Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Behavioral and Social Sciences Research (OBSSR)
National Cancer Institute (NCI)
National Center for Complementary and Alternative Medicine (NCCAM)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)

Funding Opportunity Title

Translating Basic Behavioral and Social Science Discoveries into Interventions to Improve Health-Related Behaviors (R01)

Activity Code

R01, Research Project Grant R01 

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.
  • March 7, 2011 - See Notice NOT-OD-11-049 Notice of Budget Update.
  • January 7, 2011 - See Notice NOT-OD-11-034 Notice for Changes in Letter of Intent Dates.

Funding Opportunity Announcement (FOA) Number

PA-11-063

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.213, 93.273, 93.279, 93.399, 93.837, 93.865, 93.847

FOA Purpose

 This funding opportunity announcement (FOA) is being issued by the Office of Behavioral and Social Sciences Research (OBSSR), with participation from the National Cancer Institute (NCI), National Center for Complementary and Alternative Medicine (NCCAM)), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases, (NIDDK), National Institute on Drug Abuse (NIDA), Office of Research on Women's Health (ORWH).  This FOA seeks highly innovative Research Project Grant (R01) applications that propose to translate findings from basic research on human behavior into effective clinical, community, or population-based behavioral interventions to improve health.  Specifically, this FOA will support interdisciplinary teams of basic and applied biological, behavioral and/or social science researchers in developing and refining novel behavioral interventions with high potential impact to improve health-promoting behaviors (e.g., healthy dietary intake, sun safety, physical activity, or adherence to medical regimens), and/or reduce problem health behaviors (e.g., smoking, tanning or physical activity or alcohol or substance use, abuse or dependence).

Key Dates
Posted Date
Open Date (Earliest Submission Date)

January 5, 2011

Letter of Intent Due Date

January  5, 2011 (Updated to 30 days before the submission date per NOT-OD-11-034)

Application Due Date(s)

Standard dates apply , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

January 8, 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.

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

1. Research Objectives

Purpose

This FOA encourages highly innovative research projects that propose to translate findings from basic research on human behavior into effective clinical, community, and population-based behavioral interventions to improve specific health-related behaviors (e.g., dietary intake, physical activity, sun safety, or adherence to medical regimens) and/or prevent and reduce problem health behaviors (e.g., smoking, tanning, or alcohol or substance use, abuse or dependence).  This FOA will support projects in which interdisciplinary teams of basic and applied researchers collaborate to accelerate the translation of promising discoveries in basic behavioral and/or social science research by developing and refining novel health-related behavioral interventions.

The interventions to be developed include any of a wide range of innovative strategies aimed at promoting positive behavioral changes or preventing/reducing unhealthy behaviors.  Behavioral interventions can be targeted to any age group and at the individual, family, social network, community, environmental, clinical or population level or combinations of these, and should specifically identify a behavior or constellation of behaviors that is the target of change. During the funding period, Investigators are required to conduct basic or formative research (e.g., laboratory experimental studies, qualitative research) AND applied research (e.g., early phase trials and pilot/feasibility studies) in order to create promising new avenues for promoting healthy behaviors and reducing problem health behaviors.  Studies should develop, characterize and refine new, innovative strategies rather than evaluate the effectiveness of already well-defined strategies.  At the end of the period of support, the strategies that have been developed should be well-characterized and demonstrated to be safe, feasible to implement, effective in small-scale trials or pilot studies, acceptable to the target populations of interest, and ready to be tested in larger-scale clinical and community efficacy trials.

Background

Behaviors such as smoking, sedentary lifestyles, unhealthy dietary intake, alcohol or substance abuse or dependence and poor adherence to medical and behavioral treatments are major contributors to cardiovascular disease, cancer, type 2 diabetes and other chronic conditions.  For example, the combination of excess energy intake and lack of physical activity in the U.S. population over the past several decades has produced a rapid rise in obesity that threatens to reverse recent gains in life expectancy. At last estimate, 40% of premature deaths can be attributed to preventable behavioral factors, and therefore, “the single greatest opportunity to improve health and reduce premature deaths lies in personal behavior” (Schroeder, 2007).

