Opportunity Information: Apply for RFA FD 12 005
Apply for RFA FD 12 005
- The Food Drug Administration in the consumer protection food and nutrition health information and statistics sector is offering a public funding opportunity titled "Misuse and Abuse of DEA Schedule II V Opioid Analgesic Drugs Researching Strategies to Ensure Safe Use and Reduce Preventable Harm (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Mar 15, 2012 and posted on Mar 15, 2012.
- Applicants must submit their applications by May 9, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $300,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $75,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: 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 Private institutions of higher education Special district governments For profit organizations other than small businesses Independent school districts City or township governments Native American tribal governments (Federally recognized) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public housing authorities/Indian housing authorities State governments Public and State controlled institutions of higher education.
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Opportunity Summary:
This funding opportunity (RFA-FD-12-005) is a Food and Drug Administration (FDA) cooperative agreement (U01) focused on reducing preventable harm linked to the misuse and abuse of prescription opioid analgesics classified under DEA Schedules II through V. It sits within the FDA Safe Use Initiatives and is administered through the Center for Drug Evaluation and Research (CDER). The core idea is to fund a small set of research projects that do more than describe the opioid problem in broad terms. Instead, the FOA is looking for practical, evidence-generating work that examines real-world interventions and strategies prescribers can use to improve safe opioid use and decrease misuse, abuse, and related injury and death.
The research emphasis is twofold. First, the FDA is seeking studies that help clarify the underlying knowledge, attitudes, and behaviors that drive inappropriate prescribing and inappropriate patient use. That includes issues such as misprescribing or overprescribing by clinicians, as well as patient or community use that does not align with the intended medical purpose, dosing, or schedule. The FOA also explicitly includes harm that can occur when opioids are combined with other substances in unsafe ways, including inadvertent mixing of multiple interacting drugs. Second, and more importantly from an applied standpoint, the FOA aims to support research that designs, tests, and implements strategies that can change those behaviors and reduce preventable morbidity and mortality associated with prescription opioid analgesics.
A key theme throughout the announcement is usability and sustainability. The FDA is not only interested in whether an intervention works under ideal, tightly controlled conditions; it is looking for strategies that can be applied across a variety of real clinical and community settings and can be maintained over time by the people who actually have to carry them out. In practice, this means approaches that fit into routine prescribing workflows, can be adopted by different types of healthcare systems, and do not depend on unusually high levels of staffing, funding, or specialized expertise to keep them running after the study period ends. Because this is a cooperative agreement, awardees should expect active involvement and collaboration with the FDA compared with a more hands-off grant mechanism, with the agency likely playing a role in refining deliverables, monitoring progress, and aligning work with the Safe Use Initiatives goals.
Administratively, this is a discretionary funding opportunity with an expected four awards and an estimated total funding amount of $300,000. The award ceiling is $75,000, with no stated award floor, and there is no cost-sharing or matching requirement. The opportunity was posted March 15, 2012, and closed May 9, 2012 (archived May 10, 2012). The activity categories listed for the FOA include consumer protection, food and nutrition, and health information and statistics, reflecting FDA’s broader public health mission and the emphasis on practical interventions, education, and systems-level strategies.
Eligibility is broad and includes a mix of public and private entities. Eligible applicants include state and local governments (state governments, county governments, city or township governments, special district governments, and independent school districts), tribal governments and tribal organizations, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with and without 501(c)(3) status (with the noted exception category related to institutions of higher education), public housing authorities/Indian housing authorities, for-profit organizations other than small businesses, and small businesses. This wide eligibility suggests the FDA anticipated that workable solutions could come from many corners, such as academic research teams, health systems, community-based organizations, professional associations, or private-sector groups with relevant implementation capabilities.
Overall, the FOA is essentially a call for actionable, prescriber-relevant research that identifies why inappropriate opioid use happens and tests strategies that measurably reduce that misuse and the harms that follow. The intended output is an expanded evidence base of interventions that can realistically be put into practice across different settings and sustained long enough to make a durable impact on opioid-related preventable harm.
Frequently Asked Questions (FAQs)
What is the funding opportunity number and what type of award is it?
This opportunity is RFA-FD-12-005. It is a Food and Drug Administration (FDA) cooperative agreement using the U01 activity code.
Which federal agency and FDA center administer this opportunity?
