Opportunity Information: Apply for NOT FD 13 001
Apply for NOT FD 13 001
- The Food Drug Administration in the consumer protection health science and technology and other research and development sector is offering a public funding opportunity titled "Request for Information (RFI) MDEpiNET PPP" 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 Dec 18, 2012 and posted on Dec 18, 2012.
- Applicants must submit their applications by Jan 11, 2013 Responses to this RFI are due January 11, 2013 by 1159 PM Eastern Time. Responses must be submitted electronically to Lisa.Ko@fda.hhs.gov.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The Food and Drug Administration (FDA) issued this Request for Information (RFI), titled "MDEpiNET PPP," to gather practical, multi-stakeholder input on how a public-private partnership (PPP) for the Medical Device Epidemiology Network (MDEpiNet) should be structured and operated. The core purpose is not to fund a specific project, but to collect informed perspectives that can help FDA design a partnership model that works for FDA while also supporting the missions and priorities of other participating organizations. The overall public health goal behind the effort is to strengthen the national system for medical device postmarket surveillance, meaning the ability to monitor device performance and safety after products are already in real-world use.
The RFI is centered on the operational "how" of running the MDEpiNet PPP, including governance, partner roles, financial sustainability, and project management workflows. FDA is explicitly asking stakeholders to describe what roles should be played by major partner categories such as patients and patient representatives, government entities, medical device manufacturers, academic researchers, health care providers and delivery systems, professional societies, payers, and other relevant sectors. Along with identifying roles, FDA is looking for the rules of the road for participation: what membership should look like, what expectations and responsibilities partners should take on, and what parameters should guide who is included and how they engage. A related theme is whether there are missing sectors that should be represented and, importantly, whether there are any essential groups without whom the partnership could not realistically meet its mission.
A major issue FDA highlights is the tension between broad representation and efficient decision-making. On one hand, a comprehensive partnership could improve credibility, buy-in, and access to data and expertise. On the other hand, large governing bodies can slow progress and make it difficult to act quickly. FDA is therefore asking how governance should be designed to keep the partnership representative while still allowing nimble operations, often achieved through a smaller empowered leadership or executive team. In practice, this involves questions like how decisions get made, how conflicts are managed, how working groups are chartered, and how accountability is maintained while ensuring the partnership can move quickly on urgent surveillance needs.
FDA is also requesting input on funding and long-term sustainability. This includes what financial models could support both the startup phase and ongoing operations of the partnership, potentially through a partnership management center. Respondents are asked to consider how the PPP could be funded in a way that is stable over time and acceptable to both public and private participants. FDA further asks for projections of the annual operating costs and what an ideal split might look like between federal contributions and private or non-federal sources. These questions are meant to surface realistic cost drivers such as staffing, data infrastructure, convening stakeholder groups, contracting for analytic work, maintaining governance and compliance functions, and supporting communications and reporting.
Another key focus is how the PPP would select and manage scientific work in a way that encourages participation but protects independence. FDA asks for ideal models for proposing projects, selecting them, funding them, and managing them once underway. The agency is looking for structures that create coordination and stakeholder buy-in while still allowing investigators to maintain scientific independence. That typically implies clear processes for setting priorities, avoiding undue influence, handling conflicts of interest, ensuring methodological rigor, and maintaining transparency around how projects are chosen and how results are produced and shared.
Administratively, this opportunity is listed under Funding Opportunity Number "NOT-FD-13-001" and is categorized as discretionary, using an "Other" funding instrument type. It falls under the FDA CFDA program number 93.103. There is no cost-sharing or matching requirement. Importantly, the award ceiling and floor are both listed as 0, which aligns with the fact that this is an RFI rather than a grant solicitation intended to make awards. Eligibility is described as unrestricted, meaning responses could come from any type of entity, subject to any clarifications in the full announcement. Responses were due January 11, 2013 by 11:59 PM Eastern Time and had to be submitted electronically to Lisa Ko at lisa.ko@fda.hhs.gov. The posting date was December 18, 2012, and the archive date was February 10, 2013. Contact support for accessing the full announcement is also directed to Lisa Ko, Grants Management Specialist, at the same email address.
FAQs: FDA RFI - MDEpiNET Public-Private Partnership (PPP) (NOT-FD-13-001)
1) What is this opportunity?
This opportunity is a Request for Information (RFI) issued by the U.S. Food and Drug Administration (FDA) titled "MDEpiNET PPP." It seeks practical, multi-stakeholder input on how a public-private partnership (PPP) for the Medical Device Epidemiology Network (MDEpiNET) should be structured and operated.
