Opportunity Information: Apply for PAR 15 073
Apply for PAR 15 073
- 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 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 grant opportunity titled "Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (UT2)" (Funding Opportunity Number PAR 15 073) is a National Institutes of Health (NIH) cooperative agreement aimed specifically at moving promising medication candidates for alcohol use disorder (AUD) and other alcohol-related conditions toward an FDA Investigational New Drug (IND) submission. It sits under the National Institute on Alcohol Abuse and Alcoholism (NIAAA) mission and is structured to help bridge the costly, high-risk gap between preclinical discovery and readiness to begin formal clinical testing in humans. In practical terms, the program is meant for groups that already have a real therapeutic candidate in hand and now need to complete the defined IND-enabling package that regulators typically expect before allowing first-in-human studies.
A key feature of this FOA is that it is directed to Small Business Technology Transfer (STTR) applicants, meaning it is designed for small U.S. companies working in partnership with a research institution to advance translational development. Unlike very early-stage discovery programs, this one expects that the applicant already has an identified candidate that has demonstrated enough favorable characteristics to justify an IND-enabling push. The announcement explicitly notes that the candidate should already show properties consistent with moving toward a clinical application, such as adequate bioactivity and stability, reasonable manufacturability, sufficient bioavailability, and evidence of in vivo efficacy and/or target engagement. That language signals that the project should not be centered on open-ended screening or basic mechanism work, but instead on a credible lead that is mature enough to be developed under a regulated, milestone-driven plan.
The core purpose of the funding is to support IND-enabling studies for that therapeutic candidate. While the FOA summary does not list every allowable experiment line-by-line, IND-enabling work typically includes activities like scale-up and manufacturing development, formulation work, analytical methods, pharmacokinetics and ADME characterization, dose range finding, and the safety/toxicology studies needed for regulatory submission, along with planning and documentation that align with FDA expectations. Because the funding mechanism is a cooperative agreement, the NIH program staff generally have a more active role than they would under a standard grant, often involving substantial scientific or programmatic involvement during the project period. The intended endpoint is concrete: by the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration. That makes the deliverable more like a development milestone than a publication goal.
Although the program is centered on IND preparation, it also indicates that early phase clinical trials are supported, but they are not required. In other words, the FOA is primarily meant to get a candidate to the IND filing stage, and applicants should not assume they must run a clinical trial to be considered responsive. However, teams that are positioned to proceed rapidly may be able to propose initial clinical work as part of a broader plan, provided the IND-enabling components are addressed in a way that satisfies the program intent and timeline.
Eligibility is limited to United States small business concerns (SBCs), and the FOA provides the standard SBA-style criteria for what counts as an eligible SBC. The business must be organized for profit and based in the U.S., operating primarily within the U.S. or making a significant contribution to the U.S. economy. It must fall into an allowed legal structure (for example, LLC, corporation, partnership, and similar forms), and it must meet ownership and control rules applicable to small business programs, including provisions addressing individual ownership/control and certain investor-owned structures. The company, together with its affiliates, must have no more than 500 employees. Importantly, because it is STTR-focused, applicants should also expect that the STTR partnership requirements apply, meaning a formal collaboration between the small business and a nonprofit research institution is typically integral to the application approach.
Administratively, this opportunity is categorized as discretionary funding, uses a cooperative agreement as the funding instrument type, and falls under the health activity category. It is associated with CFDA number 93.273 (Alcohol Research Programs) and does not require cost sharing or matching. The opportunity was posted on December 15, 2014, with a creation date of February 18, 2015, and it was later archived (archive date March 18, 2018). The listing includes an NIH grants guide link for the full announcement text and provides NIH Office of Extramural Research (OER) webmaster contact information for access or linking issues.
Overall, the program is best understood as a translational acceleration mechanism for small businesses that already have a viable medication candidate for AUD or alcohol-related disorders and need targeted support to complete the regulated preclinical development steps that culminate in an FDA IND submission. The emphasis on having an identified candidate with demonstrated performance characteristics before applying, combined with the defined expectation of an IND submission by the end of the award, makes this a milestone-driven opportunity intended to push real products toward first-in-human readiness rather than fund exploratory research.
Frequently Asked Questions (FAQs)
1. What is the title of this grant opportunity?
The opportunity is titled "Investigational New Drug (IND) enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol related Disorders (UT2)".
