Department of Health and Human Services

Part 1. Overview Information

Key Dates

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Areas supported by this FOA include research to inform the generation and refinement of novel substance abuse treatment and prevention interventions, modules, or adjuncts to existing treatments and prevention interventions that seek to target and modulate behavioral and/or neurobehavioral processes (e.g., impulsivity, risk-taking propensity, sensation and novelty seeking, distress tolerance, delay discounting, self-regulation, stress reactivity) in adolescents and young adults (up to 25 years old). Additionally, this FOA will encourage studies to include theoretical links that explore the relationship(s) between neural circuitry and treatment and prevention intervention effects, and in particular, how behavioral targets might be affected by treatment and prevention interventions, and how that might be used to improve targeted treatment and prevention intervention development for alcohol, tobacco, and other drugs (ATOD), and associated reduction in morbidity and mortality.

Background

CRAN Initiative. This Funding Opportunity Announcement (FOA) is part of a trans-NIH initiative known as Collaborative Research on Addiction at NIH (CRAN; http://addictionresearch.nih.gov/ ). The mission of the CRAN is to provide a strong collaborative framework to enable the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), and the National Cancer Institute (NCI) to integrate resources and expertise to advance addiction research and public health outcomes.

Novel Behavioral Targets. Recent compelling data on adolescent drug treatment suggest that behavioral targets (e.g., impulsivity, delay discounting, risk-taking propensity, sensation and novelty seeking, distress tolerance, self-regulation, stress reactivity), as well as the neurocircuitry that underlies these processes, play an important role in the initiation and onset of alcohol, tobacco, and other drug use disorders, as well as prevention intervention response and the course of treatment, including treatment drop-out, relapse, and treatment outcome. For example, research has demonstrated that the changes that occur in the brain have direct links to actual behavior change that occurs during treatment. These noted changes have been shown to be important across substance abuse problems and comorbid psychiatric conditions. Research on delay discounting, for example, has shown that targeting working memory through various tasks decreased delay discounting. Despite these scientific advances, there is a paucity of developmentally-appropriate approaches that target these processes. Because these behavioral targets can be measured in various ways (e.g., imaging, laboratory measures, physiological indices), and given their multidimensional and predictive nature, they may lend themselves to be evaluated as substance abuse treatment and prevention outcomes through the development and testing of novel treatment and prevention interventions, modules, and/or adjuncts that specifically target these behavioral processes.

Translational research is one way to guide the development and implementation of substance abuse treatments and prevention interventions. It is recommended that applications use a translational framework aimed at applying basic science to the development of treatments for disorders in clinical populations and prevention interventions for universal and at-risk populations. Technological advances have made it possible to measure the biological impact of pharmacological, behavioral and integrative treatments and prevention approaches on behavioral targets. Effective treatment and prevention interventions for SUDs have the potential to reduce associated morbidity and mortality of unintentional (overdose and other accidental events) and intentional injury (i.e., suicide attempts and deaths). Accordingly, applicants are encouraged to include assessment of suicidal behavior as a novel comorbid outcome. This FOA seeks to harness advances in technology to conduct translational research aimed at creating and augmenting treatments and prevention interventions that improve specific behavioral targets, in turn, increasing the efficacy of substance abuse treatment and prevention interventions for addressing and preventing adolescent substance abuse.

