Opportunity Information: Apply for RFA DE 12 001
Apply for RFA DE 12 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Behavioral or Social Intervention Planning and Pilot Data Grant (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research.
- This funding opportunity was created on Nov 16, 2010 and posted on Nov 16, 2010.
- Applicants must submit their applications by Jan 10, 2011. (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 $350,000.00 in funding.
- Eligible applicants include: Private institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Independent school districts City or township governments Small businesses Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) State governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities.
- 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 NIDCR Behavioral or Social Intervention Planning and Pilot Data Grant (R34) is a National Institutes of Health funding opportunity designed to help researchers get a behavioral or social intervention study ready for a full-scale clinical trial in the oral, dental, or craniofacial health space. In practical terms, it is meant to fund the early, high-effort groundwork that often determines whether a larger clinical trial is feasible and scientifically solid. Rather than paying for a full implementation trial, the R34 supports the structured planning and build-out of a rigorous trial-ready package, along with collecting enough pilot data to justify moving forward.
A central goal of this R34 is the creation of a comprehensive clinical trial protocol specifically for a behavioral or social intervention. That includes not only the main protocol itself (study aims, design, recruitment, randomization or assignment approach if applicable, outcomes, analysis plan, and operational procedures), but also the supporting documentation typically required to run a real-world trial. Those materials can include manuals of procedures, intervention manuals, fidelity monitoring plans, data collection instruments, training materials for staff, and other documentation that demonstrates the intervention can be delivered consistently and evaluated properly. The opportunity also supports pilot data collection, which is intended to reduce uncertainty about key trial elements such as recruitment and retention, acceptability of the intervention, feasibility of measurement, adherence, and preliminary signals that the intervention can influence targeted outcomes.
The program is structured so that the expected product of a successful R34 is one of two endpoints. The preferred endpoint is a strong application to a subsequent clinical trial implementation cooperative agreement (U01), using the completed protocol, associated documents, and pilot findings as the foundation. However, NIDCR also recognizes that good pilot work sometimes reveals that a full trial should not proceed as originally envisioned. In that case, the other acceptable endpoint is a report that clearly summarizes what was completed and explains why the project is not moving forward to a U01 application. This framing emphasizes that the R34 is intended to support careful, evidence-informed decision-making, not just automatic progression to a larger trial.
This particular announcement was issued as a discretionary grant mechanism under Funding Opportunity Number RFA-DE-12-001, in the Health category associated with CFDA 93.121 (Oral Diseases and Disorders Research). It was posted on November 16, 2010, with an original and current closing date of January 10, 2011, and an archive date of February 10, 2011. The stated award ceiling is $350,000, and there is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.
Eligibility is broad and includes many common research and community-affiliated entities. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), and a wide range of government bodies such as state, county, city or township governments, special district governments, and independent school districts. Tribal entities are also included, covering federally recognized tribal governments as well as other tribal organizations, and tribally controlled colleges and universities (TCCUs). The eligibility list also explicitly notes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations). In other words, the program is open to traditional academic research institutions as well as community and governmental organizations that may be positioned to design and pilot behavioral or social interventions relevant to oral health.
Overall, this R34 opportunity is best understood as a preparatory and de-risking grant for behavioral and social intervention trials in oral, dental, and craniofacial health. It funds the detailed planning, documentation, and pilot testing needed to produce a trial-ready protocol package and credible feasibility evidence. The agency’s intent is that investigators either transition into a U01 clinical trial implementation application with strong justification and well-developed materials, or conclude based on pilot results that a full trial is not warranted and document those lessons learned. For reference and full details, the announcement points to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/rfa_files/RFA-DE-12-001.html, and provides NIH Office of Extramural Research webmaster contacts for access or linking issues.
FAQs: NIDCR Behavioral or Social Intervention Planning and Pilot Data Grant (R34)
What is the NIDCR Behavioral or Social Intervention Planning and Pilot Data Grant (R34)?
This is a National Institutes of Health (NIH) funding opportunity from the National Institute of Dental and Craniofacial Research (NIDCR) that supports the planning and early pilot work needed to prepare a behavioral or social intervention study for a future full-scale clinical trial in oral, dental, or craniofacial health.
