Opportunity Information: Apply for RFA FD 15 010
Apply for RFA FD 15 010
- The Food Drug Administration in the community development education environment food and nutrition health information and statistics science and technology and other research and development sector is offering a public funding opportunity titled "IMEDS Methods Research Agenda" 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 Apr 15, 2015 and posted on Apr 15, 2015.
- Applicants must submit their applications by Jun 15, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Eligibility is limited to the Reagan Udall Foundation. The IMEDS organization has developed a network of statisticians, epidemiologists, data scientists, and clinicians that have experience operating in both the IMEDS research laboratory and also familiarity with the Sentinel distributed database. In addition, through the Reagan Udall Foundation partnership, the IMEDS Methods program has a unique ability to convene FDA, patients, academics, government and industry so that the findings and tools developed through its research agenda will be promulgated and adopted.
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Opportunity Summary:
The IMEDS Methods Research Agenda grant (RFA-FD-15-010) is a Food and Drug Administration (FDA) funding opportunity designed to strengthen the scientific methods used to monitor the safety of medical products after they are already on the market. It is rooted in Section 905 of the Food and Drug Administration Amendments Act (FDAAA), which requires FDA to build a stronger postmarket drug safety monitoring capability. To meet that requirement, FDA created the Sentinel Initiative, a long-term effort to build an electronic surveillance system that can detect and evaluate safety issues using large-scale healthcare data.
A central driver of this opportunity is the existence of the Sentinel Distributed Database, developed through FDA's Mini-Sentinel pilot. This distributed database provides access to data representing more than 150 million patient records, creating a powerful foundation for rapid, population-level safety assessments. The challenge, and the reason this grant exists, is that using such large observational healthcare datasets well requires advanced analytic methods. Traditional approaches can produce biased or misleading results if confounding, missingness, data limitations, and complex real-world treatment patterns are not properly handled. The grant is therefore focused on developing, testing, and encouraging adoption of improved methodologies that make postmarket surveillance more reliable, interpretable, and actionable for regulators and public health decision-makers.
The project is carried out through IMEDS Methods, a program housed within the Reagan-Udall Foundation (RUF). IMEDS Methods supports FDA's public health mission by initiating and facilitating research on methods for safety evaluation in large healthcare databases. In practical terms, the program acts as a bridge between FDA surveillance needs and the broader scientific community working in pharmacoepidemiology, biostatistics, and data science, with an emphasis on producing tools and findings that can be used in real FDA surveillance workflows rather than remaining purely academic.
The methods research agenda is organized around five core areas. First, it targets bias in observational study estimates, recognizing that non-randomized data can be distorted by confounding, selection effects, measurement error, and other systematic issues. Second, it aims to improve understanding of the data itself, including the strengths and limitations of automated healthcare data sources such as claims and electronic health records, and the implications those characteristics have for safety inference. Third, it emphasizes applying lessons learned from earlier IMEDS projects directly to FDA surveillance activities, which signals a strong focus on translation: taking what has already been developed and making it operational and useful for routine monitoring. Fourth, it seeks to broaden the scope of surveillance from isolated safety questions toward continuous risk/benefit assessment, reflecting the reality that regulators and clinicians often need an ongoing, balanced view of benefits and harms as evidence evolves. Fifth, it continues support for qualified investigators across industry, government, and academia by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory, which is intended to lower barriers to rigorous, reproducible methods work in secure environments.
From an administrative standpoint, this is a discretionary grant with a single expected award. The estimated total funding is $1,000,000, with an award ceiling of $1,000,000 and no cost-sharing or matching requirement. The funding opportunity was posted on April 15, 2015, with an original and current closing date of June 15, 2015, and an archive date of July 15, 2015. The CFDA number listed is 93.103, under the FDA. While the activity categories span areas like health, information and statistics, science and technology, and research and development, the central purpose is clearly methodological research for postmarket medical product safety surveillance.
Eligibility is narrowly restricted: applicants must be the Reagan-Udall Foundation. The rationale provided is that IMEDS, through RUF, already maintains a network of experienced statisticians, epidemiologists, data scientists, and clinicians who know how to operate within the IMEDS research laboratory and understand the Sentinel distributed data environment. The announcement also highlights RUF's convening power, meaning it can bring together FDA, patients, academics, government, and industry to ensure that the methods and tools produced are communicated broadly and more likely to be adopted in practice rather than staying confined to one stakeholder group.
For access issues or questions about the full announcement, the listed contact is Vieda Hubbard, Grants Management Specialist at FDA (240-402-7588; vieda.hubbard@fda.hhs.gov).
IMEDS Methods Research Agenda (RFA-FD-15-010) - Frequently Asked Questions
What is the IMEDS Methods Research Agenda grant (RFA-FD-15-010)?
The IMEDS Methods Research Agenda grant (RFA-FD-15-010) is an FDA funding opportunity intended to strengthen the scientific and analytic methods used to monitor the safety of medical products after they are already on the market (postmarket safety surveillance).
What is the main purpose of this funding opportunity?
