Opportunity Information: Apply for RFA MH 09 160
Apply for RFA MH 09 160
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Interventions for Neurodevelopmental Disorders (R34)" 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 93.273 Alcohol Research Programs.
- This funding opportunity was created on Mar 6, 2009 and posted on Mar 6, 2009.
- Applicants must submit their applications by May 12, 2009. (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.
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized).
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) .
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Opportunity Summary:
The Novel Interventions for Neurodevelopmental Disorders (R34) funding opportunity (RFA-MH-09-160) is a National Institutes of Health (NIH), National Institute of Mental Health (NIMH) grant announcement designed to move promising, new treatment ideas for neurodevelopmental disorders closer to full-scale clinical testing. The central aim is to support early-stage clinical intervention development work that focuses on improving functioning in key life domains commonly disrupted by neurodevelopmental conditions, rather than limiting projects to any single diagnosis. In practice, this means applicants are expected to identify meaningful, measurable functional targets (for example, communication, social functioning, cognitive control, emotion regulation, adaptive skills, learning-related performance, or other real-world outcomes) and develop interventions that plausibly improve those targets in ways that could generalize across multiple neurodevelopmental disorders.
This R34 mechanism is specifically meant for clinical exploratory and developmental studies that help an intervention clear the hurdles needed before a larger efficacy trial is justified. The FOA emphasizes generating the kind of preliminary evidence that reduces risk for a later, more definitive study. That includes carefully assessing feasibility (can the intervention be delivered as intended in the target setting and population), tolerability (are side effects or burdens manageable), acceptability (do participants, families, and/or providers view it as reasonable and worthwhile), and safety (are risks understood and appropriately monitored). The goal is not to run a full-powered efficacy trial under this announcement, but to produce solid pilot data and operational knowledge that can support and de-risk a subsequent larger clinical trial.
NIMH intentionally casts a wide net in terms of intervention type. Proposed approaches may be psychopharmacologic or otherwise physiological, cognitive, psychosocial, psychoeducational, or behavioral, including innovative combinations of these strategies. The announcement also explicitly invites applications that take theoretically grounded interventions already used in clinical practice but not adequately evaluated for safety and tolerability, with the expectation that the R34 can provide a structured pathway to evaluate those aspects and standardize the approach for future trials. Another recurring theme is potential for broad impact: NIMH highlights interest in interventions that could be widely deployed and cost-effective, suggesting an emphasis on scalability, practicality, and real-world applicability rather than highly specialized approaches that are difficult to disseminate.
From a program structure standpoint, this FOA uses the NIMH Clinical Exploratory/Developmental Research Grant (R34) mechanism and is paired with a parallel announcement of identical scientific scope (RFA-MH-09-161) that uses a phased innovation mechanism (R21/R33). The FOA signals that the R21/R33 track may be better suited for projects at an earlier stage where additional technical development or proof-of-principle work is still needed. By contrast, the R34 track is positioned for teams ready to do focused early clinical testing around feasibility, acceptability, tolerability, safety, and preliminary signals that justify a later efficacy study.
Administratively, this is a discretionary grant opportunity in the health category, with CFDA listings that include 93.242 (Mental Health Research Grants) and 93.273 (Alcohol Research Programs), and it does not require cost sharing or matching. The estimated total funding amount listed is $2,500,000, with an award ceiling of $225,000. The opportunity was posted and created on March 6, 2009, with an original and current closing date of May 12, 2009, and an archive date of June 12, 2009, indicating it was time-limited and is now archived.
Eligibility is broad and includes many organization types: public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses) as well as small businesses, state governments, and a range of tribal and regional organizations. The FOA also lists additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, and non-U.S. (foreign) entities, among others. In short, the announcement is structured to encourage participation from academic, clinical, community, governmental, and private-sector groups capable of developing and piloting novel intervention strategies.
For applicants seeking the full original announcement details, the FOA provides an NIH grants URL (http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-09-160.html). It also lists the NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues (FBOWebmaster@OD.NIH.GOV), reflecting that the opportunity was distributed through federal announcement systems used at the time.
Frequently Asked Questions (FAQs)
What is the Novel Interventions for Neurodevelopmental Disorders (R34) funding opportunity?
It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Mental Health (NIMH) titled "Novel Interventions for Neurodevelopmental Disorders (R34)" under opportunity number RFA-MH-09-160. It is designed to move promising new treatment ideas for neurodevelopmental disorders closer to full-scale clinical testing by supporting early-stage clinical intervention development work.
What is the main goal of this R34 announcement?
