Closed · RFA-FD-23-016 · CFDA 93.103 · Discretionary
Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $50K-$500K
- Award range
- Closed
- Status
- February 15, 2023
- Close date
- 1
- Expected awards
The verdict
Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models is a closed discretionary listing from Food and Drug Administration that offered $50,000 -- $500,000 across 1 expected award. Future funding cycles may be published under the same CFDA number.
- $50K-$500K
- award range
- Closed
- application status
- 1
- expected award
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models - is cataloged under number RFA-FD-23-016 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 -- $500,000. The agency has projected $500,000 in total estimated funding for this announcement. It expects to issue 1 award. If the agency funds the expected 1 award from the $500,000 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 February 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 -- $500,000
Close Date
February 15, 2023
Posted
December 1, 2022
Est. Total Funding
$500,000
Expected Awards
1
Instrument
Cooperative Agreement
Description
The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK) model, validated for its intended purpose, to detect formulation differences between the reference standard product and a prospective generic drug product. The workflow will explore considerations and reasonable assumptions related to performing a virtual bioequivalence assessment using mechanistic modeling and simulation tools of increased complexity, such as PBPK models.
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
Frequently Asked Questions
What is this grant opportunity?
Is this opportunity still open?
How much funding is available?
How do I apply?
More from Food and Drug Administration
Pathways for Regulatory Innovation and Strategic Modernization (PRISM)
Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens
Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed
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
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |