Opportunity Information: Apply for RFA FD 20 029
This funding opportunity is a discretionary cooperative agreement from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), focused on creating an evidence-based Clinical Practice Guideline (CPG) for treating acute dental pain in both surgical and non-surgical settings. The central aim is to improve how acute dental pain is managed while specifically advancing appropriate opioid prescribing practices. In practical terms, the FDA is looking for a project that does more than write a guideline: the applicant is expected to develop the guideline using strong evidence, then actively disseminate it, support real-world implementation, and evaluate whether it changes practice in meaningful ways.
The award mechanism is a U01 cooperative agreement, which typically indicates substantial programmatic involvement from the funding agency compared with a standard grant. The notice also specifies "Clinical Trials Not Allowed," meaning the work should not include interventional clinical trials; instead, the emphasis is on evidence synthesis, guideline development methods, implementation strategies, and evaluation approaches that do not constitute a clinical trial. The opportunity is listed under CFDA 93.103 and the activity category is grouped under agriculture, consumer protection, and food and nutrition, reflecting FDA's broader public health mission rather than dental research alone.
Only one award is expected, with an award ceiling of $1,500,000. The opportunity was created on April 1, 2020, with an original application due date of June 1, 2020, indicating it was a time-limited, competitive call intended to select a single team capable of producing a national-impact guideline and associated implementation and evaluation package.
Eligibility is broad and includes multiple levels of government (state, county, city/township, special districts), public and private institutions of higher education, federally recognized tribal governments and certain tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in that classification), and for-profit entities including small businesses. This breadth suggests FDA is open to applications from academic centers, professional organizations, health systems, policy groups, guideline development organizations, and multidisciplinary partnerships, as long as the applicant can credibly deliver a comprehensive, evidence-based guideline and ensure it is adopted and assessed in practice.
The core deliverables implied by the announcement include: (1) development of a rigorous evidence-based CPG for acute dental pain management across common dental scenarios, including both post-procedure pain and pain not directly tied to surgery; (2) dissemination plans that go beyond publication, such as outreach to clinicians, professional associations, educators, and health systems; (3) implementation supports that help dental providers apply the guideline in day-to-day care, potentially including clinical decision support concepts, prescribing aids, workflow tools, and educational materials; and (4) an evaluation component that measures uptake and impact, such as changes in prescribing behavior, alignment with recommended analgesic strategies, and other indicators of improved pain management and safer opioid use. The emphasis on appropriate opioid prescribing indicates the guideline is expected to clarify when opioids are or are not indicated, encourage effective non-opioid and multimodal pain strategies when appropriate, and provide practical prescribing parameters when opioids are considered necessary.
Overall, the opportunity is designed to produce a credible, widely adopted, evidence-based dental pain guideline that directly supports safer analgesic decision-making and helps reduce unnecessary opioid exposure while maintaining effective acute pain control. The single expected award and relatively high ceiling suggest FDA intended to fund a well-resourced, expert-led effort with national reach, capable of moving from evidence review to guideline publication to measurable changes in clinical practice.Apply for RFA FD 20 029
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain (U01) Clinical Trials Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Apr 01, 2020.
- Applicants must submit their applications by Jun 01, 2020. (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 $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Nonprofits that do not have 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, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is this funding opportunity focused on?
This opportunity supports the creation of an evidence-based Clinical Practice Guideline (CPG) for treating acute dental pain in both surgical and non-surgical settings, with a strong emphasis on advancing appropriate opioid prescribing practices.
What agency is offering this award?
The award is offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What type of award is it?
It is a discretionary cooperative agreement under the U01 activity code. A cooperative agreement generally indicates substantial programmatic involvement from the funding agency compared with a standard grant.
How is a U01 cooperative agreement different from a standard grant?
Based on the opportunity description, the U01 mechanism typically involves more direct, ongoing involvement from the FDA in the project than a traditional grant. Applicants should expect collaboration and programmatic engagement consistent with a cooperative agreement model.
Are clinical trials allowed under this opportunity?
