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Grant Analysis

Purpose & Target

This grant aims to support research and planning activities to develop new prevention strategies for reducing prenatal alcohol exposure and the incidence of Fetal Alcohol Spectrum Disorders (FASD), as well as interventions to lessen the deficits in individuals affected by FASD throughout their lifespan. - Target recipient type and size: Open to a wide range of organizations including universities, non-profits, for-profit entities (including small businesses), and various levels of government and tribal organizations. No explicit size restrictions. - Designation: This is a SECTOR-SPECIFIC grant. - Geographic scope: Organizations in the US are eligible, and non-U.S. entities (foreign organizations) are also eligible to apply. - Key filtering criteria: Focus on FASD prevention and intervention research; planning grant (R34) to prepare for larger studies. - Grant frequency and program context: Reissue of a previous funding opportunity (PAR-24-067), with multiple recurring application deadlines until 2026. This R34 mechanism supports pilot and/or feasibility data collection.

Financial Structure

Maximum direct cost per award is $450,000 over the entire three-year project period.
No more than $225,000 direct cost may be requested in a single year.
Project period is limited to 3 years.
No cost sharing is required for this NOFO.
Financial reporting requires annual Research Performance Progress Reports (RPPR) and financial statements.
A final RPPR, invention statement, and expenditure data are required for closeout.
Pre-award costs are allowable only as described in NIH Grants Policy Statement Section 7.9.1.

Eligibility Requirements

Eligible Organization Types

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: 501(c)(3) IRS Status (excluding Higher Education), and Nonprofits without 501(c)(3) IRS Status (excluding Higher Education).
For-Profit Organizations: Small Businesses, and For-Profit Organizations (other than Small Businesses).
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized and Other).
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).

Geographic Location

Organizations based in the U.S. are eligible.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
Non-domestic components of U.S. Organizations are eligible.
Foreign components, as defined by NIH, are allowed.

Required Registrations

Applicant organizations must complete and maintain active registration with:
- System for Award Management (SAM), requiring annual renewal.
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations, in lieu of CAGE code).
- Unique Entity Identifier (UEI), obtained via SAM.gov registration.
- eRA Commons: Organizations must identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov: Requires active SAM registration.
All registrations must be completed prior to application submission (can take 6+ weeks).
Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account, affiliated with the applicant organization.

Cost Sharing

No cost sharing is required.

Number of Applications

Applicant organizations may submit more than one application, provided each is scientifically distinct.
Duplicate or highly overlapping applications are not accepted if under review concurrently.

Exclusions

Applications focused on HIV/AIDS related research topics are not responsive.
Applications focused on Animal studies are not responsive (likely referring to solely animal-based clinical trials, but R34 planning grants may include preliminary animal data for broader research). Applicants are strongly encouraged to consult Scientific/Research Contact if unsure.

Application Process

Application Deadlines and Timeline

Applications are due by 5:00 PM local time of applicant organization.
Latest Application Due Dates:
- New applications: October 16, 2026
- Renewal/Resubmission/Revision applications: November 16, 2026
Earliest Start Date for latest deadline: July 2027.
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.

Application Submission Procedure

Applications must be submitted electronically via:
- NIH ASSIST system.
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Applicants must ensure all required registrations (SAM, UEI, eRA Commons, Grants.gov) are complete before submission. Registrations can take 6+ weeks.
PD(s)/PI(s) must have an eRA Commons account with their organization.
Applicants are encouraged to submit early to allow time for corrections.
Applications must be viewed in eRA Commons before the due date to ensure accurate submission.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', supplemented by this NOFO.
Standard forms include: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Research Plan:
- Detail how the proposed prevention/intervention is novel, or how it builds upon existing studies to advance outcomes/delivery/implementation.
- For integrative treatments, strong rationale for synergistic interaction between modalities is needed.
Resource Sharing Plan: Required.
Data Management and Sharing Plan (DMS Plan): Required for all research generating scientific data, regardless of direct costs. NIAAA expects specific information, including:
- Data Type (research subject, species, sex, cohort size, specimen type, nature of data, associated metadata).
- Standards (human subject data: alcohol quantity/frequency, demographic data; animal models: alcohol exposure paradigm, age, consumption measures).
- Data Preservation, Access, and Associated Timelines (repositories).
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications or other material.
PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved.

Pre-Application Requirements

Letter of Intent (LOI): Optional, but encouraged 30 days prior to the application due date. Includes descriptive title, PD(s)/PI(s) contact info, key personnel, institutions, funding opportunity number/title.

Post-Submission Materials

Applicants are required to follow instructions for post-submission materials.

Support Offered

Funding through a grant mechanism.
Access to Scientific/Research Contacts for inquiries and alignment discussions.
Access to eRA Service Desk, General Grants Information, Grants.gov Customer Support for application assistance.

