Opportunity Information: Apply for RFA FD 15 015
Apply for RFA FD 15 015
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Post market Surveillance of Generic Modified Release 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 20, 2015 and posted on Apr 20, 2015.
- Applicants must submit their applications by Jun 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 $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Small businesses Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Special district governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education State governments Independent school districts County governments.
- 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 "Post market Surveillance of Generic Modified Release Products (U01)" (Funding Opportunity Number RFA-FD-15-015) is a cooperative agreement offered by the U.S. Food and Drug Administration under CFDA 93.103. Its central goal is to generate real-world, post-market evidence on how generic modified-release (MR) drugs perform after approval, focusing on how they are used in practice, how often patients are switched or substituted between products, and whether there are meaningful differences in safety and effectiveness when compared with the corresponding brand-name MR products and with other generic drugs that use different formulation designs.
At its core, the project is designed to answer practical questions that come up once modified-release generics enter routine clinical use. Modified-release products can have formulation features intended to control how quickly or where in the body a drug is released, so the FDA is seeking rigorous surveillance work to understand whether switching between a brand and a generic MR product (or between different generics) is associated with different real-world patterns of adherence, dose changes, discontinuation, therapeutic outcomes, or adverse events. By examining substitution patterns, the study aims to capture what happens in pharmacies and health systems when state substitution laws, payer formularies, and prescribing behaviors lead to product changes over time. By examining safety and effectiveness, the study aims to determine whether patients experience comparable clinical outcomes across products and to strengthen the evidence base supporting substitutability of approved generics in this specific category.
The expected output is evidence that can help the FDA and other stakeholders evaluate whether particular generic MR products show differences in utilization and switching behavior and whether any observed differences correspond to measurable changes in patient outcomes. In other words, the study is meant to move beyond bioequivalence at the time of approval and look at post-market performance in real-world settings, producing findings that can inform regulatory science, pharmacovigilance, and confidence in generic substitution for modified-release formulations.
From an administrative standpoint, the mechanism is a U01 cooperative agreement, which generally implies substantial scientific or programmatic involvement by the funding agency during the project compared with a standard grant. The total estimated funding is $500,000, with an award ceiling of $500,000, and the FDA anticipated making one award. There is no cost-sharing or matching requirement. The opportunity was posted on April 20, 2015, with an original and current closing date of June 29, 2015, and an archive date of July 29, 2015, indicating it is no longer open but remains a useful reference for understanding FDA priorities in post-market generic drug surveillance.
Eligibility was broad and included small businesses, for-profit organizations (other than small businesses), nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, and a range of government entities (state, county, city/township, special district, and independent school districts), as well as tribal governments and tribal organizations. Importantly, the solicitation explicitly allowed non-U.S. entities and foreign components of U.S. organizations to apply, signaling that the FDA was open to international expertise and cross-border research capacity where relevant.
The funding activity category is listed under consumer protection, food and nutrition, and health, reflecting FDA’s broader mandate to protect public health by ensuring that drugs on the market remain safe and effective and that generic products can be relied upon as therapeutic alternatives. For applicants or readers seeking the full technical requirements and study expectations, the announcement referenced a full posting on the NIH Guide for Grants and Contracts. The listed grants management contact for access issues was Lisa Ko at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Post market Surveillance of Generic Modified Release Products (U01)".
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-15-015.
Which federal agency is offering this award?
The award is offered by the U.S. Food and Drug Administration (FDA).
What is the CFDA number for this program?
The program is listed under CFDA 93.103.
What is the main purpose of this cooperative agreement?
The central goal is to generate real-world, post-market evidence on how generic modified-release (MR) drugs perform after approval, including how they are used in practice, how often patients are switched or substituted between products, and whether there are meaningful differences in safety and effectiveness compared with corresponding brand-name MR products and with other generic drugs that use different formulation designs.
What kinds of products are being studied?
The focus is on generic modified-release (MR) drug products. These are formulations designed to control how quickly a drug is released and/or where in the body the drug is released.
Why is the FDA interested in post-market surveillance for modified-release generics?
The project is intended to move beyond bioequivalence at the time of approval and examine post-market performance in real-world settings. The FDA is seeking rigorous evidence on what happens after MR generics enter routine clinical use, particularly when patients experience product switching or substitution.
What real-world questions is the project designed to answer?
The project is designed to address practical, post-approval questions such as how MR generics are used in practice; how often switching or substitution occurs between brand and generic MR products or among different generics; and whether switching is associated with different patterns of adherence, dose changes, discontinuation, therapeutic outcomes, or adverse events.
What types of switching or substitution does the FDA want to understand?
The announcement highlights interest in switching or substitution between a brand-name MR product and a generic MR product, as well as switching between different generic MR products, including cases where generics may have different formulation designs.
What outcomes or measures are specifically mentioned as areas of interest?
The opportunity specifically mentions examining whether product switching or substitution is associated with changes in real-world adherence, dose changes, discontinuation, therapeutic outcomes, and adverse events.
How does this project relate to pharmacy and health system behavior?
Part of the work is to capture what happens in pharmacies and health systems when state substitution laws, payer formularies, and prescribing behaviors lead to product changes over time.
What is the expected output of the funded work?
The expected output is evidence that helps the FDA and other stakeholders evaluate whether certain generic MR products show differences in utilization and switching behavior and whether any observed differences correspond to measurable changes in patient outcomes.
How could the findings be used?
The findings are intended to inform regulatory science, pharmacovigilance, and confidence in generic substitution for modified-release formulations, by strengthening the evidence base on real-world safety and effectiveness across products.
What is the funding mechanism for this opportunity?
The mechanism is a U01 cooperative agreement.
What does a U01 cooperative agreement imply for the project?
A U01 cooperative agreement generally indicates substantial scientific or programmatic involvement by the funding agency during the project, compared with a standard grant.
What is the total estimated funding amount?
The total estimated funding is $500,000.
What is the award ceiling?
The award ceiling is $500,000.
How many awards did the FDA anticipate making?
The FDA anticipated making one award.
Is cost-sharing or matching required?
No. The opportunity states that there is no cost-sharing or matching requirement.
When was this opportunity posted?
The opportunity was posted on April 20, 2015.
What was the application closing date?
The original and current closing date listed is June 29, 2015.
Is this funding opportunity still open?
No. The archive date is listed as July 29, 2015, indicating the opportunity is no longer open and is provided as a reference for understanding FDA priorities.
What types of organizations were eligible to apply?
Eligibility included small businesses, for-profit organizations (other than small businesses), nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, and multiple types of government entities (state, county, city/township, special district, and independent school districts), as well as tribal governments and tribal organizations.
Were non-U.S. entities allowed to apply?
Yes. The solicitation explicitly allowed non-U.S. entities and foreign components of U.S. organizations to apply.
What is the funding activity category associated with this opportunity?
The funding activity category is listed under consumer protection, food and nutrition, and health, reflecting the FDA's broader public health mandate.
Where were applicants directed for full technical requirements and study expectations?
The announcement referenced a full posting in the NIH Guide for Grants and Contracts for the complete technical requirements and expectations.
Who is the listed grants management contact for access issues?
The listed grants management contact for access issues is Lisa Ko at lisa.ko@fda.hhs.gov.
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Applicants who have applied for this opportunity (RFA FD 15 015) also looked into and applied for these:
| Funding Opportunity |
|---|
| 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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