Opportunity Information: Apply for RFA FD 15 032
Apply for RFA FD 15 032
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (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 24, 2015 and posted on Mar 24, 2015.
- Applicants must submit their applications by May 29, 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 $250,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 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).
- Only the following organization is eligible to apply UNIVERSITY OF FLORIDA
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Opportunity Summary:
This FDA grant opportunity (RFA-FD-15-032) is a limited-competition request for a revision application under a U01 cooperative agreement, meaning the work is carried out with substantial involvement from the agency rather than as a fully independent research award. It is tied to an existing project funded under the earlier announcement RFA-FD-14-011 (subtopic 2). The core purpose of that original effort is to build and refine pharmacometric modeling and simulation tools that help evaluate whether generic drugs are substitutable for their reference listed drugs (RLDs) and to strengthen postmarketing risk assessment once products are on the market. In practical terms, the FDA is looking for modeling approaches that can support regulatory decision-making around generic equivalence and provide a more structured way to interpret and respond to postmarketing adverse event reports and complaints that arise when patients switch between products.
The revised/expanded scope pushes the work beyond general tool development and into a more explicitly risk-based methodology focused on identifying which generic equivalents are most vulnerable to real-world switching problems. The announcement points to specific categories where switching concerns are more likely to be clinically meaningful or noticeable, such as modified-release oral dosage forms, where small differences in release characteristics could translate into differences in exposure over time, and drugs where patients and clinicians can readily perceive changes in efficacy or safety in routine practice. Anticoagulants are provided as an example of the latter, reflecting the high clinical sensitivity to under- or over-exposure and the potential consequences of small therapeutic differences. The intent is to use pharmacometric modeling, clinical trial simulation, and clinical use/substitution simulation to predict which products are most likely to generate switching-related issues and, conversely, which are least likely to show postmarketing bioinequivalence signals once widely substituted.
From a deliverables perspective, the emphasis is on translating pharmacometrics into decision-support methods for the FDA Office of Generic Drugs (OGD). That includes simulation frameworks that can anticipate when substitution could lead to complaints or adverse event clusters, and analytic approaches that help distinguish true bioinequivalence or clinically meaningful differences from noise in spontaneous reporting systems. The risk-based methodology described is meant to be actionable: it should help prioritize attention toward products and scenarios where switching risk is highest, and help forecast which generic products are most likely to encounter substitution problems in the marketplace.
Administratively, this is a single-award opportunity with an estimated total funding amount of $250,000 and an award ceiling of $250,000, with no cost sharing or matching requirement. The activity category is listed under consumer protection, food and nutrition, and health, and the CFDA listing referenced is 93.103 (Food and Drug Administration). The posting date and creation date are March 24, 2015, and the application due date (original and current closing date) is May 29, 2015, with an archive date of June 28, 2015. Eligibility is extremely restricted: only the University of Florida is eligible to apply, reflecting the “limited competition for revision applications” nature of the announcement, which is typically used to expand or modify the scope of an ongoing, previously funded cooperative agreement.
For access issues or administrative questions, the grant lists a points of contact in FDA grants management: Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs) - FDA Grant Opportunity RFA-FD-15-032
What is the funding opportunity number for this grant?
The funding opportunity is FDA RFA-FD-15-032.
What type of award is this?
This opportunity is a U01 cooperative agreement. Under a cooperative agreement, the work is carried out with substantial involvement from the FDA, rather than being conducted fully independently as in some other research award types.
Is this a new grant or related to an existing FDA project?
It is tied to an existing project funded under the earlier announcement RFA-FD-14-011 (subtopic 2). This announcement is specifically a limited-competition request for a revision application to expand or modify the scope of that ongoing cooperative agreement.
What is the main purpose of the underlying project?
The original effort focuses on building and refining pharmacometric modeling and simulation tools to help evaluate whether generic drugs are substitutable for their reference listed drugs (RLDs) and to strengthen postmarketing risk assessment once products are on the market.
What is the goal of the revised/expanded scope under this announcement?
The revision pushes the work beyond general tool development into a more explicitly risk-based methodology. The goal is to identify which generic equivalents are most vulnerable to real-world switching problems and to help anticipate which products are most or least likely to show postmarketing bioinequivalence signals after widespread substitution.