Evaluation Criteria

Overall Impact Score

Reviewers will provide an 'overall impact score' reflecting the likelihood of the project to exert a sustained, powerful influence on the research field.

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation)
- Assesses the project's potential to significantly advance the field.
- R34 supports investigation of novel ideas, new/existing/adapted interventions, models, tools, or technologies.
- Clinical trial applications do not need innovative design/methods if they address important questions/unmet needs.
Factor 2: Rigor and Feasibility (Approach)
- Evaluates the soundness of the proposed methodology and the feasibility of achieving objectives.
- R34 applications are not required to present pilot data, but preliminary data may be included.
- Requires a well-defined theory of change (or logic model) and associated hypotheses.
- Assessment of strategies to improve evaluation, implementation, or optimization of multicomponent interventions.
Factor 3: Expertise and Resources (Investigator(s) and Environment)
- Assesses the qualifications of the research team and the adequacy of the proposed research environment.
- Applicants should provide strong evidence of ability to conduct the study through:
  - Documenting availability of needed resources.
  - Evidence of institutional support.
  - Training and experience of the investigator team.
  - Conduct of related studies.

Additional Review Criteria (Not Scored, but Impact Overall Score)

Protections for Human Subjects: Adequacy of plans for human subjects protection.
Vertebrate Animals: Adequacy of plans for vertebrate animal care and use (if applicable).
Biohazards: Assessment of hazardous materials/procedures and proposed protection.
Resubmissions: Evaluation of the full presented application.
Renewals: Evaluation of progress made in the last funding period.
Revisions: Evaluation of appropriateness of proposed scope expansion.

Additional Review Considerations (Not Scored, No Impact on Overall Score)

Authentication of Key Biological and/or Chemical Resources: Evaluation of plans for validating resources.
Budget and Period of Support: Assessment of whether the budget and requested period are fully justified and reasonable.

Other Important Considerations

Innovation: Encourages studies piloting/feasibility testing for innovative, scalable prevention/treatment interventions.
Mixed methods approaches: Encouraged for developing multi-modal interventions.
Modeling approaches: Encouraged for examining hypotheses relevant to scale-up activities.
Improved measures: Development of improved measures relevant to large-scale implementation is encouraged.
Policy, community-based, health messaging approaches: Encouraged for reducing alcohol use during pregnancy.
Reducing stigmatization: Strategies for women who use(d) alcohol, mothers of children with FASD, and individuals with FASD.
Culturally sensitive interventions: Encouraged for high-risk, vulnerable, and underserved populations.
Mitigating deficits: Development and evaluation of prenatal/postnatal therapeutic approaches, medications, dietary components.
Parenting/caregiver skills development: Approaches to improve care for children with FASD.
School-based methods: Specialized teaching strategies and implementation.
Improving health/quality of life: Innovative approaches for individuals with FASD and their families.
Evaluation of existing interventions: For use in individuals with FASD.
Improving identification and access to care: Models for integration into developmental disability services, telemedicine, novel technologies.

Compliance & Special Requirements

Regulatory Compliance

Adherence to Public Health Service Act (Sections 301 and 405), 42 CFR Part 52, and 2 CFR Part 200 (Uniform Administrative Requirements).
Compliance with all provisions of the NIH Grants Policy Statement.
Projects involving clinical trials must comply with ClinicalTrials.gov registration and results reporting (Title VIII, Section 801 of Public Law 110-85).
Clinical research projects involving investigational products must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Activities must comply with all applicable federal statutes and regulations relevant to federal financial assistance.

Data Protection and Privacy

A Data Management and Sharing Plan (DMS Plan) is mandatory for all applications generating scientific data.
Specific NIAAA guidance for DMS Plan elements (NOT-AA-23-001) and human subjects data sharing (NOT-AA-23-002) must be followed.

Ethical Standards and Oversight

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all human subjects protocols.
Data and Safety Monitoring Requirements apply to all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).

Risk Management

Projects may have small sample sizes for R34 planning grants, which could result in unstable effect size estimates.

Unique Aspects

This is an R34 Planning Grant, intended to support research that is a pre-requisite for submitting subsequent larger scale applications (e.g., R01).
Clinical trial components are optional.
Focus on both prevention and intervention strategies for FASD.
Encourages novel strategies and approaches to enhance effectiveness, reach, and scalability.
Responsive to projects addressing prenatal exposure to multiple substances, as long as alcohol is the primary focus.
Projects are expected to have a well-defined theory of change (or logic model) and associated hypotheses.

Strategic Opportunities

This grant provides an excellent opportunity to gather pilot and/or feasibility data to strengthen future applications for larger research grants (e.g., R01).
Offers a pathway to develop and test innovative, scalable prevention and treatment interventions.

Grant Details