美国FDA 指导原则 烟草产品设计和实施烟草产品感知和意图研究的原则 英文原版.pdfVIP

Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with the docket number FDA-2019-D-4188. 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 2022 Contains Nonbinding Recommendations Table of Contents INTRODUCTION 1 BACKGROUND 2 DEFINITIONS 3 DEVELOPING STUDY AIMS AND HYPOTHESES 7 MODE OF DATA COLLECTION 7 STUDY OUTCOMES 9 Tobacco Product Perceptions 9 Consumer Understanding 10 Behavioral Intentions 11 QUALITATIVE STUDY METHODS 12 QUALITATIVE ANALYSIS PLAN AND REPORTING STUDY RESULTS 13 QUANTITATIVE SURVEY METHODS 13 Quantitative Survey Method Considerations 14 Choosing a Type of Quantitative Study Design 15