Department of Health and Human Services

Office of Inspector General -- AUDIT

"Emergency Response to Hurricanes Katrina and Rita:  Audit of Food and Drug Administration’s Award Process for a Contract With Cepheid," (A-03-06-00542)

May 22, 2007

Complete Text of Report is available in PDF format (89 kb). Copies can also be obtained by contacting the Office of Public Affairs at 202-619-1343.


The audit is one of several reviews of procurements by the Food and Drug Administration (FDA) and other components of the Department of Health and Human Services (HHS) in response to Hurricanes Katrina and Rita in 2005. 

The Federal Acquisition Regulation (FAR) and the Health and Human Services Acquisition Regulation (HHSAR) provide, among other things, that HHS agencies award each contract to a responsible party and document compliance with requirements for full and open competition and the determination that the price was fair and reasonable.  

As part of HHS’s hurricane relief operations, FDA awarded a contract to Cepheid.  The contract obligated Cepheid to provide reagent test kits.  Our objective was to determine whether FDA complied with FAR and HHSAR requirements during the award process involving Cepheid.  FDA complied with the requirements.