Opportunity Information: Apply for RFA DA 16 008

  • The National Institutes of Health 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 Drug Abuse and Addiction Research Programs.
  • This funding opportunity was created on Aug 21, 2015 and posted on Aug 21, 2015.
  • Applicants must submit their applications by Dec 3, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
  • 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 3 candidate(s).
  • Eligible applicants include: Special district governments Small businesses Independent school districts For profit organizations other than small businesses Public housing authorities/Indian housing authorities County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Private institutions of higher education City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:

The NIDA Translational Avant Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3) is a National Institutes of Health (NIH) funding opportunity designed to push promising medication candidates for substance use disorders further along the path toward real-world clinical use. The program is aimed at highly capable basic and/or clinical researchers who can take discoveries from the lab or early human work and translate them into viable therapeutic molecules for treating substance use disorders tied to tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opioid misuse. The core expectation is that applicants are not simply proposing exploratory science, but can show a credible, well-supported ability to create or refine drug-like molecules and move them through key stages of the drug development continuum, with the long-term objective of positioning those candidates closer to eventual FDA approval.

This opportunity is offered as a cooperative agreement, meaning NIH (through NIDA) expects to have substantial involvement in the project as it progresses rather than acting only as a passive funder. The funding mechanism is UG3/UH3, which is commonly used as a phased, milestone-driven structure. In practical terms, that structure is intended to support an initial, time-limited phase focused on meeting defined feasibility or development milestones (UG3), with the possibility of transitioning into a subsequent phase (UH3) to continue advancement once those milestones are achieved. The overall theme is translational momentum: moving from strong scientific rationale to a development-ready therapeutic candidate, rather than stopping at proof-of-concept alone.

From an administrative and funding standpoint, the opportunity (Funding Opportunity Number RFA-DA-16-008) was posted on August 21, 2015, with an original and final application closing date of December 3, 2015, and an archive date of January 3, 2016. NIH anticipated making about three awards under this announcement. The estimated total funding listed is $3,000,000, and the award ceiling is $1,000,000. There is no cost-sharing or matching requirement, which reduces the burden on applicants to bring non-federal funds to the table.

Eligibility is broad and includes many kinds of organizations across the public, private, nonprofit, and governmental spectrum. Eligible applicants include state, county, city or township governments; special district governments; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (including both those with and without 501(c)(3) status, with the latter eligible if they are not institutions of higher education); small businesses; and for-profit organizations other than small businesses. The announcement also explicitly includes a range of mission-focused and community-anchored institutions and entities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations. Additional eligible groups include federally recognized tribal governments, other Indian/Native American tribal governments, U.S. territories or possessions, regional organizations, eligible federal agencies, and even non-U.S. entities (foreign organizations), reflecting an intent to draw strong translational drug development ideas from a wide pool.

The program sits within the NIH’s drug abuse and addiction research portfolio (CFDA 93.279, Drug Abuse and Addiction Research Programs) and is categorized under education and health. The announcement emphasizes that the work should be grounded in credible drug development capability, including the capacity to develop molecules with therapeutic potential and to advance them through preclinical and/or clinical development steps. While the short description does not list specific required activities, the language makes clear that the bar is set at practical, development-oriented outcomes, consistent with the stated end goal of bringing medication candidates closer to FDA approval for treating substance use disorders.

For applicants or readers who need the full archived announcement text and requirements, NIH provided an additional information link to the official NIH Guide posting: http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-16-008.html. For technical issues accessing or linking to the announcement, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

Frequently Asked Questions (FAQs)

What is the NIDA Translational Avant Garde Award (UG3/UH3)?

It is a National Institutes of Health (NIH) funding opportunity from the National Institute on Drug Abuse (NIDA) intended to move promising medication candidates for substance use disorders further toward real-world clinical use. The emphasis is on translational progress, not exploratory research alone.

What is the official funding opportunity number?

The Funding Opportunity Number is RFA-DA-16-008.

What is the goal of this program?

The goal is to advance viable therapeutic molecules for substance use disorders along key stages of the drug development continuum, with the long-term objective of positioning candidates closer to eventual FDA approval.

What substances or substance use disorders does this opportunity focus on?

The opportunity targets medications for substance use disorders tied to tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opioid misuse.

Who is this award designed for?

It is aimed at highly capable basic and/or clinical researchers who can translate discoveries from the lab or early human work into development-ready therapeutic molecules.

Is this opportunity meant for exploratory or early-stage science?

Not primarily. The core expectation is that applicants are not simply proposing exploratory science; they should demonstrate a credible, well-supported ability to create or refine drug-like molecules and advance them through development-oriented milestones.

What does it mean that this award is a cooperative agreement?

As a cooperative agreement, NIH (through NIDA) expects to have substantial involvement in the project as it progresses, rather than acting only as a passive funder.

What does the UG3/UH3 mechanism mean in practice?

UG3/UH3 is a phased, milestone-driven structure. The UG3 phase supports an initial, time-limited effort focused on achieving defined feasibility or development milestones. If those milestones are met, the project may transition to the UH3 phase to continue advancing the candidate.

How many awards did NIH anticipate making?

NIH anticipated making about three awards under this announcement.

What is the estimated total funding for this opportunity?

The estimated total funding listed is $3,000,000.

What is the award ceiling?

The award ceiling is $1,000,000.

Is cost sharing or matching required?

No. There is no cost-sharing or matching requirement.

When was this opportunity posted and when did it close?

It was posted on August 21, 2015. The original and final application closing date was December 3, 2015.

Is this funding opportunity still active?

The information provided indicates it is archived. The archive date is January 3, 2016.

Which types of organizations are eligible to apply?

Eligibility is broad and includes: state, county, city or township governments; special district governments; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status, with the latter eligible if they are not institutions of higher education); small businesses; and for-profit organizations other than small businesses.

Are tribal governments and U.S. territories eligible?

Yes. Eligible applicants include federally recognized tribal governments, other Indian/Native American tribal governments, and U.S. territories or possessions.

Are foreign organizations eligible to apply?

Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).

Are HBCUs, HSIs, and other designated serving institutions included in eligibility?

Yes. The announcement explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Are faith-based or community-based organizations eligible?

Yes. The opportunity explicitly includes faith-based or community-based organizations among eligible applicant types.

What program area or federal listing is this opportunity associated with?

It sits within NIH's drug abuse and addiction research portfolio and is associated with CFDA 93.279 (Drug Abuse and Addiction Research Programs). It is categorized under education and health.

What kind of capabilities does the announcement emphasize?

The description emphasizes credible drug development capability, including the capacity to develop molecules with therapeutic potential and advance them through preclinical and/or clinical development steps.

Where can applicants find the full archived announcement and requirements?

NIH provided the official NIH Guide posting link: http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-16-008.html.

Who should be contacted for technical issues accessing or linking to the announcement?

The contact listed for technical issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

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