Dpmwp 217/cdrh-2022-112765 - develop standards for data quality and data sources that increase the quality, interoperability, and usability of real-world data.

Active Definitive Contract Awarded Last action

Contract number
75F40122C00143
Awardee
Awarding agency
Obligated
$47,092,964

Award facts

Opportunity
Contract value 100% obligated
$47,188,963.80 Current and potential, with all options
Completion date 87% complete
Current and potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 165 offers Negotiated Proposal / Quote
Pricing
Firm Fixed Price
Place of performance
Silver Spring, MD 20993, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action P00011 · Systemic harmonization and interoperability enhancement for laboratory data (SHI $0
Other Administrative Action P00009 · No cost modification to change the period of performance end date to june 10, 2026. $0
Other Administrative Action P00008 · No cost modification to change the period of performance end date to april 26, 2026. $0
Supplemental Agreement for work within scope P00007 · Supplemental agreement for work within scope $200,000
Other Administrative Action P00006 · No cost modification to change the period of performance end date to march 27, 2026. $0
Other Administrative Action P00005 $0
Other Administrative Action P00004 $0
Other Administrative Action P00003 · Optimizing knowledge management processes that enable a highly reliable laboratory data life cycle $0
Supplemental Agreement for work within scope P00002 $36,893,044
Other Administrative Action P00001 · Dpmwp 217/cdrh-2022-112765 - amend the contract type: firm fixed price (FFP) with cost reimbursable (CR) travel and other direct costs (odcs), and provide a… $0
Original award $9,999,920
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About this award

Written by GovTribe AI ·

The Food and Drug Administration awarded a firm fixed-price definitive contract to Deloitte Consulting LLP on September 26, 2022, for developing standards for data quality and data sources to increase the quality, interoperability, and usability of real-world data, with a ceiling value of $47.2 million and an ultimate completion date of June 9, 2027.

The originating solicitation was the FDA's Broad Agency Announcement for Advanced Regulatory Science (posted November 20, 2020, due January 28, 2021), seeking research and development proposals across eight areas of regulatory science to modernize toxicology, stimulate clinical innovation, support manufacturing, evaluate emerging technologies, and harness data science. Place of performance is Silver Spring, Maryland.

Work encompasses systemic harmonization and interoperability enhancement for laboratory data (SHIELD), including development of knowledge architecture standards such as Solor. Under the SCI reporting framework, the contract delivered 26.8 FTEs and 55,825 contractor hours in FY2023, 40.6 FTEs and 84,580 hours in FY2024, and 54.5 FTEs and 113,262 hours in FY2025. Government-paid hourly rates increased from $176.72/hr in FY2023 to $131.64/hr in FY2024, then rose to $211.74/hr in FY2025. In FY2025, 20 percent of contractor hours were subcontracted to a team including the University of Nebraska Medical Center, M9 Solutions LLC, Goal Group LLC, RJT Compuquest Inc., Nasscomm Consulting LLC, Dexian LLC, Synensys LLC, and Trivad Inc.

Subawards

Subcontractor Amount Awarded
Trivad, Inc. Dpmwp 217/cdrh-2022-112765 - develop standards for data quality and data sources that increase the quality, interoperability, and usability of real-world… $46,486
Subcontractor not on record OPTIMIZING KNOWLEDGE MANAGEMENT PROCESSES THAT ENABLE A HIGHLY RELIABLE LABORATORY DATA LIFE CYCLE DPMWP 217/CDRH-2022-112765 - Develop standards for data… $530,324
Subcontractor not on record Dpmwp 217/cdrh-2022-112765 - develop standards for data quality and data sources that increase the quality, interoperability, and usability of real-world… $228,500
Board Of Regents Of The University Of Nebraska OPTIMIZING KNOWLEDGE MANAGEMENT PROCESSES THAT ENABLE A HIGHLY RELIABLE LABORATORY DATA LIFE CYCLE DPMWP 217/CDRH-2022-112765 - Develop standards for data… $134,152
Board Of Regents Of The University Of Nebraska OPTIMIZING KNOWLEDGE MANAGEMENT PROCESSES THAT ENABLE A HIGHLY RELIABLE LABORATORY DATA LIFE CYCLE FDA-CDRH SHIELD Knowledge Architecture (Solor) $134,152
M9 Solutions LLC OPTIMIZING KNOWLEDGE MANAGEMENT PROCESSES THAT ENABLE A HIGHLY RELIABLE LABORATORY DATA LIFE CYCLE FDA-CDRH SHIELD Knowledge Architecture (Solor) $994,600
M9 Solutions LLC OPTIMIZING KNOWLEDGE MANAGEMENT PROCESSES THAT ENABLE A HIGHLY RELIABLE LABORATORY DATA LIFE CYCLE FDA-CDRH SHIELD Knowledge Architecture (Solor) $586,608
Goal Group LLC DPMWP 217/CDRH-2022-112765 - DEVELOP STANDARDS FOR DATA QUALITY AND DATA SOURCES THAT INCREASE THE QUALITY, INTEROPERABILITY, AND USABILITY OF REAL-WORLD… $401,793
RJT Compuquest, Inc. OPTIMIZING KNOWLEDGE MANAGEMENT PROCESSES THAT ENABLE A HIGHLY RELIABLE LABORATORY DATA LIFE CYCLE FDA-CDRH SHIELD Knowledge Architecture (Solor) $171,656
Nasscomm Consulting, LLC OPTIMIZING KNOWLEDGE MANAGEMENT PROCESSES THAT ENABLE A HIGHLY RELIABLE LABORATORY DATA LIFE CYCLE FDA-CDRH SHIELD Knowledge Architecture (Solor) $69,680
Dexian, LLC DPMWP 217/CDRH-2022-112765 - DEVELOP STANDARDS FOR DATA QUALITY AND DATA SOURCES THAT INCREASE THE QUALITY, INTEROPERABILITY, AND USABILITY OF REAL-WORLD… $674,396
Synensys, LLC DPMWP 217/CDRH-2022-112765 - DEVELOP STANDARDS FOR DATA QUALITY AND DATA SOURCES THAT INCREASE THE QUALITY, INTEROPERABILITY, AND USABILITY OF REAL-WORLD… $1,017,764
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Quick answers

Who was awarded contract 75F40122C00143?

75F40122C00143 was awarded to Deloitte Consulting LLP by Food and Drug Administration (Department of Health and Human Services) on September 26, 2022.

How much is contract 75F40122C00143 worth?

The government has obligated $47,092,964 on 75F40122C00143. Its current value, with exercised options, is $47,188,964.

Was contract 75F40122C00143 competed?

The extent of competition for 75F40122C00143 was full and open competition. The government received 165 offers.

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