The central purpose is methodological research that improves how large-scale observational healthcare data are used for postmarket safety monitoring. The grant focuses on developing, testing, and encouraging adoption of better analytic approaches so that safety assessments are more reliable, interpretable, and useful for regulators and public health decision-makers.
What law or requirement is this grant rooted in?
This opportunity is rooted in Section 905 of the Food and Drug Administration Amendments Act (FDAAA), which requires FDA to build a stronger postmarket drug safety monitoring capability.
How does the Sentinel Initiative relate to this grant?
To meet the FDAAA requirement, FDA created the Sentinel Initiative, a long-term effort to build an electronic surveillance system that can detect and evaluate safety issues using large-scale healthcare data. This grant supports methods research that helps make Sentinel-based surveillance more rigorous and effective.
What is the Sentinel Distributed Database and why does it matter here?
The Sentinel Distributed Database was developed through FDA's Mini-Sentinel pilot and provides access to data representing more than 150 million patient records. It matters because it enables rapid, population-level safety assessments, but extracting valid conclusions from such observational data requires advanced methods to address bias and real-world data limitations.
Why is methods research needed for postmarket surveillance using observational healthcare data?
Large observational datasets can produce biased or misleading results if issues like confounding, missing data, data limitations, and complex real-world treatment patterns are not handled appropriately. This grant exists to improve the methodologies so postmarket surveillance findings are more trustworthy and actionable.
Who runs the project and what is IMEDS Methods?
The project is carried out through IMEDS Methods, a program housed within the Reagan-Udall Foundation (RUF). IMEDS Methods supports FDA's public health mission by initiating and facilitating research on methods for safety evaluation in large healthcare databases.
How is IMEDS Methods described in terms of its role between FDA and researchers?
IMEDS Methods is described as a bridge between FDA surveillance needs and the broader scientific community (including pharmacoepidemiology, biostatistics, and data science). The emphasis is on producing tools and findings that can be used in real FDA surveillance workflows rather than remaining purely academic.
What are the five core areas in the methods research agenda?
The agenda is organized around five core areas:
- Addressing bias in observational study estimates (including confounding, selection effects, measurement error, and other systematic issues).
- Improving understanding of the data sources (strengths and limitations of automated healthcare data such as claims and electronic health records, and what that means for safety inference).
- Applying lessons learned from earlier IMEDS projects to FDA surveillance activities (a strong translation-to-practice focus).
- Broadening surveillance toward continuous risk/benefit assessment rather than isolated safety questions.
- Supporting qualified investigators by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory.
What types of methodological problems does the agenda explicitly call out?
The opportunity explicitly highlights problems such as confounding, selection effects, measurement error, missingness (missing data), data limitations, and complex real-world treatment patterns, all of which can distort results in non-randomized (observational) settings.
Does the opportunity focus only on safety, or also on benefits?
It includes an emphasis on moving beyond isolated safety questions toward continuous risk/benefit assessment, reflecting the need for ongoing, balanced evaluation of benefits and harms as evidence evolves.
What is the IMEDS Research Laboratory mentioned in the announcement?
The IMEDS Research Laboratory is described as a way to provide qualified investigators access to de-identified electronic healthcare data and computing resources. Its purpose is to lower barriers to rigorous, reproducible methods work in secure environments.
How many awards are expected under this funding opportunity?
The announcement indicates a single expected award.
What is the total estimated funding amount and the award ceiling?
The estimated total funding is $1,000,000, and the award ceiling is also $1,000,000.
Is cost-sharing or matching required?
No. The announcement states there is no cost-sharing or matching requirement.
What type of grant is this described as?
It is described as a discretionary grant.
When was the opportunity posted, and what were the key dates?
The opportunity was posted on April 15, 2015. The original and current closing date was June 15, 2015. The archive date was July 15, 2015.
What is the CFDA number for this opportunity?
The CFDA number listed is 93.103 (under the FDA).
Which applicant organizations are eligible to apply?
Eligibility is narrowly restricted: applicants must be the Reagan-Udall Foundation.
Why is eligibility limited to the Reagan-Udall Foundation?
The rationale provided is that IMEDS, through RUF, already maintains a network of experienced statisticians, epidemiologists, data scientists, and clinicians who can operate within the IMEDS research laboratory and understand the Sentinel distributed data environment. The announcement also emphasizes RUF's convening power to bring together FDA, patients, academia, government, and industry so methods and tools are communicated broadly and are more likely to be adopted in practice.
What kinds of fields or disciplines are most relevant to this methods work?
The announcement references expertise and communities such as pharmacoepidemiology, biostatistics, data science, and clinical expertise, especially as applied to safety evaluation in large healthcare databases.
What activity categories are associated with this opportunity?
The activity categories span areas such as health, information and statistics, science and technology, and research and development, with the central focus being methodological research for postmarket medical product safety surveillance.
What is the best contact for questions or access issues about the full announcement?
The listed contact is Vieda Hubbard, Grants Management Specialist at FDA. Phone: 240-402-7588. Email: vieda.hubbard@fda.hhs.gov.
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