Opportunity Information: Apply for RFA FD 14 025
Apply for RFA FD 14 025
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Development of realistic in vitro studies to assess robustness of dose counters/indicators in metered dose inhalers (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 Apr 17, 2014 and posted on Apr 18, 2014.
- Applicants must submit their applications by Jun 2, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts City or township governments Private institutions of higher education County governments For profit organizations other than small businesses State governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments.
- Foreign Institutions are eligible to apply
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Opportunity Summary:
This FDA cooperative agreement opportunity focuses on a practical problem with metered dose inhalers (MDIs): making sure the dose counter or dose indicator attached to the inhaler can be trusted under real-world conditions. MDIs deliver medication from a pressurized canister through a valve and actuator, and the dose counter/indicator is meant to help patients track how many doses remain. FDA guidance (Integration of Dose Counting Mechanisms into MDI Drug Products, March 2003) recommends both in vitro testing that simulates normal use and misuse, and in-use studies conducted in clinical settings, to show that these counters are functional, reliable, and accurate. In practice, dose counters can fail in ways that matter to patients, such as undercounting (showing fewer doses left than there really are), overcounting (showing more doses left than there really are), or advancing counts when the device is dropped. These kinds of failures can lead to confusion about whether medication is available when needed, or whether the patient is actually receiving the intended number of doses.
The core issue the announcement is trying to solve is that common robustness tests used in laboratories do not always translate cleanly to what happens in patients hands. Typical in vitro robustness assessments for MDIs may involve drop testing, shaking, exposure to temperature extremes, shipping simulations, and accelerated storage. While these tests are reasonable stressors, FDA notes that there is limited information linking the outcomes of these bench tests to clinical outcomes or true real-world failure modes. That gap makes it harder to predict how a dose counter/indicator will behave under actual use and misuse patterns, and it limits confidence that existing test methods are really challenging devices in the most clinically relevant ways. The grant therefore aims to create better, more realistic in vitro methods that can more accurately forecast when and how dose counters/indicators will fail outside the lab.
The work proposed under the opportunity is organized into three phases. In Phase 1, the awardee would select two commercially available MDIs that already include dose counters/indicators. In Phase 2, the awardee would either design new in vitro robustness methods or improve existing ones, then run robustness testing on the two selected products. A major emphasis in this phase is calibrating the intensity of the stress tests: the testing needs to be strong enough to trigger meaningful product failures when the device is vulnerable, but not so artificial that it stops reflecting realistic patient behavior. The aim is to identify test conditions that are both predictive (they correlate with the kinds of failures that occur in practice) and relevant to actual use and misuse (they resemble what happens when people carry, store, handle, and sometimes mishandle inhalers). In Phase 3, the methods developed in Phase 2 would be validated by applying them to other marketed MDIs with dose counters/indicators, to show the approach generalizes beyond the initial two products and can serve as a broader evaluation framework.
From an administrative and funding standpoint, this is a discretionary funding opportunity from the Food and Drug Administration under CFDA 93.103, using a U01 cooperative agreement mechanism, which typically means substantial FDA involvement or collaboration during the project rather than a purely investigator-driven grant. FDA expected to make a single award. The estimated total funding is $500,000, with an award ceiling of $500,000 and a floor of $450,000, and there is no cost-sharing or matching requirement. The opportunity was posted April 18, 2014 (created April 17, 2014), with an original and current closing date of June 2, 2014, and an archive date of July 2, 2014. Eligibility was broad, spanning federal-recognized and other tribal organizations, state and local governments, public housing authorities, public and private institutions of higher education, nonprofits (including both 501(c)(3) and non-501(c)(3) organizations), for-profit entities (including small businesses and other for-profits), independent school districts, and special district governments. Foreign institutions were also eligible to apply, which is notable for an FDA program and suggests the agency was open to specialized technical expertise regardless of location.
Overall, the opportunity is aimed at strengthening the scientific basis for how dose counters/indicators on MDIs are tested before and after marketing. By developing and validating more clinically realistic in vitro robustness studies, the project is intended to improve the ability to anticipate failure modes like undercounting, overcounting, or false actuation counts due to impacts, and ultimately to support better product design, better regulatory assessment, and more reliable information for patients relying on MDIs in everyday settings.
FAQs: FDA Cooperative Agreement on MDI Dose Counter/Indicator Robustness Testing
1) What problem is this FDA grant trying to solve?
This opportunity targets a real-world reliability problem with metered dose inhalers (MDIs): dose counters or dose indicators attached to inhalers can fail in ways that affect patients. The project aims to develop and validate more clinically realistic in vitro robustness tests that better predict how these counters/indicators perform during everyday use and misuse.
2) What is an MDI and what does a dose counter/indicator do?
