Atom | HEAL Initiative: Research to Increase Implementation of Substance Use Preventive Services (R61/R33 Clinical Trial Optional)

Due Dates: June 17, 2025 | January 16, 2026

Funding Amounts: No set limit; recommended maximum $300,000 direct costs/year (R61 phase, up to 2 years) and $750,000 direct costs/year (R33 phase, up to 4–5 years); total project period up to 6 years.

Summary: Supports research to develop and test innovative strategies for implementing and sustaining substance use preventive services, with a focus on opioid misuse prevention infrastructure.

Key Information: Phased R61/R33 mechanism; pilot data not required at submission; meaningful engagement of end users is required; clinical trial optional.

Description

This NIH funding opportunity supports investigator-initiated research to address critical gaps in the implementation and sustainability of substance use preventive services, particularly for opioid misuse and use disorder. The initiative seeks to advance strategies that can be adopted, implemented, and scaled within real-world systems (e.g., healthcare, education, justice, community organizations) or through independent prevention infrastructures. Projects should focus on service delivery, workforce development, infrastructure, and/or innovative implementation models, rather than the development of new preventive interventions.

The program uses a two-phase R61/R33 mechanism: the R61 phase (up to 2 years) supports preparatory work (e.g., pilot data, stakeholder engagement, feasibility testing), and successful projects may transition to the R33 phase (up to 4–5 years) for larger-scale implementation research. Clinical trials are optional.

Due Dates

Next application deadlines:
- June 17, 2025
- January 16, 2026
Letter of Intent: 30 days prior to application due date (optional but encouraged)
All applications due by 5:00 PM local time of applicant organization

Funding Amount

Budget: No set limit, but budgets must reflect actual project needs.
- R61 phase: Strongly recommended not to exceed $300,000 direct costs per year (up to 2 years)
- R33 phase: Strongly recommended not to exceed $750,000 direct costs per year (up to 4–5 years)
- Total project period: Up to 6 years (combined R61 + R33)
Total NIH commitment: ~$4.65 million in FY2024 for this and companion NOFOs, subject to availability of funds and meritorious applications.

Eligibility

Eligible organizations:
- Public and private institutions of higher education
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Native American tribal governments and organizations (federally recognized and other)
- Faith-based and community-based organizations
- Regional organizations
- U.S. territories and possessions
- Eligible agencies of the federal government
Ineligible: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations (foreign components as defined by NIH policy are allowed).
Principal Investigator: Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research.

Application Process

Mechanism: R61/R33 Exploratory/Developmental Phased Award (Clinical Trial Optional)
Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or institutional S2S systems.
Required registrations: SAM, eRA Commons, Grants.gov (may take 6+ weeks)
Letter of Intent: Email to NIDALetterofIntent@mail.nih.gov (optional)
Application instructions: Follow the NIH SF424 (R&R) Application Guide and the full NOFO
Key attachments:
- Timeline & Milestone Plan (2-page maximum)
- Data Management and Sharing Plan
- Plan for meaningful engagement of end users (e.g., policymakers, practitioners, community members)
- Budget and justification (include travel for annual HEAL Investigators Meeting in Washington, DC)
Review criteria: Significance, innovation, approach, investigator(s), environment, engagement of end users, sustainability, generalizability, and health disparities considerations.

Additional Information

Scope: Focus is on implementation, scale-up, and sustainability of evidence-based prevention services, not on developing new preventive interventions.
End user engagement: Required throughout project design, execution, and dissemination.
Milestones: Transition from R61 to R33 phase is contingent on meeting pre-specified milestones and NIH administrative review.
Data sharing: All HEAL Initiative awardees must comply with HEAL data sharing and public access policies.
Non-responsive applications: Will not be reviewed if they do not address implementation/sustainability, lack a milestone plan, or do not include end user engagement.

External Links

Contact Information

Topic	Contact Name/Office	Email/Phone
Scientific/Research (NIDA)	Amy B. Goldstein, PhD	amy.goldstein@nih.gov / 301-827-4124
Scientific/Research (ODP)	Denise L Stredrick, PhD	stredrid@mail.nih.gov / 301-594-7553
Scientific/Research (NIA)	David Frankowski, PhD	dave.frankowski@nih.gov
Scientific/Research (NCCIH)	Jennifer N. Baumgartner, PhD	jennifer.baumgartner@nih.gov / 301-402-4084
Peer Review	NIDA Review	NIDAPeerReview@nih.gov
Grants Management (NIDA)	Chief Grants Management Officer	nidagmbemail@nida.nih.gov
Grants Management (NIA)	Kathleen Moy	kathleen.moy@nih.gov / 301-827-2856
Grants Management (NCCIH)	Wen G. Chen, M.MSc, PhD	chenw@mail.nih.gov / 301-451-3989
General Grants Info (NIH)	NIH Grants Information	GrantsInfo@nih.gov / 301-480-7075
Application System Support	eRA Service Desk	eRA Helpdesk / 301-402-7469
Grants.gov Support	Grants.gov Customer Support	support@grants.gov / 800-518-4726