Opportunity Information: Apply for RFA FD 13 022
Apply for RFA FD 13 022
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (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 29, 2013 and posted on Mar 29, 2013.
- Applicants must submit their applications by May 10, 2013. (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: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Independent school districts Small businesses City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) County governments State governments Public and State controlled institutions of higher education Special district governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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 funding opportunity titled "Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01)" (Funding Opportunity Number RFA-FD-13-022) is a Food and Drug Administration (FDA) cooperative agreement designed to strengthen real-world monitoring of certain generic drugs after they have entered the market. It is motivated by the sharp growth in generic drug use in the United States and the resulting need for patients, clinicians, and researchers to have strong confidence that FDA-approved generics are truly interchangeable with their brand-name reference products and with other approved generics across all labeled indications and conditions of use.
A key focus of the opportunity is on "complex" generic products whose approvals relied on innovative approaches that were viewed as controversial at the time. Examples named in the announcement include vancomycin capsules, sodium ferric gluconate injection, and enoxaparin injection, along with other products in a similar category. The FDA is seeking research that not only examines whether existing postmarketing surveillance tools can adequately detect safety, efficacy, and utilization issues for these kinds of generics, but also creates and validates new methods that can proactively monitor how these products perform and how they are used in practice. In addition to clinical and safety outcomes, the work is expected to study real-world usage and substitution patterns, meaning how often and under what circumstances pharmacists, prescribers, health systems, and patients switch between brand and generic versions or among generic manufacturers.
Another central research question is behavioral and perceptual: whether the controversy surrounding a generic drug during its approval process affects acceptance and uptake by physicians and patients once the product is available. That includes investigating whether prescribers hesitate to prescribe a newly approved generic, whether patients resist substitution at the pharmacy, and whether any of those patterns correlate with measurable outcomes like adherence, switching frequency, reported adverse events, or discontinuation. In effect, the FDA is looking for evidence that can separate perception-driven reluctance from true product performance issues, while still being capable of detecting legitimate safety or effectiveness signals if they exist.
The intended outcome is to provide data and methods that reinforce public assurance in generic drug safety and effectiveness, particularly for complex products where traditional bioequivalence paradigms may be harder to apply or explain. At the same time, the project is meant to support the FDA internally by informing and strengthening the agency's ability to continue developing and using innovative approval methods for generics, while demonstrating that postmarketing monitoring can serve as a backstop for detecting unexpected issues in real-world use.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism (U01), which generally means the FDA expects to have substantial involvement during the project in areas such as scientific coordination, milestone review, or methodological alignment. The activity category is listed under consumer protection, food and nutrition, and health. The announcement anticipated a single award, with an estimated total funding amount of $250,000 and an award ceiling of $250,000. There is no cost-sharing or matching requirement.
The opportunity was posted on March 29, 2013, with an original and final closing date of May 10, 2013, and an archive date of June 9, 2013. Eligibility was broad and included many domestic entity types such as state and local governments, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) organizations), for-profit organizations, small businesses, independent school districts, special district governments, public housing authorities, and tribal organizations. Importantly, foreign institutions were also eligible to apply, and foreign components of U.S. organizations were permitted under HHS grants policy definitions. The agency contact listed for access issues with the full announcement was Lisa Ko, Grants Management Specialist (lisa.ko@fda.hhs.gov).
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-13-022.
Which federal agency is offering this grant?
The opportunity is offered by the U.S. Food and Drug Administration (FDA).
What type of award mechanism is being used?
This opportunity uses a cooperative agreement mechanism (U01).
What does a U01 cooperative agreement imply for how the project will be run?
A U01 cooperative agreement generally means FDA expects substantial involvement during the project, such as scientific coordination, milestone review, and/or methodological alignment.
What is the main purpose of this opportunity?
The purpose is to strengthen real-world (postmarketing) monitoring of certain FDA-approved generic drugs after they enter the market, with an emphasis on building strong confidence that approved generics are interchangeable with their brand-name reference products and with other approved generics across labeled indications and conditions of use.
Why is FDA focusing on postmarketing surveillance for generics in this announcement?
The announcement is motivated by sharp growth in generic drug use in the United States and the need for patients, clinicians, and researchers to have strong confidence in the safety, effectiveness, and interchangeability of FDA-approved generics in real-world practice.
What types of generic products are a key focus of the research?
A key focus is on "complex" generic products whose approvals relied on innovative approaches that were viewed as controversial at the time.
Which example products are specifically mentioned?
Examples named include vancomycin capsules, sodium ferric gluconate injection, and enoxaparin injection, as well as other products in a similar category.
What kinds of research questions is FDA seeking to address?
FDA is seeking research that examines whether existing postmarketing surveillance tools can adequately detect safety, efficacy, and utilization issues for certain complex generics, and also develops and validates new methods that can proactively monitor how these products perform and how they are used in practice.
