Opportunity Information: Apply for RFA FD 24 006
This FDA funding opportunity (RFA-FD-24-006) supports research aimed at building and validating physiologically based pharmacokinetic (PBPK) model-driven, mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) drug products. The core focus is on two major LAI categories that behave very differently in the body: (1) crystalline suspensions administered as long-acting injectable depots and (2) polymer-based implants that release drug over extended periods. The overall intent is to move beyond empirical correlations and develop bottom-up, mechanistic models that can predict in vivo drug release and disposition by explicitly linking formulation properties, drug and polymer physicochemistry, and relevant physiology.
A central deliverable is the development of PBPK frameworks tailored to each LAI type. For crystalline suspensions, the modeling effort is expected to capture how the injected depot forms and evolves at the administration site and how drug particles dissolve and are absorbed over time, as influenced by critical formulation attributes (for example, particle size distribution, crystal form, surface properties, and excipients that affect wetting, aggregation, or local microenvironment). For polymer-based implants, the model is expected to represent drug release processes driven by polymer characteristics and implant design, such as diffusion through the polymer matrix, polymer hydration and swelling, degradation or erosion (when applicable), drug-polymer interactions, implant geometry, and resulting changes in release rate over time. In both cases, the point is to mechanistically connect what is measured in vitro (release testing, material characterization, and other bench experiments) to what is observed in vivo (concentration-time profiles and release behavior in living systems).
The opportunity emphasizes that the PBPK model parameters and physiological components should be informed by well-chosen in vitro and in vivo experiments, rather than relying purely on curve-fitting. That includes generating experimental data that quantify formulation attributes and capture release kinetics under conditions that can be mapped into the model, as well as in vivo pharmacokinetic data that reflect the true absorption and disposition processes for these long-acting products. Applicants are encouraged to use an appropriate preclinical animal model to validate the PBPK-based mechanistic IVIVC for both LAI suspensions and implants. This preclinical validation is intended to demonstrate that the model can reproduce observed behavior and credibly attribute outcomes to underlying mechanisms, not just match profiles numerically.
Another major theme is practical regulatory and development impact. The FDA highlights that mechanistic PBPK models can help define a "safe space" for critical formulation attributes, meaning a scientifically justified range of formulation and manufacturing variables within which the product is expected to perform similarly to a reference listed drug (RLD). In the context of generics or follow-on products, this kind of modeling can support understanding which attributes are most influential for in vivo performance and where variability is likely to matter. The models are also expected to help explain sources of pharmacokinetic variability by separating contributions from formulation differences, physiological differences, and other determinants of release and disposition.
Finally, the announcement underscores the translational value of PBPK modeling for extrapolating from animals to humans. By leveraging animal data while explicitly accounting for species-specific physiological differences, a well-constructed mechanistic PBPK-IVIVC approach can support predictions of human performance, potentially informing study design, guiding formulation optimization, and improving confidence in how in vitro tests relate to clinical outcomes. Clinical trials are described as optional, signaling that the primary expectation is a robust modeling and experimental framework with credible validation, rather than a requirement to run human studies.
Administratively, this is a discretionary cooperative agreement (U01) mechanism, meaning the FDA is expected to have substantial involvement during the project rather than acting only as a pass-through funder. The opportunity is listed under CFDA 93.103, with an award ceiling of $300,000 and an expected total of two awards. Eligible applicants are broad and include federal-recognized tribal entities, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other unrestricted applicants. The original application closing date was 2024-04-08, and the opportunity was created on 2024-01-15 under the Food and Drug Administration.Apply for RFA FD 24 006
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional" 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 2024-01-15.
- Applicants must submit their applications by 2024-04-08. (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 $300,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Unrestricted.
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Frequently Asked Questions (FAQs)
What is the name and identifier of this FDA funding opportunity?
This opportunity is an FDA funding opportunity announcement titled RFA-FD-24-006.
What is the main purpose of this grant?
The purpose is to support research that builds and validates physiologically based pharmacokinetic (PBPK) model-driven, mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) drug products, with an emphasis on bottom-up, mechanistic prediction rather than purely empirical curve-fitting.
Which types of long-acting drug products are the focus of this opportunity?
The opportunity focuses on two LAI categories that behave differently in the body: (1) crystalline suspensions administered as long-acting injectable depots and (2) polymer-based implants that release drug over extended periods.
What is meant by a "mechanistic" PBPK model-driven IVIVC in this announcement?
In this context, "mechanistic" means the model explicitly links formulation properties, drug and polymer physicochemistry, and relevant physiology to predict in vivo drug release and disposition, instead of relying on empirical correlations or simple profile matching.
What is a core deliverable expected from funded projects?
A central deliverable is the development of PBPK modeling frameworks tailored to each of the two LAI types (crystalline suspensions and polymer-based implants) that connect in vitro measurements to in vivo behavior.
What is expected in the PBPK framework for crystalline suspension LAI depots?
For crystalline suspensions, the model is expected to capture how the injected depot forms and evolves at the administration site, and how drug particles dissolve and are absorbed over time. The framework should incorporate relevant critical formulation attributes such as particle size distribution, crystal form, surface properties, and excipients that influence wetting, aggregation, or the local microenvironment.
