Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Applications for Premarket Review of New Tobacco Products." The draft guidance is intended to assist persons submitting applications for new tobacco products under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The draft guidance explains, among other things, for new tobacco product applications, who submits, when and how to submit, what information the FD&C Act requires applicants to submit, and what information FDA recommends that applicants submit.