Reporting and Recordkeeping for Electronic Products - General Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 3801 Medical UV lamps Product report	Form	Modified	Available
Form 3663 Abbreviated Report for Microwave Products	Form	Modified	Available
Form 3662 Abbreviated Report for Cephalometric Devices	Form	Modified	Available
Form 3661 Abbreviated Report for X-Ray Tables, etc.	Form	Modified	Available
Form 3660 Microwave Oven Product Report	Form	Modified	Repair queued
Form 3659 Television Products Product Report	Form	Modified	Available
Form 3649 Accidental Radiation Occurrence	Form	Modified	Available
Form 3647 Mercury Vapor Lamp Annual Report	Form	Modified	Available
Form 3646 Mercury Vapor Lamp Product Report	Form	Modified	Available
Form 3645 Ultrasound Therapy Products Annual Report	Form	Modified	Available
Form 3644 Ultrasound Therapy Products Product Report	Form	Modified	Available
Form 3643 Microwave Oven Products Annual Report	Form	Modified	Available
Form 3642 General Correspondence	Form	Modified	Available
Form 3641 Cabinet X-Ray Products Annual Report	Form	Modified	Repair queued
Form 3639 Cabinet X-Ray Products Product Report	Form	Modified	Available
Form 3634 Television Products Annual Report.	Form	Modified	Repair queued
Form 3640 Laser Light Show Product Report	Form	Modified	Available
Form 3638 X-Ray Components and Systems Annual Report	Form	Modified	Available
Form 3636 Lasers and Laser Light Show Annual Reports	Form	Modified	Available
Form 3635 Laser Light Show Notification	Form	Modified	Available
Form 3637 Laser Original Equipment Manufacturer Product Report	Form	Modified	Available
Form 3633 General Variance Request	Form	Modified	Available
Form 3632 Lasers and Products Containing Lasers Product Report	Form	Modified	Available
Form 3631 Sunlamp Products Annual Report	Form	Modified	Available
Form 3630 Sunlamp Product Report	Form	Modified	Available
Form 3629 Abbreviated Report	Form	Modified	Available
Form 3628 General Annual Report	Form	Modified	Available
Form 3627 Diagnostic X-Ray CT Products Product Report	Form	Modified	Repair queued
Form 3626 Diagnostic X-Ray Systems and Components Product Report	Form	Modified	Available
Form 2877 Importation of Electronic Product	Form	Modified	Available
Form 3147 Laser Light Show Variance Request Form	Form	Modified	Available
Form 2579 Report of Assembly of a Diagnostic XRay System	Form	Modified	Available
Form 2767 Sample Electronic Product	Form	Modified	Available
Form 3801 Medical UV lamps Product report	Form	New	Available
Form 3663 Abbreviated Report for Microwave Products	Form	New	Available
Form 3662 Abbreviated Report for Cephalometric Devices	Form	New	Available
Form 3661 Abbreviated Report for X-Ray Tables, etc.	Form	New	Available
Form 3660 Microwave Oven Product Report	Form	New	Available
Form 3659 Television Products Product Report	Form	New	Repair queued
Form 3649 Accidental Radiation Occurrence	Form	New	Available
Form 3647 Mercury Vapor Lamp Annual Report	Form	New	Available
Form 3646 Mercury Vapor Lamp Product Report	Form	New	Available
Form 3645 Ultrasound Therapy Products Annual Report	Form	New	Available
Form 3644 Ultrasound Therapy Products Product Report	Form	New	Available
Form 3643 Microwave Oven Products Annual Report	Form	New	Available
Form 3642 General Correspondence	Form	New	Available
Form 3641 Cabinet X-Ray Products Annual Report	Form	New	Available
Form 3639 Cabinet X-Ray Products Product Report	Form	New	Available
Form 3634 Television Products Annual Report.	Form	New	Available
Form 3640 Laser Light Show Product Report	Form	New	Available
Form 3638 X-Ray Components and Systems Annual Report	Form	New	Available
Form 3636 Lasers and Laser Light Show Annual Reports	Form	New	Repair queued
Form 3635 Laser Light Show Notification	Form	New	Repair queued
Form 3637 Laser Original Equipment Manufacturer Product Report	Form	New	Available
Form 3633 General Variance Request	Form	New	Available
Form 3632 Lasers and Products Containing Lasers Product Report	Form	New	Available
Form 3631 Sunlamp Products Annual Report	Form	New	Available
Form 3630 Sunlamp Product Report	Form	New	Available
Form 3628 General Annual Report	Form	New	Available
Form 3627 Diagnostic X-Ray CT Products Product Report	Form	New	Available
Form 3626 Diagnostic X-Ray Systems and Components Product Report	Form	New	Available
Form 2877 Importation of Electronic Product	Form	New	Available
Form 3147 Laser Light Show Variance Request Form	Form	New	Available
Form 2579 Report of Assembly of a Diagnostic XRay System	Form	New	Available
Form 2767 Sample Electronic Product	Form	New	Available
Form 3629 Abbreviated Report	Form	New	Available
0910-0025 ss 2010.doc	Supporting Statement A	Uploaded 2010-05-11	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Medical UV lamps Product report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Abbreviated Report for Microwave Products
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Abbreviated Report for Cephalometric Devices
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Abbreviated Report for X-Ray Tables, etc.
