Opportunity Information: Apply for PAR 15 074
Apply for PAR 15 074
- 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 Feb 18, 2015 and posted on Dec 15, 2014.
- Applicants must submit their applications by Feb 18, 2015. (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 followingOnly United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture3. i. SBIR and STTR. Be a concern which is more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 percent directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these ORii. SBIR only. Be a concern which is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 percent of the concern ORiii. SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements.4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
The Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (U44) opportunity (Funding Opportunity Number PAR 15 074) is a National Institutes of Health (NIH) program run under the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It is offered as a discretionary funding opportunity using a cooperative agreement mechanism (U44) under the Small Business Innovation Research (SBIR) program. The overall aim is straightforward: support U.S. small businesses that already have a promising therapeutic candidate for Alcohol Use Disorder (AUD) or other alcohol-related disorders, and help move that candidate through the key preclinical and regulatory steps needed to submit an IND to the U.S. Food and Drug Administration (FDA). In other words, this announcement is not meant for basic discovery or very early target identification work; it is intended for groups that are past the idea stage and are ready to do the practical development work that makes a drug candidate viable for entry into human testing.
A central requirement is that applicants come in with an identified candidate in hand before applying, and that the candidate already shows features consistent with the intended clinical use. The FOA highlights the kinds of attributes NIH expects to see at that point, such as enough bioactivity to justify continued investment, acceptable stability and manufacturability, reasonable bioavailability, and evidence of in vivo efficacy and/or target engagement. This emphasis signals that the program is designed to de-risk a candidate and prepare a credible regulatory package, rather than fund open-ended experimentation. The funded work is described as IND-enabling development, meaning studies typically associated with getting an FDA IND ready, such as activities supporting safety evaluation, dosing justification, product formulation and manufacturing readiness, and other development steps that strengthen the eventual IND submission.
The expected end point of a successful project is clearly defined: by the end of the award period, the project should have, at a minimum, an IND application submitted to the FDA. The announcement also notes that the program can support early phase clinical trials, but those trials are not required. That framing makes the intent clear: the primary deliverable is regulatory readiness and IND submission, with clinical entry as an optional extension depending on what is feasible within the project’s scope, timeline, and budget.
Eligibility is limited to only United States small business concerns (SBCs) that meet the SBIR definition at the time of award for Phase I and Phase II. The FOA lays out the standard federal SBA/NIH SBIR eligibility elements, including being organized for profit with a U.S. place of business and primary U.S. operations (or otherwise making a significant contribution to the U.S. economy), being in an allowable legal form (such as LLC, corporation, partnership, joint venture under specified limits, and similar forms), and having no more than 500 employees including affiliates. Ownership and control rules follow SBIR norms and include pathways for majority ownership by U.S. citizens or permanent residents, as well as SBIR-only allowances for certain venture capital operating companies, hedge funds, and private equity firm ownership structures, provided no single such entity owns more than 50 percent of the concern. Joint ventures are allowed as long as each participating entity meets the applicable ownership/control requirements, with additional compliance requirements referenced for joint venture registration and proposal rules.
From an administrative standpoint, the opportunity is categorized under the health activity area and is associated with CFDA 93.273 (Alcohol Research Programs). There is no cost sharing or matching requirement. The FOA was posted on December 15, 2014, created on February 18, 2015, and later archived on March 18, 2015. Key dates listed include an original closing date of December 11, 2017, with a current closing date shown as February 18, 2015 in the provided record, reflecting the lifecycle of the posting and archival status rather than an open, active competition today. The full announcement was made available via the NIH grants guide page linked in the source data, and technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster contact.
In practical terms, this FOA is best understood as a translational bridge for small companies developing medications for AUD and related alcohol-driven conditions: it is meant to fund the concrete, regulated development work that turns a biologically interesting compound into an FDA-ready clinical candidate. The program’s success metric is not a publication or a proof-of-concept experiment, but a regulatory milestone: an IND submission that positions the candidate to enter human testing, with optional support for early clinical evaluation when appropriate.
Frequently Asked Questions (FAQs)
What is the IND-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (U44) opportunity?
