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The proposed rule would define investigational tobacco product (ITP) and describe the procedures and requirements relating to the use of investigational tobacco products in investigations. The proposed rule would establish the information an ITP application to FDA must include, such as study protocol and adverse events. FDA will use this information to review the investigation for important concerns, such as the protection of human subjects. The proposed rule will provide detail on what happens when an investigation does not meet regulatory requirements. Finally, the proposed rule will also state responsibilities of those involved with administering the investigation and recordkeeping requirements.