Opportunity Information: Apply for RFA DA 13 004
Apply for RFA DA 13 004
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Synthesis and Preclinical Evaluation of Medications to Treat Substance Use Disorders (SUDs) (R01)" 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 May 15, 2012 and posted on May 15, 2012.
- Applicants must submit their applications by Aug 15, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,500,000.00 to eligible and selected applicants.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments City or township governments Special district governments Public and State controlled institutions of higher education State governments Public housing authorities/Indian housing authorities Small businesses Private institutions of higher education Native American tribal governments (Federally recognized) Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have 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 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
This funding opportunity, RFA-DA-13-004, is an NIH/NIDA R01 grant solicitation focused on moving potential medications for Substance Use Disorders (SUDs) from early discovery into solid preclinical development. The central aim is to support projects that create and refine new molecular entities and then evaluate them in preclinical studies so that the most promising candidates can be advanced toward an Investigational New Drug (IND) submission. In practical terms, NIDA is looking for teams that can do the hands-on medicinal chemistry or biologics development work, generate credible efficacy and safety signals in appropriate preclinical models, and make disciplined, data-driven decisions about whether a compound deserves further investment.
Projects considered responsive can include the synthesis, identification, and optimization of lead compounds, along with preclinical efficacy testing and/or safety assessment. The announcement is intentionally broad about what a "new molecular entity" can be: traditional small-molecule drug candidates are welcome, but so are enzymes, antibodies, and vaccines, reflecting NIDA's interest in multiple therapeutic strategies to address addiction and relapse. The expectation is not simply to screen compounds and report positive findings, but to carry a candidate through iterative optimization and structured preclinical evaluation in a way that resembles real development planning.
A key requirement is that applications include clear timelines and explicit decision trees that define go/no-go criteria. This means applicants must spell out, in advance, what specific results would justify advancing a compound to the next step (for example, potency thresholds, selectivity margins, target engagement, pharmacokinetics, efficacy in a validated model, or acceptable safety/tolerability signals), and what outcomes would trigger stopping or redirecting the project. This emphasis on milestones and decision points signals that NIDA wants proposals to operate with development discipline, prioritizing candidates that can realistically progress toward IND-enabling work rather than remaining in open-ended exploratory research.
Administratively, this is a discretionary grant opportunity using the NIH R01 funding mechanism. The CFDA listing is 93.279 (Drug Abuse and Addiction Research Programs). The opportunity did not require cost sharing or matching. The posting and creation date were May 15, 2012, with an original and current closing date of August 15, 2012, and an archive date of September 15, 2012. The estimated total funding amount listed for the opportunity was $2,500,000.
Eligibility is broad and includes many categories of applicants: nonprofit organizations (including 501(c)(3) and other nonprofits), for-profit organizations (including small businesses), local and state governmental entities (such as county governments, city/township governments, special district governments, and state governments), public and private institutions of higher education, public housing authorities/Indian housing authorities, independent school districts, and eligible tribal entities and tribal organizations. The announcement also explicitly allows applications from non-domestic (non-U.S.) entities (foreign institutions), non-domestic components of U.S. organizations, and foreign components as defined under NIH policy. Additional eligible applicant types called out include Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), regional organizations, U.S. territories or possessions, and eligible agencies of the federal government.
From a practical standpoint, NIDA is signaling that competitive applications should look like a preclinical development plan rather than a basic science proposal. Strong projects would typically lay out a coherent path from molecule creation or selection, through optimization and characterization, into targeted preclinical efficacy and safety studies, all tied together by predefined milestones and stopping rules. The end goal is to deliver one or more credible candidate compounds positioned to move toward IND submission, meaning the work should generate the kind of package that can support later-stage development decisions and regulatory planning, even if the IND itself is not part of the immediate scope.
For full details, NIDA directed applicants to the official NIH Guide announcement page associated with RFA-DA-13-004. Technical access issues were routed to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQ) - RFA-DA-13-004 (NIH/NIDA R01)
1) What is this funding opportunity (RFA-DA-13-004) about?
RFA-DA-13-004 is an NIH/NIDA solicitation using the R01 mechanism to support the transition of potential medications for Substance Use Disorders (SUDs) from early discovery into solid preclinical development. The focus is on creating/refining new molecular entities and evaluating them in preclinical studies so the strongest candidates can be advanced toward an Investigational New Drug (IND) submission.
