JA JOFOC CDER Sentinel 2.0 Bridge 2 25 2026 word 2 26 2026.pdf

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Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Department of Health and Human Services (HHS) Food and Drug Administration (FDA)

b. Sponsoring organization.

Center for Drug Evaluation and Research (CDER) Office Surveillance and Epidemiology (OSE) Regulatory Science Staff (RSS)

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

i. Name: Sam Carter

ii. Mailing address: WO22 RM2454, 10903 New Hampshire Avenue, Silver Spring MD 20993

iii. E-mail address: Samuel.Carter@fda.hhs.gov

iv. Telephone number: (301) 412-6122

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

Request for approval to enter a sole source bridge contract with Harvard Pilgrim Health Care, Inc. for the continuation of the congressionally mandated Sentinel System program services, under the authority of FAR 6.103-1 – Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Currently, the contract with Harvard Pilgrim Health Care Inc. for the support for the Sentinel System ends on 3/28/2026. The recompeted Sentinel 3.0 contract has not been awarded and is estimated that the award will be executed sometime in Fiscal Year 2026.

To continue support of the Sentinel System until the new contract is awarded, a sole source bridge contract with the incumbent Harvard Pilgrim Health Care Inc. is needed to achieve the continuation of services.

Template mailto:Samuel.Carter@fda.hhs.gov

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a. Acquisition purpose and objectives.

• To supportthe continuation of the Sentinel System until the new contract is awarded, the bridge contract will contain the following activities:

o Implementing ARIA through query design, implementation, and reporting that interrogates insurance billing claims and electronic healthcare data used for post-approval studies

• Maintaining 16 simultaneous queries (or “slots”) and 152 principal programming hours.

• Analytic Tool Maintenance o Real World Evidence (RWE) capabilities o Program and Project management

• Leadership and Program Management, Atlassian Access and Supporting FISMA Compliance

b. Project background.

The Sentinel System is a Congressionally mandated program (FDA Amendments Act (FDAAA) 2007) that requires FDA to collaborate with public, academic, and private entities to develop methods for obtaining access to disparate data sources and to validate means of linking and analyzing safety data from multiple sources. FDA has created a national electronic Active Post-market Risk Identification and Analysis (ARIA) system with at least 100 million individuals. ARIA fulfills FDA's mandate (section 505(o)(3)(D)(i) of the Federal Food, Drug, and Cosmetic Act) to modernize safety surveillance by capitalizing on electronic healthcare data, advancing epidemiological methods, and expanding the FDA's capabilities.

The Sentinel System also responded to the congressionally-mandated Real-World Evidence Medical Data Enterprise that requires a “Queryable–EHR” with at least 10 million lives. This aligns with the 21st Century Cures Act (“Cures Act”) which promotes and strengthens the use of Real-World Evidence (RWE) to support or satisfy post-approval study requirements. The Sentinel System uses RWE for this purpose and is dedicated to developing new analytical approaches and more efficient mechanisms to access data from electronic healthcare data, including electronic health records (EHRs) for at least ten million individuals.

The Sentinel System delivers on these statutory requirements and helps to fulfill the Office of Surveillance and Epidemiology (OSE) mission to monitor and evaluate the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs.

The Sentinel System portfolio of work included in this contract supports the Tasks needed to support, monitor, and operationalize the Sentinel System as well as to support the Sentinel System’s presence in the public sphere to provide the public with transparency on Sentinel System work.

The Harvard Pilgrim Health Care Inc. is the incumbent Contractor collaborating with FDA for the Sentinel System requirements and services and their contract will be ending on March 28, 2026.

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

a. Project title.

SENTINEL SYSTEM SOLE SOURCE BRIDGE CONTRACT WITH HARVARD PILGRIM HEALTH CARE INC FOR THE BASE PERIOD MARCH 29, 2026 THROUGH SEPTEMBER 28, 2026 WITH TWO (2) SIX MONTH OPTION PERIODS.

b. Project Description.

Scope of Work:

The Contractor shall furnish the required personnel, operations, maintenance, enhancements, data resources, analytic capabilities, facilities, and all aspects of the delivery and administration necessary for the performance of this contract, as outlined below. The Contractor shall provide detailed technical/scientific requirements via Work Orders or an equivalent format and as approved by the FDA Sentinel Team.

FDA and the Contractor shall collaborate on the details of the projects for the following tasks, utilizing staff to the best advantage.

Task Areas 1-3 shall be accomplished by the issuance of a firm-fixed price contract for the following areas:

• Task Area 1: ARIA System and Regulatory Support

• Task Area 2: RWE Claims-EHR Linked Data

• Task Area 3: Leadership, Program/Project Management

Requirement type.

☒ Research & Development (R&D) ☐ R&D support services ☐ Support services (non-R&D) ☐ Supplies/equipment ☐ Information Technology (IT) ☐ Construction ☐ Architect-Engineer (A&E) services ☐ Design-build ☐ Other:

Type of action.

☒ New requirement ☐ Follow-on ☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price ☐ Other fixed-price:

☐ Cost-plus-fixed-fee ☐ Other cost reimbursement:

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Time and materials ☐ Indefinite delivery:

☐ Other:

☐ Completion Form ☐ Term Form

Acquisition identification number.

