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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

  Background

Prenatal alcohol exposure is a leading preventable cause of birth defects and neurodevelopmental deficits in the United States. Fetal alcohol spectrum disorders (FASD) can occur in individuals who were prenatally exposed to alcohol. Alcohol can disrupt prenatal development at any stage during pregnancy, including the earliest stages, often before a woman knows that she is pregnant. A 2018 study estimated that 1 to 5 percent children in the first grade in the US have FASD, the majority of whom were previously undiagnosed.

FASD is an umbrella term for a range of physical, cognitive, and behavioral abnormalities caused by prenatal alcohol exposure. FASD may include any disorder within the FASD spectrum, e.g. fetal alcohol syndrome (FAS), partial FAS (pFAS), alcohol-related neurodevelopmental disorder (ARND), alcohol-related birth defects (ARBD), and neurobehavioral disorder associated with prenatal alcohol exposure (ND-PAE).

As prenatal alcohol exposure leads to heterogeneous clinical and non-clinical symptoms, individuals with FASD tend to have their own unique combination of day-to-day challenges, which may include medical, behavioral, educational, and social problems. People with FASD may have difficulty in areas of neurocognition (including global intellectual impairment, executive function deficits, poor working memory, learning problems);  self-regulation (impulse control problems, impaired mood or behavioral regulation, attention deficits, organization difficulties); and adaptive functioning (communication issues, problems with daily living, poor social skills, gross or fine motor delay). Individuals are affected differently, with some having minor impairments in a single domain, whereas others have multiple difficulties and a lifelong developmental disability.

Through this initiative, NIAAA is interested in developing evidence-based prevention strategies to reduce the incidence of FASD and interventions/treatments to lessen the deficits in individuals affected by prenatal alcohol exposure. Reports from prenatal clinics and postnatal studies suggest that as many as 20-30 percent of women drink at some time during pregnancy. Several risk factors have been identified that place offspring at higher risk for FASD, including the level of alcohol consumption before and during pregnancy, later initiation of prenatal care, family history of drinking, and other factors.

Over the past decade, NIAAA supported the development of various treatment approaches using dietary supplements, sensorimotor training, behavioral interventions, and parenting strategies to improve outcomes in individuals with FASD.  Similarly, NIAAA has funded research into screening, brief interventions, and treatment approaches for high-risk and vulnerable populations, including pregnant women. Despite these investments, challenges remain, with a critical need to build the evidence base for interventions to improve outcomes in individuals with FASD and for prevention strategies, including primary, secondary, and tertiary approaches, to decrease alcohol use during pregnancy and the incidence of FASD. 

Research Scope

This NOFO encourages studies that propose strategies for prevention of FASD or intervention for individuals affected by FASD throughout the lifespan, through an R61/R33 mechanism. The R61 phase is the first two (2) years of the award, while the R33 spans the following three (3) years. The R61 phase supports initial technical development and proof-of-principle projects, whereas the R33 phase supports further development, application, and evaluation of clinical utility to lay the foundation with which to pursue a larger efficacy trial or study. The application should provide clear aims and measurable objectives for each phase of the proposed research, with explicit discussion of how the results of the R61 phase will inform the R33 phase. Initiation of the second (R33) phase of support is contingent upon successful accomplishment of the objectives and milestones investigators set out in the first (R61) phase of their research.

This NOFO is intended to support biomedical, behavioral, social sciences research in prevention and/or intervention, including new, exploratory and developmental efforts. Applicants should explicate a clear conceptual link between relevant biomedical, psychological, behavioral, or social factors, and the prevention or intervention components being proposed (including a description of the mechanism of action by which these components are hypothesized to have an effect), and their relationship to the outcomes that are being targeted. 

Research aims may include, but are not limited to, determination of dosing levels and duration; side effects and safety monitoring; demonstration that outcome measures have appropriate sensitivity to change in the target population; demonstration of feasibility (implementing the intervention and study procedures, evaluating attrition); and working out details of the experimental protocol (e.g., the assessment, experimental intervention and comparison intervention protocols; and randomization procedures, if appropriate). 

