# Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional

Source: https://welltoldgrants.com/grants/rfa-fd-21-015-computational-fluid-dynamics-cfd-models-to-aid-the/  
Official notice: https://www.grants.gov/search-results-detail/330747

> Food and Drug Administration offered grants of up to $400,000 (at least $200,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 2 awards. Applications closed on March 15, 2021.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-21-015 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 15, 2021 |
| Award ceiling | $400,000 |
| Award floor | $200,000 |
| Expected awards | 2 |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- 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
- Others (see text field entitled "Additional Information on Eligibility" for clarification)

Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits 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 Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Foreign Institutions Non-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.

## What the grant funds

Current U.S. Food and Drug Administration product-specific guidances for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically recommend using a weight-of-evidence approach for demonstrating bioequivalence (BE) that includes in vitro studies, an in vivo pharmacokinetics study, and either an in vivo pharmacodynamics or comparative clinical endpoint BE study. To produce a generic MDI or DPI that can meet acceptance criteria from all 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 funding opportunity 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 and to develop an in vitro-in vivo correlation (IVIVC) between model predictions and at least one relevant in vitro metric. Generic drug developers may then use this IVIVC to interpret in vitro results in a manner that may increase confidence in their products prior to in vivo testing

## Questions people ask

### Is RFA-FD-21-015 still open?

No. It closed on March 15, 2021. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional?

Closed March 15, 2021. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $400,000 each.

### 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.