An MDI delivers medication from a pressurized canister through a valve and actuator. A dose counter/indicator is intended to help a patient track how many doses remain so they can avoid running out unexpectedly and understand whether doses are still available when needed.
3) What kinds of dose counter/indicator failures are described in the announcement?
The announcement highlights failures that matter to patients, including:
- Undercounting (showing fewer doses left than actually remain)
- Overcounting (showing more doses left than actually remain)
- Advancing counts due to impacts such as dropping the device (counts change even if a dose was not properly delivered)
These failures can cause confusion about whether medication is available when needed, or whether the patient is receiving the intended number of doses.
4) What does FDA guidance recommend for evaluating dose counting mechanisms?
FDA guidance titled Integration of Dose Counting Mechanisms into MDI Drug Products (March 2003) recommends using both:
- In vitro testing that simulates normal use and misuse
- In-use studies conducted in clinical settings
The goal is to demonstrate counters/indicators are functional, reliable, and accurate.
5) Why are current laboratory robustness tests considered insufficient?
FDA notes there is limited information linking common bench robustness tests to clinical outcomes or true real-world failure modes. While typical in vitro stressors are reasonable, the gap is that lab results do not always translate cleanly to what happens in patients hands, making it harder to predict real-world behavior and to be confident existing test methods are challenging devices in the most clinically relevant ways.
6) What are examples of typical in vitro robustness assessments mentioned?
The opportunity references common laboratory stressors such as drop testing, shaking, exposure to temperature extremes, shipping simulations, and accelerated storage.
7) What is the main goal of the proposed project work?
The central goal is to create better, more realistic in vitro methods that can more accurately forecast when and how MDI dose counters/indicators will fail outside the lab, improving confidence that the tests reflect actual use and misuse patterns.
8) How is the work organized (project phases)?
The announcement describes three phases:
- Phase 1: Select two commercially available MDIs that already include dose counters/indicators.
- Phase 2: Design new in vitro robustness methods or improve existing ones, then run robustness testing on the two selected products, with emphasis on calibrating stress intensity to be realistic yet capable of triggering meaningful failures.
- Phase 3: Validate the Phase 2 methods by applying them to other marketed MDIs with dose counters/indicators to demonstrate the approach generalizes beyond the first two products.
9) What does Phase 1 require regarding product selection?
Phase 1 requires the awardee to select two commercially available MDIs that already include dose counters/indicators.
10) What is the key focus of Phase 2 robustness testing?
Phase 2 emphasizes developing or refining in vitro robustness methods and calibrating the intensity of the stress tests. The stress must be strong enough to trigger meaningful failures when a device is vulnerable, but not so artificial that it no longer reflects realistic patient behavior.
11) What does FDA mean by making tests "predictive" and "relevant"?
In this announcement, "predictive" means the test conditions correlate with the kinds of failures that occur in practice. "Relevant" means the stressors resemble real-world use and misuse, such as what happens when people carry, store, handle, and sometimes mishandle inhalers.
12) What happens in Phase 3 and why is it important?
Phase 3 applies the developed methods to additional marketed MDIs with dose counters/indicators. This step is meant to validate that the approach generalizes beyond the initial two products and can serve as a broader evaluation framework.
13) What is the funding agency and CFDA number?
The funding agency is the U.S. Food and Drug Administration (FDA). The CFDA program number listed is 93.103.
14) What is the award mechanism and what does it imply?
The mechanism is a U01 cooperative agreement. The announcement notes that this typically means substantial FDA involvement or collaboration during the project, rather than a purely investigator-driven grant.
15) How many awards did FDA expect to make?
FDA expected to make a single award.
16) How much funding is available under this opportunity?
The estimated total funding is $500,000. The award ceiling is $500,000 and the award floor is $450,000.
17) Is cost sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
18) When was the opportunity posted and what were the key dates?
- Created: April 17, 2014
- Posted: April 18, 2014
- Original and current closing date: June 2, 2014
- Archive date: July 2, 2014
19) Who was eligible to apply?
Eligibility was broad and included: federally recognized and other tribal organizations; state and local governments; public housing authorities; public and private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit entities (including small businesses and other for-profits); independent school districts; and special district governments.
20) Were foreign institutions eligible?
Yes. Foreign institutions were eligible to apply, indicating FDA openness to specialized technical expertise regardless of location.
21) What real-world behaviors are these improved tests expected to reflect?
The improved methods are intended to reflect real use and misuse patterns, including how people carry, store, handle, and sometimes mishandle inhalers (for example, impacts such as drops), while still being structured and controlled enough for in vitro evaluation.
22) What is the broader intended impact of this project?
The opportunity is aimed at strengthening the scientific basis for testing dose counters/indicators on MDIs before and after marketing. By developing and validating more clinically realistic in vitro robustness studies, the work is intended to support better product design, better regulatory assessment, and more reliable information for patients relying on MDIs in everyday settings.
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