ALP #: CDER-2026-132482

Requisition No. 1288661

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

Total estimated dollar value: $23,569,683.00 Period of Performance: 3/29/2026 – 9/28/2026 (Base), 9/29/2026 – 3/28/2027 (Option 1), 3/29/2027 – 9/28/2027 (Option 2)

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):

☒ 6.103-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C.

2304(c)(1) or 41 U.S.C. 3304(a)(1).

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.

Harvard Pilgrim Health Care Inc 93 Worcester St.

Wellesley, MA 02481

b. Nature of the acquisition.

The Agency determined that awarding the sole source bridge contract to the incumbent Harvard Pilgrim Health Care Inc was the most appropriate decision to make under the circumstances. Harvard Pilgrim is the only known sources capable of meeting the current requirements given their historical execution of the current work with the staff expertise in place to perform the work. Harvard has been the incumbent over the last 15 years. Subject action is to allow for additional time to determine the appropriate acquisition approach for the follow-on services since the current Sentinel services expire on March 28, 2026.

6. 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.

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Market Research was performed by the Program which assessed that no other contractor except for Harvard Pilgrim Health Care Inc. can provide the services needed for this requirement (See attached Market Research document).

To verify this market research and/or to receive comments from the marketplace, the “intent to sole source the bridge contract” was posted to SAM.gov on January 28, 2026 at 3:00 PM ET with an end response date of February 4, 2026, 3:30 PM ET. No contractors responded to the posting (See SAM posting attachment).

Based on the above facts, the market research and the no responses to the “Intent to Sole Source the Bridge Contract” posted on SAM.gov supports the decision to sole source the Sentinel bridge contract to Harvard Pilgrim Health Care Inc.

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

The required work, duration, and cost are defined based on historical knowledge of the program. Harvard Pilgrim Health Care Inc has been the incumbent contractor over a 15-year period and has a firm understanding of the sub-contractor costs, labor categories and rates associate with the contract work efforts. This historical awareness and understanding enables the FDA to conduct effective comparative task analysis to determine price reasonableness.

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

Sufficient marketing research was conducted and is detailed in the marketing research document.

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

Approval to award a sole source bridge contract to the incumbent contractor to ensure continuity of services while a follow-on competitive procurement is completed. The current contract is scheduled to expire next on March 28, 2026. The services provided under this contract are critical to ongoing operations and cannot be interrupted without negatively impacting mission performance. The incumbent contractor possesses unique, project-specific knowledge, technical familiarity, and operational experience developed over the course of the past and current contract. This includes an established understanding of internal processes, system configurations, stakeholder coordination requirements, and performance standards specific to this requirement. Additionally, the contractor has access to established data partners to furnish the necessary medical data for analysis during this period of time.

Transitioning to a new contractor at this time would require a significant learning curve, including onboarding, knowledge transfer, security processing (if applicable), systems access, and operational familiarization. This would result in: Increased risk of service disruption Reduced productivity during the transition period, Additional government oversight and training burden Increased overall costs due to inefficiencies and ramp-up time The cost and time required to train and transition a new contractor for a short-term bridge effort would outweigh any potential cost savings from competition during this interim period. Awarding a bridge contract to the incumbent is the most efficient and cost-effective method to maintain uninterrupted services while the full and open competitive procurement is finalized." This sole source bridge contract will be limited in duration strictly to the time necessary to complete the competitive acquisition process and award the follow-on contract. This request is not intended to circumvent competition, but rather to prevent mission disruption and avoid unnecessary transition costs. Based on the above, I respectfully request approval to proceed with a sole source bridge contract to the incumbent contractor to ensure continuity of services and protection of Government interests.

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

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None.

11. 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.

No further action is considered at this time since program has conducted sufficient marketing research as reflected in the attached marketing research document

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

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WEI

Date

Samuel Carter -S -S Digitally signed by Samuel Carter

Date: 2026.01.26 15:50:51 -05'00'

Signature:

Samuel Carter COR/Requiring Activity POC

Nana Dwumfour COR/POC Immediate Supervisor

Digitally signed by Amarilys Vega

Amarilys Vega -S -S Signature: Date: 2026.01.26 15:58:57 -05' 0 0_'

Amarilys Vega Head of the Sponsoring Program Office

11. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Ian Weiss Contracting Officer

12. Division Director and Head of the Contracting Activity signature(s).

Digitally signed by VIDYA VISH -S Date: 2026.02.04 16:55:36 -05'00'

Signature:

Vidya Vish Division Director

13. Competition Advocate signature.

Bryan Jones Competition Advocate

Bryan E.

Jones -S

Digitally signed by Bryan

-05'00'

DigitaDllyigsiigtnaelldybsyigIAnNedS.by IAN S.

SWSE-SISS -S

08:18:12 11:13-:0485'0-005''00'

Nana N Dwumfour -S

Digitally signed by Nana N.

Dwumfour -S

Date: 2026.01.26 15:47:15

VIDYA VISH -S

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14. Head of Contracting Authority:

Digitally signed by Leonard Grant -S Date: 2026.02.13 12:56:59

Leonard Grant