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Business Analysis & Requirements Engineering

Active

Federal

Response Deadline11/19/2026, 07:00:00 PM UTC

Contract Overview

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

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This subcontract opportunity, posted by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, focuses on business analysis and requirements engineering for regulatory support projects. The selected provider will support prime contractors by facilitating requirements gathering, developing user stories with acceptance criteria, and managing User Acceptance Testing. Key deliverables include business requirement documents, user stories, and UAT validation reports, requiring a strong proficiency in Agile methodology and requirements traceability. The project is designated as a total Small Business Set Aside under NAICS code 541611, with the place of performance located in Silver Spring. Interested parties must submit their responses by November 19, 2026.

General Info

Agency

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

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

SBA

Documents

This scope was carved out of 75F40127R00007.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FDA Scientific & Regulatory Support Services(SRS)

AI Contract Breakdown

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Timeline

PostedNov 4

subcontract

Response DeadlineNov 19

Submission deadline

Response Deadline

11/19/2026, 07:00:00 PM UTCin 15 days

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Organization & Contact Information

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

ContactsNo contacts available

OfficeN/A

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

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs business analysis and requirements engineering for prime contractors on FDA regulatory support projects. Facilitates requirements gathering, develops user stories with acceptance criteria, and oversees User Acceptance Testing (UAT). Requires expertise in Agile methodology and requirements traceability. Delivers user stories, business requirement documents, and UAT validation reports.

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