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

---
identifier: "/us/fr/2019-04431"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Data Integrity and Compliance With Drug Current Good Manufacturing Process: Questions and Answers; Guidance for Industry; Availability; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2019-04431"
section_name: "Data Integrity and Compliance With Drug Current Good Manufacturing Process: Questions and Answers; Guidance for Industry; Availability; Correction"
positive_law: false
currency: "2019-03-12"
last_updated: "2019-03-12"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2019-04431"
document_type: "notice"
publication_date: "2019-03-12"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "84 FR 8875"
fr_volume: 84
docket_ids:
  - "Docket No. FDA-2016-D-1113"
fr_action: "Notice; correction."
---


#  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].”

Dated: March 6, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.