This grant from the National Institutes of Health aims to fund the development of advanced Physiologically Based Pharmacokinetic (PBPK) models for nasal drug delivery. While current nasal PBPK models primarily target local or systemic effects, an emerging focus is direct nose-to-brain drug delivery. Existing models lack pathways for this crucial route. This funding opportunity seeks proposals to create a comprehensive nasal PBPK model that incorporates at least one nose-to-brain pathway, effectively linking with a full-body PBPK model including a brain compartment. Developed models must extensively rely on experimental data, and proposals may include studies to generate necessary supporting data. Ultimately, the developed model is expected to produce accurate pharmacokinetic predictions for a specified target compound, addressing a significant gap in drug delivery research.
Opportunity ID: 336327
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-22-016 |
| Funding Opportunity Title: | Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 12, 2022 |
| Last Updated Date: | Jan 12, 2022 |
| Original Closing Date for Applications: | Mar 31, 2022 |
| Current Closing Date for Applications: | Mar 31, 2022 |
| Archive Date: | Apr 30, 2022 |
| Estimated Total Program Funding: | $600,000 |
| Award Ceiling: | $600,000 |
| Award Floor: | $50,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-22-016 | FORMS G | PKG00271304 | Jan 14, 2022 | Mar 31, 2022 | View |
Package 1
Mandatory forms
336327 RR_SF424_5_0-5.0.pdf
336327 PHS398_CoverPageSupplement_5_0-5.0.pdf
336327 RR_OtherProjectInfo_1_4-1.4.pdf
336327 PerformanceSite_4_0-4.0.pdf
336327 RR_KeyPersonExpanded_4_0-4.0.pdf
336327 RR_Budget_3_0-3.0.pdf
336327 PHS398_ResearchPlan_4_0-4.0.pdf
336327 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336327 RR_SubawardBudget30_3_0-3.0.pdf
336327 PHS_AssignmentRequestForm_3_0-3.0.pdf
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