Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose

The purpose of this PAR is to advance research on various topics that fall within NIAAA’s Division of Treatment and Recovery (DTR). DTR’s research interests are wide-ranging but typically encompass broad categories such as medications development; behavioral therapies, including mechanisms of behavioral change (MOBC); recovery; translational research; and innovative methods and technologies for alcohol use disorder (AUD) treatment. Other areas of interest include topics focusing on special-emphasis and underserved populations. Specific examples include research related to health disparities, age, sex/gender, race and ethnicity, co-occurring disorders, and military populations.

Background

AUD is a global health problem, affecting more than 76 million adults worldwide, including over 14.5 million Americans, and resulting in a myriad of medical, psychological, social, economic, and personal problems. AUD ranks among the leading causes of decreased disability-adjusted life-years and ranks third in preventable causes of death in the United States. The total economic cost to society in the United States is a staggering $249 billion each year. Research is needed to develop effective treatments for AUD and to better understand the complex nature of recovery across a broad range of topic areas and populations, as described in detail below.

Research Objectives

Medications Development

During the past 2 decades, progress has been made in developing efficacious medications and behavioral therapies to treat AUD. Currently, there are three medications approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence: disulfiram, oral and long-term injectable naltrexone, and acamprosate. In addition, nalmefene recently was approved in Europe. However, given the heterogeneous nature of AUD, many patients show only limited or no response to these medications. Because of this, developing and evaluating new, more efficacious and safe medications remains a top priority.

All studies must be conducted in humans. Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

• Evaluate the efficacy and safety of experimental medications (either repurposed or novel compounds) that bind to new targets to treat AUD.
• Assess the efficacy and safety of medications to treat comorbid AUD and psychiatric (e.g., posttraumatic stress disorder [PTSD]) disorders.
• Determine who responds favorably during the trial by exploring clinical and behavioral characteristics and biological markers.
• Explore new human laboratory paradigms that will help predict efficacy in clinical trials of experimental medications.
• Leverage relationships with pharmaceutical and biotechnology companies to identify new compounds for testing in clinical trials.

Behavioral Therapies

Several behavioral therapies have shown efficacy in treating AUD. These include cognitive behavioral therapy, motivation enhancement therapy, twelve-step facilitation, brief intervention, contingency management, community reinforcement approach, and mindfulness therapy. Although progress has been made in developing a broad menu of treatment options, not all individuals with AUD respond to today’s behavioral therapies. Incorporating new scientific discoveries and technologies into behavioral treatment may improve clinical outcomes and help disseminate different, more effective, treatments in clinical practice.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that evaluate evidence-based behavioral therapies in real-world treatment settings, especially for culturally diverse and special emphasis and underserved populations.

• Use dynamic and person-centered statistical modeling approaches to evaluate how heterogeneity impacts alcohol use behavior within specific AUD treatments.
• Conduct micro-intervention studies to isolate and test the importance of key treatment-related mediators and moderators.
• Develop new and adapt existing interventions for AUD based on emerging findings from research on MOBC.
• Translate evidence-based MOBC best practices into clinical practice.
• Engage in complex research designs (e.g., dismantling studies), which enhance support and provide evidence for the mechanisms underlying established AUD behavioral treatments

Recovery from AUD

Recovery from AUD is complex and highly individualized. NIAAA is interested in research to learn more about the risk and resiliency factors related to recovery and relapse, including the factors that allow some people to recover without receiving formal treatment. This research will inform the development of additional effective treatment interventions, as well as strategies to sustain recovery.

To fully clarify the concept of recovery and to improve consistency across recovery research, NIAAA developed an operational definition of “recovery” from AUD (LINK). The definition involves remission from AUD and cessation from heavy drinking. Moreover, recovery is associated with improvements in dimensions of well-being, quality of life, and biopsychosocial functioning.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

• Explore the neurobiological, psychological, environmental, social, and spiritual factors that influence post-treatment recovery.
• Identify novel mechanisms of behavioral change (MOBC) that help maintain behavior change in recovery (e.g., self-regulation), and evaluate how knowledge about these mechanisms can be applied to recovery.
• Determine the trajectories of recovery in subgroups of people with different cultural and socioeconomic backgrounds, cognitive abilities, and medical histories, including examining gender-related differences in trajectories of recovery within these groups.
• Characterize the relationships among relapse severity, frequency, and timing in the recovery process, including how relapse impacts the potential for long-term recovery and improvement in biopsychosocial functioning.
• Understand the role of understudied mutual support groups, as well as spirituality and religion, in treatment and recovery from AUD.
• Identify the factors associated with so-called spontaneous or “natural” recovery and how these factors can be applied to change the behavior of those in treatment.
• Explore continuing care treatments and interventions that aim to support long-term recovery.
• Define and measure dimensions of functioning and well-being associated with recovery (e.g., which of these dimensions of functioning and well-being are positively vs. negatively associated with recovery? Which of these dimensions of functioning and well-being are the most integral in recovery? To what degree might these functioning measures be feasible in clinical practice?).

