Reductions in Illicit Drug Use and Functional Outcomes (R21/R33) | Apply Online

Frequently Asked Questions (FAQs)

What is the PA 15-099 funding opportunity about?

PA 15-099, titled "Reductions in Illicit Drug Use and Functional Outcomes (R21/R33)," is an NIH grant announcement focused on strengthening the evidence base for how to measure success in treatment for substance use disorders (SUDs). Its core aim is to determine whether measurable reductions in illicit drug use are reliably linked to meaningful improvements in peoples lives and health.

What central question is NIH trying to answer through this FOA?

The central question is whether reductions in illicit drug use translate into real-world, meaningful benefits. The FOA is interested not just in whether someone uses less, but whether using less is tied to improvements that matter to patients, clinicians, health systems, policymakers, and regulators.

What does the FOA mean by "functional outcomes"?

"Functional outcomes" refer to broader health and societal impacts that can be observed and quantified beyond drug use measures alone. The announcement emphasizes outcomes that reflect meaningful changes in health, daily functioning, and social systems.

What are examples of functional outcomes mentioned in the announcement?

Examples called out include reductions in morbidity and mortality, less involvement with the criminal justice system, and lower overall healthcare expenditures. The FOA also describes observable downstream outcomes such as fewer overdoses, fewer emergency department visits, improved health status, reduced hospitalizations, fewer arrests or incarcerations, and reduced costs associated with medical care and related services.

Why is NIH emphasizing the linkage between drug-use reductions and functional outcomes?

The FOA is designed to clarify whether reductions in illicit drug use can serve as a valid and meaningful endpoint in treatment research. By establishing strong, measurable links between reduced use and improved downstream outcomes, researchers can help determine whether drug-use reductions are credible indicators of clinical benefit.

What grant mechanism is used for this opportunity?

This FOA uses a Phased Innovation award mechanism with two linked stages: an R21 phase followed by a potential R33 phase.

How long can the R21 phase last, and what is it meant to support?

The R21 portion can support up to two years of early-stage work. The FOA describes R21 activities such as research planning, establishing methods and measures, building or validating datasets, conducting feasibility studies, testing recruitment and retention strategies, and piloting analytic approaches needed for a larger effort.

Is the transition from R21 to R33 automatic?

No. The R33 phase is not automatic. Transition depends on NIH program staff evaluation of whether clearly specified R21 milestones were successfully achieved and whether the project is positioned to deliver the larger-scope evidence the FOA seeks.

What is the purpose of the R33 phase?

If R21 milestones are met, NIH may authorize a transition into the R33 phase, which provides expanded support to carry out the next stage of the project at a larger scope than the R21.

What is meant by "milestones" in this phased approach?

Milestones are clearly specified targets set for the R21 period that demonstrate whether the early-stage work has been successfully completed. NIH program staff use achievement of these milestones to decide whether to authorize the transition to the R33 phase.

What is the practical end goal of research supported under this FOA?

The FOA explicitly highlights regulatory relevance. NIH is looking for research that can help regulatory authorities accept reductions in illicit drug use as a valid outcome measure in clinical trials of pharmacotherapies for SUDs.

Why is regulatory relevance important in this announcement?

The FOA notes that reductions in illicit drug use can be easier to observe over shorter time periods than longer-term endpoints like mortality. If reductions are strongly linked to improved functioning and health, they can serve as credible indicators of clinical benefit for medication development and regulatory decision-making.

What does the FOA suggest about clinical trial endpoints?

It indicates an interest in bridging the gap between what clinical trials often measure (such as drug-use reduction) and what regulators need to see to judge meaningful benefit (clear links to improved health and functioning).

Is this a mandatory or discretionary grant opportunity?

It is described as a discretionary grant opportunity under the NIH umbrella.

What CFDA number is associated with this opportunity?

The FOA is listed under CFDA 93.279 (Drug Abuse and Addiction Research Programs).

Does the opportunity require cost sharing or matching funds?

No. The announcement states that cost sharing or matching is not required.

Is PA 15-099 still open for applications?

No. The FOA was posted January 23, 2015. The original and final listed closing date was September 7, 2017, and the archive date was October 8, 2017. This means the announcement is no longer active, though it may remain useful as a reference.

Why might someone still look at an archived FOA like this?

Based on the description provided, it remains a useful reference for understanding the kinds of projects NIH sought in this area and for understanding the structure and expectations of the R21/R33 phased approach.

Who is eligible to apply under the eligibility language described?

Eligibility is broad and includes many applicant organization types, including small businesses; for-profit entities (other than small businesses) and nonprofit organizations (including those with and without 501(c)(3) status, other than institutions of higher education); public and private institutions of higher education; independent school districts; and multiple levels of government (city or township, county, special district, and state governments), as well as public housing authorities/Indian housing authorities.

Are tribal governments and tribal organizations included as eligible applicants?

Yes. The eligibility description includes federally recognized Native American tribal governments and tribal organizations.

Does the eligibility description mention specific institution types such as HBCUs or Hispanic-serving institutions?

Yes. The eligibility clarification references Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander-serving institutions (AANAPISIs), among others.

Are faith-based or community-based organizations mentioned as potentially eligible?

Yes. The eligibility language indicates that faith-based or community-based organizations may be eligible, depending on the detailed terms in the full FOA.

Are non-U.S. (foreign) organizations mentioned in the eligibility language?

Yes. The eligibility language indicates that non-U.S. entities (foreign organizations) may be eligible, depending on the detailed terms in the full FOA.

Are U.S. territories or possessions mentioned?

Yes. The eligibility language notes that U.S. territories or possessions may be eligible, depending on the detailed terms in the full FOA.

Where can the official NIH posting for PA 15-099 be found?

The announcement points to the NIH Grants Guide posting at http://grants.nih.gov/grants/guide/pa-files/PA-15-099.html.

Who should be contacted for access or technical issues with the electronic posting?

For difficulties accessing or linking to the announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.