Opportunity Information: Apply for RFA MH 09 090
Apply for RFA MH 09 090
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Pharmacotherapy for PTSD Single and Collaborative Studies (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.
- This funding opportunity was created on Oct 20, 2008 and posted on Oct 20, 2008.
- Applicants must submit their applications by Jan 14, 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 $2,000,000.00 to eligible and selected applicants.
- Eligible applicants include: County governments Small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments For profit organizations other than small businesses Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities City or township governments Native American tribal organizations (other than Federally recognized tribal governments).
- 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) U.S. Territory or Possession.
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Opportunity Summary:
The Clinical Pharmacotherapy for PTSD Single and Collaborative Studies (R34) funding opportunity (RFA-MH-09-090) was a discretionary federal grant announcement issued by the National Institutes of Health, focused on jump-starting and strengthening research on medication-based treatments for Post Traumatic Stress Disorder (PTSD). The core aim was to encourage studies that can move promising pharmacologic approaches closer to larger, definitive trials by generating the kind of early, practical evidence that is often missing when a medication is first considered for PTSD. Rather than limiting applicants to a narrow class of drugs, the FOA explicitly welcomed a broad pipeline of candidate medications, including exploratory compounds ready for human testing, existing medications used in other medical areas that might be repurposed for PTSD, and psychiatric medications already being used off-label in PTSD care. In other words, the agencies were looking for well-justified clinical pharmacotherapy ideas at different stages of maturity, as long as the proposed work could clarify whether a larger, more expensive trial would be warranted.
The announcement emphasized that the studies should produce actionable information about how feasible and acceptable a medication strategy is in real clinical research settings, and what the early signal looks like in terms of patient experience and clinical outcomes. Priority outcomes and decision points included feasibility of recruitment and retention, tolerability and side effect burden, participant acceptance and adherence, and safety considerations. The FOA also called for data that helps quantify potential benefit and risk, such as changes in PTSD symptoms and symptom severity, the nature and frequency of adverse effects, and whether medication-related symptom improvements translate into meaningful functional gains. The underlying expectation was that funded R34 projects would reduce uncertainty and improve planning for subsequent large-scale efficacy, effectiveness, or services research by identifying which medications appear most suitable to advance.
In terms of structure, the mechanism of support was the NIMH R34 (a clinical trial planning and pilot/feasibility style award commonly used to prepare for larger trials). The FOA allowed either single-site applications or a collaborative R34 option when two study sites would participate, reflecting an interest in encouraging designs that can test procedures across settings or improve generalizability early in the development process. The funding outlook stated that NIMH anticipated committing approximately $2,000,000 in fiscal year 2009 to support an estimated 5 to 8 awards. In addition, the Department of Veterans Affairs Office of Research and Development indicated that, depending on funds availability, it expected to commit up to an additional $2,000,000 to the initiative, reinforcing the relevance of PTSD pharmacotherapy to veteran and military populations while still keeping the eligibility and scope broad.
Administrative details show the opportunity was posted on October 20, 2008, with an original and current closing date of January 14, 2009, and an archive date of February 14, 2009. It was categorized as a health-related grant opportunity under CFDA 93.242 (Mental Health Research Grants) and did not require cost sharing or matching. Eligibility was expansive and included many types of public and private entities, such as state and local governments, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), small businesses and other for-profit organizations (with limits noted in the eligibility text), tribal governments and tribal organizations, U.S. territories and possessions, and certain foreign or non-U.S. entities where allowed. The eligibility list also explicitly included mission- and capacity-relevant institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations, indicating an intent to encourage broad participation and potentially diverse study populations or settings.
Overall, this FOA was designed to fill the critical gap between promising PTSD medication ideas and the evidence threshold needed to justify large-scale clinical trials. By funding early clinical studies centered on feasibility, safety, tolerability, and initial indications of benefit, the program aimed to create a clearer, data-driven path for selecting which pharmacotherapies should move forward into more definitive testing and eventual implementation research.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Clinical Pharmacotherapy for PTSD Single and Collaborative Studies (R34) and is identified as RFA-MH-09-090.
Which federal agency issued this announcement?
