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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
(Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 1020.30
21 CFR 1030.10
21 CFR 1040.10
21 CFR 1002.10
21 CFR 1002.11
21 CFR 1002.12
21 CFR 1002.20
21 CFR 1002.50
21 CFR 1002.51
21 CFR 1002.13
21 CFR 1005.10
21 CFR 1005.25
21 CFR 1010.2
21 CFR 1010.4
21 CFR 1010.5
21 CFR 1010.13
21 CFR 1002.13
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
FDA 3626
Diagnostic X-Ray
3626 DX Product Report form.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3626
Diagnostic X-Ray (esubmitter)
3626 DX Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3627
CT X-Ray
3627 CT Product Report form.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3627
CT X-Ray (esubmitter)
3627 CT Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3639
Cabinet X-Ray (esubmitter)
3639 Cabinet X-Ray Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3632
Laser
3632 Laser Product Report form.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3632
Laser (esubmitter)
3632 Laser Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3640
Laser Light Show
3640 LLS Report form.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3640
Laser Light Show (esubmitter)
3640 LLS Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3630
Sunlamp
3630 Sunlamp Product Report form.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3630
Sunlamp (esubmitter)
3630 Sunlamp Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3646
Mercury vapor lamp (esubmitter)
3646 Mercury Vapor Lamp Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3644
Ultrasonic therapy (esubmitter)
3644 Therapy Ultrasound Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3659
TV (esubmitter)
3659 TV Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3660
Microwave oven (esubmitter)
3660 MWO Product Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3801
UV lamps
3801 Medical UV Lamp Report form.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3629
General abbreviated report (esubmitter)
3629 General Abbreviated Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3661
X-Ray Report (esubmitter)
3661 Abbrev X-Ray report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3662
Cephalometric Report (esubmitter)
3662 Abbrev Cephalometric report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3663
Microwave products (non-oven) (esubmitter)
3663 Abbrev Microwave report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3628
General Med X-ray annual report (esubmitter)
3628 General Annual Report (includes medical, analytical, industrial x-ray products) .pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3634
TV annual report (esubmitter)
3634 TV Annual Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3638
Diagnostic X-ray annual report (esubmitter)
3638 DX Annual Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3641
Cabinet x-ray annual report (esubmitter)
3641 Cabinet X-Ray Annual Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3643
MIcrowave oven annual report
3643 MWO Annual Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3636
Laser annual report (esubmitter)
3636 Laser Annual Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3631
Sunlamp annual report (esubmitter)
3631 Sunlamp Annual Report.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 2579
Report of Assembly of a Diagnostic X-Ray System
FDA.2579.Modified.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 2767
Notice of Availability of Sample Electronic Product
2767 Sample Availability form.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 2877
Declaration for Imported Electronic Products Subject to Radiation Control Standards
2877 EPRC Imports form.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3649
Accidental Radiation Occurrence Report
3649 ARO Report form .pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3649
Accidental Radiation Occurrence Report (esubmitter)
3649 ARO Report.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3633
General Variance Request (esubmitter)
3633 General Variance Application.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3635
Laser Show Notification (esubmitter)
3635 LLS Notification.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3637
Original Equipment Manufacturer (OEM) Report (esubmitter)
3637 Laser OEM Component Report.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3147
Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device
3147 Application for LLS Variance form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3147
Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (esubmitter)
3147 Application for LLS Variance.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3642
General Correspondence
3642 General Correspondence.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3645
Therapy Ultrasound Annual Report
3645 Therapy Ultrasound Annual Report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3645
Therapy Ultrasound Annual Report (esubmitter)
3645 Therapy Ultrasound Annual Report.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3646
Mercury Vapor Lamp Product Report
3646 Mercury Vapor Lamp Product Report form.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3647
Mercury Vapor Lamp Annual Report
3647 Mercury Vapor Lamp Annual Report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3647
Mercury Vapor Lamp Annual Report (esubmitter)
3647 Mercury Vapor Lamp Annual Report.pdf
Yes
Yes
Fillable Fileable Signable
Form and Instruction
FDA 3636
Laser Annual Report
3636 Laser Annual Report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3639
Cabinet X-Ray Product Report
3639 Cabinet X-Ray Product Report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3644
Therapy Ultrasound Product Report
3644 Therapy Ultrasound Product Report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3660
Microwave oven
3660 MWO Product Report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3661
X-Ray Report
3661 Abbrev X-Ray report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3662
Cephalometric Report
3662 Abbrev Cephalometric report form.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3663
Microwave products (non-oven)
3663 Abbrev Microwave report form.pdf
Yes
Yes
Fillable Printable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
16,181
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
Requested
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
24
0
-18,009
0
0
18,033
Annual IC Time Burden (Hours)
102,744
0
-31,622
0
0
134,366
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.