This Government Contract opportunity from Department Of Health And Human Services was posted on July 24, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Design History File (DHF) and Manufacturing Specifications Development
Contract Overview
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AI Contract Overview
The contract requires the development and delivery of a complete Design History File and final manufacturing specifications under the oversight of the CDC Office of Acquisition Services, with performance based in Atlanta, Georgia, 30329. The work is scoped to support the scale-up of a product or process, necessitating thorough documentation aligned with regulatory and quality standards to ensure traceability, consistency, and compliance throughout manufacturing transitions. The deliverables must reflect full adherence to CDC requirements and be submitted for review and approval prior to advancing production. This is a subcontract opportunity posted on July 24, 2026, with proposals due by July 29, 2026, and classified under NAICS code 541715 for research and development in the physical, engineering, and life sciences. The contracting entity operates under the U.S. Department of Health and Human Services, indicating that the project is tied to public health initiatives requiring rigorous documentation and oversight. While no set-aside designation is specified, the urgency of the deadline and the technical nature of the deliverables suggest the need for a qualified subcontractor with demonstrated experience in regulated manufacturing environments and design control systems.
General Info
Agency
NAICS
Place of Performance
Atlanta, GA, 30329, USASet-Aside
Documents
This scope was carved out of 75D30126Q79099.
The full solicitation package (4 documents), including the RFP, is on the prime solicitation, not on this scope.
Procurement of lateral flow (LFA) strips for the rapid HIV nucleic acid diagnostic test
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Timeline
Submission Closed
Organization & Contact Information
Full Description
More opportunities from Department Of Health And Human Services → CDC Office Of Acquisition Services
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