This discretionary federal grant announcement was issued by the National Institutes of Health (NIH), with the National Institute of Mental Health (NIMH) using the R34 mechanism of support.
What is the main purpose of the RFA?
The main purpose was to jump-start and strengthen research on medication-based treatments for Post Traumatic Stress Disorder (PTSD) by supporting early clinical studies that can generate practical evidence needed to justify and design larger, definitive trials.
What research gap was this FOA trying to address?
The FOA aimed to fill the gap between a promising medication idea and the level of evidence typically required to move into large-scale clinical trials. It focused on producing early, decision-ready data on feasibility, safety, tolerability, and initial indications of benefit.
What kinds of studies were encouraged under this FOA?
The FOA emphasized clinical pharmacotherapy studies designed to produce actionable information about how feasible and acceptable a medication strategy is in real clinical research settings, and what early signals look like in terms of patient experience and clinical outcomes.
Does the FOA restrict applicants to a specific class of medications?
No. The FOA explicitly welcomed a broad pipeline of candidate medications rather than limiting applicants to a narrow drug class.
What types of candidate medications were considered responsive?
The FOA welcomed (1) exploratory compounds ready for human testing, (2) existing medications used in other medical areas that might be repurposed for PTSD, and (3) psychiatric medications already being used off-label in PTSD care, as long as the proposed work could clarify whether a larger trial would be warranted.
What stage of research was the R34 meant to support?
The R34 was presented as a clinical trial planning and pilot/feasibility style award intended to reduce uncertainty and improve planning for subsequent large-scale efficacy, effectiveness, or services research.
What were the key outcomes or decision points the FOA wanted projects to address?
Priority outcomes and decision points included feasibility of recruitment and retention, tolerability and side effect burden, participant acceptance and adherence, and safety considerations.
What types of data were applicants expected to generate?
The FOA called for data to help quantify potential benefit and risk, including changes in PTSD symptoms and symptom severity, the nature and frequency of adverse effects, and whether medication-related symptom improvements translate into meaningful functional gains.
Was the FOA focused only on symptom change, or also on real-world functioning?
It was not limited to symptom change. The FOA also highlighted the importance of understanding whether symptom improvements translate into meaningful functional gains.
Were both single-site and multi-site approaches allowed?
Yes. The FOA allowed single-site applications and also included a collaborative R34 option when two study sites would participate.
Why did the FOA include a collaborative two-site option?
The collaborative option reflected interest in encouraging designs that can test procedures across settings or improve generalizability early in the development process.
How much funding did NIMH expect to commit, and how many awards were anticipated?
NIMH anticipated committing approximately $2,000,000 in fiscal year 2009 to support an estimated 5 to 8 awards.
Was any additional funding mentioned beyond NIMH?
Yes. The Department of Veterans Affairs Office of Research and Development indicated that, depending on funds availability, it expected to commit up to an additional $2,000,000 to the initiative.
Does the mention of VA funding mean the program was only for veteran-focused organizations?
No. The FOA described the VA commitment as reinforcing the relevance of PTSD pharmacotherapy to veteran and military populations while still keeping eligibility and scope broad.
When was the opportunity posted, and what were the key dates?
The opportunity was posted on October 20, 2008. The original and current closing date was January 14, 2009. The archive date was February 14, 2009.
What is the CFDA number and program category?
The FOA was categorized under CFDA 93.242, described as Mental Health Research Grants.
Was cost sharing or matching required?
No. The FOA stated that it did not require cost sharing or matching.
Who was eligible to apply?
Eligibility was expansive and included many public and private entities, such as state and local governments, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), small businesses and other for-profit organizations (with limits noted in the eligibility text), tribal governments and tribal organizations, U.S. territories and possessions, and certain foreign or non-U.S. entities where allowed.
Did the eligibility list encourage participation by specific institution types?
Yes. The eligibility list explicitly included institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations, signaling an intent to encourage broad participation and potentially diverse study populations or settings.
What was the overall expected impact of funded projects?
Funded projects were expected to reduce uncertainty and create a clearer, data-driven path for selecting which pharmacotherapies should advance to larger, more definitive testing and eventual implementation research by producing early evidence on feasibility, safety, tolerability, and initial indications of benefit.
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