Regulatory review support services

Ended Awarded Last action

Contract number
75F40119A10019
Awardee
Awarding agency
Task orders
45 $139,012,975 obligated

Award facts

Combined order value
  • $139,642,324 Current, with exercised options
  • $154,624,241 Potential, with all options
Last date to order 100% complete
IDV ceiling 85% used
$163,000,000.00
Maximum order
$10,000,000.00
Award type
Multiple award
Who can order
Only the awarding agency
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 4 offers Multiple Award, Fair Opportunity
Pricing
Firm Fixed Price
Legislative mandates

Award details come from SAM.gov/FPDS.

About this IDV

Written by GovTribe AI ·

This Blanket Purchase Agreement (BPA) contract was awarded by the Food and Drug Administration (FDA), a civilian agency within the U.S. Department of Health and Human Services, to International Business Machines Corporation (IBM) as the prime contractor. The contract has a ceiling value of $163,000,000 and a performance period through March 29, 2025. Under this BPA, IBM will provide a range of regulatory review support services to the FDA, including data management, analysis, standards development, and system modernization. Multiple task orders have been issued to IBM, valued at over $60 million, to deliver specific services such as data quality assurance, clinical data safety analysis, data standards testing, and regulatory submission support across the FDA's Centers for Drug Evaluation and Research, Cosmetics and Colors, and Tobacco Products. IBM has subcontracted portions of the work to several small and minority-owned businesses to provide specialized computer programming and IT services in support of the FDA's mission-critical initiatives.

The original solicitation was issued by the General Services Administration's Federal Acquisition Service for the IT Schedule 70 contract vehicle, which provides federal agencies access to a broad range of commercial information technology products and services. The BPA was established under Schedule 70 to enable the FDA to efficiently procure the necessary technology solutions and subject matter expertise to support its regulatory review activities. While no small business set-asides were used, IBM has demonstrated a track record of partnering with small and disadvantaged firms as subcontractors on these types of federal contracts.

Task orders

Task order Ordering agency Obligated Awarded
OCS service desk 75F40124F19047 Food and Drug Administration $1,919,214
Improvements in pharmaceutical quality/chemistry, manufacturing, and control (PQ/CMC) data standards for regulatory… 75F40124F19046 Food and Drug Administration $1,941,470
Task order - continuation of office of biostatistics development of DHT training materials phase 2 75F40124F19045 Food and Drug Administration $201,242
Office of computational science regulatory review support services 75F40124F19044 Food and Drug Administration $5,269,992
To provide specialized programming and analytical support to OCS- cder 75F40124F19042 Food and Drug Administration $1,524,429
Data standards testing and implementation 75F40124F19040 Food and Drug Administration $525,894
Clinical data safety analysis 75F40124F19043 Food and Drug Administration $813,782
Support for data quality services - OCS contract that supports subject matter expertise for the development of data… 75F40124F19041 Food and Drug Administration $691,894
Data management and analysis support for the OCS clinical services 75F40124F19038 Food and Drug Administration $2,248,319
Cder OCS kickstart 75F40124F19037 Food and Drug Administration $1,215,041
Regulatory review support services: data management and quality support 75F40123F19035 Food and Drug Administration $4,084,553
To provide analytical and programming expertise to support OCS- cder 75F40123F19033 Food and Drug Administration $1,498,404
Real world data-data standards 75F40123F19036 Food and Drug Administration $2,370,763
OB development of digital health technologies (DHT) biostatistics training mate 75F40123F19034 Food and Drug Administration $399,824
Data modernization phase 2 75F40123F19032 Food and Drug Administration $17,654,993
Title: analysis data standards support ?digital health technologies task order phase 3 75F40123F19030 Food and Drug Administration $1,199,687
Adims legacy systems operation & maintenance support 75F40123F19029 Food and Drug Administration $1,764,729
?data management and data quality -bimo ? 75F40122F19028 Food and Drug Administration $349,913
Real world data - data standards for submission to FDA 75F40122F19027 Food and Drug Administration $989,937
To provide safety analytic support for cder. 75F40122F19026 Food and Drug Administration $1,819,358
Analysis data standards support digital health technologies 75F40122F19025 Food and Drug Administration $383,562
Improvements in pharmaceutical quality chemistry manufacturing and control (PQ CMC) data standards for regulatory… 75F40121F19024 Food and Drug Administration $6,078,383
Task order for subject matter expertise and project management to continue support of the OCS strategic plan and… 75F40121F19021 Food and Drug Administration $283,901
Real world data- data standards for submission to FDA 75F40121F19023 Food and Drug Administration $1,281,034
Data standards testing and implementation for cder. 75F40121F19022 Food and Drug Administration $1,197,732
Evaluation of modernization of submission file transport at FDA 75F40121F19020 Food and Drug Administration $499,625
Regulatory review support services 75F40121F19019 Food and Drug Administration $5,032,844
Analysis data standards support phase III 75F40121F19018 Food and Drug Administration $817,474
To provide data modernization for CTP office. 75F40121F19017 Food and Drug Administration $14,143,768
Regulatory review support services 75F40120F19016 Food and Drug Administration $366,537
Real world data - data standards for submission to FDA 75F40120F19015 Food and Drug Administration $920,775
Regulatory review support services 75F40120F19014 Food and Drug Administration $5,794,063
Improvements in pharmaceutical quality chemistry manufacturing and control (PQ CMC) data standards for regulatory… 75F40120F19013 Food and Drug Administration $1,491,235
Core data fitness 75F40120F19012 Food and Drug Administration $2,577,856
Statistical programming support services 75F40120F19011 Food and Drug Administration $3,030,551
Data standards testing and implementation 75F40120F19010 Food and Drug Administration $355,175
Data management and analysis support for the OCS clinical services 75F40120F19008 Food and Drug Administration $8,495,440
Data management & analysis support for the OCS nonclinical services. 75F40120F19009 Food and Drug Administration $4,152,159
CTP OS customer service center contract 75F40120F19006 Food and Drug Administration $19,414,884
Provide office of computational science service desk support and communications services. 75F40120F19007 Food and Drug Administration $9,039,263
Data standards: nonalcoholic steatohepatitis clinical trials data technical specification project task order 75F40120F19005 Food and Drug Administration $239,867
Adapting to evolving HL7 standards to ensure continuity of operations and enabling enhancements at FDA 75F40120F19003 Food and Drug Administration $1,396,672
Scientific support JMP JMP clinical program training and support 75F40120F19004 Food and Drug Administration $1,371,097
Data standards support 75F40120F19002 Food and Drug Administration $379,305
Adims legacy systems operation and maintenance support 75F40120F19001 Food and Drug Administration $1,786,337
Show all 45

