Opportunity Information: Apply for FOR FD 20 001

This grant opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) centers on creating a rigorous, evidence-based clinical practice guideline (CPG) for managing dental pain, covering both surgical and non-surgical scenarios. The effort stems from the SUPPORT Act, a federal law enacted in October 2018 to address the opioid crisis. Section 3002 of that law directs the FDA Commissioner to develop indication-specific, evidence-based opioid analgesic prescribing guidelines for acute pain in areas where such guidance is missing. In response, FDA worked with the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline a broader framework for guideline development. A NASEM consensus report released in December 2019 highlighted specific procedures and medical conditions where more research and guideline development were needed, and it identified dental pain and common dental surgeries as top priorities.

The rationale for focusing on dentistry is tied to both public health impact and prescribing patterns. Dental procedures such as third molar (wisdom tooth) extraction are extremely common, and they frequently involve adolescents and young adults, a population that can be especially vulnerable to first exposures to opioid medications. The NASEM report pointed to existing evidence showing that nonopioid pain management strategies can be highly effective for dental pain, particularly after routine dental surgeries. At the same time, dental pain has been documented as one of the leading reasons adolescents and young adults receive opioid prescriptions in emergency department settings. Taken together, those factors create a strong case for a clear, widely adopted guideline that supports effective pain relief while reducing unnecessary opioid exposure.

FDA’s proposed funding is not limited to writing a guideline document. The scope explicitly includes development, dissemination, implementation, and evaluation. In practical terms, this means the funded project is expected to do more than convene experts and review the literature; it also needs a real-world plan to get the guideline into clinical workflows and measure whether it changes prescribing and patient outcomes. NASEM specifically recommended that organizations producing evidence-based opioid-related acute pain guidelines also establish processes to disseminate the guideline, support implementation, and monitor uptake and impact. This opportunity aligns with that recommendation by making dissemination and evaluation core deliverables rather than optional add-ons.

The award is structured as a cooperative agreement, which typically signals substantial federal involvement during the project period, such as ongoing coordination, shared decision-making on key milestones, and alignment with FDA’s broader guideline framework. The opportunity anticipates a single award (ExpectedAwards: 1), suggesting FDA is looking for one lead organization or consortium to coordinate the full guideline lifecycle from evidence synthesis through adoption and impact assessment.

Eligibility is broad and includes many types of applicants that could credibly lead a national guideline effort. Eligible entities include state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including entities other than small businesses); small businesses; and other applicants as clarified in the funding notice. The funding opportunity is listed under CFDA 93.103 and the activity category is labeled Agriculture, Consumer Protection, Food and Nutrition, reflecting FDA’s cataloging conventions rather than dentistry specifically. The funding opportunity number is FOR FD 20 001, and it was created May 25, 2021.

Overall, the grant is aimed at producing a trustworthy, evidence-driven dental pain guideline that helps clinicians choose effective treatments while minimizing avoidable opioid prescribing. Just as importantly, it is designed to ensure the guideline does not sit on a shelf: the funded work is expected to actively drive awareness and use across dental and related care settings and to generate evidence on whether the guideline meaningfully improves prescribing practices and patient care.

  • 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 "An evidence-based clinical practice guideline for dental pain (surgical and non-surgical)" 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 May 25, 2021.
  • Applicants must submit their applications by Archiving forecast. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • 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).
Apply for FOR FD 20 001

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Frequently Asked Questions (FAQs)

What is the main purpose of this FDA grant opportunity?

The opportunity supports the creation of a rigorous, evidence-based clinical practice guideline (CPG) for managing dental pain. The guideline is intended to cover both surgical and non-surgical dental pain scenarios and to promote effective pain relief while reducing unnecessary opioid exposure.

Which federal agency is offering this funding?

The funding is offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).

What problem is this grant trying to address?

The effort is tied to the national opioid crisis and focuses on improving acute pain prescribing practices where indication-specific guidance is missing. Dentistry is a key focus area because dental procedures are common and can be a first point of opioid exposure for adolescents and young adults.

What law is driving the need for this guideline?

This work stems from the SUPPORT Act, enacted in October 2018. Section 3002 directs the FDA Commissioner to develop indication-specific, evidence-based opioid analgesic prescribing guidelines for acute pain in areas where such guidance is lacking.

