Opportunity Information: Apply for PA 09 075
Apply for PA 09 075
- 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): 93.213 Research and Training in Complementary and Integrative Health 93.242 Mental Health Research Grants.
- This funding opportunity was created on Jan 9, 2009 and posted on Jan 9, 2009.
- Applicants must submit their applications by Jan 7, 2012. (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: State governments Small businesses Native American tribal governments (Federally recognized) County governments Native American tribal organizations (other than Federally recognized tribal 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Special district governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Independent school districts.
- 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 grant opportunity titled "Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders (Collaborative R34)" (Funding Opportunity Number PA-09-075) is a National Institutes of Health (NIH) discretionary grant program led by the National Institute of Mental Health (NIMH) in partnership with the National Center for Complementary and Alternative Medicine (NCCAM). Its central goal is to fund early-stage, collaborative pilot intervention studies that help investigators determine whether a new treatment approach for mental disorders is feasible and safe enough to justify moving forward to larger, more definitive trials. Rather than funding full-scale efficacy or effectiveness studies, this FOA is geared toward generating the kind of practical, preliminary data that is typically required before launching bigger and more expensive clinical or services research projects.
This FOA specifically targets innovative treatment ideas that may still be in relatively early development. It supports studies evaluating novel mechanism drug candidates, promising investigational new drugs (INDs), and novel psychosocial strategies. In practical terms, the funded projects are expected to focus on questions such as whether participants will enroll and stay in the study, whether the intervention can be delivered as intended across real research settings, whether participants can tolerate the intervention, whether it is acceptable to the target population, and whether there are safety concerns that need to be identified before scaling up. The emphasis is on establishing a credible foundation for later-stage research, including the operational lessons and early signals needed to plan a future efficacy or effectiveness trial.
A defining feature of this program is its collaborative structure across multiple research sites. The FOA is intended for projects that require at least two and no more than three sites to complete the work. The multi-site design is not just a formality; it is meant to strengthen the pilot phase by increasing sample size, accelerating recruitment timelines, and/or improving the diversity and representation of participants. This matters for mental health research because many early studies struggle with slow enrollment and narrow participant pools, which can limit how confidently results can be used to design a larger trial. By running coordinated pilot studies at multiple sites, the program aims to produce more robust, generalizable feasibility and safety information.
For linked collaborative R34 applications, each participating site must have its own Project Director/Principal Investigator, reflecting the expectation that each site is substantively responsible for conducting the study locally. At the same time, the group must build a clear cross-site coordination plan. The FOA highlights the need for mechanisms to ensure consistent implementation and oversight across sites, including quality control procedures, database management, statistical analysis, and coordinated reporting. In other words, applicants are expected to show how they will operate like a coherent network rather than a set of disconnected pilot projects. This typically implies shared protocols, harmonized data collection, agreed-upon standards for participant safety monitoring, and an organized approach to combining and analyzing data across sites.
From an administrative and eligibility standpoint, the opportunity was posted on January 9, 2009, with an original and final closing date of January 7, 2012, and an archive date of February 7, 2012. The award ceiling is listed as $225,000, and the opportunity does not require cost sharing or matching. The Catalog of Federal Domestic Assistance (CFDA) numbers associated with the program are 93.213 (Research and Training in Complementary and Integrative Health) and 93.242 (Mental Health Research Grants), reflecting the joint interests of NCCAM and NIMH in supporting both mental health treatment development and, where relevant, complementary or integrative health-related approaches.
Eligibility is broad and includes a wide range of public and private organizations. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (including small businesses and other for-profits); public housing authorities/Indian housing authorities; and Native American tribal governments and organizations. The eligibility section also notes additional eligible entities such as Alaska Native and Native Hawaiian Serving Institutions, Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and even non-U.S. (foreign) organizations and eligible federal agencies, indicating that the program was designed to accommodate many types of institutions capable of conducting rigorous multi-site pilot intervention research.
For anyone who needs the original full announcement text, the FOA provided a link to the NIH Grants Guide (http://grants.nih.gov/grants/guide/pa-files/PA-09-075.html) and included NIH Office of Extramural Research (OER) webmaster contact information for access or technical linking issues.
Frequently Asked Questions (FAQs)
What is the "Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders (Collaborative R34)" opportunity?
