Annual Report Filing
In order to renew and maintain an existing FDA Variance, an Annual Report Filing must be submitted each year. Pangolin provides this Annual Report filing service at no charge as a courtesy to Pangolin customers. The service includes preparing and submitting FDA Form 3636 using the information you provide.
In this annual report, you will report the number of laser light show events you have produced in the 12-month period spanning from July 1 of the previous year through June 30 of the current year. This number of Laser Light Shows can be acquired from your record of laser safety checklists. Annual reports for the previous year can begin to be submitted on July 1st and must be submitted before September 1st.
You are responsible for ensuring that all information is complete and accurate and that it is provided with enough time to meet the applicable filing deadline. Pangolin cannot guarantee FDA acceptance, approval, processing times, or continued availability of this service.
Pangolin is not responsible for delays, rejected filings, expired variances, or other consequences resulting from incomplete, inaccurate, or late information, technical interruptions, FDA actions, or circumstances outside our reasonable control. This service is limited to preparing and submitting FDA Form 3636. It does not include legal advice, regulatory representation, expedited FDA processing, or assistance resolving unrelated compliance issues.
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FAQ
I forgot to file my annual report and missed the september 1st deadline. What do I do now?
While not ideal, use the form below to submit the annual report as soon as possible.
I used to have an existing variance but never filled out an annual report and has expired. Do I need a new variance?
You do not need a new variance, applying for a new one will only appear as a duplicate variance application. Use the form below to submit an annual report for the missing years and you will once again be in good standing.
Where can I find the laser safety checklist?
Please see the resources section on our laser show safety page: https://pangolin.com/pages/laser-show-safety?_pos=1&_sid=08f413a6a&_ss=r
Don't I need to fill out and submit form 3636 for an annual report?
That is correct and in fact what this form is doing! This system automatically fills out all of the annual report forms that we then file on your behalf in the same way we file the variance application.
I just submitted my annual report. What now?
You should recieve a confirmation email from us, and an acknowlegement letter from the FDA once the report has been recieved and processed. Keep these acknolegement letters in a safe place as they are proof that your variance is still active and current!