This grant, offered by the Regulatory Science Department, aims to gather direct in vivo evidence of gastric retention for extended-release oral drug products. Gastro-retentive dosage forms are designed to prolong residence in the upper gastrointestinal tract to enhance drug bioavailability, but direct in vivo confirmation is lacking. The project will utilize imaging technologies to monitor gastric retention of both reference and corresponding generic products after oral administration. Furthermore, this grant is for developing optimal in vitro test methodologies that generic applicants can use to demonstrate bioequivalence to reference products. This research is crucial for supporting generic drug development and improving regulatory decision-making, ultimately enhancing the regulatory standard of such products.
Opportunity ID: 336280
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-018 |
| Funding Opportunity Title: | Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 12, 2022 |
| Last Updated Date: | Jan 12, 2022 |
| Original Closing Date for Applications: | Mar 31, 2022 |
| Current Closing Date for Applications: | Mar 31, 2022 |
| Archive Date: | Apr 30, 2022 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs)o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | FULL ANNOUNCEMENT |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-22-018 | FORM G | PKG00271322 | Jan 14, 2022 | Mar 31, 2022 | View |
Package 1
Mandatory forms
336280 RR_SF424_5_0-5.0.pdf
336280 PHS398_CoverPageSupplement_5_0-5.0.pdf
336280 RR_OtherProjectInfo_1_4-1.4.pdf
336280 PerformanceSite_4_0-4.0.pdf
336280 RR_KeyPersonExpanded_4_0-4.0.pdf
336280 RR_Budget_3_0-3.0.pdf
336280 PHS398_ResearchPlan_4_0-4.0.pdf
336280 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336280 RR_SubawardBudget30_3_0-3.0.pdf
336280 PHS_AssignmentRequestForm_3_0-3.0.pdf
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