Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Drug Abuse Prevention Intervention Research (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

Reissue of PA-08-218

Related Notices

  • August 11, 2014 - See Notice NOT-DA-14-023. Extended the expiration date to January 8, 2014.
  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • 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.
  • April 23, 2012 - See Issuance of PA-12-171, Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials (R34).

Funding Opportunity Announcement (FOA) Number

PA-11-312

Companion FOA

PA-11-311, R01 Research Project Grant
PA-11-313, R03 Small Grant Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279

FOA Purpose

The purpose of this FOA is to encourage Exploratory/Developmental (R21) applications from institutions/organizations that propose to advance the science of drug abuse and drug-related HIV prevention through 1) the development of novel prevention approaches, 2) the testing of novel and adapted prevention intervention approaches 3) the elucidation of processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions, and 4) the development of new methodologies suitable for the design and analysis of prevention research studies. Programs of research are intended to provide pathways toward the discovery of population-level approaches for the prevention of drug abuse and dependence, drug-related problems (such as mental health, interpersonal violence, criminal involvement, and productivity loss), and drug-related disorders (e.g., comorbid drug and psychiatric disorders; infections such as HIV, hepatitis B, and hepatitis C).   

Key Dates
Posted Date

August 16, 2011

Open Date (Earliest Submission Date)

September 16, 2011

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

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

AIDS Application Due Date(s)

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

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

New Date January 8, 2015 per issuance of NOT-DA-14-023. (Original Expiration Date: September 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.


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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

The purpose of the National Institute on Drug Abuse's (NIDA) Prevention Research Branch (PRB) is to support a developmentally grounded program of research on the prevention of the initiation of drug use, progression to abuse and dependence, and transmission of drug-related HIV infection. This research involves the use of rigorous scientific methods to test theoretically derived hypotheses to advance our understanding of the science of prevention within diverse populations and settings. The program’s focus involves studies targeting the prevention of many substances (often collectively) including but not limited to nicotine, inhalants, marijuana, cocaine/crack, methamphetamine, club drugs, non-medical use of prescription and over the counter drugs, or any of these drugs in combination with alcohol. Studies that support this purpose include investigations of cognitive, behavioral, and social processes as they relate to 1) the development of novel prevention approaches, 2) the efficacy and effectiveness of newly developed and/or modified prevention programs, 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and cost effectiveness of science-based interventions, and 4) methodologies appropriate for studying complex aspects of prevention science. Programs of research are intended to provide pathways toward the discovery of population-level approaches for the prevention of drug abuse and dependence, drug-related problems (such as mental health, interpersonal violence, criminal involvement, and productivity loss), and drug-related disorders (i.e., comorbid drug and psychiatric disorders, or infections including HIV, hepatitis B (HBV), and hepatitis C (HCV), and co-occurring, disorders and illnesses.

The National Institutes of Health (NIH) Exploratory/Developmental Grant (R21) funding opportunity supports the development of new research activities in categorical program areas. The R21 mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Significance

Significant progress has been made in understanding effective approaches to prevention of drug abuse over the past few decades, in part because of careful attention given to understanding basic, developmental processes involved in the transition to drug use, abuse and dependence. Drug abuse and dependence are disorders that interfere with the normal, healthy functioning of persons across the lifespan, and are preventable causes of medical and psychiatric problems and disorders, injuries, lost income and productivity, and family dysfunction. While the initiation of licit and illicit drug use, a necessary precursor to abuse and dependence, grows dramatically during the adolescent years, this behavior is preceded by proximal and distal biological, psychological, social, and environmental precursors originating as early as the prenatal period. Furthermore, the misuse and illicit use of drugs extends well beyond adolescence and, for some, begins in adulthood, even in late adulthood.

