Opportunity Information: Apply for PA 18 775

The National Institutes of Health (NIH) grant opportunity "Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials (R34 Clinical Trial Optional)" (Funding Opportunity Number: PA-18-775) supports early-stage research meant to lay the groundwork for later, larger prevention trials. It uses the R34 mechanism, which is designed for pilot and feasibility studies rather than full-scale effectiveness testing. The central idea is to help investigators generate the practical evidence they need to confidently move into a subsequent, larger clinical or community prevention trial focused on drug and alcohol misuse and related health harms.

The FOA prioritizes two main types of projects. First, it funds pilot and feasibility testing of innovative prevention interventions, including interventions that are brand-new, meaningfully revised, or carefully adapted for new populations or settings. These interventions should aim to prevent or delay the initiation of drug and alcohol use, slow or stop progression from use to misuse or problem use, and reduce the likelihood of developing alcohol or other substance use disorders. The opportunity also explicitly includes prevention work aimed at reducing drinking and driving and preventing deaths related to impaired driving. In addition, it encourages prevention approaches that reduce drug- or alcohol-related risks for acquiring or transmitting HIV infection and viral hepatitis, recognizing the overlap between substance use patterns and infectious disease transmission in many communities.

Second, the FOA supports pre-trial feasibility and acceptability testing in the area of prevention services and systems research. That includes work that tests whether prevention programs, service delivery approaches, or system-level strategies can realistically be implemented, adopted, and sustained in the real-world settings where prevention actually happens (for example, schools, primary care clinics, community organizations, justice settings, or other public health systems). In practice, this kind of R34 work often focuses on questions like: Can the target population be recruited and retained? Will participants and providers accept the intervention? Can staff be trained with fidelity? Are the procedures workable in a busy service setting? Are the proposed outcomes measurable and sensitive enough for a later trial? The aim is to reduce risk before a larger, more expensive study is launched.

A key boundary of this announcement is that it does not fund applications whose only purpose is to develop manuals, protocols, or standardized materials. Intervention development is allowed, but only when it is embedded inside a pilot or feasibility study, meaning there must be an actual empirical test of feasibility, acceptability, or other pre-trial milestones rather than just writing or packaging an intervention.

The FOA emphasizes prevention research that aligns with current public health priorities and priority settings and systems. That signals an interest in studies that respond to pressing and evolving needs in communities and service environments, including diverse populations and varied implementation contexts. Projects are expected to be practical and preparatory: the work should directly support the design and justification of a future, larger-scale prevention trial, whether focused on substance use prevention broadly, alcohol-specific outcomes such as impaired driving, or substance-related HIV and viral hepatitis prevention.

Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and foreign (non-U.S.) organizations. This wide eligibility reflects NIH's interest in reaching diverse communities and settings where prevention research can be tested and refined.

From the posted opportunity details, the funding instrument is a grant under the discretionary category, and the activity areas are health and education. The CFDA numbers listed are 93.273 and 93.279. The award ceiling shown is $225,000, indicating the intended scale is modest and consistent with a preparatory pilot stage rather than a definitive trial. The original closing date listed is 2021-01-07, and the FOA record was created on 2018-05-09.

Overall, this R34 opportunity is best understood as a stepping-stone grant: it is meant to finance the critical pilot testing and feasibility work needed to strengthen a later, full-scale prevention intervention application. Competitive projects under this FOA typically make a clear case that the proposed study will answer practical pre-trial questions, produce actionable feasibility data, and directly position the team to submit a subsequent larger trial aimed at preventing substance use initiation and escalation, reducing impaired driving harms, and limiting substance-related HIV and viral hepatitis transmission in real-world populations and systems.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials (R34 Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273, 93.279.
  • This funding opportunity was created on 2018-05-09.
  • Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $225,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)

What is the purpose of the NIH grant opportunity PA-18-775?

This funding opportunity supports early-stage pilot and feasibility studies that lay the groundwork for later, larger prevention trials focused on drug and alcohol misuse and related health harms. The intent is to help investigators generate practical, real-world evidence (for example, feasibility, acceptability, recruitment/retention capability, and workable procedures) so they can move forward confidently to a subsequent full-scale clinical or community prevention trial.

What is the funding mechanism used in this opportunity?

The opportunity uses the NIH R34 mechanism, which is designed specifically for pilot and feasibility studies rather than definitive, full-scale effectiveness testing.

Is a clinical trial required under this FOA?

No. The FOA is labeled "Clinical Trial Optional," meaning a clinical trial is not required. The focus is on preparatory work (pilot/feasibility) to inform a later, larger trial.

What kinds of projects does the FOA prioritize?

