The Agency's Antimicrobials Division efficacy staff has worked with representatives from industry, testing laboratories and consulting agencies in creating standard report formats for efficacy studies submitted to the Agency. The study report form contains all of the required elements of a study report as found in 40 CFR part 160, and meets the requirements of PR Notice 2011-3. All registrants are encouraged to use this report format to facilitate the review process; however, it is not mandatory.
The Efficacy Study Summary provides a form to create a summary of the important information and variables that are presented in detail in the final report. The summary may be inserted into the study report form.
How to Use the Forms
- Registrants may provide this template to their testing laboratories.
- It is recommended, but not required, to have the testing laboratory insert the Efficacy Study Summary into the final study report after the Table of Contents. Therefore, the sequence of the first five pages would be:
- Title Page
- Statement of Confidentiality Claims
- Good Laboratory Practice Compliance Statement
- Table of Contents
- Efficacy Study Summary
- If the report is already completed, the Summary can be inserted behind the first 3 pages (required by Pesticide Registration Notice 2011-3) and numbered as 3A and 3B (if necessary).
- The Summary may be more than one page.