
[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71044-71045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0720]


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Transmission of Individual Case Safety Reports; Draft Guidance on 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.

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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 The document announced the availability of a draft guidance 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appendix to the draft guidance entitled ``ICSRs: Appendix to the 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

[[Page 71045]]

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.
[FR Doc. 2011-29485 Filed 11-15-11; 8:45 am]
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