Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics
Award Notice Posted
- Solicitation number
- FDA-18-223-SOL-1196209
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Awarded
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- HHSF223201810021I
- NAICS code
- 518210 Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services
- PSC
- Not on record
- Place of performance
- Contractor's facility, United States
Notice details come from SAM.gov. Updated .
Notice text
11 versions
Update #11 · Latest ·
Multiple Award Indefinite Delivery / Indefinite Quantity (ID/IQ) contract for the Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. (aka BEST 1).
$75,000,000.00 IDIQ Ceiling for each contract.
Contract:
Old PIID HHSF223201810020I
New UPIID 75F40118D10020
Award date: 9/7/18
Acumen, LLC
500 Airport Blvd., Ste 100
Burlingame, CA 94010
Contract:
Old PIID HHSF223201810021I
New UPIID 75F40118D10021
Award date: 9/7/18
Dovel Technologies, LLC
7901 Jones Branch Drive, Suite 600
Mc Lean, VA 22102
Contract:
Old PIID HHSF223201810022I
New UPIID 75F40118D10022
Award date: 9/10/18
IBM
6710 Rockledge Drive
Bethesda, MD 20817
Contract:
Old PIID HHSF223201810023I
New UPIID 75F40118D10023
Award date: 9/7/18
IQVIA Government Solutions, Inc.
8280 Willow Oaks Corporate Dr., Ste 7
Fairfax, VA 22031
Update #10 ·
Multiple Award Indefinite Delivery / Indefinite Quantity (ID/IQ) contract for the Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. (aka BEST 1).
$75,000,000.00 IDIQ Ceiling for each contract.
Contract:
Old PIID HHSF223201810020I
New UPIID 75F40118D10020
Acumen, LLC
500 Airport Blvd., Ste 100
Burlingame, CA 94010
Contract:
Old PIID HHSF223201810021I
New UPIID 75F40118D10021
Dovel Technologies, LLC
7901 Jones Branch Drive, Suite 600
Mc Lean, VA 22102
Contract:
Old PIID HHSF223201810023I
New UPIID 75F40118D10023
IQVIA Government Solutions, Inc.
8280 Willow Oaks Corporate Dr., Ste 7
Fairfax, VA 22031
Update #9 ·
Multiple Award Indefinite Delivery / Indefinite Quantity (ID/IQ) contract for the Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. (aka BEST 1)
Old PIID HHSF223201810021I
New UPIID 75F40118D10021
Update #8 ·
Multiple Award Indefinite Delivery / Indefinite Quantity (ID/IQ) contract for the Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. (aka BEST 1).
Old PIID HHSF223201810020I
New UPIID 75F40118D10020
Update #7 ·
Amendment 5 attached.
Update #6 ·
Amendment 4 attached.
Update #5 ·
Amendment 3 attached.
Update #4 ·
Amendment 2 attached.
Update #3 ·
Amendment 1
Update #2 ·
The solicitation/RFP is posted.
Update #1 ·
The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics. The primary goal of the contract is to expand and enhance the current CBER capabilities with respect to data sources, infrastructure, methods, and tools and to conduct surveillance and epidemiologic studies that promote CBER's Office of Biostatistics and Epidemiology's (OBE) mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics. The goal is to:
1. provide FDA with indirect access to large-scale United States (US) health care data of millions of patients including administrative and claims as well as electronic health records (EHR) data sources using a distributed data model and network which would require the use of a common data model (CDM).
2. To build an infrastructure to provide data sources and the capability and capacity to run queries and observational studies on the data sources for CBER-regulated biologic products.
3. To develop semi-automated processes for medical chart review to augment manual review of charts.
This requirement will be unrestricted, full and open competition.
The associated North American Industry Classification System (NAICS) Code is-518210- Data Processing, Hosting, and Related Services; Small Business Size Standard is $32.5 million.
We anticipate a multiple award Indefinite Delivery/Indefinite Quantity contract. The anticipated performance period of this contract will have a 5-year ordering period.
Vendors are encouraged to sign up on the Interested Vendors List to receive automated notification from FBO when changes are made to the posting; however, contractors are responsible to monitor this website for further information concerning this procurement.
Interested Parties with comments, questions, etc., shall respond to Nick Sartain at nick.sartain@fda.hhs.gov.
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