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This Government Contract opportunity from Department Of Health And Human Services was posted on April 20, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Botulinum Neurotoxin (BoNT) Assay Validation and Regulatory Strategy

Closed
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

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This contract involves the development of regulatory strategies and support for the validation of botulinum neurotoxin (BoNT) potency assays based on neuromuscular junction (NMJ) models. The work includes engaging with regulatory pathways established by the FDA, specifically utilizing the iSTAND program to pursue assay qualification. The objective is to ensure these potency assays meet regulatory standards for their intended use, supporting the advancement of BoNT products. Issued by the Department of Health and Human Services under the BARDA office, this subcontract with NAICS code 541611 focuses on research and development services. The contract was posted on April 20, 2026, with a proposal deadline of May 11, 2026. Performance is expected to take place in Washington, and the scope emphasizes integration with FDA processes to facilitate regulatory acceptance and validation of the innovative BoNT assays.

General Info

Develop regulatory strategies and validate botulinum neurotoxin potency assays with FDA iSTAND program.

Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda DcmaView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Washington, DC, USA

Set-Aside

NONE

Documents

This scope was carved out of SSN-BARDA-04202026.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

RRPV BoNT-NMJ

AI Contract Breakdown

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No contract breakdown available.

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Develop regulatory strategies and support validation of NMJ-based BoNT potency assays, including engagement with FDA pathways such as iSTAND for qualification.

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