HHS FDA - Regulated Product Sampling Services - MRAS

The U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services (HHS), is seeking to establish an Indefinite Delivery-Indefinite Quantity (IDIQ) contract for Regulated Product Sampling Services. This initiative is being facilitated by the General Services Administration (GSA) as part of their market research efforts. The FDA's primary goal with this contract is to enhance its regulatory oversight capabilities by ensuring the safety and efficacy of food, drugs, medical devices, and other regulated products within the United States. By outsourcing sampling services, the FDA aims to focus its internal resources on critical inspections, investigations, emergency responses, and other high-risk activities.

The work requested involves comprehensive sample collection services that are crucial for monitoring and evaluating products for potential adulterants or verifying product labeling accuracy. Sampling will occur at various locations such as warehouses, distributors, retail outlets, ports of entry, and other designated facilities. The products sampled may include those produced domestically or imported into the U.S., including items that were originally exported from the U.S. before being re-imported. These samples will undergo laboratory analysis to support FDA's regulatory decisions which may include actions like initiating recalls or conducting further regulatory operations.

This IDIQ contract will encompass multiple ordering periods over a five-year span with an additional six-month option period. It includes labor categories such as Program Manager, Project Manager, Quality Assurance Specialist, and Sampling Technician with fully burdened hourly rates applicable to both governmental and non-governmental sites. Most task orders are expected to be Time and Materials (T&M), although Firm Fixed Price (FFP) and Labor-Hour (LH) task orders may also be issued at the discretion of the Contracting Officer.

To ensure effective execution of this contract while maintaining high standards of security and integrity, contractor staff may require credentials as officers of HHS/FDA if necessary for access to sampling locations. Additionally, non-disclosure agreements will be mandatory for all individuals involved in handling FDA information due to stringent information security protocols enforced by the FDA's Office of Security Operations. Furthermore, contractors must avoid conflicts of interest by recusing themselves from sampling any entity or product where they have existing contractual or financial relationships.