FDA Issues IDIQ Solicitation to Support Data Management of Adverse Reporting System

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The FDA is looking to award an indefinite-delivery/indefinite-quantity contract to support its Adverse Event Reporting System Data Management Program.

In a notice posted Wednesday on SAM.gov, the agency said it seeking a company that can provide services including data organization, training, and software testing and validation related to processing FAERS reports.

FAERS is a computerized database used in FDA’s safety surveillance operations for products already approved and on the market. It is supported by a data management program that processes the electronic reports.

To aid the DMP, FDA intends to develop and enhance standard operating procedure requirements and improve the management of physical and electronic information it receives.

The potential five-year contract will involve collecting and processing voluntary and mandatory safety reports forwarded to the agency’s safety evaluation teams, conducting quality assurance and training programs and testing software platforms that may be used in the entire adverse event reporting system.

The single-award solicitation, which is open until Jan. 20, is part of a partnership agreement between the Department of Health and Human Services and the Small Business Administration.

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