Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

---
identifier: "/us/fr/2012-31027"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2012-31027"
section_name: "Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction"
positive_law: false
currency: "2012-12-26"
last_updated: "2012-12-26"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2012-31027"
document_type: "notice"
publication_date: "2012-12-26"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "77 FR 76049"
fr_volume: 77
docket_ids:
  - "Docket No. FDA-2010-D-0643"
fr_action: "Notice; correction."
---


#  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction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 The document announced the availability of a draft guidance entitled “Electronic Source Data in Clinical Investigations.”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: 301-847-8443.

**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.