The Food and Drug Administration (FDA) has issued a notice about a new system of records involving information collected from those required to submit user fees to the agency. The notice outlines the types of information collected relating to fees assessed under the Freedom of Information Act, Animal Drug User Fee Act, Animal Generic Drug User Fee Act, and Food Safety Modernization Act, among others. The notice also pertains to fees assessed under the authority of the Federal Food, Drug, and Cosmetic Act, such as “color additive certification fees and export certificate fees.”
According to FDA, this information is unclassified and can be used for “routine purposes,” a term that FDA further elaborates in the notice. As FDA notes, “[t]he Privacy Act allows FDA to disclose information without an individual’s consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected.” Routine use includes disclosure to other agencies, the Department of Justice, Department of Homeland Security, entities under the Debt Collection Improvement Act, banks, courts, and agency contractors. The notice also provides information about record storage, retention, disposal, and access. The new system of records took effect November 14, 2012, and the “routine uses” will take effect on December 31, 2012. Comments may be submitted by December 31. See Federal Register, November 14, 2012.