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Clarification: No deadline set for public comments on Philip Morris products...
Story Date: 12/11/2017
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Source: FDA, 12/8/17
On Nov. 21, FDA issued a Federal Register notice extending the period for public comment on modified risk tobacco product (MRTP) applications for Philip Morris Products S.A.’s iQOS system and three types of Marlboro HeatSticks. At this time, there is no deadline for public comments on these applications. Comments may be submitted to docket FDA-2017-N-3001-3002 on regulations.gov.
Questions & Answers
Are there separate deadlines for comments related to the upcoming Tobacco Products Scientific Advisory Committee meeting?
Yes. The following deadlines apply to comments that the submitter would like to provide to TPSAC members:
•Requests to present an oral comment at the meeting must be received by Dec. 27, 2017.
•Written comments should be received by FDA by 4 p.m. (Eastern) on Jan. 4, 2018.
Further instructions, including who to contact about the meeting and where written comments should be mailed, are detailed on the January TPSAC meeting webpage.
To reiterate, the above deadlines apply only to the TPSAC meeting and do not apply to the public docket for Philip Morris Products S.A.’s MRTP applications. Public comments, including data, research, and other related information on those applications may be submitted to docket FDA-2017-N-3001-3002 on regulations.gov until further notice.
Why is the information on the FDA website about this public comment period different from regulations.gov or federalregister.gov?
Please note that the docket URL on regulations.gov to submit public comments has been updated since the public comment period was extended. FDA is also aware that there may be conflicting deadlines posted on regulations.gov and federalregister.gov. While we cannot control how information is displayed on those websites, the docket will remain open beyond any currently posted, specific closing dates.
How will the public know when the closing date is set and how much advance warning will FDA provide?
While these MRTP applications remain under scientific review, Philip Morris Products S.A. may submit additional amendments. As such, we cannot anticipate when the last amendment will be submitted to FDA and when all application documents will be made publicly available. Once all application documents, including all current and future amendments, have been posted, FDA will issue another Federal Register notice announcing the closing date for public comments, which will be at least 30 days after the final application materials are posted.
When will FDA post the amendments to these applications?
FDA anticipates making amendments received thus far publicly available over the next several months, and amendments received in the future will be made publicly available as they are redacted. Comments may be submitted on all publicly available applications documents throughout the comment period.
You can read the publicly available MRTP applications and find out more about the January TPSAC meeting on the FDA website.
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