Opportunity Information: Apply for RFA FD 15 016
Apply for RFA FD 15 016
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Limited Competition for Revision Applications for Evaluation of Formulation Effects of Metered Dose Inhalers on Pharmacokinetics (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 21, 2015 and posted on Mar 20, 2015.
- Applicants must submit their applications by May 29, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $800,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $800,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Only the following organization is eligible to apply University of Florida
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Opportunity Summary:
The funding opportunity titled "Limited Competition for Revision Applications for Evaluation of Formulation Effects of Metered Dose Inhalers on Pharmacokinetics (U01)" (Funding Opportunity Number RFA FD 15 016) is a discretionary grant program offered by the U.S. Food and Drug Administration (FDA) under a cooperative agreement mechanism. It sits within the broader activity areas of consumer protection, food and nutrition, and health, and it is tied to CFDA 93.103 (Food and Drug Administration Research). The central purpose of the project is to improve scientific understanding of metered dose inhalers (MDIs) by building an in vitro-in vivo correlation, meaning a defensible relationship between laboratory-based tests and what actually happens in the body when an inhaled product is used.
At its core, the opportunity is focused on systematically studying how changes in MDI formulation affect pharmacokinetics, which refers to how a drug is absorbed, distributed, metabolized, and eliminated. For inhaled drugs, pharmacokinetic behavior can be influenced by a range of formulation variables that affect aerosol generation, particle size distribution, plume characteristics, and ultimately how much drug reaches the lungs versus remaining in the mouth/throat or being swallowed. By linking in vitro measurements (for example, device and aerosol performance tests conducted in the lab) to in vivo pharmacokinetic outcomes, the study aims to support more reliable evaluation methods for MDIs and help interpret how formulation adjustments may translate into clinically relevant exposure differences.
This is a limited competition announcement, meaning it was not open to the general research community. Eligibility was restricted to a single institution: the University of Florida. The announcement specifically indicates that only that organization could apply, and it was framed as a revision application competition, which typically implies the funding supported an expansion, continuation, or modification of an existing, previously funded effort rather than a completely new, open competition.
Financially, the FDA expected to make one award, with an estimated total funding amount of $800,000 and an award ceiling of $800,000. There was no cost sharing or matching requirement, so the applicant was not required to contribute non-federal funds as a condition of the award. Because the instrument is a cooperative agreement (U01), the project structure is generally more collaborative than a standard grant, with substantial FDA scientific or programmatic involvement anticipated during performance of the work, such as coordination on study design, milestones, data expectations, or alignment with regulatory science needs.
The timeline for the opportunity was short and tied to 2015 submission dates. It was posted on March 20, 2015, created on May 21, 2015, and had an original closing date of May 22, 2015, later extended to a current closing date of May 29, 2015. The archive date was June 21, 2015, indicating the opportunity is no longer active.
For administrative questions or issues accessing the full announcement, the listed contact was Lisa Ko, Grants Management Specialist at the FDA, reachable by email at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Limited Competition for Revision Applications for Evaluation of Formulation Effects of Metered Dose Inhalers on Pharmacokinetics (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA FD 15 016.
Which federal agency is offering this grant?
The program is offered by the U.S. Food and Drug Administration (FDA).
What type of funding mechanism is used?
The mechanism is a cooperative agreement (U01), which typically involves substantial FDA scientific or programmatic involvement during the project.
Is this a discretionary grant program?
Yes. The opportunity is described as a discretionary grant program.
Which CFDA program is this associated with?
This opportunity is tied to CFDA 93.103, titled "Food and Drug Administration Research."
What general activity areas does this opportunity fall under?
It sits within the broader activity areas of consumer protection, food and nutrition, and health.
What is the main purpose of the project?
The central purpose is to improve scientific understanding of metered dose inhalers (MDIs) by building an in vitro-in vivo correlation (IVIVC), meaning a defensible relationship between laboratory-based tests and what happens in the body when an inhaled product is used.