The life course developmental perspective suggests that individual and environmental factors interact to increase or reduce vulnerability to drug use, abuse and dependence. Vulnerability can occur at many points along the life course but peaks at critical life transitions. Thus, prevention researchers should recognize the significance of timing interventions to coincide with important biological transitions, such as puberty; normative transitions, such as moving from elementary to middle school; social transitions, such as dating; and traumatic transitions, such as the death of a parent. In addition, because vulnerability to drug abuse involves dynamic intrapersonal (e.g., temperament), interpersonal (e.g., family and peer interactions) and environmental (e.g., school environment and neighborhood) influences, prevention intervention research must target interactions between individuals and social systems across the life span. To address this complexity, intervention research needs to test strategies designed to alter specified modifiable mediators to determine which are most related to and effective in reducing drug use initiation and escalation, with what audiences, and under what conditions. There is recognition that developmental patterns may vary by gender, gender identity, race/ethnicity, sexual orientation, and other population-based or cultural factors, and that these need to be better understood so that they can be addressed in interventions as appropriate.  Drug use, abuse, and dependence often co-occur with delinquency and criminal behavior, interpersonal violence, mental health problems, HIV, other sexually transmitted infections, and reproductive health problems. Therefore, understanding the prevention of co-occurring problems and their contribution to elevated levels of risk is important to NIDA's mission.

Successful drug abuse and drug-related HIV prevention programs have utilized a number of theoretical perspectives for predicting differential drug use trajectories and elucidating developmentally grounded mediators, or risk and protective factors, amenable to change. Notable among these theories are Problem Behavior Theory, Social Cognitive Theory, and the Social Development Model. Resulting research has focused on prevention approaches involving positive modification of various precursors of substance use, such as sensation-seeking, emotion regulation, aggressive behavior, academic problems and failure, poor social skills, misperceptions of social norms, poor parent-child attachment, and inappropriate parental expectations and responses. Because theoretical grounding of prevention programs is an essential feature for their success, further progress in prevention research relies on a stronger understanding of successful theories and their application and potentially the development of new theoretical approaches or meta-theories.

Prevention context impacts upon the feasibility, acceptability, and effectiveness of prevention approaches. Successful programs have intervened in multiple contexts, such as schools, health care settings, community service organizations, workplaces, and within the family context. Drug abuse and related HIV prevention research is most successful when there is an existing or created delivery system for prevention interventions to be delivered (e.g., the intervention delivery contexts provide ready access to the target population). That is, the more central the delivery context is to the target audience's existing life routines, the more likely the intervention and associated research will be able to recruit and retain members of the target population and have sustainability of the intervention over time.

Audiences or targets for prevention interventions are generally classified into one of three categories depending on level of risk: universal, selective, or indicated. Universal prevention interventions are targeted to the general public or to a whole population group, such as all children in a school. Selective prevention interventions are targeted to individuals or subgroups of the population with defined risk factors for the development of substance abuse, such as children of drug abusers, children of parents in the criminal justice system, sexual minority youth, and youth in the child welfare system. Indicated prevention interventions are targeted to individuals or subgroups that are identified as having non-clinical but detectable signs or symptoms foreshadowing drug abuse, dependence, and addiction. A tiered approach to prevention interventions incorporates two or more of these levels of intervention with increasing intervention intensity for individuals at greater risk or with greater problem severity.

To advance the field, novel interventions must build on basic science findings from diverse fields. Opportunities exist to expand upon our growing knowledge by incorporating neuroscience, genetics, and physiology to better understand prevention pathways in order to improve effect sizes for successful approaches, increase the breadth of impact, develop personalized prevention approaches, and build efficiency or optimization into the processes of increasing protection or decreasing risk.  Furthermore, because of recent advances in a number of disciplines, important opportunities exist to build upon findings from drug abuse etiology and epidemiology research and the fields of human development, neuroscience, criminology, psychology, sociology, anthropology, and communications. An interdisciplinary approach to prevention, with research teams comprised of scientists bringing complementary expertise and critical and innovative research paradigms, will strengthen prevention efforts. In addition, studies addressing the unique opportunities to examine the interaction between biological, interpersonal, intrapersonal, and environmental variables in the context of the design and implementation of prevention research, need to be developed and tested.

Three underdeveloped areas of drug abuse/drug-related HIV prevention research are discussed briefly here: developmental transitions, differential effectiveness and fidelity of implementation, and emerging technologies. Characteristics and differences that contribute to drug abuse risk during late adolescence and emerging adulthood have not been well studied. This is a particularly important area of research because late adolescence is a significant transition point in human development, and the initiation of use of so-called hard drugs often takes place during this period. Other normative transitions during this life course stage, such as learning to drive, entering college, the military, or the first job; and courtship, marriage and the transition to parenthood as well as non-normative life events such as victimization have not been seriously considered as targets for drug abuse prevention interventions. Moreover, very few prevention interventions for later stages of adulthood have been developed despite the fact that individuals who have used licit and illicit drugs, and prescription drugs for non-medical use, for long periods of time without developing dependency can move toward abuse and dependence as the result of biological (e.g., lower tolerance with aging), medical (e.g., onset or ongoing chronic diseases, endocrine system changes, chronic pain; treatment of major medical conditions), normative (e.g., retirement), social (e.g., making new friends in retirement) or traumatic (e.g., loss of a spouse) transitions. Thus, greater attention to a wide variety of transitions and the risk and protective factors related to them is needed for the development and testing of innovative interventions that target high-risk periods across the life course.

