This department is offering a grant to develop clinically relevant in vitro studies assessing the robustness of dose counters/indicators in metered dose inhalers (MDIs) under actual-use/misuse conditions. The study aims to select MDIs with dose counters/indicators, design new in vitro methods, and validate the studies with other MDIs. The goal is to enhance the prediction of failure modes of MDI dose counters/indicators in real-world scenarios and improve product performance. Applicants have the opportunity to contribute to advancing the understanding of in vitro robustness testing for MDIs. Closing date for applications is Jun 02, 2014.
Opportunity ID: 254037
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-025 |
| Funding Opportunity Title: | Development of realistic in vitro studies to assess robustness of dose counters/indicators in metered dose inhalers (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 17, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 02, 2014 |
| Current Closing Date for Applications: | Jun 02, 2014 |
| Archive Date: | Jul 02, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | County governments Special district governments For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Independent school districts State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | Foreign Institutions are eligible to apply |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Metered dose inhalers (MDIs) consist of a formulation, with active ingredient(s) and possibly excipients in a propellant contained in a pressurized canister, and are aerosolized using a valve fitted to an actuator. Dose counters/indicators are an add-on mechanism to MDIs and aid in tracking the number of doses remaining in the canister. According to the Guidance for Industry: Integration of Dose-Counting Mechanisms into MDI Drug Products (March 2003), in vitro testing (simulating both actual-use and misuse) and in-use studies are recommended to be conducted in order to establish functionality, reliability, and accuracy of dose counters/indicators in MDIs. The in-use studies supplement the in vitro testing and provide information regarding any problems when the dose counter/indicator is used in a clinical setting. The potential failure modes reported for MDI dose counters/indicators include, but are not limited to, undercounting, over counting and count(s) upon dropping.In general, in vitro robustness studies for MDIs include, but are not limited to, effect of dropping, shaking, exposure to temperature extremes, shipping, and storage under accelerated conditions on MDI drug product performance. Due to limited information available on the relevance of these in vitro robustness studies to clinical outcomes, it may be difficult to predict the failure modes of dose counters/indicators in MDIs under actual-use conditions. Therefore, there is a need to develop new or improve the existing in vitro studies used to assess robustness of dose counters/indicators in MDIs to better predict occurrence and type of failure for dose counters/indicators under actual-use conditions.The goal of this study is to develop clinically relevant in vitro studies to assess robustness of dose counters/indicators in MDIs representing the actual-use/misuse conditions. This study will consist of three phases. Phase 1: Select two commercially available MDIs with dose counters/indicators. Phase 2: Design new or modify existing in vitro methods and conduct in vitro robustness studies for the MDIs selected in Phase 1. Identify the intensity of in vitro tests needed to cause product failures, while ensuring that the proposed tests are predictive and relevant to actual-use conditions. Phase 3: Validate the proposed in vitro robustness studies using other marketed MDIs with dose counters/indicators. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Martin Bernard
Grants Management Specialist Phone 240-402-7564 Email:Martin.Bernard@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 254037 Full Announcement-1 -> sf424_rr_guide_general_adobe_verc1.pdf
Folder 254037 Full Announcement-1 -> rfa-fd-14-025_ development of realistic in vitro studies to assess robustnes.pdf
Packages
| Agency Contact Information: | Martin Bernard Grants Management Specialist Phone 240-402-7564 Email: Martin.Bernard@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-C | RFA-FD-14-025 | PKG00195435 | Apr 21, 2014 | Jun 02, 2014 | View |
Package 1
Mandatory forms
254037 RR_SF424_2_0-2.0.pdf
254037 PHS398_ResearchPlan_2_0-2.0.pdf
254037 PHS398_CoverPageSupplement_2_0-2.0.pdf
254037 RR_Budget_1_3-1.3.pdf
254037 RR_KeyPersonExpanded_2_0-2.0.pdf
254037 RR_OtherProjectInfo_1_3-1.3.pdf
254037 PerformanceSite_2_0-2.0.pdf
Optional forms
254037 PlannedReport-1.0.pdf
254037 PHS398_CumulativeInclusionReport-1.0.pdf
254037 RR_SubawardBudget30_1_3-1.3.pdf
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