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

The summary for the Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (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.

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

Federal Grant Title:	Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required
Federal Agency Name:	Food and Drug Administration (HHS-FDA)
Grant Categories:	Consumer Protection Food and Nutrition Science and Technology
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-21-020
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Information not provided
Current Application Deadline:	April 26th, 2021
Original Application Deadline:	April 26th, 2021
Posted Date:	February 22nd, 2021
Creation Date:	February 22nd, 2021
Archive Date:	May 26th, 2021
Total Program Funding:
Maximum Federal Grant Award:	$1,000,000
Minimum Federal Grant Award:	$500,000
Expected Number of Awards:	1
Cost Sharing or Matching:	No
Last Updated:	February 22nd, 2021

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 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)
Link to Full Grant Announcement: RFA-FD-21-020 - FULL ANNOUNCEMENT
Grant Announcement Contact: Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected]
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