Some effective prevention interventions show differential effectiveness by gender, ethnicity, and other factors. Research is needed to understand underlying biological, psychological and social processes and mechanisms that account for these differences so that interventions can be adapted as needed for specific sub-groups while maintaining the integrity of the intervention core components. Methodologies that help identify core elements, subpopulation effects, and other factors related to effective implementation are in need of further development. The importance of fidelity of implementation is well established, yet there are situations where strict adherence is not possible. Developing a better understanding of what constitutes the core content or effective ingredients of an intervention and how modification can be made while maintaining or boosting effect sizes may be a superior approach to developing a wholly new intervention. Moreover, research to elucidate under what conditions adaptation is indicated would advance our capability to understand how to optimize prevention services.

Emerging technologies, such as, social networking tools, and wireless communication (e.g., texting and cell phone applications), may have application to both intervention design and prevention methodology. While the full impact of such changes on prevention programming and research is unknown, possible improvements to intervention processes and data collection methodology should be explored. Technology-assisted interventions have the potential to be both more personalized, through the use of individualized programs, and more confidential, as they involve less face-to-face contact than more traditional methods. Technologies that are promising for their role in prevention research include hand held devices to collect data and new HIV testing technologies, particularly those that identify early infection.  Less is known about whether the integration of media or other high-tech intervention components into existing interventions boosts intervention effectiveness.  Emerging biological modalities for HIV prevention (e.g., pre-exposure prophylaxis) may have differential utilization and adherence where significant substance use is present and integrated biobehavioral interventions are needed to optimally implement these approaches. 

Specific Areas of Research Interest

This FOA for R21 applications seeks to support developmental and/or exploratory efforts across the spectrum of drug abuse and drug-related HIV prevention research. Applications submitted under this mechanism should reflect novel approaches to advancing the science of drug abuse prevention. Outcomes of this research should inform future prevention efforts through enhancing knowledge base in areas of basic, intervention and methodological research. NIDA's drug abuse prevention research program is comprehensive in nature and fully reflects the prevention research mission, objectives, and study areas advanced by the Department of Health and Human Services and the National Institutes of Health. The following sections address drug abuse prevention research areas of specific interest to NIDA. Under each research section, examples of topics requiring further study are given. However, many areas for future research are not addressed, and there is an ongoing emergence of new areas.  Thus, investigators should not view the examples provided as limiting the areas of research of interest to NIDA.

1. Basic Prevention Research

NIDA recognizes the need to maximize the use of existing underutilized approaches and basic science findings for the development of innovative preventive interventions targeting the initiation and escalation of drug abuse and the prevention of drug-related HIV infection. The goal of basic prevention research is to identify and test new prevention paradigms informed by basic science. Basic science discoveries utilized in basic prevention research include findings from biological (e.g. neurobiology, stress reactivity, pubertal maturation, or physical development), psychological (e.g. emotional, behavioral, cognitive, and developmental) and social (e.g., social work, criminology, sociology, urban planning, and communications) sciences that address individual and group vulnerabilities to drug use initiation and escalation from experimentation, to occasional use, to abuse. Investigators’ efforts over the past two decades have focused on the translation of basic research to produce prevention programs with proven efficacy and effectiveness in addition to science-based prevention principles. However, much existing basic science on biological, neurobiological, psychological, and social processes and mechanisms has not been fully utilized for purposes of developing and testing innovative, potentially efficacious, drug abuse prevention interventions. Moreover, recent scientific advances have provided opportunities to integrate knowledge from diverse fields such as biochemistry, biology, biomedicine, health care policy, computational science, computer science, education, economics, engineering, geography, genetics, sociology, urban planning, informatics/information science, mathematics, neurobiology, neuroscience, and physiology.

