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 2014_register executive 2014-02-21 article Notices D09002ee1c7fa6818 D09002ee1c7fa685b 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 announcing the availability of a guidance for industry entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification" (the E2B(R3) implementation guidance) and an appendix to the guidance entitled "ICSRs: Appendix to the Implementation Guide--Backwards and Forwards Compatibility" (the BFC appendix). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and the E2B(R3) implementation guidance. 79 FR 9908 https://www.govinfo.gov/app/details/FR-2014-02-21/2014-03677 2014-03677 fr21fe14-37 4160-01-P Docket No. FDA-2011-D-0720 https://www.govinfo.gov/app/details/FR-2014-02-21/2014-03677 https://www.govinfo.gov/content/pkg/FR-2014-02-21/html/2014-03677.htm https://www.govinfo.gov/content/pkg/FR-2014-02-21/pdf/2014-03677.pdf 2 p. 9908 9909 79 FR 9908 International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Federal Register Vol. 79, Issue NOTICE 2014-03677 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2011-D-0720 4160-01-P 2014-03677 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification" (the E2B(R3) implementation guidance) and an appendix to the guidance entitled "ICSRs: Appendix to the Implementation Guide--Backwards and Forwards Compatibility" (the BFC appendix). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and the E2B(R3) implementation guidance.

Submit either electronic or written comments on Agency guidances at any time. Regarding the guidance: Roger Goetsch, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 22, Rm. 4491, Silver Spring, MD 20993- 0002, 240-402-3730; or Lise Stevens, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-2743, Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and Research, International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3342, Rockville, MD 20993-0002, 301-796- 8377. Guidance for Industry: International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports, etc. , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 35 Office of the Federal Register, National Archives and Records Administration 2014-02-21 continuing daily deposited born digital 133 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-02-21 P0b002ee18753f4eb 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21fe14 https://www.govinfo.gov/app/details/FR-2014-02-21 https://www.govinfo.gov/content/pkg/FR-2014-02-21/pdf/FR-2014-02-21.pdf https://www.govinfo.gov/content/pkg/FR-2014-02-21/xml/FR-2014-02-21.xml fdlp 9855 9979 DGPO 2014-02-21 2024-06-03 FR-2014-02-21 machine generated eng FR FR-2014-02-21 79 35