ForecastedResearch announcementOpportunity FOR-FD-24-004

Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)

Food and Drug Administration · Department of Health and Human Services

At a glance

Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) is a forecasted federal cooperative agreement 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. Individual awards are listed as $250K, with about 1 award expected. The notice is unrestricted by applicant type, subject to any clarifications in the notice. 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 24, 2023
Est. close date: Not listed
Award floor: $250,000
Award ceiling: $250,000
Est. total funding: Not specified
Expected awards: 1
Cost sharing: Not required
Funding instrument: Cooperative Agreement
Opportunity category: Discretionary
Fiscal year: FY2024

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
Others (see notice)
Unrestricted (any entity type)

Additional information on eligibility (from the notice)

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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.

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.

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 Grantor · 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.

Agency contact (as published)

Terrin Brown Grantor
terrin.brown@fda.hhs.gov
2403387494

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 notice lists eligibility as unrestricted — open to any type of entity — subject to clarifications in the notice's additional eligibility information.

How much funding is available through this opportunity?

Per the notice, individual awards are listed as $250k 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-24-004), 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.

OpenResearchALN 93.103