NOI CPRD.docx

FDA-Sole Source-XXX

Intends to make a sole source award:

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) requires a contractor to provide international Electronic Healthcare Record (EHR) data to expand the Sentinel System. In 2019, Congress funded a new mandate for FDA to develop a Real-World Evidence (RWE) Medical Data Enterprise to expand FDA’s access to Real-World Data (RWD) sources to more electronic medical record data (EHR) and to advance a system that can leverage all types of RWD.

The award will be made to:

Clinical Practice Research Datalink (CPRD) Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU, UK www.cprd.com

In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. CPRD is the largest source of longitudinal primary care data that is representative of the United Kingdom (UK) population and jointly sponsored by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health Research (NIHR). It has one of the most established research databases containing high quality data capable of informing clinical guidance and best practices with more than 2,600 peer-reviewed publications investigating drug safety, medication use, effectiveness of health policy and disease risk factors. CPRD is a UK government, not-for-profit research service that receives daily updates from participating general practices that undergo over 1,000 daily data quality checks. Data quality assurance practices are codified in standard operating procedures for data collection, curation and processing. The data are time-stamped with capability to revert to a snapshot of the data at any point in history. CPRD can also validate the primary care data on a study-specific basis and can administer general practice questionnaires to verify the accuracy of recording in the structured clinical record. Furthermore, CPRD has the largest number of standard linkages to other healthcare datasets including secondary care, death registration and cancer registry data. Finally, CPRD is used to support statutory public health surveillance of vaccines and medicines by Public Health England (PHE) and the MHRA.

By integrating CPRD into the Sentinel System as a full Data Partner, FDA can leverage Sentinel’s sophisticated data quality assurance programs and Sentinel’s existing data analysis tools to efficiently analyze CPRD’s EHR data to inform regulatory decision making.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within eight (8) days after the publication of this synopsis which shall be considered by the agency.

Responses received after 8 days or without the required information may not be considered. For information concerning this acquisition contact:

Tara Hobson Contract Specialist Email: Tara.Hobson@fda.hhs.gov No phone calls please

A determination by the Government not to compete because of information received is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.

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