Data Integrity and Compliance With Drug Current Good Manufacturing Process: Questions and Answers; Guidance for Industry; Availability; Correction

AGENCY:

Food and Drug Administration, HHS

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration is correcting a notice entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry; Availability” that appeared in the Federal Register of December 13, 2018. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error. Previously submitted comments will be transferred to the correct docket number.

FOR FURTHER INFORMATION CONTACT:

Karen Takahashi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6686, Silver Spring, MD 20993-0002, 301-796-3191.

SUPPLEMENTARY INFORMATION:

In the Federal Register of Thursday, December 13, 2018 (83 FR 64132), in FR Doc. 2018-26957, the following correction is made:

On page 64132, in the first column, in the header of the document, “[Docket No. FDA-2018-D-3984]” is corrected to read “[Docket No. FDA-2016-D-1113].”