Opportunity Information: Apply for RFA FD 14 013
Apply for RFA FD 14 013
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Post market surveillance evaluation of authorized generic drug products (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: Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Public and State controlled institutions of higher education County governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments For profit organizations other than small businesses Independent school districts State governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility Small businesses Native American tribal governments (Federally recognized).
- FOREIGN INSTITUTIONS ARE ELIGIBLE TO APPLY
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Opportunity Summary:
The grant opportunity "Post market surveillance evaluation of authorized generic drug products (U01)" (Funding Opportunity Number RFA FD 14 013) is a Food and Drug Administration (FDA) research initiative focused on how authorized generics perform in the real world after they reach the market. It is structured as a cooperative agreement (U01), which typically means the FDA expects to have an active role in shaping or coordinating the work as it progresses rather than simply providing funds and receiving results at the end. The central aim is to evaluate current post-market surveillance tools and to create or refine new methods that can track and compare safety, effectiveness, utilization, and substitution patterns for selected "model" authorized generic products across different therapeutic areas, benchmarking those findings against corresponding brand-name drugs and other generics.
At its core, the project is trying to answer a practical and often controversial question: when patients, clinicians, or pharmacists report problems after switching from a brand drug to a generic, or between different generic versions, are those complaints tied to measurable differences in outcomes or usage patterns, or could some of the signal be explained by bias or perception effects against generics? Authorized generics are a particularly useful case study because they are essentially the brand product marketed as a generic (often by the brand company or a partner) and can therefore help researchers separate issues related to product formulation/manufacturing differences from issues related to expectations, labeling, appearance, or reporting behavior. By monitoring how authorized generics are used and substituted, and how their safety and effectiveness profiles look in post-market data, the study aims to clarify whether generic drug complaints may sometimes reflect nocebo effects, attribution errors, or other forms of bias that could influence generic substitution practices.
The opportunity falls under Health Science and Technology and other Research and Development and was posted on April 29, 2014, with an application closing date of June 21, 2014, and an archive date of July 21, 2014. The FDA anticipated making about two awards under this announcement. Total estimated funding was $400,000, with individual awards expected in the range of $350,000 to $400,000. There was no cost-sharing or matching requirement, which means applicants were not expected to contribute non-federal funds as a condition of receiving the award.
A wide range of organizations were eligible to apply. Eligible applicants included public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses, but excluding for-profits that are not small businesses only where specified in general eligibility lists), and various government entities such as city/township, county, state, special district governments, and certain housing authorities. Tribal organizations were also included, and notably, foreign institutions were explicitly eligible to apply, expanding the pool of potential research teams beyond the United States.
Operationally, the work envisioned by the announcement centers on post-market evaluation, meaning the methods would likely rely on real-world data sources and surveillance approaches that can capture outcomes after drugs are dispensed and used in routine care. The emphasis on "existing tools" suggests the FDA wanted applicants to assess how well current pharmacovigilance and utilization monitoring systems can distinguish among brand drugs, authorized generics, and other generics, and where those systems fall short. The emphasis on "develop new methods" signals an expectation of methodological innovation, such as improved approaches to detecting switching and substitution events, better identification of product versions at the dispensing level, more sensitive ways to detect adverse event patterns, and stronger analytic designs for comparing products while accounting for confounding factors like patient characteristics, prescribing habits, and insurer or formulary rules.
The intended payoff is not just academic. The FDA frames the outcome as a way to inform whether complaints about generics could be influenced by bias and whether that bias might affect generic substitution decisions. In practical terms, results could help regulators and stakeholders understand when a complaint trend should trigger deeper scientific investigation into product quality or bioequivalence questions versus when it may reflect reporting artifacts or perception-driven responses to switching. It also supports broader public health goals by strengthening confidence in generic drugs when the evidence supports equivalence, while still improving the ability to detect genuine safety or effectiveness issues when they arise.
For administrative questions or help accessing the full announcement, the listed contact was Martin Bernard, Grants Management Specialist, reachable by phone at 240-402-7564 through the FDA office.
FAQs: Post market surveillance evaluation of authorized generic drug products (U01) (RFA FD 14 013)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Post market surveillance evaluation of authorized generic drug products (U01)" and the Funding Opportunity Number is RFA FD 14 013.