One opportunity for basic prevention research is the translation of intervention findings into further basic science study. Because preventive intervention trials include at least one non-intervention control group, they have unique contributions to make in advancing our understanding of the mechanisms through which risk and protective factors operate, including how biological, psychological, social and environmental factors interact to influence risk or how such mechanisms operate within and across different phases of development or for groups at risk for different reasons (e.g., LGBT), or at different levels of risk (i.e., accumulated risk, chronic vs. acute). Ultimately, this research will have implications for further development of new intervention paradigms or refinement/improvement of existing programs and strategies, as well as for the natural history of problem behaviors and the effect of intervention on those behaviors.

Most basic prevention science investigations are expected to be human laboratory studies or small-scale field randomized controlled trial (RCT) studies of well-defined hypotheses derived from prior research. When appropriate, researchers can propose basic research applications as stand-alone R21 applications associated with a prevention research study in its early stages. Possible exploratory/developmental research foci include:

Studies that use findings on learning styles, cognitive strategies, and neurocognitive functioning to improve or develop targeted prevention strategies.

Examination of interaction between emotional and cognitive responses to prevention messages to construct messages more likely to elicit appropriate responses (e.g., triggering refusal behaviors when confronted with potential drug use situations).

Secondary analyses of prevention trial data to examine understudied mediators and moderators of program effects on hypothesized primary outcome variables and on conceptually related outcomes such as sexual risk taking behaviors.

Research to discern what theoretical approaches have the greatest promise for informing intervention strategies/modalities leading to durable behavior change.

Construction and dismantling studies, and adaptive designs that systematically examine the impact of program components, alone and together, to determine mechanisms of effectiveness, especially those core to program effectiveness.

Pilot studies using basic science research and emerging technologies to explicate under-explored mechanisms of neurobiological risk and to facilitate understanding of the biological and neurobiological effects of social, emotional, and behavioral preventive interventions.

2. Prevention Intervention Research

Research on prevention intervention programs and strategies should focus on the manipulation of presumed causal, malleable factors derived from basic prevention and other studies on the origins, pathways and mechanisms of vulnerability to drug abuse, addiction, and drug-related HIV. Even relatively modest prevention intervention research trials can address complex and varied questions on drug etiology, theory testing, mechanisms of intervention effects, process measures, fidelity measures, and implementation cost in addition to assessing short term and long term trial outcomes. Three types of prevention intervention research that will be discussed further here include efficacy, effectiveness, and systems research.

Efficacy trials are designed to establish the impact of the intervention approach on targeted outcomes under ideal and well-monitored implementation conditions. In preparation for efficacy research, pilot studies are typically conducted to gather evidence for feasibility and acceptability, and potential efficacy in advance of proposing an efficacy trial. Mechanisms other than the R01 (e.g., R34, R21, and R03) are often more appropriate for pilot studies and other developmental work, such as the testing of methods and materials, and manualization of the intervention.  Efficacy trials may be small-scale trials or more moderate in size depending on the level of current evidence for the work and other considerations regarding the design of the trial.

Efficacy trials utilize small randomized controlled trials (RCTs) or, if well justified, other highly rigorous research designs. Quasi-experimental designs are discouraged, except in cases where the research question cannot be tested using a more rigorous approach. It is essential to articulate a theoretical framework or basis for the intervention effects anticipated. The theoretical or empirical basis of the intervention defines the role of mediating factors, that is, how various programmatic components have been designed to alter these elements in order to impact upon measurable intervention outcomes. An important aspect of efficacy studies is determining the relevance and acceptability of the program for translation to real world settings. 

Effectiveness trials replicate efficacious strategies and interventions in less controlled, real-world settings with larger more diverse samples, and generally employ a RCT or equivalent research design (such as, multiple baseline, cross over, etc.). In addition to determining effectiveness, these studies usually incorporate prevention services research questions related to factors such as participant recruitment and retention, dosage, cost, fidelity of implementation, and implementer training (for further discussion see below). That is, they examine issues that affect the transportability of programs to real world settings, facilitators and barriers to implementation, and generalizability to diverse populations and geographic settings.

Systems research takes prevention programs or strategies with demonstrated efficacy and effectiveness to scale. Systems trials are implemented through existing (e.g., schools, primary care settings, workplaces) or newly created delivery systems with large samples. Random assignment to intervention and control conditions remains the ideal study design. A major emphasis of systems trials is identifying and understanding how factors that affect the sustainability of programming operate. Thus, addressing prevention services research questions is a core goal of this type of study. All three intervention study types, efficacy, effectiveness, and systems, generally incorporate a longitudinal design to allow for the examination of the role of moderators, mediators, and a variety of proximal and distal outcomes over time.

