2019-11313. 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.