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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FAQs: FDA Cooperative Agreement (U01) for 3D Nasal Drug Delivery Modeling (RFA-FD-18-020)
What is the main goal of this FDA funding opportunity?
The opportunity is aimed at developing a validated, end-to-end computational modeling framework for nasal drug delivery that goes beyond predicting where spray droplets land. The FDA is specifically looking for a three-dimensional, anatomically accurate approach that can predict deposition, mucociliary transport (clearance), dissolution of suspended drug particles in mucus, and region-specific absorption through the nasal epithelium.
Why is mucociliary clearance such a big focus in this grant?
The nose does not hold deposited drug in place. Mucociliary clearance continuously moves mucus (and anything trapped in it) toward the throat to be swallowed. That transport can reduce the time available for a drug to dissolve, permeate the mucus layer, and absorb into tissue. The FOA emphasizes that clearance can directly limit therapeutic effect if the drug clears before meaningful absorption occurs.
Why does the FOA emphasize suspension nasal sprays rather than solution sprays?
Suspension sprays carry solid drug particles in a liquid. Unlike solution sprays, modeling suspensions requires more than droplet flight and deposition. The model must also address how drug particles dissolve into moving mucus while mucociliary clearance is actively transporting material. If particles dissolve too slowly, are too large, or have low solubility, they may be cleared before absorption, reducing efficacy.
What type of computational approach does the FDA want applicants to build?
The FOA calls for a framework that couples computational fluid dynamics (CFD) for airflow and spray transport/deposition with a physiologically realistic, three-dimensional mucociliary clearance and absorption model. The intent is a single connected workflow that begins at the device-generated spray conditions and ends with region-specific predictions of epithelial uptake.
What problem with existing nasal CFD models is this FOA trying to solve?
Prior CFD work is described as relatively mature for predicting airflow and deposition and often aligns well with in vitro deposition measurements. However, many models stop at deposition. The FDA is pushing the field toward modeling what happens after deposition: mucus-driven transport, dissolution (for suspensions), and absorption. A newer approach existed for suspensions but relied on a simplified flattened surface and could not resolve region-specific outcomes in a true 3D anatomy.
What does the FDA mean by a “three-dimensional, anatomically accurate” nasal airway model?
The FOA indicates the desired modeling domain should be anatomically realistic and three-dimensional, spanning from the nostrils through to the throat. This matters because realistic geometry strongly influences airflow patterns, which in turn influence where droplets and particles deposit and how much drug can reach specific regions.
Why are region-specific outcomes (like the olfactory region) important to this opportunity?
For targeted nasal therapies, knowing total deposition is not enough. The FDA is seeking methods that can predict where drug deposits and is absorbed in specific anatomical areas, including the ability to resolve whether material reaches (and is absorbed in) regions such as the olfactory area. The FOA frames regional prediction as a central point of the work.
What endpoints or outputs is the model expected to produce?
Based on the FOA description, the model is expected to estimate (1) where drug deposits, (2) how it dissolves into mucus, (3) how it is transported by mucociliary motion along the surface, and (4) how much drug partitions into and is absorbed through the epithelium, with results resolved by anatomical region rather than only as a whole-nose average.
What physics and processes does the FOA explicitly encourage including?
The FOA encourages including the relevant physics needed for credible predictions, explicitly citing factors such as spray turbulence, droplet and particle dynamics, mucus properties, mucociliary transport, particle dissolution, and drug partitioning between mucus and tissue. The intent is to avoid a partial model and instead build a defensible end-to-end toolchain.
Does the model need to include the spray device and how the spray plume forms?
Yes. The FOA describes the desired model as end-to-end and calls for including device effects, meaning how the spray device produces the plume and the initial droplet/particle conditions that drive downstream transport and deposition.
Does the FOA expect the model to account for inhalation patterns?
Yes. The FOA states the model should incorporate inhalation patterns and span the nasal airway from the nostrils to the throat. Inhalation conditions influence airflow and therefore deposition and subsequent downstream behavior.
How does interindividual variability factor into the expected work?
Interindividual variability is a major theme. The FOA emphasizes that people differ substantially in nasal geometry, which can strongly alter airflow and deposition. The modeling approach is expected to capture intersubject differences rather than producing only a single idealized prediction.
