FDA releases solicitation for $19M FDA HL7/SPL related IT systems support task

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“The scope of this contract is improving the management of structured data and unstructured data across agency enterprise initiatives. This work involves implementation management of interoperable standards for exchanging and storing the HL7/SPL data. Integral to this effort, this contract provides for the operation and life-cycle service and support of FDA HL7/SPL submission and data processing systems and applications.


The current FDA HL7/SPL Submission and data processing systems within scope of this contract include, but are not limited to:

• CDER Direct – The CDER Direct system was developed to support HL7 message compliant SPL submissions by providing the industry submitter an interactive and user friendly web interface that allows industry to securely enter data, generate SPL submission packages, submit, and manage their SPL submissions of Establishment Registration, Listing, GDUFA Facility self-identification, and others.

• eList - The eList system provides a mechanism to receive, validate, and process the HL7 SPL based electronic submissions. eList system distributes valid submissions to downstream systems for further data processing, and also transmit selected sets of valid submissions to the National Library of Medicine (NLM) as well as to FDA public information communication group (OCOMM) for publishing to the public in general.

• DQ&C Portal – The Drug Quality and Compliance Portal system provides HL7/SPL submission processing service and also provides CDER and other centers with the metadata from the HL7/SPL submissions to support drug review process, drug import control process, and drug compliance control etc.

• SRSustil – The SRSustil is an…”


Response Due: 08/14/2017 09:00 AM EST


G2X TAKE: The objective of this 5-year BPA is to support the continued operation, expansion, and performance improvement of HL7/SPL related IT systems, as well as for improved management of information across the agency. 


Looking to Partner? A good place to start is this list of the top 8(a)s winning prime work at FDA today.


This solicitation was released concurrently on both IT-70 132-51 and 132-56 SINs as an 8(a) set-aside. Need a copy of the SOW? A link can be found in the thread below

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