2. What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR 15 073.
3. Which federal agency runs this opportunity?
This is a National Institutes of Health (NIH) opportunity, aligned with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) mission.
4. What is the main goal of this program?
The main goal is to support IND-enabling development so that a promising medication candidate for alcohol use disorder (AUD) or other alcohol-related disorders can be advanced to an FDA Investigational New Drug (IND) submission.
5. What stage of development is this funding meant for?
This program is designed for groups that already have an identified therapeutic candidate in hand and need to complete the defined IND-enabling package typically expected by regulators before first-in-human studies can begin.
6. Is this program for early discovery or screening research?
No. The description emphasizes that the project should not be centered on open-ended screening or basic mechanism work. It is intended for a credible, identified lead that is mature enough to move forward under a regulated, milestone-driven plan.
7. What characteristics should the medication candidate already demonstrate?
The opportunity indicates the candidate should already show properties consistent with moving toward clinical application, such as adequate bioactivity and stability, reasonable manufacturability, sufficient bioavailability, and evidence of in vivo efficacy and/or target engagement.
8. What kinds of activities are generally considered "IND-enabling" under this opportunity?
While the summary does not list every allowable experiment line-by-line, it describes IND-enabling work as typically including scale-up and manufacturing development, formulation work, analytical methods, pharmacokinetics and ADME characterization, dose range finding, and the safety/toxicology studies needed for regulatory submission, along with planning and documentation aligned with FDA expectations.
9. What is the expected endpoint or deliverable by the end of the award?
The intended endpoint is concrete: by the end of the funding period, a successful project should have, at a minimum, an IND application submitted to the U.S. Food and Drug Administration (FDA).
10. Does this funding require running a clinical trial?
No. Early phase clinical trials are described as supported, but not required. The program is primarily meant to get a candidate to the IND filing stage, and applicants should not assume a clinical trial must be included to be responsive.
11. Can an application include early phase clinical trials?
Yes. The description indicates that early phase clinical trials may be proposed by teams positioned to proceed rapidly, as part of a broader plan, as long as the IND-enabling components are addressed in a manner that satisfies the program intent and timeline.
12. What type of funding mechanism is used?
The opportunity uses a cooperative agreement as the funding instrument type.
13. What does it mean that this is a cooperative agreement?
Because it is a cooperative agreement, NIH program staff generally have a more active role than under a standard grant, often involving substantial scientific or programmatic involvement during the project period.
14. Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs), and the opportunity is directed to Small Business Technology Transfer (STTR) applicants.
15. What business requirements must an applicant meet to qualify as an eligible small business concern (SBC)?
The business must be organized for profit and based in the U.S., operating primarily within the U.S. or making a significant contribution to the U.S. economy. It must fit an allowed legal structure (such as an LLC, corporation, partnership, or similar form) and must meet applicable ownership and control rules used in small business programs. The company and its affiliates must have no more than 500 employees.
16. Is an STTR partnership required?
Yes. Because the opportunity is STTR-focused, the description indicates that STTR partnership requirements apply, meaning a formal collaboration between the small business and a nonprofit research institution is typically integral to the application approach.
17. What is the activity category associated with this opportunity?
The activity category is health.
18. Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
19. How is this opportunity categorized administratively?
It is categorized as discretionary funding and uses a cooperative agreement funding instrument.
20. What CFDA number is associated with this program?
The opportunity is associated with CFDA number 93.273 (Alcohol Research Programs).
21. When was the opportunity posted?
The opportunity was posted on December 15, 2014.
22. What is the creation date listed for the opportunity?
The creation date is February 18, 2015.
23. Is this opportunity still active?
No. The listing indicates the opportunity was archived, with an archive date of March 18, 2018.
24. Where can applicants find the full announcement text?
The listing includes an NIH grants guide link for the full announcement text.
25. Who is the contact for technical issues with access or linking?
The listing provides NIH Office of Extramural Research (OER) webmaster contact information for access or linking issues.
26. What is this program best understood as, in practical terms?
It is a translational acceleration mechanism for small businesses that already have a viable medication candidate for AUD or alcohol-related disorders and need targeted support to complete regulated preclinical development steps culminating in an FDA IND submission.
27. What makes this opportunity "milestone-driven"?
The description emphasizes both the requirement that applicants already have an identified candidate with demonstrated performance characteristics and the defined expectation of an IND submission by the end of the award, making the deliverable more like a development milestone than a publication goal.
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