Notice of Intent to Sole Source

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services intends to award a sole source, firm fixed-price contract to International Consulting Associates, Inc. (“ICA”) for Real-World Data Analyses. Currently, no single report from FDA databases currently includes a support to conduct RWE analyses of 10 high-priority, medical-device safety signals identified by CDRH. The Center will provide study criteria (e.g. retrospective RWE analysis, scope of device or problem to be analyzed) to help the Contractor develop a corresponding study protocol. ICA is familiar with and has successfully performed on developing other medical device post-market surveillance tools for the CDRH, the method of procurement most beneficial to the Government is to award this requirement as an 8(a) directed award to ICA. ICA is considered suitable for this particular acquisition due to its successful performance on previously awarded CDRH contracts for similar services related to medical device post-market signals. ICA is an SBA Certified 8(a) Program Participant and approved by the Office of Small and Disadvantage Business Utilization Control Number 2021-FDA-0248.

The anticipated period of performance for this procurement is a 12-month base period.  The proposed simplified acquisition action is for supplies or services for which the Government intends to solicit and negotiate with only one source in accordance with FAR Part 13.106(b)(1). The proposed NAICS code for this requirement is 541611 - Administrative Management and General Management Consulting Services.  Interested parties may identify their interests and capabilities by providing a response to this requirement prior to the response due date listed on this notice showing their ability and willingness to fulfill this requirement. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive requirement.

FDA will consider all responses received prior to the closing date of this notice and will use responses in determining whether it is necessary to use full and open competition for this requirement. Responses to this notice will not be considered adequate responses to a solicitation. No further solicitation is available at this time. A determination by the Government not to compete this proposed simplified acquisition based upon responses to this notice is solely within the discretion of the Government. Reponses shall be emailed to Rodney D. Aytch at [email protected] no later than 3:00pm EST on July 9, 2021.