Closed · RFA-FD-21-015 · CFDA 93.103 · Discretionary
Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $200K-$400K
- Award range
- Closed
- Status
- March 15, 2021
- Close date
- 2
- Expected awards
The verdict
Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional is a closed discretionary listing from Food and Drug Administration that offered $200,000 -- $400,000 across 2 expected awards. Future funding cycles may be published under the same CFDA number.
- $200K-$400K
- award range
- Closed
- application status
- 2
- expected awards
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional - is cataloged under number RFA-FD-21-015 and tied to CFDA assistance listing 93.103, posted by Food and Drug Administration. Grants.gov currently shows the opportunity as closed, first posted on January 7, 2021. The funding category is Discretionary, delivered as a cooperative agreement.
Award economics. The award range on file is $200,000 -- $400,000. It expects to issue 2 awards. Cost sharing is not required, so applicants do not need to commit matching funds to be competitive on this opportunity. Federal award ranges are often upper bounds; actual allocations reflect program appropriations, the strength of the applicant pool, and the evaluation committee's scoring.
Deadline and action path. This opportunity closed on March 15, 2021. Future funding cycles may be published under the same CFDA number, so monitoring the parent program page is the most reliable way to catch re-announcements. Every Grants.gov submission requires an active SAM.gov registration and a Unique Entity ID. Review the Eligibility section below carefully, federal eligibility categories (nonprofit, state or local government, tribal, individual, educational institution, small business) have distinct registration and reporting requirements. Pre-application outreach to the listed agency contact is permitted and often welcomed, it helps clarify scope and scoring priorities. Before acting on the deadline or award figures above, verify them directly on the official Grants.gov listing, amendments can change dates and amounts after this page was last refreshed.
Award Range
$200,000 -- $400,000
Close Date
March 15, 2021
Posted
January 7, 2021
Expected Awards
2
Instrument
Cooperative Agreement
Description
Current U.S. Food and Drug Administration product-specific guidances for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically recommend using a weight-of-evidence approach for demonstrating bioequivalence (BE) that includes in vitro studies, an in vivo pharmacokinetics study, and either an in vivo pharmacodynamics or comparative clinical endpoint BE study. To produce a generic MDI or DPI that can meet acceptance criteria from all these recommended studies, it would be useful to have an enhanced understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue. Computational fluid dynamics (CFD) is a technique capable of predicting these relationships between in vitro study metrics and regional lung deposition. The purpose of this funding opportunity announcement is to use CFD to produce verified and validated predictions of regional lung deposition for at least one currently marketed MDI or DPI in human upper and lower airways and to develop an in vitro-in vivo correlation (IVIVC) between model predictions and at least one relevant in vitro metric. Generic drug developers may then use this IVIVC to interpret in vitro results in a manner that may increase confidence in their products prior to in vivo testing
Eligibility
Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23, 25. These codes correspond to applicant types (state/local government, tribal organization, nonprofit, educational institution, individual, small business, etc.) defined in Grants.gov's own eligibility reference. See the current Grants.gov eligibility categories or check the official listing below for this opportunity's exact eligibility statement.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Shashi Malhotra Grants Management Specialist Phone 2404027592
Key Dates
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Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
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Related
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |