National Mammograph Quality Surveillance Act (MQSA) Non-Federal Inspection State Contracts Program
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The Food and Drug Administration is seeking to award sole source contracts for the inspection of certified non-federal mammography facilities to ensure compliance with quality standards under 21 CFR Part 900. This program is restricted to state or local governmental organizations that possess the legal authority to conduct regulatory inspections and investigations within their respective states. Eligible contractors must have trained personnel experienced in evidence development and state regulatory procedures for correcting violative practices. The current contract, held by the Pennsylvania Department of Environmental Protection, is valued at 2,643,485.30 dollars and is expected to end on September 19, 2026. Due to the unique legal requirements and the nature of state-designated authority, this opportunity is not available for open competition. There is a medium confidence level that this will be a recompete opportunity, utilizing a firm fixed price pricing structure.
General Info
Place of Performance
MD, 171012301, USASet-Aside
Documents
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Timeline
Organization & Contact Information
Full Description
Current Contract: 75F40122C00127 Incumbent: PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION Contract Value: $2,643,485.3 Potential End Date: 2026-09-19T00:00:00.000Z Competition: NOT AVAILABLE FOR COMPETITION Pricing: FIRM FIXED PRICE Classification: recompete-likely (Confidence: medium - 50/100)
The Food and Drug Administration intends to award sole source contracts to State and/or local assistance in the inspection of certified non-Federal mammography facilities in order to document and report compliance with mammography quality standards issued under 21 CFR Part 900. The program meets the criteria set forth in 41 U.S.C. 253(c) (5). In accordance with the Mammography Quality Standards Act, the inspection services are restricted to state organizations possessing the authority necessary to conduct regulatory MQSA inspections. Contractors must meet the following special requirements: (1) possess legal authority under state law necessary to gain access to any regulated private commercial establishment for the unique purpose of conducting regulatory inspections and investigations to determine compliance with the Mammography Quality Standards Act at any geographical location within the state; (2) have trained personnel experienced with the inspectional procedures and evidence development techniques necessary to assess the conformance of an establishment with the federal law or comparable state requirements; (3) demonstrate experience with state regulatory procedures for correcting violative practices. Only governmental organizations have the unique qualification to perform this kind of activity. Competition within states does not exist for this program. Within any state, its legislature designates the governmental organizations which have the authority and resources to accomplish a program. The prospective contractors for this solicitation are those designated state organizations. This notice is issued for informational purposes and not a request for competitive proposals.
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