Required Application Instructions

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

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

Drug use, abuse and addiction interfere with the healthy functioning of persons across the lifespan and are preventable causes of numerous medical and behavioral health problems and disorders, injuries and fatalities, lost income and productivity, and other personal and societal costs. The mission of the National Institute on Drug Abuse's (NIDA) Prevention Research Program is to support a developmentally grounded program of research to prevent or delay the initiation and onset of drug use, the progression to abuse, and the drug abuse aspects of HIV/AIDS and viral hepatitis. This Funding Opportunity Announcement (FOA) encourages R21 grant applications for research that will advance NIDA's program of research in prevention science. Applications submitted to this FOA are expected to employ rigorous scientific methods that test theoretically derived hypotheses to increase understanding of the science of drug use prevention within diverse populations and settings and across the lifespan. The FOA seeks applications that encompass investigations of cognitive, behavioral, and social processes as they relate to: 1) development of novel prevention approaches; 2) efficacy and effectiveness of prevention interventions or programs; 3) processes that optimize the selection, integration, implementation and sustainability of science-based prevention, including systems-level and health economic factors; and 4) methodologies appropriate for studying complex aspects of prevention science. Studies will seek to prevent the use of various substances including but not limited to nicotine, marijuana, cocaine/crack, methamphetamine, club drugs, inhalants, non-medical use of prescription and over-the-counter drugs, or any of these drugs in combination with alcohol. This FOA seeks research that will identify and test population-level approaches for the prevention of: drug use and abuse; drug-related problems (such as mental health, interpersonal violence, criminal involvement, and productivity loss); and conditions where drug use or drug administration (e.g., injection) significantly contributes to risk (HIV, hepatitis B [HBV], hepatitis C [HCV], recurrence [HBV, HCV]) or severity (psychiatric disorder) of other illnesses.

NIDA seeks research that targets diverse populations, particularly those that have been underrepresented in prevention research and those at increased levels of risk (such as youth involved in the juvenile justice system or the child welfare/foster care system; lesbian gay, bisexual and transgender [LGBT] individuals; military families; children of parents in the criminal justice system; children and families of individuals with drug abuse or drug-related problems; children and young adults with mental health disorders; homeless individuals; migrant populations; and school dropouts).

The R21 activity code 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. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the R03 small grant activity code.

While the initiation of drug use most often begins during the adolescent years and ongoing use and abuse frequently continues through adulthood, these behaviors are preceded by identifiable biological, psychological, social, and environmental factors originating earlier in life, even as early as the prenatal period. Significant progress has been made over the past few decades in gaining an understanding of effective approaches to the prevention of drug use, because of the careful attention given to understanding the developmental processes and ecological frameworks involved, leading to the identification of factors that can increase the risk of, or protect against, the onset of drug use and abuse . Interventions that aim to mediate these factors within individual, family, school and community contexts have demonstrated considerable effectiveness. In fact, prevention interventions can have long-term impact; interventions implemented early in life have been found to have significant effects that can be measured during adolescence and in later years. These distal effects are mediated through more proximal outcomes related to risk and protective factors. Furthermore, because risk factors often cluster together, substance abuse prevention interventions can have cross-over effects; that is to say, they can result in benefits across a range of outcomes not directly targeted by the intervention, such as psychiatric conditions, sexual risk behaviors, criminal or delinquent activities, educational and academic achievements, and prosocial behaviors. Nevertheless, despite this wealth of accumulated evidence, wide scale implementation of prevention interventions into real-world practice has lagged considerably. More attention needs to be given to expanding the reach of proven prevention programs.

NIDA seeks research that targets the multiple contexts and social settings in which people live and interact on a regular basis (e.g., family/home, schools, peer networks, health care settings, community/neighborhood, community service organizations and agencies, workplaces); and addresses the appropriate level of risk (e.g., universal, selective, indicated).[1] Given that vulnerability to drug use and drug related problems can occur at various points along the life course but often peaks at critical life transition points, NIDA encourages research that takes into account the significance of the timing of interventions to understand whether (and potentially how) intervention effects coincide with important developmental, social, traumatic and other life transitions (e.g., puberty, transition from elementary to middle school or from middle to high school, transition from adolescence to young adulthood, death of a parent or family member, divorce).Interventions should aim at developmentally appropriate targets, including risk or protective factors that are known to be precursors or mitigators, respectively, of later drug use. While universal prevention interventions have been found to have particular impact on individuals at higher risk, there is a need for research to advance understanding of the characteristics of individuals who do not benefit from universal interventions (i.e., non-responders) and who may be in need of more targeted selective and indicated prevention interventions. Some prevention interventions have shown differential effectiveness by gender, ethnicity and other factors. NIDA is interested in research that elucidates the underlying processes and mechanisms (e.g., biological, psychological and social) that account for these differences. This research may inform potential adaptations for specific subgroups. Research on the optimization of prevention interventions to improve efficiency and/or impact is encouraged and may include research on core components of interventions, adaptive designs or other approaches. Simply stated, there is a need for greater understanding of what prevention interventions work, for whom, and under what circumstances. Finally, NIDA strongly encourages investigators to integrate the perspectives of prevention practitioners meaningfully into the research process, from inception through completion, to ensure that interventions meet identified needs and to foster implementability and sustainability.

