Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials (R34)

Activity Code

R34 Clinical Trial Planning Grant Program

Announcement Type

Reissue of PA-09-146

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number
PA-12-171
Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279, 93.273   

Funding Opportunity Purpose

This FOA for R34 applications seeks to support: (a) pilot and/or feasibility testing of new, revised, or adapted preventive intervention approaches targeting the initiation of drug and alcohol use, the progression to abuse or dependence, and the acquisition or transmission of HIV infection among diverse populations and settings; and (b) pre-trial feasibility testing for prevention services and systems research. This R34 mechanism does not support the development of intervention protocols, manuals, or the standardization of protocols. It is expected that research conducted via this R34 mechanism will consist of early stage efficacy, effectiveness or services research that will provide intervention pilot and/or feasibility data that is a pre-requisite for submitting larger drug or alcohol abuse and/or drug- or alcohol-related HIV prevention intervention studies.  Particularly highlighted are prevention interventions targeting the health care system.

Key Dates
Posted Date

April 23, 2012

Open Date (Earliest Submission Date)

May 16, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

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

AIDS Application Due Date(s)

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

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

May 8, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

This FOA for R34 applications seeks to support: (a) pilot and/or feasibility testing of new, revised, or adapted preventive intervention approaches targeting the initiation of drug or alcohol use, the progression to abuse or dependence, and the acquisition or transmission of HIV infection among diverse populations and settings; and (b) pre-trial feasibility testing for prevention services and systems research. This R34 mechanism does not support the development of intervention protocols, manuals, or the standardization of protocols. Rather, this mechanism is intended for research that aims to test: (1) novel preventive interventions based on translation of basic science findings; (2) preventive interventions in use that are untested; (3) novel approaches to taking efficacious interventions to scale in broad population settings; (4) novel preventive 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. Particularly highlighted are prevention interventions targeting the health care system. It is expected that research conducted via this R34 mechanism will consist of early stage efficacy, effectiveness or services research that will provide intervention pilot and/or feasibility data that is a pre-requisite for preparing and submitting larger drug or alcohol abuse and/or drug- or alcohol-related HIV prevention intervention efficacy and effectiveness trials, or prevention services and systems research studies. Efficacy trials are designed to establish the impact of a preventive intervention approach 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 studies are typically conducted to gather evidence of feasibility and potential efficacy/effectiveness in advance of proposing full-scale trials.

Prevention services research forms the link between efficacy and effectiveness research on prevention interventions and adoption of evidence-based prevention practice in real world settings. In preparation for large scale prevention services and systems research projects, pilot studies are often needed to empirically test and establish evidence for the feasibility of intervention protocols, implementation and fidelity measures, or training and implementation methodologies.  Applications to this R34 FOA are not required to present pilot data in support of the proposed 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 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 for use in later, larger-scale studies should not be submitted under this FOA. However, they may be appropriate for submission to the R21 FOAs on Drug Abuse Prevention Intervention Research (PA-11-312)  and Epidemiology and Prevention in Alcohol Research (PA-11-018).

Significance

Significant progress has been made in understanding effective approaches to prevention of drug and alcohol abuse over the past few decades, in part because of the careful attention given to understanding basic developmental processes involved in the transition to drug and alcohol use, abuse and dependence. Drug and alcohol abuse and dependence are disorders that 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 dysfunction.

While the initiation of licit and illicit drug use, a necessary precursor to abuse and dependence, grows dramatically during the adolescent years, this behavior is preceded by proximal and distal biological, psychological, social, and environmental precursors originating as early as the prenatal period. Furthermore, initiation and progression of misuse of licit and use of illicit drugs extends well beyond adolescence and, for some, begins in adulthood, including late adulthood. Drug use has many consequences beyond the potential for dependence and addiction. Drug use is associated with increased risk of HIV exposure due to physiological, cognitive, social and/or emotional effects and constitutes a substantial risk for HIV acquisition.

Alcohol is the most widely used substance among U.S. adolescents and adults, and alcohol consumption is only illegal in a subgroup of the population (under-aged drinkers).  Initiation of alcohol use can occur as early as pre-adolescence, with the highest prevalence occurring in young adulthood.  Early initiation of heavy drinking is associated with increased risk for developing an alcohol use disorder.  Many of the consequences of alcohol use depend on developmental timing and pattern of use or exposure.  For example, binge drinking in women of childbearing age is associated with fetal alcohol spectrum disorder in the 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.

