The Food and Drug Administration (FDA) is reopening the comment period only for the agency information collection activity associated with the Premarket Tobacco Product Applications (PMTAs) and Recordkeeping Requirements proposed rule, which published on Sept. 25, 2019. FDA is doing so to seek public input on an additional draft form that has been added to the docket. FDA is not reopening the comment period on any other aspects of the proposed rule.
The additional proposed form may assist both FDA and industry in identifying the products of submissions where an applicant groups multiple PMTAs into a single submission (referred to as a grouped or bundled submission). The agency believes that the draft form could assist applicants in providing the information – which would be required under the proposed rule – for each individual product in a grouped submission. Additionally, by having product information more clearly organized, FDA would be able to more efficiently process and review the applications contained in grouped submissions.
To read background documents, including the PMTA proposed rule, comments on the proposed rule, and additional documents added to the docket, visit regulations.gov [FDA-2019-N-2854]. As of March 10, 2020, you may submit electronic or written comments on the form to Office of Information and Regulatory Affairs, OMB through April 9, 2020.