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GAO-16-298R 1 (2015-12-16)

handle is hein.gao/gaobadrtq0001 and id is 1 raw text is: GAOU.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-327614 December 16, 2015 The Honorable Lamar Alexander Chairman The Honorable Patty Murray Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Fred Upton Chairman The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Food and Drug Administration: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals 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 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (RIN: 0910-AG64). We received the rule on December 1, 2015. It was published in the Federal Register a final rule on November 27, 2015. 80 Fed. Reg. 74,226. The final rule requires importers of food for humans and animals to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act, is not adulterated, and is not misbranded with respect to food allergen labeling. The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major rule from the date of publication in the Federal Register or receipt of the rule by Congress, whichever is later. 5 U.S.C. § 801(a)(3)(A). The final rule has a stated effective date of January 26, 2016. It was published in the Federal Register as a final rule on November 27, 2015. 80 Fed. Reg. 74,226. We received the rule on December 1, 2015. Therefore, this rule does not have a 60-day delay in effective date. 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 the procedural steps taken indicates that, with the exception of the required 60-day delay in effective date, FDA complied with the applicable requirements. GAO-1 6-298R

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