The opportunity is administered by the FDA through the Center for Drug Evaluation and Research (CDER) and is positioned within the FDA Safe Use Initiatives.
What problem is this funding opportunity trying to address?
The focus is on reducing preventable harm linked to the misuse and abuse of prescription opioid analgesics, including resulting injury and death. The scope includes opioids classified under DEA Schedules II through V.
What substances are included in the scope of the research?
The scope is limited to prescription opioid analgesics that fall under DEA Schedules II, III, IV, and V.
What kind of projects is FDA looking to fund?
FDA is looking for a small set of research projects that generate practical, usable evidence. The intent is not to only describe the opioid problem broadly, but to examine real-world interventions and prescriber-relevant strategies to improve safe opioid use and reduce misuse, abuse, and related harms.
What are the two main research emphasis areas described in the announcement?
The announcement emphasizes: (1) studies that clarify the knowledge, attitudes, and behaviors that drive inappropriate prescribing and inappropriate patient use; and (2) applied research that designs, tests, and implements strategies intended to change those behaviors and reduce preventable morbidity and mortality associated with prescription opioid analgesics.
Does the opportunity cover both prescriber behavior and patient/community behavior?
Yes. The opportunity explicitly includes research on clinician misprescribing or overprescribing, as well as patient or community use that does not align with the intended medical purpose, dosing, or schedule.
Are harms from combining opioids with other substances included?
Yes. The scope includes harm that occurs when opioids are combined with other substances in unsafe ways, including inadvertent mixing of multiple interacting drugs.
Is FDA looking for interventions that work only in tightly controlled research environments?
No. A repeated theme is usability and sustainability in real-world settings. The FDA is interested in strategies that can be applied across a variety of clinical and community environments and maintained over time by the people responsible for carrying them out.
What does "usability and sustainability" mean in the context of this FOA?
It means the proposed strategies should fit into routine prescribing workflows, be adoptable by different types of healthcare systems and settings, and not rely on unusually high staffing levels, ongoing funding infusions, or highly specialized expertise to keep operating after the study period ends.
How is a cooperative agreement (U01) different from a more hands-off grant mechanism?
Because this is a cooperative agreement, awardees should expect active involvement and collaboration with the FDA. The agency is likely to participate in refining deliverables, monitoring progress, and aligning the work with the goals of the FDA Safe Use Initiatives.
How many awards were expected under this funding opportunity?
The opportunity indicated an expectation of four awards.
What was the estimated total funding amount available?
The estimated total funding amount stated for the opportunity was $300,000.
What is the maximum award amount (award ceiling)?
The award ceiling was $75,000.
Is there a minimum award amount (award floor)?
No award floor was stated.
Is cost-sharing or matching required?
No. The announcement states there is no cost-sharing or matching requirement.
What are the posting and closing dates for the opportunity?
The opportunity was posted on March 15, 2012 and closed on May 9, 2012. It was archived on May 10, 2012.
What does it mean that the opportunity is archived?
Based on the provided information, archived status indicates the opportunity is no longer open (it closed in 2012 and was archived the following day).
What activity categories were associated with the FOA?
The activity categories listed include consumer protection, food and nutrition, and health information and statistics, consistent with the FDA public health mission and the emphasis on practical interventions and systems-level strategies.
Who is eligible to apply?
Eligibility is broad and includes public and private entities, including: state governments; county governments; city or township governments; special district governments; independent school districts; tribal governments and tribal organizations; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (with a noted exception category related to institutions of higher education); public housing authorities/Indian housing authorities; for-profit organizations other than small businesses; and small businesses.
Does the eligibility list include both nonprofit and for-profit organizations?
Yes. Nonprofits (with and without 501(c)(3) status) and for-profit organizations (including small businesses, as well as for-profits other than small businesses) are listed as eligible, along with a wide range of government and education entities.
What kinds of applicant organizations does FDA appear to be anticipating?
The broad eligibility suggests the FDA anticipated workable solutions from many sources, such as academic research teams, healthcare systems, community-based organizations, professional associations, and private-sector groups with implementation capabilities.
What is the overall goal or intended output of funded projects?
The stated aim is to expand the evidence base for interventions that prescribers can realistically put into practice across different settings and sustain over time, with measurable reductions in prescription opioid misuse and the preventable harms that follow.
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