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This proposed rule would establish content and format requirements to ensure that premarket tobacco product applications contain sufficient information for FDA to determine whether the marketing of a new tobacco product should be authorized. Additionally, the proposed rule would set forth the basic procedures for premarket tobacco product application review and require applicants receiving marketing authorization to establish records and make postmarket reports to FDA. The proposed rule would also require tobacco product manufacturers to keep records to support legal marketing of certain tobacco products, such as documents showing that a tobacco product does not need to undergo premarket review.