Opportunity Information: Apply for RFA FD 16 024
Apply for RFA FD 16 024
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation 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.
- This funding opportunity was created on Mar 18, 2016 and posted on Mar 18, 2016.
- Applicants must submit their applications by May 16, 2016. (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 $200,000.00 in funding.
- The number of recipients for this funding is limited to 1 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
This funding opportunity is a cooperative agreement (U01) from the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA), specifically FDA's Center for Drug Evaluation and Research (CDER). The project focus is on understanding how much small-airway drug delivery can vary from one adult to another when using orally inhaled drug products (OIDPs) that are used to manage asthma. The core idea is that two patients can inhale the same product and still receive meaningfully different amounts of drug in different regions of the lungs, especially in the smaller airways, and FDA is looking for high-quality deposition data that helps quantify and explain that variability.
The work FDA is soliciting centers on computational modeling approaches that can generate deposition (where the inhaled particles end up) in the respiratory tract, with an emphasis on the small airways in adults. The agency is interested in deposition data that reflect realistic differences between people, rather than a single "average" airway model. The opportunity highlights several drivers of intersubject variability that the modeling should consider, including anatomical differences such as the lengths and diameters of various airway segments, disease-related changes like heterogeneous versus homogeneous airway constriction, and behavioral or technique-related differences such as inhalation patterns (for example, variations in inspiratory flow rate, inhaled volume, and timing). In other words, the project is expected to look at how both anatomy and breathing maneuvers influence where the drug actually deposits.
A key expected outcome is regional deposition data for reference listed drugs (RLDs). In practical terms, FDA wants modeling outputs that can help indicate whether a given asthma inhalation product meaningfully targets the small airways in asthmatic patients, and which product attributes most strongly affect deposition in those regions. "Product attributes" here generally points to factors such as aerodynamic particle size distribution, plume or spray characteristics, device resistance, emitted dose, and other formulation or device properties that influence particle behavior during inhalation. The deliverables are meant to support better regulatory science by clarifying what drives small-airway deposition and how consistent (or inconsistent) that deposition may be across different adult patients with asthma.
Administratively, the opportunity is identified as RFA-FD-16-024 and falls under the activity category of consumer protection, food and nutrition, and health (CFDA 93.103). It was posted March 18, 2016, with an application closing date of May 16, 2016 (original and current closing dates are the same). FDA anticipated making a single award, with an award ceiling of $200,000. Because it is a cooperative agreement, awardees should generally expect substantial federal involvement during the project, such as coordination on scientific direction, milestones, data expectations, and alignment with CDER's research needs.
Eligibility is broad and includes many types of organizations capable of doing sophisticated modeling work. Eligible applicants include state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit entities (including small businesses); and other applicants as described in the opportunity's additional eligibility information. Overall, the grant is structured to attract researchers and groups with expertise in computational aerosol dynamics, lung airway modeling, asthma physiology, and deposition simulation, with the aim of producing deposition datasets that can inform FDA's understanding of small-airway delivery and variability for asthma OIDPs.
Frequently Asked Questions (FAQs)
What is the name and identifier of this funding opportunity?
This opportunity is identified as RFA-FD-16-024.
Which federal agency is offering this award?
The award is offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), specifically the FDA Center for Drug Evaluation and Research (CDER).
What type of funding mechanism is this?
This opportunity is a cooperative agreement under the U01 activity code.
What does it mean that this is a cooperative agreement (U01)?
Because it is a cooperative agreement, substantial federal involvement is expected during the project. Based on the opportunity description, this can include coordination with FDA/CDER on scientific direction, milestones, data expectations, and alignment with CDER research needs.
What problem is FDA trying to address with this project?
FDA is seeking to understand how much small-airway drug delivery can vary from one adult to another when using orally inhaled drug products (OIDPs) for asthma. The central issue is that two adults can inhale the same product but still receive meaningfully different amounts of drug in different lung regions, especially in the small airways.
What kinds of products are in scope for this project?
The focus is on orally inhaled drug products (OIDPs) used to manage asthma.
What is the scientific focus of the requested work?
