Opportunity Information: Apply for RFA FD 12 019
Apply for RFA FD 12 019
- The Food Drug Administration in the consumer protection health science and technology and other research and development sector is offering a public funding opportunity titled "Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (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 May 17, 2012 and posted on Apr 27, 2012.
- Applicants must submit their applications by Jun 8, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $300,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education State governments For profit organizations other than small businesses Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education 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) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments County governments Independent school districts.
- 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 FDA Grants Policy Statement, are allowed.
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Opportunity Summary:
The Food and Drug Administration (FDA) grant opportunity titled "Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01)" (Funding Opportunity Number RFA-FD-12-019) supports research aimed at improving how regulators and developers predict where inhaled medicines land in the respiratory tract and what that means for both therapeutic effect and safety. It is offered as a cooperative agreement (U01), which typically means the FDA expects active scientific involvement during the project rather than acting only as a passive funder. The overarching objective is to build a computational framework that can connect inhaler product performance characteristics to real-world lung deposition outcomes, and then connect deposition to clinical-relevant measures such as local delivery in the lungs and systemic exposure.
At the center of the project is the development of a computational fluid dynamics (CFD) model for orally inhaled drug products. The model is expected to account for key product variables, especially aerodynamic particle size distribution (APSD), and key human factors, particularly breathing patterns and airway geometry. By incorporating both the aerosol physics and the complexity of the respiratory tract, the CFD approach is intended to predict total deposition as well as regional deposition (where in the lungs the particles deposit). A major technical expectation is that the model can resolve highly localized deposition patterns for pharmaceutically relevant, polydisperse aerosols delivered by two common device types: metered dose inhalers (MDIs) and dry powder inhalers (DPIs). In practical terms, this means moving beyond coarse estimates of "lung dose" and toward spatially detailed predictions that can differentiate deposition in different airway generations or lung regions, which is often critical for locally acting therapies.
The opportunity also emphasizes a second stage: using the CFD deposition outputs as a foundation for a linked CFD-compartment model. This linked model is meant to translate deposition predictions into implications for safety and efficacy by tying regional deposition to pharmacokinetics (PK) and local drug delivery. Safety, in this context, is framed primarily as systemic exposure, since drug deposited in certain regions (or swallowed after oropharyngeal deposition) can contribute to systemic absorption and side effects. Efficacy is framed as local delivery, since many inhaled drugs are designed to act directly in the lungs, and therapeutic benefit depends not just on how much drug is delivered, but where it deposits relative to disease-relevant sites.
A key motivation for the FDA is regulatory impact, especially for bioequivalence (BE) policy development for generic orally inhaled products. Demonstrating BE for inhaled drug-device combination products is challenging because clinical endpoint studies can be expensive and variable, and in vitro tests alone may not always capture clinically meaningful differences. By improving mechanistic prediction of deposition and linking it to PK and local delivery, the project is positioned as a step toward a stronger scientific basis for assessing sameness or equivalence between products, potentially informing how the FDA evaluates generic MDIs and DPIs.
Beyond BE policy, the announcement highlights several development and quality-related applications. One is advancing quality by design (QbD) for inhaled products, meaning the model could be used as a tool during development to understand how formulation and device parameters influence deposition and performance. Another is enabling more accurate dose predictions, which matters for selecting strengths, setting dosing instructions, and anticipating variability across patient populations with different breathing patterns or airway geometries. A third is helping define clinically relevant APSD specifications, which would support setting product quality standards that are meaningfully connected to clinical performance rather than being based only on convention or limited empirical correlations. Because APSD is a central in vitro performance metric for inhaled aerosols, linking APSD specifications to predicted deposition and downstream exposure/delivery could directly influence how manufacturers design and control these products.
From an administrative perspective, the opportunity was posted on April 27, 2012, created May 17, 2012, with an original closing date of May 31, 2012 and a revised closing date of June 8, 2012; it was archived June 30, 2012. The estimated total funding amount is $300,000, with an award ceiling of $150,000 and an expected number of awards listed as one, indicating a relatively focused, single-project effort rather than a broad multi-award program. There is no cost-sharing or matching requirement. The funding activity category is listed under consumer protection and health science/technology research and development, and the agency is the FDA (CFDA number 93.103, FDA Research).
Eligibility is broad and includes public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), and various government entities. Importantly, non-U.S. (foreign) institutions are eligible to apply, as are foreign components of U.S. organizations, consistent with the FDA Grants Policy Statement. The contact listed for access issues related to the full announcement is Lisa Ko, Grants Management Specialist, at lisa.ko@fda.hhs.gov.
Overall, this grant opportunity is designed to push inhaled drug evaluation toward a more mechanistic, predictive science: starting with CFD-based modeling of aerosol transport and deposition that incorporates APSD and patient physiology, then extending that work into linked models that can forecast systemic exposure and local lung delivery. The intended payoff is both scientific and regulatory: better understanding of APSD-PK-local delivery relationships, improved tools for product development and QbD, and stronger evidence and methods to support FDA decision-making on bioequivalence and quality standards for generic inhaled drug-device combination products.
Frequently Asked Questions (FAQs)
What is the title of this FDA funding opportunity?
The opportunity is titled "Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01)."
