Opportunity Information: Apply for RFA MH 16 406
Apply for RFA MH 16 406
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R61/R33)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants.
- This funding opportunity was created on May 22, 2015 and posted on May 22, 2015.
- Applicants must submit their applications by Oct 14, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Eligible applicants include: City or township governments Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments State governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Independent school districts Special district governments Native American tribal governments (Federally recognized) Small businesses.
- 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 grant opportunity titled "Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R61/R33)" (Funding Opportunity Number RFA-MH-16-406) is a National Institutes of Health (NIH) discretionary grant focused on speeding up early-stage clinical testing of new interventions for mental disorders in both adults and children. The core idea is to fund clinical trials that follow an experimental therapeutics approach, meaning the study is not just asking whether an intervention "works" in a general sense, but whether it engages a clearly defined therapeutic target tied to the underlying mechanism or process of the disorder. A central expectation is that the trial is designed so the results will be highly informative either way; even a negative outcome should produce useful scientific information and allow a clear go/no-go decision about whether the intervention should move forward for further development, refinement, or larger testing.
This FOA is broad in what it considers an eligible "novel intervention." It can include behavioral approaches, medications, biologics-based strategies, cognitive interventions, device-based approaches, interpersonal treatments, physiological methods, or combinations of these. What matters is that the intervention is being tested in a way that can directly evaluate target engagement and connect that engagement to clinically meaningful outcomes. The emphasis on target engagement reflects NIH's interest in moving beyond loosely defined clinical endpoints and toward mechanistically grounded trials that can clarify how and why an intervention produces change, and whether changing the target is plausibly linked to improvements in symptoms or functioning.
The award uses a two-stage phased structure, R61 followed by R33, to support efficient progression from initial pilot testing to more confirmatory work. The first phase (R61) can provide up to two years of support and is explicitly milestone-driven. In practice, this means investigators are expected to define concrete, measurable milestones that demonstrate early feasibility and, especially, evidence that the intervention engages its intended therapeutic target. Only if those predetermined milestones are met can the project potentially transition to the second phase. The second phase (R33) can provide up to three additional years and is intended to replicate target engagement and more strongly link changes in the intervention target to functional or clinical effects. This structure is designed to reduce wasted time and resources by funding projects that can demonstrate early mechanistic promise and discontinuing those that cannot meet key scientific benchmarks.
From a translational perspective, the FOA is meant to accelerate the movement of emerging basic science discoveries about mechanisms and processes involved in mental disorders into practical, testable interventions. Rather than waiting for long, expensive trials to learn whether an approach has value, this program prioritizes well-controlled, informative early trials that can quickly tell the field whether a novel strategy is worth scaling up. The long-term goal is to advance interventions that can restore function and reduce symptoms for people living with mental disorders, while also improving the scientific quality of decision-making during intervention development.
Administratively, the opportunity is categorized under Health and aligns with CFDA number 93.242 (Mental Health Research Grants). The posted date and creation date were May 22, 2015, with an original and current closing date of October 14, 2016, and an archive date of November 14, 2016. The estimated total funding amount listed is $4,000,000, and the FOA does not require cost sharing or matching. Eligible applicants are broadly defined and include many types of U.S. and non-U.S. organizations. Examples include state, county, city, township, and special district governments; public housing authorities; independent school districts; public and private institutions of higher education; nonprofits (including those with and without 501(c)(3) status); and for-profit organizations other than small businesses, as well as small businesses themselves. Eligibility also extends to a wide range of other entities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, Asian American and Native American Pacific Islander serving institutions, faith-based and community-based organizations, U.S. territories or possessions, regional organizations, and foreign organizations (non-U.S. entities), along with eligible federal agencies.
The full announcement was provided through NIH with an additional information link at http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-406.html. For technical issues accessing or linking to the announcement, the listed contact is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R61/R33)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-MH-16-406.
Which agency is offering this funding opportunity?
This funding opportunity is offered through the National Institutes of Health (NIH).
What is the main purpose of this FOA?
The purpose is to speed up early-stage clinical testing of new (novel) interventions for mental disorders in both adults and children, using an experimental therapeutics approach focused on clearly defined targets and mechanisms.
What does "experimental therapeutics approach" mean in this FOA?
It means the trial is designed not only to test whether an intervention "works" in general, but to determine whether it engages a clearly defined therapeutic target tied to the underlying mechanism or process of the mental disorder.
What is meant by "therapeutic target" in this announcement?
A therapeutic target is a clearly defined mechanism or process linked to the disorder that the intervention is intended to change. The trial should be able to test whether that target is actually engaged by the intervention.