Studies such as the Trials of Hypertension Prevention, Weight Loss Maintenance and the Diabetes Prevention Program have shown that behavioral interventions can improve behavior and prevent disease.  However, even the most successful behavior change interventions are limited in their ability to induce significant, long-term behavioral changes in the majority of adults.  Often change occurs only for the highly motivated and is limited to a single health behavior rather than multiple behaviors.  Furthermore, even individuals committed to behavior change find it hard to maintain healthy behavioral patterns over time.  For example, most smoking studies show a pattern of relapse and cessation that may continue for years.

Exceptions to this pattern have been found in preventive interventions, such as the Nurse Home Visitation Program, that have shown lasting and long-term effects. In addition, some prevention research suggests that the greatest gains can be made with those at most risk. But even these successes are not as common as they should be and points to the need for innovative, high quality behavioral research is needed in both the prevention and intervention areas.

As with development of more effective drugs, surgical techniques and medical devices, the development of more powerful health-related behavioral interventions is dependent on improving our understanding of human behavior, and then translating that knowledge into new and more effective interventions with enduring effects.  This FOA seeks to promote an innovative intervention development process, for the behavioral and social sciences, that is analogous to Type I translation in the biomedical sciences, with the ultimate goal of achieving greater effectiveness for health-related behavior change strategies.

Translational research can be defined as “the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease,” and is  often characterized as either Translation I (T1), in which basic science discoveries are used to develop new interventions for disease (“bench to bedside”), or Translation II (T2), which is aimed at improving utilization of proven interventions in clinical practice and community settings (“bedside to public health”). 

In pharmacotherapy development research, translation I research (treatment development) includes the conduct of small human trials or series (Phase I & II clinical trials) in which data on the safety of the drug and the dosages needed to affect biomarkers of the disease being studied are collected.  In Phase I safety studies, the purpose is to gather information on which dosages are well tolerated by patients with minimal toxicity; in Phase II studies, the goal is to test for and characterize effects of the treatment, for example, to determine the amounts of treatment needed to produce biologic responses, such as reduction in the size of a tumor or lesion.  If the treatment is found to be safe and effective in altering disease-related biomarkers in these early phase studies, large-scale randomized clinical trials or RCTs (Phase III studies) are then conducted to test the effects of the treatments developed on morbidity and mortality outcomes.  Often, prior to instituting a full-scale RCT, a pilot or feasibility study is conducted in the population and setting of interest in order to assess feasibility and acceptance of the approach used, refine intervention and measurement procedures, gain experience in and information concerning screening, recruitment and retention of the target population (e.g., estimates of yield, pre-testing of screening/recruitment procedures), and determine estimates of variability and levels of response in the target population.  The same translation process can be applied to the development of behavioral treatments or interventions. For example, Translation I (intervention development) research in the behavioral and social sciences is a phased approach aimed at determining the Phase I safety profile of a treatment,  the “dosages” required (i.e., intensity, frequency, duration of intervention) to effect change in the intermediate outcomes of interest, and in Phase II to identify whether and how a treatment works in specific patient groups under well-specified conditions, and the feasibility and acceptance of the intervention in the target population. This work would culminate in Phase III trials that would test the intervention in a large-enough sample of patients to determine its effects on health outcomes.  Basic behavioral and social science research in humans is concerned with elucidating the fundamental principles and processes that govern how we perceive the environment, process information, make decisions, experience, express and regulate emotion, form and change attitudes, beliefs and values, and become and remain motivated to change behavior.  As defined by the NIH, basic behavioral and social science research can involve research at the individual, small group, institution, organization, and community or population level.  At the individual level, this research may involve the study of behavioral factors such as cognition, memory, language, perception, personality, emotion, motivation, and others.  At higher levels of aggregation, it includes the study of social variables such as the structure and dynamics of small groups (e.g., couples, families, work groups, etc.); institutions and organizations (e.g., schools, religious organizations, etc.); communities (defined by geography or common interest); and larger environmental, demographic, political, economic, and cultural systems. 

