Opportunity Information: Apply for RFA FD 11 024
Apply for RFA FD 11 024
- The Food Drug Administration in the agriculture business and commerce community development education employment, labor and training environment food and nutrition health information and statistics science and technology and other research and development sector is offering a public funding opportunity titled "Novel Interventions and Collaborations to Improving the Safe Use of Medications (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 Jun 22, 2011 and posted on Jun 17, 2011.
- Applicants must submit their applications by Jul 18, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $250,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $50,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: For profit organizations other than small businesses State governments Public housing authorities/Indian housing authorities City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Native American tribal governments (Federally recognized) County governments Private institutions of higher education.
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Opportunity Summary:
The funding opportunity titled "Novel Interventions and Collaborations to Improving the Safe Use of Medications (U01)" (Funding Opportunity Number RFA-FD-11-024) is a Food and Drug Administration (FDA) cooperative agreement program designed to reduce preventable harm caused by the suboptimal use of prescription and over-the-counter medications. It sits under the FDA Safe Use Initiative, described as "Collaborating to Reduce Preventable Harm," which focuses on practical, real-world medication safety problems where injuries, errors, or adverse outcomes could be avoided through better use, clearer processes, and targeted interventions. Rather than focusing only on discovering new drugs, this opportunity is aimed at improving how existing FDA-regulated medicines are used across healthcare settings so patients experience fewer avoidable harms.
A central feature of the program is that FDA will identify specific drugs, drug classes, or therapeutic areas that are linked to preventable harm and need immediate attention. Applicants are expected to conduct research that first characterizes and documents the nature and scope of the preventable harm for the targeted medication area, then digs into why the harm is happening by identifying sources and root causes. From there, projects are expected to move beyond describing the problem and into action by designing, developing, and implementing interventions that can reduce the harm. The emphasis is on interventions that are practical and implementable in real healthcare environments, not just theoretical recommendations, and that can demonstrate a clear pathway to safer medication use.
The FOA strongly emphasizes cross-sector collaboration as the strategy for making safety improvements stick. The Safe Use Initiative is built on the idea that medication safety is not owned by one group; it requires coordination among different parts of the healthcare system such as clinicians, pharmacists, health systems, payers, educators, patient organizations, technology vendors, and other stakeholders who influence medication use. In this spirit, the program supports projects that bring partners together to address safety problems collaboratively, aligning incentives and responsibilities across settings where medication errors or misuse occur, such as hospitals, outpatient clinics, pharmacies, long-term care, and home use.
From a funding and administrative standpoint, this is a discretionary cooperative agreement (U01), meaning FDA is expected to have substantial involvement during the project compared with a standard grant. The announcement anticipated up to 5 awards, with an estimated total funding amount of $250,000 and an award ceiling of $50,000. The award floor is listed as $0, indicating that there was no guaranteed minimum per award beyond what would be justified and approved. There is no cost sharing or matching requirement, which lowers the barrier for organizations that may not have funds available to contribute directly to project costs.
Eligibility is broad and includes many types of organizations across sectors. Eligible applicants include for-profit organizations (other than small businesses) and small businesses, state and local governments (including county, city/township, special district governments, and independent school districts), public housing authorities/Indian housing authorities, and a wide range of nonprofit and higher-education institutions (both public and private, including nonprofits with or without 501(c)(3) status, and public and state-controlled institutions of higher education). Federally recognized Native American tribal governments and other tribal organizations are also eligible. This wide eligibility aligns with the program's collaborative intent by allowing participation from the many entities that shape medication use and safety.
Key timing details show the opportunity was posted June 17, 2011, created June 22, 2011, and had an original and current closing date of July 18, 2011, with an archive date of July 19, 2011. The CFDA number associated with the program is 93.103 (Food and Drug Administration Research). Additional information was made available through the NIH Guide for Grants and Contracts, reflecting the federal grants infrastructure used to distribute and manage the announcement even though FDA is the sponsoring agency.
For applicants or interested parties who had trouble accessing the full announcement, the listed contact was Stephanie Bogan, Grants Management Specialist, reachable at stephanie.bogan@fda.hhs.gov. Overall, the opportunity was structured to fund focused, collaborative projects that move from identifying preventable medication-related harm to understanding its root causes and then implementing real interventions that measurably improve safe medication use.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Novel Interventions and Collaborations to Improving the Safe Use of Medications (U01)" and the Funding Opportunity Number is RFA-FD-11-024.
Which federal agency is sponsoring this opportunity?
