Grants / Department of Health and Human Services / Food and Drug Administration

RFA-FD-21-015: Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional

Closed Closed March 15, 2021 Opportunity RFA-FD-21-015 ☆ Save

This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2021.

• Award ceiling$400,000
• Award floor$200,000
• Expected awards2
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

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.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $400,000 per award.
• Most of the program's money (35% over five years) went to nonprofits.
• No cost sharing or match is required.

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

Category: Agriculture, Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development.

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.