An important emphasis of NIDA's prevention research program is on prevention services research questions. Prevention services research involves identifying and determining how features internal and external to interventions contribute to efficacy and effectiveness. Examples of internal features are: content, implementation strategies, fidelity, dosage, delivery setting and implementer training. Examples of external features are: exposure to other programs, media, enforcement of regulations and laws related to substance use and community norms around substance abuse. One important area of prevention services research is replication of efficacious interventions with other population groups and in alternate contexts in an effort to develop a clear understanding of those features that are essential to program integrity (i.e., core elements) and those that can be adapted to meet the needs of specific groups and settings.  Prior research suggests that features such as program duration, reinforcement of prevention messages over time, consistency of messages across settings, use of developmentally appropriate content and materials, use of interactive teaching techniques, use of intermittent reinforcement, client-facilitator fit, grouping of clients, and interactions between these features need further investigation to improve the quality of programming and increase the potential for translation into real-world settings. Questions around these and other features that concentrate on the availability, organization, management, financing and sustainability of prevention interventions fall into the broad category of prevention services research. This also includes understanding community-level decision-making regarding the selection, adoption, adaptation, implementation and sustainability of prevention programs, policies and practices. 

Prevention services research is integral to intervention research and forms the link between research and practice. For that reason researchers are encouraged to include services research questions that address (or inform) real-world implementation issues in efficacy and effectiveness trials as appropriate.  In addition, researchers are encouraged to integrate prevention practitioners into the research process, from inception through to completion to ensure that successful interventions meet identified needs and to foster ownership and sustainability.

Examples of prevention topics appropriate for exploratory/developmental research include:

Efficacy

Developing and testing strategies to strengthen existing group and environmental anti-drug norms and characteristics that have been show to be protective against drug abuse and addiction.

Developing and pilot testing preventive interventions designed to strategically target understudied periods in the life course, such as intervening in early childhood to alter precursors, intervening in late adolescence with youth who discontinue their education, or intervening in adulthood with individuals experiencing high stress, such as military personnel, returning veterans and their families, displaced, bereaved, or victimized persons, or sexual minorities.

Small-scale studies on the efficacy of drug abuse prevention programs and strategies that are untested but widely used such as: case management, mentoring, job training, and challenge activities.

Pilot testing the efficacy of drug use and/or HIV/STI screening tests for their potential effects in reducing or preventing drug abuse and dependence and/or HIV/STI infection.

Small-scale studies of the effects of environmental manipulations, such as school policies, state or local laws, and local law enforcement strategies, or the built environment on drug use and drug-related activities such as gang involvement.

Developing and pilot testing the efficacy of brief prevention interventions for drug abuse and HIV (including combination behavioral and biomedical HIV prevention) in specific contexts such as primary care settings and college or workplace health programs.

Pilot testing theoretically grounded interventions with demonstrated efficacy for preventing drug use for their effects on sexual risk behaviors.

Development and feasibility testing of new prevention interventions or adaptation and testing of evidence-based interventions for at-risk groups of children and youth who have been underrepresented in research efforts (e.g., military youth and families, children of parents in the criminal justice system and their families, children in foster care and their foster and biological families, adopted children and their families, lesbian, gay bisexual and transgender (LGBT) youth.

Small-scale studies of structural or environmental interventions designed to prevent drug use and abuse in communities.

Small-scale tiered studies that include screening, implementation of universal interventions and selective or indicated interventions for those who continue to experience difficulties for a maximal impact in a setting or with a population. 

Studies to identify core elements of intervention models—e.g., features/elements that need to be retained, those that can be adapted or eliminated to streamline programming—while maintaining or boosting efficacy.

Conducting feasibility studies of culturally congruent intervention approaches to reduce drug abuse and drug-related HIV among Native Americans, Pacific Islanders and other understudied minority populations that are adversely affected by the consequences of drug use.

Studies that examine the preliminary efficacy of novel strategies for addressing the rise in prescription drug misuse and abuse that reflect the unique roles of medical and dental providers, social networks, and policy makers in prevention.

