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

This FOA for R34 applications seeks to support: (a) pilot and/or feasibility testing of innovative new, revised, or adapted prevention intervention approaches to prevent or delay the initiation and onset of drug or alcohol use, the progression to problem use or alcohol and other substance use disorder, reduce drinking and driving and deaths related to impaired driving, and the drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings; and (b) pre-trial feasibility testing for prevention services and systems research. This FOA is intended for research that aims to pilot and/or feasibility test: (1) novel prevention interventions based on and informed by translation of basic science findings; (2) theoretically-based examination of prevention interventions that are in use but untested; (3) novel approaches to take efficacious prevention interventions to scale in broad population settings; (4) prevention interventions in new settings not previously studied; or (5) effects of combining multiple efficacious or effective prevention interventions or strategies in ways that have a likelihood of demonstrating additive or multiplicative effects. This R34 FOA does not support applications for which the sole focus is development of intervention protocols, manuals, or the standardization of protocols; rather, this type of development work must be imbedded within a pilot/feasibility study. Of particular interest are studies of prevention interventions targeting the healthcare system. It is expected that research conducted via this R34 FOA will consist of early stage efficacy, effectiveness or services research that will provide intervention pilot and/or feasibility data that are a pre-requisite for preparing and submitting subsequent applications for larger scale drug or alcohol abuse prevention or HIV prevention intervention efficacy and effectiveness trials, or prevention services and systems research studies.

Efficacy trials are designed to establish the impact of prevention intervention approaches on targeted outcomes under ideal implementation conditions. Effectiveness trials replicate efficacious strategies and interventions in less controlled, real-world settings with larger more diverse samples, and generally employ a randomized controlled trial (RCT) or equivalent research design (such as, multiple baseline, cross over, etc.). In preparation for efficacy and effectiveness research, pilot and feasibility studies are typically conducted to design measures and instruments if needed, gather evidence of feasibility, estimate participation and retention rates, and collect data on potential efficacy/effectiveness in advance of proposing full-scale trials. Prevention services research focuses on the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions. In preparation for large scale prevention services and systems research projects, pilot studies often are needed to: engage and solicit input from prevention practitioners and participant populations; and empirically test and establish evidence for the feasibility and acceptability of intervention protocols, implementation and fidelity measures, or training and implementation strategies.

Applications to this FOA are not required to present pilot data in support of the proposed approaches, hypotheses and aims; rather, a well-defined theory of change (or logic model) and associated hypotheses are expected. Thus, applications are not penalized for a lack of preliminary data supporting the proposed approaches, hypotheses and aims. Applicants are encouraged to provide strong evidence of their capability to conduct the proposed study, through documenting the availability of needed resources, evidence of institutional support, the training and experience of the investigator team, and/or the conduct of related studies.

Exploratory or pilot research studies for purposes other than collecting pilot or feasibility data in preparation for subsequent, larger-scale prevention intervention studies are not appropriate for this FOA. However, such applications may be appropriate for submission to the R21 mechanism FOAs on Drug Abuse Prevention Intervention Research (PA-15-080) and Epidemiology and Prevention in Alcohol Research (PA-14-188).

Significant progress has been made in understanding effective approaches to prevention of drug and alcohol use and alcohol and other substance use disorders over the past few decades, in part because of the careful attention given to understanding basic developmental processes involved in the initiation of drug and alcohol use, and the transition to problem use and disorder. Drug and alcohol use, problem use, and alcohol and other substance use disorders interfere with the normal, healthy functioning of persons across the lifespan, and are preventable causes of health problems, injuries, lost income and productivity, and family and community dysfunction.

