Reporting and Recordkeeping for Electronic Products - General Requirements

Forms and Documents

Document Name	Status
Form FDA 3626 Reporting for Electronic Products: General Requirements Form and Instruction	Modified
0025_Change Request Memo_Oct. 2018.doc Justification for No Material/Nonsubstantive Change	2018-10-26
0025_Supporting Statement_6-12-2017.doc Supporting Statement A	2017-06-12

IC Document Collections

IC ID	Document Title	Status
5678	Reporting for Electronic Products: General Requirements Form and Instruction	Modified
209387	Third party disclosure for Electronic Products: General Requirements	Unchanged
193017	Recordkeeping for Electronic Products: General Requirements	Unchanged

ICR Details

OMB Control No: 0910-0025	ICR Reference No: 201810-0910-013
Status: Historical Active	Previous ICR Reference No: 201706-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Reporting and Recordkeeping for Electronic Products - General Requirements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/30/2018
	Date Received in OIRA: 10/30/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	07/31/2020	07/31/2020
Responses	22,995	0	22,995
Time Burden (Hours)	471,994	0	471,994
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. This ICR collects information from electronic product and x-ray manufacturers, importers, and assemblers. These respondents report and maintain information related to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data reported to the Food and Drug Administration (FDA) and the records maintained are used by FDA and industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. The information collections are either specifically called for in legislation or were developed to aid FDA in performing its obligations under legislation.

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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:
	81 FR 79030	11/10/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 26937	06/12/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Reporting for Electronic Products: General Requirements	FDA 3633, FDA 3643, FDA 3635, FDA 3637, FDA 3147, FDA 3147, FDA 3642, FDA 3645, FDA 3645, FDA 3646, FDA 3647, FDA 3647, FDA 3636, FDA 3639, FDA 3644, FDA 3661, FDA 3662, FDA 3663, FDA 3660, FDA 3662, FDA 3626, FDA 3626, FDA 3627, FDA 3627, FDA 3639, FDA 3632, FDA 3632, FDA 3640, FDA 3640, FDA 3630, FDA 3630, FDA 3646, FDA 2877, FDA 3649, FDA 3649, FDA 3644, FDA 3659, FDA 3660, FDA 3801, FDA 3629, FDA 3661, FDA 3663, FDA 3628, FDA 3634, FDA 3638, FDA 3641, FDA 3636, FDA 3631, FDA 2579, FDA 2767	Diagnostic X-Ray ,   Diagnostic X-Ray (esubmitter) ,   CT X-Ray ,   CT X-Ray (esubmitter) ,   Cabinet X-Ray (esubmitter) ,   Laser ,   Laser (esubmitter) ,   Laser Light Show ,   Laser Light Show (esubmitter) ,   Sunlamp ,   Sunlamp (esubmitter) ,   Mercury vapor lamp (esubmitter) ,   Ultrasonic therapy (esubmitter) ,   Report of Assembly of a Diagnostic X-Ray System ,   Notice of Availability of Sample Electronic Product ,   Declaration for Imported Electronic Products Subject to Radiation Control Standards ,   Accidental Radiation Occurrence Report ,   Accidental Radiation Occurrence Report (esubmitter) ,   General Variance Request (esubmitter) ,   Laser Show Notification (esubmitter) ,   Original Equipment Manufacturer (OEM) Report (esubmitter) ,   Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device ,   Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (esubmitter) ,   General Correspondence ,   Therapy Ultrasound Annual Report ,   Therapy Ultrasound Annual Report (esubmitter) ,   Mercury Vapor Lamp Product Report ,   Mercury Vapor Lamp Annual Report ,   Mercury Vapor Lamp Annual Report (esubmitter) ,   Laser Annual Report ,   Cabinet X-Ray Product Report ,   Therapy Ultrasound Product Report ,   Microwave oven ,   X-Ray Report ,   Microwave products (non-oven) ,   TV (esubmitter) ,   Cephalometric Report ,   Microwave oven (esubmitter) ,   UV lamps ,   General abbreviated report (esubmitter) ,   MIcrowave oven annual report ,   Laser annual report (esubmitter) ,   Sunlamp annual report (esubmitter) ,   X-Ray Report (esubmitter) ,   Cephalometric Report (esubmitter) ,   Microwave products (non-oven) (esubmitter) ,   General Med X-ray annual report (esubmitter) ,   TV annual report (esubmitter) ,   Diagnostic X-ray annual report (esubmitter) ,   Cabinet x-ray annual report (esubmitter)
Recordkeeping for Electronic Products: General Requirements
Third party disclosure for Electronic Products: General Requirements

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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	22,995	22,995	0	0	0	0
Annual Time Burden (Hours)	471,994	471,994	0	0	0	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: The number of respondents/responses per respondent for each IC has been adjusted to reflect updated Agency data. The burden estimates are based on data from the CDRH Center Tracking System and the CARS business objects system. We believe the current burden estimates are improved due to enhanced IT systems and staff training.

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Annual Cost to Federal Government: $3,209,160

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 10/30/2018

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