Opportunity Information: Apply for RFA FD 09 012
Apply for RFA FD 09 012
- The Food Drug Administration in the consumer protection disaster prevention and relief education employment, labor and training environment health science and technology and other research and development sector is offering a public funding opportunity titled "Convener of Active Medical Product Surveillance Discussions (U13)" 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 24, 2009 and posted on Jun 24, 2009.
- Applicants must submit their applications by Jul 15, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $600,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $600,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Eligible Institutions The following organizations/institutions are eligible to apply Non profit organizations. Foreign institutions are not eligible to apply for conference grant support. An international conference can be supported through the U.S. representative organization of an established international scientific or professional society. Eligible Individuals Any individual with the skills, knowledge, and resources necessary to carry out the proposed activities as the Project Director (PD) is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply. Other Special Eligibility Criteria Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct. Resubmissions. Resubmission applications are not permitted in response to this FOA. Renewals. Renewal applications are not permitted in response to this FOA.
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Opportunity Summary:
The Convener of Active Medical Product Surveillance Discussions (U13) funding opportunity (RFA-FD-09-012) is a Food and Drug Administration (FDA) cooperative agreement issued through the Office of Critical Path Programs (OCPP) in the Office of the Commissioner. Its central purpose is to support a neutral, independent organization in bringing together a wide range of stakeholders to hold conferences and meetings focused on improving the field of active medical product surveillance. In practical terms, the FDA is looking for an entity that can serve as an honest broker and organizer, creating a structured forum where experts and affected parties can work through the real-world challenges of detecting, evaluating, and communicating safety signals and other findings using active surveillance approaches rather than relying only on passive reporting systems.
The funded work is centered on convening and facilitation. The awardee is expected to plan, host, and manage meetings that explore methodological questions (how surveillance studies should be designed and analyzed), data development issues (what data sources are needed and how to improve them), technical barriers (tools, infrastructure, and implementation details that make surveillance workable at scale), and communication challenges (how to responsibly share findings with regulators, industry, clinicians, researchers, and the public). A key deliverable is not just holding events, but also synthesizing what comes out of them: summarizing discussions, capturing consensus and disagreements, and translating the outcomes into materials that can be broadly shared with organizations and individuals who can actually build or improve surveillance methods and systems.
This is a discretionary funding opportunity using a cooperative agreement mechanism, meaning FDA involvement is typically more hands-on than with a standard grant. It is listed under CFDA 93.103 (Food and Drug Administration Research) and spans multiple activity categories, including consumer protection, health, science and technology, and other research and development areas, reflecting the cross-cutting nature of active surveillance across medical products and public health. The FOA anticipated making one award, with total estimated funding of $600,000 and a fixed award ceiling and floor of $600,000, signaling a single, fully funded convening effort rather than multiple smaller projects.
Eligibility is limited to nonprofit organizations, including those with and without 501(c)(3) status, excluding institutions of higher education as the applicant category specified here. Foreign institutions are not eligible to apply for conference grant support, although an international conference could be supported if organized through a U.S. representative organization of an established international scientific or professional society. The FOA also notes that any qualified individual may serve as Project Director if they have the skills and resources to lead the effort, and it encourages participation by individuals from underrepresented racial and ethnic groups and individuals with disabilities. Applicants may submit more than one application as long as each is scientifically distinct, but resubmissions and renewals are not permitted under this announcement.
Timing details indicate the opportunity was posted on June 24, 2009, with an application closing date of July 15, 2009, and an archive date of August 14, 2009. For administrative or access issues related to the full announcement, the listed contact was Marc Pitts, Electronic Research Liaison at FDA (301-827-7162, MARC.PITTS@FDA.HHS.GOV).
Frequently Asked Questions (FAQ): Convener of Active Medical Product Surveillance Discussions (U13) (RFA-FD-09-012)
1) What is this funding opportunity?
This opportunity is the Convener of Active Medical Product Surveillance Discussions (U13) funding opportunity, RFA-FD-09-012. It is a Food and Drug Administration (FDA) cooperative agreement issued through the Office of Critical Path Programs (OCPP) in the Office of the Commissioner.
2) What is the main purpose of the award?