While the initiation of licit and illicit drug use, a necessary precursor to problem use and abuse increases dramatically during the adolescent years, this behavior is preceded by identifiable biological, psychological, social, and environmental precursors originating as early as the prenatal period. Initiation and escalation of illicit drug use and misuse of licit drugs can extend well beyond adolescence and, for some, initiation begins in adulthood, including late adulthood. Drug use has many consequences beyond the potential for addiction and other problematic use. Drug use is associated with increased risk of HIV exposure due to physiological, cognitive, social and/or emotional effects and the use of injection equipment to use drugs constitutes a substantial risk for HIV acquisition. In addition, drug use is associated with other comorbidities such as mental disorders and acquisition of infectious disease such as viral hepatitis, as well as risky behaviors, such as violence, criminal activity, and impaired driving.

Alcohol is the most widely used psychoactive substance among U.S. adolescents and adults, and alcohol consumption is illegal only for a subgroup of the population (i.e., under-aged drinkers). Initiation of alcohol use can occur as early as pre-adolescence; the highest prevalence of alcohol use occurs in young adulthood. Early initiation of heavy drinking is associated with increased risk for developing an alcohol use disorder and also associated with traffic and other unintentional injuries, homicide, suicide, and poor academic performance. Many of the consequences of alcohol use depend on developmental timing and pattern of exposure or use. For example, alcohol use in women of childbearing age is associated with fetal alcohol spectrum disorders in their offspring. In addition, developmental processes occurring in the brain during adolescence and the sensitivity of these processes to alcohol may be responsible for some of the long-term consequences of adolescent binge drinking. Alcohol use and abuse is one of the factors that thwarts efforts to prevent the spread of HIV infection in individuals who are at risk for acquisition. Alcohol use is associated with increased sexual and HIV risk behaviors and increased susceptibility to HIV acquisition. Alcohol use also interferes with HIV treatment among individuals living with HIV by increasing risk for HIV complications and negatively affecting medication adherence. Thus, prevention of alcohol use and abuse is important to controlling and preventing transmission of HIV.

Individual and environmental factors interact to increase or reduce vulnerability to drug and alcohol use, abuse and addiction; vulnerability can occur at many points along the life course but may peak at critical developmental and life transitions. NIDA and NIAAA encourage research that takes into account the significance of the timing of interventions to understand whether and/or how prevention intervention effects coincide with important developmental, social, traumatic and other life transitions (e.g., puberty; transitions from elementary school to middle school, to high school, to college; entry to the workforce or the military; divorce; or death of a parent, family member, or loved one). In addition, vulnerability to drug and alcohol problems and substance use disorders involves dynamic intrapersonal (e.g., temperament, self-regulation), interpersonal (e.g., family and peer interactions, role expectations) and contextual (e.g., school environment, neighborhood characteristics, cultural and subpopulation norms) influences; therefore it is important for prevention intervention research to target interactions among individuals, social and environmental systems across the life span. Addressing these complex interactions calls for research to test strategies designed to alter modifiable mediators and test the effects on drug and alcohol use initiation, escalation of use and problem use, and the subsequent consequences, such as acquisition and transmission of HIV, drug and alcohol impaired driving, violence and other adverse or risky behaviors and consequences. Alcohol and other substance use problems and disorders can co-occur with other risk behaviors, such as delinquency and criminal behavior, violence (e.g., self-directed, interpersonal, community), mental health problems, academic failure, impaired driving, and sexual and HIV risk behaviors. Research on the prevention of drug and alcohol use and co-occurring risk behaviors and problems is important to the missions of NIDA and NIAAA.

Successful drug and alcohol prevention and HIV prevention programs have utilized a number of theoretical perspectives for predicting differential drug and alcohol use trajectories and elucidating developmentally grounded mediators, or risk and protective factors, amenable to change. Continued progress in prevention research relies on a strong understanding and refinement of successful theories and their application. This FOA encourages research that focuses on improving and refining existing theories as well as developing and testing new theoretical models and approaches informed by basic and behavioral research findings from diverse disciplines.