Translational Research

Clinical research examines the neurobiological, cognitive, emotional, and genetic processes underlying addiction and offers ways for applying those findings to practice and predicting treatment outcomes.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

• Translate key neuroscience research findings (e.g., neurobiological, cognitive, emotion regulation, and genetic) to develop more effective treatments.

Innovative Methods and Technologies for AUD Treatment and Recovery

New technology (e.g., mobile, computer, and web-based applications) has the potential to expand both the accessibility and effectiveness of a variety of treatments and interventions. Research is needed to further advance digital technology for the diagnosis, intervention, treatment, and maintenance of recovery from AUD. Developing new analytical approaches can be critical for evaluating treatment, such as tracking results in subpopulations of people with AUD, comparing linear and dynamic models of clinical findings, conducting trajectory analysis and growth mixture modeling to capture changes in recovery over time, and developing and implementing adaptive clinical trial designs and statistical analyses.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

• Apply new technology (e.g., mobile devices, computer, web-based applications) to evidence-based behavioral treatments to improve the effectiveness of telemedicine and to reach remote and underserved, vulnerable populations.
• Investigate new ways of capturing real-time data in clinical trials and treatment protocols (e.g., interactive voice response technology, smartphones, and alcohol sensors).
• Explore new analytical methods for evaluating treatment and recovery.

Special-Emphasis Populations

Health Disparities

Research examining disparities in access to and quality of treatment for harmful drinking and AUD typically has not kept pace with other areas of investigation. Thus, there is a need for more research to develop and implement effective treatments for marginalized and vulnerable populations. It is important to understand how the social determinants of health (i.e., environmental, social, cultural, and economic factors) influence outcomes and sustainability of effects. There is a need for greater emphasis on developing novel, accessible, cost-effective, culturally grounded treatment interventions in diverse populations. Special areas of interest also include research examining the role of harmful drinking in creating and exacerbating disparities in the onset, progression, and treatment of other health conditions.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

• Develop and implement effective treatments tailored to populations affected by health disparities in diverse clinical and nontraditional settings.
• Determine how social/cultural factors influence treatment accessibility, effectiveness, and long-term recovery.
• Develop measures to assess care delivery models to better understand the issues underlying disparities (e.g., health literacy, access to health care, confidence in the proximal health system, socioeconomic status, sociocultural beliefs and practices related to alcohol use, multi-morbidity with other health issues, and personal health care).

AUD Patients with Psychiatric Comorbidity

AUD patients often suffer from comorbid psychiatric disorders, such as depression, anxiety, PTSD, insomnia, bipolar disorder, and schizophrenia. This population experiences poorer treatment outcomes, and tends to have higher rates of clinical impairment, psychosocial and medical problems, utilization of health services, and suicide, as well as lower quality of life than patients who suffer from AUD alone. Developing effective personalized treatment strategies is essential in treating multiple disorders. For example, how can treatments be integrated to address both mental health disorders and AUD? How does treatment of one disorder affect the outcome of the other? How do the disorders interact to increase the severity and clinical course of each disorder?

Examples of high-priority research areas appropriate for evaluation include, but are not limited to, investigations that:

• Integrate treatment for co-occurring AUD and mental health conditions to address the heterogeneity that exists among patients. Explore how behavioral interventions and medications can be combined to treat AUD patients with co-occurring PTSD; anxiety; depression; insomnia; and other mental health conditions, including timing of interventions (serial vs. concurrent), separate vs. fully integrated treatment, and dose/frequency of treatment components.
• Identify which types of services, service providers, and treatment settings work best for specific subgroups receiving treatment.
• Determine how the treatment of one disorder can influence the risks and outcomes for other disorders.

