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DataFit Operation and Maintenance

Active

FDA-75F40126Q00317Federal

Response Deadline08/22/2026, 05:00:00 PM UTC

Contract Overview

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

AI Contract Overview

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The FDA Center for Drug Evaluation and Research is seeking support to maintain and enhance DataFit, its platform for validating data standards used in drug evaluation processes. The contract requires the vendor to handle installation, updates, technical support, and development of new features to ensure the platform remains effective, secure, and aligned with evolving regulatory and technical requirements. This ongoing operation and maintenance effort is critical to sustaining the integrity of data submitted to the FDA and supporting efficient drug review workflows. The solicitation, identified as FDA-75F40126Q00317, was posted on August 7, 2026, with responses due by August 22, 2026. It is classified under NAICS code 541519 for other computer-related services and does not use a set-aside provision, meaning it is open to all eligible businesses. The work is based at the FDA’s Office of Acquisition and Grant Services in Rockville, Maryland, with performance occurring in Silver Spring, Maryland. Primary point of contact for questions is Tiffany Gates, reachable via email at tiffany.gates@fda.hhs.gov.

General Info

FDA seeks vendor to maintain and enhance DataFit platform for drug data validation in Silver Spring, Maryland.

Agency

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

NAICS

541519 - Other Computer Related ServicesView NAICS

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

(3)

CDER DataFit Operations, Maintenance and Support Services Pricing Workbook

XLSX•pricing-excel-workbook

RFQ FDA-75F40126Q00317 DataFit Operation and Maintenance

PDF•rfq

FDA CDER DataFit Platform Statement of Work

PDF•sow

AI Contract Breakdown

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Timeline

PhaseCombined Synopsis

PostedAug 7

Combined Synopsis

Response DeadlineAug 22

Submission deadline

Response Deadline

08/22/2026, 05:00:00 PM UTCin 14 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person 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

Tiffany Gates

contact@example.gov

Full Description

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The Food and Drug Administration (FDA) / Center for Drug Evaluation and Research (CDER) requires support to install, update, support, and develop enhancements to maintain DataFit, CDER’s data standards validation platform.

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