Grand Opportunity in Medications Development for Substance Related Disorders (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the "Grand Opportunity in Medications Development for Substance Related Disorders (U01)"?

It is a National Institutes of Health (NIH) funding opportunity designed to speed up the development of medications for Substance Related Disorders (SRDs). The program supports preclinical and/or clinical research intended to generate decisive, high-impact results on a fast timeline, especially results that help move candidate medications closer to eventual U.S. Food and Drug Administration (FDA) approval.

What is the main purpose of this opportunity?

The core purpose is to fund medications development studies that efficiently answer key development questions, reduce uncertainty about whether a medication should advance, and generate evidence that regulators and the field can use to justify the next stage of development toward FDA approval.

What types of research projects does this announcement aim to support?

The opportunity is aimed at preclinical and/or clinical research projects that can produce clear, development-informing outcomes. Examples described include advanced preclinical packages and early-stage clinical testing, as well as other development-focused work where speed, coordination, and rigorous oversight are important.

Does this program focus on basic research or development-oriented studies?

Based on the description, it is positioned as a development-oriented program. The emphasis is on studies that move a candidate medication forward by producing actionable results on a rapid timeline, rather than open-ended or exploratory work.

What funding mechanism is used (U01), and why does it matter?

This opportunity uses a U01 cooperative agreement rather than a standard research grant. In practical terms, that means awardees should expect substantial federal scientific involvement during the project, with close monitoring and active participation by National Institute on Drug Abuse (NIDA) staff.

How is a U01 cooperative agreement different from an R01 in this program context?

The announcement frames these awards as supporting critical medications development work that may be difficult under a traditional R01. Compared with an R01 (which generally provides investigators more independence and less ongoing agency engagement), the U01 structure is described as more actively managed, closely monitored, and better suited to tightly coordinated, high-cost development studies.

What level of involvement should awardees expect from NIDA?

Awardees should expect substantial federal scientific involvement, close monitoring, and active participation by NIDA staff. The description highlights execution, milestone-driven progress, rapid translation, and frequent communication as typical expectations under the cooperative agreement format.

Are projects expected to be milestone-driven?

Yes in general terms. While the summary does not list specific required milestones, it notes that the cooperative agreement format typically implies well-defined plans, measurable progress, and frequent communication with NIDA program staff, consistent with milestone-driven management.

How long can projects be funded under this opportunity?

Projects may be supported for up to 3 years.

What is the maximum budget per award?

The program anticipates budgets up to 5 million per year per award.

How much total funding is estimated for the program?

The estimated total funding is 15,000,000.

Is cost sharing or matching required?

No. The opportunity does not require cost sharing or matching funds.

Who is issuing this funding opportunity?

It is issued by the National Institutes of Health (NIH) and is described as involving close coordination with the National Institute on Drug Abuse (NIDA) during execution.

What is the Funding Opportunity Number for this announcement?

The Funding Opportunity Number is PAR 11 109.

What CFDA program is this associated with?

It is categorized under CFDA 93.279, Drug Abuse and Addiction Research Programs.

When was the opportunity posted, and what are the key dates?

It was posted on Feb 9, 2011. The original and current closing date is Aug 14, 2013. The archive date is Sep 14, 2013.

Is this a discretionary funding opportunity?

Yes. It is described as a discretionary funding opportunity issued by NIH.

What kinds of organizations are eligible to apply?

Eligibility is broad. Eligible applicants include many government entities, academic institutions, nonprofits, and for-profit organizations, as well as additional categories such as faith-based/community-based organizations and designated institution types (for example, HBCUs and Hispanic-serving institutions).

Are government entities eligible applicants?

Yes. Eligible government applicants include state, county, city or township, special district, and certain tribal governments.

Are colleges and universities eligible?

Yes. Public and private institutions of higher education are eligible.

Are nonprofit organizations eligible?

Yes. Nonprofits with or without 501(c)(3) status are eligible, with the description noting these nonprofit categories as excluding institutions of higher education.

Are for-profit organizations eligible?

Yes. For-profit organizations, including small businesses and other for-profit entities, are eligible.

Are school districts eligible?

Yes. Independent school districts are included as eligible applicants.

Are housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The additional eligibility list includes faith-based or community-based organizations.

Are minority-serving institutions specifically included?

Yes. The additional eligibility list includes historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.

Can federal agencies apply?

Yes. The additional eligibility list includes eligible federal agencies.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are listed as eligible.

Are regional organizations eligible?

Yes. Regional organizations are included in the eligibility list.

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

Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).

What is meant by "Substance Related Disorders (SRDs)" in this context?

The opportunity is specifically focused on substance-related disorders, with the stated goal of developing medications to address these conditions through preclinical and clinical development work.

What does "move candidate medications closer to FDA approval" mean in practical terms for projects?

It means the studies supported should generate the kind of decisive evidence that reduces key uncertainties, supports development decisions (for example, whether a candidate should advance), and strengthens the justification for the next stage of development on a path that could ultimately support FDA approval.

Why does the program emphasize speed and "decisive" results?

The description highlights a push for rapid translation: funding is meant to enable efficient studies that answer key questions quickly, with close coordination and oversight, so that promising candidates can be advanced (or ruled out) with high confidence.

Is the program designed for large, resource-intensive studies?

Yes. The program is described as short-term and large, with budgets up to 5 million per year and up to 3 years of support, intended to make ambitious, resource-intensive medications development studies feasible.

What is the overall way to think about this program?

It is presented as a time-limited, high-budget, milestone-oriented effort to advance promising SRD medications through decisive preclinical and clinical studies, using a cooperative agreement structure to support close coordination with NIDA and maximize actionable outcomes.