Opportunity Information: Apply for RFA FD 12 010
Apply for RFA FD 12 010
- The Food Drug Administration in the consumer protection education health science and technology and other research and development sector is offering a public funding opportunity titled "Developing Innovative Methodologies and Device Specific Infrastructure through the Medical Device Epidemiology Network Applications for Medical Countermeasure Associated Devices (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 19, 2012 and posted on Mar 19, 2012.
- Applicants must submit their applications by Apr 30, 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 $2,680,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $490,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses State governments Private institutions of higher education Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Small businesses Public and State controlled institutions of higher education Independent school districts.
- Non doemstic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
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Opportunity Summary:
This funding opportunity, titled "Developing Innovative Methodologies and Device Specific Infrastructure through the Medical Device Epidemiology Network Applications for Medical Countermeasure Associated Devices (U01)" (Funding Opportunity Number RFA-FD-12-010), is a Food and Drug Administration (FDA) cooperative agreement designed to strengthen how the United States (and collaborating partners) generate, connect, and use evidence about the safety and effectiveness of medical devices that are considered medical countermeasures (MCM). In practical terms, it focuses on improving the scientific tools, data infrastructure, and surveillance approaches needed to evaluate devices used in emergencies, public health preparedness, and radiological or related health contexts, while supporting regulatory-grade research that can inform FDA decision making across a device's total product life cycle (TPLC), from development and premarket evaluation through real-world use after clearance or approval.
A central goal of the program is to advance and apply innovative methodologies that close the gap between premarket and postmarket evidence for MCM-related devices. Premarket studies often happen in controlled settings with limited populations and specific endpoints, while postmarket evidence reflects real-world performance across broader and more diverse patients, clinical environments, and usage patterns. This announcement calls for methodological solutions that help link these two worlds so that conclusions about device safety, effectiveness, and patient outcomes remain coherent as the evidence base evolves over time. The opportunity explicitly highlights approaches such as evidence synthesis and the evaluation of patient-centered outcomes, signaling interest in methods that go beyond traditional clinical endpoints and incorporate outcomes that matter to patients (for example, functional status, quality of life, symptom burden, usability, or other meaningful experiences), assessed longitudinally across the TPLC.
Another major emphasis is conducting high-quality, independent research that directly contributes to medical device regulatory decision making for priority MCM devices and radiological health. This means the work is expected to be rigorous, credible, and policy-relevant, with a clear line of sight to how results could support or improve regulatory evaluations, benefit-risk determinations, labeling considerations, postmarket actions, or broader regulatory science. Because this is a cooperative agreement (U01), the intent is not just to fund an isolated research project, but to support a more collaborative relationship with the FDA, where the agency may have substantial programmatic involvement to help align the research with regulatory needs, data standards, or priority questions.
The opportunity also targets the advancement, implementation, and evaluation of postmarketing surveillance systems and their application to MCM priority medical device regulatory science. In this context, postmarket surveillance involves building or improving systems that can detect safety signals, characterize real-world performance, and support timely assessment when devices are deployed broadly, including in urgent or high-consequence situations. The announcement suggests interest in not only creating surveillance capabilities, but also evaluating whether they work well in practice, how they perform for specific device types, and how they can be applied to answer regulatory science questions. This could include developing device-specific infrastructure, improving data linkage and quality, enhancing signal detection methods, or designing analytic approaches that better account for confounding, missingness, and changing patterns of use over time.
A further objective is stakeholder communication and educational outreach related to innovative MCM medical device surveillance and scientific strategies. The intent here is to ensure that methods and findings do not stay confined to technical reports, but are translated into usable knowledge for relevant audiences. Stakeholders can include regulators, clinicians, health systems, patients, manufacturers, public health partners, and researchers. Outreach could involve sharing best practices, building common understanding of surveillance approaches, promoting transparency around methods, and supporting broader adoption of improved methodologies or infrastructure.
From an administrative and funding standpoint, the award is categorized as discretionary funding and uses a cooperative agreement mechanism. The agency is the FDA, and the CFDA number listed is 93.103 (Food and Drug Administration Research). The program anticipated one award, with an estimated total funding amount of $2,680,000. The award ceiling is $490,000 (with an award floor listed as 1). There is no cost sharing or matching requirement. The opportunity was posted on March 19, 2012, with an original and current closing date of April 30, 2012, and an archive date of May 30, 2012.
Eligibility is broad and includes many U.S.-based public and private entity types, such as state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), special district governments, independent school districts, and certain housing authorities. Importantly, non-domestic (non-U.S.) entities are also eligible to apply, and foreign components of U.S. organizations are allowed, consistent with the HHS Grants Policy Statement. This international eligibility aligns with the reality that medical countermeasure preparedness, device supply chains, and evidence generation can be global, and that collaborations across borders may strengthen data and methodological innovation.
For applicants or interested parties who needed access to the full announcement at the time, the listing provides a point of contact in FDA grants management: Lisa Ko, Grants Management Specialist (lisa.ko@fda.hhs.gov).
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Developing Innovative Methodologies and Device Specific Infrastructure through the Medical Device Epidemiology Network Applications for Medical Countermeasure Associated Devices (U01)."
What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-FD-12-010.