Research addressing the context of prevention interventions also is of interest, particularly in terms of contextual factors impact on targeted mediators, and intervention delivery, and on the feasibility, acceptability, effectiveness and ultimately the uptake of prevention approaches. Successful alcohol and drug prevention programs have targeted and been delivered in varied contexts, such as schools, healthcare settings, tribal settings, neighborhoods, communities, community service organizations, workplaces, and businesses. Drug, alcohol, impaired driving, and HIV prevention interventions have been most successful when delivered in contexts that provide ready access to the target population. This FOA seeks research efforts to develop and test new contexts, modalities and methods for intervention delivery, as new contexts and modalities for access and use of alcohol and drugs become evident (e.g., social media), new technologies for intervention delivery develop (e.g., eHealth, mobile technologies, social media), and new service delivery settings and processes emerge.

Targets for drug or alcohol prevention interventions can be classified according to level of risk: universal, selective, or indicated. Universal prevention interventions are targeted to the general public or to an entire population group, such as all children in a school, all adults in a workplace. 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 parents in the criminal justice system, youth in the child welfare system, adults taking opiate analgesics for chronic pain, and young minority men who have sex with men. Indicated prevention interventions are targeted to individuals or subgroups that are identified as having non-clinical but detectable signs or symptoms foreshadowing an alcohol or other substance use disorder; they also may be individuals whose substance use is episodic but problematic as in the case of elevated HIV sexual risk among stimulant users or driving under the influence of alcohol or drugs. 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. This FOA encourages intervention research in all categories.

Universal alcohol prevention interventions are classified as: 1) individually targeted behavioral interventions that include messages, information, norms clarification, social support and other strategies targeted to the individual; and, 2) environmental intervention strategies, which seek to change aspects of the environment in which individual choices are made (e.g., legal restrictions and policies prohibiting selling alcohol to minors). The methods for implementing the two kinds of strategies and the methods to study their effects are quite distinct. This announcement encourages research on both individual and environmental alcohol strategies. An area of particular interest to NIAAA is research on prevention interventions to reduce driving while intoxicated (DWI) and/or impaired driving. Research findings have suggested the potential of prevention programs to reduce DWI and impaired driving and resulting injuries. Multiple prevention strategies, including improved laws, enhanced enforcement, improved public transportation, greater public awareness and changes in social norms have contributed to reductions in the prevalence of driving while alcohol impaired. Despite progress in reducing the prevalence of DWI in the last several decades, more comprehensive efforts may be needed. The associations between risky driving, alcohol and drug use, and DWI suggest a constellation of risk-taking behaviors; there is interest in prevention intervention studies that incorporate and test both individually targeted and environmental strategies to reduce risky and impaired driving.

To advance the field, novel prevention interventions must build on basic science findings from diverse disciplines. Opportunities exist to incorporate neurobiological, genetic and physiological measures to better understand the impact of prevention interventions on individual functioning across the course of development. Furthermore, because of recent advances in a number of disciplines, important opportunities exist to build upon findings from drug and alcohol use etiology and epidemiology research and the fields of human development, neuroscience, biology, psychology, sociology, anthropology, communications, technology, economics, computational science and systems science. An interdisciplinary approach to prevention, with research teams comprised of scientists bringing complementary expertise and critical and innovative research paradigms, will strengthen prevention efforts. Studies addressing the unique opportunities to examine the interaction between biological, environmental, intrapersonal and interpersonal variables in the context of the design and implementation of prevention research need to be developed and tested. In addition, investigators are strongly encouraged to integrate the perspectives of prevention practitioners and implementers meaningfully into the research process from its inception to ensure that prevention interventions and practices meet real-world needs and realities and to foster implementability and sustainability.

This FOA is issued during a time of rapid and significant policy shifts across the nation. Transformations in the healthcare environment open new opportunities for increasing integration of prevention services, including greater attention to the prevention of drug and alcohol use, misuse and disorders. Shifts in healthcare policy as well as corresponding changes in healthcare delivery systems provide an opening to implement alcohol and drug abuse prevention in a wide variety of medical settings (e.g., hospitals, academic medical centers, Federally Qualified Health Centers) and may also increase opportunities to deliver prevention intervention services in specialty care settings (e.g., sexually transmitted infection (STI) clinics, mental health treatment settings, and pain or physical rehabilitation settings). Despite the potential for new models to integrate and deliver prevention services in healthcare settings, evidence of the effectiveness of such models is limited at this time. There is a need for research on models and strategies for integrating prevention interventions and services within healthcare settings. Both NIDA and NIAAA have an interest in feasibility and pilot studies that will contribute to expanding the knowledge base in this area.

