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Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction

---
identifier: "/us/fr/2017-26938"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2017-26938"
section_name: "Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction"
positive_law: false
currency: "2017-12-14"
last_updated: "2017-12-14"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2017-26938"
document_type: "notice"
publication_date: "2017-12-14"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "82 FR 58815"
fr_volume: 82
docket_ids:
  - "Docket No. FDA-2015-D-4562"
fr_action: "Notice; correction."
---

#  Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice; correction.

**SUMMARY:**

The Food and Drug Administration is correcting a notice entitled “Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop” that appeared in the *Federal Register* of November 27, 2017. The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled “Safety Assessment for IND Safety Reporting.” The date of the meeting has changed.

**FOR FURTHER INFORMATION CONTACT:**

Lauren Wedlake, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6362, Silver Spring, MD 20993, 301-796-2728, *[email protected].*

In the *Federal Register* of Monday, November 27, 2017, in FR Doc. 2017-25454, the following correction is made:

1. On page 56036, in the first column, in the first sentence of the *DATES* section, “The public workshop will be held on January 11, 2018, from 9 a.m. to 4 p.m., Eastern Time.” is corrected to read “The public workshop will be held on March 8, 2018, from 9 a.m. to 4 p.m., Eastern Time.”

Dated: December 8, 2017.

Leslie Kux,

Associate Commissioner for Policy.