Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

Streszczenie

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collections in the guidances for industry and FDA staff entitled "Guidance for Industry and Food and Drug Administration Staff on Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products" and "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions."