Opportunity Information: Apply for RFA MH 16 400
Apply for RFA MH 16 400
- 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 (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 Mar 30, 2015 and posted on Mar 30, 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 $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
- Eligible applicants include: State governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Small businesses County governments Independent school districts 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 Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Special district governments.
- 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 Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33) opportunity (Funding Opportunity Number RFA-MH-16-400) is a National Institutes of Health grant program aimed at funding early, efficient pilot clinical trials that test brand-new interventions for mental disorders in both adults and children. The central idea is to move promising discoveries from basic mental health science into real-world clinical testing faster, while keeping the studies focused and decision-oriented. Rather than supporting large, definitive efficacy trials, this mechanism emphasizes exploratory trials that generate clear, high-value results that can guide a straightforward go/no-go decision about whether an intervention should advance to larger studies or further development.
A defining feature of this FOA is its experimental therapeutics approach. Applicants are expected to design trials around a specific, measurable target that the intervention is supposed to engage. In practice, that means the study is not only asking, "Do symptoms improve?" but also, "Does the intervention change the biological, cognitive, behavioral, or physiological mechanism it is intended to change?" The grant supports work that tests and validates whether the intervention actually affects that pre-specified target, and it also supports linking target engagement to functional or clinical outcomes. Importantly, the FOA stresses that trials should be informative even if the results are negative. A well-run study that shows a novel intervention fails to engage its intended target, or engages the target without producing meaningful clinical change, can still be considered a success under this framework because it provides actionable knowledge and prevents wasted time and resources later.
The scope of "novel interventions" is intentionally broad. Proposed interventions can be behavioral, pharmacological, biologics-based, cognitive, device-based, interpersonal, physiological, or a combined or multi-component approach. The common thread is that the intervention should be innovative and grounded in an emerging understanding of mechanisms and processes involved in mental disorders, with a trial design that can clearly test whether the intervention is doing what it is supposed to do mechanistically and whether that change matters for symptoms or functioning.
Administratively, this is a discretionary NIH grant in the health activity category, tied to CFDA number 93.242 (Mental Health Research Grants). The FOA was posted on March 30, 2015, and the original and current closing date listed is October 14, 2016, with an archive date of November 14, 2016. The estimated total funding amount listed is $2,000,000, and the award ceiling is also listed as $2,000,000. Cost sharing or matching is not required, which means applicants generally are not expected to provide non-federal matching funds as a condition of award.
Eligibility is broad and includes many types of U.S. entities and some non-U.S. organizations. Eligible applicants include state, county, city or township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; small businesses; for-profit organizations (including those other than small businesses); nonprofits with or without 501(c)(3) status (with the specified distinctions noted in the listing); public housing authorities and Indian housing authorities; and Native American tribal governments, including federally recognized tribes as well as tribal organizations that are not federally recognized. The FOA also explicitly includes additional eligible categories such as Historically Black Colleges and Universities, 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 or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and foreign (non-U.S.) entities.
For more details, the announcement points applicants to the NIH grants page for the full FOA text (http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-400.html). For access or linking issues, the contact provided is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33) - RFA-MH-16-400
What is the RFA-MH-16-400 funding opportunity?
RFA-MH-16-400 is an NIH grant opportunity titled "Exploratory Clinical Trials of Novel Interventions for Mental Disorders (R33)." It is intended to support early, efficient pilot clinical trials that test brand-new interventions for mental disorders in both adults and children, with an emphasis on generating clear results that guide next-step decisions.
What is the main goal of this R33 program?
The main goal is to move promising discoveries from basic mental health science into real-world clinical testing faster, using focused and decision-oriented exploratory trials. These studies are designed to produce high-value information that supports a straightforward go/no-go decision about whether an intervention should advance to larger studies or further development.
Is this FOA meant to fund large, definitive efficacy trials?
No. This FOA emphasizes exploratory clinical trials rather than large, definitive efficacy trials. The intent is to run pilot studies that efficiently answer key questions needed to determine whether continued investment in an intervention is justified.
