SUBMITTING FDA VARIANCES ELECTRONICALLY

On March 2 2017, the U.S. Food and Drug Administration sent the following email message regarding how to submit variances electronically.

Electronic Product Variance applications can be submitted electronically to the FDA's Division of Dockets Management (DDM)

The Center for Devices and Radiological Health (CDRH) would like to inform you that variances, including laser light show variances, can be submitted electronically through the Regulations.gov website. Online submission is simple, fast, and will allow easier tracking of your submission.

To submit a variance electronically, follow these steps:

1. Save an electronic copy of your variance application to your computer. For information on preparing laser light show variance requests, please see: https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/ucm118907.htm. For more general information on submitting variance requests, please see: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1010.

2. On the www.regulations.gov website, type “FDA-2013-S-0610” into the search bar and click the Search button. You should see a search result entitled “Citizen Petition Submission; Technical Amendment.” Click the button that says Comment Now! located next to this search result.

    or

Copy and paste the following link into your internet browser: https://www.regulations.gov/comment?D=FDA-2013-S-0610-0001

3. Enter a simple explanatory message into the Comment area, for example, “Please see the attached laser light show variance application”.

4. Click the Choose files button and select the file you’d like to upload, or you can drag and drop your file into the area labeled “Drop files here.”

5. Enter your first and last name.

6. We strongly recommend that you provide your email address by checking the box next to “I want to provide my contact information.” This will make communication easier if a problem occurs, and allow you to receive your variance approval more quickly by email.

7. If you are submitting a variance on behalf of someone else, please check the “I am submitting on behalf of a third party” box and enter your information as well. The first and last name of the person for whom you are submitting the variance should still be listed above.

8. Select category: Private Industry – C0003 from the drop down box.

9. Click the Continue button to see a summary of your information.

10. If all of your information is correct and you are ready to submit, check the box next to “I read and understand the statement above” and click the Submit Comment button. If you need to correct anything, click the Edit button.

11. Once submitted, a tracking number will be immediately displayed for your records.

If you have any problems submitting your variance, you can contact the Regulations.gov Helpdesk at 1-877-378-5457 or use the Contact Us link on the Regulations.gov webpage. For processing questions after submission, you may contact the FDA’s Division of Dockets Management at 240-402-7500.

Please note that for the Laser Light Show industry, a laser light show report and possibly a laser projector report are also required to be submitted to CDRH in order to have a variance approved. Don’t submit these reports to DDM.