It is a National Institutes of Health (NIH) funding opportunity run by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) under the Small Business Innovation Research (SBIR) program. It uses a cooperative agreement mechanism (U44) to support IND-enabling development activities for medications targeting Alcohol Use Disorder (AUD) and other alcohol-related disorders.
What is the Funding Opportunity Number (FOA number) for this program?
The Funding Opportunity Number is PAR 15 074.
Which NIH institute administers this program?
The program is run under NIH by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
What is the main goal of this funding opportunity?
The goal is to support U.S. small businesses that already have a promising therapeutic candidate for AUD or other alcohol-related disorders and help move that candidate through key preclinical and regulatory steps needed to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).
Is this FOA intended for basic research or early-stage discovery?
No. The announcement is not meant for basic discovery, very early target identification, or idea-stage projects. It is intended for groups that are past the idea stage and ready to conduct practical development work required to make a drug candidate viable for entry into human testing.
Do applicants need to have a therapeutic candidate identified before applying?
Yes. A central requirement is that applicants have an identified therapeutic candidate in hand before applying, and that the candidate already shows features consistent with the intended clinical use.
What kinds of candidate attributes does the FOA expect at the time of application?
The FOA highlights expectations such as sufficient bioactivity to justify continued investment, acceptable stability and manufacturability, reasonable bioavailability, and evidence of in vivo efficacy and/or target engagement.
What does "IND-enabling development" mean in this context?
It refers to the studies and development activities typically associated with preparing an FDA IND, including work supporting safety evaluation, dosing justification, product formulation, manufacturing readiness, and other development steps that strengthen an eventual IND submission.
What is the expected endpoint or primary deliverable of a successful project?
By the end of the award period, the project should have, at a minimum, an IND application submitted to the FDA.
Are clinical trials required under this FOA?
No. The FOA notes that the program can support early phase clinical trials, but those trials are not required. The primary deliverable is IND submission and regulatory readiness.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs) that meet the SBIR definition at the time of award for Phase I and Phase II.
What general SBIR small business requirements are referenced?
The FOA references standard SBA/NIH SBIR eligibility elements, including being organized for profit, having a U.S. place of business and primary U.S. operations (or otherwise making a significant contribution to the U.S. economy), being in an allowable legal form (such as LLC, corporation, partnership, or certain joint ventures within specified limits), and having no more than 500 employees including affiliates.
Are there ownership and control rules for applicants?
Yes. Ownership and control follow SBIR norms, including pathways for majority ownership by U.S. citizens or permanent residents. The FOA also references SBIR-only allowances for certain venture capital operating companies, hedge funds, and private equity firm ownership structures, provided no single such entity owns more than 50 percent of the concern.
Are joint ventures allowed to apply?
Yes. Joint ventures are allowed as long as each participating entity meets applicable ownership/control requirements. The FOA also references additional compliance requirements related to joint venture registration and proposal rules.
What is the funding mechanism used for this opportunity?
This opportunity uses a cooperative agreement mechanism (U44) under the SBIR program and is described as a discretionary funding opportunity.
Is cost sharing or matching required?
No. The FOA indicates there is no cost sharing or matching requirement.
What activity area and CFDA number are associated with this FOA?
It is categorized under the health activity area and is associated with CFDA 93.273 (Alcohol Research Programs).
When was this FOA posted and what is its current status based on the provided record?
The FOA was posted on December 15, 2014, created on February 18, 2015, and later archived on March 18, 2015. The dates shown in the record reflect the posting lifecycle and archival status rather than an open, active competition today.
What closing dates are listed in the provided information?
The record lists an original closing date of December 11, 2017, and also shows a current closing date as February 18, 2015, which aligns with the archived lifecycle information included in the record.
Where was the full announcement made available?
The full announcement was made available via the NIH grants guide page linked in the source data.
Who was listed as the contact for technical access issues?
Technical access issues were directed to the NIH Office of Extramural Research (OER) webmaster contact.
In practical terms, what type of project is this FOA designed to support?
It is designed as a translational bridge for small companies developing medications for AUD and related alcohol-driven conditions, funding regulated, concrete development work that de-risks a candidate and prepares a credible regulatory package for FDA IND submission.
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