What specific scientific focus does the opportunity emphasize?
The focus is on systematically studying how changes in MDI formulation affect pharmacokinetics (how a drug is absorbed, distributed, metabolized, and eliminated).
What does "in vitro-in vivo correlation" mean in this context?
In this context, it means linking in vitro measurements (such as lab-based device and aerosol performance tests) to in vivo pharmacokinetic outcomes (drug exposure observed in the body) to create a defensible relationship between the two.
Why are MDI formulation changes important to pharmacokinetics?
For inhaled drugs, pharmacokinetic behavior can be influenced by formulation variables that affect aerosol generation, particle size distribution, plume characteristics, and ultimately how much drug reaches the lungs versus remaining in the mouth/throat or being swallowed.
What kinds of in vitro measurements are referenced?
The description references device and aerosol performance tests conducted in the laboratory as examples of in vitro measurements.
What are the intended outcomes or uses of linking in vitro and in vivo results?
The aim is to support more reliable evaluation methods for MDIs and to help interpret how formulation adjustments may translate into clinically relevant exposure differences.
Is this an open competition for all eligible applicants?
No. This is a limited competition announcement and was not open to the general research community.
Who was eligible to apply?
Eligibility was restricted to a single institution: the University of Florida.
What does "limited competition" mean for this opportunity?
It means the announcement restricted eligibility to a specific organization rather than allowing applications from the broader research community.
What does "revision application" indicate about the nature of the funding?
The announcement was framed as a revision application competition, which typically implies support for an expansion, continuation, or modification of an existing, previously funded effort rather than a completely new, open competition.
How many awards did FDA expect to make?
The FDA expected to make one award.
What was the estimated total funding amount?
The estimated total funding amount was $800,000.
What was the maximum award amount (award ceiling)?
The award ceiling was $800,000.
Was cost sharing or matching required?
No. There was no cost sharing or matching requirement.
What does the U01 cooperative agreement imply about FDA involvement?
It implies a more collaborative structure than a standard grant, with substantial FDA involvement anticipated during performance of the work, such as coordination on study design, milestones, data expectations, or alignment with regulatory science needs.
When was the opportunity posted?
The opportunity was posted on March 20, 2015.
When was the opportunity created?
The opportunity was created on May 21, 2015.
What was the original closing date?
The original closing date was May 22, 2015.
Was the closing date extended?
Yes. The closing date was extended to May 29, 2015.
What was the current closing date after the extension?
The current closing date was May 29, 2015.
Is this funding opportunity still active?
No. The archive date was June 21, 2015, which indicates the opportunity is no longer active.
Who is the listed contact for administrative questions?
The listed contact is Lisa Ko, Grants Management Specialist at the FDA.
How can the listed contact be reached?
Lisa Ko can be reached by email at lisa.ko@fda.hhs.gov.
What types of questions is the contact intended to address?
The contact is listed for administrative questions or issues accessing the full announcement.
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| Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01) Apply for RFA FD 15 032 Funding Number: RFA FD 15 032 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $250,000 |
| Post market Surveillance of Generic Modified Release Products (U01) Apply for RFA FD 15 015 Funding Number: RFA FD 15 015 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 15 031 Funding Number: RFA FD 15 031 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Development and Application of Case Control Analysis for Generic Drugs (U01) Apply for RFA FD 15 027 Funding Number: RFA FD 15 027 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $200,000 |
| Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) Apply for RFA FD 15 040 Funding Number: RFA FD 15 040 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 15 036 Funding Number: RFA FD 15 036 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Apply for RFA FD 15 014 Funding Number: RFA FD 15 014 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
| Smokeless Tobacco Reference Products (UC2) Apply for RFA FD 15 026 Funding Number: RFA FD 15 026 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $3,000,000 |
| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 16 003 Funding Number: RFA FD 16 003 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 16 004 Funding Number: RFA FD 16 004 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
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