Opportunity Information: Apply for RFA FD 15 027
Apply for RFA FD 15 027
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Development and Application of Case Control Analysis for Generic Drugs (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 Jul 6, 2015 and posted on May 5, 2015.
- Applicants must submit their applications by Jul 7, 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 $200,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public housing authorities/Indian housing authorities County governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments 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) State governments Special district governments Private institutions of higher education Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts.
- Non domestic (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:
The grant opportunity titled "Development and Application of Case Control Analysis for Generic Drugs (U01)" (Funding Opportunity Number RFA-FD-15-027) is a discretionary funding program from the U.S. Food and Drug Administration (FDA) focused on strengthening how postmarket evidence is analyzed when patients switch between brand-name drugs and their generic equivalents, or among generic versions. The core aim is methodological: to develop and apply case-control analysis approaches that can be used with real-world, postmarket data to better evaluate outcomes potentially associated with generic drug substitution. In practice, this means improving the statistical and epidemiologic tools used to detect, quantify, and interpret safety signals or effectiveness concerns that might arise after substitution, using observational data sources rather than pre-approval clinical trials.
This opportunity uses the cooperative agreement mechanism (U01), which generally indicates substantial scientific involvement by the funding agency during the project. In a cooperative agreement, the awardee typically leads the work, but FDA staff may collaborate on key aspects such as refining analytic strategies, ensuring the methods align with regulatory science needs, and helping guide how results are interpreted for public health decision-making. The activity category is listed under consumer protection, food and nutrition, and health, reflecting FDA's broader mission to protect and promote public health and to ensure confidence in approved medical products, including generic drugs.
The funding profile is small and targeted. FDA anticipated making one award, with an estimated total funding amount of $200,000 and an award ceiling of $200,000, suggesting a single, focused project intended to produce practical, usable methods rather than a large multi-site program. There is no cost-sharing or matching requirement, meaning applicants were not required to contribute non-federal funds as a condition of receiving the award.
Eligibility for this funding opportunity was broad and inclusive across many organization types. Eligible applicants included federal-recognized tribal governments and other tribal organizations, state and local governments (including counties, cities/townships, special district governments, and independent school districts), public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations other than small businesses. Importantly, non-U.S. entities (foreign institutions) were explicitly eligible to apply, non-U.S. components of U.S. organizations could participate, and foreign components as defined by HHS policy were allowed. This suggests FDA was open to the best expertise regardless of geography, likely because methodological development in pharmacoepidemiology and causal inference is a global research area.
The program sits within FDA's research assistance listing (CFDA) 93.103 and was posted on May 5, 2015. Key administrative dates indicate it was a time-limited solicitation: the original closing date was July 2, 2015, later extended to July 7, 2015, with an archive date of August 1, 2015. The full announcement was made available through the NIH Guide for Grants and Contracts, which is a common distribution channel for HHS-related funding opportunities even when the sponsoring agency is FDA.
From a substance standpoint, the emphasis on "case-control analysis methods" signals a focus on observational study designs that compare people who experience an event of interest (cases, such as an adverse outcome or treatment failure) to similar people who do not experience that event (controls), looking retrospectively at exposures, including whether and when generic substitution occurred. In the context of generic drugs, improved case-control methods can be especially valuable because randomized trials are often not feasible post-approval, and because real-world substitution patterns can be influenced by insurance policies, pharmacy practices, patient characteristics, and clinical context. Better methods can help separate true safety or performance issues from confounding factors such as disease severity, adherence differences, switching due to clinical deterioration, or differences in health care utilization. The overall public health value is to increase confidence in the safety and effectiveness of generic substitution while also improving FDA's ability to identify and evaluate potential risks when they occur.
For applicants or interested parties who needed help accessing the full announcement, the listed grants management contact was Lisa Ko (lisa.ko@fda.hhs.gov).
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Development and Application of Case Control Analysis for Generic Drugs (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-15-027.
Which federal agency is offering this grant?
