Redacted JA EIRB FY25-0041_Redacted.pdf

CUI

Control Number: FY25-0041

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

Justification and Approval (J&A) for Other than Full and Open Competition Federal Acquisition Regulation (FAR) Part 6

1. Identification of the Agency and Contracting Activity: The Defense Health Agency (DHA), 7700 Arlington Blvd, Suite 5101, Falls Church, VA 22042. Professional Services � Contracting Directorate, plans to award a contract on an exception to fair opportunity basis based on the statutory exception and supporting rationale provided herein.

2. Nature and/or Description of Action being Approved: The Government intends to award a firm fixed price (FFP) contract, on a sole source basis, to Aderas, Inc., 11911 Freedom Drive Suite 580, Reston, VA 20190-5629 in support of the Solution Delivery Division (SDD) Electronic Institutional Review Board (EIRB) program. The Government is utilizing Fiscal Year 2025 Operations and Maintenance (O&M) funds. The overall period of performance of the resultant contract will be 3 September 2025 through 2 September 2030, consisting of a base period and four 12-month options. A FAR 52.217-8 Option to Extend Services will be included in the resultant contract should a need arise in accordance with FAR 37.111. The total overall estimated dollar value is $13,739,985.58.

3. Description of Supplies/Services and Estimated Value:

DHA requires renewal of specific commercial enterprise software licenses and associated Tier III Information Technology maintenance and support services in support of the EIRB system. The scope is to renew current Cayuse integrated Research Information Software (iRIS) enterprise software license subscriptions with the developer-supported license agreement and to provide the required platform and software maintenance and support services for the EIRB information technology solution. The government intends to make a sole-source award to Aderas, Inc., 11911 Freedom Drive Suite 580, Reston, VA 20190-5629 in support of the Solution Delivery Division EIRB program.

EIRB is the DoD-approved enterprise system for managing the lifecycle research review and oversight processes for DoD Institutional Review Boards. EIRB automates the following processes:

Human Subjects biomedical and social/behavioral research;

Institutional Animal Care and Use Committee;

Institutional Biosafety Committee, Radiation Safety, Cooperative Research and Development Agreement (CRADA)/Grants, Scientific Review, and Publication Clearance;

Unique DoD review needs (e.g., Federal Health Program and Resource Program Manager Network, etc.).

EIRB gathers data to support enterprise level strategic decisions regarding regulatory system

Control Number: FY25-0041

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

Approval Based on the foregoing justification, I hereby approve the procurement of EIRB program services being procured and total dollar value of $13,739,985.58 on an other than full and open competition basis pursuant to the authority of FAR 6.302-1(a)(2)(iii)(A), Substantial duplication of cost to the Government that is not expected to be recovered through competition., subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.