Center for biologics evaluation and research (CBER) requirement for biologics effectiveness and safety (BEST) initiative #3: health care data sources for surveillance of biologics (BEST 3)

Active Awarded Last action

Contract number
75F40124D00044
Awardee
Awarding agency
Task orders
2 $16,102,809 obligated

Award facts

Combined order value
$16,102,809 Current and potential, with all options
Last date to order 42% complete
IDV ceiling 21% used
$75,000,000.00
Award type
Multiple award
Who can order
Only the awarding agency
Set-aside
No set-aside
Competition
Full and Open Competition · 8 offers Negotiated Proposal / Quote
Pricing
Order Dependent (IDV only)
Legislative mandates

Award details come from SAM.gov/FPDS.

About this IDV

The Lewin Group, Inc., a subsidiary of UnitedHealth Group Incorporated, was awarded a $75M Indefinite Delivery Contract (IDC) by the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) to support the Biologics Effectiveness and Safety (BEST) Initiative #3. This multiple-award IDC has a 5-year ordering period and aims to obtain large-scale, longitudinal healthcare data from the U.S. covering tens of millions of patients, as well as access to full medical charts for patient data review and adjudication.

Under a $8.26M Delivery Order, The Lewin Group will provide the FDA with distributed-type access to administrative claims data or claims and electronic health record data, using a common data model if necessary. The contractor must be a primary source of the data, such as a health insurer, payer, or provider. This unrestricted, full and open competition contract supports the CBER's surveillance activities for biologic products. The performance period runs through September 2025, leveraging The Lewin Group's expertise in health policy research, data analytics, program evaluation, and implementation support.

Task orders

Transactions

Action Obligated Date
Other Administrative Action P00001 $0
Original award $10,000

Quick answers

Who was awarded contract 75F40124D00044?

75F40124D00044 was awarded to The Lewin Group, Inc. by Food and Drug Administration (Department of Health and Human Services) on September 26, 2024.

How much is contract 75F40124D00044 worth?

Orders under 75F40124D00044 have obligated $16,102,809. 75F40124D00044's own ceiling is $75,000,000.

How many orders have been placed under contract 75F40124D00044?

2 orders have been placed under 75F40124D00044, the latest on September 30, 2026.

Who can order from contract 75F40124D00044?

75F40124D00044 is a multiple award indefinite delivery contract. Only the awarding agency can place orders on it.

Is contract 75F40124D00044 part of a contract vehicle?

Yes. 75F40124D00044 is part of CBER BEST Initiative 3 - Data Sources for Surveillance of Biologics.

Was contract 75F40124D00044 competed?

The extent of competition for 75F40124D00044 was full and open competition. The government received 8 offers.

On GovTribe

See this IDV's full record

  • Every order and transaction
  • The awardee's other awards and teaming partners
  • Similar IDVs and recompete opportunities
  • Ask GovTribe AI about this IDV