JA for CGI Power_Redacted.pdf

Justification and Approval (J&A):

BBrand-Name at or Below the Simplified Acquisition Threshold

Project Title: GCI PowerTools for Viewer Annual Maintenance Renewal

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, OSMO, OCICB, CIB

Requestors name:

Requestors phone number:

Requestors email address:

Address of the requesting lab/office: 5601 Fishers Lane, Rockville, Maryland 20852

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action: (check the appropriate box)

New requirement Follow-on

Name of the previous contractor(s): Global Cents GCI Live, LLC, Sequence number, if available: 1770699, 1821567, 1879951, 1940936, 1995430, 2046434, 2099246, 2146671, 2201665, 2231168, 2231168 & 2248281 Was the initial and any subsequent awards competed? Yes No

B. AMBIS Sequence number for this requirement: 2280721 C. Total estimated dollar value of the requirement (including options, if applicable): $ D. Period of performance, inclusive of options: from 1/30/2026 to 12/31/2026 E. Project Background

The Office of Cyber Infrastructure and Computational Biology (OCICB) provides leadership and direction on effective strategies, policies, and standards for technology services, support for biomedical research programs, information technology resources, and customer support. This includes ensuring information technology infrastructure, tools, and applications fully and comprehensively support the NIAID mission. The Clinical Informatics Branch (CIB) within the OCICB provides specialized support to facilitate the integration of IT and clinical expertise to support NIAID’s research mission. The branch specializes in leveraging expertise to manage the implementation and configuration of industry standard research management tools. The GCI PowerTools Viewer supports clinical research studies by providing web-based, read-only viewing for controlled clinical trials artifacts and documentation to support regulatory compliance.

F. Description of the supplies/services to be purchased

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

41 USC 3304(a)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source / Brand Name F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition / Brand Name

Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this

Item # Description Of Item

1 GCI PowerTools for Viewer Annual Maintenance authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

41 USC 3304(a)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute / Brand Name

IV. Demonstration that the proposed brand name product’s salient characteristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

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

Global Cents

GCI LIVE, LLC

830 West Route 22, Suite 138 Lake Zurich, IL 60047

B. Describe why only the requested supply/service will meet the government’s needs

GCI PowerTools for Workflow and Deployments has been used since 2016 to assist with deploying document management and workflow solutions for NIAID and NIH. The GCI PowerTools have been used since 2016 to assist with deploying document management and workflow solutions in support of human safety human and animal healthcare and biosafety.

OpenText Content Server with GCI PowerTools workflows is used to configure and execute business workflows and workflow maps that support time-sensitive operational and administrative processes within NIAID. These workflows manage the routing review and approval of tasks and records required to support clinical operations and system access. Delays or failures in completing required workflow steps may result in interruptions to operational readiness or access to systems that support patient care. The use of GCI PowerTools – Workflows ensures consistent task routing automated notifications and tracking of workflow completion thereby supporting safe and reliable clinical operations. The workflows support business workflows used across both human clinical and animal care environments to manage the execution and approval of records related to protocols training acknowledgments access requests and operational readiness. In animal care settings workflow maps are used to coordinate review and approval steps associated with animal study operations and care activities. By enforcing required workflow steps and providing visibility into task status GCI PowerTools – Workflows supports continuity of care animal welfare and adherence to established operational environments. Also, there are workflows associated with biosafety-related activities including personnel onboarding training verification, access coordination and approval of records required for work conducted in Biosafety Level 3 and 4 facilities. These environments require strict sequencing and completion of defined workflow steps prior to personnel performing high-risk laboratory activities. GCI PowerTools – Workflows ensures that required tasks are routed completed and recorded in a controlled and auditable manner reducing the risk of procedural gaps that could lead to biosafety incidents. OpenText Content Server with GCI PowerTools – Workflows provides controlled auditable workflow execution task tracking and record management capabilities. These capabilities support operational integrity accountability and compliance with applicable NIH policies and regulatory requirements while ensuring that records supporting clinical animal care and biosafety operations are managed in accordance with established standards.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable Price reasonableness determination will be included in the acquisition file.