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GAO-11-841R 1 (2011-07-26)

handle is hein.gao/gaobadxez0001 and id is 1 raw text is: GAO Accountability * Integrity * Reliability United States Government Accountability Office Washington, DC 20548 B-322217 July 26, 2011 The Honorable John D. Rockefeller IV Chairman The Honorable Kay Bailey Hutchison Ranking Member Committee on Commerce, Science, and Transportation United States Senate The Honorable Fred Upton Chairman The Honorable Henry A. Waxman Ranking Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Food and Drug Administration: Required Warnings for Cigarette Packages and Advertisements Pursuant to section 801 (a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Food and Drug Administration (FDA), entitled Required Warnings for Cigarette Packages and Advertisements (RIN: 0910-AG41). We received the rule on July 12, 2011. It was published in the Federal Register as a final rule on June 22, 2011. 76 Fed. Reg. 36,628. The final rule amends FDA's regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany nine new textual warning statements required under the Tobacco Control Act. The final rule specifies the color graphic images that must accompany each of the nine new textual warning statements required by the Tobacco Control Act. Enclosed is our assessment of FDA's compliance with the procedural steps required by section 801 (a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review of GAO-1 1-841R

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