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Microwave Oven Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Television Products Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Accidental Radiation Occurrence
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Mercury Vapor Lamp Annual Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Mercury Vapor Lamp Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Ultrasound Therapy Products Annual Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Ultrasound Therapy Products Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Microwave Oven Products Annual Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	General Correspondence
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Cabinet X-Ray Products Annual Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Cabinet X-Ray Products Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Television Products Annual Report.
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Laser Light Show Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	X-Ray Components and Systems Annual Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Lasers and Laser Light Show Annual Reports
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Laser Light Show Notification
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Laser Original Equipment Manufacturer Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	General Variance Request
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Lasers and Products Containing Lasers Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Sunlamp Products Annual Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Sunlamp Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Abbreviated Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	General Annual Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Diagnostic X-Ray CT Products Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Diagnostic X-Ray Systems and Components Product Report
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Importation of Electronic Product
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Laser Light Show Variance Request Form
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Report of Assembly of a Diagnostic XRay System
5678	Reporting for Electronic Products - General Requirements	Form	Modified	Sample Electronic Product
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Medical UV lamps Product report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Abbreviated Report for Microwave Products
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Abbreviated Report for Cephalometric Devices
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Abbreviated Report for X-Ray Tables, etc.
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Microwave Oven Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Television Products Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Accidental Radiation Occurrence
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Mercury Vapor Lamp Annual Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Mercury Vapor Lamp Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Ultrasound Therapy Products Annual Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Ultrasound Therapy Products Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Microwave Oven Products Annual Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	General Correspondence
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Cabinet X-Ray Products Annual Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Cabinet X-Ray Products Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Television Products Annual Report.
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Laser Light Show Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	X-Ray Components and Systems Annual Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Lasers and Laser Light Show Annual Reports
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Laser Light Show Notification
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Laser Original Equipment Manufacturer Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	General Variance Request
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Lasers and Products Containing Lasers Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Sunlamp Products Annual Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Sunlamp Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	General Annual Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Diagnostic X-Ray CT Products Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Diagnostic X-Ray Systems and Components Product Report
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Importation of Electronic Product
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Laser Light Show Variance Request Form
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Report of Assembly of a Diagnostic XRay System
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Sample Electronic Product
193017	Recordkeeping for Electronic Products - General Requirements	Form	New	Abbreviated Report