Objectives and Scope

The FOA is aimed at understanding mechanisms as well as the development of novel treatments and prevention interventions that directly target and modulate behavioral mechanisms relevant to substance use and abuse, including but not limited to impulsivity, risk-taking propensity, sensation seeking, distress tolerance and delay discounting, self-regulation stress reactivity. This can be achieved through investigations using neurobiological and behavioral mechanisms, particularly those that underlie initiation of substance use, progression to abuse, as well as research designed to improve the translation of existing knowledge into strategies for the treatment and prevention of substance abuse (e.g., neurocircuitry associated with suicidal behavior). This announcement encourages research aimed at the development and testing of novel behavioral treatment and prevention interventions or combined behavioral and pharmacologic treatments that specifically target and modulate behavioral targets and associated neurocircuitry underpinnings in adolescent populations, with or without psychiatric comorbidity. All applications should address a theoretical rationale for behavioral targets and neurocircuitry relevant to understand the treatment and prevention of substance abuse, and the hypothesized ways in which these target mechanisms are modulated throughout the course of treatment or by prevention interventions. Additionally, research should inform the next generation of behavioral and/or integrative treatment and prevention interventions for substance use and abuse or expand existing treatments and prevention interventions.

This FOA facilitates applications that are analogous to Stage II and III (see https://grants.nih.gov/grants/guide/PA-files/PA-13-077.html ), treatment research to test efficacy, conduct clinical trials, examine mechanisms of behavior change, optimize combinations, and/or sequencing of behavioral, combined, sequential, or integrated behavioral and pharmacological treatments.

Neurobiological research on brain plasticity has demonstrated that changes in the brain have resulted from actual behavior change that occurs during substance abuse treatment. Treatment research should incorporate basic research findings on the malleability of behavioral targets. Studies linking behavioral treatments and neurocircuitry for drug abusing adolescents across the spectrum of abused drugs may provide drug abuse treatment researchers, practitioners and other providers with important data and new approaches for developing and/or adapting treatment interventions.

To advance the field, novel prevention interventions must build on basic science findings from diverse fields. 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. Important opportunities exist to build upon findings from substance abuse etiology and epidemiology and from multiple fields of human behavior and development including biology, neurobiology, psychology, sociology, anthropology, communications and technology. An interdisciplinary approach conducted by teams comprised of researchers bringing diverse and complementary expertise and innovative research paradigms will strengthen prevention intervention research efforts. Of importance are studies that examine the interaction between neurobiological, biological, interpersonal, intrapersonal, and environmental factors in the design refinement and testing of prevention interventions.

Areas of Interest

The following are intended only as conceptual examples of the types of topics and approaches and should not be regarded as a call to pursue any specific line of investigation:

Research to identify behavioral targets and generate interventions designed to modify these targets in adolescents with or at risk for developing substance use disorders. For example, these potential targets include but are not limited to, impulsivity, delay discounting, risk-taking propensity, sensation and novelty seeking, distress tolerance, self-regulation, reward circuitry, stress reactivity.

Research aimed at testing promising: 1) new stand-alone treatments or prevention interventions; 2) adjunctive treatment or prevention interventions to boost the efficacy of existing interventions; 3) promoting adherence to existing efficacious interventions

Research to test modules to be used in conjunction with evidence-based treatments for substance use disorders or prevention interventions based on modulating impulsiveness and risky choice

Research to examine long-term effects of prevention interventions delivered earlier in life to determine effects on suicidal ideation and behaviors in adolescence, and the potential mediators of these benefits

Research to include neuroimaging as a marker of change in the targeted mechanisms for treatment or prevention interventions

Research to improve treatments by elucidating the ways in which medications that may enhance context-specific learning can be used to potentiate the effects of specifically targeted behavioral processes and their associated neurobiological mechanisms

Studies to identify and increase understanding of mediating and moderating effects of neurobiological processes on the efficacy and impact of treatment and prevention interventions

Studies to examine the impact that interventions may have on neurobiological functions and processes. For example, studies to elucidate the extent to which individuals become less impulsive during the course of targeted substance abuse treatment and prevention interventions, measure the relationship between impulsivity, initiation of substance use, progression from use to abuse, and other hypothesized morbidity (e.g., mania) to examine the hypothesized biological mechanisms of impulsivity

Studies to test treatment guided by research findings that indicate specific neurobiological circuitry and/or processes related to putative behavioral mechanisms to increase community participation and enhance invention potency

