Reporting and Recordkeeping for Electronic Products - General Requirements

Forms and Documents

Document Name	Status
Form 2767 Reporting for Electronic Products - General Requirements Form	Modified
Form 3629 Recordkeeping for Electronic Products - General Requirements Form	New
0910-0025 ss 2010.doc Supporting Statement A	2010-05-11

IC Document Collections

IC ID	Document Title	Status
5678	Reporting for Electronic Products - General Requirements Form	Modified
193017	Recordkeeping for Electronic Products - General Requirements Form	New

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
	Date Received in OIRA: 05/24/2010
Terms of Clearance:

	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 Name of Law: null
  

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

IC Title	Form No.	Form Name
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
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	Abbreviated Report ,   Sunlamp Product Report ,   Sunlamp Products Annual Report ,   Lasers and Products Containing Lasers Product Report ,   Sample Electronic Product ,   Report of Assembly of a Diagnostic XRay System ,   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 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 ,   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

	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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