Form Fda 3147 - Application For A Variance Page 3

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Advance written notification will be made as early as possible to appropriate federal, state, and local authorities providing show itinerary with

dates and locations clearly and completely identified, and a basic description of the proposed effects including a statement of the maximum power

output intended. Such notifications will be made, but not necessarily be limited, to:

(1) Information about particular laser shows will be maintained in the records for the show and will be provided upon request to the Center for

Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Division of Radiological Health, Magnetic Resonance

Branch, Silver Spring, MD 20993. This information will provide the initial and closing dates for fixed installations and the itinerary for mobile

shows. In addition, unless all aspects of each show have been reported and accession numbers clearly referenced, each notice will include

detailed descriptions of each show and a listing of all effects to be performed in sufficient detail to confirm compliance with the regulations and

this variance.

(2) The Federal Aviation Administration (FAA) for any projections into open airspace at any time (i.e., including set up, alignment, rehearsals,

performances, etc.). If the FAA objects to any laser effects, the objections will be resolved and any conditions requested by FAA will be

adhered to. If these conditions cannot be met, the objectionable effects will be deleted from the show.

(3) State and local radiation control offices/agencies for all shows to be performed within their jurisdictions. All requirements of state and local law

will be satisfied and any objections raised by local authorities will be resolved or the effects deleted. (A list of federal and state offices is

available from the Center for Devices and Radiological Health upon request.)

14. REMARKS

CERTIFICATION

I CERTIFY that all of the above information and statements are true, complete, and correct to the best of my knowledge and acknowledge that

my variance application may be denied or my variance may be revoked if this application is found to be false, misleading or incorrect in any

material way. I have submitted and will submit all reports required by 21 CFR 1002.10 and 1002.11 on the laser equipment and show(s). I further

understand that I may be required by regulation or by the Director, Center for Devices and Radiological Health, to supply such other information

as may be necessary to evaluate and act on this application.

16. NAME (Type or Print)

17. TITLE

15. SIGNATURE