Study topics include, but are not limited to, the following:

• Design and evaluate novel policy, community-based, and health messaging and other behavioral and social science approaches to help women reduce or abstain from drinking during pregnancy
• Advance strategies to reduce stigmatization of women who use(d) alcohol, biological mothers of children with FASD, and individuals with FASD
• Improve current prevention strategies to reduce use of alcohol in women of childbearing age
• Identify and mitigate risk factors in populations with high incidence rates of FASD
• Design and evaluate cost-effective, culturally sensitive interventions aimed at preventing FASD in high risk and vulnerable, and diverse populations
• Understand the effects of policies regarding alcohol consumption on maternal health and infant outcomes
• Develop and evaluate prenatal and postnatal therapeutic approaches, medications, and/or dietary components to mitigate the physical, neurocognitive and behavioral deficits associated with FASD across the lifespan
• Advance approaches for parenting/caregiver skills development to improve care for children with FASD
• Develop school-based methods focused on specialized teaching strategies and approaches, including implementation strategies
• Develop and evaluate innovative approaches to improve health and quality of life for individuals with FASD and their families
• Evaluate and implement interventions previously shown to be effective in populations with developmental disabilities for use in individuals with FASD
• Evaluate models for improving identification and access to care for individuals with FASD, such as integration into developmental disability health care services and networks, utilization of telemedicine, or novel technologies.

Milestones

The R61 phase supports initial technical development and proof-of-principle projects, whereas the R33 phase supports further development, application, and evaluation of clinical utility to lay the foundation with which to pursue a larger efficacy trial or study. The application should provide clear aims and measurable objectives for each phase of the proposed research, with explicit discussion of how the results of the R61 phase will inform the R33 phase. Projects should include the following:

Identification of previous studies and data that will be used to generate or support hypotheses about prevention and/or intervention research in the R33 phase

Measurable outcomes for the R61 phase studies, i.e. an intervention protocol, pilot projects, feasibility data

Clear milestones for the R61 phase and related scientific goals for the R33 phase

Proposed pre-clinical studies during the R61 should translate to clinical human studies during the R33 phase

The objectives for the R33 phase should be based on the findings from the R61 phase. Examples of the goals for the R33 phase include, but are not limited to:

Identification of points of prevention or intervention for alcohol use or alcohol use disorder, based on the biological response and amount and timing of prenatal alcohol exposure

Studies of pharmacological targets or drug candidates for prevention of FASD or intervention to improve FASD-related outcomes

Identification of specific targets and intervention components based on psychosocial mechanisms Rigorous efficacy or effectiveness trials of prevention strategies and/or interventions that translate into clinical practice; studies that assess implementation and scalability of efficacious prevention strategies, policy, and/or interventions.

Transition to the R33 phase is contingent upon programmatic review that will include, but is not limited to, satisfactory demonstration that the R61 milestones have been achieved. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO.

Notes on priorities

The main goal of this opportunity is to support research on prevention and intervention strategies to reduce prenatal alcohol exposure and its effects. Applications relating to prenatal exposure to multiple substances (nicotine, cannabis, opioids, methamphetamine, and/or prescription drugs) will be considered as responsive; however, the focus is expected to be prenatal alcohol exposure. Animal experiments may be necessary for pre-clinical testing; however, the focus of this NOFO  is the translation of findings. 

Applications Not Responsive to this NOFO 

Applications on the following topics will not be considered responsive to this NOFO  and will not be reviewed.

• HIV/AIDS related research topics
• Animal research only. (Research strategies must contain components of clinical translation during the R33 phase of the award.)

It should be noted that although estimation of effect sizes is a logical step in evaluating the efficacy of a prevention or intervention strategy or treatment, studies conducted under this mechanism are likely to have small sample sizes, resulting in potentially unstable and unreliable effect size estimates that would have limited utility in power calculations for a larger clinical trial. Therefore, while encouraged, attempting to obtain an estimate of effect size is not an expected outcome.

Applicants are strongly encouraged to consult the Scientific/Research Contact listed below to discuss the alignment of their proposed work with the objectives of this NOFO.

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 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 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference 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.

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 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:

Dr. Philippe Marmillot
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 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 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:

Specific Aims: Describe and clearly demarcate the specific aims for each of the two phases (R61and R33) on the single Specific Aims attachment. For the R61 phase, the specific aims should be focused on experiments that will test the proposed innovative concept/hypothesis. For the R33 Phase, the specific aims should outline generally the plan to explore the innovative concept/hypothesis if it is unambiguously supported by the experiments in the R61 phase.

Research Strategy:

The Research Strategy should contain separate sections that describe the R61 and R33 phases.

R61 Phase:

Applicants should include one or more critical experiments for rigorously testing the proposed concept/hypothesis. These experiments must be scientifically justified, specific, and feasible. Applicants should state explicitly the results that support, reject, or are inconclusive regarding testing of their concept/hypothesis, and are strongly encouraged to calculate and report effect size, in addition to statistical significance, whenever possible.

