The Food and Drug Administration intends to award a Purchase Order on a sole source basis to Dr. Madelyn Gould from Columbia University to conduct the project title: “Sudden death and use of stimulant medications in youth”, based on the authority granted by FAR Part 6.302-1. As the principal investigator on the original study, Dr Gould is uniquely qualified to continue the analysis of the additional ADHD drugs and sudden death. Dr. Gould’s comprehensive understanding and working knowledge of the initial study are critical to the overall assessment of this study. This not only allows an efficient use of data that have already been collected, but also allows for a timely analysis of a very important public health issue. Scope of Work: The Contractor shall provide Office of Surveillance and Epidemiology (OSE) a completed case-control analysis in a final report. This analysis will require the review of state mortality data collected from 47 states for the years 1985 to 1996. Investigators will review state mortality data to identify cases and controls; death certificates are requested for cases (a sudden unexplained death that has been listed as ICD code: E-798, sudden death, cause unknown; E799.9, other ill-defined and unknown causes of deaths; and E427, cardiac arrhythmia). Deaths will be excluded if there are known physical causes for the deaths or co-existing physical disorders known to be associated with sudden death. Controls will include groups of children who died in motor vehicle accidents (ICD code E812.1) where the victim was a passenger. Controls will be matched on year of death, age and gender. After reviewing the death certificates the investigators will conduct a follow-back survey by contacting the parents of the victim in a letter. The letter will include a description of the study and a one-page survey. The survey collects information on past medical history and medications taken at the time of death. Pharmacy and medical records are obtained to confirm survey information. The Contractor shall provide evidence of the quality of the data. An award will be made in fifteen (15) days from the date of this notice. Sources may submit a quote, which fully demonstrate their capabilities, which will be considered by the agency. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to [email protected]. No phone calls will be accepted. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.

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