Closed · RFA-FD-23-017 · CFDA 93.103 · Discretionary
Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed
Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.
- $50K-$500K
- Award range
- Closed
- Status
- February 28, 2023
- Close date
- -
- Expected awards
The verdict
Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed is a closed discretionary listing from Food and Drug Administration that offered $50,000 -- $500,000. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 481 other opportunities from Food and Drug Administration.
- $50K-$500K
- award range
- Closed
- application status
- 93.103
- CFDA program
- 481
- other opportunities from Food and Drug Administration
Archived opportunity record
Population Pharmacokinetic Modeling of System… is closed (last close February 28, 2023). The parent program page for CFDA 93.103 is the reliable place to catch re-announcements. Food and Drug Administration still indexes 481 other opportunities here.
According to Grants.gov (extract vintage 2026-08-10), this record reflects the officially published listing. See methodology.
Deadline tracker
Application window closed
Closed February 28, 2023
Est. Total Funding
$1,000,000
Instrument
Cooperative Agreement
Description
Orally Inhaled Drug Products (OIDPs) are complex drug-device combination products. To establish bioequivalence for locally acting OIDPs, FDA is currently using a weight-of-evidence approach which generally includes a combination of in vitro BE studies; in vivo pharmacokinetic (PK) studies and comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies; along with formulation sameness and device similarity. For some OIDPs, both CCEP and PD studies can pose a challenge due to a lack of sensitivity to detect formulation differences. The purpose of this funding opportunity is to support research that will use modeling and simulation to investigate the feasibility of assessing formulation differences in regional lung exposure based on systemic PK concentration data to establish BE for OIDPs with different drug and product properties.
Wide-open applicant board · 15 Grants.gov doors
Population Pharmacokinetic Modeling of System… prints 15 distinct Grants.gov eligibility doors (State governments; County governments; City or township governments; Special district governments; +11 more). Filter fit before reading award size as demand — most applicant classes appear on the row. The extract does not mark applicant cost-sharing as required. Instrument: Cooperative Agreement. Funding-activity codes span Consumer Protection · Science and Technology / R&D (CP;ST). 120 other Food and Drug Administration listings share this eligibility-code string (25% of 482).
- Code 00
- State governments
- Code 01
- County governments
- Code 02
- City or township governments
- Code 04
- Special district governments
- Code 05
- Independent school districts
- Code 06
- Public / state-controlled institutions of higher education
- Code 07
- Federally recognized tribal governments
- Code 08
- Public / Indian housing authorities
- Code 11
- Native American tribal organizations (other than Federally recognized tribal governments)
- Code 12
- Nonprofits with 501(c)(3) status (other than IHEs)
- Code 13
- Nonprofits without 501(c)(3) status (other than IHEs)
- Code 20
- Private institutions of higher education
- Code 22
- For-profit organizations other than small businesses
- Code 23
- Small businesses
- Code 25
- Others (see official listing text)
Codes are Grants.gov eligibility category values from the extract vintage 2026-08-10. Confirm the full eligibility statement on the official listing or the Grants.gov eligibility reference.
Official Listing on Grants.gov
View full details, application forms, and submission instructions.
Parent Grant Program
Food and Drug Administration Research
U.S. Department of Health and Human Services
Agency Contact
Shashi Malhotra Grants Management Specialist Phone 2404027592
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What to do next
Population Pharmacokinetic Modeling of System… is closed; use the parent program and agency catalog for the next funding cycle.
- Parent CFDA 93.103 may publish future NOFOs under the same assistance listing. Open program
- Food and Drug Administration Research indexes 42 Grants.gov listings in this extract. Program profile
- Food and Drug Administration lists 481 other indexed opportunities on PlainGrants. Agency catalog
Opportunity deadlines and eligibility change on Grants.gov; PlainGrants mirrors the extract and is not the submission system.
Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.
Read our methodology - how this data is sourced, computed, and verified.
| Publisher | PlainGrants |
| Sources | the SAM.gov Assistance Listings and Grants.gov |