Transactions

Action Obligated Date
Supplemental Agreement for work within scope P00008 $0
Supplemental Agreement for work within scope P00007 $0
Supplemental Agreement for work within scope P00006 $0
Other Administrative Action P00005 $0
Exercise an Option P00004 $0
Other Administrative Action P00003 $0
Other Administrative Action P00002 $0
Other Administrative Action P00001 $0
Original award $0

Subawards

Subcontractor Amount Awarded
Callideo, Inc. Data modernization phase 2 0 $66,913
Callideo, Inc. DATA MODERNIZATION PHASE 2 Computer Programmers - Time & Material - Tech Services $382,018
Callideo, Inc. ODC CHANGE -- DATA MODERNIZATION PHASE 2 Computer Programmers - Time & Material - Tech Services $51,623
Eclaro International Inc. ADIMS LEGACY SYSTEMS OPERATION & MAINTENANCE SUPPORT Computer Programmers - Time & Material - Tech Services $251,040
Eclaro International Inc. ADIMS LEGACY SYSTEMS OPERATION & MAINTENANCE SUPPORT Computer Programmers $375,640
Samvit Solutions LLC TO CORRECT P00006 PERIOD OF PERFORMANCE AND TOTAL OBLIGATED AMOUNT. Computer Programmers $689,588

Quick answers

Who was awarded contract 75F40119A10019?

75F40119A10019 was awarded to International Business Machines Corporation by Food and Drug Administration (Department of Health and Human Services) on September 26, 2019.

How much is contract 75F40119A10019 worth?

Orders under 75F40119A10019 have obligated $139,012,975. Their combined current value, with exercised options, is $139,642,324. Their combined potential value, with all options, is $154,624,241. 75F40119A10019's own ceiling is $163,000,000. A single order can be worth up to $10,000,000.

How many orders have been placed under contract 75F40119A10019?

45 orders have been placed under 75F40119A10019, the latest on September 16, 2024.

Who can order from contract 75F40119A10019?

75F40119A10019 is a multiple award blanket purchase agreement. Only the awarding agency can place orders on it.

Is contract 75F40119A10019 under another contract?

Yes. 75F40119A10019 is a blanket purchase agreement under GS35F110DA, a federal supply schedule, on Regulatory Review Support Services.

Was contract 75F40119A10019 competed?

The extent of competition for 75F40119A10019 was full and open competition. The government received 4 offers.

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