NOTICE OF INTENT TO SOLE SOURCE-MPF-ZAI SOLUTIONS

The Food and Drug Administration (FDA) intends to award a Firm-Fixed-Price Purchase Order to MPF-ZAI SOLUTIONS LLC.

In accordance with FAR Part 6.302-1, MPF-ZAI SOLUTIONS LLC is the only known responsible source who can provide the products/services that meet our standards. No other source has been identified who can provide the required services.

• Only MPF -ZAI is capable of performing data abstraction due to their exclusive access to the proprietary database system and specialized methodologies and training. No other vendor possesses technical expertise and validated processes and several years of working with the systems being used which makes them uniquely qualified to meet the project requirements.

The Government intends to negotiate and solicit with only one source MPF-ZAI SOLUTIONS LLC, 702 RUSSELL AVE, STE 400, GAITHERSBURG, MD 20877-2632, USA for the purchase of Center for Biologics Evaluation and Research (CBER) Scientific Data Abstraction and Information Management under the authority of FAR (6.302-3). This is not a request for competitive quotes; however, any responsible offeror may submit a quote which will be given due consideration by the agency.

Any other firms desiring consideration must fully identify their interest in and capability to provide this service or submit a proposal within 10 days to the individual listed.

A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government.

Responses to this notice must be sent via email to:

Natalie.Brown@fda.hhs.gov

This notice will close on April 18, 2026.