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 2014-05-28 article Notices D09002ee1c7fa06b5 D09002ee1c7fa075f 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 Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) is announcing a pilot project to evaluate its current systems for receiving postmarketing safety reports involving vaccine products electronically for processing into the Vaccine Adverse Event Reporting System (VAERS). As part of this pilot project, CBER also plans to assess the updated International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2B(R3) specification for electronic transmission of vaccine Individual Case Safety Reports (ICSRs). Participation in the pilot project is open to firms that submit postmarketing reports into VAERS. CBER plans to accept participation from up to six applicants. The pilot project is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate current system capabilities for sending and receiving postmarketing safety reports for vaccine products using FDA's Electronic Submissions Gateway (ESG), including the use of the updated ICH E2B(R3) specification. 79 FR 30620 https://www.govinfo.gov/app/details/FR-2014-05-28/2014-12291 2014-12291 fr28my14-102 4160-01-P Docket No. FDA-2014-N-0604 https://www.govinfo.gov/app/details/FR-2014-05-28/2014-12291 https://www.govinfo.gov/content/pkg/FR-2014-05-28/html/2014-12291.htm https://www.govinfo.gov/content/pkg/FR-2014-05-28/pdf/2014-12291.pdf 2 p. 30620 30621 79 FR 30620 Electronic Submission of Postmarketing Safety Reports Involving Vaccine Products; Notice of Pilot Project; Federal Register Vol. 79, Issue NOTICE 2014-12291 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-06-27 Docket No. FDA-2014-N-0604 4160-01-P 2014-12291 Notice.

The Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) is announcing a pilot project to evaluate its current systems for receiving postmarketing safety reports involving vaccine products electronically for processing into the Vaccine Adverse Event Reporting System (VAERS). As part of this pilot project, CBER also plans to assess the updated International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2B(R3) specification for electronic transmission of vaccine Individual Case Safety Reports (ICSRs). Participation in the pilot project is open to firms that submit postmarketing reports into VAERS. CBER plans to accept participation from up to six applicants. The pilot project is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate current system capabilities for sending and receiving postmarketing safety reports for vaccine products using FDA's Electronic Submissions Gateway (ESG), including the use of the updated ICH E2B(R3) specification.

Submit an electronic request to participate in this pilot project by June 27, 2014. Lise Stevens, Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7323, Silver Spring, MD 20993-0002, 240- 402-8169, email: lise.stevens@fda.hhs.gov. Electronic Submission of Postmarketing Safety Reports Involving Vaccine Products; Pilot Project , CBER_eSubmitter_program@fda.hhs.gov eSubmitter_program@fda.hhs.gov lise.stevens@fda.hhs.gov http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm Vol. 79, no. 102 Office of the Federal Register, National Archives and Records Administration 2014-05-28 continuing daily deposited born digital 278 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-05-28 P0b002ee1892b4c76 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28my14 https://www.govinfo.gov/app/details/FR-2014-05-28 https://www.govinfo.gov/content/pkg/FR-2014-05-28/pdf/FR-2014-05-28.pdf https://www.govinfo.gov/content/pkg/FR-2014-05-28/xml/FR-2014-05-28.xml fdlp 30431 30697 DGPO 2014-05-28 2024-06-02 FR-2014-05-28 machine generated eng FR FR-2014-05-28 79 102