

H. 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.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF 424 (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 actual needs of the proposed project.

Award Project Period

The maximum period is 5 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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the SF 424 (R&R) 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 Director(s)/Principal Investigator(s) (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 least four (4) 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.  Add additional eligibility requirements above for individuals.

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.

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 SF 424 (R&R) Application Guide.

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:

The letter of intent should be sent to:

Shobha Srinivasan, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 4E432
Bethesda, MD  20892-9764 (for regular mail)
Rockville, MD  20850 (for express delivery)
Telephone: 240-276-6938
Fax: 240-276-7908
E-mail: ss688k@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

PHS 398 Research Plan Component

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

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. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). 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 SF 424 (R&R) Application Guide.  

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.

Overall Impact

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).

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(s)/PI(s), 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

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

Revisions

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/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) convened by the Center for Scientific Review, 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 Public Health Service (PHS) referral guidelines to the appropriate NIH Institute or Center. Applications 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/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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
E-mail: 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

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
E-mail: commons@od.nih.gov

Scientific/Research Contact(s)

Shobha Srinivasan, Ph.D.
National Cancer Institute
Telephone: 240-276-6938
E-mail: ss688k@nih.gov

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

Dionne Godette, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-5726
E-mail:  dionne.godette@nih.gov

Aria Davis Crump, Sc.D.
National Institute on Drug Abuse
Telephone: 301-443-6504
E-mail: acrump@nida.nih.gov

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

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

Paul Cotton, Ph.D.
National Institute of Nursing Research
Telephone: 301.402.6423
E-mail: Paul.Cotton@nih.gov

Caroline H. Dilworth, Ph.D.
National Institute of Environmental Health Sciences
Telephone: 919-541-7727
E-mail: dilworthch@niehs.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)

Connie Murphy
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 301-631-3008
E-mail: murphco@mail.nih.gov

Robert Tarwater
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., Room 7150
Bethesda, MD  20892-7926
301-402-6090
tarwater@nhlbi.nih.gov

Judy S. Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Telephone:  302-443-4704
Fax:  301-443-3891
E-mail:  jfox@mail.nih.gov

Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd.
Bethesda, MD  20892-9560
Telephone: (301) 774.-3803
Email: mconnell@nida.nih.gov

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9689
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8811
Fax: (301) 443-6885
E-mail: jk173@nih.gov

Diana Ly
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Blvd, RM 710
One Democracy Plaza
Bethesda, MD 20892-4870 (Courier use 20817)
Phone: (301) 594-1764

Molly Puente, Ph.D.
Grants Management Branch
National Institute of Environmental Health Sciences
530 Davis Drive, Room 3056
Durham, NC 27713
Telephone: (919) 541-1373
E-mail: 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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