What is expected in the PBPK framework for polymer-based implants?
For polymer-based implants, the model is expected to represent drug release processes driven by polymer characteristics and implant design. Examples include diffusion through the polymer matrix, polymer hydration and swelling, degradation or erosion (when applicable), drug-polymer interactions, implant geometry, and changes in release rate over time.
How should the models relate in vitro data to in vivo outcomes?
The intent is to mechanistically connect what is measured in vitro (for example, release testing, material characterization, and other bench experiments) to what is observed in vivo (concentration-time profiles and release behavior in living systems).
Does the opportunity prefer curve-fitting or experimentally informed modeling?
The opportunity emphasizes that PBPK model parameters and physiological components should be informed by well-chosen in vitro and in vivo experiments, rather than relying purely on curve-fitting.
What types of experimental data are implied as important for this work?
The announcement highlights generating experimental data that quantify formulation attributes and capture release kinetics under conditions that can be mapped into the model, as well as in vivo pharmacokinetic data that reflect true absorption and disposition for long-acting products.
Is preclinical animal validation encouraged or required?
Applicants are encouraged to use an appropriate preclinical animal model to validate the PBPK-based mechanistic IVIVC for both LAI suspensions and implants.
What is the goal of the preclinical validation described in the announcement?
The goal is to demonstrate that the model can reproduce observed behavior and credibly attribute outcomes to underlying mechanisms, not merely match concentration-time profiles numerically.
What kind of regulatory or development impact does the FDA highlight for these models?
The FDA highlights that mechanistic PBPK models can help define a scientifically justified "safe space" for critical formulation attributes, meaning a range of formulation and manufacturing variables within which the product is expected to perform similarly to a reference listed drug (RLD).
How might this work be relevant to generics or follow-on products?
In the context of generics or follow-on products, the modeling can support understanding which formulation attributes are most influential for in vivo performance and where variability is likely to matter when aiming for similar performance to an RLD.
Can the models help explain pharmacokinetic variability?
Yes. The announcement expects the models to help explain sources of pharmacokinetic variability by separating contributions from formulation differences, physiological differences, and other determinants of release and disposition.
Does the opportunity discuss translating findings from animals to humans?
Yes. The announcement underscores the translational value of PBPK modeling for extrapolating from animals to humans by explicitly accounting for species-specific physiological differences.
Are clinical trials required under this funding opportunity?
No. Clinical trials are described as optional, indicating the primary expectation is a robust modeling and experimental framework with credible validation rather than a requirement to conduct human studies.
What funding mechanism is used for this award?
This opportunity uses a discretionary cooperative agreement (U01) mechanism.
What does the cooperative agreement (U01) structure imply about FDA involvement?
It implies the FDA is expected to have substantial involvement during the project, rather than acting only as a pass-through funder.
What is the CFDA number associated with this opportunity?
The opportunity is listed under CFDA 93.103.
What is the maximum award amount (award ceiling)?
The award ceiling is $300,000.
How many awards does the FDA expect to make?
The FDA expects a total of two awards.
Who is eligible to apply?
Eligible applicants are broad and include federal-recognized tribal entities, state and local governments, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other unrestricted applicants.
Which agency created this opportunity and when was it created?
The opportunity was created under the Food and Drug Administration on 2024-01-15.
What was the original application closing date?
The original application closing date was 2024-04-08.
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| Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) Apply for RFA FD 24 008 Funding Number: RFA FD 24 008 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
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| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 24 011 Funding Number: RFA FD 24 011 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed Apply for RFA FD 24 010 Funding Number: RFA FD 24 010 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional Apply for RFA FD 24 038 Funding Number: RFA FD 24 038 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033 Funding Number: RFA FD 24 033 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $15,000,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032 Funding Number: RFA FD 24 032 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) Clinical Trials Not Allowed Apply for RFA FD 24 039 Funding Number: RFA FD 24 039 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $340,000 |
| Drug Development Tools Research Grants (U01) Clinical Trials Optional Apply for RFA FD 24 030 Funding Number: RFA FD 24 030 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Apply for RFA FD 24 031 Funding Number: RFA FD 24 031 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed Apply for RFA FD 24 034 Funding Number: RFA FD 24 034 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016 Funding Number: RFA FD 24 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional Apply for RFA FD 24 037 Funding Number: RFA FD 24 037 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed Apply for RFA FD 24 035 Funding Number: RFA FD 24 035 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed Apply for RFA FD 24 036 Funding Number: RFA FD 24 036 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $700,000 |
| FY 2024 SNAP Fraud Framework Implementation Grant Apply for USDA FNS SNAP FFIG 2024 Funding Number: USDA FNS SNAP FFIG 2024 Agency: Food and Nutrition Service Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040 Funding Number: RFA FD 24 040 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 24 041 Funding Number: RFA FD 24 041 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required) Apply for RFA FD 19 024 Funding Number: RFA FD 19 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Apply for PAR 19 306 Funding Number: PAR 19 306 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
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