Change Request Memo

“Tobacco Health Document Submission”

(OMB Control Number 0910-0654)

Change Request (83-C)

March 6, 2017

The Food and Drug Administration (FDA) is submitting this nonmaterial/non-substantive change request (83-C) to incorporate minor changes to the associated form.

On November 17, 2016 OMB approved a change request under this control number allowing FDA to revise the associated guidance. The guidance revisions reflected FDA’s authority over newly deemed products and helped industry to comply with the health document submission requirements.

FDA revised the associated form FDA 3743 with minor non substantive changes to incorporate language from the guidance. FDA is seeking OMB approval of these minor form updates. Attached is the tracked form and definitions.

OMB has previously concurred with the submission of minor the form changes.