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IdiQ Sentinel System 3.0: Program Management Organization (PMO)   2

ID: RFP75F40124R00181 • Type: Synopsis Solicitation

Description

Posted: Aug. 27, 2024, 1:43 p.m. EDT

FDA is launching the new Sentinel System 3.0 in fiscal year 2025.

The Sentinel System 3.0 will include the following components: (1) the FDA Sentinel Coordinating Center (SCC) managed by the Sentinel Core Team (SCT)) in CDER's OSE, (2) the Sentinel Data Hub (a contract that will provide access to health care data and scientific support services), (3) the Sentinel Program Management Organization (PMO) (a contract that will provide program/project management and business informatics support services), and (4) Federal Partners with which FDA has established interagency agreements to support scientific research (e.g., Centers for Medicare and Medicaid Services (CMS)).

This procurement is for the Sentinel Program Management Organization (PMO).

8/27/2024: This modification to this solicitation includes the following attachments.:

1. Contractor Questions and Government Responses

2. Solicitation (Instructions to Offerors and Evaluation Criteria) updated based on Contractor Questions

3. FDA IT and Privacy Document

4. Medical Code Lookup Tool and Evaluation Report

5. Updated Attachment I: Task Order Pricing Table

6. Updated Attachment B: IDIQ Pricing Table

Posted: Aug. 19, 2024, 3:19 p.m. EDT
Background
The FDA is launching the new Sentinel System 3.0 in fiscal year 2025 to enhance its safety surveillance mission. This initiative is based on previous assessments and experiences with the Sentinel System, aiming to improve regulatory science methods and tools while addressing key FDA regulatory needs.

The Sentinel System 3.0 consists of several components, including the FDA Sentinel Coordinating Center (SCC), the Sentinel Data Hub, and the Program Management Organization (PMO). The PMO will provide program/project management and business informatics support services.

Work Details
The contractor will be responsible for various tasks under the PMO, including:
1. Development and maintenance of a Collaboration Platform to facilitate secure communication and data exchange among stakeholders.
2. Transitioning content from the current Sentinel Initiative Website and Source Code Repository to the new platform.
3. Providing operations and maintenance (O&M) support for the Collaboration Platform, Website, and Source Code Repository.
4. Regulatory operations support, including managing requests for services, workflow management, project management planning, and conducting program meetings.
5. Developing Program Management Plans that include quality management, risk management, communication strategies, and staffing plans.
6. Transition-In/Out services to ensure continuity during changes in contract performance.

Place of Performance
The work will primarily take place at the contractor's site but may involve collaboration with various federal partners and stakeholders.

Overview

Response Deadline
Aug. 30, 2024, 2:00 p.m. EDT Past Due
Posted
Aug. 19, 2024, 3:19 p.m. EDT (updated: Aug. 27, 2024, 1:43 p.m. EDT)
Set Aside
Women-Owned Small Business (WOSB)
Place of Performance
Silver Spring, MD United States
Source
SAM

Current SBA Size Standard
$19.5 Million
Est. Level of Competition
Average
Vehicle Type
Indefinite Delivery Contract
Signs of Shaping
61% of obligations for similar contracts within the Food and Drug Administration were awarded full & open.
On 8/19/24 Center for Drug Evaluation and Research issued Synopsis Solicitation RFP75F40124R00181 for IdiQ Sentinel System 3.0: Program Management Organization (PMO) due 8/30/24. The opportunity was issued with a Women-Owned Small Business (WOSB) set aside with NAICS 541990 (SBA Size Standard $19.5 Million) and PSC R499.
Primary Contact
Name
Howard S. Yablon   Profile
Phone
None

Secondary Contact

Name
Ian Weiss   Profile
Phone
None

Documents

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > FOOD AND DRUG ADMINISTRATION > FDA CENTER FOR DRUG EVALUATION AND RESEARCH
FPDS Organization Code
7524-75DKKN
Source Organization Code
500024274
Last Updated
Sept. 14, 2024
Last Updated By
howard.yablon@fda.hhs.gov
Archive Date
Sept. 14, 2024