Closed · RFA-FD-22-018 · CFDA 93.103 · Discretionary
Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $50K-$1M
- Award range
- Closed
- Status
- March 31, 2022
- Close date
- 1
- Expected awards
The verdict
Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products is a closed discretionary listing from Food and Drug Administration that offered $50,000 -- $1,000,000 across 1 expected award. Future funding cycles may be published under the same CFDA number.
- $50K-$1M
- award range
- Closed
- application status
- 1
- expected award
- 93.103
- CFDA program
Opportunity snapshot. This Grants.gov announcement - Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products - is cataloged under number RFA-FD-22-018 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 -- $1,000,000. The agency has projected $1.0 million in total estimated funding for this announcement. It expects to issue 1 award. If the agency funds the expected 1 award from the $1.0 million estimated pool, the average award works out to roughly $1.0 million. 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 -- $1,000,000
Close Date
March 31, 2022
Posted
January 12, 2022
Est. Total Funding
$1,000,000
Expected Awards
1
Instrument
Cooperative Agreement
Description
Gastro-retentive dosage forms are designed to have a prolonged residence time in the upper gastrointestinal tract to enhance bioavailability. However there has been no direct evidence of gastric retention in vivo. This project aims to gather direct evidence about the gastric retention of oral drug products which are claimed to be formulated as gastro-retentive dosage forms. This information may be helpful in supporting generic drug development and regulatory decision making. This opportunity solicits research proposals to use imaging technologies to monitor the gastric retention behavior of a reference product and its corresponding generic product, following oral administration. Various in vitro test methodologies should be explored to develop optimal method(s) that can be used by prospective generic applicants to support a demonstration of bioequivalence to the reference product, potentially for additional strengths of these generic products.
Eligibility
Grants.gov lists this opportunity under eligibility category code 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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| Sources | the SAM.gov Assistance Listings and Grants.gov |