National Mammograph Quality Surveillance Act (MQSA) Non-Federal Inspection State Contracts Program
Closed Pre-Solicitation Posted
- Solicitation number
- 75F40122R00022
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 923120 Administration of Public Health Programs
- PSC
- H199 Quality Control- Miscellaneous
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration intends to award sole source contracts to state and local governments to conduct inspections of certified non-federal mammography facilities and ensure compliance with quality standards under the Mammography Quality Standards Act. Contractors must have legal authority under state law to access commercial establishments for regulatory inspections, employ trained personnel experienced in MQSA procedures and evidence collection, and demonstrate experience addressing regulatory noncompliance. The closing date for questions and proposals is May 13, 2022.
There is no set-aside designated for this requirement. Current MQSA inspection contracts valued at millions of dollars annually are held by state health departments and radiological boards. Inspections will be restricted to state organizations with the unique qualifications of possessing authority under state law to perform the regulatory activities required and experience with corrective actions.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| Standard Form 33 section A.pdf | ||
| Sol_Doc.pdf |
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