Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) (U43/U44 - Clinical Trail Not Allowed)

This FOA provides support using the SBIR cooperative agreement mechanisms for the development, regulatory qualification and commercialization of alternative approaches methods (NAMs) that specifically utilizes the neuromuscular junction Tissue Chips (TC) platforms that will replace the LD50 assay (mouse

lethality bioassay (MLB) as a potency assay for botulinum toxin.

The NIH NCATS and FDA are partners in this FOA and will collaborate and coordinate efforts with award recipients.

The goal of this collaboration is to establish the Botulinum Toxin Potency Assay using Tissue Chips (BoT PATCh) as a Drug Development Tool (DDT).

A main objective for this funding opportunity would be to position BoT PATCh as an alternative test method that can be utilized as a stand-alone replacement for MLB.

As a cooperative agreement, small business concerns (SBCs) will be expected to work with NIH and FDA staff to develop and implement the final validation plan for the proposed alternative test method.
Related Programs

Extramural Research Programs in the Neurosciences and Neurological Disorders

Department of Health and Human Services

Agency: Department of Health and Human Services

Office: National Institutes of Health

Estimated Funding: $3,500,000

Who's Eligible

Obtain Full Opportunity Text:

Additional Information of Eligibility:
Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U. S. Organizations are not eligible to apply.

Foreign components- are not allowed.

Full Opportunity Web Address:


Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

Agency Email:

Date Posted:

Application Due Date:

Archive Date:

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