75N98026Q00716_-_Pre-Solicitation_-_Moffitt_Cancer_-_SS.docx

NOTICE OF INTENT: CORRECTIVE EDITING OF SPLICING FACTOR MUTANT MYELODYSPLASTIC SYNDROMES AND CHRONIC MYELOMONOCYTIC LEUKEMIA

(75N98026Q00716)

Sole Source Justification and Notice Authority FAR 6.302-1 — Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements Contracting Activity: National Cancer Institute (NCI) Proposed Contractor: Moffitt Cancer Center & Research Institute Description of Requirement:

Corrective Editing of Splicing Factor Mutant Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia Justification for Sole Source:

The National Cancer Institute intends to negotiate on a sole source basis with Moffitt Cancer Center & Research Institute pursuant to FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Moffitt Cancer Center & Research Institute is uniquely qualified to perform the proposed work because it possesses the specialized clinical, scientific, and translational research capabilities required for this project. Specifically:

1. Moffitt is internationally recognized for its expertise in the biology and treatment of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

2. Moffitt maintains a highly specialized malignant hematology program with one of the largest referral populations of patients with MDS and CMML in the United States, providing access to the patient specimens necessary to support this research.

3. Moffitt has established expertise in the development and utilization of patient-derived xenograft (PDX) models for hematologic malignancies, including the specialized laboratory capabilities and technical personnel required to generate and evaluate these models.

4. Moffitt maintains an integrated clinical and research infrastructure that enables patient evaluation, specimen procurement, cellular manipulation, and transplantation into mouse models to be performed within a single institution. This integrated workflow eliminates the need to transport patient specimens between institutions, thereby preserving sample viability and integrity while reducing logistical complexity and regulatory burden.

The Government is unaware of any other source possessing the combination of specialized clinical expertise, sufficient patient access, established PDX capabilities, and integrated translational research infrastructure necessary to perform all required aspects of this effort. Accordingly, Moffitt Cancer Center & Research Institute is considered the only responsible source capable of satisfying the Government's requirement.

Small Business Notification:

This notice is not a request for competitive quotations. However, any responsible source, including small businesses, 8(a) firms, service-disabled veteran-owned small businesses, HUBZone small businesses, women-owned small businesses, veteran-owned small businesses, and small disadvantaged businesses, may submit a capability statement demonstrating its ability to satisfy the Government's requirement.

Capability statements will be evaluated solely to determine whether a competitive procurement should be conducted. A determination not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Anticipated Award Date:

The Government anticipates making an award approximately five (5) days after the closing date of this notice, unless the Government determines that another source is capable of satisfying the requirement.

Capability statements shall be submitted via email to haunp@mail.nih.gov no later than 9:00 a.m. EDT on July 9, 2026.