The life course developmental perspective suggests that individual and environmental factors interact to increase or reduce vulnerability to drug and alcohol use, abuse and dependence. Vulnerability can occur at many points along the life course but peaks at critical life transitions. Thus, prevention researchers should recognize the significance of timing interventions to coincide with important biological transitions, such as puberty; normative transitions, such as moving from middle to high school; social transitions, such as dating; and traumatic transitions, such as the death of a parent, spouse or significant other. In addition, because vulnerability to drug and alcohol abuse involves dynamic intrapersonal (e.g., temperament), interpersonal (e.g., family and peer interactions, role expectations) and environmental (e.g., school environment, neighborhood characteristics, cultural and subpopulation norms) influences, prevention intervention research must target interactions between individuals and social systems across the life span. To address this complexity, intervention research needs to test strategies designed to alter modifiable mediators to determine which are most related to drug and alcohol use initiation and escalation and its consequences such as acquisition and transmission of HIV. Mediating conditions often are nested in particular settings or social groupings and effective interventions need to take these factors into consideration. Drug and alcohol use, abuse, and dependence often co-occur with delinquency and criminal behavior, interpersonal violence (bullying and victimization), mental health problems, school failure, sexually transmitted infections (including HIV), and reproductive health problems. Therefore, understanding the prevention of co-occurring problems and their contribution to elevated levels of substance use risk is important to NIDA's and NIAAA's mission.

Successful drug abuse and drug-related HIV prevention programs have utilized a number of theoretical perspectives for predicting differential drug use trajectories and elucidating developmentally grounded mediators, or risk and protective factors, amenable to change. Testing of new intervention perspectives based on an understanding of emergent basic behavioral and biomedical research is encouraged, along with integration of emerging biomedical agents for HIV prevention. Resulting research has focused on prevention approaches involving positive modification of various precursors of substance use, such as emotional dysregulation, sensation-seeking, aggressive behavior, academic problems and failure, poor social skills, misperceptions of social norms, poor parent-child attachment, and inappropriate parental expectations and responses. Many of these same approaches have been incorporated into HIV prevention interventions in populations where drug use or risk for drug use is highly prevalent. HIV prevention efforts may benefit from further consideration of concepts and methods which have proven useful for drug abuse prevention, in general, with attention to appropriate developmental (e.g., sexual debut, exploration of sexual orientation and identity, change in relationship status) and contextual (e.g., cultural practices and social norms, background prevalence of sexually transmitted infections) factors. Because theoretical grounding of prevention programs is an essential feature for their success, further progress in prevention research relies on a stronger understanding and refinement of successful theories and their application and potentially the development of new theoretical approaches or meta-theories.

Prevention context impacts upon the feasibility, acceptability, and effectiveness of prevention approaches. Successful programs have intervened in varied contexts, such as schools, health care settings, tribal settings, community service organizations, and workplaces. Substance use and related HIV prevention research is most successful when the intervention delivery contexts provide ready access to the target population. That is, the more central the delivery context is to the target audience's existing life routines, the more likely the intervention and associated research will be able to recruit and retain members of the target population. Efforts to develop new modalities and methods for intervention delivery are needed, as new contexts for substance use become evident (e.g., social media), new technologies for intervention develop (e.g., eHealth, mHealth), and new service delivery settings emerge.

Audiences or targets for prevention interventions are generally classified into one of three categories depending on level of risk: universal, selective, or indicated. Universal prevention interventions are targeted to the general public or to a whole population group, such as all children in a school. Selective prevention interventions are targeted to individuals or subgroups of the population with defined risk factors for the development of substance abuse, such as children of drug and alcohol abusers, children of parents in the criminal justice system, youth in the child welfare system, adults receiving 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 drug abuse, dependence, and addiction; 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.

It is important to recognize populations where problem drug or alcohol use is emergent, particularly where co-morbidities or adverse consequences also are evident. Prescription drug abuse at various points in the life course, and methamphetamine initiation in middle age among men who have sex with men are two domestic examples of this. Emergent epidemics of opiate injection in the former Soviet Bloc, and various forms of substance use along international trafficking routes in Asia and Africa represent some international examples.

To advance the field, novel interventions must build on basic science findings from diverse fields. Opportunities exist to incorporate neurological, 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 abuse etiology and epidemiology research and the fields of human development, biology, neurology, criminology, psychology, sociology, anthropology, and communications and technology. An interdisciplinary approach to prevention, with research teams comprised of scientists bringing complementary expertise and critical and innovative research paradigms, will strengthen prevention efforts. In addition, studies addressing the unique opportunities to examine the interaction between biological, interpersonal, intrapersonal, and environmental variables in the context of the design and implementation of prevention research need to be developed and tested.