The central purpose is to support a neutral, independent organization that can bring together a wide range of stakeholders to hold conferences and meetings focused on improving the field of active medical product surveillance. The goal is to create a structured forum where stakeholders can work through practical challenges in detecting, evaluating, and communicating safety signals and other findings using active surveillance approaches (rather than relying only on passive reporting systems).
3) What does "active medical product surveillance" mean in the context of this FOA?
Based on the description provided, active surveillance refers to approaches that use organized, proactive methods and data sources to detect and evaluate safety signals and findings, as opposed to relying only on passive reporting systems. The meetings are intended to address real-world challenges in how these active approaches are designed, implemented, and communicated.
4) What kind of organization is FDA looking to fund?
FDA is looking for a neutral, independent entity that can serve as an "honest broker" and organizer. The awardee is expected to convene stakeholders, facilitate structured discussions, and synthesize outcomes in a way that can be broadly shared and used by others working to improve surveillance methods and systems.
5) What activities are expected under this award?
The funded work is centered on convening and facilitation. The awardee is expected to plan, host, and manage conferences and meetings that focus on improving active medical product surveillance, including capturing and synthesizing what comes out of those discussions.
6) What topics should the meetings and conferences cover?
The FOA calls for meetings that explore:
- Methodological questions (how surveillance studies should be designed and analyzed)
- Data development issues (what data sources are needed and how to improve them)
- Technical barriers (tools, infrastructure, and implementation details that make surveillance workable at scale)
- Communication challenges (how to responsibly share findings with regulators, industry, clinicians, researchers, and the public)
7) Are deliverables limited to holding meetings?
No. A key deliverable is synthesizing the outcomes of the events. This includes summarizing discussions, capturing areas of consensus and disagreement, and translating the outcomes into materials that can be broadly shared with organizations and individuals who can build or improve surveillance methods and systems.
8) What makes this a cooperative agreement (U13) rather than a standard grant?
This opportunity uses a cooperative agreement mechanism, which the FOA notes typically involves more hands-on FDA involvement than a standard grant.
9) Which federal listing or assistance number is associated with this opportunity?
The opportunity is listed under CFDA 93.103 (Food and Drug Administration Research).
10) What program areas does this opportunity fall under?
The FOA spans multiple activity categories, including consumer protection, health, science and technology, and other research and development areas. This reflects the cross-cutting nature of active surveillance across medical products and public health.
11) How many awards were anticipated?
The FOA anticipated making one award.
12) What is the total funding amount for this opportunity?
The total estimated funding is $600,000.
13) Is there a minimum or maximum award amount?
Yes. The FOA lists a fixed award ceiling and floor of $600,000, indicating a single, fully funded convening effort rather than multiple smaller projects.
14) Who is eligible to apply?
Eligibility is limited to nonprofit organizations, including those with and without 501(c)(3) status. The applicant category specified excludes institutions of higher education.
15) Are institutions of higher education eligible to apply?
No. The FOA specifies eligibility for nonprofit organizations while excluding institutions of higher education as the applicant category.
16) Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply for conference grant support under this announcement.
17) Can an international conference be supported under this FOA?
Yes, an international conference could be supported if it is organized through a U.S. representative organization of an established international scientific or professional society.
18) Who can serve as the Project Director (PD)?
The FOA states that any qualified individual may serve as Project Director if they have the skills and resources to lead the effort.
19) Does the FOA encourage participation from any particular groups?
Yes. The FOA encourages participation by individuals from underrepresented racial and ethnic groups and individuals with disabilities.
20) Can an applicant submit more than one application?
Yes. Applicants may submit more than one application as long as each application is scientifically distinct.
21) Are resubmissions allowed?
No. Resubmissions are not permitted under this announcement.
22) Are renewals allowed?
No. Renewals are not permitted under this announcement.
23) What are the key dates for this opportunity?
- Posted date: June 24, 2009
- Application closing date: July 15, 2009
- Archive date: August 14, 2009
24) Who is the listed contact for administrative or access issues?
The listed contact is Marc Pitts, Electronic Research Liaison at FDA. Phone: 301-827-7162. Email: MARC.PITTS@FDA.HHS.GOV.
25) What is the practical role of the awardee described in the FOA?
The awardee is expected to act as an honest broker and organizer: bringing together experts and affected parties, structuring the conversations, facilitating discussion across stakeholders, and producing usable summaries and materials that reflect both consensus and disagreements on how to improve active medical product surveillance.
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