Preliminary Data:

An R61/R33 grant application need not have preliminary data, but they may be included if available.

Milestones:

Transition from the R61 to the R33 phase is contingent upon the successful completion of proposed milestones. These milestones are to be included as the last element of the Research Strategy section of the application and will be evaluated as part of the scientific and technical merit of the R61/R33 application. The milestones proposed in the application should be well-described, quantifiable, and scientifically justified to allow program staff to assess progress and successful completion of the R61 phase. Include a section labeled "Milestones" describing milestones to be achieved during the R61 phase to qualify for the transition to the R33 as part of Research Strategy within the approach section.

R33 Phase:

Although the Research Strategy for the R33 Phase is expected to be broad and somewhat speculative due to the unpredictable nature of the explorative research in the R61 Phase, the research strategy for the R33 phase of the award should be described based on anticipated results.

It is understood that the proposed milestones for the R33 phase may be revised based on activities during the R61 planning phase. In the event of an award, the PD/PI and NIH staff will negotiate a list of milestones for each year of support.

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.

As described in NOT-AA-23-001, NIAAA expects specific information in the Data Management and Sharing Plan (DMS Plan) to be included in NIAAA grant applications for due dates on or after January 25, 2023. In addition to the general NIH guidance regarding the information to include in the DMS Plan (NOT-OD-21-014, Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan, and the NIH Data Management and Sharing Plan format page), NIAAA expects that the DMS Plan elements contain the following specific information:

Elements of the Data Management and Sharing Plan

Data Type:

This section should include details about the research subject, including species, sex, and cohort size. If specimens are collected from specimen sources, the type of specimen is to be listed, i.e., blood, tissue, urine, and whether the sample was collected in a prospective or retrospective time period

The data type specifies the nature of data: omics, medical and non-medical imaging, biological types (biochemical assays and biophysical such as X-ray and NMR, preclinical assays, electrophysiology), and phenotypic. Additional data to be included, i.e., associated metadata, epidemiology and surveillance, social/behavioral, clinical trials results, survey/questionnaire, and algorithms or simulations.

Standards:

For human subject data, a measure(s) of alcohol quantity and frequency is expected to be reported. Measures may include lifetime use, 30-day quantity and frequency, and/or maximum drinks per 24 hours. Demographic data should include sex, age, race, and ethnicity. Applicants are encouraged to consult the PhenX (https://www.phenxtoolkit.org/index.php) website and the Alcohol, Tobacco and Other Substances and the Demographics domains for protocols.

Studies that include animal models should include the alcohol exposure paradigm, age of the animal at the start and end of the alcohol exposure, a measure of alcohol consumption or exposure. A blood alcohol concentration measurement is recommended.

Data Preservation, Access, and Associated Timelines:

For additional information on submitting scientific data from studies with human subjects, see "Notice of NIAAA Data-Sharing Information for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) [5th Revision]" (NOT-AA-23-002). For data types without human subjects, applicants will provide the name(s) of the repositories where the scientific data and metadata will be archived.

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 Organizations

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

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed

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.

For this particular announcement, note the following:

This NOFO supports exploratory and developmental research on strategies on prevention of FASD and intervention for individuals with FASD. An R61/R33 grant application need not have preliminary data, but they may be included if available. Accordingly, reviewers will emphasize the following:

• The importance of the scientific problem
• Technical feasibility of the research approach
• Translation potential of the research into clinical practice (in the R33 phase)

Reviewers will assign a single impact score for the entire application, which includes both the R61 and R33 Phases.

In addition, for applications involving clinical trials:

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.

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:

• Federalwide 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.

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 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.

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 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

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.

• For NIAAA-specific Data Management and Sharing Plan elements see NOT-AA-23-001.
• For additional NIAAA-specific information on submitting scientific data from studies with human subjects see NOT-AA-23-002. 

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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 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]

Preclinical Studies and Medical Care
William Dunty, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7351
Email: [email protected]

Elizabeth Powell, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0786
Email: [email protected]

Prevention and Epidemiology
Tatiana Balachova, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301.443.5726
Email: [email protected]

Behavioral, Pharmacological and Education Therapy
Deidra Roach, MD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301.443.5820
Email: [email protected]

Ranga Srinivas, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: [email protected]

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

Section VIII. Other Information

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

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.