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Access to Outpatient Longitudinal Data IDIQ   2

ID: 75F40125R00037 • Type: Synopsis Solicitation • Match:  95%
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Description

Posted: June 25, 2025, 4:06 p.m. EDT

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

The solicitation is issued as a request for proposal (RFP) in accordance with the procedures of FAR Part 12, Acquisition of Commercial Products and Commercial Services, in conjunction with the policies and procedures for solicitation, evaluation and award prescribed in FAR Part 15, Contracting by Negotiation.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-03, effective January 17, 2025.

The Government anticipates awarding a multiple-award Indefinite-Delivery Indefinite-Quantity (IDIQ) contract. The Government anticipates issuing two (2) awards to the Offerors who represent the best value to the Government, technical, price and other factors considered, in accordance with the evaluation criteria set forth in this solicitation; however, the Government may make additional awards if determined to be in the best interest of the Government. This RFP is unrestricted; however, the Government will reserve a minimum of one (1) additional award for a small business concern who is determined to be technically capable and who is determined to have proposed a fair and reasonable price, in accordance with the evaluation criteria set forth in this solicitation. The small business program eligibility requirements apply. The North American Industry Classification System (NAICS) code is 541519 with a small business size standard of $34 million or 150 employees.

Offerors must have an active registration in SAM.gov when submitting a proposal and at time of award in order to comply with the annual representations and certifications requirements. Proposals submitted by Offerors without an active registration in SAM.gov or without completed representations and certifications by the close date of the solicitation may not be considered.

See the solicitation and attachments for full details.

NOTE: Both the IDIQ and Task Order #1 are being solicited concurrently. Offerors may be considered ineligible for award if separate proposals for both the IDIQ and Task Order, as specified in the attachments, are not submitted by the proposal due date.

UPDATE 6/25/2025 (AMENDMENT #1): See the amended solicitation and attachments for further details and responses to solicitation questions received. Please ensure pricing is submitted using the amended Attachment 13, Pricing Worksheet, due to changes in the periods of performance and values of both the IDIQ and Task Order.

Posted: June 2, 2025, 1:41 p.m. EDT
Background
The U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) aim to protect public health through various approaches, including evaluating drug risks and promoting safe drug use.

This solicitation seeks to establish a multiple-award Indefinite-Delivery Indefinite-Quantity (IDIQ) contract to provide FDA personnel with access to outpatient longitudinal data, which is essential for understanding adverse event reports and modeling drug risk based on usage patterns.

The contract will support regulatory impact studies, particularly those assessing risk management plans and labeling changes.

Work Details
The contractor shall provide:
1. Continuous automated access to nationally-based outpatient prescription-level data, including historical prescription information at national and sub-national levels.
2. Patient-level data describing outpatient prescription drug use longitudinally, with immediate automated access to counts of current and historical aggregate national and sub-national drug utilization information.
3. A description of the data acquisition process for prescription claims and medical claims data, detailing all data flow and management procedures.
4. The ability to characterize concomitant drug use and duration of drug exposure based on the provided data.
5. Technical support including custom programming, analytical support, training programs, monthly progress reports, disclosure clearance for aggregated data, clearance for third-party collaborations, and ad-hoc technical services.

Overview

Response Deadline
July 3, 2025, 3:00 p.m. EDT Past Due
Posted
June 2, 2025, 1:41 p.m. EDT (updated: June 25, 2025, 4:06 p.m. EDT)
Set Aside
None
Place of Performance
Silver Spring, MD United States
Source
SAM

Current SBA Size Standard
$34 Million
Pricing
Likely Fixed Price
Evaluation Criteria
Best Value
Est. Level of Competition
Average
Vehicle Type
Indefinite Delivery Contract
Signs of Shaping
52% of similar contracts within the Food and Drug Administration had a set-aside.
On 6/2/25 Food and Drug Administration issued Synopsis Solicitation 75F40125R00037 for Access to Outpatient Longitudinal Data IDIQ due 7/3/25. The opportunity was issued full & open with NAICS 541519 and PSC B529.
Primary Contact
Name
Noah Wills   Profile
Phone
None

Documents

Posted documents for Synopsis Solicitation 75F40125R00037

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > FOOD AND DRUG ADMINISTRATION > FDA OFFICE OF ACQ GRANT SVCS
FPDS Organization Code
7524-00223
Source Organization Code
100188033
Last Updated
July 19, 2025
Last Updated By
noah.wills@fda.hhs.gov
Archive Date
July 18, 2025