Which agency is offering this grant?
The awarding agency is the U.S. Food and Drug Administration (FDA).
What type of funding mechanism is this?
This is a cooperative agreement (U01), which typically involves an active, collaborative relationship with the FDA, including substantial programmatic involvement to help align the work with regulatory needs and priorities.
Is this mandatory or discretionary funding?
It is categorized as discretionary funding.
What is the CFDA number associated with this program?
The CFDA number listed is 93.103 (Food and Drug Administration Research).
What is the overall purpose of this opportunity?
The purpose is to strengthen how the United States (and collaborating partners) generate, connect, and use evidence about the safety and effectiveness of medical devices considered medical countermeasures (MCM). The focus is on improving scientific tools, data infrastructure, and surveillance approaches that can support regulatory-grade research across a device's total product life cycle (TPLC).
What kinds of devices does this opportunity focus on?
The opportunity focuses on medical devices that are considered medical countermeasures (MCM), including those used in emergencies, public health preparedness, and radiological (or related) health contexts.
What does "total product life cycle (TPLC)" mean in this announcement?
In this context, TPLC refers to generating and using evidence from development and premarket evaluation through real-world use after clearance or approval, so that device safety and effectiveness can be understood over time as use expands and evolves.
What is the central methodological goal described in the opportunity?
A central goal is to advance and apply innovative methodologies that close the gap between premarket and postmarket evidence for MCM-related devices. The intent is to make conclusions about safety, effectiveness, and patient outcomes coherent as evidence accumulates from controlled studies and real-world use.
Why is linking premarket and postmarket evidence important here?
Premarket studies often occur in controlled settings with limited populations and specific endpoints, while postmarket evidence reflects real-world performance across broader and more diverse patients, settings, and usage patterns. This opportunity emphasizes methodological solutions that help connect these evidence sources across the TPLC.
Does the opportunity emphasize patient-centered outcomes?
Yes. The announcement explicitly highlights the evaluation of patient-centered outcomes, indicating interest in outcomes beyond traditional clinical endpoints, such as functional status, quality of life, symptom burden, usability, and other meaningful patient experiences, assessed longitudinally across the TPLC.
Is evidence synthesis mentioned as an area of interest?
Yes. Evidence synthesis is specifically highlighted as an example of an approach of interest to help integrate and interpret evidence across premarket and postmarket settings.
What kind of research quality and orientation is expected?
The opportunity emphasizes high-quality, independent research that directly contributes to medical device regulatory decision making for priority MCM devices and radiological health. The work is expected to be rigorous, credible, and clearly relevant to regulatory science needs.
How is this work expected to support FDA regulatory decision making?
The announcement indicates a clear line of sight from research results to FDA decision making across the TPLC, potentially informing regulatory evaluations, benefit-risk determinations, labeling considerations, postmarket actions, and broader regulatory science.
What is the role of postmarket surveillance in this opportunity?
Advancing, implementing, and evaluating postmarketing surveillance systems is a major emphasis. This includes building or improving systems that detect safety signals, characterize real-world performance, and enable timely assessments when devices are deployed broadly, including in urgent or high-consequence situations.
Does the opportunity focus only on creating surveillance systems, or also on evaluating them?
It includes both. The announcement suggests interest in not only developing surveillance capabilities, but also evaluating how well they work in practice, how they perform for specific device types, and how they can be applied to regulatory science questions.
What kinds of infrastructure or data improvements are contemplated?
The opportunity references device-specific infrastructure and improvements such as better data linkage and data quality, enhanced signal detection methods, and analytic approaches that address issues like confounding, missing data, and changing patterns of device use over time.
Is stakeholder communication and educational outreach part of the program?
Yes. The opportunity includes stakeholder communication and educational outreach related to innovative MCM medical device surveillance and scientific strategies, with the goal of translating methods and findings into usable knowledge.
Who are considered stakeholders for communication and outreach?
Stakeholders may include regulators, clinicians, health systems, patients, manufacturers, public health partners, and researchers.
How many awards were anticipated?
The program anticipated one award.
What was the estimated total funding amount for this opportunity?
The estimated total funding amount is $2,680,000.
What is the award ceiling?
The award ceiling is listed as $490,000.
What is the award floor?
The award floor is listed as 1.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
When was the opportunity posted?
The opportunity was posted on March 19, 2012.
What was the closing date?
The original and current closing date listed is April 30, 2012.
When was the opportunity archived?
The archive date listed is May 30, 2012.
Who was eligible to apply?
Eligibility is broad and includes many public and private entity types, including state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), special district governments, independent school districts, and certain housing authorities.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The listing states that non-domestic (non-U.S.) entities are eligible to apply.
Are foreign components of U.S. organizations allowed?
Yes. Foreign components of U.S. organizations are allowed, consistent with the HHS Grants Policy Statement.
Why does the opportunity allow international participation?
The description notes that this aligns with the global nature of medical countermeasure preparedness, device supply chains, and evidence generation, and that cross-border collaborations may strengthen data and methodological innovation.
Who is the grants management contact for this opportunity?
The listed FDA grants management contact is Lisa Ko, Grants Management Specialist, at lisa.ko@fda.hhs.gov.
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