This is a discretionary funding opportunity from the U.S. Food and Drug Administration (FDA).
What is the main purpose of this funding opportunity?
The core aim is methodological: to develop and apply case-control analysis approaches that can be used with real-world, postmarket data to better evaluate outcomes potentially associated with generic drug substitution.
What types of drug switching does the grant focus on?
The focus is on postmarket evidence related to patients switching between brand-name drugs and their generic equivalents, or switching among generic versions.
What kind of data is this program concerned with?
The emphasis is on real-world, postmarket observational data sources, rather than pre-approval clinical trial data.
What is meant by "case-control analysis" in this context?
Case-control approaches compare people who experience an event of interest (cases, such as an adverse outcome or treatment failure) to similar people who do not experience that event (controls), and then look retrospectively at exposures, including whether and when generic substitution occurred.
Why is FDA interested in improving case-control methods for generic substitution?
Because randomized trials are often not feasible post-approval, and real-world substitution patterns can be influenced by insurance policies, pharmacy practices, patient characteristics, and clinical context. Improved methods can help separate true safety or effectiveness issues from confounding factors.
What kinds of confounding factors are highlighted in the opportunity description?
Examples mentioned include disease severity, adherence differences, switching due to clinical deterioration, and differences in health care utilization.
What is the expected public health value of this research?
The stated value is to increase confidence in the safety and effectiveness of generic substitution, while improving FDA's ability to identify and evaluate potential risks when they occur.
What funding mechanism is used for this opportunity?
The opportunity uses a cooperative agreement mechanism (U01).
What does a cooperative agreement (U01) generally imply?
It generally indicates substantial scientific involvement by the funding agency during the project. The awardee typically leads the work, but FDA staff may collaborate on key aspects such as refining analytic strategies, ensuring alignment with regulatory science needs, and helping guide interpretation for public health decision-making.
What is the activity category listed for this opportunity?
The activity category is listed under consumer protection, food and nutrition, and health.
How many awards did FDA anticipate making?
FDA anticipated making one award.
What is the estimated total funding amount?
The estimated total funding amount is $200,000.
What is the award ceiling?
The award ceiling is $200,000.
Is there a cost-sharing or matching requirement?
No. The opportunity states there is no cost-sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes: federally recognized tribal governments and other tribal organizations; state and local governments (including counties, cities/townships, special districts, and independent school districts); public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); small businesses; and for-profit organizations other than small businesses.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. entities (foreign institutions) were explicitly eligible to apply.
Can non-U.S. components of U.S. organizations participate?
Yes. Non-U.S. components of U.S. organizations could participate.
Are foreign components (as defined by HHS policy) allowed?
Yes. Foreign components as defined by HHS policy were allowed.
What is the CFDA number associated with this program?
The program sits within FDA's research assistance listing (CFDA) 93.103.
When was the opportunity posted?
The opportunity was posted on May 5, 2015.
What was the original application closing date?
The original closing date was July 2, 2015.
Was the closing date extended?
Yes. The closing date was extended to July 7, 2015.
What is the archive date for the opportunity?
The archive date was August 1, 2015.
Where was the full announcement made available?
The full announcement was made available through the NIH Guide for Grants and Contracts.
What types of outcomes is the methodology intended to evaluate?
The methods are intended to evaluate outcomes potentially associated with generic drug substitution, including the ability to detect, quantify, and interpret safety signals or effectiveness concerns that might arise after substitution.
Does this opportunity focus on developing methods, applying them, or both?
Both. The description emphasizes developing and applying case-control analysis approaches using real-world, postmarket data.
Why might observational methods be especially important for generic substitution questions?
The description notes that post-approval randomized trials are often not feasible, and that real-world switching is shaped by multiple factors. Better observational methods can improve interpretation of postmarket evidence in this setting.
Who is the listed grants management contact for assistance?
The listed grants management contact is Lisa Ko.
What is the contact email address for the grants management contact?
The email address provided is lisa.ko@fda.hhs.gov.
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