This FOA is issued during a time of rapid and significant policy shifts across the Nation. Current and impending transformations in the healthcare environment open new opportunities for increasing integration of prevention services within the U.S. healthcare system, including greater attention to the prevention of drug use and abuse. Shifts in national and state-level healthcare policy as well as corresponding changes in public and private healthcare delivery systems provide an opening to implement substance use prevention in a wide variety of medical care settings (e.g., stand-alone or hospital clinics, academic medical centers, Federally Qualified Health Centers) and may increase prevention intervention options in specialty care settings such as sexually transmitted infection (STI), pain or physical rehabilitation clinics. However, despite the potential for new models to deliver prevention in healthcare settings and to collaborate with traditional prevention providers such as community based organizations, evidence to support the effectiveness of such models currently is limited. These limitations may be compounded by a general lack of understanding by healthcare providers and systems about the availability, effectiveness and relevance of substance use prevention options. Research on drug abuse prevention interventions delivered within or through health care settings will help to advance understanding of the potential to impact drug abuse, drug related HIV and viral hepatitis, and other related behavioral health outcomes in medical settings. Such advances may aid healthcare decision-making and advisory bodies (such as the U.S. Preventive Services Task Force). Also, in the context of expanded prevention services under health reform, there are potential policy implications for research in medical settings. NIDA has a strong interest in research that will expand this knowledge base.

In addition, legislation in many States has changed local policies regarding the medicinal and other use of marijuana, resulting in major new challenges for prevention efforts. The impact of these rapidly changing marijuana policies will be felt both locally and nationally. Therefore, while NIDA will continue to support research that studies critical issues related to preventing the use and abuse of all drugs, the Institute is particularly interested in research on prevention interventions that explicitly address these shifting marijuana policies as well as new policies that may emerge.

[1] Universal prevention interventions are targeted to the general public or to a whole population group. Selective prevention interventions are targeted to individuals or subgroups of the population with defined risk factors for the development of substance abuse. Indicated prevention interventions are targeted to individuals or subgroups that are identified as having non-clinical but detectable signs or symptoms foreshadowing substance use, abuse and addiction.

The following sections describe examples of prevention research areas of specific interest to NIDA. Nevertheless, additional important areas for future research continually emerge and other research topics may be appropriate to this FOA. The examples provided below do not limit the research areas that may be of interest to NIDA. Potential applicants are strongly encouraged to contact NIDA Scientific/Research to discuss possible research ideas prior to submitting an application (see Section VII, below).

Basic Prevention Research

Effective prevention programs have been constructed from an understanding of basic cognitive, behavioral and social processes represented in scientific disciplines such as developmental psychopathology, social psychology, sociology, communications, and social work. Previous basic prevention research studies have focused on impulsivity, sensation seeking, self-regulation, and stress reactivity in the development of strategic research directions. In addition, research has focused on the role of genetic markers as effect modifiers. Novel intervention approaches are sought that build upon newer findings in these fields and/or integrate the growing research in fields such as neuroscience, genetics, and neurobiology. Investigators are encouraged to consider malleable factors that can be the focus of broader prevention intervention strategies as well as factors that are important for targeting interventions based on risk or vulnerability of the target population. In addition, applications that advance the science by demonstrating impacts on biologically-based indicators of prevention intervention effects are desired. Basic prevention research efforts are needed to build upon successes in these areas and in emerging areas of science. Ultimately, such studies should address the challenges of improving effect sizes for prevention; identifying novel, highly potent prevention intervention approaches; elucidating mechanisms of action for interventions; and, understanding and providing solutions for non-response to prevention interventions. This FOA encourages research on the following and other related topics:

Use of biological targets and basic research findings to illuminate the mechanisms of actions of prevention interventions, to advance knowledge about what prevention interventions work best for what populations and individuals, to better understand the characteristics of intervention responders and non-responders, and to utilize these findings to increase the effectiveness of personalized prevention.

Use of findings from prevention intervention research to generate and inform new basic research questions.

Studies that use findings on learning, motivation, or neurocognitive functioning to improve or develop targeted prevention strategies

Studies that translate findings on self-regulation and impulsivity to improve approaches to prevention messaging and delivery of preventive interventions.