ICR Details

OMB Control No: 0910-0025	ICR Reference No: 201005-0910-011
Status: Historical Active	Previous ICR Reference No: 200703-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Reporting and Recordkeeping for Electronic Products - General Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/11/2010
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/24/2010
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	10/31/2010
Responses	40,449	0	47,355
Time Burden (Hours)	324,112	0	342,889
Cost Burden (Dollars)	0	0	0

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Abstract: To protect the public from unnecessary exposure to radiation from electronic products, FDA must collect certain information from manufacturers and dealers/distributors about electronic products they sell or install.

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Authorizing Statute(s): US Code: 21 USC 360
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 8963	02/26/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 26964	05/13/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Recordkeeping for Electronic Products - General Requirements	2767, 2579, 3147, 2877, 3626, 3627, 3628, 3629, 3630, 3631, 3632, 3633, 3637, 3635, 3636, 3638, 3640, 3634, 3639, 3641, 3642, 3643, 3644, 3645, 3646, 3647, 3649, 3659, 3660, 3661, 3662, 3663, 3801	Sample Electronic Product ,   Report of Assembly of a Diagnostic XRay System ,   Laser Light Show Variance Request Form ,   Importation of Electronic Product ,   Diagnostic X-Ray Systems and Components Product Report ,   Diagnostic X-Ray CT Products Product Report ,   General Annual Report ,   Abbreviated Report ,   Sunlamp Product Report ,   Sunlamp Products Annual Report ,   Lasers and Products Containing Lasers Product Report ,   General Variance Request ,   Laser Original Equipment Manufacturer Product Report ,   Laser Light Show Notification ,   Lasers and Laser Light Show Annual Reports ,   X-Ray Components and Systems Annual Report ,   Laser Light Show Product Report ,   Television Products Annual Report. ,   Cabinet X-Ray Products Product Report ,   Cabinet X-Ray Products Annual Report ,   General Correspondence ,   Microwave Oven Products Annual Report ,   Ultrasound Therapy Products Product Report ,   Ultrasound Therapy Products Annual Report ,   Mercury Vapor Lamp Product Report ,   Mercury Vapor Lamp Annual Report ,   Accidental Radiation Occurrence ,   Television Products Product Report ,   Microwave Oven Product Report ,   Abbreviated Report for X-Ray Tables, etc. ,   Abbreviated Report for Cephalometric Devices ,   Abbreviated Report for Microwave Products ,   Medical UV lamps Product report
Reporting for Electronic Products - General Requirements	2767, 2579, 3147, 2877, 3626, 3627, 3628, 3629, 3630, 3631, 3632, 3633, 3637, 3636, 3638, 3640, 3634, 3639, 3641, 3642, 3643, 3644, 3645, 3646, 3647, 3649, 3659, 3660, 3661, 3662, 3663, 3801, 3635	Sample Electronic Product ,   Report of Assembly of a Diagnostic XRay System ,   Laser Light Show Variance Request Form ,   Importation of Electronic Product ,   Diagnostic X-Ray Systems and Components Product Report ,   Diagnostic X-Ray CT Products Product Report ,   General Annual Report ,   Abbreviated Report ,   Sunlamp Product Report ,   Sunlamp Products Annual Report ,   Lasers and Products Containing Lasers Product Report ,   General Variance Request ,   Laser Original Equipment Manufacturer Product Report ,   Laser Light Show Notification ,   Lasers and Laser Light Show Annual Reports ,   X-Ray Components and Systems Annual Report ,   Laser Light Show Product Report ,   Television Products Annual Report. ,   Cabinet X-Ray Products Product Report ,   Cabinet X-Ray Products Annual Report ,   General Correspondence ,   Microwave Oven Products Annual Report ,   Ultrasound Therapy Products Product Report ,   Ultrasound Therapy Products Annual Report ,   Mercury Vapor Lamp Product Report ,   Mercury Vapor Lamp Annual Report ,   Accidental Radiation Occurrence ,   Television Products Product Report ,   Microwave Oven Product Report ,   Abbreviated Report for X-Ray Tables, etc. ,   Abbreviated Report for Cephalometric Devices ,   Abbreviated Report for Microwave Products ,   Medical UV lamps Product report

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	40,449	47,355	0	0	-6,906	0
Annual Time Burden (Hours)	324,112	342,889	0	0	-18,777	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $2,586,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/24/2010

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