No. The notice specifies "Clinical Trials Not Allowed." The project should focus on evidence synthesis, guideline development methods, dissemination, implementation strategies, and evaluation approaches that do not constitute an interventional clinical trial.
What is the main goal of the project?
The central aim is to improve acute dental pain management while specifically advancing appropriate opioid prescribing. The project is expected to produce a guideline and also drive real-world uptake and measurable changes in practice.
Does the FDA want only a written guideline, or something more?
Something more. The FDA is looking for a project that develops the guideline using strong evidence and then actively disseminates it, supports real-world implementation, and evaluates whether it changes practice in meaningful ways.
What clinical situations should the guideline address?
The guideline is intended to address acute dental pain across common dental scenarios, including post-procedure pain (surgical contexts) and pain not directly tied to surgery (non-surgical contexts).
What is the role of opioid prescribing in the guideline?
Appropriate opioid prescribing is a central emphasis. The guideline is expected to clarify when opioids are or are not indicated, encourage effective non-opioid and multimodal pain strategies when appropriate, and provide practical prescribing parameters when opioids are considered necessary.
What deliverables are implied by the announcement?
The announcement implies four core deliverables: (1) a rigorous evidence-based CPG for acute dental pain management; (2) dissemination that goes beyond publication; (3) implementation supports to help providers use the guideline in daily care; and (4) an evaluation component to measure uptake and impact.
What does "dissemination" mean in this context?
Dissemination is expected to go beyond publishing the guideline. Examples mentioned include outreach to clinicians, professional associations, educators, and health systems to promote awareness and use of the guideline.
What kinds of implementation supports are expected?
The opportunity anticipates practical supports that help dental providers apply the guideline in day-to-day care. Examples mentioned include clinical decision support concepts, prescribing aids, workflow tools, and educational materials.
What should the evaluation component measure?
Evaluation is expected to measure uptake and impact, such as changes in prescribing behavior, alignment with recommended analgesic strategies, and other indicators of improved pain management and safer opioid use.
How many awards does the FDA expect to make?
Only one award is expected.
What is the maximum funding amount (award ceiling)?
The award ceiling is $1,500,000.
When was this opportunity created, and when was the application due?
The opportunity was created on April 1, 2020, with an original application due date of June 1, 2020.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.103.
What is the listed activity category?
The activity category is grouped under agriculture, consumer protection, and food and nutrition, reflecting FDA's broader public health mission.
Who is eligible to apply?
Eligibility is broad and includes multiple levels of government (state, county, city/township, special districts), public and private institutions of higher education, federally recognized tribal governments and certain tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in that classification), and for-profit entities including small businesses.
Can for-profit organizations apply?
Yes. For-profit entities, including small businesses, are listed as eligible applicants.
Can nonprofit organizations apply if they do not have 501(c)(3) status?
Yes. Nonprofit organizations with or without 501(c)(3) status are included in the eligibility list, with the noted exclusion applying to institutions of higher education within that classification.
Are tribal governments or tribal organizations eligible?
Yes. Federally recognized tribal governments and certain tribal organizations are included in the eligibility list.
Are state and local governments eligible?
Yes. State governments, county governments, city or township governments, and special district governments are all included as eligible applicants.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.
What kinds of applicants does the FDA appear to be seeking?
Based on the breadth of eligibility and the described deliverables, the opportunity is suited to teams that can credibly deliver an evidence-based guideline and ensure it is adopted and assessed in practice. The description suggests potential applicants could include academic centers, professional organizations, health systems, policy groups, guideline development organizations, and multidisciplinary partnerships.
Is the project expected to have national impact?
Yes. The opportunity is framed around producing a credible, widely adopted guideline with national reach, supported by dissemination, implementation, and evaluation aimed at measurable changes in clinical practice.
What outcomes is the FDA trying to influence through this project?
The project is designed to support safer analgesic decision-making, reduce unnecessary opioid exposure, and maintain effective acute pain control by improving practice patterns around acute dental pain management.
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