NOI_DarkSky.pdf

NOTICE OF INTENT TO SOLE SOURCE

In support of Project No: CDRH-2024-123474

The U.S. Food and Drug Administration (US FDA), Office of Acquisitions and Grants Services (OAGS), Office of Strategic Partnerships and Technology Innovation (OST) intends to award a firm fixed price purchase order to Dark Sky Technology, Inc, 1400 W Oak St. Fort Collins, CO 80521 for Software Component/Package Risk and Vulnerability Periodic Database for the Center for Devices and Radiological Health (CDRH).

The acquisition of proprietary data from Dark Sky Technology, LLC is to support Cybersecurity efforts in association with medical devices which use and contain software is peculiar to one manufacturer because only Dark Sky Technology, LLC can provide the data required. CDRH seeks a contractor to develop and/or provide a more interconnected, automated Software Bill of Materials (SBOM) analysis solution in which the data reporting on software risks is cohesively integrated into the point of review as well as in an ongoing feedback loop of known vulnerabilities, risks, and exploitations, which are constantly being found (or added) within devices that contain or leverage software, hardware, or firmware. This award will involve proprietary data which provides insights into vulnerabilities which exist within software components on a daily basis, as well as information on the severity of said vulnerabilities. Similarly, alias information will be necessitated to help facilitate the matching protocols that CDRH will be developing. These specific data are not widely available, and Dark Sky has been building these data sets and resultants over the past twenty years to help identify and understand Cybersecurity vulnerabilities and attacks. The data they aggregate include nuanced and essential information such as risk calculations and alias comparisons. These specific elements which are intellectual property of theirs are unique and not available outside of their organization.

This procurement is being conducted in accordance with FAR subpart 6.302-1 which allows for the Contracting Officer to solicit one source if only one source is reasonably available. The North American Classification System Code (NAICS) is 541511 – Custom Computer Programming Services. This hereby constitutes a synopsis of this requirement.

This notice is being distributed solely System for Awards Management website (www.SAM.gov). As Dark Sky Technology, LLC is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to the Contract Specialist, Brian Wodzisz, at Brian.Wodzisz@fda.hhs.gov no later than 12:00 PM EST on September 5th, 2024. Responses sent utilizing other means will not be considered. The Government will not be responsible for any costs incurred by responding to this notice.

Information received will be used solely to determine whether to conduct a competitive procurement.

A determination by the Government not to compete the proposed action based upon responses to this notice is at the discretion of the Government.

All responses must include the following business information:

a. Unique Entity Identification (UEI) Number

b. Company Name, address, primary point of contact and their email and phone number

c. Type of company (i.e., small business, 8a, woman owned, HUBZone, veteran owned, etc.) as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government awards.

d. Technical capability as detailed in the attached Statement of Work (SOW).

http://www.sam.gov/ mailto:Brian.Wodzisz@fda.hhs.gov