Biologics Effectiveness and Safety (BEST) Initiative: Data, Tools and Infrastructure for Surveillance of Biologics

expired opportunity(Expired)
From: Federal Government(Federal)
FDA-18-223-SOL-1196209

Basic Details

started - 20 Jul, 2018 (about 5 years ago)

Start Date

20 Jul, 2018 (about 5 years ago)
due - 27 Jul, 2018 (about 5 years ago)

Due Date

27 Jul, 2018 (about 5 years ago)
Bid Notification

Type

Bid Notification
FDA-18-223-SOL-1196209

Identifier

FDA-18-223-SOL-1196209
Department of Health and Human Services

Customer / Agency

Department of Health and Human Services

Attachments (20)

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Added:
May 25, 2018 3:46 pm 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.

Added:
Jun 21, 2018 2:55 pm The solicitation/RFP is posted.

Added:
Jun 22, 2018 3:00 pm Amendment 1

Added:
Jul 02, 2018 3:09 pm Amendment 2 attached.

Added:
Jul 18, 2018 5:16 pm Amendment 3 attached.

Added:
Jul 20, 2018 1:49 pm Amendment 4 attached.

Contractor's facility United StatesLocation

Address: Contractor's facility United States

Country : United States

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Classification

518 -- Data Processing, Hosting and Related Services/518210 -- Data Processing, Hosting, and Related Services