FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

ADVICE

March 8, 2016

American Cleaning Institute

Attention: Paul C. DeLeo
Associate Vice President, Environmental Safety
1331 L Street, NW, Suite 650
Washington, DC 20005

Dear Mr. DeLeo:

We refer to your submission dated January 5, 2016, which was received on January 8, 2016 to
Docket Number: FDA-2015-N-0101 Safety and Effectiveness ofHealth Care Antiseptics;
Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment
of the Tentative Final Monograph: Reopening of Administrative Record. This submission
contained a draft protocol entitled An In Vitro Time-Kill Evaluation ofSix Test Materials When
Challenged With Twenty-Eight Bacterial and Yeast Species.

We have completed our review of this protocol and have the following comments:

1. If the test strain was stored frozen or lyophilized, subculture the strain three times before
using the assay to ensure that the organisms have reached optimal growth and metabolic
status.

2. Include one antibiotic resistant microorganism, which may be either methicillin resistant
Staphylococcus aureus ATCC 33591 or 33592, in the neutralization validation testing.

3. Include the name of the neutralizer used in the study when you submit your final report.

If you have any questions, call Celia Peacock, Regulatory Project Manager at (30 I) 796-4154.

~'Yr)~
Theresa Michele, MD
Director
Division of Nonprescription Drug Products
Office of Drug Evaluation IV
Center for Drug Evaluation and Research