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

The summary for the In Vivo Regional Deposition Measurements for Supporting Model Validation (U01) Clinical Trial Required grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.

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

Federal Grant Title:	In Vivo Regional Deposition Measurements for Supporting Model Validation (U01) Clinical Trial Required
Federal Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Consumer Protection Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-23-014
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	April 3rd, 2023
Original Application Deadline:	April 3rd, 2023
Posted Date:	December 12th, 2022
Creation Date:	December 12th, 2022
Archive Date:	May 3rd, 2023
Total Program Funding:	$2,000,000
Maximum Federal Grant Award:	$1,000,000
Minimum Federal Grant Award:	$250,000
Expected Number of Awards:	2
Cost Sharing or Matching:	No
Last Updated:	January 5th, 2023

Applicants Eligible for this Grant: 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.)
Additional Information on Eligibility: 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)
Link to Full Grant Announcement: FULL ANNOUNCEMENT
Grant Announcement Contact: Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected]
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