Form Fda 3147 - Application For A Variance
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4Form Approved: OMB No. 0910-0025
APPLICATION FOR A VARIANCE
Expiration Date: January 31, 2017
FROM 21 CFR 1040.11(c) FOR A
DEPARTMENT OF HEALTH AND HUMAN SERVICES
See Page 4 for PRA Statement.
Food and Drug Administration
LASER LIGHT SHOW, DISPLAY,
DOCKET NUMBER
OR DEVICE
NOTE: No laser light show, projection system, or device may vary from compliance with 21 CFR 1040.11(c) in design or use without the approval of this
application in accordance with 21 CFR 1010.4.
INSTRUCTIONS
1. Check all applicable boxes and type or print the
3. Mail your application to the Division of Dockets Management (HFA-305), Food
requested information.
and Drug Administration, Rm 1061, 5630 Fishers Lane, Rockville, MD 20852.
2. Submit an original and four (4) copies.
4. Enter docket number if assigned.
1. NAME OF COMPANY
2. ADDRESS OF COMPANY (Include ZIP Code)(If P.O. Box is used, include actual street address also.)
3. NAME AND TITLE OF RESPONSIBLE PERSON
4.a. TELEPHONE NO. (Include area code)
4.b. EMAIL ADDRESS
5. DATE OF SUBMISSION
6. THE APPLICANT REQUESTS THE VARIANCE TO BE IN EFFECT FOR A PERIOD OF
YEARS FROM THE DATE OF ISSUE.
(In
general, the Agency will approve a variance for only two years. If a longer period is requested, a justification must be attached as part of the application.)
7.
PRODUCT DESCRIPTION AND USE
a. LIST NAME AND/OR MODEL NUMBER(S) FOR THE LASER LIGHT SHOW(S) AND PROJECTOR(S)
b. PRODUCT FOR WHICH A VARIANCE IS REQUESTED
f. PRODUCT IS INTENDED TO BE USED AT ANY ONE LOCATION
More than 15 days
A laser display device
More than 5 but not more than 15 days
A projector for a laser light show
Less than 5 days
A laser light show
g. TOUR IS INTENDED TO RUN FOR
Other (Specify)
c.
PROJECTORS ARE INTENDED FOR SALE, LEASE, OR LOAN TO
More than 6 months
OTHER LASER LIGHT SHOW PRODUCERS
1 - 6 months
d. PRODUCT IS INTENDED FOR USE IN A
Less than one month
Planetarium or other dome projection structure
Not applicable (Not a tour)
Theater
Other (Specify)
Hotel/motel ballroom or meeting room
h. PRODUCT UTILIZES THE FOLLOWING LASER EFFECTS
Store displays
Front screen projections
Trade show or convention
Rear screen projections
Discotheque or night club
Holographic displays
Pavilion
Multiple reflection/diffraction effects
Indoor arena
Audience scanning (Also includes scanning any accessible
uncontrolled areas)
Outdoor arena
Museum
Reflections from stationary mirrors or mirrored
surfaces (Beam Matrices)
Outdoor unenclosed area
Other (Specify)
Stationary irradiation of rotating mirror balls, etc.
e. PRODUCT IS INTENDED TO BE USED
Scanning irradiation of rotating mirror balls, etc.
At only one (Fixed) location
Fiber optic projections
At a variety of (Tour) locations
Fog, smoke, or other scattering enhancement effects
Other (Specify)
Other (Specify)
8.
LASER RADIATION LEVELS
LASER MEDIUM (Ar, He-Ne, etc.)
PEAK POWER (watts)
WAVE LENGTHS (nm)
9. IF ANY LASER RADIATION IS PULSED OR SCANNED, GIVE THE PULSE DURATION AND RATE AND SCANNING FREQUENCY AND AMPLITUDE
10. REASON FOR REQUESTING VARIANCE
Compliance with the limits of 21 CFR 1040.11(c) would restrict the intended use of the product because compliance would
limit the output power to the extent that the desired effects would not be sufficiently visible
Other or additional explanation (Specify)
FORM FDA 3147 (8/16)
PREVIOUS EDITION IS OBSOLETE
PAGE 1 OF 4 PAGES
EF
PSC Publishing Services (301) 443-6740
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