Effectiveness

Secondary analysis of prevention intervention data to better understand the impact of drug abuse prevention intervention on drug use, drug disorders, and sexual risk taking behaviors among specific subgroups of individuals such as high risk youth, females, ethnic minorities, and gay/lesbian/bisexual/transgender youth in order to elucidate the need for intervention modifications and specialized intervention approaches.

Secondary analysis of prevention intervention trial data to assess factors accounting for variation in response to drug and HIV prevention interventions such as psychiatric disorders, family functioning, environmental exposures, stress responsivity, and cognitive or neurocognitive functioning.

Studies on adaptation of effective drug abuse and HIV prevention approaches to understand the added value of efforts to customize prevention for specific populations such as underserved racial and ethnic minority populations.

Examination of program effectiveness in reducing HIV sexual and drug use risks, as well as risks for acquiring related infections (i.e., other sexually transmitted infections, viral hepatitis), where research takes into account emerging knowledge about HIV risks such as population-based biological vulnerability, and network patterns.

Systems

Examining how differences in school environments, including drug abuse rules, and their enforcement, and policies, influence mediators of drug abuse--such as attitudes, norms and intentions—and eventually substance abuse behaviors with particular attention to the pattern and duration of the environmental change processes.

Feasibility studies of the initiation, development, and continuity of community coalitions to prevent drug abuse, and impact on selection and implementation of effective drug abuse prevention strategies.

Examining access and adaptability of research-based strategies for training high-risk parents—such as those who abuse drugs, or in situations where abusive child-rearing practices have been documented—through existing service delivery systems.

Determination of the cost and cost-effectiveness of brief drug abuse and HIV prevention programs that have been integrated into primary care, mental health and community settings, including federally qualified community health centers.

Small-scale studies that examine community-level decision-making regarding the selection, adoption, adaptation, implementation and sustainability of prevention programs, policies and practices.

Studies of the impact of prevention policies on the prevention of drug use and abuse in communities.

Studies that examine dissemination of evidence-based prevention interventions in communities.

3. Methodological Research

Methodological research is needed in the field of drug abuse prevention on promising data collection, data management, analysis, and reporting techniques. Special attention should be given to the hierarchical and longitudinal nature of most prevention trial data, the adaptation of measures for intervention cohorts over the course of time and development, the measurement and analysis of complex theoretical process models including moderating and mediating variables, the development of adaptive designs, the problems of missing data and attrition when following intervention and control subjects over time, and the development of analytic strategies to determine important features of prevention interventions (i.e., core components). NIDA supports the adaptation and assessment of proven scientific procedures from other disciplines to determine their applicability to drug abuse prevention research such as those from systems science. Specific areas of research include:

Development, testing, and application of complex statistical models to examine differential impacts of preventive interventions across individuals, across time, and across contexts.

Designs to improve causal inference from non-experimental and quasi-experimental research and natural prevention experiments.

Research to improve the analysis of longitudinal data—in particular, the analysis of correlated data, the modeling of different sources of error, and techniques for dealing with missing data at various levels of aggregation that may occur in prevention trials, as well as refining methods for evaluating effects in small, high risk subpopulations.

Methodological research to improve the analysis of complex prevention trial data, including the statistical modeling of non-response and other survey errors.

Analytic methods that appropriately model social structures, social processes, and spatial relationships such as social networks, social influence, diffusion, and contextual effects within randomized prevention trial datasets.

Methods for the detection and analysis of non-linear or discontinuous changes in response to preventive interventions.

Methodological research examining complex interactions between qualitative (e.g., process data) and quantitative outcome data.

Applications of systems science to improve the ability of complex trials to model real world clinical operations and decision making.

Research that evaluates ethical issues in the implementation of prevention interventions in particular populations, settings, or policy contexts, including evaluation of specific intervention modalities, study designs, and data collection methods.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse:  In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV,  NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information see http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at

http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html

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

Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.

Award Project Period

 The maximum period is 2 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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, 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 (Program Director/Principal Investigator)

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

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

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.

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 Institutions

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

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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

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

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

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. 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
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)

Harold I Perl, PhD
Acting Chief
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
Room 5171, MSC 9589
Bethesda, MD 20892-9589
Send overnight mail to Rockville, MD 20852
Ph: 301-443-9982
Fax: 301-480-2542
Email: hperl@nida.nih.gov
www.nida.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)

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

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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