76 FR 221 pgs. 71044-71045 - International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction
Type: NOTICEVolume: 76Number: 221Pages: 71044 - 71045
Docket number: [Docket No. FDA-2011-D-0720]
FR document: [FR Doc. 2011-29485 Filed 11-15-11; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction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.
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 The document announced the availability of a draft guidance entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide-Data Elements and Message Specification" (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled "ICSRs: Appendix to the Implementation Guide-Backwards and Forwards Compatibility" (the draft BFC appendix).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.
[FR Doc. 2011-29485 Filed 11-15-11; 8:45 am]
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