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Proficiency Testing Contract

Active
75F40126Q00312Federal

Contract Overview

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

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The U.S. Food and Drug Administration intends to award a sole-source, firm-fixed-price order to QuoData GmbH of Dresden, Germany, for the continued support and specialized enhancements of the ProLab Plus software platform, which is exclusively used to analyze proficiency testing and inter-laboratory study data. The contract, issued under FAR 6.103-1, justifies noncompetitive procurement because QuoData is the sole provider of this proprietary software, which is essential to the FDA’s Human Foods Program for evaluating laboratory performance and supporting accreditation. Market research confirms no alternative solutions exist that can meet the technical requirements, particularly the need for advanced statistical methodologies aligned with ISO standards, which require direct expertise from the original developer beyond standard technical support. The contract structure includes a one-year base period followed by four optional one-year extensions, with a total potential duration of five years. The North American Industry Classification System code is 541611 for Administrative Management and General Management Consulting Services. The order will be performed from Silver Spring, Maryland, with procurement managed by the FDA Office of Acquisition and Grant Services based in Rockville, Maryland. Interested parties may submit inquiries by the response deadline of August 4, 2026, but this presolicitation notice does not constitute a request for competitive proposals. Primary and secondary points of contact have been designated for further information regarding the procurement.

General Info

FDA awards sole-source contract to QuoData GmbH for ProLab Plus software support and enhancements.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Silver Spring, MD, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PhasePresolicitation
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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts2 people available
OfficeRockville, MD, 20852, USA
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
View Agency Profile
Office AddressRockville, MD, 20852, USA
Contacts
Amanda Lusk
contact@example.gov
Nicholas Bisher
contact@example.gov

Full Description

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5.101 Presolicitation notice.


(vii)For noncompetitive contract actions (including those at or below the SAT), identify the intended source and explain why competition is lacking.



Based on market research conducted in accordance with FAR Part 10, the contracting officer has determined that soliciting from a single source is appropriate for this requirement under the following circumstances: Sole provider of the proprietary ProLab Plus software platform currently used to support proficiency testing and statistical analysis activities. 



The U.S. Food and Drug Administration (FDA) intends to solicit a 1-year base and four (4) 1- year option periods, sole source (in accordance with FAR 6.103-1), firm-fixed-price order from QuoData GmbH PRELLERSTR. 14, Dresden, Sachsen, 01309, Germany. The North American Industry Classification System (NAICS) code is 541611 - Administrative Management and General Management Consulting Services.



This notice is not a request for competitive proposals.



The FDA’s Human Foods Program utilizes the ProLab Plus software platform, developed and proprietary by Quo Data, for analysis of proficiency testing (PT) and inter-laboratory study data. This platform is integral to evaluating laboratory performance and supporting accreditation efforts.



The PT program has expanded and requires implementation of advanced statistical methods aligned with International Organization for Standardization (ISO) standards. These capabilities extend beyond the standard technical support provided with the software license and require specialized expertise from the software developer.

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Generic Drug Pathway Curriculum: From ANDA Submission to Global RelianceThe U.S. Food and Drug Administration’s Office of Acquisitions and Grants Services is conducting market research to identify qualified vendors capable of delivering the Global Abbreviated New Drug Application (ANDA) Training Program, with a focus on developing and delivering a comprehensive curriculum covering the generic drug pathway from ANDA submission to global reliance. This notice is strictly a sources sought announcement under FAR Part 10, meant solely for planning and market intelligence purposes, and does not constitute a solicitation, commitment, or obligation to award a contract or compensate respondents. The anticipated contract, if pursued, would have a five-year performance period from September 15, 2026, through September 14, 2031, including a base year and four optional years. Interested parties are requested to submit a completed Vendor Feedback Form, tracked comments on the Draft Statement of Work and Draft Global ANDA Training - Generic Drug Curriculum in MS Word format, and a Capability Statement, all sent via email to Lawrence Edelmann by 12:00 p.m. Eastern Time on July 28, 2026. Responses will inform the development of a potential future solicitation, and the government reserves the right to follow up with respondents for additional details without providing feedback to all submitters. The NAICS code associated with this effort is 61143, and the primary point of contact is located at the FDA’s office in Rockville, Maryland, with performance expected in Silver Spring, Maryland.

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NAICS: 334516
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Combined Synopsis/Solicitation & Notice of Intent to Sole Source: Purchase of a Factory-Certified Refurbished HUMIMIC Starter Kit Control UnitThe FDA Office of Acquisition and Grant Services is soliciting the purchase of a factory-certified refurbished HUMIMIC Starter Kit Control Unit from TissUse GmbH in Berlin, Germany, under solicitation number 75F40126Q135669. This is a sole-source procurement because TissUse GmbH is the exclusive provider with access to the proprietary software source codes, diagnostic calibration fixtures, and engineering data essential for the proper factory recertification and maintenance of this specific hardware, making it impossible for any other commercial vendor to perform the required services. The acquisition is classified under NAICS code 334516 and is not subject to any set-aside requirements. The combined synopsis and notice of intent to sole source was posted on July 17, 2026, with responses due by August 1, 2026, at 6:00 p.m. Eastern Time. The contract will be performed at the agency’s location in Rockville, Maryland, and all inquiries should be directed to Suzanne Martella, the designated point of contact.
Analytical Laboratory Instrument Manufacturing

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NAICS: 325413
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ProteinSimple Maurice consumablesThe FDA is seeking information from potential suppliers regarding consumables and materials required for the Protein Simple Maurice system, model Maurice – OBM, serial number KF-1804, which is used in regulatory research and testing for complex biopharmaceuticals. This sources sought notice, identified by solicitation number 75F40126SSN133285, was posted on July 17, 2026, with a response deadline of July 24, 2026, at 7:00 PM Eastern Time. The procurement falls under NAICS code 325413, indicating classification within the pharmaceutical and biological product manufacturing sector. The requesting organization is the FDA Office of Acquisition and Grant Services under the U.S. Department of Health and Human Services, located in Rockville, Maryland, with Suzanne Martella listed as the primary point of contact for inquiries. The place of performance is not specified, but the equipment is in use at FDA facilities, and responses are expected to address the technical specifications and availability of compatible consumables. This is not a formal solicitation for award but a request for market research to inform future procurement planning.
In-Vitro Diagnostic Substance Manufacturing

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