Closed · RFA-FD-22-017 · CFDA 93.103 · Discretionary
Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $50K-$1.5M
- Award range
- Closed
- Status
- March 31, 2022
- Close date
- 2
- Expected awards
The verdict
Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products is a closed discretionary listing from Food and Drug Administration that offered $50,000 -- $1,500,000 across 2 expected awards. Future funding cycles may be published under the same CFDA number.
- $50K-$1.5M
- award range
- Closed
- application status
- 2
- expected awards
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products - is cataloged under number RFA-FD-22-017 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 12, 2022. The funding category is Discretionary, delivered as a cooperative agreement.
Award economics. The award range on file is $50,000 -- $1,500,000. The agency has projected $1.0 million in total estimated funding for this announcement. It expects to issue 2 awards. If the agency funds the expected 2 awards from the $1.0 million estimated pool, the average award works out to roughly $500,000. 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 31, 2022. 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
$50,000 -- $1,500,000
Close Date
March 31, 2022
Posted
January 12, 2022
Est. Total Funding
$1,000,000
Expected Awards
2
Instrument
Cooperative Agreement
Description
The primary objective of this funding opportunity is to optimize clinical study designs and data analysis techniques that can support a comparative assessment of the relative bioavailability of topically administered drugs, and which can support a demonstration of BE for prospective generic topical products. The specific aims of this research would include comparing in vivo cutaneous PK measurements by independent techniques (e.g., dermal Open Flow Microperfusion (dOFM), dermal microdialysis (dMD), spectroscopic tomography), exploring the removal of the topical formulations at different time points and characterizing the PK profiles of the test and reference products; developing data analysis techniques (described in detail below); and identifying appropriate PK endpoints for the evaluation of topical BE. Based on the multidisciplinary nature of the research supported by this funding opportunity, it is encouraged that researchers with expertise in measuring cutaneous drug concentrations (e.g., experts in techniques such as dOFM, dMD and/or spectroscopy based techniques) collaborate with experts in PK data analysis and with statisticians, to achieve the overall objectives of the research. Specific areas of scientific interest would include the following:1. Expansion of the current theoretical framework to describe the relationship between the concentration of drug sampled by a given technique (dOFM, dMD, or spectroscopy based techniques) and the actual amount of drug in the epidermis/dermis, and the relationships between the free drug vs protein-bound drug sampled, when relevant, so that not only could the relative amounts of drug in the epidermis/dermis be compared, but also that the actual drug exposures at the site of action could be calculated.2. Comparison of the available techniques for characterizing cutaneous PK in parallel, within the same clinical setting. (e.g., comparison of dOFM or dMD with other technique(s) that monitor cutaneous PK, like spectroscopic tomography, ideally using commercially available instrumentation).3. Exploration of different study designs to characterize the cutaneous PK profiles for topical drugs that may not reach the maximum drug concentration (Cmax) within the 24 hours of administration.4. Development and implementation of data analysis strategy(ies), including statistical assessments of cutaneous PK data for the methods explored within the scope of this research, including identifying appropriate PK endpoints for establishing BE using cutaneous PK based approaches.
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 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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| Sources | the SAM.gov Assistance Listings and Grants.gov |