International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, October 20, 2011 (76 FR 65199). The document announced the availability of a draft guidance entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification" (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled "ICSRs: Appendix to the Implementation Guide--Backwards and Forwards Compatibility" (the draft BFC appendix). The document was published with an incorrect date in the DATES section. This document corrects that error.