International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction

---
identifier: "/us/fr/2011-29485"
source: "fr"
legal_status: "authoritative_unofficial"
title: "International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2011-29485"
section_name: "International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction"
positive_law: false
currency: "2011-11-16"
last_updated: "2011-11-16"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2011-29485"
document_type: "notice"
publication_date: "2011-11-16"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "76 FR 71044"
fr_volume: 76
docket_ids:
  - "Docket No. FDA-2011-D-0720"
fr_action: "Notice; correction."
---


#  International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice; correction.

**SUMMARY:**

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 The document announced the availability of a draft guidance entitled “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide—Data Elements and Message Specification” (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled “ICSRs: Appendix to the Implementation Guide—Backwards and Forwards Compatibility” (the draft BFC appendix).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.

**FOR FURTHER INFORMATION CONTACT:**

Olivia Pritzlaff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, (301) 796-3601.

**SUPPLEMENTARY INFORMATION:**

In FR Doc. 2011-27147, appearing on page 65199  in the *Federal Register* of Thursday, October 20, 2011, the following correction is made:

1. On page 65199, in the first column, in the *DATES* section, the date “January 18, 2011” is corrected to read “January 18, 2012.”

Dated: November 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.