0910-AF61 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Label Requirement for Food That Has Been Refused Admission Into the United States

The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, "UNITED STATES: REFUSED ENTRY." The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Deregulatory 21 CFR 1.98 15 U.S.C. 1453 to 1455 21 U.S.C. 321 21 U.S.C. 342 and 343 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 381 42 U.S.C. 216 42 U.S.C. 264 No NPRM 09/18/2008 73 FR 54106 NPRM Comment Period End 12/02/2008 NPRM; Withdrawal 08/00/2018 Yes Businesses None No No Yes Yes Anthony Taube C. Branch Chief 0910 Food and Drug Administration FDA 240 420-4565 703 261-8625 anthony.taube@fda.hhs.gov Office of Regulatory Affairs, Office of Regional Operations, 12420 Parklawn Drive, ELEM-4051, Rockville MD 20857