Opportunity Information: Apply for RFA FD 14 014
Apply for RFA FD 14 014
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Effect of Therapeutic Class on Generic Drug Substitutions (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 Apr 29, 2014 and posted on Apr 29, 2014.
- Applicants must submit their applications by Jun 21, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $400,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $400,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Native American tribal governments (Federally recognized) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses City or township governments Special district governments Public and State controlled institutions of higher education County governments Private institutions of higher education Small businesses Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities.
- FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY
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Opportunity Summary:
The Food and Drug Administration (FDA) released this funding opportunity, titled "Effect of Therapeutic Class on Generic Drug Substitutions (U01)," to support research that takes a close, data-driven look at why some generic drugs are substituted smoothly in real-world practice while others are not. The central goal is to rank generic drugs by therapeutic class according to which classes show relatively low generic substitution or acceptance rates, and then dig into the specific factors that appear to drive those lower rates within each class. In practical terms, the FDA is looking for work that can identify where substitution breaks down (for example, at the prescriber level, pharmacy level, payer level, or patient level) and help clarify whether the barriers are clinical, behavioral, market-based, policy-related, or tied to perceptions about safety and effectiveness. The intended impact is to sharpen FDA regulatory science priorities by highlighting where additional evidence, monitoring, or communication is needed to support confident and successful generic substitution, ultimately reinforcing public trust in generic drug safety and efficacy.
This award uses a cooperative agreement mechanism (U01), which generally indicates substantial involvement by the FDA during the project. Instead of a hands-off grant, a U01 commonly involves coordination with the agency on elements like study design refinement, data sources, analytic approaches, milestones, and dissemination plans. The activity area is categorized under health science and technology and other research and development, emphasizing applied research that can inform regulatory decision-making and oversight rather than purely theoretical work.
The opportunity (Funding Opportunity Number RFA-FD-14-014) was posted on April 29, 2014, with an application deadline of June 21, 2014, and an archive date of July 21, 2014. The FDA anticipated making up to two awards under this announcement. The estimated total funding available was $400,000, with individual awards expected to fall roughly between an award floor of $350,000 and an award ceiling of $400,000. There was no cost-sharing or matching requirement, which means applicants were not required to contribute non-federal funds as a condition of receiving the award.
Eligibility was broad and included many types of entities: state, county, city/township, and special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; public and private institutions of higher education; independent school districts; nonprofits (including those with and without 501(c)(3) status, with certain distinctions for institutions of higher education); for-profit organizations (other than small businesses); and small businesses. Importantly, foreign institutions were also eligible to apply, which expands the applicant pool to international academic or research organizations with relevant expertise and data access.
From a research standpoint, the scope points toward studies that can quantify and compare substitution/acceptance patterns across therapeutic classes and then explain the differences using measurable determinants. That can include prescribing norms within a specialty, clinical concerns tied to certain drug categories, patient adherence and beliefs, formulary and insurance design (such as tiering or prior authorization), state substitution laws, dispensing practices, availability of generics, market dynamics, and communication issues that affect confidence in generics. The FDA frames the expected outcome as a clearer map of where substitution is less successful and why, so the agency can better target research needs and regulatory science efforts aimed at ensuring generics are used appropriately and confidently when interchangeable.
For applicants who needed help accessing the complete announcement, the listed point of contact was Martin Bernard, Grants Management Specialist, reachable by phone at 240-402-7564 through the FDA office.
Frequently Asked Questions (FAQs)
1) What is the title of this funding opportunity?
The title is "Effect of Therapeutic Class on Generic Drug Substitutions (U01)."
2) Which agency is offering this opportunity?
The opportunity was released by the U.S. Food and Drug Administration (FDA).
3) What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-14-014.
4) What is the main purpose of this opportunity?
The purpose is to support research that uses data to understand why generic drug substitution works smoothly in some therapeutic classes but not in others, and to identify specific factors that drive lower substitution or acceptance rates within those classes.
5) What is the central research goal FDA wants funded?
The central goal is to rank generic drugs by therapeutic class based on which classes have relatively low generic substitution or acceptance rates, and then analyze what factors appear to cause or contribute to those lower rates within each class.
6) What kinds of barriers or "breakdown points" does FDA want studies to examine?
FDA is interested in identifying where substitution breaks down in real-world practice, such as at the prescriber level, pharmacy level, payer level, or patient level.
7) What categories of factors does FDA expect applicants to investigate?
The announcement highlights factors that may be clinical, behavioral, market-based, policy-related, or related to perceptions about safety and effectiveness.
8) What types of determinants are mentioned as being within scope?
Examples mentioned include prescribing norms within a specialty, clinical concerns tied to certain drug categories, patient adherence and beliefs, formulary and insurance design (including tiering or prior authorization), state substitution laws, dispensing practices, availability of generics, market dynamics, and communication issues affecting confidence in generics.
9) What is the intended impact of the funded work?
The intended impact is to sharpen FDA regulatory science priorities by showing where more evidence, monitoring, or communication may be needed to support confident and successful generic substitution, ultimately reinforcing public trust in generic drug safety and efficacy.
10) What award mechanism is being used?
This opportunity uses a cooperative agreement mechanism (U01).
11) What does a U01 cooperative agreement generally imply for how the project is run?
A U01 generally indicates substantial FDA involvement during the project, with coordination on elements such as refining study design, selecting or validating data sources, analytic approaches, milestones, and dissemination plans.
12) Is this described as applied research or purely theoretical research?
It is categorized under health science and technology and other research and development, emphasizing applied research intended to inform regulatory decision-making and oversight.
13) When was the opportunity posted?
It was posted on April 29, 2014.
14) What was the application deadline?
The application deadline was June 21, 2014.
15) When was the archive date?
The archive date was July 21, 2014.
16) How many awards did FDA anticipate making?
FDA anticipated making up to two awards under this announcement.
17) What was the estimated total funding available?
The estimated total funding available was $400,000.
18) What was the expected size of individual awards?
Individual awards were expected to fall roughly between an award floor of $350,000 and an award ceiling of $400,000.
19) Is cost sharing or matching required?
No. There was no cost-sharing or matching requirement, meaning applicants were not required to contribute non-federal funds as a condition of receiving the award.
20) Who was eligible to apply?
Eligibility was broad and included state, county, city/township, and special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; public and private institutions of higher education; independent school districts; nonprofits (including those with and without 501(c)(3) status, with certain distinctions for institutions of higher education); for-profit organizations (other than small businesses); and small businesses.
21) Are foreign institutions eligible?
Yes. Foreign institutions were eligible to apply.
22) What does FDA want researchers to produce at a high level?
FDA expects a clearer map of which therapeutic classes have less successful generic substitution and why, so the agency can better target regulatory science efforts to support appropriate and confident use of generics when interchangeable.
23) How does FDA describe the real-world focus of this research?
The work is framed as "real-world practice" research that examines substitution and acceptance patterns and explains differences using measurable determinants, including stakeholder-level barriers (prescriber, pharmacy, payer, patient).
24) Who is the listed point of contact for accessing the complete announcement?
The listed point of contact is Martin Bernard, Grants Management Specialist.
25) How can the point of contact be reached?
He can be reached by phone at 240-402-7564 through the FDA office.
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