2) What is the main goal NIDA is trying to achieve with this RFA?
The central goal is to fund projects that look and operate like disciplined preclinical development programs. Applicants are expected to do hands-on candidate creation/optimization (medicinal chemistry or biologics development), generate credible preclinical efficacy and safety signals in appropriate models, and use predefined, data-driven decision rules to determine whether a candidate should advance toward IND-enabling work.
3) What types of projects are considered responsive?
Responsive projects can include synthesis, identification, and optimization of lead compounds, along with preclinical efficacy testing and/or safety assessment. The work should be structured as iterative optimization paired with structured preclinical evaluation, rather than simple screening and reporting of positive results.
4) What kinds of therapeutic candidates are allowed under "new molecular entity"?
The RFA is intentionally broad. In addition to traditional small-molecule drug candidates, NIDA indicates interest in enzymes, antibodies, and vaccines as potential therapeutic strategies to address addiction and relapse.
5) Is this opportunity focused on basic science or development-style work?
NIDA signals that competitive applications should resemble a preclinical development plan rather than a basic science proposal. The expectation is a coherent path from candidate creation or selection, through optimization and characterization, into targeted preclinical efficacy and safety studies tied to predefined milestones and stopping rules.
6) What does NIDA expect beyond screening compounds?
NIDA is not looking for projects that only screen compounds and report promising hits. The intent is to carry one or more candidates through iterative optimization and structured preclinical evaluation with development discipline, similar to real-world development planning.
7) What are the required timeline and decision-tree elements in the application?
Applications must include clear timelines and explicit decision trees that define go/no-go criteria. Applicants are expected to state in advance what specific outcomes justify advancing to the next step and what outcomes would trigger stopping, redirecting, or deprioritizing a candidate.
8) What are examples of go/no-go criteria mentioned in the opportunity description?
Examples called out include potency thresholds, selectivity margins, target engagement, pharmacokinetics, efficacy in a validated model, and acceptable safety/tolerability signals. The application should specify which criteria apply and how they will be used to make advancement decisions.
9) Does the RFA require applicants to plan for IND submission?
The stated aim is to advance the most promising candidates toward an IND submission by generating a credible preclinical package that supports later development decisions and regulatory planning. The description indicates that an IND itself is not necessarily within the immediate scope, but the work should position candidates to move in that direction.
10) What funding mechanism is being used?
This is a discretionary NIH grant opportunity using the R01 funding mechanism.
11) What is the CFDA number for this opportunity?
The CFDA listing provided is 93.279 (Drug Abuse and Addiction Research Programs).
12) What is the estimated total funding amount listed?
The estimated total funding amount listed for the opportunity is $2,500,000.
13) Is cost sharing or matching required?
No. The opportunity states that cost sharing or matching was not required.
14) Who is eligible to apply?
Eligibility is broad and includes nonprofit organizations (including 501(c)(3) and other nonprofits), for-profit organizations (including small businesses), local and state governmental entities, public and private institutions of higher education, public housing authorities/Indian housing authorities, independent school districts, eligible tribal entities and tribal organizations, U.S. territories or possessions, regional organizations, and eligible agencies of the federal government.
15) Are specialized institution types explicitly included in eligibility?
Yes. The announcement explicitly calls out Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and tribal organizations among eligible applicants.
16) Are foreign (non-U.S.) organizations allowed to apply?
Yes. The opportunity explicitly allows applications from non-domestic (non-U.S.) entities (foreign institutions), non-domestic components of U.S. organizations, and foreign components as defined under NIH policy.
17) What were the key dates for this opportunity?
The posting and creation date was May 15, 2012. The original and current closing date was August 15, 2012. The archive date was September 15, 2012.
18) Where were applicants directed to find full details?
NIDA directed applicants to the official NIH Guide announcement page associated with RFA-DA-13-004 for full details.
19) Who should be contacted for technical access issues?
Technical access issues were routed to the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
20) What does NIDA mean by "development discipline" in this context?
Based on the description provided, "development discipline" means operating the project with predefined milestones, timelines, and decision points (including stopping rules), and using credible preclinical efficacy and safety evidence to guide whether a candidate should advance toward IND-oriented development rather than remaining exploratory.
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