Opportunity Information: Apply for RFA FD 18 020
The FDA (within the Department of Health and Human Services) offered this cooperative agreement (U01) to push nasal drug delivery modeling beyond basic spray deposition and toward a full, three-dimensional picture of what happens after droplets and particles land in the nose. The core problem is that the nose does not simply hold deposited drug in place. Mucociliary clearance, the coordinated motion of mucus and cilia along the nasal lining, steadily transports deposited material toward the throat for swallowing. That natural clearing action can shorten the time a drug has to dissolve, permeate the mucus layer, and absorb into the epithelium. The opportunity is especially focused on suspension nasal sprays (where solid drug particles are carried in liquid) because, unlike solution sprays, suspensions require modeling not just droplet flight and impact but also particle dissolution in mucus while the mucus is moving. If particles dissolve too slowly, are too large, or are poorly soluble, the drug may clear before meaningful absorption occurs, reducing therapeutic effect.
The grant calls for a computational framework that couples computational fluid dynamics (CFD) with a physiologically realistic mucociliary clearance and absorption model in an anatomically accurate, three-dimensional nasal airway. Prior CFD work in this space is described as mature for predicting airflow and spray transport and often matches in vitro deposition data well, but many models stop once droplets deposit. A newer approach had started to include mucociliary clearance and absorption for suspensions, but it relied on a simplified flattened surface and could not resolve region-specific outcomes such as what reaches (and is absorbed in) the olfactory region. For targeted nasal therapies, regional prediction is the point: the FDA is looking for a method that can estimate where drug deposits, how it dissolves in mucus, how it is transported by mucociliary motion, and how much ultimately partitions into and is absorbed through the nasal epithelium in specific anatomical areas.
A major theme is interindividual variability and disease relevance. The FOA emphasizes that people differ substantially in nasal geometry, which can strongly alter airflow patterns and therefore deposition. On top of anatomy, real-world users may have inflamed tissue, altered mucus rheology, impaired mucociliary function, or other disease-related changes that can shift clearance rates and absorption conditions away from the healthy baseline. Because many nasal products are used specifically in diseased states, the modeling approach is expected to handle scenarios such as changed mucus properties, modified clearance speeds, and geometry differences, so the output is not a single idealized prediction but a tool that can explore variability and its impact on efficacy.
From a technical standpoint, the desired model is end-to-end: it should span the nasal airway from the nostrils through to the throat, incorporate inhalation patterns, and include device effects (how the spray device produces the plume and initial droplet/particle conditions). It should use CFD to simulate airflow and droplet/particle transport and deposition (for example through Lagrangian particle tracking), then interface directly with a three-dimensional mucociliary clearance model that moves deposited material along the mucosal surface while accounting for dissolution of suspended drug particles into the mucus and subsequent absorption at the epithelium. The FOA explicitly encourages including all relevant physics needed for credible predictions, listing items such as spray turbulence, droplet and particle dynamics, mucus properties, mucociliary transport, particle dissolution, and drug partitioning between mucus and tissue. Suspension formulations and insufflation-type studies are called out as particularly encouraged because they stress the very mechanisms (dissolution plus clearance) that are missing from many existing workflows.
Validation is not optional. Applicants are expected to validate the CFD and clearance/absorption predictions using in vitro and/or in vivo data, with an emphasis on showing that predicted local clearance behavior aligns with observed in vivo clearance of drug particles. Where feasible, the FDA prefers validation across multiple drug products rather than tuning the method to a single example. While proposals may nominate specific products to study, the FOA notes that final product selection would be revisited after award in collaboration with the FDA, reflecting the cooperative-agreement nature of the mechanism and the agency’s intent to shape the work toward regulatory-science needs.
The work plan is organized into phased deliverables. Phase 1 focuses on choosing and constructing the physiological models and inhalation patterns that best capture intersubject differences (including geometry and likely clearance-rate ranges). Phase 2 covers development and validation of both the CFD deposition model and the mucociliary clearance model, including the interface between them. Phase 3 is the main simulation and post-processing stage, where scenarios are run and regional outcomes are extracted. Phase 4 is the synthesis step: assessing how formulation properties (especially suspensions), mucociliary clearance, anatomical variability, and disease-like changes combine to influence regional absorption and overall performance. Phase 5 is manuscript preparation, expected to be concentrated in year three, and the FOA notes this as the rationale for a reduced budget in that year.
A notable expectation is openness and reproducibility. Because the development of the three-dimensional CFD-mucociliary clearance methodology is treated as a primary outcome, the FDA expects the approach to be made available to the agency and preferably to the public in a form that others can reproduce. That could mean detailed methodological publications, shared code, shared models, or other transparent deliverables that allow regulators and researchers to apply or audit the workflow.
Administratively, this opportunity is RFA-FD-18-020, offered by the FDA as a discretionary cooperative agreement (U01) under CFDA 93.103. It was open to a wide set of applicants, including government entities, tribes and tribal organizations, public and private higher-education institutions, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and even individuals. The posting indicated an award ceiling of $280,000 and anticipated up to two awards, with an original application closing date of June 4, 2018 (creation date March 22, 2018). Overall, the grant is aimed at producing a validated, three-dimensional, region-resolving modeling toolchain that connects device-driven deposition to mucus-driven transport, dissolution, and epithelial uptake, while explicitly accounting for variability across people and clinically relevant disease conditions.Apply for RFA FD 18 020
- 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 "Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01)" 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 Mar 22, 2018.
- Applicants must submit their applications by Jun 04, 2018. (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 $280,000.00 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, Individuals, For profit organizations other than small businesses, Small businesses.
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| Funding Opportunity |
|---|
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 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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