This is a Food and Drug Administration (FDA) funding opportunity. It is associated with the FDA Safe Use Initiative.
What is the main goal of this program?
The goal is to reduce preventable harm caused by suboptimal use of prescription and over-the-counter medications. The focus is on practical, real-world medication safety problems where injuries, errors, or adverse outcomes could be avoided through better use, clearer processes, and targeted interventions.
How does this opportunity relate to the FDA Safe Use Initiative?
The program sits under the FDA Safe Use Initiative, described as "Collaborating to Reduce Preventable Harm." The initiative emphasizes collaboration to address medication safety issues that can be prevented through improved processes and interventions.
Is this grant about discovering new drugs?
No. The emphasis is on improving how existing FDA-regulated medications are used across healthcare settings so patients experience fewer avoidable harms, rather than on discovering new drugs.
What type of award mechanism is used?
This is a discretionary cooperative agreement (U01). That means FDA is expected to have substantial involvement during the project compared with a standard grant.
What does "substantial involvement" mean in a U01 cooperative agreement?
Based on the description of a U01 cooperative agreement, FDA is expected to be actively involved during the project in ways that go beyond what is typical for a standard grant. (The specific activities for that involvement are not detailed in the provided information.)
What kinds of medication safety problems are intended to be addressed?
The program targets preventable harm linked to the use of prescription and over-the-counter medications, including practical safety issues where injuries, errors, or adverse outcomes occur and could be avoided with improved use and processes.
Who selects the medication areas to be addressed?
FDA will identify specific drugs, drug classes, or therapeutic areas that are linked to preventable harm and need immediate attention.
What are applicants expected to do as part of the research?
Projects are expected to: (1) characterize and document the nature and scope of preventable harm for the targeted medication area, (2) identify sources and root causes of why the harm is happening, and (3) design, develop, and implement interventions intended to reduce the harm.
Does the program require moving beyond describing the problem?
Yes. The expectation is that projects move beyond describing the harm and into action by implementing interventions that can reduce the harm.
What types of interventions does the FOA emphasize?
The FOA emphasizes interventions that are practical and implementable in real healthcare environments, not merely theoretical recommendations, and that demonstrate a clear pathway to safer medication use.
Is collaboration required or encouraged?
Cross-sector collaboration is strongly emphasized as the strategy for making safety improvements stick. The Safe Use Initiative is built on the idea that medication safety requires coordination among multiple stakeholders.
Which kinds of partners or stakeholders are relevant for collaboration?
The opportunity highlights collaboration among groups that influence medication use, such as clinicians, pharmacists, health systems, payers, educators, patient organizations, technology vendors, and other stakeholders.
In what settings can projects address medication safety issues?
The description references multiple settings where errors or misuse can occur, including hospitals, outpatient clinics, pharmacies, long-term care, and home use.
How many awards were anticipated?
The announcement anticipated up to 5 awards.
What was the estimated total funding amount for the program?
The estimated total funding amount was $250,000.
What was the maximum award amount (award ceiling)?
The award ceiling was $50,000.
What was the minimum award amount (award floor)?
The award floor is listed as $0, meaning there was no guaranteed minimum per award beyond what would be justified and approved.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes for-profit organizations (other than small businesses) and small businesses; state and local governments (including county, city/township, special district governments, and independent school districts); public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); public and private institutions of higher education (including public and state-controlled institutions of higher education); and federally recognized Native American tribal governments and other tribal organizations.
Are small businesses eligible?
Yes. Small businesses are included in the eligible applicant categories.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible.
Are nonprofit organizations required to have 501(c)(3) status?
No. The eligibility list includes nonprofits with or without 501(c)(3) status.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible applicants.
What is the CFDA number for this opportunity?
The CFDA number associated with the program is 93.103 (Food and Drug Administration Research).
When was the opportunity posted and when did it close?
The opportunity was posted on June 17, 2011. The original and current closing date was July 18, 2011. The archive date was July 19, 2011. (It was created on June 22, 2011.)
Where was additional information made available?
Additional information was made available through the NIH Guide for Grants and Contracts, reflecting the federal grants infrastructure used to distribute and manage the announcement even though FDA is the sponsoring agency.
Who was the contact person for access issues or questions about the announcement?
The listed contact was Stephanie Bogan, Grants Management Specialist. Email: stephanie.bogan@fda.hhs.gov.
What is the overall structure of a project under this FOA?
Projects were structured to fund focused, collaborative work that starts by identifying and documenting preventable medication-related harm, then analyzing root causes, and then implementing real interventions aimed at measurably improving safe medication use.
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