FDA Regulated Products Sampling Services
Closed Pre-Solicitation Posted
- Solicitation number
- 75F40125R00032
- 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
- 541990 All Other Professional, Scientific, and Technical Services
- PSC
- Not on record
- Place of performance
- Maryland 20704, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking a contractor to provide Regulated Product Sampling Services nationwide. The contract will involve collecting physical samples of FDA-regulated products from various locations including warehouses, retail sites, ports of entry, and manufacturing facilities to support the agency's regulatory oversight and product safety surveillance efforts. The sampling services will cover a wide range of products such as human and animal foods, cosmetics, and their ingredients, with the primary objective of monitoring for potential adulterants and verifying product labeling accuracy. The FDA will evaluate potential vendors based on their nationwide sampling capabilities, expertise with FDA-regulated product categories, pricing structures, professional certifications, and staff training qualifications. Interested vendors must respond by January 9, 2025 at 12:00 PM ET, submitting a 15-page response addressing 17 specific questions about their capabilities and qualifications.
The pre-solicitation notice indicates this will be an Indefinite Delivery-Indefinite Quantity (IDIQ) contract with a 5-year period of performance from July 2025 through June 2030, including a 6-month option period. There is no specific set-aside designation for small businesses or disadvantaged vendors. The contract will utilize multiple pricing models including Time & Materials, Firm Fixed Price, and Labor Hour task orders, with four required labor categories: Program Manager, Project Manager, Quality Assurance Specialist, and Sampling Technician. While specific ceiling values and contract minimums are still being determined, the contract will require contractors to provide comprehensive sampling services, maintain chain of custody documentation, and deliver samples to FDA laboratories. Contractors must also develop quality control plans, provide monthly status reports, and ensure staff are trained in aseptic techniques and current Good Manufacturing Practices.
Notice text
The FDA, or U.S. Food and Drug Administration, is responsible for ensuring the safety and efficacy of food, drugs, medical devices, and other products in the United States. The sample collection process is an important component of the FDA's regulatory oversight activities. The FDA collects samples of regulated products ready for consumption or sale, as well as in-process and raw ingredient samples, to monitor and evaluate these products for potential adulterants, or to verify the accuracy of product labeling.
Sample collection involves taking physical samples of products from warehouses, distributors, retail locations, ports of entry, or other designated holding facilities for laboratory analysis. The products being sampled may be produced in the U.S. or may be of foreign origin and have been imported into the U.S., including products originally produced in the U.S. before being exported and re-imported back into the U.S.
The results of sample collection and testing will be used by the FDA to ensure the safety and quality of products, expand knowledge of FDA regulated products and areas of concern through surveillance, and used to make regulatory decisions, such as pursuing voluntary recalls or initiating official FDA operations.
Files
| File | Type | Posted |
|---|---|---|
| Attachment A - Draft Statement of Work.pdf | ||
| 12-19-2024 Sources Sought Notice.pdf |
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