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 2023_register executive 2023-10-12 article Rules and Regulations D09002ee1c7974c5b D09002ee1c797607c 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, Agency, or we) is announcing the availability of a final guidance entitled "Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry." The guidance document updates the current version of the guidance by including three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter or transmitter of prior notice of an FDA refusal for inadequate prior notice or hold, if the food article is from a foreign facility that is not registered and addresses the timeframe for making requests for FDA review of such refusal or hold. FDA is also making other technical editorial changes. The guidance announced in this notice finalizes the draft guidance of the same title dated September 13, 2022. 88 FR 70887 https://www.govinfo.gov/app/details/FR-2023-10-13/2023-22649 2023-22649 fr13oc23-2 4164-01-P Docket No. FDA-2011-N-0179 https://www.govinfo.gov/app/details/FR-2023-10-13/2023-22649 https://www.govinfo.gov/content/pkg/FR-2023-10-13/html/2023-22649.htm https://www.govinfo.gov/content/pkg/FR-2023-10-13/pdf/2023-22649.pdf 3 p. 70887 70889 88 FR 70887 Title 21 Part 1 21 CFR Part 1 Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability; Federal Register Vol. 88, Issue RULE 2023-22649 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2011-N-0179 4164-01-P 2023-22649 Notification of availability.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry." The guidance document updates the current version of the guidance by including three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter or transmitter of prior notice of an FDA refusal for inadequate prior notice or hold, if the food article is from a foreign facility that is not registered and addresses the timeframe for making requests for FDA review of such refusal or hold. FDA is also making other technical editorial changes. The guidance announced in this notice finalizes the draft guidance of the same title dated September 13, 2022.

The announcement of the guidance is published in the Federal Register on October 13, 2023. Peter Ajuonuma, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20852, 301-796-2277, Peter.Ajuonuma@fda.hhs.gov. Guidance: Prior Notice of Imported Food Questions and Answers (Edition 4), Peter.Ajuonuma@fda.hhs.gov https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 88, no. 197 Office of the Federal Register, National Archives and Records Administration 2023-10-13 continuing daily deposited born digital 394 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2023-10-13 P0b002ee1c178ee92 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13oc23 https://www.govinfo.gov/app/details/FR-2023-10-13 https://www.govinfo.gov/content/pkg/FR-2023-10-13/pdf/FR-2023-10-13.pdf https://www.govinfo.gov/content/pkg/FR-2023-10-13/xml/FR-2023-10-13.xml fdlp 70885 71271 DGPO 2023-10-12 2024-05-28 FR-2023-10-13 machine generated eng FR FR-2023-10-13 88 197