2017-26938. 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 The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled “Safety Assessment for IND Safety Reporting.”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, [e-mail].

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.