Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction

---
identifier: "/us/fr/2019-11313"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2019-11313"
section_name: "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction"
positive_law: false
currency: "2019-05-30"
last_updated: "2019-05-30"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2019-11313"
document_type: "notice"
publication_date: "2019-05-30"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "84 FR 25060"
fr_volume: 84
docket_ids:
  - "Docket No. FDA-2018-D-1456"
fr_action: "Notice; correction."
---


#  Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; 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 “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability” that appeared in the *Federal Register* of May 10, 2019. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error.

**FOR FURTHER INFORMATION CONTACT:**

Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240-402-4246.

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of Friday, May 10, 2019 (84 FR 20633), in FR Doc. 2019-09692, the following correction is made:

On page 20633, in the first column, in the headings of the document, “[Docket No. FDA-2019-D-1798]” is corrected to read “[Docket No. FDA-2018-D-1456].”

Dated: May 24, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.