Opportunity Information: Apply for RFA DA 17 015
Apply for RFA DA 17 015
- The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on Mar 09, 2016 and posted on Mar 09, 2016.
- Applicants must submit their applications by Jul 28, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3), funding opportunity number RFA-DA-17-015, is a National Institutes of Health (NIH) initiative from HHS (specifically NIDA) designed to push promising medication ideas for substance use disorders further down the real-world drug development path. The focus is on moving beyond basic discovery alone and supporting researchers who can translate strong scientific findings into actual therapeutic candidates that could eventually become FDA-approvable medications. In practical terms, the program is aimed at helping investigators take a molecule or drug concept that looks promising and do the work needed to make it more “development-ready,” such as refining the compound, generating key preclinical and/or clinical evidence, and clearing the kinds of milestones that typically stand between an academic insight and an industry-grade development program.
The target conditions are substance use disorders tied to major public health drivers: tobacco, cannabis, cocaine, methamphetamine, heroin, and prescription opioid misuse. NIDA is explicitly looking for outstanding basic and/or clinical researchers who already have the vision and skill set to operate in the translational space, meaning applicants should be able to show they can discover or optimize molecules and then advance those candidates through the drug development continuum. The language of the announcement stresses that eligibility depends on demonstrating the capacity to develop molecules with real therapeutic potential and to move them forward in a way that plausibly brings them closer to FDA approval, rather than stopping at early-stage proof-of-concept.
This opportunity uses the cooperative agreement mechanism and the UG3/UH3 structure. A cooperative agreement generally means there is substantial programmatic involvement by the funding agency compared with a standard research grant, and the UG3/UH3 format typically reflects a phased approach where an initial stage supports planning and early development activities, followed by a subsequent stage that supports more advanced development work once certain expectations or milestones are met. The overall intent is to de-risk and accelerate the translational steps needed to position a candidate medication for later-stage development and, ultimately, the regulatory pathway.
The award falls under a discretionary funding category and is associated with CFDA number 93.279, within the health and education activity area. The program anticipated making about two awards, with an award ceiling of $1,000,000. The opportunity was posted on March 9, 2016, created the same day, and had an application closing date of July 28, 2016.
Eligibility is broad and includes many organization types that commonly participate in biomedical research and development. Eligible applicants include state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those specific nonprofit categories); for-profit organizations other than small businesses; small businesses; and additional entities as described in the full eligibility text. This wide net reflects the program’s translational emphasis, since credible medication development efforts can be housed in academia, government labs, nonprofit research organizations, or commercial settings.
Overall, the central message of this FOA is that NIDA wants to back researchers who can convert scientific discoveries into tangible medication candidates for substance use disorders and do the disciplined development work required to move those candidates meaningfully closer to eventual FDA approval.
FAQs: NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3) - RFA-DA-17-015
What is this funding opportunity?
This is the NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3), funding opportunity number RFA-DA-17-015. It is a National Institutes of Health (NIH) initiative under HHS, specifically through the National Institute on Drug Abuse (NIDA), focused on advancing promising medication concepts for substance use disorders further along the real-world drug development path.
What is the main goal of the program?
The main goal is to move beyond basic discovery and support investigators who can translate strong scientific findings into therapeutic candidates that could plausibly become FDA-approvable medications. The emphasis is on making a candidate more development-ready by completing key steps that commonly block progress between an academic insight and an industry-grade development program.
What kinds of research or development activities does this program emphasize?
Based on the description provided, the program emphasizes practical translational work such as refining or optimizing a compound, generating key preclinical and/or clinical evidence, and meeting milestones that help position a candidate medication for later-stage development and eventual regulatory consideration.
Which substance use disorders or drug categories are targeted?
The target conditions are substance use disorders tied to major public health drivers, specifically: tobacco, cannabis, cocaine, methamphetamine, heroin, and prescription opioid misuse.
Who is NIDA looking to support as applicants or project leaders?
NIDA is explicitly looking for outstanding basic and/or clinical researchers who can operate in the translational space. The announcement stresses that applicants should be able to demonstrate the capacity to develop or optimize molecules with real therapeutic potential and to advance those candidates along the drug development continuum in a way that brings them closer to FDA approval.
Is this opportunity focused only on basic discovery research?
No. The focus is specifically on moving beyond basic discovery alone. The central theme is translation: turning scientific discoveries into tangible medication candidates and doing the disciplined development work needed to move them meaningfully closer to eventual FDA approval.
What funding mechanism is used for this opportunity?
This opportunity uses a cooperative agreement mechanism and follows the UG3/UH3 structure.
What does it mean that this is a cooperative agreement?
A cooperative agreement generally means there is substantial programmatic involvement by the funding agency compared with a standard research grant. In this program, that structure supports the intent to de-risk and accelerate translational development steps through closer involvement from the funding agency.
How does the UG3/UH3 phased structure work at a high level?
The UG3/UH3 format typically reflects a phased approach: an initial stage that supports planning and early development activities, followed by a subsequent stage that supports more advanced development work once certain expectations or milestones are met.
How many awards were anticipated?
The program anticipated making about two awards.
What is the maximum award amount (ceiling)?
The award ceiling was listed as $1,000,000.
What is the CFDA number associated with this opportunity?
The associated CFDA number is 93.279.
What is the activity area or category for this opportunity?
The opportunity is within the health and education activity area and falls under a discretionary funding category.
When was this opportunity posted and created?
The opportunity was posted on March 9, 2016, and it was created the same day (March 9, 2016).
What was the application closing date?
The application closing date was July 28, 2016.
What types of organizations are eligible to apply?
Eligibility is broad and includes many organization types that commonly participate in biomedical research and development, including:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Other Native American tribal organizations
- Public housing authorities / Indian housing authorities
- Nonprofit organizations (501(c)(3) and non-501(c)(3), excluding institutions of higher education in those specific nonprofit categories)
- For-profit organizations other than small businesses
- Small businesses
- Additional entities as described in the full eligibility text
Why is eligibility so broad for this FOA?
The description emphasizes the translational nature of the program and notes that credible medication development efforts can be housed in academia, government labs, nonprofit research organizations, or commercial settings. A broad eligibility list supports participation from all of these environments.
What is the central message or priority of this FOA?
The central message is that NIDA wants to back researchers who can convert scientific discoveries into tangible medication candidates for substance use disorders and complete the development work required to move those candidates meaningfully closer to eventual FDA approval.
What does "development-ready" mean in the context of this opportunity?
In the context provided, "development-ready" refers to doing the work needed to make a promising molecule or drug concept more suitable for real-world development, such as refining the compound, generating key preclinical and/or clinical evidence, and clearing milestones that typically separate early research from an industry-grade development program.
Is the program aimed at de-risking translational steps?
Yes. The described intent is to de-risk and accelerate the translational steps needed to position a candidate medication for later-stage development and ultimately the regulatory pathway.
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