Opportunity Information: Apply for PAR 12 071
Apply for PAR 12 071
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders (Collaborative 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 Sep 12, 2013 and posted on Jan 4, 2012.
- Applicants must submit their applications by Sep 12, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $225,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Special district governments Private 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:
The National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), released this Funding Opportunity Announcement (FOA) to fund early, collaborative pilot studies that test innovative treatments for mental disorders. The main purpose is to generate the kind of practical, real-world preliminary evidence that is usually required before a research team can credibly move on to larger and more expensive studies that focus on efficacy, effectiveness, or broader service delivery outcomes. In other words, this opportunity is meant for the stage where a treatment idea looks promising but still needs careful pilot testing to show that it can be delivered safely and that people will actually use it and tolerate it.
This FOA supports preliminary intervention research that evaluates feasibility, tolerability, acceptability, and safety. It is designed for novel mechanism drug candidates, promising investigational new drugs (including those in or approaching IND-level development), and new psychosocial strategies. The emphasis is not on proving that the treatment works at scale, but on answering the crucial pilot questions: Can the intervention be implemented as intended across sites? Will participants enroll and stay in the study? Are procedures workable and acceptable? Are there any early safety concerns? Do the resulting data look strong enough to justify a subsequent full-scale trial?
A defining feature of this announcement is that it is specifically for collaborative, linked R34 projects involving multiple sites. Applicants should use this FOA when they need at least two, but no more than three, sites from different institutions or organizations to complete the pilot study. The reason for the multi-site requirement is practical and scientific: collaboration can increase sample size, speed up recruitment, and improve participant diversity and representation. NIMH is clearly signaling that these pilot studies should be structured to benefit from cross-site enrollment and broader reach rather than relying on a single local setting.
For linked collaborative R34s, each participating site submits its own application and has its own Program Director/Principal Investigator (PD/PI). At the same time, the linked group is expected to operate like one coordinated pilot program, not like disconnected parallel projects. That means the collaboration must include a clear plan and infrastructure for cross-site coordination and quality control, along with shared or harmonized approaches to database management, statistical analysis, and reporting. The intent is to make sure data collected across sites are comparable, well-managed, and analyzable as a combined dataset, while maintaining consistent study conduct and oversight at each location.
From an administrative perspective, this is a discretionary grant opportunity in the health category (CFDA 93.242, Mental Health Research Grants) and does not require cost sharing or matching. The listed award ceiling is $225,000. The FOA number is PAR-12-071, and it was originally posted January 4, 2012. It is now archived (archive date October 13, 2013), with an original closing date of January 7, 2015, and a current closing date shown as September 12, 2013, reflecting the historical record of the opportunity.
Eligibility is broad and includes many common applicant types across the public, private, nonprofit, and academic sectors. Eligible applicants include for-profit organizations (including small businesses), nonprofits with or without 501(c)(3) status, public and private institutions of higher education, state and local governments (including county, city/township, special district governments), independent school districts, and public housing authorities/Indian housing authorities. The eligibility list also explicitly includes a wide range of mission-focused and community-centered institutions, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions. Foreign institutions are allowed to apply, non-U.S. components of U.S. organizations may participate, and foreign components are permitted as defined under the NIH Grants Policy Statement.
Overall, PAR-12-071 is best understood as an NIMH mechanism for coordinated, small-scale, multi-site pilot intervention work that de-risks the next step in treatment development. It supports teams that need a two- or three-site structure to recruit enough participants, move quickly, and ensure representation, while producing high-quality preliminary data and operational lessons that can directly inform a later, definitive clinical trial or services study.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is a National Institute of Mental Health (NIMH), National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) that supports early, collaborative pilot studies testing innovative treatments for mental disorders. The FOA number is PAR-12-071.
What is the main purpose of PAR-12-071?
The purpose is to fund practical, real-world pilot intervention studies that generate preliminary evidence needed to justify moving to larger, more expensive studies (for example, later trials focused on efficacy, effectiveness, or broader service delivery outcomes). It is meant for the stage where a treatment concept is promising but still needs careful pilot testing.
