Document ID: FDA-2019-D-1798-0003
Agency: fda
Document Type: Notice
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
Posted Date: 2019-09-03T04:00Z

[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Page 25060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11313]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1456]

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.

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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.
[FR Doc. 2019-11313 Filed 5-29-19; 8:45 am]
 BILLING CODE 4164-01-P