Opportunity Information: Apply for PAR 15 153
Apply for PAR 15 153
- 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 (UT2)" 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 24, 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 Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (UT2) opportunity (Funding Opportunity Number PAR 15-153) is a National Institutes of Health (NIH) funding announcement aimed specifically at Small Business Technology Transfer (STTR) applicants working on new therapeutic agents that fit within the mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The overall purpose is to help small businesses, in partnership with a research institution as required under STTR rules, push a promising medication candidate through the key preclinical and translational steps needed to reach the point where an IND can be filed with the U.S. Food and Drug Administration (FDA). In practical terms, this program is designed to bridge the gap between having a strong therapeutic lead and being ready to ask FDA for permission to begin clinical testing in humans.
A central feature of this FOA is that applicants must already have an identified therapeutic candidate before they apply. This is not a basic discovery or early hit-finding program; it assumes you are past the stage of simply proposing a target or a general mechanism. The candidate should already show convincing characteristics that support moving toward clinical development, such as measurable bioactivity, adequate stability, a realistic path to manufacturing, acceptable bioavailability, and evidence of in vivo efficacy and/or target engagement. The emphasis on properties like manufacturability and bioavailability signals that NIAAA is looking for projects that have thought through real-world development constraints, not just laboratory proof-of-concept results.
The funding supports IND-enabling studies, meaning the package of work typically required to prepare a credible IND submission. While the FOA text in the provided description does not list specific study types, IND-enabling work commonly includes activities such as refining formulation, establishing or scaling manufacturing processes, conducting required toxicology and safety pharmacology studies, collecting pharmacokinetics and dose-exposure data, and generating the documentation and quality controls expected for regulatory review. The end-of-project milestone is explicit: by the conclusion of the award, a successful project should have, at minimum, submitted an IND application to the FDA. That framing makes the program strongly milestone-driven, with a clear regulatory deliverable rather than a purely academic endpoint like publications.
The award mechanism is a cooperative agreement, which generally indicates substantial involvement by the funding agency compared with a standard grant. Under a cooperative agreement, NIH program staff often play an active role in oversight, milestone tracking, and coordination, which can be especially relevant for development programs where go/no-go decisions and regulatory alignment matter. The activity category is Health, and the relevant CFDA listing is 93.273 (Alcohol Research Programs). There is no cost sharing or matching requirement stated for this opportunity, which reduces barriers for small businesses that may not have significant non-federal capital available.
An additional point is that, while the FOA’s main focus is IND-enabling development, it also allows support for early phase clinical trials, though clinical trials are not required. This means a project can be structured either to stop at IND submission (the minimum expected outcome) or, if appropriate and feasible within the award scope and timeline, to proceed into initial human testing once regulatory clearance is obtained. That flexibility can be helpful for teams that are ready to move quickly into first-in-human or other early clinical evaluations, but it does not force applicants to promise clinical execution if their most urgent need is completing the preclinical regulatory package.
Eligibility is limited to small businesses applying under the STTR framework. Foreign (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible either, although foreign components as defined in the NIH Grants Policy Statement may be allowed in some circumstances. The opportunity was posted on March 24, 2015 (created March 25, 2015), with an original and final closing date of December 11, 2017, and an archive date of January 11, 2018. The archived status indicates it is no longer open for applications, but it can still serve as a useful template for understanding how NIAAA structures STTR-based translational funding aimed at moving alcohol-related therapeutics toward clinical readiness.
For reference, the full announcement was provided through NIH’s grants guide (http://grants.nih.gov/grants/guide/pa-files/PAR-15-153.html), and NIH’s Office of Extramural Research (OER) webmaster contact information was listed for access or linking issues.
Frequently Asked Questions (FAQs)
What is PAR 15-153 (UT2) trying to fund?
PAR 15-153, titled "Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (UT2)," is an NIH funding announcement intended to support Small Business Technology Transfer (STTR) projects that advance a medication candidate toward IND readiness. The practical goal is to move a promising therapeutic agent through key preclinical and translational development steps so the team can file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).
