# Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products

Source: https://welltoldgrants.com/grants/rfa-fd-22-018-investigating-the-in-vivo-behavior-and-in-vitro/  
Official notice: https://www.grants.gov/search-results-detail/336280

> Food and Drug Administration offered grants of up to $1.0 million (at least $50,000) to the applicants described in the notice. It expected to make one award worth $1.0 million in total. Applications closed on March 31, 2022.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-22-018 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 31, 2022 |
| Award ceiling | $1.0 million |
| Award floor | $50,000 |
| Expected awards | 1 |
| Total funding | $1.0 million |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- Others (see text field entitled "Additional Information on Eligibility" for clarification)

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.

## What the grant funds

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.

## Questions people ask

### Is RFA-FD-22-018 still open?

No. It closed on March 31, 2022. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products?

Food and Drug Administration accepted applications from the applicants described in the notice. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products?

Closed March 31, 2022. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $1.0 million each. About $1.0 million in total for one award.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.