FOR-FD-20-023: CFD Models to aid the development of generic inhalation products
Closed
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 2021.
Food and Drug Administration offered grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 2 awards. It is no longer open on Grants.gov.
From the official notice on Grants.gov, last changed May 25, 2021. Checked November 7, 2026.
- Expected awards2
- Award amountsNot given on Grants.gov
- Cost sharingNot required
- Funding typeGrant
Key dates
| Posted | May 25, 2021 |
|---|---|
| Archived by Grants.gov | May 26, 2021 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 14 applicant types the notice lists
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
Is this a realistic fit?
- Most of the program's money (35% over five years) went to nonprofits.
- No cost sharing or match is required.
What the grant funds
Current US Food and Drug Administration product specific guidance (PSG) bioequivalence (BE) recommendations for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically use a weight-of-evidence approach that includes in vitro studies, an in vivo pharmacokinetics (PK) study, and either an in vivo pharmacodynamics (PD) or comparative clinical endpoint (CCEP) study. To produce a generic MDI or DPI that is capable of passing all of these recommended studies, it would be useful to have an enhanced understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue. Computational fluid dynamics (CFD) is a technique capable of predicting these relationships between in vitro study metrics and regional lung deposition. The purpose of this grant announcement is to use CFD to produce verified and validated predictions of regional lung deposition for at least one currently marketed MDI or DPI in human upper and lower airways. Once predictions are appropriately verified and validated using either in vitro or in vivo data, a parameter sensitivity analysis will be conducted to assess the biopredictive capabilities of relevant in vitro studies. For DPIs, discrete element modeling (DEM) may be considered as a means for predicting the effects of agglomeration and deagglomeration of carrier-active pharmaceutical ingredient combination particles on regional deposition and the relationships of those phenomena with APSD. For MDIs, it is preferred that formulations considered include at least three components.
Who has won Food and Drug Administration Research grants before
From fiscal 2021 to 2025, Food and Drug Administration Research (93.103) awarded $1.2 billion across 940 grant awards, an average of $1.3 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Critical Path Institute | Arizona | 13 | $94.0 million |
| National Environmental Health Association | Colorado | 9 | $55.4 million |
| Association of Food & Drug Officials | Pennsylvania | 14 | $50.3 million |
| The Medical Device Innovation Consortium | Virginia | 1 | $48.6 million |
| Duke University | North Carolina | 11 | $35.6 million |
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.
Questions people ask
Is FOR-FD-20-023 still open?
No. It is no longer open on Grants.gov. A newer notice is open: PAR-27-017, rolling or no fixed deadline.
Who can apply for CFD Models to aid the development of generic inhalation products?
Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
What is the deadline for CFD Models to aid the development of generic inhalation products?
Closed. Applications are no longer accepted; the program's newer notices are on this page when there are any.
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.
Similar open grants
- Data Coordinating Center for the Aging and Alzheimer’s Disease Mouse Brain Atlas (AD-MBA) (U24 Clinical Trial Not Allowed)
- Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
- Advanced Development and Validation of Emerging Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)
- Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)
- Infectious Diseases Clinical Trials Network (IDCTN) (UM1 Clinical Trial Required)
- Clinical Research Network on Antimicrobial Resistance (UM1 Clinical Trial Required)