Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability; Correction

---
identifier: "/us/fr/2019-14362"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2019-14362"
section_name: "Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability; Correction"
positive_law: false
currency: "2019-07-05"
last_updated: "2019-07-05"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2019-14362"
document_type: "notice"
publication_date: "2019-07-05"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "84 FR 32189"
fr_volume: 84
docket_ids:
  - "Docket No. FDA-2017-D-4303"
fr_action: "Notice; correction."
---


#  Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability; Correction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 “Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability” that appeared in the *Federal Register* of September 5, 2017. 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:**

Lisa Granger, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of Tuesday, September 5, 2017 (82 FR 41968), in FR Doc. 2017-18506, the following correction is made:

On page 41968, in the first column, in the header of the document, and in the second column, under *Instructions,* “[Docket No. FDA-2017-E-4282]” is corrected to read “[Docket No. FDA-2017-D-4303].”

Dated: July 1, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.