2012-31027. Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction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 Tuesday, November 20, 2012 (77 FR 69632). The document announced the availability of a draft guidance entitled “Electronic Source Data in Clinical Investigations.” The document was published with an incorrect date in the DATES section. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Ron Fitzmartin, Office of Planning & Informatics, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1160, Silver Spring, MD 20993-0002, 301-796-5333, FAX: [phone].

SUPPLEMENTARY INFORMATION:

In FR Doc. 2012-28198, appearing on page 69632 in the Federal Register of Tuesday, November 20, 2012, the following correction is made:

1. On page 69632, in the third column, in the DATES section, the date “January 22, 2013” is corrected to read “March 26, 2013.”

Dated: December 20, 2012.

Leslie Kux,

Assistant Commissioner for Policy.