Which agency is offering this grant?
This is a Food and Drug Administration (FDA) research initiative.
What type of award mechanism is this?
It is a cooperative agreement (U01). This typically means the FDA is expected to have an active role during the project (for example, helping shape, coordinate, or collaborate as work progresses), rather than only providing funding and receiving a final report at the end.
What is the main goal of the project described in the opportunity?
The central aim is to evaluate existing post-market surveillance tools and create or refine methods to track and compare safety, effectiveness, utilization, and substitution patterns for selected model authorized generic products across different therapeutic areas. Findings are intended to be benchmarked against corresponding brand-name drugs and other generics.
What are "authorized generics" in the context of this announcement?
Authorized generics are essentially the brand product marketed as a generic (often by the brand company or a partner). Because they are closely tied to the brand product, they can be used to help separate concerns related to product differences from issues related to expectations, labeling, appearance, or reporting behavior.
What question is this FDA initiative trying to address?
A key practical question is whether complaints or reported problems after switching from a brand drug to a generic, or between different generic versions, are associated with measurable differences in outcomes or usage patterns, or whether some signals could be explained by bias or perception effects against generics.
Why does the opportunity focus specifically on authorized generics?
Authorized generics are a useful case study because they allow researchers to more cleanly examine whether reported issues may be driven by non-product factors (such as nocebo effects, attribution errors, expectations, labeling, or appearance) versus factors tied to differences among products.
What kinds of outcomes or patterns is the project expected to monitor?
The announcement emphasizes methods that can track and compare safety, effectiveness, utilization, and substitution patterns for selected authorized generic products, with comparisons benchmarked against brand-name drugs and other generics.
What is meant by "post-market surveillance" in this opportunity?
Post-market surveillance refers to evaluation using real-world use after products reach the market. The work is framed around monitoring and evaluating how products perform once they are dispensed and used in routine care, using surveillance approaches and post-market data sources.
What does the FDA mean by evaluating "existing tools" and developing "new methods"?
Based on the description, the FDA wanted applicants to assess how well current pharmacovigilance and utilization monitoring systems can distinguish among brand drugs, authorized generics, and other generics, identify gaps or limitations, and develop or refine methods to improve detection and comparison. Examples mentioned include better approaches for detecting switching and substitution events, better identification of product versions at the dispensing level, more sensitive detection of adverse event patterns, and stronger analytic designs that account for confounding factors.
What kinds of confounding factors does the opportunity highlight as important to account for?
The announcement notes the importance of accounting for confounding factors such as patient characteristics, prescribing habits, and insurer or formulary rules when comparing products and interpreting observed patterns.
How many awards did the FDA anticipate making?
The FDA anticipated making about two awards under this announcement.
What was the estimated total funding amount for this opportunity?
The total estimated funding was $400,000.
What was the expected funding range per award?
Individual awards were expected to be in the range of $350,000 to $400,000.
Is cost sharing or matching required?
No. The opportunity states there was no cost-sharing or matching requirement, meaning applicants were not expected to contribute non-federal funds as a condition of receiving the award.
When was the opportunity posted?
The opportunity was posted on April 29, 2014.
What was the application closing date?
The application closing date was June 21, 2014.
When was the opportunity archived?
The archive date was July 21, 2014.
What broad topic area does this opportunity fall under?
The opportunity is described as falling under Health Science and Technology and other Research and Development.
Who was eligible to apply?
A wide range of organizations were eligible, including public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses); and government entities such as city/township, county, state, and special district governments, as well as certain housing authorities. Tribal organizations were also included.
Were foreign institutions eligible to apply?
Yes. Foreign institutions were explicitly eligible to apply, expanding eligibility beyond the United States.
What is the intended practical impact of the research described?
The FDA frames the work as supporting real-world decision-making about generic substitution and complaint trends. Results could help stakeholders distinguish when complaint patterns should prompt deeper scientific investigation into product quality or bioequivalence versus when they may reflect reporting artifacts or perception-driven responses to switching. The work also supports public health goals by strengthening confidence in generic drugs when evidence supports equivalence while improving detection of genuine safety or effectiveness issues.
Who is the listed contact for administrative questions or for help accessing the full announcement?
The listed contact is Martin Bernard, Grants Management Specialist. The phone number provided is 240-402-7564.
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