Research designed to better integrate specific processes linked with a natural inclination or risk toward novelty, arousal, emotion regulation and excitement in adolescence into a novel or adapted treatment or prevention approach

Studies to test novel stand-alone treatments, treatment modules, or prevention interventions to target distress tolerance and other targets to increase community participation and enhance intervention potency

Studies of neurodevelopment, self-regulation, impulsivity, gender differences in personality profiles, behavioral disinhibition and multiple drug experimental designs, and working memory training to inform treatment and prevention intervention development

Studies on adaptive behavioral and/or pharmacological interventions that build upon knowledge of individual (e.g., impulsivity, neurocognitive development) and contextual (e.g., familial, intergenerational, peer) factors and characteristics

Studies that examine the continuum of risk-taking, and ways in which these aspects can be optimized for treatment and prevention interventions

Research on self-regulation or self-management and how impulsivity influences behavior over time and across circumstances in treatment and prevention intervention studies

Research to disentangle the extent to which changes in behavioral targets occur as a function of the changes that happen in treatment versus abstinence or may result from prevention interventions

Studies to examine neurocognitive and emotional responses to treatment and prevention communication messages and to develop or refine messages that are tailored to individual neurobehavioral vulnerabilities, such as impulsivity, risk-taking propensity, sensation and novelty seeking, distress tolerance, self-regulation, stress reactivity.

Studies that use adaptive and other methodologies that allow for systematic examination of individual and combined program components to determine mechanisms of effects of treatment and prevention interventions and to determine program components most responsible for program effects.

Using basic science research and emerging technologies to explicate experimental and theoretically derived under-explored mechanisms of neurobiological risk, and to facilitate understanding of the biological and neurobiological effects of social, emotional, and behavioral treatment and preventive interventions

Studies that use findings on learning styles, cognitive strategies, and neurocognitive functioning to develop, refine and test targeted treatment and prevention strategies

Notes on Priorities

Applicants are encouraged to propose projects related to multiple substances, including polysubstance use or abuse. Consistent with the overall goals of the CRAN initiative, such projects will receive programmatic priority over projects focused on a single substance.

Applications should address a theoretical rationale for behavioral targets and neurocircuitry relevant to understand the treatment and/or prevention of substance use and abuse and its associated morbidity and mortality, and the hypothesized ways in which these target mechanisms are modulated throughout the course of treatment and prevention interventions.

While the testing of targeted treatments and prevention interventions may be done in randomized clinical trials, other methodologies may be used as appropriate (e.g., adaptive designs, multiphase optimization strategies).

Section II. Award Information

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

• 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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator)

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

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.

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

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

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

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

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, 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.

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: All applications must address how the proposed investigations are relevant to the understanding, treatment and/or prevention of substance abuse or how they may be applicable to universal, at-risk and substance abusing populations. Any application under this announcement must include pilot data and provide a justification for which the elements of proof-of-principle has been established and demonstrated with sufficient signal of target engagement to justify the proposed study.

In addition to a translational framework aimed at applying basic science to the development of treatments for substance use disorders in diverse clinical populations, it is expected that behavioral mechanisms and targets be well-specified and precisely defined, and assessments psychometrically valid and reliable (e.g., innovative tools including sensor technology and mobile prompts), and include common data elements, where appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide , with the following modification:

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

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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 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.

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 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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

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

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 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 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?

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 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?

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

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

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) convened by the Center for 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to 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.

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 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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

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

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

Scientific/Research Contact(s)

Will M. Aklin, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-3207
Email: [email protected]

Geetha Subramaniam, M.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0974
Email: [email protected]

Brett Hagman, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)]
Telephone: 301-443-0638
Email: [email protected]

Annette Kaufman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6706
Email: [email protected]

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)

Deborah Wertz
National Institute on Drug Abuse (NIDA)
Telephone: 301-649-1715
Email: [email protected]

Jacquelyn Boudjeda
National Cancer Institute (NCI)
Telephone: 240-276-6312
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

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.