Tender Details

Title	Center for Biologics Evaluation and Research (Cber), Biologics Effectiveness and Safety (Best) Initiative \ 3: Data Sources for Surveillance of Biologics Tender Notice International Competitive Bidding
Country	United States of America
Language	English
Organization	HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Published Date	01.07.2024
Deadline Date	08.07.2024
Overview	Center for Biologics Evaluation and Research (Cber), Biologics Effectiveness and Safety (Best) Initiative \ 3: Data Sources for Surveillance of Biologics Description The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative \ 3: Data Sources for Surveillance of Biologics (BEST 3). The primary goal of this Contract is to obtain new data sources including administrative claims data or claims and EHR data with access to complete medical chart information, provided directly from primary sources such as an insurer, payer or provider. Contractor must provide FDA with: distributed-type access to large-scale, United States (US) health care data covering tens of millions of patients; adjudicated administrative claims data but data sources may also include EHR using a distributed data network which may use a common data model (CDM) (potentially OMOP CDM) (data sources shall provide longitudinal health care data for participating patients); access to full medical charts of patients whose health care data are available for review, abstraction, and adjudication in the context of biologic products surveillance activities; contractor must be a provider and primary source of the data such as health insurer, payer or provider. This requirement will be unrestricted, full and open competition. The associated North American Industry Classification System (NAICS) Code is 518210- Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services; Small Business Size Standard is $40 million. The FDA anticipates a multiple award Indefinite Delivery Indefinite Quantity contract with an anticipated performance period of a 5-year ordering period. Vendors are encouraged to sign up on the Interested Vendors List to receive automated notification from SAM.gov when changes are made to the posting; however, contractors are responsible to monitor this website for further information concerning this procurement. HEALTH AND HUMAN SERVICES, DEPARTMENT OF Contracting Office Address : BETHESDA , MD 20892 Primary Point of Contact : Janna Weber janna.weber@nih.gov nick.sartain@fda.hhs.gov Tender Notice International Competitive Bidding 75F40124R00002 United States of America GT-103493325
NAICS	Business Computing Infrastructure Providers Other Direct Insurance (except Life Computing Infrastructure Providers Medical Direct Insurance (except Life Computing Infrastructure Providers Computing Infrastructure Providers Direct Life International Medical
CPVS	Earthmoving and excavating machinery, and associated parts System, storage and content management software package Networks Networking, Internet and intranet software development services Control, safety, signalling and light equipment Lavatory seats, covers, bowls and cisterns Office, school and office equipment cleaning services Research, testing and scientific technical simulator Safety cases Intelligence, surveillance, target acquisition and reconnaissance System, storage and content management software development services Food, beverage and tobacco-processing machinery Networking, Internet and intranet software package Monitors Food, beverages, tobacco and related products Other services Posts Seats, chairs and related products, and associated parts Administration, defence and social security services
UNSPSC	Post Awards Business cases Drug cases Case making services Financial Instruments, Products, Contracts and Agreements Tent, for office use
Regions	APEC Countries North America Northern America
Sectors	Building Environment and Pollution-Recycling Automobiles and Auto Parts Supply Postal and Courier Services Roads and Highways-Bridge Infrastructure Printing and Publishing Services Railways-Rail-Railroad Defence and Security Construction Energy-Power and Electrical Computer Hardwares and Consumables Industry Building Material Marine
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Title
Center for Biologics Evaluation and Research (Cber), Biologics Effectiveness and Safety (Best) Initiative \ 3: Data Sources for Surveillance of Biologics Tender Notice International Competitive Bidding
Country
United States of America
Language
English
Organization
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Published Date
01.07.2024
Deadline Date
08.07.2024
Overview
Center for Biologics Evaluation and Research (Cber), Biologics Effectiveness and Safety (Best) Initiative \ 3: Data Sources for Surveillance of Biologics Description The Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) requirement for Biologics Effectiveness and Safety (BEST) Initiative \ 3: Data Sources for Surveillance of Biologics (BEST 3). The primary goal of this Contract is to obtain new data sources including administrative claims data or claims and EHR data with access to complete medical chart information, provided directly from primary sources such as an insurer, payer or provider. Contractor must provide FDA with: distributed-type access to large-scale, United States (US) health care data covering tens of millions of patients; adjudicated administrative claims data but data sources may also include EHR using a distributed data network which may use a common data model (CDM) (potentially OMOP CDM) (data sources shall provide longitudinal health care data for participating patients); access to full medical charts of patients whose health care data are available for review, abstraction, and adjudication in the context of biologic products surveillance activities; contractor must be a provider and primary source of the data such as health insurer, payer or provider. This requirement will be unrestricted, full and open competition. The associated North American Industry Classification System (NAICS) Code is 518210- Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services; Small Business Size Standard is $40 million. The FDA anticipates a multiple award Indefinite Delivery Indefinite Quantity contract with an anticipated performance period of a 5-year ordering period. Vendors are encouraged to sign up on the Interested Vendors List to receive automated notification from SAM.gov when changes are made to the posting; however, contractors are responsible to monitor this website for further information concerning this procurement. HEALTH AND HUMAN SERVICES, DEPARTMENT OF Contracting Office Address : BETHESDA , MD 20892 Primary Point of Contact : Janna Weber janna.weber@nih.gov nick.sartain@fda.hhs.gov Tender Notice International Competitive Bidding 75F40124R00002 United States of America GT-103493325
NAICS
Business Computing Infrastructure Providers Other Direct Insurance (except Life Computing Infrastructure Providers Medical Direct Insurance (except Life Computing Infrastructure Providers Computing Infrastructure Providers Direct Life International Medical
CPVS
Earthmoving and excavating machinery, and associated parts System, storage and content management software package Networks Networking, Internet and intranet software development services Control, safety, signalling and light equipment Lavatory seats, covers, bowls and cisterns Office, school and office equipment cleaning services Research, testing and scientific technical simulator Safety cases Intelligence, surveillance, target acquisition and reconnaissance System, storage and content management software development services Food, beverage and tobacco-processing machinery Networking, Internet and intranet software package Monitors Food, beverages, tobacco and related products Other services Posts Seats, chairs and related products, and associated parts Administration, defence and social security services
UNSPSC
Post Awards Business cases Drug cases Case making services Financial Instruments, Products, Contracts and Agreements Tent, for office use
Regions
APEC Countries North America Northern America
Sectors
Building Environment and Pollution-Recycling Automobiles and Auto Parts Supply Postal and Courier Services Roads and Highways-Bridge Infrastructure Printing and Publishing Services Railways-Rail-Railroad Defence and Security Construction Energy-Power and Electrical Computer Hardwares and Consumables Industry Building Material Marine
URL
Download Document
Share