What stage of research does this FOA support?
This FOA supports preliminary intervention research designed to "de-risk" the next step in treatment development. It focuses on whether an intervention can be delivered safely and whether people will use it and tolerate it, rather than establishing definitive effectiveness at scale.
What kinds of interventions are appropriate for this FOA?
The FOA supports pilot testing of innovative treatments for mental disorders, including novel mechanism drug candidates, promising investigational new drugs (including those in or approaching IND-level development), and new psychosocial strategies.
What outcomes or questions should the pilot study address?
The FOA emphasizes pilot questions and preliminary outcomes such as feasibility, tolerability, acceptability, and safety. It also highlights operational questions like whether the intervention can be implemented as intended across sites, whether participants will enroll and remain in the study, whether procedures are workable and acceptable, whether there are early safety concerns, and whether the data are strong enough to support a later full-scale trial.
Is this FOA intended to prove that a treatment works?
No. The emphasis is not on proving efficacy or effectiveness at scale. The purpose is to produce high-quality preliminary data and operational lessons that inform and justify subsequent, definitive studies.
What makes this FOA "collaborative" and "linked"?
A defining feature is that it is specifically for collaborative, linked R34 projects involving multiple sites. The linked group is expected to operate as one coordinated pilot program rather than separate, disconnected projects.
How many sites are required?
Applicants should use this FOA when the pilot study requires at least two, but no more than three, sites.
Do the sites need to be from different institutions or organizations?
Yes. The FOA is intended for two to three sites from different institutions or organizations.
Why does NIMH require multiple sites?
The multi-site requirement is intended to increase sample size, speed recruitment, and improve participant diversity and representation. The FOA signals that these pilot studies should benefit from cross-site enrollment and broader reach rather than relying on a single local setting.
How are applications submitted for linked collaborative R34 projects?
Each participating site submits its own application, and each site has its own Program Director/Principal Investigator (PD/PI). Even so, the linked applications are expected to function together as a coordinated pilot effort.
What expectations are there for coordination across sites?
The collaboration is expected to include a clear plan and infrastructure for cross-site coordination and quality control, along with shared or harmonized approaches to database management, statistical analysis, and reporting. The intent is to ensure that data across sites are comparable and can be analyzed as a combined dataset, while maintaining consistent study conduct and oversight at each site.
What types of organizations are eligible to apply?
Eligibility is broad and includes for-profit organizations (including small businesses), nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, and a range of government entities (including state and local governments such as county, city/township, and special district governments), independent school districts, and public housing authorities/Indian housing authorities.
Are community-based, faith-based, and mission-focused institutions eligible?
Yes. The eligibility list explicitly includes faith-based or community-based organizations and a range of mission-focused institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, regional organizations, and U.S. territories or possessions.
Are foreign institutions allowed to apply?
Yes. Foreign institutions are allowed to apply, non-U.S. components of U.S. organizations may participate, and foreign components are permitted as defined under the NIH Grants Policy Statement.
Is cost sharing or matching required?
No. This opportunity does not require cost sharing or matching.
What is the award ceiling?
The listed award ceiling is $225,000.
What is the CFDA number and program area?
The CFDA number is 93.242, Mental Health Research Grants, and the opportunity is categorized under health.
When was this FOA posted, and what is its status now?
The FOA was originally posted on January 4, 2012. It is now archived, with an archive date of October 13, 2013.
What are the closing dates listed for this opportunity?
The historical record shows an original closing date of January 7, 2015, and a current closing date shown as September 12, 2013, reflecting the archived status and historical timeline of the opportunity.
What is the R34 mechanism being used for in this FOA?
Within this FOA, the R34 mechanism is used to support coordinated, small-scale, multi-site pilot intervention research intended to produce the preliminary evidence and operational experience needed to move toward a later, definitive clinical trial or services study.
What is the overall "fit" for a project under PAR-12-071?
PAR-12-071 is a fit for teams that need a two- or three-site structure to recruit enough participants, move quickly, and ensure representation, while generating high-quality preliminary feasibility, acceptability, tolerability, and safety data that directly inform a subsequent larger study.
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