0650 Change Request memo

0650 Change Request memo.docx

Tobacco Product Establishment Registration and Submission of Certain Health Information

0650 Change Request memo

OMB: 0910-0650

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Tobacco Product Establishment Registration and Submission of Certain Health Information

(OMB Control Number 0910-0650)


Change Request (83-C)


December 26, 2017


The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to include revised versions of the associated Registration and Listing guidance’s. FDA is extending the compliance deadline to submit ingredient listings for deemed tobacco products by six months due to technical issues users encountered with eSubmitter. Additionally, FDA updated the compliance policy for product listing updates for December 2017 with respect to the manufacture of newly deemed tobacco products provided they registered and listed those products by October 12, 2017.


OMB has concurred with the submission of this change request. There are no other changes to this collection.





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