Basic behavioral and social science research may also involve biobehavioral research, which concerns the study of the interactions of biological factors with behavioral or social variables and how they affect each other.  Additional details and examples of basic behavioral and social science research can be found at http://oppnet.nih.gov/about-bssr.asp

Significant advances in basic behavioral and social science research have contributed to a more sophisticated understanding of the fundamental biological, cognitive, emotional, and social underpinnings of human behavior.  Recent discoveries in fields such as cognitive and affective neuroscience, communication science and social marketing, decision-making and choice, the formation of habits, the psychophysiology of stress and behavior, behavioral economics, and the nature and impact of social networks, coupled with the development of more sophisticated tools for understanding the psychosocial determinants and physiologic bases of human behavior (e.g., brain imaging, systems dynamics theories, mobile technologies, geospatial methods), are yielding new and important insights about human cognition, affect, motivation and behavior.  These findings suggest promising new directions for developing behavior change interventions to improve the public health.

This FOA seeks to fund systematic collaborations between basic and applied biological, behavioral and social scientists from diverse disciplines and in doing so, to encourage the kind of high-risk, potentially high-impact research needed to develop innovative new strategies for improving health-related behaviors.

Objectives and Scope

The purpose of this FOA is to fund highly innovative Translation I behavioral science research aimed at developing and refining novel health-related behavioral interventions specifically targeting adoption or maintenance of health behavior.  Each award will support interdisciplinary project teams composed of scientists from a range of disciplines (for example, teams may include basic and applied biological, clinical, behavioral, and/or social scientists) who will adapt findings from basic behavioral and/or social science research to develop behavioral interventions aimed at improving health-related behaviors.  The proposed interventions may target any one or more of these levels (i.e., individuals, social groups, institutions/organizations, environments or systems), and any age group.  Populations of interest include healthy individuals, those at high risk for a particular disease or condition, and those with an existing disease (e.g., cardiovascular disease, cancer or diabetes). 

Behavioral targets of the interventions being developed may be any one or more of the behaviors thought to be important for the treatment or prevention of disease.  Broader social, organizational or systems level interventions that involve changing aspects of the social environment (e.g., the behavior of individuals within social networks), cultural environment (e.g., norms or values within institutions such as worksites or schools) and/or physical environments (e.g., features of neighborhoods) may use aggregate measures of behavior as outcomes (e.g., use of walking paths, prescriptions filled, purchases of fruits and vegetables or other healthy foods).

The behavioral target(s) of the intervention should be well-specified and precisely defined.  For example, the distinction between sedentariness and a physically active lifestyle is important as these two behaviors may not represent opposite points along the same continuum, and both are known to contribute to health.  This type of distinction has important implications for how basic behavioral research is used to inform translational efforts, since basic research may inform intervention development in different ways depending upon whether the target of the intervention is promoting an activity versus preventing or reducing a behavior (e.g., strategies that involve motivation, affective response, reinforcement and incentivizing behavior may be structured differently when the goal is to reduce behavior rather than to promote activity).  Similarly, different intervention strategies may be more effective when the behavioral target involves initial adoption of a health behavior than when the goal is maintenance of the behavior over time.

While these grants seek to develop highly innovative behaviorally-based interventions to improve health-related behaviors and prevent and reduce problem health behaviors, the use of pharmacological agents (drugs, biologics) or medical devices in the interventions being developed is allowed, as long as they occur in the context of or in combination with a behavioral strategy, and not as stand-alone interventions. 

