Notice of Intent.pdf
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- Clinical trial design for HPS pulmonary fibrosis
- Solicitation number
- 75N98026Q00776
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Notice of Intent for Sole Source Award
This is a Notice of Intent issued by the National Institutes of Health announcing its intention to award a Firm-Fixed-Price Purchase Order to Berry Consultants LLC under contract number 75N98026Q00776, in accordance with FAR Part 6.302-1 (sole source justification). The primary service required is the development of a proposed clinical trial design for HPS pulmonary fibrosis suitable for presentation to potential sponsors and regulatory agencies. The scope of work includes using available natural history, observational, and clinical trial data to characterize disease progression, evaluate candidate endpoints and analysis methods, and identify a recommended design strategy for future interventional trials.
Berry Consultants is identified as the sole source based on their previous work modeling the NIH's HPS cohort and their possession of preliminary data from prior contracts, which positions them to continue clinical trial simulation with pulmonary fibrosis patients and provide outcome parameters and endpoint measurements. While this is not a competitive solicitation, small businesses—including 8(a), service-disabled veteran-owned, HUBZone, small disadvantaged, veteran-owned, and women-owned small businesses—may submit written capability statements by the deadline of July 21, 2026 at 11:00 p.m. EDT to david.shen@nih.gov. The Government reserves the right to compete the award based on responses received. An award is anticipated approximately ten days after the notice date unless the Government determines another vendor has the capability to meet the requirement.
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Notice of Intent: Clinical trial design for HPS pulmonary fibrosis
(75N98026Q00776)
In accordance with FAR Part 6.302-1, the National Institutes of Health intends to award a Firm- Fixed-Price Purchase Order to Berry Consultants LLC.
Berry Consultants will support the development of a proposed clinical trial design for HPS pulmonary fibrosis that is suitable for presentation to potential sponsors and for early regulatory advice. The goal of this work is to use available natural history, observational, and clinical trial data to characterize disease progression, evaluate candidate endpoints and analysis methods, and identify a recommended design strategy for future interventional trials in HPS pulmonary fibrosis.
Berry Consultants has previously worked on modeling with our HPS cohort. The continuation of this project will continue to simulate a clinical trial with our pulmonary fibrosis patients. They will give outcome parameters and measuring endpoints that will be helpful to our cohort and how we can approach disease management and progression. Since Berry Consultants has in depth knowledge of this cohort already and has preliminary data from previous contracts, they are the sole source for this project and the patient care output will be very beneficial to our large affected cohort.
This notice is not a request for competitive quotes. However, any available small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government.
It is anticipated that an award will be issued approximately ten (10) days after the date of this notice unless the Government determines that another vendor has the capability to meet this requirement.
Please email responses to david.shen@nih.gov no later than 11:00 p.m. EDT on July 21, 2026.
mailto:david.shen@nih.gov
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