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.

This NOFO uses the R34, Grant Planning Program, to address these topics. The focus of applications responding to this announcement may focus on:

• Establishment of the research team
• Development of tools for data management and research oversight
• Development of a trial design or experimental research designs
• Finalization of the protocol
• Preparation of an operations/procedures manual
• Pilot studies or collection of feasibility data for subsequent research projects, excluding the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial

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)

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

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

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 Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• 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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply-Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- 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 How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-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 How to Apply- 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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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

See Part 2. 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. 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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply 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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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 submitted in response to this NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

Consistent with the 2023 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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 2 CFR Part 200.301.

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 2 CFR Part 200.