The changing marijuana policy landscape and more permissive policies pertaining to medicinal, recreational and other use of marijuana is bringing about new challenges for prevention efforts. While NIDA will continue to support research that studies critical issues related to preventing the use of all drugs, the Institute is particularly interested in research on prevention interventions that explicitly address shifts in recent and future marijuana policies. There also is interest in prevention strategies that address the simultaneous use of marijuana with alcohol and other licit and illicit drugs.

This FOA provides support for testing and evaluating the feasibility and acceptability of novel approaches to improving drug and alcohol prevention interventions, obtaining estimates of participation and retention, designing and testing measures, and obtaining preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) prevention intervention or prevention services study. Long-standing priorities for NIDA and NIAAA include innovative approaches for addressing health disparities, particularly in vulnerable and at-risk populations. NIDA priorities include medical settings and healthcare systems, juvenile justice and criminal justice populations, youth in the child welfare and foster care systems, children of parents in the criminal justice system, military personnel and their families, brief prevention interventions, physical activity, the built environment, and HIV prevention in high risk populations, particularly among non-injection drug users and men who have sex with men (MSM). Priorities for NIAAA include underage drinking, driving while alcohol impaired, college-age binge drinking, negative birth outcomes associated with alcohol use, such as fetal alcohol spectrum disorders, military personnel and their families, and prevention of HIV in MSM, heavy drinking, and binge drinking populations. NIDA and NIAAA both are interested in combined HIV biomedical and behavioral prevention interventions and integration of drug and alcohol prevention services into HIV and STI prevention and treatment settings, as well as interventions that prevent conditions which promote HIV and substance use risk.

The following sections describe examples of prevention research areas of specific interest to NIDA and NIAAA. 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 and NIAAA. Potential applicants are strongly encouraged to contact NIDA and NIAAA Scientific/Research staff to discuss possible research concepts prior to submitting an application (see Section VII below).

A. Pilot and Feasibility Testing of New, Revised, or Adapted Interventions

This FOA is appropriate for pilot testing of new, revised, or adapted prevention interventions targeting drug or alcohol use or abuse and drug- and alcohol-related risk behaviors, such as impaired driving, HIV acquisition and transmission, and other risk behaviors. This mechanism is intended for research that aims to test: (1) novel prevention interventions based on translation of basic science findings; (2) theoretically-based evaluations of prevention interventions in use that are untested; (3) novel approaches to taking efficacious interventions to scale in broad population settings, such as service system settings, medical settings and health care systems; (4) prevention interventions in settings not previously studied; or (5) effects of combining multiple efficacious or effective interventions in ways that have a likelihood of demonstrating additive or multiplicative effects.

This FOA encourages pilot and feasibility research on the following and related topics:

Feasibility and pilot testing of screening and universal brief interventions models to prevent alcohol and drug use for delivery in medical settings and the broader healthcare system (e.g., primary care, obstetrics and gynecology, pediatrics, adolescent medicine, and emergency medicine)

Development and pilot testing of novel drug and alcohol use prevention interventions for delivery in healthcare settings, particularly settings that serve persons at high risk for initiating alcohol and drug use or at risk for problem use, such as pain and rehabilitation clinics or community behavioral healthcare facilities.

