Notice of Intent to Award a Sole Source - CBER Biologics Effectiveness and Safety (BEST) BEST1 Initiative: BEST Coordinating Center

The U.S. Food and Drug Administration (FDA) intends to solicit a 12-month base year, plus three (3) four-month option periods, sole source, time-and-materials type contract from Acumen LLC; 500 Airport Blvd., Suite 100; Burlingame, CA 94010, in accordance with the authority under Federal Acquisition Regulation (FAR) 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements, and 15.101 Contracting by Negotiation. The North American Industry Classification System (NAICS) code is 518210 – Data Processing, Hosting, and Related Services. The anticipated period of performance consists of a 12-month base year, plus three (3) four-month option periods.

This acquisition is for a short-term, sole-source bridge contract to Acumen, LLC, the incumbent Coordinating Center for the Biologics Effectiveness and Safety (BEST) Initiative, which supports post market active surveillance of biologics. The bridge contract will enable continuation of mission-critical operations during the transition to a new and fully competed contract, which is currently in the planning phase.

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting the requirements as stated herein may submit a written response which clearly supports and demonstrates its ability to perform the requirements. Any response must be received by the response date and time set forth in this notice. Any response will undergo a review to determine whether the respondent can meet the contract requirements. A determination by the Government whether to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Response Date and Time: 4:00 p.m. ET on August 4, 2025. Responses must be emailed to maevexavier@fda.hhs.gov, with a CC: to james.jenretteiii@fda.hhs.gov.