# Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional

Source: https://welltoldgrants.com/grants/rfa-fd-22-016-physiologically-based-pharmacokinetic-model-for-nose-to/  
Official notice: https://www.grants.gov/search-results-detail/336327

> Food and Drug Administration offered grants of up to $600,000 (at least $50,000) to the applicants described in the notice. It expected to make one award worth $600,000 in total. Applications closed on March 31, 2022.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-22-016 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 31, 2022 |
| Award ceiling | $600,000 |
| Award floor | $50,000 |
| Expected awards | 1 |
| Total funding | $600,000 |
| 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

Nasal drug products are typically designed to target either local or systemic pharmacokinetics (PK) following deposition of the inhaled aerosol. However, an emerging target for nasal drug product development is nose-to-brain delivery via a variety of pathways in the nasal cavity. Physiologically based pharmacokinetic (PBPK) models have previously been developed by several groups for a variety of reasons related to toxicology and drug delivery. However, currently available nasal PBPK models do not include pathways for nose-to-brain drug delivery. The purpose of this funding opportunity is to fund the development of a nasal PBPK model that includes at least one pathway for nose-to-brain drug delivery and links with a full body PBPK model that includes, at least, a brain compartment. It is expected that the model will rely on experimental data as much as possible, where experimental studies may need to be included in the proposal to support model development. Once the model has been developed, it is expected that PK predictions will be produced for a preselected target compound.

## Questions people ask

### Is RFA-FD-22-016 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 Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional?

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 Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional?

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 $600,000 each. About $600,000 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.