Notice of Intent to Sole Source

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Subpart 5.101, which requires dissemination of information for proposed contract actions. The National Library of Medicine (NLM), an institute of the National Institutes of Health (NIH), Office of Acquisition, intends to issue a sole-source award to ICF Incorporated LLC under Task Order GS00F010CA-75N97023F00106.

The contractor shall provide complex professional specialized expertise, some of which is Information Technology (IT) services, to support the continuation of operations, maintenance, and modernization of ClinicalTrials.gov. The statutory authority for this sole-source procurement is FAR 6.302-1 ¿ Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements (41 U.S.C. 3304(a)(1)).

Justification for Sole Source: At the time of task order award (GS00F010CA-75N97023F00106), the Government incorporated FAR 52.217-8 (Option to Extend Services) into the task order; however, the cost associated with exercising this option was not evaluated or negotiated. As a result, the Government must now enter into a new procurement action to extend services under this clause.

The incumbent contractor, ICF Incorporated LLC, has been leading the modernization of ClinicalTrials.gov, and the modernization effort is now materially in its completion phase, anticipated completion date on or before September 2025. Given the highly specialized knowledge under this effort, ICF is uniquely qualified to continue providing uninterrupted support and finalizing the modernization.

Transitioning to a new contractor at this stage would introduce significant operational risks, delays, and substantial duplication of costs, particularly as the system modernization nears final completion and implementation.

Additionally, since the modernization is now nearing completion, the Program Office anticipates pursuing a new post-modernization procurement to support the long-term maintenance and evolution of ClinicalTrials.gov after September 2025. This 6-month extension allows for continuity of operations until the modernization is complete and a follow-on procurement strategy for post-modernization is finalized and implemented.

Additional Information: ¿ Period of Performance: Not to exceed six (6) months, from March 27, 2025 to September 26, 2025 ¿ NAICS Code: 541511 ¿ Custom Computer Programming Services NIH will negotiate directly with ICF Incorporated LLC, and no solicitation will be issued. This notice of intent is not a request for competitive proposals or quotations.

However, interested parties may submit a Statement of Capabilities, which must be in writing and provide sufficient detail for the Government to determine whether the party is potentially capable of meeting the requirement and whether the Government can decide to create an open competitive action. All interested parties must express their interest and capabilities via email to delfo.sacomizhquiri@nih.gov no later than Friday, March 7, 2025, at 4:00 PM EST. Faxed documents will not be accepted. The Government is not required to respond to any capability statements received. For additional details, see the attached Statement of Work (SOW).