Is target engagement required, or just recommended?
Target engagement is a central expectation of this FOA. Studies are expected to directly evaluate target engagement and connect it to clinically meaningful outcomes.
Why does this FOA emphasize target engagement instead of only clinical endpoints?
The FOA reflects NIH's interest in mechanistically grounded trials that clarify how and why an intervention produces change, and whether changing the target is plausibly linked to improvements in symptoms or functioning.
What kinds of interventions are considered eligible "novel interventions" under this FOA?
The FOA is broad and includes behavioral approaches, medications, biologics-based strategies, cognitive interventions, device-based approaches, interpersonal treatments, physiological methods, and combinations of these.
Are combination interventions allowed?
Yes. The FOA explicitly includes combinations of intervention types, as long as the trial can evaluate target engagement and connect it to meaningful outcomes.
Who is the intended participant population for these trials?
The FOA supports interventions for mental disorders in both adults and children.
What is the R61/R33 structure?
This award uses a two-stage phased structure: an initial R61 phase followed by an R33 phase, intended to support efficient progression from pilot testing to more confirmatory work.
How long can the R61 phase last?
The R61 phase can provide up to two years of support.
How long can the R33 phase last?
The R33 phase can provide up to three additional years of support.
What is the R61 phase expected to accomplish?
The R61 phase is milestone-driven and is expected to demonstrate early feasibility and, especially, evidence that the intervention engages its intended therapeutic target.
What does "milestone-driven" mean for the R61 phase?
Investigators are expected to define concrete, measurable milestones in advance. Progress is assessed against those milestones, particularly around feasibility and evidence of target engagement.
Does an R61 award automatically transition into R33?
No. Transition to the R33 phase is contingent on meeting the predetermined R61 milestones.
What is the R33 phase intended to do?
The R33 phase is intended to replicate target engagement and more strongly link changes in the intervention target to functional or clinical effects.
Why is this phased approach used?
The structure is designed to reduce wasted time and resources by continuing support for projects that demonstrate early mechanistic promise and discontinuing those that cannot meet key scientific benchmarks.
Are negative trial outcomes considered useful under this FOA?
Yes. A central expectation is that results should be highly informative either way, so that even a negative outcome produces useful scientific information and supports a clear go/no-go decision.
What types of decisions should the results support?
The trial should allow a clear go/no-go decision about whether the intervention should move forward for further development, refinement, or larger testing.
What is the broader translational goal of this FOA?
The FOA aims to accelerate movement of emerging basic science discoveries about mechanisms and processes involved in mental disorders into practical, testable interventions.
What is the long-term goal of the program?
The long-term goal is to advance interventions that can restore function and reduce symptoms for people living with mental disorders, while improving the scientific quality of decision-making during intervention development.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.242 (Mental Health Research Grants).
What category is this opportunity listed under?
The opportunity is categorized under Health.
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
What is the estimated total funding amount for this FOA?
The estimated total funding amount listed is $4,000,000.
When was this opportunity posted?
The posted date is May 22, 2015.
What is the creation date listed for the announcement?
The creation date is May 22, 2015.
What was the closing date for applications?
The original and current closing date listed is October 14, 2016.
When was this opportunity archived?
The archive date is November 14, 2016.
Who is eligible to apply?
Eligible applicants are broadly defined and include many types of U.S. and non-U.S. organizations, including government entities, educational institutions, nonprofits, for-profit organizations (including small businesses), and various designated institution types and community-based organizations.
Are non-U.S. (foreign) organizations eligible?
Yes. The eligibility list includes foreign organizations (non-U.S. entities).
Are U.S. government entities eligible to apply?
Yes. Examples listed include state, county, city, township, and special district governments, as well as eligible federal agencies.
Are institutions of higher education eligible?
Yes. The eligibility list includes public and private institutions of higher education.
Are nonprofits eligible to apply?
Yes. The eligibility list includes nonprofits with and without 501(c)(3) status.
Are for-profit organizations eligible to apply?
Yes. The eligibility list includes for-profit organizations other than small businesses, and also includes small businesses.
Are HBCUs and other minority-serving institutions included in eligibility?
Yes. The eligibility examples include Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander serving institutions.
Are faith-based and community-based organizations eligible?
Yes. Faith-based and community-based organizations are included in the eligibility examples.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included in the eligibility examples.
Where can applicants find the full announcement?
The full NIH announcement is available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-406.html
Who should be contacted for technical issues accessing or linking to the announcement?
For technical issues, the listed contact is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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