JEFO - FY25 CORE DF Annual Service Support - CO signed - 8.15.25.pdf

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Justification for an Exception to Fair Opportunity - Core DataFit (DF) Annual Service Support

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Health and Human Services (HHS) - Food and Drug Administration (FDA)

b. Sponsoring organization.

Center for Drug Evaluation and Research (CDER) - Office of Translation Sciences (OTS), Office of

Computational Sciences (OCS)

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

i. COR/POC: Nikolaos Rementelas

ii. E-mail address: Nikolaos.Rementelas@fda.hhs.gov

iii. Telephone number: 240-559-4058

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

a. Acquisition purpose and objectives

The nature of the action being approved is a request to enter into a sole-source bridge Task Order with

International Business Machines Corp (IBM) for Core Data Fitness (CoreDF) Service. This sole-source designation has been determined to be the only reasonable path forward as IBM possesses distinctive specialized Subject Matter expertise, technological capabilities and proprietary analytical tools, and that the FDA has determined is essential for its regulatory mission and cannot be adequately replicated by other vendors in the required timeframe or quality level. The task order is currently being executed by

International Business Machines Corp (IBM), under Contract 75F40119A10019 Task Order

75F40124F19041.

mailto:Nikolaos.Rementelas@fda.hhs.gov

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The objectives of this task order are to obtain data management and analysis to support the OCS’s delivery of its Core Data Fitness Assessment for the review of clinical and non-clinical study data.

The Data Fitness activity is based on the assumption that all submissions will be validated by DataFit. The

Core Data Fitness Assessment includes using the DatFit tool to produce the appropriate reports and communicating the results to the reviewers.

b. Project background.

The CDER Office of Computational Science (OCS) was created in 2009 with the mission of improving the effectiveness and efficiency of regulatory review work through development and introduction of new technology. Since then, the CSC has led several initiatives with the goal of identifying, developing, and implementing new technologies to improve review capabilities.

In FY2018, the OCS launched a pilot to provide a “Core DataFitness” service. The service along with the tool it utilizes will ensure all submissions receive an automated data quality validation early in the review cycle to provide reviewers information that would help them assess the quality and “reviewability” of clinical trials study data. Core DataFitness findings are intended to help clinical reviewers gain a better understanding of submission study data and the types of analyses that could be performed, and to identify potential information requests for the sponsor.

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

This is a single-award GSA task order to prevent service disruption of mission-critical operations and support of the Core DataFitness program.

a. Project title.

FY25 Core Data Fitness (CoreDF) Annual Service Support

b. Project Description.

The Statement of Work has attached in lieu of providing a project description.

Requirement type.

☒ Information Technology (IT)

Type of action.

☒ Follow-on (GS35F110DA/BPA 75F40119A10019 Task Order 75F40124F19041)

Proposed contract/order type.

☒ Labor Hour/ Firm-Fixed Price

Acquisition identification number.

CIN: CDER-OTS-25-C-1147

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ALP: CDER-2025-127621

• Required Service Continuity Date: 09/15/2025

• Maximum Allowable Service Gap: Zero days (mission-critical designation)

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

The total estimated dollar value is $689,620.00 with the performance period from 9/15/2025 to 9/14/2026.

4. Identification of the exception to fair opportunity (see 16.505(b)(2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g., in terms of scope, period of performance, or value).

☒ (A) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays (See supporting rationale in section 6).

☒ (B) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

IAW 16.505(a)(4)(ii) suggests placing brand-name justifications under this exception (See supporting rationale in section 6).

☐ (C) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

☐ (D) It is necessary to place an order to satisfy a minimum guarantee.

☐ (E) For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source.

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

GSA Pricing is predetermined fair and reasonable cost to the Government. Additionally, price reasonableness will be determined by the Contracting Officer during pricing negotiation, as necessary, in order to achieve FDA’s cost-saving initiative; ensuring IBM’s GSA proposed pricing is not to exceed 5% average industrial annual price adjustment.

https://www.acquisition.gov/far/html/Subpart%2016_5.html https://www.acquisition.gov/far/html/Subpart%2016_5.html

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6. Any other facts supporting the justification.

