Justification_for_Exception_to_Fair_Opportunity_-_NCI_CCDIPS_SAM_1.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

AUTHORITY: FAR 16.505(b)(2)

NATIONAL CANCER INSTITUTE

CHILDHOOD CANCER DATA INITIATIVE PROGRAM SUPPORT

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for an Exception to Fair Opportunity.”

This document is a Justification for an Exception to Fair Opportunity for the Department of the Interior (DOI), Interior Business Center (IBC), Acquisition Services Directorate (AQD), on behalf of the Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI).

2. Nature and/or description of the action being approved.

This proposed action is to issue a new task order requirement to Essex Management for Childhood Cancer Data Initiative Program Support (CCDIPS) services. This action is being issued in accordance with Federal Acquisition Regulation (FAR) Subpart 16.505(b)(2)(i)(B) via Essex’s Biomedical Information Technology, Software Development, and Informatics Support (BITSDIS) Indefinite-Delivery Indefinite-Quantity (IDIQ) Contract.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The National Cancer Institute’s (NCI) Center for Biomedical Informatics and Information Technology (CBIIT) is tasked with developing innovative approaches to cancer data sharing and collaboration. In 2019 Congress funded the Childhood Cancer Data Initiative (CCDI), a key goal of which is to improve treatment outcomes for pediatric cancer patients through accelerated data collection and efficient analysis and sharing of those data. Currently, researchers and clinicians can face challenges when attempting to access pediatric cancer data spread across multiple repositories. Since childhood cancers are relatively rare as compared to adult cancers, the amount of data across these repositories is also limited.

The Childhood Cancer Data Initiative (CCDI) is an NCI program which collects, analyzes, and shares data to address cancer in children, adolescents, and young adults. The initiative intends to integrate new and existing data sources into a broader research ecosystem. The objective of the CCDI is to ensure that data from each of the 16,000 children and adolescents diagnosed with cancer in the United States each year contributes to reducing the burden of this disease. Major components of the CCDI are being managed by the NCI Office of Data Sharing (ODS).

The success of the CCDI is predicated upon many factors, including making use of comprehensive, well integrated information systems into which data will be collected, processed and harmonized, and from which they will be distributed. The information systems identified to support the CCDI include those within the Cancer Research Data Commons (CRDC) rubric and the Moonshot’s nascent National Cancer Data Ecosystem. The ODS planning efforts for the

Centers and NCI initiatives submit multiomics data and provide cancer clinical trial information to CCDI, which is abstracted and coded for distribution. The coded data are then distributed for public searching through NCI’s data sharing resources. Disruption of any aspect of this complex interplay would have substantial impact on cancer clinical research. Essex has in-depth knowledge of the processes for data acquisition and distribution and is uniquely positioned to provide these critical processes without interruption to the existing work flows. If the processes for data acquisition, processing and reporting were disrupted, this would have a negative impact on the ability of Cancer Centers to submit their data. No other vendor would have similar knowledge and expertise to assume deployment of these vital functions in a seamless fashion.

Essex Management is the only vendor with subject matter expertise capable of providing these services to CCDI at this time. Attempting to use any other vendor at this time would result in significant delays and could have significant negative impacts that jeopardize the success of CCDI’s mission.

5. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

Essex’s BITSDIS IDIQ rates were deemed fair and reasonable at IDIQ contract award. Even though the rates for services offered under the IDIQ are fair and reasonable, additional discounts will be requested. Proposed labor rates will be compared to the existing contract, and to the other IDIQ contract holder labor rates. As a result, it has been determined by the Contracting Officer that the task order will represent the best value to the Government considering price, and administrative costs.

6. Any other facts supporting the justification.

None.

7. A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

The Statement of Work (SOW) will require the Contractor to continually assess and document CCDI components, processes and technical details, dependencies, and operations. These efforts will lead to better documentation of the workflows associated with program operations, and the resulting in-depth and detailed documentation will then be used to provide more detailed requirements in the future. As the design processes and workflows become thoroughly established, the subject matter expertise gained from the architectural designs of the data systems may become less important to supporting this requirement. This will allow for the effective and efficient transition of future support to any subsequent contractor with reduced risk to the Government.