Studies that postulate specific prevention mechanisms and approaches to support the prevention needs of individuals who experience trauma and affective disorders

Studies to improve the magnitude or durability of cognitive, attitudinal or behavior change supporting key prevention outcomes, including studies to address the most efficient use of boosters as a part of effective interventions.

Prevention Intervention Research

Significant progress has been made over the past few decades in identifying effective prevention interventions, strategies, and approaches to prevent or delay the initiation of drug use and the progression to abuse. NIDA seeks theory-based research applications aimed at the development of novel or the refinement of existing prevention interventions for diverse populations and settings, in particular for those populations, settings, and developmental periods that have been understudied and for which there is a limited evidence base, as well as for the prevention of drug-related transmission of HIV infection and viral hepatitis. Such research may be conducted via efficacy, effectiveness, or systems-level trials. This FOA encourages research on the following and other related topics:

Development and testing of strategies for communications and messaging interventions, particularly how they may interact with other prevention interventions, strategies and tools, as well as how they may be targeted to specific populations and age groups.

Development and testing of structural and environmental intervention strategies to prevent substance use.

Development and testing of screening and brief intervention (SBI) models for drug abuse prevention, STI and HIV prevention, for delivery in healthcare and other settings.

Development and testing of screening and prevention interventions that incorporate technology to permit point of care testing for HIV or substance use.

Development and testing of novel interventions to reduce substance use and sexual risk among populations at high risk for HIV acquisition.

Development and testing of information technology platforms for delivering efficacious substance use prevention interventions, such as electronic delivery in clinic, school or other venues and social media environments.

Theory-based evaluation of existing prevention interventions that are widely used in real-world settings but for which an adequate evidence base does not yet exist.

Development and testing of adaptations of efficacious substance use prevention interventions among sexual minorities or ethnic/racial minorities at particular risk for problematic substance use or substance use disorder.

Development and testing of novel substance use interventions for delivery in health care settings, particularly for settings that serve persons at high risk for initiating substance use, abuse and addiction, such as pain and rehabilitation clinics or community mental health centers.

Development and testing of substance use prevention interventions that integrate substance use and sexual risk reduction for use in AIDS-specialty or STI healthcare settings.

Identifying the core components of evidence based interventions through theory driven adaptations or tests of mechanisms of action.

Prevention Services Research

Prevention services research focuses on the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions. Services research may focus on underlying processes and mechanisms at systems and organizational levels that contribute to the effectiveness, uptake, adoption and sustainability of prevention interventions and examine domains such as the availability, utilization, appropriateness, and cost-benefit/cost-effectiveness of prevention interventions and services. Organization, management, delivery and financing are critical factors which may affect the type and quality of prevention interventions implemented in settings and systems as well as the outcomes they produce.

Furthermore, despite a wealth of evidence demonstrating the efficacy and effectiveness of a variety of interventions to prevent or delay the initiation and onset of drug use, relatively few have been widely adopted or faithfully implemented, thereby limiting their potential for public health impact. Many services research questions remain unanswered, including understanding the processes through which science-based interventions enter broad practice, such as the decision-making processes that prevention providers, agencies or communities use to select interventions for adoption; the processes though which interventions may be adapted to meet the particular needs of specific settings and contexts; the organizational, leadership and management characteristics; and operational practices that impact the effectiveness and reach of interventions. Research is needed to increase understanding of the process for selection and adoption of, and implementation of evidence-based prevention interventions into substance abuse prevention systems, general healthcare settings and the community, social service and judicial systems, and other settings.. NIDA encourages research that seeks to understand the systems-level, organizational, environmental, community, and provider attributes, processes, and practices that influence the quality, outcomes and sustainability of prevention interventions. This FOA encourages research on the following and other related topics:

Development and testing of models for implementation of efficacious and effective prevention interventions in real world settings and systems, including integration into community/regional/state prevention systems.

Identifying and improving the processes through which evidence-based prevention interventions enter routine practice, including the decision-making processes by prevention practitioners, agencies, communities or systems for the selection, adoption, adaptation, implementation and sustainability of interventions.

Identifying factors that contribute to improving the implementation fidelity of prevention interventions, including processes for training in and maintenance of necessary skills.

Identifying factors and processes that can improve the sustainability of prevention interventions and systems.

Identifying the essential elements of evidence based interventions so as to better inform the decision making of potential adopters who may only be able to implement select portions of a program due to limited agency/community resources or cultural constraints.

Identifying contextual, setting and system level factors that may facilitate or impede the adoption, implementation and uptake of EBIs.

Economic and cost studies of evidence-based prevention interventions, including cost-benefit, cost-effectiveness, and cost-utility analyses; financing and purchasing of substance use prevention services; and economic incentives to improve the quality and efficiency of prevention services.

Economic studies to determine 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.

