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

Posted Dec 1 Closes Feb 28

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.

View on Grants.gov

Agency Contact

Shashi Malhotra Grants Management Specialist Phone 2404027592

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.

Data sourced from the SAM.gov Assistance Listings and Grants.gov. See our methodology for details. Retrieved and formatted by PlainGrants