美国FDA 指导原则 提交雪茄行业指南警示计划 英文原版.pdfVIP

Submission of Warning Plans for Cigars (Revised)* Guidance for Industry Comments may be submitted at any time for Agency consideration. Electronic comments may be submitted to . Alternatively, submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877- CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. EDT. Additional copies are available online at /TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. You may send an e-mail request to SmallBiz.Tobacco@ to receive an electronic copy of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. U.S. Department of Health and Human Services Food and Drug Administration Center for Tobacco Products August 2018 OMB control number: 0910-0768 Expiration Date: 10/31/2022 See additional PRA statement in section IV of the guidance *This is the first revision to this guidance. The first edition was published in December 2016. Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. DISCUSSION 4 A. What Definitions Apply to This Guidance?