The requested work centers on computational modeling approaches that can generate deposition results (i.e., where inhaled particles deposit) within the respiratory tract, with an emphasis on small-airway deposition in adults.
What kind of deposition data is FDA looking for?
FDA is looking for high-quality deposition data that quantify and help explain intersubject variability, with a specific emphasis on deposition in the small airways of adults.
Is FDA interested in a single "average" airway model?
No. The opportunity emphasizes deposition data that reflect realistic differences between people rather than relying on only a single average airway model.
What drivers of intersubject variability should the modeling consider?
The opportunity highlights several drivers, including:
- Anatomical differences (for example, different lengths and diameters of airway segments)
- Disease-related changes (for example, heterogeneous versus homogeneous airway constriction)
- Behavioral or technique-related differences in inhalation patterns (for example, variations in inspiratory flow rate, inhaled volume, and timing)
Does the opportunity focus only on anatomy, or also on breathing technique?
It expects consideration of both. The description specifically calls out the influence of anatomy and breathing maneuvers (inhalation patterns) on where drug particles deposit.
What is meant by "deposition" in this context?
Deposition refers to where inhaled particles end up within the respiratory tract (which regions of the lungs and airways receive the particles).
What is the expected emphasis regarding small airways?
The modeling and resulting datasets are expected to emphasize deposition in the small airways in adults, particularly in the context of asthma.
What is a key expected outcome or deliverable mentioned in the opportunity?
A key expected outcome is regional deposition data for reference listed drugs (RLDs).
How does FDA plan to use the modeling outputs?
Based on the opportunity description, FDA wants outputs that can help indicate whether an asthma inhalation product meaningfully targets the small airways in asthmatic patients, and identify which product attributes most strongly affect deposition in those regions.
What kinds of "product attributes" are relevant to deposition in this opportunity?
The opportunity describes product attributes in terms of formulation and device properties that influence particle behavior during inhalation, including examples such as:
- Aerodynamic particle size distribution
- Plume or spray characteristics
- Device resistance
- Emitted dose
- Other formulation or device properties that influence inhaled particle behavior
Is this opportunity aimed at improving regulatory science?
Yes. The deliverables are intended to support better regulatory science by clarifying what drives small-airway deposition and how consistent (or inconsistent) deposition may be across different adult patients with asthma.
What is the activity/category listing associated with this opportunity?
The opportunity falls under the activity category of consumer protection, food and nutrition, and health, and it is listed under CFDA 93.103.
When was the opportunity posted?
It was posted on March 18, 2016.
What was the application closing date?
The application closing date was May 16, 2016 (the original and current closing dates are the same).
How many awards did FDA anticipate making?
FDA anticipated making a single award.
What was the award ceiling?
The award ceiling was $200,000.
Who is eligible to apply?
Eligibility is broad and includes:
- State, county, and local governments
- Public and private institutions of higher education
- Federally recognized tribal governments and other tribal organizations
- Public housing authorities
- Nonprofit organizations (501(c)(3) and non-501(c)(3))
- For-profit entities (including small businesses)
- Other applicants as described in the opportunity's additional eligibility information
What kinds of expertise does this opportunity appear to target?
It is structured to attract applicants with expertise in computational aerosol dynamics, lung airway modeling, asthma physiology, and deposition simulation, with the goal of producing deposition datasets relevant to small-airway delivery and variability for asthma OIDPs.
Does this opportunity specify the population of interest?
Yes. The focus is on adults, and specifically adult patients with asthma (for small-airway deposition and variability considerations).
Does the opportunity mention the need to compare different patients?
Yes. The purpose includes quantifying how much deposition can vary from one adult to another and examining realistic intersubject differences rather than using only an average model.
Does the opportunity mention specific breathing parameters to evaluate?
Yes. It provides examples of inhalation-pattern differences such as inspiratory flow rate, inhaled volume, and timing.
Does the opportunity mention specific disease-state patterns to evaluate?
Yes. It calls out disease-related changes such as heterogeneous versus homogeneous airway constriction as drivers of variability.
Does the opportunity mention specific anatomical factors to evaluate?
Yes. It references differences in airway segment lengths and diameters as examples of anatomical variability to consider.
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