The FOA prioritizes two main categories of projects: (1) pilot and feasibility testing of innovative prevention interventions, and (2) pre-trial feasibility and acceptability testing in prevention services and systems research.

What types of prevention interventions are in scope?

Projects may test innovative prevention interventions that are brand-new, meaningfully revised, or carefully adapted for new populations or settings. The intervention focus should be prevention-oriented (not treatment) and positioned as a stepping-stone toward a later, larger prevention trial.

What prevention outcomes are emphasized for drug and alcohol use?

Interventions should aim to prevent or delay initiation of drug and alcohol use, slow or stop progression from use to misuse or problem use, and reduce the likelihood of developing alcohol or other substance use disorders.

Does the FOA include impaired driving prevention (drinking and driving)?

Yes. The FOA explicitly includes prevention work aimed at reducing drinking and driving and preventing deaths related to impaired driving.

Does the FOA include work related to HIV or viral hepatitis prevention?

Yes. The FOA encourages prevention approaches that reduce drug- or alcohol-related risks for acquiring or transmitting HIV infection and viral hepatitis.

What is meant by "prevention services and systems research" in this FOA?

This refers to pre-trial studies that examine whether prevention programs, service delivery approaches, or system-level strategies can realistically be implemented, adopted, and sustained in real-world settings where prevention occurs (such as schools, primary care clinics, community organizations, justice settings, or other public health systems).

What kinds of feasibility questions are appropriate for an R34 project under this FOA?

Examples highlighted by the FOA include whether the target population can be recruited and retained, whether participants and providers accept the intervention, whether staff can be trained with fidelity, whether study procedures are workable in busy service settings, and whether proposed outcomes are measurable and sensitive enough to support a later trial.

Is this FOA meant to fund full-scale effectiveness testing?

No. The R34 mechanism is described as supporting pilot and feasibility studies rather than full-scale effectiveness testing. The aim is to reduce risk before launching a larger, more expensive trial.

Can an application focus only on developing manuals, protocols, or standardized materials?

No. A key boundary stated in the FOA is that it does not fund applications whose only purpose is to develop manuals, protocols, or standardized materials.

Is intervention development allowed at all?

Yes, but only if it is embedded inside a pilot or feasibility study. In other words, there must be an empirical test of feasibility, acceptability, or other pre-trial milestones rather than only writing or packaging an intervention.

What settings does the FOA consider relevant for pilot and feasibility work?

The FOA points to real-world prevention settings and systems such as schools, primary care clinics, community organizations, justice settings, and other public health systems.

What does the FOA mean by aligning with current public health priorities and priority settings and systems?

It signals interest in prevention research that responds to pressing and evolving needs in communities and service environments, including work relevant to diverse populations and varied implementation contexts.

How should a project connect to a future larger trial?

Projects are expected to be practical and preparatory, producing actionable feasibility data that directly supports the design and justification of a subsequent larger-scale prevention trial.

Who is eligible to apply?

Eligibility is broad and includes many domestic and non-domestic organizations. Examples listed include state, county, city, township, and special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; non-federally recognized tribal organizations; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities.

Are foreign (non-U.S.) organizations eligible?

Yes. The FOA explicitly includes foreign (non-U.S.) organizations among eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The FOA highlights faith-based or community-based organizations as eligible applicants.

Are minority-serving institutions specifically highlighted as eligible?

Yes. The FOA highlights several categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, and TCCUs.

Are U.S. territories or possessions included in eligibility?

Yes. The FOA highlights U.S. territories or possessions among additional eligible applicants.

What are the activity areas associated with this opportunity?

The posted opportunity details list the activity areas as health and education.

What is the funding instrument and category?

The funding instrument is a grant, and it is listed under a discretionary category.

What are the CFDA numbers associated with this FOA?

The CFDA numbers listed are 93.273 and 93.279.

What is the award ceiling shown for this opportunity?

The award ceiling shown is $225,000, reflecting a modest budget consistent with a preparatory pilot stage rather than a definitive trial.

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is PA-18-775.

What was the original closing date listed in the opportunity details?

The original closing date listed is 2021-01-07.

When was the FOA record created?

The FOA record was created on 2018-05-09.

What is the overall "best fit" use of this R34 opportunity?

This opportunity is best suited as a stepping-stone grant to fund the critical pilot testing and feasibility work needed to strengthen a later full-scale prevention trial application focused on preventing substance use initiation and escalation, reducing impaired driving harms, and limiting substance-related HIV and viral hepatitis transmission.

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Funding Number: RFA CA 18 025
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Administrative Supplements to Support Cancer Disparity Collaborative Research (Clinical Trial Optional) Apply for PA 18 842

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Funding Number: PAR 18 847
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Funding Number: PA 18 849
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