Internet Monitoring Services of FDA Related Products

**AMENDMENT 2

Please see updated Attachment_A_SOW_Amendment2, Attachment_B_PricingExcelWorkbook_Amendment2, Attachment_C_SOL_RFQ_Amendment2, and QA_FDA OCI Internet Monitoring Services_75F40124Q00348 - The purpose of this amendment is to provide responses to questions submitted by interested vendors as well as revise ALL attachments associated.** FDA is responsible for regulating products to ensure the safety of foods, prescription and over-the-counter drugs, biological products such as vaccines and blood, medical devices, cosmetics, radiation-emitting products, and more.

Since 1993, Office of Criminal Investigation (OCI) has investigated thousands of criminal schemes involving the distribution of potentially dangerous FDA-regulated products.

These investigations have involved a wide variety of criminal conduct, including street level distribution of counterfeit, unapproved, and designer drugs, major organized illicit diversion of prescription drugs, fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures, large scale product substitution conspiracies, application and clinical investigator fraud, and health frauds involving harmful FDA-regulated drugs and medical devices.

As FDA’s criminal law enforcement arm, OCI protects the American public by conducting criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution. The Food and Drug Administration (FDA) requires contractor support to further its on-going efforts to counter the widespread illicit trafficking and/or marketing of FDA-regulated products over the Internet.

These products include prescription drugs; dietary supplements; tobacco; medical devices; blood and biologics; vaccines; cosmetics; radiation-emitting products; animal and veterinary medicines; and foods.