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Human Foods Program: FDA-State Integrated Inspections Support

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Federal

Contract Overview

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This subcontract under the FDA Negotiated Contracts Branch of the Department of Health and Human Services provides critical analysis and support to accelerate integrated inspections between the FDA and state agencies. The primary objective is to coordinate regulatory alignment between state and federal entities while applying specific food safety inspection protocols for Human Foods Program projects. The scope of work includes the delivery of comprehensive Phase I and Phase II implementation and analysis reports. This effort is categorized under NAICS code 541611 and is based in Silver Spring, Maryland, with a response deadline of September 21, 2026.

General Info

FDA subcontract for state-federal food safety inspection alignment and analysis in Maryland.

Agency

Department Of Health And Human Services → FDA Negotiated Contracts BranchView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of FDASSOC136354.

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

View the prime solicitation

The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its ts congressionally mandated regulatory mission across 16 project areas

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Negotiated Contracts Branch
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → FDA Negotiated Contracts Branch
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Office AddressN/A
ContactsNo contact information available

Full Description

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Provides analysis and support to accelerate integrated inspections between the FDA and state agencies for prime contractors on FDA Human Foods Program projects. Coordinates state and federal regulatory alignment and applies food safety inspection protocols. Delivers Phase I and Phase II implementation and analysis reports.

Similar Contracts

Same NAICS industry code

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Same awarding agency

NAICS: 541618
New
Federal
The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its ts congressionally mandated regulatory mission across 16 project areas
Solicitation # FDASSOC136354
The Food and Drug Administration intends to award a firm fixed price sole source contract to the Reagan-Udall Foundation for the FDA (RUF) for the period of September 30, 2026, through September 29, 2027. This engagement is designed to support the FDA's congressionally mandated regulatory mission across 16 project areas, utilizing the Pathways for Regulatory Innovation and Strategic Modernization (PRISM) framework. The scope of work includes independent stakeholder convening, scientific engagement, operational evaluation, and landscape research to address critical regulatory science gaps and public health challenges. Key focus areas include emerging neurotechnologies, rare disease diagnostics, real-world evidence for medical devices, generic drug quality, cosmetovigilance under MoCRA, food inspection modernization, and nicotine use disorder treatment. The RUF will operate as an independent private nonprofit partner and is strictly prohibited from participating in FDA regulatory decision-making or providing advice on specific regulatory policy matters. Deliverables include publicly available or agency-facing reports, white papers, and the facilitation of workshops and expert panels. All work must adhere to strict cybersecurity standards, including NIST SP 800-53 or 800-171, and comply with Executive Order 13556 regarding controlled unclassified information. The contract is justified as a sole source based on the foundation's statutory mandate under the FDAAA of 2007. Performance will take place at the contractor's facility, with the FDA's Contracting Officer's Representative overseeing the inspection and acceptance of all deliverables.
Other Management Consulting Services

POSTED

about 14 hours ago

DEADLINE

in 7 days
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