Why is dental pain a priority area for guideline development?

Dental pain and common dental surgeries were identified as top priorities in a National Academies of Sciences, Engineering, and Medicine (NASEM) consensus report released in December 2019. The priority reflects both the public health impact and real-world prescribing patterns, including opioid exposure among adolescents and young adults.

What dental procedures or scenarios are specifically mentioned as important?

Common dental surgeries, including third molar (wisdom tooth) extraction, are highlighted. The guideline is also expected to address non-surgical dental pain scenarios, consistent with the stated scope of covering both surgical and non-surgical cases.

What is the evidence basis for emphasizing nonopioid strategies?

The NASEM report pointed to existing evidence that nonopioid pain management strategies can be highly effective for dental pain, particularly following routine dental surgeries.

How does this opportunity relate to emergency department opioid prescribing?

Dental pain has been documented as one of the leading reasons adolescents and young adults receive opioid prescriptions in emergency department settings. This supports the need for clear guidance that can reduce avoidable opioid exposure while still addressing pain effectively.

Is the funded work limited to writing a guideline document?

No. The stated scope explicitly includes development, dissemination, implementation, and evaluation. The funded project is expected to produce the guideline and also actively support real-world adoption and measure impact.

What does "dissemination" mean in the context of this grant?

Based on the opportunity description, dissemination refers to actively getting the guideline out to relevant audiences and settings so it is known and accessible, rather than remaining a standalone document.

What does "implementation" mean in the context of this grant?

Implementation refers to supporting the guideline's use in clinical workflows and practice settings. The opportunity indicates the project should have a real-world plan to integrate the guideline into care delivery where dental pain is managed.

What does "evaluation" mean for this project?

Evaluation means measuring whether the guideline changes prescribing behaviors and affects patient outcomes. The opportunity emphasizes monitoring uptake and assessing impact as core deliverables.

Why are dissemination, implementation, and evaluation required parts of the scope?

NASEM recommended that organizations producing evidence-based opioid-related acute pain guidelines establish processes to disseminate the guideline, support implementation, and monitor uptake and impact. This opportunity aligns with that recommendation by making these components central expectations.

What is a cooperative agreement and why does it matter here?

The award is structured as a cooperative agreement, which typically indicates substantial federal involvement during the project period. The description suggests ongoing coordination, shared decision-making on key milestones, and alignment with FDA's broader guideline framework.

How many awards does FDA expect to make?

The opportunity anticipates a single award (ExpectedAwards: 1), indicating FDA is likely looking for one lead organization or consortium to coordinate the full guideline lifecycle.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including entities other than small businesses); small businesses; and other applicants as clarified in the funding notice.

Does the opportunity allow applications from for-profit organizations and small businesses?

Yes. The eligibility list explicitly includes for-profit organizations (including entities other than small businesses) and also includes small businesses.

Does the opportunity allow applications from tribal governments and tribal organizations?

Yes. Eligibility includes federally recognized tribal governments and other tribal organizations.

What is the CFDA number associated with this funding opportunity?

The opportunity is listed under CFDA 93.103.

What is the activity category listed for this opportunity?

The activity category is labeled "Agriculture, Consumer Protection, Food and Nutrition." The description notes this reflects FDA cataloging conventions rather than dentistry specifically.

What is the funding opportunity number?

The funding opportunity number is FOR FD 20 001.

When was this funding opportunity created?

The opportunity was created on May 25, 2021.

What are the expected outcomes of the funded project?

The expected outcomes include a trustworthy, evidence-driven dental pain clinical practice guideline, active efforts to drive awareness and use across dental and related care settings, and evidence on whether the guideline improves prescribing practices and patient care.

What makes this guideline "rigorous" and "evidence-based" according to the description?

The description emphasizes a rigorous, evidence-based approach and references the broader guideline development framework outlined through FDA's work with NASEM, including a consensus report that identified priority areas needing more research and guideline development.

Is the guideline intended to be widely adopted?

Yes. The opportunity describes a goal of producing a clear, widely adopted guideline and includes dissemination and implementation expectations to support adoption in practice.

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