United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2008_register executive 2010-09-23 article Part II Rules and Regulations D09002ee1c807bb03 D09002ee1c807bbd3 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." 73 FR 66294 https://www.govinfo.gov/app/details/FR-2008-11-07/E8-26282 E8-26282 fr07no08-13 RIN 0910-AC41 4160-01-S Docket No. FDA-2002-N-0233 https://www.govinfo.gov/app/details/FR-2008-11-07/E8-26282 https://www.govinfo.gov/content/pkg/FR-2008-11-07/html/E8-26282.htm https://www.govinfo.gov/content/pkg/FR-2008-11-07/pdf/E8-26282.pdf Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements 117 p. 66294 66410 73 FR 66294 Title 21 Part 1 21 CFR Part 1 RIN 0910-AC41 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Federal Register Vol. 73, Issue RULE E8-26282 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2009-05-06 Docket No. FDA-2002-N-0233 4160-01-S E8-26282 Final rule.

The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002."

This rule is effective May 6, 2009. Laura Draski, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 866-521-2297. Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act (2002), industry@fda.hhs.gov http://www.access.fda.gov http://www.access.fda.gov/ http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM http://www.bea.gov/newsreleases/international/trade/2007/pdf/trad0907.pdf http://www.cbp.gov/linkhandler/cgov/trade/cargo_security/ctpat/fast/fast_ref_guide.ctt/fast_ref_guide.pdf http://www.cbp.gov/linkhandler/cgov/trade/legal/informed_compliance_pubs/icp052.ctt/icp052.pdf http://www.cbp.gov/linkhandler/cgov/trade/legal/informed_compliance_pubs/icp069.ctt/icp069.pdf http://www.cbp.gov/xp/cgov/trade/cargo_security/ctpat/security_criteria/criteria_importers/questions.xml http://www.cbp.gov/xp/cgov/travel/vacation/kbyg/ http://www.cfsan.fda.gov/˜dms/ffregui4.html http://www.cfsan.fda.gov/˜dms/fsbtac17/sld014.htm http://www.cfsan.fda.gov/˜dms/htsguid3.html http://www.cfsan.fda.gov/˜furls/cpgreg2.html http://www.cfsan.fda.gov/˜furls/ffregsum.html http://www.cfsan.fda.gov/˜furls/fisstat.html http://www.cfsan.fda.gov/˜furls/helpf.html http://www.cfsan.fda.gov/˜furls/helpol.html http://www.cfsan.fda.gov/˜mow/internat.html http://www.cfsan.fda.gov/˜pn/htscodes.html http://www.cfsan.fda.gov/˜pn/pcb-tut.html http://www.cfsan.fda.gov/˜pn/pndguid.html http://www.cfsan.fda.gov/˜pn/pndguid.html/ http://www.cfsan.fda.gov/˜pn/pnentgui.html http://www.cfsan.fda.gov/˜pn/pnmail.html http://www.cfsan.fda.gov/˜pn/pnoview.html http://www.cfsan.fda.gov/˜pn/pnplan2.html http://www.cfsan.fda.gov/˜pn/pnqagui2.html http://www.cfsan.fda.gov/˜pn/pnstep2.html#copywe http://www.cfsan.fda.gov/˜pn/pnsum.html http://www.cfsan.fda.gov/˜pn/pntips.html http://www.cfsan.fda.gov/˜pnts/pnsitut.html http://www.fda.gov http://www.fda.gov/oc/bioterrorism/bioact.html http://www.fda.gov/oc/bioterrorism/moucustoms.html http://www.fda.gov/ora http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9/default.htm http://www.naics.com http://www.naics.com/naics42.htm http://www.sba.gov/advo/stats/sbfaq.pdf Vol. 73, no. 217 Office of the Federal Register, National Archives and Records Administration 2008-11-07 continuing daily deposited born digital 353 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2008-11-07 P0b002ee1809b40b6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07no08 https://www.govinfo.gov/app/details/FR-2008-11-07 https://www.govinfo.gov/content/pkg/FR-2008-11-07/pdf/FR-2008-11-07.pdf https://www.govinfo.gov/content/pkg/FR-2008-11-07/xml/FR-2008-11-07.xml fdlp 66143 66486 DGPO 2010-09-23 2024-06-05 FR-2008-11-07 machine generated eng FR FR-2008-11-07 73 217