Depending on the types of interventions being developed, awardees are required to conduct three types of studies to translate basic science findings into behavioral interventions, including: (1) basic research involving experimental studies of behavioral, cognitive, emotional and/or biological responses to stimuli aimed at characterizing the behavioral responses that will form the basis of an intervention and/or formative research to determine attitudes and preferences with regard to specific intervention approaches and intervention components; (2) “proof of concept” and small-scale safety/efficacy studies (early phase trials) that translate the concepts and findings from previous basic science research into specific, novel interventions, demonstrate safety, and characterize the interventions and their effects in controlled settings; and (3) pilot/feasibility studies to test and refine intervention protocols to be used in the specific populations of interest and to determine the acceptability and feasibility of interventions in clinical and community settings.

Applicants are encouraged to propose the use of innovative study designs for building and optimizing behavioral and systems interventions, where appropriate. For example: (1) intervention designs  that utilize recent innovations in the  iterative development of technological devices (e.g., mobile phones, sensors, electronic games and computers) to capitalize on the potential for individually tailoring interventions for  behavior change and/or behavior change maintenance; or (2) adaptive treatment designs  that customize an intervention strategy to the individual or to specific subgroups of individuals based on genotype, ethnicity, gender or other characteristics, evaluate for whom a treatment should be employed, and/or when it should change over time in order to maximize its effects; or (3) systems science approaches that determine how, when and with whom to intervene in a social group, family, health care setting, neighborhood, community, or other system (see Systems science research at NIH for an in-depth description of this area).

Selected Research Examples

Please see http://obssr.od.nih.gov/scientific_areas/health_behaviour/behaviour_changes/translational_R01.aspx  for information about specific Institute or Center research topics and examples. The following are intended only as conceptual examples of the types of topics and approaches relevant to the proposed FOA, and should not be regarded as a call to pursue any specific line of investigation:

Plan for Intervention Development

Projects submitted must include an overall plan for intervention development, which will include a timeline or flow chart showing types, sequence, and duration of each study and the milestones to be achieved for each study within the Intervention Development plan.  The stages of intervention development to be included and the types of studies appropriate to each stage are described below.

The plan will describe the particular behavior(s) (e.g., diet and exercise, tanning and sun safety, smoking or chemical dependency) for which their intervention will be developed; provide a detailed description of the basic biological, behavioral and/or social science research findings being used to inform intervention development and (where relevant), the theoretical model that will be applied to development of the intervention; describe key features of the intervention to be developed, phases of the intervention development process and specific studies to be conducted in developing the intervention; outline the goals and objectives of the intervention, describe the population and behaviors that are targets of the intervention, the hypotheses to be tested, the specific outcomes to be assessed and the criteria or milestones to be achieved in determining progress and/or intervention success at each stage of the intervention development process.

Stages of Intervention Development

The following presents the stages of research and the types of studies within each stage that should be included as part of the applicant’s intervention development proposal.  Each of the three stages outlined below should be included in the application, with the duration of each stage depending on the goals and nature of the project being proposed (there is no requirement regarding the duration of each stage within the overall period of support).

(1) Defining the Intervention Target

During this stage, applicants may conduct foundational studies to refine understanding of the basic biobehavioral, behavioral or social science research finding(s) or concepts being used in relation to the particular intervention and/or population of interest.  These experimental, observational and/or formative studies must be related to the development of the proposed intervention(s); e.g., to elucidate the behaviors being targeted for intervention, point along behavior change continuum (e.g., adoption or maintenance of health behavior), the characteristics of individuals for whom the intervention is being developed, and/or the psychophysiologic processes involved in the intervention process being studied.

