2011-29485. International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; ...

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 The document announced the availability of a draft guidance entitled “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide—Data Elements and Message Specification” (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled “ICSRs: Appendix to the Implementation Guide—Backwards and Forwards Compatibility” (the draft BFC appendix).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

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.