Grants / Department of Health and Human Services / Food and Drug Administration

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

Closed Closed March 31, 2022 Opportunity RFA-FD-22-016 ☆ Save

This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2022.

• Award ceiling$600,000
• Award floor$50,000
• Total funding$600,000
• Expected awards1
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity was open to the applicants described in the notice.

• 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.

Is this a realistic fit?

• Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $600,000 per award.
• Most of the program's money (35% over five years) went to nonprofits.
• No cost sharing or match is required.

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.

Category: Consumer Protection, Health, Science and Technology and other Research and Development.

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.