Which NIH institute is this opportunity associated with?
This opportunity aligns with the mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is part of the National Institutes of Health (NIH).
Who is eligible to apply?
Eligibility is limited to small businesses applying under the STTR framework. The project must be structured as an STTR partnership, meaning the small business must collaborate with a research institution as required by STTR rules.
Are foreign organizations eligible to apply?
No. Foreign (non-U.S.) entities are not eligible to apply. In addition, non-U.S. components of U.S. organizations are not eligible to apply under this opportunity.
Are any foreign components allowed as part of a project team?
The description notes that foreign components (as defined in the NIH Grants Policy Statement) may be allowed in some circumstances, even though foreign entities and non-U.S. components of U.S. organizations are not eligible to apply.
What stage should a project be in before applying?
Applicants must already have an identified therapeutic candidate before applying. This program is not designed for basic discovery, early target identification, or hit-finding. It assumes the project is beyond proposing a general mechanism and is ready for development-oriented work tied to IND submission.
What characteristics should the therapeutic candidate already demonstrate?
The candidate is expected to show convincing characteristics supporting clinical development readiness, such as measurable bioactivity, adequate stability, a realistic path to manufacturing, acceptable bioavailability, and evidence of in vivo efficacy and/or target engagement.
What does "IND-enabling" mean in the context of this opportunity?
"IND-enabling" refers to the body of preclinical and translational work typically needed to prepare a credible IND submission to FDA. The description emphasizes that the funded effort is meant to bridge the gap between a strong therapeutic lead and being ready to request FDA permission to begin human clinical testing.
What kinds of activities might be supported as IND-enabling work?
While the provided description does not list a required set of study types, it describes common IND-enabling activities such as formulation refinement, establishing or scaling manufacturing processes, required toxicology and safety pharmacology studies, pharmacokinetics and dose-exposure studies, and generating documentation and quality controls for regulatory review.
What is the expected end-of-project outcome?
The end-of-project milestone is explicit: by the conclusion of the award, a successful project should have, at minimum, submitted an IND application to the FDA. The program is framed around a clear regulatory deliverable rather than an academic output like publications.
Does the program require clinical trials?
No. Clinical trials are not required. However, the opportunity allows support for early phase clinical trials, giving applicants the option to move into initial human testing if appropriate after regulatory clearance is obtained.
If clinical trials are optional, how can a project be structured?
A project may be structured to end at IND submission (the minimum expected outcome), or it may include early phase clinical trials if that is feasible within the award scope and timeline and if regulatory clearance is obtained.
What is the funding mechanism for this opportunity?
The award mechanism is a cooperative agreement. This generally means there is substantial involvement by the funding agency compared with a standard grant, often including more active oversight, milestone tracking, and coordination by NIH program staff.
Why does the cooperative agreement structure matter for applicants?
Because the goal is milestone-driven and tied to a regulatory endpoint (IND submission), the cooperative agreement structure suggests NIH program staff may be actively involved in monitoring progress, tracking milestones, and supporting coordination that is relevant to go/no-go decisions and regulatory alignment.
Is there a cost sharing or matching requirement?
No cost sharing or matching requirement is stated in the provided description of this opportunity.
What is the activity category and CFDA listing associated with this opportunity?
The activity category is Health, and the CFDA listing is 93.273 (Alcohol Research Programs).
Is this funding opportunity currently open for applications?
No. The opportunity is archived and is no longer open for applications.
When was the opportunity posted and when did it close?
The opportunity was posted on March 24, 2015 (created March 25, 2015). The original and final closing date listed is December 11, 2017, and the archive date is January 11, 2018.
What therapeutic areas does this opportunity focus on?
It focuses on developing medications to treat Alcohol Use Disorder and alcohol-related disorders, specifically within NIAAA's mission.
Where can the full announcement be found?
The full announcement was provided through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-153.html
Who was listed as a contact for access or linking issues?
The NIH Office of Extramural Research (OER) webmaster contact information was listed for access or linking issues related to the announcement.
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