Development and testing of structural and environmental intervention strategies and multi-level strategies to prevent alcohol and drug use and abuse, HIV infection, and drug and alcohol related risk behaviors across health, justice, education and social service settings and systems

Use of biological targets and basic research findings (e.g., from neuroscience, genetics) as well as findings on learning and motivation to guide development, improvement, and pilot testing of innovative prevention interventions and strategies

Translation of findings on self-regulation and impulsivity to develop, improve and pilot test prevention messaging content and delivery strategies

Studies that evaluate application of new HIV prevention modalities (e.g. novel biomedical approaches, such as PrEP, PEP, home testing) in drug and alcohol using populations

Studies that evaluate the application of new technologies for delivering, implementing and testing prevention interventions

Studies of interventions to reduce drug and alcohol use related intentional and unintentional injuries, accidents, motor vehicle crashes, overdoses and violence, including suicide, interpersonal violence, and community violence

Development and pilot testing of novel drug and alcohol prevention interventions and adaptations of efficacious interventions in sexual minority, ethnic/racial minority and other health disparity populations as well as in other vulnerable populations at particular risk for problem drug or alcohol use or for alcohol or other substance use disorder (e.g., children of substance using parents, underage drinkers)

Studies that test integrated drug/alcohol prevention and HIV prevention and treatment strategies in a variety of healthcare, social service and educational settings

B. Feasibility Testing for Prevention Services Research

An important emphasis of NIDA’s and NIAAA's prevention research programs is answering prevention services research questions. Prevention services research focuses on system- and organizational-level processes and mechanisms associated with the uptake, selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated prevention interventions. Such research also examines domains pertaining to the availability, utilization, appropriateness, and cost-benefit/cost-effectiveness of prevention interventions and services. In preparation for large scale prevention services research projects, pilot studies often are needed to empirically validate the feasibility of intervention and implementation protocols, implementation and fidelity measures and monitoring systems, as well as training and implementation methodologies. Such pilot studies would be appropriate for support under this FOA.

This FOA encourages feasibility research on the following and related topics:

Evaluating the feasibility of integrating drug and alcohol prevention interventions and strategies into pre-existing infrastructures and systems such as medical settings (e.g., primary healthcare, obstetrics and gynecology, pediatrics, adolescent medicine, HIV/STI clinics, AIDS service organizations, emergency departments) and other service systems, particularly where high risk populations are found (e.g., child welfare, foster care, justice)

Developing and feasibility testing models for implementing efficacious and effective prevention interventions in real world service settings and systems, such as healthcare, schools, workplaces, justice, military

Developing and feasibility testing innovative strategies and models for improving key implementation processes: adaptation and customization processes, implementation fidelity, sustainability

Determining the feasibility of innovative strategies for training and retaining prevention personnel

Evaluating the feasibility and acceptability of integrating screening and combined biomedical and behavioral strategies for HIV prevention in populations where alcohol and drug use often occurs

Feasibility and pilot testing innovative technology and communication strategies and platforms (e.g., eHealth, mobile and portable devices, social media) for integrating and delivering efficacious prevention interventions into healthcare and other settings and infrastructures, such as schools, workplaces, recreational settings

Developing and pilot testing innovative strategies and models that address organizational and/or workforce factors, or financing to improve implementation and sustainability of evidence-based drug abuse prevention interventions in systems and settings.

Special Considerations

Women and Gender: Accumulating epidemiological research indicates that risk and protective factors for drug and alcohol use and drug and alcohol 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 and NIAAA are 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, feasibility and pilot test 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, feasibility and pilot test interventions for high risk, vulnerable and other select female populations, including pregnant girls/women, girls who experience trauma, girls/women who experience violence (e.g., intimate partner violence, sexual assault), 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: https://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.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.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA and NIAAA strongly encourage 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).

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.

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 involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a delayed onset study record.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

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.

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.

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).

For this particular announcement, note the following: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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? Is there a strong scientific premise for the project? 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?

In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?

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?

In addition, for applications proposing clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications proposing clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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?

In addition, for applications proposing clinical trials: Does the application adequately address the following, if applicable:

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications proposing clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Specific to applications proposing clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

Not Applicable

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.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

As part of the scientific peer review, all applications:

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

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

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

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.

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials by law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Jacqueline Lloyd, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-8892
E-mail: [email protected]

Beverly A. Ruffin, Ph.D
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-0281
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]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
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 Part 75.