This opportunity (Funding Opportunity Number PA-09-075) is an NIH discretionary grant program led by the National Institute of Mental Health (NIMH) in partnership with the National Center for Complementary and Alternative Medicine (NCCAM). It supports early-stage, collaborative pilot intervention studies focused on innovative treatments for mental disorders.
What is the main purpose of this FOA?
The central goal is to fund pilot studies that help determine whether a new treatment approach is feasible and safe enough to justify moving to larger, more definitive clinical or services research trials. The emphasis is on generating practical preliminary data needed to plan a future efficacy or effectiveness study.
Is this grant meant to fund full-scale efficacy or effectiveness trials?
No. This FOA is not intended to fund full-scale efficacy or effectiveness studies. It is designed to support the pilot phase and produce feasibility, acceptability, tolerability, and safety information that can inform later, larger trials.
What kinds of treatments or interventions does the program support?
The FOA targets innovative treatment ideas that may be in relatively early development. It supports studies evaluating novel mechanism drug candidates, promising investigational new drugs (INDs), and novel psychosocial strategies aimed at treating mental disorders.
What types of questions are pilot projects expected to answer?
Funded projects are expected to focus on practical pilot-stage questions, such as whether participants will enroll and remain in the study, whether the intervention can be delivered as intended across research settings, whether participants tolerate the intervention, whether it is acceptable to the target population, and whether there are safety concerns that should be identified before scaling up.
Why does this FOA require a collaborative, multi-site structure?
A defining feature of this program is that it is designed for coordinated work across multiple research sites. The multi-site design is intended to strengthen the pilot phase by increasing sample size, accelerating recruitment, and/or improving participant diversity and representation, leading to more robust feasibility and safety information for planning a larger trial.
How many sites are required for a project under this FOA?
The FOA is intended for projects that require at least two sites and no more than three sites to complete the work.
Do all participating sites need their own Principal Investigator (PI) or Project Director (PD)?
Yes. For linked collaborative R34 applications, each participating site must have its own Project Director/Principal Investigator, reflecting that each site is substantively responsible for conducting the study locally.
What does "linked collaborative R34 applications" mean in this FOA?
Based on the FOA description, the collaboration is structured so that each site submits its own application with its own PD/PI, while the sites operate under a coordinated, shared plan to implement and manage the pilot study as a unified effort.
What kind of cross-site coordination is expected?
Applicants are expected to describe how they will coordinate consistent implementation and oversight across sites, including quality control procedures, database management, statistical analysis, and coordinated reporting. This implies shared protocols, harmonized data collection, agreed-upon safety monitoring standards, and a clear plan for combining and analyzing data across sites.
What is the maximum award amount (ceiling) listed for this opportunity?
The award ceiling is listed as $225,000.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
When was this funding opportunity posted and when did it close?
It was posted on January 9, 2009. The original and final closing date was January 7, 2012, and the archive date was February 7, 2012.
Which federal agencies or NIH components led this program?
The program was led by NIMH in partnership with NCCAM, reflecting joint interests in mental health treatment development and, where relevant, complementary or integrative health-related approaches.
What CFDA numbers are associated with this FOA?
The CFDA numbers associated with the program are 93.213 (Research and Training in Complementary and Integrative Health) and 93.242 (Mental Health Research Grants).
Who is eligible to apply?
Eligibility is broad and includes many public and private organizations, including state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (including small businesses); public housing authorities/Indian housing authorities; and Native American tribal governments and organizations.
Are specific institution types (like HBCUs or Tribal Colleges) mentioned as eligible?
Yes. The eligibility section also notes entities such as Alaska Native and Native Hawaiian Serving Institutions, Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, and regional organizations.
Are non-U.S. (foreign) organizations eligible?
Yes. The eligibility information indicates that non-U.S. (foreign) organizations are included among eligible applicants.
Are federal agencies eligible to apply?
Yes. The eligibility section indicates that eligible federal agencies are included among eligible applicants.
Where can applicants find the original full announcement text?
The FOA provided a link to the NIH Grants Guide: http://grants.nih.gov/grants/guide/pa-files/PA-09-075.html
Who should be contacted for access or technical linking issues related to the announcement?
The FOA included NIH Office of Extramural Research (OER) webmaster contact information for access or technical linking issues.
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