Women

Historically, men have tended to drink at higher rates and experience more alcohol-related problems than women. However, in recent years, the gender gap has narrowed. Women are increasingly likely to have rates of drinking and heavy drinking similar to those observed in men, to be diagnosed with AUD, and to experience the negative consequences of drinking (such as car crashes). Moreover, many of alcohol’s harmful physiological effects have been found to occur more rapidly and severely in women than men. This includes blackouts, liver inflammation, brain atrophy, cognitive deficits, certain cancers, negative affect during withdrawal, and stress and anxiety-induced relapse. More research is needed to better understand sex differences in alcohol use and alcohol-related consequences.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

•  
  • Develop new strategies for alcohol screening, diagnosis, and interventions; and tailor these approaches to women in diverse settings, including prenatal care and specialty health care.
  • Examine the effects of stress, early childhood trauma, and co-occurring disorders on women’s drinking.
  • Determine the effectiveness of standard treatment approaches, such as group counseling and relapse prevention, in single-gender vs. mixed-gender groups.
  • Develop innovative strategies to improve coordination of care for women and their families across primary care, maternal health services, specialty alcohol treatment services, and other integrated health system components.

Adolescents and Young Adults

Although recent data show that U.S. adolescents in general are drinking less alcohol, when they do drink, they consume alcohol in ways that are particularly harmful. Many young adults are also drinking heavily, and experience myriad associated negative consequences. These include an increased risk for alcohol overdose, blackouts, falls, drowning, unplanned sexual encounters, intimate partner violence, and co-occurring mental health conditions. Epidemiological data clearly show an association between early onset of drinking (particularly before age 14) and later alcohol-related problems. Finally, research also shows that alcohol may cause changes in the developing brain. Because the human brain continues to develop past adolescence and into young adulthood, young people are at particularly high risk for experiencing alcohol-related harms. Future research needs to examine whether alcohol-related brain changes occurring in adolescence and young adulthood have long-term consequences. Research also needs to examine how treatment strategies can be better tailored to this special population.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

• Develop and test integrated behavioral treatments in adolescents and young adults with AUD that are tailored to the developmental, biological, psychological, emotional, and social needs of these ages.
• Test novel approaches (e.g., sequential, multiple assignment, randomized trials–[SMART] trials) to adapt interventions at the individual level and/or to account for comorbidity and cultural factors or other considerations specific to diverse groups.

Older Adults

In the United States, 1 in 10 older adults engages in binge drinking. Alcohol misuse is increasing in this population, in both men and women, with potentially serious consequences. Drinking among older adults contributes to accelerated aging in some brain regions, including the frontal cortex, leading to impaired cognitive function and resulting in deficits in learning, memory, and motor function. Developing and evaluating early intervention approaches may help to stem these brain effects.

Examples of high-priority research areas appropriate for evaluation in clinical trials include, but are not limited to, investigations that:

• Develop screening and behavioral and pharmaceutical therapies targeted to older adults.
• Identify vulnerabilities in high-risk subgroups of older adults, including those with physical and/or mental health comorbidities; women; and people with cultural, socioeconomic, immigrant, and sex/gender minority status.

Applications that focus on the following topics will not be considered responsive to this NOFO and will not be reviewed:

• Efficacy and dissemination studies of brief interventions for high risk and understudied populations (e.g., individuals who are not 4-year college students or graduates, individuals from underrepresented minority groups, individuals experiencing poverty or comorbidity).
• Approaches that focus on enhancing positive health or other behaviors that might have an indirect positive effects on drinking, sleep improvement, and fitness,
• Role of life events and social factors as contributors to changes in the patterns of drinking. This includes understanding how the positive social effects of drinking influence the initiation and escalation of drinking, and how social forces and life events facilitate change are needed.
• Link changes in environmental factors such as the relative availability and price of alcohol and alcohol-free rewards associated with changes in drinking, and how to leverage these factors in treatment.
• Preclinical animal studies, only human studies are allowed in this PAR.
• HIV-AIDS related Studies
• Studies that include substances other than alcohol or on poly-substance use disorders
• Clinical trials on prevention
• Clinical trials in community settings (community centers, college campuses etc.)
• Clinical Trials that include organ-associated diseases.
• Basic experimental studies involving humans (BESH)

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) – 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. 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 SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 NOFO 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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Philippe Marmillot, Ph.D.
Telephone: 301-443-2861
Email: [email protected]

Page Limitations

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

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

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:

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

Foreign Institutions

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 and responsiveness by NIAAA  , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIAAA  Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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 a Scientific/ Research Contact 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 the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

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

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

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIAAA, 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 will receive a written critique.

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.

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

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

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

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

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

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

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

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, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients 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 RPPR, 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

Medications Development
Dan Falk, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0788
Email: [email protected]

RV Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-451-2067
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.