Does the FOA require addressing disease states or disease-like changes?
Yes. The FOA highlights that real-world users may have inflamed tissue, altered mucus rheology, impaired mucociliary function, or other disease-related changes. Because many nasal products are used in diseased states, the tool is expected to handle scenarios involving changed mucus properties, modified clearance speeds, and geometry differences that move conditions away from a healthy baseline.
What specific disease-relevant changes does the FOA mention?
The FOA mentions inflamed tissue, altered mucus rheology, and impaired mucociliary function as examples of factors that can change clearance rates and absorption conditions. It also emphasizes geometry differences across individuals as a major driver of variability.
What modeling techniques are implied for deposition and transport within CFD?
The FOA references simulating droplet/particle transport and deposition using CFD and gives Lagrangian particle tracking as an example approach for tracking droplets and particles through the airflow to deposition sites.
What is the key interface the FDA wants between deposition modeling and clearance/absorption modeling?
The FOA calls for the CFD deposition model to interface directly with a three-dimensional mucociliary clearance model, so that deposited material becomes the input to a surface transport (clearance) model that also accounts for particle dissolution into moving mucus and subsequent absorption at the epithelium.
Are insufflation-type studies or products encouraged?
Yes. The FOA calls out suspension formulations and insufflation-type studies as particularly encouraged because they stress the mechanisms that are missing in many existing workflows, especially dissolution coupled with mucociliary clearance.
Is validation required, or just recommended?
Validation is described as not optional. Applicants are expected to validate both the CFD predictions and the clearance/absorption predictions using in vitro and/or in vivo data.
What kind of validation is the FDA especially interested in?
The FOA places emphasis on demonstrating that predicted local clearance behavior aligns with observed in vivo clearance of drug particles. This highlights that validation should not only be about deposition but also about what happens after deposition on the mucosa.
Does the FDA prefer validation on multiple drug products?
Where feasible, yes. The FOA states a preference for validation across multiple drug products rather than tuning the method to a single example. The intent appears to be a more generalizable regulatory-science tool rather than a one-off model.
Can applicants propose specific drug products to study?
Yes. The FOA indicates proposals may nominate specific products. However, it also notes that final product selection would be revisited after award in collaboration with the FDA, reflecting the cooperative agreement structure.
What does it mean that this is a cooperative agreement (U01)?
The FOA describes the mechanism as a cooperative agreement (U01) and notes that product selection would be revisited after award in collaboration with the FDA. Based on the provided information, this indicates the FDA intends to actively shape or collaborate on aspects of the work to meet regulatory-science needs.
How is the work organized (phases and deliverables)?
The FOA describes a phased plan: Phase 1 focuses on selecting and constructing physiological models and inhalation patterns that capture intersubject differences (including geometry and clearance-rate ranges). Phase 2 covers development and validation of the CFD deposition model and the mucociliary clearance model, including their interface. Phase 3 runs the main simulations and post-processing to extract regional outcomes. Phase 4 synthesizes the findings, assessing how formulation properties, clearance, variability, and disease-like changes influence regional absorption and overall performance. Phase 5 centers on manuscript preparation, expected to be concentrated in year three.
Why does the FOA mention a reduced budget in year three?
The FOA links the reduced budget in year three to Phase 5 manuscript preparation, noting that publication-focused activity in that period is the rationale for the lower year-three budget.
What expectations does the FDA set for openness and reproducibility?
The FOA sets an expectation that the developed 3D CFD-mucociliary clearance methodology be made available to the FDA and preferably to the public in a reproducible form. Examples mentioned include detailed methodological publications, shared code, shared models, or other transparent deliverables that allow others to reproduce, apply, or audit the workflow.
What is the solicitation identifier and agency for this opportunity?
The opportunity is identified as RFA-FD-18-020 and is offered by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services.
What is the CFDA number listed for this opportunity?
The FOA lists CFDA 93.103.
Who was eligible to apply based on the posting?
The posting described broad eligibility, 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 individuals.
What was the award ceiling and how many awards were anticipated?
The posting indicated an award ceiling of $280,000 and anticipated up to two awards.
When was the application due, and when was the opportunity created?
The original application closing date was June 4, 2018. The creation date was March 22, 2018.
What is the overall intended outcome of the funded work?
The FOA 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.
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