What kinds of scientific approaches are emphasized?
The announcement emphasizes pharmacometric modeling, clinical trial simulation, and clinical use/substitution simulation as approaches to predict switching-related issues and inform FDA regulatory decision-making.
What does the FDA mean by "switching" in this context?
Switching refers to patients being substituted from one product to another in real-world use, such as switching between a generic drug and its reference listed drug (RLD), or among equivalents, where postmarketing complaints or adverse event clusters may occur.
Which drug/product categories are highlighted as having higher potential switching concerns?
The announcement points to categories where switching concerns may be more clinically meaningful or noticeable, including modified-release oral dosage forms and drugs where patients and clinicians can readily perceive changes in efficacy or safety in routine practice.
Does the opportunity give a specific example of a high-sensitivity drug class?
Yes. Anticoagulants are provided as an example, reflecting high clinical sensitivity to under- or over-exposure and the potential consequences of small therapeutic differences.
What are the expected deliverables or outcomes?
The emphasis is on translating pharmacometrics into decision-support methods for the FDA Office of Generic Drugs (OGD). This includes simulation frameworks to anticipate when substitution could lead to complaints or adverse event clusters, and analytic approaches to help distinguish true bioinequivalence or clinically meaningful differences from noise in spontaneous reporting systems.
How will the risk-based methodology be used?
It is meant to be actionable for FDA use: helping prioritize attention toward products and scenarios where switching risk is highest and forecasting which generic products are most likely to encounter substitution problems in the marketplace.
How many awards does the FDA expect to make?
This is a single-award opportunity.
What is the total estimated funding amount?
The estimated total funding amount is $250,000.
What is the maximum award amount (award ceiling)?
The award ceiling is $250,000.
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement listed for this opportunity.
What is the activity category associated with this grant?
The activity category is listed under consumer protection, food and nutrition, and health.
What CFDA listing is referenced?
The referenced CFDA listing is 93.103 (Food and Drug Administration).
When was this opportunity posted?
The posting date (and creation date) is March 24, 2015.
What is the application due date?
The application due date is May 29, 2015. The information provided indicates this is both the original and current closing date.
When is the archive date?
The archive date is June 28, 2015.
Who is eligible to apply?
Eligibility is extremely restricted. Only the University of Florida is eligible to apply, because this is a limited-competition opportunity for revision applications to an ongoing, previously funded cooperative agreement.
Why is eligibility limited to a single institution?
The announcement is described as a "limited competition for revision applications" tied to an existing cooperative agreement. This type of announcement is typically used to expand or modify the scope of a project that is already funded, rather than to open competition to new applicants.
Who is the FDA grants management point of contact for access or administrative questions?
The listed FDA grants management contact is Lisa Ko, Grants Management Specialist. Email: lisa.ko@fda.hhs.gov.
Which FDA office is specifically mentioned as the target user of the decision-support methods?
The FDA Office of Generic Drugs (OGD) is specifically mentioned as the office the deliverables are intended to support.
What kinds of postmarketing data issues is the work intended to address?
The work is intended to provide a more structured way to interpret and respond to postmarketing adverse event reports and complaints, particularly those that arise when patients switch between products, and to help separate true signals of bioinequivalence or clinically meaningful differences from noise in spontaneous reporting systems.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 15 032) also looked into and applied for these:
| Funding Opportunity |
|---|
| Post market Surveillance of Generic Modified Release Products (U01) Apply for RFA FD 15 015 Funding Number: RFA FD 15 015 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 15 031 Funding Number: RFA FD 15 031 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Development and Application of Case Control Analysis for Generic Drugs (U01) Apply for RFA FD 15 027 Funding Number: RFA FD 15 027 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) Apply for RFA FD 15 040 Funding Number: RFA FD 15 040 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 15 036 Funding Number: RFA FD 15 036 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Apply for RFA FD 15 014 Funding Number: RFA FD 15 014 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Smokeless Tobacco Reference Products (UC2) Apply for RFA FD 15 026 Funding Number: RFA FD 15 026 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $3,000,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 16 003 Funding Number: RFA FD 16 003 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 16 004 Funding Number: RFA FD 16 004 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
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