FDA_JA.pdf

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Justification for Other than Full and Open Competition

Identification of the agency and contracting activity:

Federal agency and contracting activity.

U.S. Department of Health and Human Services (HHS) U.S. Food and Drug Administration (FDA) Office of Acquisition and Grants Services (OAGS)

Sponsoring organization.

U.S. Department of Health and Human Services (HHS) U.S. Food and Drug Administration (FDA) Office of the Commissioner (OC) Office of Digital Transformation (ODT)

Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

Nature and/or description of the action being approved.

KNIME Business Hub Software – Standard & Enterprise Technical Support

Acquisition purpose and objectives.

The objective of the acquisition is to obtain additional KNIME Business Hub Software Licenses and Maintenance & Support hours in support of the Food & Drug Administration (FDA) Office of Digital Transformation (ODT). The additional items would be a modification under FDA Purchase Order (PO) award #75F40123P00312.

This will assist the FDA with leading risk mitigation efforts to ensure the nation’s supply of critical medical and food products, including infant formula, are safe and secure. FDA has developed an enterprise Data Analytics as a Service (DAaaS) and this service is designed to provide rapid respond to urgent and diverse data analytics needs. This service engages both internal (across the agency) and external (such as CDC, White House, etc.) stakeholders. By acquiring this software, it will provide the following capabilities to the FDA along with D aaS.

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b. Project background.

The KNIME Business Hub licenses and maintenance and support was procured by issuing PO #75F40123P00312. The requirement for this PO came out of FDA ODT. The PO was awarded competitively to Equinoxy’s for the KNIME Business Hub solution. KNIME Business Hub is an enterprise software for collaborating on and deploying data science solutions to drive analytic insights across the organization and provides organizations with single, scalable environment to securely collaborate and share best practices, as well as deploy and monitor their analytical workflows. The scalable, cloud-native architecture as well, as team-controlled execution, enables fast community adoption and reduces the burden on central IT. This suite of features enables organizations to build vibrant data science communities and accelerate the spread of data-driven decisioning.

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

a. Project title.

KNIME Business Hub Licenses & Maintenance & Support (M&S)

b. Project Description.

KNIME Business Hub Software

Provide Standard Enterprise licenses for KNIME Business Hub Software.

Maintenance & Technical Support Services

The Contractor shall provide all maintenance and technical support services described below:

Service Level Support Agreement of 24 hours per day, 7 days a week, 365 days per year (7x24x365).

Response time to Severity level 1 issues of less than 30 minutes.

Response time to Severity level 2 issues of less than 2 hours or less.

Response time for Severity level 3 and 4 is 4 hours or less.

Account Management service includes dedicated regional focal point Unlimited service requests.

Direct Phone access Account management service includes weekly calls and quarterly service reviews Technical Support services includes installations, new releases, patches, minor upgrades, major upgrades, training, and operation assistance

Requirement type.

Supplies/equipment

Information Technology (IT)

Type of action.

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Modification to Purchase Order # 75F40123P00312

Proposed contract/order type.

Firm-fixed-price

Acquisition identification number.

c. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

The statutory authority permitting items peculiar to one (1) manufacturer is in accordance with 13.501(a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Equinoxy’s, Inc 11200 Branton LN Great Falls, VA 22066 POC: Jeet Jagtap

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

In a sole exclusive letter sent to the FDA from KNIME Inc., they stated that contractor, “Equinoxy’s Inc. is the sole license distributor and implementation partner for the US Federal Government.

Equinoxys Inc. has demonstrated expertise in providing high-quality service and support for KNIME products. [They] are confident that Equinoxys Inc. will provide the necessary resources and assurance to ensure a seamless procurement process for KNIME licenses and their subsequent installation and ongoing support.”

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Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

This justification will be made publicly available on SAM.gov in accordance with 5.102(a)(6).

Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Contracting Officer (CO) will ensure the prices for the modification represents a fair and reasonable price. The CO will leverage data from the PO to inform pricing strategy for the additional requirements. Leveraging the expertise of technical evaluator(s) of the requirement and real time operational environment will support the CO in evaluating quoted pricing.

Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Informal market research was conducted locally within FDA’s portfolio of procurement instruments for the required items. The conclusion resulting from this survey indicates that there exists only one solution which would best maximize return on recent FDA investments to the ODT applications, exhaust immediately available private sector institutional understanding of FDA Centers’ needs for ODT and avoid schedule delays associated with knowledge transfer and onboarding new contractor employees. It is imperative the items required not only be provided with the greatest efficiency, but they must also be performed in a manner which greatest maximizes schedule in order to meet the needs of ODT. To ensure continuity of efforts and best manage risk, awarding a modification to Equinoxy’s Inc for the items discussed herein represents the most efficient and low risk solution. For that reason, performing market research to determine alternate sources of supply to meet the requirement was not conducted.

Any other facts supporting the use of other than full and open competition.

No other facts

Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No sources have expressed interest in writing, for the proposed acquisition.

Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

As of now, there are no subsequent actions planned. However, the FDA will continue to evaluate and review new solutions and add additional assets as they see fit in future years.