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FDA is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing. This proposed rule covers registration and listing requirements for both domestic and foreign manufacturers of tobacco products. The proposed rule defines who would be required to register and list, when they would be required to register and list, and how they would be required to register and list. The proposed rule also describes the type of listing information that manufacturers would be required to submit to FDA. The proposed regulations generally would require the electronic submission of all registration and listing information. In addition, the rule would require owners or operators to maintain a historical file of labeling and advertisements.