Refuse To Accept Procedures for Premarket Tobacco Product Submissions

The Food and Drug Administration (FDA) is issuing a rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. FDA is issuing this action directly as a final rule because we believe there is little likelihood that we will receive any significant adverse comments opposing the rule given the specific deficiencies identified that will result in FDA's refusal to accept the submission.