Specific Areas of Research Interest

This FOA for R34 applications seeks to support: (a) pilot and/or feasibility testing of new, revised, or adapted preventive intervention approaches targeting the initiation of drug and alcohol use, the progression to abuse or dependence, and the transmission of HIV infection among diverse populations and settings; and (b) pre-trial feasibility testing for prevention services research. This R34 mechanism does not support the development of intervention protocols, manuals, or the standardization of protocols. It is expected that research conducted via this R34 mechanism will consist of early stage efficacy, effectiveness or services research that will provide intervention pilot and/or feasibility data that is a pre-requisite for preparing and submitting larger drug or alcohol abuse and/or drug- or alcohol-related HIV prevention intervention studies.

This R34 mechanism provides resources for testing and evaluating the feasibility, tolerability, acceptability and safety of novel approaches to improving drug and alcohol use preventive interventions, and for obtaining preliminary data needed as a pre-requisite to a larger-scale (efficacy or effectiveness) preventive intervention or prevention services study. For NIDA, long-standing priorities include innovative approaches for addressing health disparities and criminal justice populations.  Emerging areas of priority for NIDA include clinical medical settings (or the broader health care system), children in the welfare system, children of parents in the criminal justice system, the military and their families, brief interventions, physical activity, the built environment, and HIV prevention among non-injection drug using populations. Priorities for NIAAA include innovative approaches for addressing health disparities, prevention of underage drinking and negative birth outcomes associated with alcohol use, such as fetal alcohol spectrum disorder.  

NIDA's and NIAAA's drug and alcohol prevention research programs are comprehensive in nature and fully reflect the prevention research mission, objectives, and study areas advanced by the Department of Health and Human Services and the National Institutes of Health. Examples of R34 topics are given below.  These are illustrative and not exhaustive; investigators should not view the examples provided as limiting the areas of research of interest to NIDA and NIAAA.

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

The R34 mechanism is appropriate for pilot testing of new, revised, or adapted preventive interventions targeting drug or alcohol use or abuse, or prevention of HIV acquisition/transmission. This R34 mechanism does not support the development of intervention protocols, manuals, or the standardization of protocols. Rather, this mechanism is intended for research that aims to test: (1) novel preventive interventions based on translation of basic science findings; (2) preventive interventions in use that are untested; (3) novel approaches to taking efficacious interventions to scale in broad population settings, such as clinical medical settings or the broader health care system; (4) novel preventive 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.

Examples of possible pilot and feasibility studies include, but are not limited to:

B. Feasibility Testing for Prevention Services Research

An important emphasis of NIDA’s and NIAAA's prevention research programs is on prevention services research questions.  Prevention services research forms the link between efficacy and effectiveness research on prevention interventions and adoption of evidence-based prevention practice; as such it involves identifying and determining how an intervention's internal and external features contribute to efficacy and effectiveness in services settings. Examples of internal features are: content, implementation strategies, fidelity, dosage, delivery setting and implementer training. Examples of external features are: exposure to other programs, media, enforcement of regulations and laws related to drug and alcohol use and community norms pertaining to drug and alcohol use and abuse. Questions around features that concentrate on the availability, organization, management, financing and sustainability of prevention interventions fall into the broad category of prevention services research. In preparation for large scale prevention services research projects, pilot studies are often needed to empirically test or validate in advance the feasibility of intervention protocols, implementation and fidelity measures and monitoring systems, or training and implementation methodologies. Such studies would be most appropriate for research under this R34 pilot project mechanism.

Examples of possible feasibility studies include, but are not limited to:

Special Considerations

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

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Applicants may request direct costs of up to $450,000 for three years. Although variations from year to year are permissible, in no case may any year be more than $225,000 in direct costs, and total direct costs for the entire project period may not exceed $450,000.

Award Project Period

The maximum period is 3 years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

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

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

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

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

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

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

Jacqueline Lloyd, Ph.D.
Health Scientist Administrator
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 5166
Bethesda, MD 20892-9589
Telephone: (301) 443-8892
FAX: (301) 443-2636
E-mail: lloydj2@nida.nih.gov

Judith A. Arroyo, Ph.D.
Minority Health and Health Disparities Coordinator
Office of the Director
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2011
Bethesda, MD 20892-9304
Telephone: (301) 402-0717
Fax: (301) 443-7034
Email: Jarroyo@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. ICs should insert IC-specific regulations if applicable.


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