The types of studies to be proposed for this stage include:

1.         Laboratory or field experiments or observational studies necessary to develop the intervention of interest, including studies of behavioral, cognitive and/or emotional responses to stimuli to deconstruct and quantify the behavioral responses that will form the basis of an intervention, psychophysiologic research to identify biological and behavioral mechanisms underlying the relationship of psychosocial risk factors and health-related behaviors, and/or studies to delineate how an intervention can best be targeted to subgroups of respondents based on particular psychological, behavioral, or physiological characteristics of these respondents; and/or

2.         Formative research, involving ethnographic interviews, focus groups, cognitive testing, and other accepted qualitative research methods designed to engage the community of participants in the development of strategies (user-centered design), explore the acceptability of the approach being used, and assess attitudes, norms, values, and meanings of relevance to the population being targeted in order to guide development of the intervention.

In addition to the above types of studies, secondary analyses of existing data (qualitative or quantitative) may be used as an additional (but not the sole) source of information to aid in defining the intervention and to guide later stages of the intervention development process.

Animal research during Stage 1 may be used to augment the basic research conducted with humans.

(2) Characterizing the Intervention’s Effects

This stage consists of safety, “proof of concept” and small-scale efficacy studies that translate the concepts and findings from previous basic science research into specific, novel behavior change interventions.  In this stage, applicants should propose any one or more of the following types of studies which are aimed at developing, refining and characterizing the intervention:

1.      Phase I studies to determine the safety of the intervention or intervention components, and Phase II research that investigates:  effects of the intervention on the outcomes (cognitive, affective, behavioral, or biological) of interest; effects of individual components of an intervention versus combinations; effects of varying an intervention’s content, timing, mode of delivery, duration and frequency of contact; and dose-response relationships (effects of varying the intensity of an intervention or its components on outcomes of interest).

2.      Studies using adaptive designs, fractional factorial experiments and pre-specified decision rules based on participant characteristics and responses to treatment to customize the intervention strategy to the individual, evaluate for whom a treatment should be employed, or when it should change over time in order to maximize its effects.

3.  Studies using modeling techniques and systems science approaches (e.g., network analyses and systems dynamics approaches) to develop systems-level interventions and/or to determine how, when and where an intervention should be targeted within a social group, family, health care or other system to achieve maximum benefit.

(3) Assessing Feasibility and Refining the Intervention

In this stage, applicants will conduct pilot/feasibility studies to ensure the intervention procedures can be performed in the specific populations and settings of interest, to refine the intervention, and to gather data in preparation for future efficacy trials of the intervention.  These studies may use combinations of qualitative (focus groups, ethnographic interviews) and quantitative (small-scale pilot studies) methods to determine the acceptability and feasibility of the intervention within the populations and setting(s) of interest, and to evaluate the effects of tailoring interventions to subpopulations of interest.

These studies may also be used to refine intervention and measurement procedures, gain experience in and information concerning screening, recruitment and retention of the target population (e.g., estimates of yield, pre-testing of screening/recruitment procedures), determine estimates of variability and levels of response in the target population, obtain preliminary information about sustainability and cost-effectiveness of the intervention, and engage community residents and leadership in preparation for future large-scale randomized trials of the intervention.

Timeline, Goals and Milestones. 

The intervention development plan should be based on a clearly stated project timeline that includes practical, achievable goals, and project milestones. Milestones toward intervention development are goals that create go/no-go decision points in the project, including quantitative success criteria.  Applications should include a linear timeline or flowchart of project tasks and milestones, including the stages and types, sequence and expected duration of studies to be performed, and the milestones/criteria needed to proceed to the next stage.  For each proposed stage of intervention development, applicants should also include a plan for dealing with unexpected or more negative results than originally planned (e.g. detail the approach that will be taken to course correct before proceeding to the next phase of the intervention development).

It is understood that during the intervention development process, deviation from this timeline may occur based on study results; for example, findings at one stage may require a return to an earlier stage to further refine an intervention or its conceptual basis.  In addition, although studies are expected to be conducted in sequential fashion, some projects may be performed concurrently, as when multiple components of an intervention are being developed simultaneously, or tools and materials relevant to several aspects of an intervention are being evaluated in separate, concurrent studies.  Applicants should propose their best estimate of the sequence of studies, timeline and milestones needed to develop the proposed intervention.