2) Is this a grant that will fund a project?
No. The stated purpose is not to fund a specific project. The RFI is meant to collect informed perspectives to help FDA design a partnership model that works for FDA and supports the missions and priorities of participating organizations.
3) What is the public health goal behind this RFI?
The overarching public health goal is to strengthen the national system for medical device postmarket surveillance, meaning the ability to monitor medical device performance and safety after devices are in real-world use.
4) What is MDEpiNET in the context of this RFI?
In this RFI, MDEpiNET refers to the Medical Device Epidemiology Network, and the focus is on how to structure and operate a PPP that supports MDEpiNET's postmarket surveillance-related mission.
5) What topics is FDA specifically asking about?
FDA is asking about the operational "how" of running an MDEpiNET PPP, including governance, partner roles, financial sustainability, and project management workflows.
6) Which stakeholder groups does FDA want input on?
FDA explicitly requests input on roles for major partner categories including patients and patient representatives, government entities, medical device manufacturers, academic researchers, health care providers and delivery systems, professional societies, payers, and other relevant sectors.
7) What does FDA mean by "rules of the road" for participation?
FDA is looking for guidance on what membership should look like, what expectations and responsibilities partners should take on, and what parameters should guide who is included and how they engage in the partnership.
8) Is FDA interested in identifying missing or essential partner sectors?
Yes. FDA asks whether there are missing sectors that should be represented and whether there are any essential groups without whom the partnership could not realistically meet its mission.
9) Why does FDA raise concerns about representation versus efficiency?
FDA highlights a tension: broad representation can improve credibility, buy-in, and access to data and expertise, but large governing bodies can slow progress and make it difficult to act quickly. FDA is seeking ideas on governance that keeps the partnership representative while still allowing nimble operations.
10) What governance design elements is FDA looking to understand?
The RFI discusses governance questions such as how decisions get made, how conflicts are managed, how working groups are chartered, and how accountability is maintained while ensuring the partnership can move quickly on urgent surveillance needs. FDA notes that nimble operations are often supported through a smaller empowered leadership or executive team.
11) What does FDA want to learn about funding and sustainability?
FDA requests input on funding and long-term sustainability, including financial models that could support both the startup phase and ongoing operations of the PPP, potentially through a partnership management center.
12) What kinds of cost drivers does FDA expect respondents to consider?
FDA indicates these questions should surface realistic cost drivers such as staffing, data infrastructure, convening stakeholder groups, contracting for analytic work, maintaining governance and compliance functions, and supporting communications and reporting.
13) Does this opportunity require cost sharing or matching?
No. The information provided states there is no cost-sharing or matching requirement.
14) Why are the award ceiling and award floor both listed as 0?
Because this is an RFI rather than a grant solicitation intended to make awards. The ceiling and floor being 0 aligns with the information-gathering nature of the opportunity.
15) How does FDA want the PPP to select and manage scientific work?
FDA seeks input on ideal models for proposing projects, selecting them, funding them, and managing them once underway, in ways that encourage participation while protecting scientific independence.
16) What issues does FDA raise about scientific independence and integrity?
FDA is looking for structures that create coordination and stakeholder buy-in while allowing investigators to maintain scientific independence. The RFI points to needs such as clear processes for setting priorities, avoiding undue influence, handling conflicts of interest, ensuring methodological rigor, and maintaining transparency about how projects are chosen and how results are produced and shared.
17) What is the Funding Opportunity Number for this RFI?
The Funding Opportunity Number listed is NOT-FD-13-001.
18) What type of funding instrument is listed?
The opportunity is categorized as discretionary and uses an "Other" funding instrument type.
19) What CFDA program number is associated with this opportunity?
The FDA CFDA program number listed is 93.103.
20) Who was eligible to respond?
Eligibility is described as unrestricted, meaning responses could come from any type of entity, subject to any clarifications in the full announcement.
21) When was the RFI posted, and when were responses due?
The posting date was December 18, 2012. Responses were due January 11, 2013 by 11:59 PM Eastern Time.
22) How were responses submitted and to whom?
Responses had to be submitted electronically to Lisa Ko at lisa.ko@fda.hhs.gov.
23) What is the archive date listed for this opportunity?
The archive date is February 10, 2013.
24) Who is the contact for support or for accessing the full announcement?
Contact support is directed to Lisa Ko, Grants Management Specialist, at lisa.ko@fda.hhs.gov.
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