Closed · RFA-FD-23-013 · CFDA 93.103 · Discretionary
Evaluation of oral modified release drug tablet to support the approval of additional strengths
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $50K-$450K
- Award range
- Closed
- Status
- March 15, 2023
- Close date
- 1
- Expected awards
The verdict
Evaluation of oral modified release drug tablet to support the approval of additional strengths is a closed discretionary listing from Food and Drug Administration that offered $50,000 -- $450,000 across 1 expected award. Future funding cycles may be published under the same CFDA number.
- $50K-$450K
- award range
- Closed
- application status
- 1
- expected award
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - Evaluation of oral modified release drug tablet to support the approval of additional strengths - is cataloged under number RFA-FD-23-013 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 December 1, 2022. The funding category is Discretionary, delivered as a cooperative agreement.
Award economics. The award range on file is $50,000 -- $450,000. The agency has projected $450,000 in total estimated funding for this announcement. It expects to issue 1 award. If the agency funds the expected 1 award from the $450,000 estimated pool, the average award works out to roughly $450,000. 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 15, 2023. 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 -- $450,000
Close Date
March 15, 2023
Posted
December 1, 2022
Est. Total Funding
$450,000
Expected Awards
1
Instrument
Cooperative Agreement
Description
The FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021), provides recommendations for demonstrating the bioequivalence of additional strengths of a proposed modified release drug product. The recommendations involve evidence to demonstrate the same drug release mechanism and similar dissolution profiles across strengths, as well as ratios of drug excipients across strengths that are appropriate for the drug release mechanism. The purpose of this project is to determine the critical quality attributes for different release controlling platform technologies and to determine the appropriate factors to scale the formulation for additional strengths. The outcomes of this research are intended to support generic drug development and regulatory decision making.
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.
Read our methodology - how this data is sourced, computed, and verified.
Related
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| Sources | the SAM.gov Assistance Listings and Grants.gov |