Does the opportunity focus only on clinical outcomes and safety?
No. In addition to clinical and safety outcomes, the work is expected to study real-world usage and substitution patterns.
What are "usage and substitution patterns" in the context of this opportunity?
They refer to how often and under what circumstances pharmacists, prescribers, health systems, and patients switch between brand and generic versions or among generic manufacturers in real-world settings.
Is there a behavioral or perception component to the research?
Yes. A central research question is whether controversy surrounding a generic drug during its approval process affects acceptance and uptake by physicians and patients after the product becomes available.
What kinds of acceptance and uptake behaviors does FDA want studied?
The announcement describes studying whether prescribers hesitate to prescribe a newly approved generic, whether patients resist substitution at the pharmacy, and whether these patterns correlate with outcomes such as adherence, switching frequency, reported adverse events, or discontinuation.
What is the overall intended outcome of the project?
The intended outcome is to provide data and methods that reinforce public assurance in generic drug safety and effectiveness, particularly for complex products, and to support FDA by informing and strengthening the agency's ability to develop and use innovative approval methods while using postmarketing monitoring as a backstop for detecting unexpected issues in real-world use.
How many awards were anticipated?
The announcement anticipated a single award.
What was the estimated total funding amount?
The estimated total funding amount was $250,000.
What was the award ceiling?
The award ceiling was $250,000.
Is there any cost-sharing or matching requirement?
No. The opportunity states there is no cost-sharing or matching requirement.
What is the activity category for this funding opportunity?
The activity category is listed under consumer protection, food and nutrition, and health.
When was the opportunity posted?
The opportunity was posted on March 29, 2013.
What were the application due dates?
The original and final closing date was May 10, 2013.
When was the opportunity archived?
The archive date was June 9, 2013.
Who was eligible to apply?
Eligibility was broad and included many domestic entity types such as state and local governments, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) organizations), for-profit organizations, small businesses, independent school districts, special district governments, public housing authorities, and tribal organizations.
Are foreign institutions eligible to apply?
Yes. Foreign institutions were eligible to apply.
Are foreign components of U.S. organizations permitted?
Yes. Foreign components of U.S. organizations were permitted under HHS grants policy definitions.
Who is the listed contact for access issues with the full announcement?
The listed contact is Lisa Ko, Grants Management Specialist.
What is the email address for the listed contact?
The email address provided is lisa.ko@fda.hhs.gov.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 13 022) also looked into and applied for these:
| Funding Opportunity |
|---|
| Bioequivalence of Generic Bupropion (U01) Apply for RFA FD 13 021 Funding Number: RFA FD 13 021 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $800,000 |
| Development of Bio relevant In vitro Assay to Determine Labile Iron in the Parenteral Iron Complex Product (U01) Apply for RFA FD 13 017 Funding Number: RFA FD 13 017 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Collection of Dose Adjustment and Therapeutic Monitoring Data to Aid Narrow Therapeutic Index Drug Classification (U01) Apply for RFA FD 13 020 Funding Number: RFA FD 13 020 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $250,000 |
| Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) Apply for RFA FD 13 019 Funding Number: RFA FD 13 019 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01) Apply for RFA FD 14 082 Funding Number: RFA FD 14 082 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $600,000 |
| Development of Process Simulation and Modeling Tools for Integrated Pharmaceutical Manufacturing Processes (U01) Apply for RFA FD 14 083 Funding Number: RFA FD 14 083 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| The Use of Polyethylene Glycol in the Pediatric Population (R01) Apply for RFA FD 14 088 Funding Number: RFA FD 14 088 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $325,000 |
| Predictive in vitro Methods for Characterizing Product Performance, Case Study Furosemide (U01) Apply for RFA FD 14 080 Funding Number: RFA FD 14 080 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $100,000 |
| Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study Furosemide (U01) Apply for RFA FD 14 081 Funding Number: RFA FD 14 081 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $100,000 |
| Kidney Health Initiative (R18) Apply for RFA FD 14 018 Funding Number: RFA FD 14 018 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Dissolution Methods for Long acting Levonorgestrel Intrauterine System (U01) Apply for RFA FD 15 006 Funding Number: RFA FD 15 006 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $125,000 |
| Dissolution Methods for Long acting Periodontal Drug Products (U01) Apply for RFA FD 15 007 Funding Number: RFA FD 15 007 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $125,000 |
| Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) Apply for RFA FD 15 008 Funding Number: RFA FD 15 008 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| Limited Competition for Revision Applications for Evaluation of Formulation Effects of Metered Dose Inhalers on Pharmacokinetics (U01) Apply for RFA FD 15 016 Funding Number: RFA FD 15 016 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $800,000 |
| Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01) Apply for RFA FD 15 032 Funding Number: RFA FD 15 032 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $250,000 |
| 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 |
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