What does "experimental therapeutics approach" mean in this FOA?
In this FOA, an experimental therapeutics approach means the clinical trial is designed around a specific, measurable target that the intervention is intended to engage. The study is expected to test not only whether symptoms change, but also whether the intervention changes the biological, cognitive, behavioral, or physiological mechanism it is supposed to change.
What is meant by a "target" in the context of this program?
A target is a pre-specified, measurable mechanism or process the intervention is designed to affect. The trial is expected to assess whether the intervention engages that target, and (where supported by the design) to relate target engagement to clinical or functional outcomes.
Does the FOA require linking target engagement to clinical or functional outcomes?
The FOA supports studies that test and validate whether the intervention affects the pre-specified target, and it also supports linking target engagement to functional or clinical outcomes. In other words, it is not only about changing a mechanism, but also about whether that mechanism change matters for symptoms or functioning.
Are negative trial results acceptable under this FOA?
Yes. The FOA stresses that trials should be informative even if results are negative. A well-run study showing that an intervention fails to engage its intended target, or engages the target without producing meaningful clinical change, can still be considered a success because it provides actionable knowledge and prevents wasted time and resources later.
What kinds of interventions are considered "novel" and eligible?
The scope of novel interventions is intentionally broad. Interventions may be behavioral, pharmacological, biologics-based, cognitive, device-based, interpersonal, physiological, or combined/multi-component approaches. The key expectation is that the intervention is innovative and grounded in an emerging understanding of mechanisms and processes involved in mental disorders.
Who can be studied under this funding opportunity (adults, children, or both)?
This FOA supports pilot clinical trials in both adults and children with mental disorders.
What is the expected style or design emphasis of the supported trials?
The program emphasizes early, efficient, focused, and decision-oriented pilot trials. The design should be able to clearly test whether the intervention engages its intended target and whether that target engagement relates to meaningful symptom or functional change, producing results that support a clear go/no-go decision.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.242 (Mental Health Research Grants).
What type of grant is this administratively?
It is described as a discretionary NIH grant in the health activity category.
How much total funding is estimated for this opportunity?
The estimated total funding amount listed is $2,000,000.
What is the award ceiling for this opportunity?
The award ceiling is listed as $2,000,000.
Is cost sharing or matching required?
No. Cost sharing or matching is not required, meaning applicants generally are not expected to provide non-federal matching funds as a condition of award.
When was this FOA posted?
The FOA was posted on March 30, 2015.
What is the closing date for applications?
The original and current closing date listed is October 14, 2016.
When is (or was) the archive date for this FOA?
The archive date listed is November 14, 2016.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. entities and some non-U.S. organizations. Eligible applicants include state, county, city or township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; small businesses; for-profit organizations (including those other than small businesses); nonprofits with or without 501(c)(3) status (with the distinctions noted in the listing); public housing authorities and Indian housing authorities; and Native American tribal governments, including federally recognized tribes as well as tribal organizations that are not federally recognized.
Are minority-serving institutions specifically included as eligible applicants?
Yes. The FOA explicitly includes categories such as Historically Black Colleges and Universities, 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 or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among eligible categories.
Are regional organizations eligible?
Yes. Regional organizations are explicitly listed as eligible applicants.
Are federal agencies eligible to apply?
Yes. The FOA lists eligible federal agencies among eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included as eligible categories.
Are foreign (non-U.S.) organizations eligible?
Yes. The FOA explicitly includes foreign (non-U.S.) entities as eligible applicants.
Where can applicants find the full FOA text?
The announcement directs applicants to the NIH grants page for the full FOA text at: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-400.html
Who should be contacted if there are access or linking issues with the FOA page?
For access or linking issues, the contact provided is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
What is the simplest way to describe what a successful project looks like under this FOA?
A successful project is one that runs an early, efficient pilot clinical trial of a novel intervention, directly tests whether the intervention engages a clearly defined and measurable target, and produces clear results (positive or negative) that enable a practical go/no-go decision about advancing the intervention to larger studies or further development.
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