# Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional

Source: https://welltoldgrants.com/grants/rfa-fd-23-015-development-and-validation-of-a-multi-functional-multi/  
Official notice: https://www.grants.gov/search-results-detail/344259

> Food and Drug Administration offered grants of up to $750,000 (at least $50,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 2 awards worth $1.0 million in total. Applications closed on March 21, 2023.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-23-015 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 21, 2023 |
| Award ceiling | $750,000 |
| Award floor | $50,000 |
| Expected awards | 2 |
| 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
- Others (see text field entitled "Additional Information on Eligibility" for clarification)

ligible 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:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian 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)Local 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)

## What the grant funds

The purpose of this funding opportunity is to develop and validate an enhanced mechanistic PBPK model to reliably describe the skin permeation of active pharmaceutical ingredients in topical drug products applied on the skin surface of virtual subjects by accounting for the drug product quality attributes and the metamorphosis these products undergo post application. The goal is to develop an in silico tool and to assess its capability to predict skin absorption for reference listed drug and test drug products considering their potentially different formulation compositions and quality attributes and the dynamic changes they undergo post application. This in silico tool (validated using appropriate datasets) is intended to identify parameters that may impact therapeutic equivalence between a reference listed drug and a test drug product applied on the skin and to inform decisions on generic drug development for these products.

## Questions people ask

### Is RFA-FD-23-015 still open?

No. It closed on March 21, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional?

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 Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional?

Closed March 21, 2023. 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 $750,000 each. About $1.0 million in total across about 2 awards.

### 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.