Use of Investigational Tobacco Products; Revised Draft Guidance for Industry and Investigators; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Résumé

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry and investigators entitled "Use of Investigational Tobacco Products." The revised draft guidance replaces the draft guidance of the same title announced in the Federal Register of September 24, 2015 (September 2015 draft guidance). The revised draft guidance, when finalized, will describe FDA's current thinking regarding the definition of "investigational tobacco product" and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy.