Regulated activities support for the US army medical research and development command office of regulated activities

Active Indefinite Delivery Contract Awarded Last action

Contract number
W81XWH21D0003
Awardee
Awarding agency
Task orders
8 $35,059,587 obligated

Award facts

Combined order value
  • $35,059,587 Current, with exercised options
  • $35,972,716 Potential, with all options
Last date to order 56% complete
IDV ceiling 18% used
$190,000,000.00
Maximum order
$35,000,000.00
Award type
Single award
Who can order
Only the awarding agency
Contracting staff
Funding agency
Medical Command Department of the Army, Department of Defense
Set-aside
No set-aside
Competition
Full and Open Competition · 3 offers Negotiated Proposal / Quote
Pricing
Firm Fixed Price
Legislative mandates

Award details come from SAM.gov/FPDS.

About this IDV

The Army Medical Command awarded a single-award indefinite-delivery contract to General Dynamics Information Technology, Inc. on April 1, 2021, with a $190 million ceiling for regulated activities support and non-personal support services to the U.S. Army Medical Research and Development Command Office of Regulated Activities, with final completion on March 31, 2031.

Performance occurs in Frederick, Maryland. The originating solicitation, posted December 22, 2020, sought clinical research support, quality management, regulatory compliance, data management, and product oversight services under a base period of one year plus four one-year options, with an estimated value of $50 million and anticipated maximum value of $95 million over five years plus options. The contract was awarded unset-aside.

The contract operates through firm fixed-price delivery orders. Recent task order activity includes a $7.51 million delivery order issued August 1, 2025, for non-personal support services with completion by July 31, 2026, with Allied Technologies and Consulting, LLC (service-disabled veteran-owned small business) and Aotek, LLC (women-owned small business) as subcontractors; a $7.02 million delivery order issued August 1, 2024, for non-personal support services with completion by July 31, 2025, also engaging Allied Technologies and Consulting and Aotek as subcontractors; and a $311,081.26 delivery order issued March 11, 2024, through the Defense Health Agency for FDA regulatory compliance training in support of the Office of Regulatory Affairs training program, with completion by March 10, 2025. Additional task orders include a $1.45 million delivery order for clinical protocol data management support (tecovirimat) with completion September 24, 2028; a $6.61 million delivery order for non-personal support services to the Office of Regulated Activities with completion August 31, 2025; a $6.95 million delivery order for Office of Regulatory Affairs support with completion July 31, 2023; and a $446,171 delivery order for Office of Research and Analysis training program support with completion October 31, 2023.

Task orders

Transactions

Action Obligated Date
Other Administrative Action P00007 · Non-personal support services for the office of regulated activities. $0
Supplemental Agreement for work within scope P00006 $0
Supplemental Agreement for work within scope P00005 $0
Supplemental Agreement for work within scope P00004 · Office of regulatory affairs support services $0
Supplemental Agreement for work within scope P00003 · ORA support services base contract $0
Supplemental Agreement for work within scope P00002 · Add labor categories and ceiling rates. Per section 711 of the 2019 ndaa, usamraa transferred to DHA 10/01/2022. $0
Other Administrative Action P00001 $0
Original award $0

Subawards

Subcontractor Amount Awarded
Allied Technologies And Consulting, LLC NON-PERSONAL SUPPORT SERVICES FOR THE OFFICE OF REGULATED ACTIVITIES. services $934,323
Aotek, LLC NON-PERSONAL SUPPORT SERVICES FOR THE OFFICE OF REGULATED ACTIVITIES. services $875,314
Allied Technologies And Consulting, LLC NON-PERSONAL SUPPORT SERVICES ORA services $975,710
Aotek, LLC NON-PERSONAL SUPPORT SERVICES FOR ORA services $876,394
PPD Development LP FDA REGULATORY COMPLIANCE TRAINING services $280,030

Quick answers

Who was awarded contract W81XWH21D0003?

W81XWH21D0003 was awarded to General Dynamics Information Technology, Inc. by Defense Health Agency (Department of Defense) on April 1, 2021.

How much is contract W81XWH21D0003 worth?

Orders under W81XWH21D0003 have obligated $35,059,587. Their combined potential value, with all options, is $35,972,716. W81XWH21D0003's own ceiling is $190,000,000. A single order can be worth up to $35,000,000.

How many orders have been placed under contract W81XWH21D0003?

8 orders have been placed under W81XWH21D0003, the latest on August 1, 2025.

Which agency awarded contract W81XWH21D0003?

Defense Health Agency (Department of Defense) awarded W81XWH21D0003, with funding from Medical Command (Department of the Army).

Who can order from contract W81XWH21D0003?

W81XWH21D0003 is a single award indefinite delivery contract. Only the awarding agency can place orders on it.

Was contract W81XWH21D0003 competed?

The extent of competition for W81XWH21D0003 was full and open competition. The government received 3 offers.

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