# Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required

Source: https://welltoldgrants.com/grants/rfa-fd-21-020-impulse-oscillometry-endpoint-sensitivity-to-regional-lung/  
Official notice: https://www.grants.gov/search-results-detail/331662

> Food and Drug Administration offered grants of up to $1.0 million (at least $500,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make one award. Applications closed on April 26, 2021.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-21-020 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | April 26, 2021 |
| Award ceiling | $1.0 million |
| Award floor | $500,000 |
| Expected awards | 1 |
| 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: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o 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)

## What the grant funds

Impulse oscillometry (IOS) is a technique used to assess lung function that does not require patient coordination, that uses sound waves that are introduced to the subject's lung airways. Research has suggested that in some cases, one or more IOS clinical endpoints may be more sensitive to differences in lung function than the spirometric measurement forced expiratory volume after 1 second (FEV1). With respect to generic orally inhaled drug products (OIDPs), a more sensitive clinical endpoint than FEV1 may be useful for the purposes of product comparison. The objective of this study is to conduct a small in vivo study using IOS and spirometry endpoints to assess the treatment effect of an OIDP, and to concurrently develop a computational fluid dynamics (CFD) model that may be used to better understand the applicability of IOS endpoints for generic product comparison with the reference product.

## Questions people ask

### Is RFA-FD-21-020 still open?

No. It closed on April 26, 2021. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required?

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 Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required?

Closed April 26, 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 $1.0 million 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.