ForecastedResearch announcementOpportunity FOR-FD-24-001

Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed

Food and Drug Administration · Department of Health and Human Services

At a glance

Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed is a forecasted federal grant opportunity from the Food and Drug Administration (Department of Health and Human Services). The agency has forecast this opportunity but has not yet set an application deadline. Total estimated funding is $600K across about 1 awards. Applicant types listed as eligible include state governments, county governments, city or township governments, special district governments, independent school districts and 9 more. Cost sharing is not required. It is funded under Assistance Listing 93.103 (Food and Drug Administration Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted: Nov 20, 2023
Est. close date: Not listed
Award floor: Not specified
Award ceiling: Not specified
Est. total funding: $600,000
Implied average award: $600,000 calculated
Expected awards: 1
Cost sharing: Not required
Funding instrument: Grant, Cooperative Agreement
Opportunity category: Discretionary
Fiscal year: FY2024

Typical awards for this program (SAM.gov listing for ALN 93.103, not this notice): Varies by grant mechanism and program specific requirements.

Implied average = estimated total funding ÷ expected number of awards, calculated by GrantsJunction. Actual awards vary.

Who can apply

State governments
County governments
City or township governments
Special district governments
Independent school districts
Public colleges & universities
Federally recognized tribal governments
Public & Indian housing authorities
Native American tribal organizations
501(c)(3) nonprofits
Nonprofits without 501(c)(3) status
Private colleges & universities
For-profit organizations (not small businesses)
Small businesses

Can your organization apply?

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs.

How to apply

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Read the full announcement (NOFO)Eligibility, evaluation criteria, page limits and required attachments are in the full notice on Grants.gov. Open ↗
Confirm eligibility and fitCheck your organization type above; no cost sharing is required.
Register (or renew) in SAM.gov and get a UEIFree. New registrations can take several weeks; registrations must be renewed every year. Open ↗
Set up Grants.gov accessCreate a Grants.gov account and make sure someone has the Authorized Organization Representative (AOR) role. Open ↗
Watch for the full noticeSave this grant to track when it opens.
Prepare narrative, budget and attachmentsFollow the notice's format exactly — page limits and required forms are common reasons applications are rejected.
Ask the agency contact any questions earlyTerrin Brown Grants Management Specialist · terrin.brown@fda.hhs.gov Open ↗
Submit before the deadlineSubmit a few days early and keep your Grants.gov confirmation and validation emails.

Assistance Listing

What is an ALN?

93.103Food and Drug Administration ResearchProgram →

Reported obligations under ALN 93.103

Historical data · not a prediction

FY18

$173M

FY19

$199M

FY20

$212M

FY21

$219M

FY22

$256M est.

FY23

$247M est.

Source: SAM.gov Assistance Listing 93.103. Program-wide totals, not awards from this specific opportunity.

Who was funded under ALN 93.103

Historical data · not a prediction

Since October 1, 2023, 991 grant awards had funding actions under Food and Drug Administration Research, with 430 sub-awards passed on to other organizations. These are program-wide awards, not awards from this specific notice.

THE CRITICAL PATH INSTITUTE$56.2M
NATIONAL ENVIRONMENTAL HEALTH ASSOCIATION$39.7M
ASSOCIATION OF FOOD & DRUG OFFICIALS$29.5M
DUKE UNIVERSITY$19.1M
THE MEDICAL DEVICE INNOVATION CONSORTIUM$15.6M

Recipients, states, recent awards and sub-awards →Source: USAspending.gov.

Agency contact (as published)

Terrin Brown Grants Management Specialist
terrin.brown@fda.hhs.gov
240-402-7610

Quick answers

Is this opportunity open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. Forecast details and dates can change.

Who is eligible to apply for this opportunity?

The official notice names these applicant types as eligible: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public colleges & universities, Federally recognized tribal governments, Public & Indian housing authorities, Native American tribal organizations, 501(c)(3) nonprofits, Nonprofits without 501(c)(3) status, Private colleges & universities and 2 more. Additional restrictions may apply; review the full notice.

How much funding is available through this opportunity?

Per the notice, total estimated program funding is $600,000 and the agency expects to make about 1 awards.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity FOR-FD-24-001), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

ForecastedResearchALN 93.103