What is the Funding Opportunity Number?
The Funding Opportunity Number is RFA-FD-12-019.
What type of award mechanism is this?
This opportunity is offered as a cooperative agreement (U01), which typically indicates active scientific involvement by the FDA during the project rather than the agency acting only as a passive funder.
What is the main purpose of the project?
The overarching objective is to build a computational framework that links inhaler product performance characteristics to real-world lung deposition outcomes, and then links deposition to clinically relevant measures tied to efficacy (local lung delivery) and safety (systemic exposure).
What research approach is emphasized in this grant?
The announcement centers on developing a computational fluid dynamics (CFD) model for orally inhaled drug products, and then extending it into a linked CFD-compartment model to translate deposition predictions into implications for pharmacokinetics (PK), local delivery, and systemic exposure.
What kinds of inhaled products are the focus?
The focus is on orally inhaled drug products delivered by two common device types: metered dose inhalers (MDIs) and dry powder inhalers (DPIs).
What key product variable must the model account for?
A major product variable called out in the opportunity is aerodynamic particle size distribution (APSD), which is a core in vitro performance metric for inhaled aerosols.
What key human factors must the model include?
The model is expected to incorporate human factors such as breathing patterns and airway geometry, reflecting how patient physiology and inhalation behavior can influence deposition.
What deposition outcomes is the CFD model expected to predict?
The CFD approach is intended to predict both total deposition and regional deposition (where particles deposit within different lung regions or airway generations).
How detailed does the deposition prediction need to be?
The opportunity emphasizes moving beyond coarse "lung dose" estimates to spatially detailed predictions that can resolve highly localized deposition patterns for pharmaceutically relevant, polydisperse aerosols.
What does the "second stage" of modeling involve?
The second stage involves using CFD deposition outputs as the foundation for a linked CFD-compartment model that connects regional deposition to pharmacokinetics (PK), local lung delivery (efficacy-related), and systemic exposure (safety-related).
How does the opportunity define safety in this context?
Safety is framed primarily in terms of systemic exposure, since drug deposited in certain regions (or swallowed after oropharyngeal deposition) can contribute to systemic absorption and potential side effects.
How does the opportunity define efficacy in this context?
Efficacy is framed as local delivery in the lungs, since many inhaled drugs are intended to act locally and benefit depends not only on how much drug is delivered but also where it deposits relative to disease-relevant sites.
Why is the FDA interested in this work from a regulatory standpoint?
A key motivation is regulatory impact on bioequivalence (BE) policy development for generic orally inhaled products. The project aims to strengthen the mechanistic basis for assessing equivalence by predicting deposition and linking it to PK and local delivery.
How might this work relate to bioequivalence for generic MDIs and DPIs?
By improving mechanistic prediction of deposition and linking it to clinically relevant outcomes, the project is positioned to support how the FDA evaluates sameness or equivalence for generic metered dose inhalers and dry powder inhalers.
Does the announcement mention applications beyond bioequivalence?
Yes. It highlights development and quality-related applications such as advancing quality by design (QbD), enabling more accurate dose predictions, and helping define clinically relevant APSD specifications tied to predicted deposition and downstream exposure/delivery.
How could the model support quality by design (QbD) for inhaled products?
The model could be used during development to understand how formulation and device parameters influence deposition and performance, which aligns with QbD principles focused on building quality and performance into product design.
What does the opportunity say about APSD specifications?
It emphasizes helping define clinically relevant APSD specifications by linking APSD to predicted deposition and downstream exposure/local delivery, supporting quality standards that are meaningfully connected to clinical performance.
What is the estimated total funding amount for this opportunity?
The estimated total funding amount is $300,000.
What is the award ceiling?
The award ceiling is $150,000.
How many awards are expected?
The opportunity lists an expected number of awards as one, indicating a single-project effort rather than a broad multi-award program.
Is cost sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
Which agency is offering this grant?
The awarding agency is the U.S. Food and Drug Administration (FDA).
What is the CFDA number associated with this opportunity?
The CFDA number is 93.103 (FDA Research).
What are the funding activity categories listed?
The funding activity category is listed under consumer protection and health science/technology research and development.
Who is eligible to apply?
Eligibility includes public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), and various government entities.
Are non-U.S. (foreign) institutions eligible?
Yes. Non-U.S. (foreign) institutions are eligible, and foreign components of U.S. organizations are also eligible, consistent with the FDA Grants Policy Statement.
When was the opportunity posted and created?
It was posted on April 27, 2012, and created on May 17, 2012.
What was the original closing date and the revised closing date?
The original closing date was May 31, 2012, and the revised closing date was June 8, 2012.
When was the opportunity archived?
The opportunity was archived on June 30, 2012.
Who is the listed contact for access issues related to the full announcement?
The contact listed is Lisa Ko, Grants Management Specialist. The email provided is lisa.ko@fda.hhs.gov.
What is the intended end result or payoff of the research described?
The intended payoff is to push inhaled drug evaluation toward more mechanistic, predictive science by linking APSD and patient physiology to deposition, and then linking deposition to systemic exposure and local lung delivery, supporting product development, QbD, clinically meaningful specifications, and FDA decision-making for bioequivalence and quality standards.
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