# In Vivo Regional Deposition Measurements for Supporting Model Validation (U01) Clinical Trial Required

Source: https://welltoldgrants.com/grants/rfa-fd-23-014-in-vivo-regional-deposition-measurements-for-supporting/  
Official notice: https://www.grants.gov/search-results-detail/344260

> Food and Drug Administration offered grants of up to $1.0 million (at least $250,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 2 awards worth $2.0 million in total. Applications closed on April 3, 2023.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-23-014 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | April 3, 2023 |
| Award ceiling | $1.0 million |
| Award floor | $250,000 |
| Expected awards | 2 |
| Total funding | $2.0 million |
| 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 OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits 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 OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)

## What the grant funds

Locally-acting orally inhaled drug products (OIDPs) treat various pulmonary diseases by targeting relevant lung tissue via aerosolized medicine. Regional deposition models are useful for understanding the in vivo performance of OIDPs but require comparator data to support their use for product development purposes. In vivo imaging studies of regional deposition, using techniques such as gamma scintigraphy or single photon emission computed tomography (SPECT) /computed tomography (CT) can provide comparator data for regional deposition models, but the data collected may not be ideally suited to comparison with model predictions. For example, gamma scintigraphy studies produce two-dimensional region specific data while model predictions produce three-dimensional lung generation-level information. The purpose of this funding opportunity announcement is to support the conduct of an in vivo imaging study that uses gamma scintigraphy or SPECT/CT techniques to measure regional lung deposition in human subjects following administration of at least one OIDP with data analysis procedures that are optimized to facilitate a direct comparison with model predictions of branch-level deposition, thereby supporting model validation.

## Questions people ask

### Is RFA-FD-23-014 still open?

No. It closed on April 3, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for In Vivo Regional Deposition Measurements for Supporting Model Validation (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 In Vivo Regional Deposition Measurements for Supporting Model Validation (U01) Clinical Trial Required?

Closed April 3, 2023. 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. About $2.0 million in total across about 2 awards.

### 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.