Opportunity Information: Apply for PAR 14 342
Apply for PAR 14 342
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Behavioral or Social Intervention Clinical Trial Planning 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 Sep 19, 2014 and posted on Sep 19, 2014.
- Applicants must submit their applications by Sep 7, 2017. (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 $150,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments Public housing authorities/Indian housing authorities Small businesses Private institutions of higher education City or township governments Special district governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 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 NIDCR Behavioral or Social Intervention Clinical Trial Planning Grant (R34) (Funding Opportunity Number PAR-14-342) is a National Institutes of Health discretionary grant designed to help researchers do the practical, front-end work needed to plan and design a future clinical study that will test a behavioral or social intervention aligned with the National Institute of Dental and Craniofacial Research (NIDCR) mission in oral health and related conditions. In plain terms, this opportunity is meant to fund the groundwork that turns an intervention idea into a well-specified, operationally ready clinical trial plan, so that a later, larger trial application can be stronger, more feasible, and more likely to succeed.
The focus of the R34 is on planning activities rather than proving whether an intervention works. NIDCR expects applicants to use this mechanism to build the key components required to launch a subsequent behavioral or social intervention clinical trial. That includes developing or refining the intervention itself into a usable format (often an intervention manual), creating detailed procedures and materials for training the people who will deliver the intervention (interventionists), and writing the clinical protocol that will guide the later trial. It also supports the less visible but essential infrastructure that makes a trial run smoothly and safely, such as tools and systems for data management, participant safety monitoring, operational oversight, and other preparatory steps needed to ensure a future study is well controlled and implementable.
While this is a planning grant, small-scale involvement of human subjects can be appropriate when it is clearly tied to planning goals. For example, applicants may include limited feasibility or acceptability work to test whether participants will engage with the intervention, whether recruitment and retention plans are realistic, whether outcome measures and data collection methods are workable, or whether training approaches for staff are effective. The key boundary is that the R34 is not intended to support efficacy testing. In other words, it is not meant to be used to run a powered clinical trial aimed at determining whether the intervention produces statistically or clinically meaningful improvements. Any human subjects work should be positioned as preparatory and exploratory, focused on de-risking the later full-scale trial rather than answering the ultimate effectiveness question.
From an administrative standpoint, the opportunity is categorized as a grant in the health funding activity area and is listed under CFDA 93.121 (Oral Diseases and Disorders Research). It does not require cost sharing or matching. The award ceiling listed is $150,000. The opportunity was posted on September 19, 2014, with an original and final closing date of September 7, 2017, and it was archived on October 8, 2017, meaning it is no longer active for new submissions under that specific posting.
Eligibility is broad and includes many types of organizations that commonly participate in NIH research. Eligible applicants include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status, other than institutions of higher education), for-profit organizations (including small businesses), and a wide range of government entities (state, county, city/township, special district). Housing authorities and tribal governments and organizations are also included. The announcement explicitly notes eligibility for various mission-serving institutions (such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities), as well as faith-based and community-based organizations. Importantly, non-U.S. entities and foreign institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined under the NIH Grants Policy Statement.
For more detailed requirements and official instructions, the announcement points applicants to the full NIH guide posting at http://grants.nih.gov/grants/guide/pa-files/PAR-14-342.html. For technical access issues, the contact listed is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).
Frequently Asked Questions (FAQs)
What is the NIDCR Behavioral or Social Intervention Clinical Trial Planning Grant (R34)?
This opportunity (Funding Opportunity Number PAR-14-342) is an NIH discretionary grant from the National Institute of Dental and Craniofacial Research (NIDCR) intended to support the practical planning and design work needed before launching a future behavioral or social intervention clinical trial aligned with the NIDCR mission in oral health and related conditions.
What is the main purpose of this R34 planning grant?
The main purpose is to fund the front-end groundwork that turns an intervention concept into a well-specified, operationally ready clinical trial plan. The goal is to make a later, larger clinical trial application stronger, more feasible, and more likely to succeed.
Is this grant intended to prove whether an intervention works?
No. This R34 is focused on planning activities rather than testing efficacy. It is not intended to support a powered clinical trial designed to determine whether the intervention produces statistically or clinically meaningful improvements.
What kinds of activities does NIDCR expect to be supported under this R34?
NIDCR expects applicants to use the R34 to build the key components required to launch a subsequent behavioral or social intervention clinical trial. Examples include refining the intervention into a usable format (often an intervention manual), developing training procedures and materials for the people who will deliver the intervention, and writing the clinical protocol for the later trial.
Can the R34 support development of an intervention manual?
Yes. One example of supported planning work is developing or refining the intervention itself into a usable format, often described as an intervention manual.
Does the R34 support training development for intervention delivery staff?
Yes. The opportunity explicitly includes creating detailed procedures and materials for training the people who will deliver the intervention (interventionists).
Can R34 funds be used to write the clinical protocol for a later trial?
Yes. Writing the clinical protocol that will guide the future clinical trial is called out as a supported planning activity.
What trial infrastructure and operational planning can be supported?
The R34 supports preparatory infrastructure needed to ensure a future study is well controlled and implementable. Examples provided include tools and systems for data management, participant safety monitoring, operational oversight, and other preparatory steps needed for smooth and safe trial operations.
Are human subjects allowed under this planning grant?
Small-scale involvement of human subjects can be appropriate when it is clearly tied to planning goals and is preparatory in nature.
What kinds of small-scale human subjects work are considered appropriate?
Examples described include limited feasibility or acceptability work to assess whether participants will engage with the intervention, whether recruitment and retention plans are realistic, whether outcome measures and data collection methods are workable, and whether staff training approaches are effective.
What is the key boundary for human subjects activities under this R34?
Human subjects work must be positioned as preparatory and exploratory, focused on reducing risk for a later full-scale trial. The R34 should not be used for efficacy testing or for running a powered trial intended to answer the ultimate effectiveness question.
What is the funding activity area and CFDA listing for this opportunity?
The opportunity is categorized as a grant in the health funding activity area and is listed under CFDA 93.121 (Oral Diseases and Disorders Research).
Is cost sharing or matching required?
No. The opportunity states that it does not require cost sharing or matching.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $150,000.
When was this opportunity posted and when did it close?
It was posted on September 19, 2014. The original and final closing date was September 7, 2017.
Is PAR-14-342 still active?
No. The opportunity was archived on October 8, 2017, meaning it is no longer active for new submissions under that specific posting.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status, other than institutions of higher education), for-profit organizations (including small businesses), and a wide range of government entities (state, county, city/township, and special district). Housing authorities, tribal governments, and tribal organizations are also included.
Are mission-serving institutions specifically included in eligibility?
Yes. The announcement explicitly notes eligibility for mission-serving institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities.
Are faith-based and community-based organizations eligible?
Yes. The announcement explicitly includes faith-based and community-based organizations.
Can non-U.S. or foreign institutions apply?
Yes. Non-U.S. entities and foreign institutions are eligible to apply. In addition, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined under the NIH Grants Policy Statement.
Where can applicants find the official instructions and full announcement text?
The announcement points to the full NIH guide posting at http://grants.nih.gov/grants/guide/pa-files/PAR-14-342.html.
Who should be contacted for technical access issues related to the opportunity?
For technical access issues, the listed contact is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
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