# In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required

Source: https://welltoldgrants.com/grants/rfa-fd-22-015-in-vitro-approaches-to-evaluate-and-compare-the/  
Official notice: https://www.grants.gov/search-results-detail/336296

> Food and Drug Administration offered grants of up to $1.3 million (at least $50,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make one award worth $1.0 million in total. Applications closed on March 31, 2022.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-22-015 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 31, 2022 |
| Award ceiling | $1.3 million |
| Award floor | $50,000 |
| Expected awards | 1 |
| Total funding | $1.0 million |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses

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

The purpose of this funding opportunity is to support the research to develop in vitro test methods for Transdermal and Topical delivery systems (collectively, TDS) that can correlate with and be predictive of TDS adhesion performance in vivo. Differences in product design, formulation, or quality attributes between a prospective generic TDS and it reference TDS may have the potential to alter the adhesion quality or performance of the test TDS, compared to the reference TDS. The in vitro test methods to be developed are expected to be useful for the industry to evaluate potential failure modes related to TDS adhesion during the development of prospective generic TDS, and useful in FDA's assessment of potential differences in the adhesion quality and performance of prospective generic TDS relative to their reference TDS.

## Questions people ask

### Is RFA-FD-22-015 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 In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required?

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 $1.3 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.