Opportunity Information: Apply for PAR 15 154
Apply for PAR 15 154
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs.
- This funding opportunity was created on Mar 25, 2015 and posted on Mar 25, 2015.
- Applicants must submit their applications by Dec 11, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
The grant opportunity titled "Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (U44)" (Funding Opportunity Number PAR 15-154) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program run under the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It is designed to help small business concerns move promising therapeutic candidates for alcohol use disorder (AUD) and other alcohol-related disorders from the advanced preclinical stage into the formal regulatory pathway needed to begin human testing. The award uses a cooperative agreement mechanism (U44), which generally means the NIH expects to have substantial scientific or programmatic involvement during the project, beyond what is typical for a standard grant.
A key feature of this announcement is that it is not meant for early discovery work. Applicants are expected to come in with an already identified drug candidate and a convincing package of evidence showing the candidate is ready for IND-enabling development. Specifically, the candidate should already demonstrate strong bioactivity and other practical drug-like characteristics aligned with its intended clinical use. The FOA highlights properties such as stability, manufacturability, bioavailability, and evidence of in vivo efficacy and/or target engagement. In other words, this opportunity targets the stage where a company has moved past the question of "does it work in principle?" and is now focused on "can it be developed into a regulated clinical product?"
The core purpose of the funding is to support the set of IND-enabling studies required to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). IND-enabling work typically includes activities such as refining manufacturing and formulation approaches, generating required pharmacology and toxicology data under appropriate standards, characterizing pharmacokinetics and dose exposure relationships, and addressing other preclinical and CMC (chemistry, manufacturing, and controls) requirements that regulators expect before approving a first-in-human trial. The FOA sets a clear expectation for the endpoint of a successful project: by the end of the funding period, the project should have at minimum an IND submission to the FDA. The program also notes that it can support early phase clinical trials, but those trials are not required, meaning the emphasis is on reaching the regulatory milestone rather than necessarily completing human testing within the award.
Eligibility is focused on small businesses, consistent with SBIR rules. Foreign (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" as defined by the NIH Grants Policy Statement may be allowed, which usually means certain well-justified project elements could be carried out outside the U.S. under NIH policy, even though the applicant organization itself must be a qualifying U.S. small business. The opportunity does not require cost sharing or matching funds.
Administratively, this was a discretionary funding opportunity in the health category and is associated with CFDA number 93.273 (Alcohol Research Programs). It was posted on March 25, 2015, and the original and final closing date listed is December 11, 2017, with an archive date of January 11, 2018, indicating the announcement is no longer active but remains available for reference. The official NIH listing for the announcement was provided through the NIH grants guide webpage (PAR-15-154). For technical issues accessing the full announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Overall, the opportunity is best understood as a translational, preclinical-to-clinic bridge for SBIR-eligible companies developing medications within NIAAA's mission area. It supports the practical and regulatory work needed to convert a validated therapeutic candidate into an IND-ready product package, with IND submission as the minimum expected deliverable and optional support for early clinical testing if the project is positioned to reach that stage.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (U44)" and the Funding Opportunity Number is PAR 15-154.
Which federal agency and institute run this program?
This is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program run under the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
What is the main purpose of this funding opportunity?
The purpose is to help small business concerns move promising therapeutic candidates for alcohol use disorder (AUD) and other alcohol-related disorders from an advanced preclinical stage into the formal regulatory pathway needed to begin human testing. The funding is intended to support IND-enabling studies that lead to submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).
What award mechanism is used, and what does it imply?
The award uses a cooperative agreement mechanism (U44). This generally indicates NIH expects to have substantial scientific or programmatic involvement during the project, beyond what is typical for a standard grant.
Is this program intended for early-stage discovery research?
No. This announcement is not meant for early discovery work. Applicants are expected to have already identified a drug candidate and to provide a convincing evidence package that the candidate is ready for IND-enabling development.
What level of readiness is expected for the therapeutic candidate?
The candidate should already demonstrate strong bioactivity and practical drug-like characteristics aligned with its intended clinical use. The description highlights readiness indicators such as stability, manufacturability, bioavailability, and evidence of in vivo efficacy and/or target engagement.
What kinds of activities does "IND-enabling" work typically include?
IND-enabling development typically includes refining manufacturing and formulation approaches, generating required pharmacology and toxicology data under appropriate standards, characterizing pharmacokinetics and dose exposure relationships, and addressing other preclinical and CMC (chemistry, manufacturing, and controls) requirements that regulators expect before approving a first-in-human trial.
What is the expected endpoint or deliverable of a successful project?
By the end of the funding period, the project is expected to have, at minimum, an IND submission to the FDA.
Are human clinical trials required under this funding opportunity?
No. The program notes it can support early phase clinical trials, but clinical trials are not required. The emphasis is on reaching the regulatory milestone of an IND submission.
Who is eligible to apply?
Eligibility is focused on small businesses, consistent with SBIR rules.
Can a foreign (non-U.S.) organization apply as the main applicant?
No. Foreign (non-U.S.) entities are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible.
Are any project activities outside the U.S. allowed?
The information notes that "foreign components" as defined by the NIH Grants Policy Statement may be allowed. This generally means certain well-justified project elements could potentially be carried out outside the U.S. under NIH policy, even though the applicant must be a qualifying U.S. small business.
Is cost sharing or matching funding required?
No. The opportunity does not require cost sharing or matching funds.
What is the associated CFDA number and program area?
The opportunity is associated with CFDA number 93.273, Alcohol Research Programs.
What category is this funding opportunity listed under?
It was described as a discretionary funding opportunity in the health category.
When was the opportunity posted, and is it still active?
It was posted on March 25, 2015. The original and final closing date listed is December 11, 2017, with an archive date of January 11, 2018. Based on those dates, the announcement is no longer active and remains available for reference.
Where was the official announcement listed?
The official NIH listing was provided through the NIH grants guide webpage for PAR-15-154.
Who should be contacted for technical issues accessing the full announcement?
For technical issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
How should applicants think about the stage and fit of this opportunity?
This opportunity is best understood as a translational bridge from advanced preclinical development to the clinic for SBIR-eligible companies working on medications within NIAAA's mission area. It supports the practical and regulatory work needed to convert a validated therapeutic candidate into an IND-ready product package, with IND submission as the minimum expected milestone.
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Previous opportunity: Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (UT2)
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