Advocacy Submits Request for Extension of Comment Period on FDA’s PMTA Proposed Rule

On September 25, 2019, the Food and Drug Administration (FDA) published a proposed rule titled Premarket Tobacco Product Applications and Recordkeeping Requirements (PMTA), with a comment period ending on November 25, 2019. Advocacy commends the FDA for holding a public meeting on October 28-29, to discuss the PMTA process and the FDA’s expectations on how that process will work. However, the meeting was held less than one month before the close of the proposed rule’s comment period. At the meeting, the FDA announced that the presentation slides and a transcript of the meeting would not be available until 30 to 60 days after the date of the meeting, after the comment period will have already closed. The information provided at the meeting would be extremely helpful to small businesses drafting comment letters to the agency. For this reason, Advocacy respectfully requests that the FDA extend the PMTA proposed rule comment period for 60 days, to Friday, January 24, 2020.

Comment letter

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