Opportunity Information: Apply for RFA FD 20 020
This FDA cooperative agreement opportunity (RFA-FD-20-020) is a renewal/expansion of earlier FDA-funded work (RFA-FD-15-006) focused on levonorgestrel-releasing intrauterine systems (IUS). These products are considered especially challenging from a generic development standpoint because they combine several layers of complexity at once: they are long-acting (designed to release drug for up to about five years), they act locally in the uterus rather than systemically, and they are drug-device combination products where performance depends on both formulation and device/manufacturing features. Even though multiple levonorgestrel IUS products are already marketed, FDA notes that there have been no approved ANDAs for this category, highlighting how difficult it is to establish bioequivalence and to define the right in vitro tests and manufacturing controls for generics.
The scientific premise for this renewal is that the earlier FDA grant successfully delivered enabling tools that were missing before: a reliable method to prepare IUS samples for testing, a real-time dissolution method with discriminatory power, and an accelerated dissolution method. With those methods in hand, FDA now wants a more systematic, quantitative investigation of how manufacturing differences and formulation changes influence the levonorgestrel release rate. The practical goal is to generate evidence that can support clearer expectations for generic developers and help FDA craft more accurate and efficient bioequivalence approaches that do not require unnecessarily long testing timelines.
The central objective is to identify critical process parameters (CPPs) and understand how they affect critical quality attributes (CQAs), then connect those quality attributes to drug release behavior. In other words, the project is meant to map the chain from how the product is made (process settings and manufacturing choices), to what measurable properties the finished IUS has (physicochemical and structural attributes), to how much and how fast levonorgestrel comes out over time. A key deliverable is an estimate of what ranges of variation in physicochemical properties can be considered acceptable because they do not meaningfully change release rate. That type of threshold-setting is important for both generic product design and regulatory assessment, because it helps distinguish meaningful differences from normal manufacturing variability.
The work is organized around three main aims. First, applicants are asked to deliberately create levonorgestrel IUS formulations that are not Q1/Q2 the same as a reference (meaning the inactive ingredients are qualitatively different and/or quantitatively different) and measure how those formulation variations impact drug release. This aim explicitly calls attention to the role of the polymer matrix, particularly polydimethylsiloxane (PDMS), which is commonly used in these systems. FDA encourages development of analytical methods capable of discriminating PDMS sourced from different suppliers and PDMS with different crosslinking densities, because changes in polymer source or crosslinking can alter diffusion pathways and mechanical properties and therefore change release performance.
Second, the project must identify the CPPs and CQAs that matter most for levonorgestrel IUS products and evaluate how shifts in CPPs propagate into changes in CQAs and ultimately into changes in release rate. This is essentially a quality-by-design style investigation tailored to a complex, long-acting drug-device product, where subtle manufacturing changes (for example, mixing, curing, extrusion/coating, assembly, or other process conditions) may change microstructure and drug distribution in ways that standard tests might miss unless specifically designed to be discriminatory.
Third, the opportunity requires comparative dissolution studies under both real-time and accelerated conditions using two marketed reference products: Mirena (52 mg levonorgestrel) and Liletta (52 mg levonorgestrel). Beyond simply measuring release profiles, the work should identify differences in excipients and differences in CQAs between these two products, then correlate those differences with observed levonorgestrel release behavior. FDA is looking for data strong enough to help them estimate what physicochemical differences can exist without causing significant changes in release rate, which directly supports regulatory decision-making for sameness, equivalence, and acceptable variability.
From a programmatic standpoint, this is a discretionary FDA funding opportunity under a cooperative agreement mechanism (U01) and explicitly states clinical trials are not allowed, signaling that the expected work is laboratory, analytical, and manufacturing/process science rather than human studies. The award information included an expected single award with an award ceiling of $600,000. The intended impact is regulatory-science focused: strengthen FDA product-specific guidance (PSGs) for levonorgestrel IUS products, reduce uncertainty around what controls and tests are needed, and ultimately lower barriers to the development and approval of high-quality generic levonorgestrel IUS options.Apply for RFA FD 20 020
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Renewal - Investigation of impact of manufacturing difference and formulation variation on drug release for Levonorgestrel Intrauterine System (U01) Clinical Trials Not Allowed" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Jan 10, 2020.
- Applicants must submit their applications by Mar 16, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $600,000.00 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).
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| Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional) Apply for RFA FD 20 021 Funding Number: RFA FD 20 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
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| Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed Apply for PAR 20 105 Funding Number: PAR 20 105 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed Apply for RFA FD 20 027 Funding Number: RFA FD 20 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $8,000,000 |
| FDA's National Curriculum Standard Development and Training Delivery and Development (U18) Clinical Trial Not Allowed Apply for RFA FD 20 024 Funding Number: RFA FD 20 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 030 Funding Number: RFA FD 20 030 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed Apply for RFA FD 20 028 Funding Number: RFA FD 20 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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| Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain (U01) Clinical Trials Not Allowed Apply for RFA FD 20 029 Funding Number: RFA FD 20 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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| Renewal - Federal and University Partnership to Improve the Safety of Seafood from the Gulf of Mexico (U19) Clinical Trials Not Allowed Apply for RFA FD 21 009 Funding Number: RFA FD 21 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $125,000 |
| Renewal - Cooperative Agreement to Support Shellfish Assistance Project (U01) Clinical Trial Not Allowed Apply for RFA FD 21 006 Funding Number: RFA FD 21 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
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