The central aim is to support clinical exploratory and developmental studies that generate early evidence and operational knowledge needed before a larger, definitive clinical efficacy trial is justified. The focus is on improving functioning in key life domains commonly disrupted by neurodevelopmental conditions.
Does this opportunity require focusing on a single neurodevelopmental diagnosis?
No. The announcement emphasizes functional outcomes that may generalize across multiple neurodevelopmental disorders, rather than limiting projects to any single diagnosis.
What kinds of outcomes or targets are applicants expected to focus on?
Applicants are expected to identify meaningful, measurable functional targets such as communication, social functioning, cognitive control, emotion regulation, adaptive skills, learning-related performance, or other real-world outcomes relevant to functioning.
What stage of research is the R34 mechanism intended to support?
This R34 is intended for early clinical testing and intervention development work where a team is ready to conduct focused exploratory/developmental clinical studies aimed at feasibility, acceptability, tolerability, safety, and early signals that could justify a later efficacy trial.
Is this FOA intended to fund a full-powered efficacy trial?
No. The goal is not to run a full-powered efficacy trial under this announcement. Instead, it is intended to produce solid pilot data and reduce risk for a later, larger and more definitive clinical trial.
What types of evidence does NIMH expect projects to generate under this R34?
The FOA emphasizes preliminary evidence that de-risks subsequent trials, including careful assessment of feasibility (deliverability in the target setting/population), tolerability (manageable side effects or burden), acceptability (participant/family/provider views of reasonableness and value), and safety (risks understood and appropriately monitored).
What intervention approaches are allowed or encouraged?
NIMH describes a wide range of intervention types as responsive, including psychopharmacologic or otherwise physiological approaches, cognitive interventions, psychosocial approaches, psychoeducational interventions, behavioral interventions, and innovative combinations of these strategies.
Can an intervention that is already used in clinical practice be proposed?
Yes. The announcement explicitly invites theoretically grounded interventions already used in clinical practice but not adequately evaluated for safety and tolerability, with the expectation that the R34 can provide a structured pathway to evaluate those aspects and standardize the approach for future trials.
Does the FOA emphasize scalability or real-world deployment?
Yes. NIMH highlights interest in interventions that could be widely deployed and cost-effective, suggesting an emphasis on scalability, practicality, and real-world applicability rather than approaches that are difficult to disseminate.
What grant mechanism is used for this opportunity?
This opportunity uses the NIMH Clinical Exploratory/Developmental Research Grant (R34) mechanism.
Is there a related or parallel funding opportunity mentioned?
Yes. The FOA notes a parallel announcement with identical scientific scope (RFA-MH-09-161) that uses a phased innovation mechanism (R21/R33).
How does the R34 track differ from the R21/R33 track mentioned?
Based on the FOA description, the R21/R33 track may be better suited for projects at an earlier stage where additional technical development or proof-of-principle work is still needed. The R34 track is positioned for teams ready for focused early clinical testing around feasibility, acceptability, tolerability, safety, and preliminary signals supporting a later efficacy study.
What is the estimated total funding amount for this opportunity?
The estimated total funding amount listed is $2,500,000.
What is the award ceiling listed for this opportunity?
The award ceiling is $225,000.
Is cost sharing or matching required?
No. The announcement states that it does not require cost sharing or matching.
What is the funding category and what CFDA listings are associated with it?
The opportunity is described as a discretionary grant opportunity in the health category. CFDA listings include 93.242 (Mental Health Research Grants) and 93.273 (Alcohol Research Programs).
When was this opportunity posted and when did it close?
It was posted and created on March 6, 2009. The original and current closing date is May 12, 2009. The archive date is June 12, 2009.
Is this funding opportunity still open?
No. The information provided indicates it was time-limited and is now archived (archive date June 12, 2009), with a closing date of May 12, 2009.
Who is eligible to apply?
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), state governments, and a range of tribal and regional organizations. Additional eligible applicants listed include Alaska Native and Native Hawaiian Serving Institutions, Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, and non-U.S. (foreign) entities, among others.
Are for-profit organizations and small businesses eligible?
Yes. The eligibility list includes for-profit organizations (other than small businesses) as well as small businesses.
Are non-U.S. (foreign) entities eligible?
Yes. The FOA explicitly lists non-U.S. (foreign) entities among eligible applicants.
Where can applicants find the full original FOA text?
The FOA provides an NIH grants URL for full details: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-09-160.html
Who is listed as a contact for access or linking issues related to the announcement?
The NIH Office of Extramural Research (OER) webmaster contact listed for access or linking issues is FBOWebmaster@OD.NIH.GOV.
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