Test models of integrating efficacious and effective substance use prevention interventions into healthcare settings, including evaluation of different models for adaptation, implementation and quality improvement.

Test new reimbursement and financing models for drug abuse prevention interventions and services that are being implemented through Accountable Care Organizations or other local experiments to integrate prevention services and prevention delivery systems into health care to evaluate costs and benefits of substance use prevention.

Develop and test novel approaches to organizing substance use prevention within healthcare settings, including varied referral models (e.g., electronic medical records and other decisional support systems); different configurations of prevention delivery (e.g., integration into multi-service clinics, co-location of prevention services, or referral to specialized prevention providers); and different delivery formats (e.g., electronic, in person, and delivery by professional, paraprofessional or other staff).

Studies of mechanisms, local policies, and decision processes for increased implementation of HIV prevention services under health reform.

Examination of approaches to building capacity within new and/or underutilized service settings for quality implementation of proven drug abuse and HIV prevention strategies (e.g., child welfare, criminal justice, and military and veteran service settings)

Studies to develop and test novel service delivery models for prevention interventions designed to target children, adolescents, adults or geriatric individuals with complex, comorbid and/or chronic conditions that make use of traditional prevention settings (e.g., school or community-based settings), or underutilized settings (e.g., primary care, mental health, federal qualified health centers, military medical settings, juvenile justice, child welfare, employee assistance programs, etc.).

Examination of the effects of dosage on intervention outcomes.

Studies examining implementation fidelity and adaptation as prevention interventions are delivered under real world conditions by practitioners.

Methodological Research

Research on study design and methodology is critical to advancing the field of substance use prevention. NIDA encourages applications aimed at expanding and enhancing the existing robust portfolio of methodological research in prevention. NIDA's areas of interest in prevention methodology include innovative research designs such as optimization and adaptive design approaches; development and validation of novel analytic approaches for evaluating mediation and moderation in complex longitudinal designs; research to advance techniques such as latent class analysis and approaches for enhancing the use of longitudinal intervention data sets (e.g., improving the imputation of missing data); and research that can facilitate the adaptation and assessment of proven designs and methods from a variety of scientific disciplines to determine their applicability to substance abuse prevention research, including new approaches to measurement. This FOA encourages research on the following and other related topics:

Developing, testing, and applying new and innovative statistical techniques to examine the differential impacts of preventive interventions across individuals, groups, time, and contexts.

Advancing design and analytic strategies, such as optimization, that delineate critical factors to identify core elements or explain processes of change in extant or new prevention interventions.

Development and testing new statistical techniques to increase the usability of complex data sets, including tools for data harmonization, imputational methods, and evaluation of complex longitudinal patterns of mediation or moderation.

Development of methodological research to improve the analysis of longitudinal and other data collected in complex design prevention trials, including the analysis of correlated data, the modeling of different sources of error, techniques for dealing with missing data and/or non-response errors, and methods for evaluating effects in small subpopulations.

Developing, testing, and applying study designs that strengthen causal inference and maximize the external validity of prevention research that utilizes quasi-experiment and non-experimental methods or naturally occurring experiments.

Developing and testing of measures to assess adoption, implementation quality, fidelity and sustainability.

Development of analytic methods that appropriately model social structures, social processes, and spatial relationships such as social networks, social influence, diffusion, and contextual effects.

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

Methodological research on mixed-methods designs that examine complex interactions between qualitative and quantitative data.

Special Considerations

Women and Gender: Accumulating epidemiological research indicates that risk and protective factors for drug use and drug use problems often differ in males and females. Risk and protective factors can be gender-sensitive, gender-specific, and some might be different or even opposite in males and females, raising the potential that prevention interventions that target gender-based risk and protective factors and that are guided by gender differences might influence outcomes. NIDA is interested in applications for research that assesses the differential effects of prevention interventions in males and females and intervention components that account for differences, as well as in studies that develop, adapt and test the efficacy and effectiveness of sex/gender-based and sex/gender-specific interventions and strategies that are informed by sex/gender-based theories. Also of interest are applications to develop, adapt and test interventions for high risk, vulnerable and other select female populations, including pregnant girls/women, girls who experience trauma, women who experience intimate partner violence, lesbians, and transgender individuals.

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.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 for further details.

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.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (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.

Applicant Organizations

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

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

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

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

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

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

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

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

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

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

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

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

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

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

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

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

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

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

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

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

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 as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

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.

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

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

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

This initiative is not subject to intergovernmental review.

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.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

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

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.

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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

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?

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

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

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?

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

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

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

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

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.

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.

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.

Not Applicable

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.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

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.

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

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.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

Bethany Deeds, PhD, MA
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: [email protected]

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

Diana Haikalis
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1373
Email: [email protected]

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.

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.