What is the main purpose of this R34 opportunity?
The main purpose is to fund the early, high-effort groundwork that helps determine whether a larger behavioral or social intervention clinical trial is feasible and scientifically sound. It supports building a trial-ready package and collecting pilot data to reduce uncertainty about key trial elements.
Is this R34 meant to pay for a full clinical trial?
No. The R34 is described as supporting structured planning and build-out for a rigorous, trial-ready package and pilot data collection, rather than paying for a full implementation trial.
What kind of research is this funding aimed at?
The focus is on behavioral or social interventions in the oral, dental, or craniofacial health space, with the expectation that the work will prepare for a future clinical trial implementation effort.
What is the central product expected from an R34 award?
A central goal is the creation of a comprehensive clinical trial protocol for a behavioral or social intervention, along with the supporting materials typically needed to run a real-world trial.
What elements are expected to be included in the clinical trial protocol package?
The protocol package is described as including study aims, design, recruitment approach, randomization or assignment approach (if applicable), outcomes, analysis plan, and operational procedures, plus supporting documentation required to run the trial.
What supporting documents can be developed under this R34?
Examples given include manuals of procedures, intervention manuals, fidelity monitoring plans, data collection instruments, training materials for staff, and other documentation that shows the intervention can be delivered consistently and evaluated properly.
What does the pilot data collection portion of the R34 support?
Pilot data collection is intended to reduce uncertainty around practical and scientific aspects of a future trial, such as recruitment and retention, acceptability of the intervention, feasibility of measurement, adherence, and preliminary signals that the intervention can influence targeted outcomes.
What are the expected endpoints of a successful R34 project?
The opportunity describes two acceptable endpoints. The preferred endpoint is submission of a strong application to a subsequent clinical trial implementation cooperative agreement (U01), using the completed protocol, documents, and pilot findings. The other acceptable endpoint is a report summarizing what was completed and explaining why the project is not moving forward to a U01 application.
Does the R34 require that projects automatically progress to a U01 trial?
No. NIDCR explicitly recognizes that pilot work may show that a full trial should not proceed as originally envisioned. In that case, producing a clear report explaining why it is not moving forward is an acceptable endpoint.
What funding opportunity number (FOA) is associated with this announcement?
The announcement is identified as Funding Opportunity Number RFA-DE-12-001.
What agency and institute are associated with this opportunity?
This is an NIH opportunity associated with NIDCR (National Institute of Dental and Craniofacial Research).
What category and CFDA number are listed for this opportunity?
The announcement is listed in the Health category and associated with CFDA 93.121 (Oral Diseases and Disorders Research).
What are the key dates for this opportunity?
The information provided states it was posted on November 16, 2010, with an original and current closing date of January 10, 2011, and an archive date of February 10, 2011.
What is the award ceiling for this grant?
The stated award ceiling is $350,000.
Is cost sharing or matching required?
No. The information provided states there is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.
Who is eligible to apply?
Eligibility is described as broad and includes public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and many government entities (state, county, city or township, special district, and independent school districts).
Are tribal entities eligible?
Yes. The eligibility list includes federally recognized tribal governments, other tribal organizations, and tribally controlled colleges and universities (TCCUs).
Are minority-serving institutions specifically mentioned as eligible?
Yes. The eligibility list explicitly notes Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, and Historically Black Colleges and Universities (HBCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed as eligible.
Are U.S. territories or possessions eligible?
Yes. The eligibility list includes U.S. territories or possessions.
Are regional organizations eligible?
Yes. Regional organizations are included in the eligibility list.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).
Where can applicants find the official announcement and full details?
The information provided points to the NIH Grants Guide page at http://grants.nih.gov/grants/guide/rfa_files/RFA-DE-12-001.html for reference and full details.
Who is listed for access or linking issues with the announcement page?
The announcement notes NIH Office of Extramural Research webmaster contacts for access or linking issues.
How should this grant be understood in practical terms?
It is presented as a preparatory and de-risking grant that funds detailed planning, documentation, and pilot testing to create a trial-ready protocol package and credible feasibility evidence, supporting an informed decision to proceed to a U01 application or to stop and document lessons learned.
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