Closed · FOR-FD-20-023 · CFDA 93.103 · Discretionary
CFD Models to aid the development of generic inhalation products
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- Varies
- Award range
- Closed
- Status
- -
- Close date
- 2
- Expected awards
The verdict
CFD Models to aid the development of generic inhalation products is a closed discretionary listing from Food and Drug Administration that offered Varies by applicant across 2 expected awards. Future funding cycles may be published under the same CFDA number.
- Varies
- award range
- Closed
- application status
- 2
- expected awards
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - CFD Models to aid the development of generic inhalation products - is cataloged under number FOR-FD-20-023 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 May 25, 2021. The funding category is Discretionary, delivered as a grant.
Award economics. The award range on file is Varies by applicant. 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 is closed. Monitoring the parent program page is the most reliable way to catch re-announcements in the next funding cycle. 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
Varies by applicant
Close Date
Not specified
Archiving forecast
Posted
May 25, 2021
Expected Awards
2
Instrument
Grant
Description
Current US Food and Drug Administration product specific guidance (PSG) bioequivalence (BE) recommendations for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically use a weight-of-evidence approach that includes in vitro studies, an in vivo pharmacokinetics (PK) study, and either an in vivo pharmacodynamics (PD) or comparative clinical endpoint (CCEP) study. To produce a generic MDI or DPI that is capable of passing all of 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 grant 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. Once predictions are appropriately verified and validated using either in vitro or in vivo data, a parameter sensitivity analysis will be conducted to assess the biopredictive capabilities of relevant in vitro studies. For DPIs, discrete element modeling (DEM) may be considered as a means for predicting the effects of agglomeration and deagglomeration of carrier-active pharmaceutical ingredient combination particles on regional deposition and the relationships of those phenomena with APSD. For MDIs, it is preferred that formulations considered include at least three components.
Eligibility
Grants.gov lists this opportunity under eligibility category codes 00, 01, 02, 04, 05, 06, 07, 08, 11, 12, 13, 20, 22, 23. 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
Key Dates
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| Sources | the SAM.gov Assistance Listings and Grants.gov |