The proposed competitive Regulatory Review BPAs that were intended to be utilized, to fulfill this requirement is undergoing a protest. The award decision has been delayed by three rounds of protests that are still being adjudicated as of August 14, 2025. Contracting anticipates a protest resolution within the next 90 days. However, even if the award is made sooner, contracting would not have sufficient time to conduct a competitive procurement turnaround by 09/16/25.

Due to the on-going protest, adequate transition-out and transition-in time is unavailable, creating substantial project failure risk including:

• Operational Downtime and Loss of Reviewer Productivity: Without continuity of support, reviewers and CDER staff may face delays accessing critical regulatory review tools, troubleshooting issues, or receiving timely support, directly impacting regulatory timelines and workload management.

• Incomplete or Inaccurate Knowledge Transfer: Given the contractor’s institutional knowledge of CDER systems, tools, processes, and stakeholder needs, insufficient transition time would lead to knowledge loss, poor SOP adherence, and inaccurate or inefficient support resolution pathways.

Failure to Maintain FDA-Specific Security and Compliance Standards: The contractor operates within FDA’s IT and communications framework and adheres to sensitive security and privacy protocols. Introducing a new vendor without adequate onboarding time increases the risk of compliance violations or delayed onboarding due to clearance or system access constraints.

In accordance with FAR 16.505(b)(2)(A), the agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays. As a result, a direct task order will be issued to a sole-source awardee, utilizing GSA GWAC, in accordance with FAR 16.505(a)(4)(ii); as only one awardee is capable of providing the services required, at the level of quality required because the services ordered are unique - Brand Name justification is not required for nonitemized services.

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7. 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.

Service continuations are anticipated for this requirement. The new competitive BPA will be awarded by the beginning of FY26. The contract establishment will provide the IPT the ability to place new task orders, including transition-in tasks, against the BPA for FY26 actions and any other requirements within scope over the next five (5) year from 2026 to 2030. This will allow for a seamless transition of work from the current incumbent to the new awardee, without any major disruptions in mission-critical support.

The proposed preparations for the competitive procurement milestone are indicated as follows:

Phase 1 - BPA Award (FY26 Q1):

• Complete competitive BPA award process

• Finalize multi-vendor selections

• Establish ordering procedures Phase 2 - Transition Planning (FY26 Q2):

• Develop comprehensive transition plans

• Conduct vendor capability assessments

• Create knowledge transfer protocols Phase 3 - Competitive Ordering (FY26 Q3 and beyond):

• Issue competitive task orders under new BPA

• Execute seamless transition from incumbent

• Ensure continued mission-critical support

8. Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel

(e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

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Signature:

Nikolaos Rementelas COR/Requiring Activity POC

Digitally signed by Susanne M.

Susanne M. Lenk -S Lenk -S

Date: 2025.08.15 13:18:05 -04'00'

Susanne Lenk

COR/POC Immediate Supervisor

Digitally signed by Isaac A.

Chang -S Date: 2025.08.15 15:36:04 -04'00'

Signature:

ShaAvhree Buckman-Garner

Head of the Sponsoring Program Office

9. Contracting Officer Certification.

The CO shall complete the information required below and sign the certification in the block provided.

(NOTE: The CO’s signed certification may serve as approval of a JEFO over $250,000 but not exceeding

$750,000, FAR 16.505(b)(2)(A) and FAR 16.505(a)(4)(ii), depending on OPDIV procedures.)

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

James Jenrette III Contracting Officer

10. Division Director and Head of the Contracting Activity signature

Vidya Vish Division Director

11. Competition Advocate signature.

Tommy Kim Competition Advocate

NIKOLAOS D.

-04'00'

Isaac A. Chang -S