Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration User Fee System

Streszczenie

In accordance with the requirements of the Privacy Act of 1974 and the Food and Drug Administration's (FDA) regulations for the protection of privacy, FDA is publishing notice of a Privacy Act system of records entitled, "FDA User Fee System, HHS/FDA," System Number 09-10-0021. FDA utilizes the User Fee System (UFS) to collect fees pursuant to Federal law and FDA's implementing regulations. The records kept in this system relate to fees assessed under the Freedom of Information Act (FOIA), the Prescription Drug User Fee Act, the Medical Device User Fee and Modernization Act, the Animal Drug User Fee Act, the Animal Generic Drug User Fee Act, the Mammography Quality Standards Act, the Family Smoking Prevention and Tobacco Control Act, the Food Safety Modernization Act, the Biosimilar User Fee Act, the Generic Drug User Fee Act, and other fees assessed by FDA under its Federal Food, Drug and Cosmetic Act authority such as color additive certification fees and export certificate fees. For purposes of this notice, these fees are collectively referred to as user fees.