Applicants should also provide preliminary evidence of their ability to recruit participants, to provide appropriate oversight of participants, and to maintain high rates of participant follow-up throughout the intervention development process. Studies should incorporate quality control procedures for measurements, data collection, and data management, as well as for assuring fidelity to intervention delivery.

Protocol and manual of procedures development

To facilitate future efficacy testing of the interventions developed through this FOA, Investigators should plan to develop an intervention protocol and an intervention procedures manual.  It is expected that these documents will be finalized at the end of the funding period to reflect the outcomes of the intervention development process.

Areas of research that are inconsistent with the goals of this FOA include:

Program Coordination

Each awardee should plan to attend an annual grantee meeting in which issues of common interest and concern will be shared and discussed.  Each applicant should include in his/her budget funds for attending these meetings.  For budgeting purposes, the applicants should assume that in-person meetings will be convened one time a year for each funding year, will last for 2 days, be located in the Washington, DC metro area and will require the attendance of the Principal Investigator and one other staff member.           

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

Renewal
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.  Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.  The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.

Award Budget

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

Award Project Period

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 (non-U.S.) components of U.S. Organizations are 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 Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (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.

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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Wendy J. Nilsen, Ph.D.
Office of Behavioral and Social Sciences Research
Building 31C, Room B1C19, MSC 2027 
Bethesda, MD 20892-2027
Telephone: (301) 496-0979 
Email: nilsenwj@od.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 application submission. 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, with the following exceptions or additional requirements:

PHS 398 Research Plan Component

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

Resource Sharing Plans

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) Sharing Plan) as provided in the SF424 (R&R) Application Guide.

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.

Foreign Organizations

 Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout 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.

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/PIs 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/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the 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.

Annual Investigators Meeting

Note that the principal investigator and one other study personnel will be required to attend this annual investigators meeting in the Washington, DC area and that travel funds to attend this meeting should be included in the proposed budget.   

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

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

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

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/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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)  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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:

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 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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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
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

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

Scientific/Research Contact(s)

Wendy Weber, ND, PhD, MPH
National Center for Complementary & Alternative Medicine (NCCAM)
Telephone: 301.402.1272
Email: weberwj@mail.nih.gov

Frank Perna, Ed.D., Ph.D.
National Cancer Institute (NCI )
Telephone: 240-276-6782
Email: pernafm@mail.nih.gov

Susan M. Czajkowski, Ph.D.
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0406
Email: czajkows@mail.nih.gov

Cherry Lowman, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0637
Email: clowman@niddk.nih.gov

Lynne Haverkos, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6881
Email: LH179R@nih.gov

Belinda Simms, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1533
Email: bsims@nida.nih.gov

Christine Hunter, Ph.D., ABPP
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
Telephone: 301-594-4728
Email: hunterchristine@niddk.nih.gov

Dennis Mangan, Ph.D.
Office of Research on Women’s Health (ORWH)
Office of the Director
Telephone:  (301) 496-9006
Email:  Dennis.Mangan@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)

George Tucker, M.B.A.
National Center for Complementary and Alternative Medicine  (NCCAM)
Telephone: (301) 594-9102
Email: tuckerg@mail.nih.gov

Carol Perry
National Cancer Institute  (NCII)
Telephone: 301-496-7205
Email: perryc@mail.nih.gov

Susan M. Czajkowski, Ph.D.
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0406
Email: czajkows@mail.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 443-4704
Email: jfox@mail.nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-435-6975
Email: clarkb@mail.nih.gov

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

Elizabeth Guiterrez
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8844
Email: guiterrezl@niddk.nih.gov

Teresa R. Kendrix
Office of Research on Women’s Health (ORWH)
Telephone:  301-435-6724
Email:  KendrixT@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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