Electronic Products Requirements

Forms and Documents

Document Name	Status
Form 3646 Mercury Vapor Lamp Products Radiation Safety Report Form	Modified
Form FDA 2579 REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM Form	Modified
Form FDA 3637 Laser OEM Component Report Form and Instruction	Modified
Form FDA 3635 LLS Notification Form and Instruction	Modified
Form FDA 3633 General Variance Application Form and Instruction	Modified
Form FDA 2877 Declaration for Imported Electronic Products Subject to Radiation Control Standards Form and Instruction	Modified
Form FDA 2767 Notice of Availability of Sample Electronic Product Form and Instruction	Modified
Form FDA 3642 General Correspondence Form and Instruction	Modified
Form FDA 3649 Accidental Radiation Occurrence Report Form and Instruction	Modified
Form FDA 3645 Guide for Preparing Annual Reports for Ultrasonic Therapy Products Form and Instruction	Modified
Form FDA 3647 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps Form and Instruction	Modified
Form FDA 3631 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products Form and Instruction	Modified
Form FDA 3636 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products Form and Instruction	Modified
Form FDA 3643 Microwave Oven Products Annual Report Form and Instruction	Modified
Form FDA 3641 Guide for Filing Annual Reports for X-Ray Components and Systems Form and Instruction	Modified
Form FDA 3638 Guide for Filing Annual Reports for X-Ray Components and Systems Form and Instruction	Modified
Form FDA 3634 TV Annual Report Form and Instruction	Modified
Form FDA 3628 Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) Form and Instruction	Modified
Form FDA 3663 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) Form and Instruction	Modified
Form FDA 3662 A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use Form and Instruction	Modified
Form FDA 3661 A Guide for the Submission of an Abbreviated Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use Form and Instruction	Modified
Form FDA 3629 General Abbreviated Report Form and Instruction	Modified
Form FDA 3801 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps Form and Instruction	Modified
Form FDA 3660 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens Form and Instruction	Modified
Form FDA 3659 TV Product Report Form and Instruction	Modified
Form FDA 3644 Guide for Preparing Product Reports for Ultrasonic Therapy Products Form and Instruction	Modified
Form FDA 3630 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products Form and Instruction	Modified
Form FDA 3640 Reporting Guide for Laser Light Shows and Displays Form and Instruction	Modified
Form FDA 3632 Guide for Preparing Product Reports for Lasers and Products Containing Lasers Form and Instruction	Modified
Form FDA 3639 Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 Form and Instruction	Modified
Form FDA 3627 A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems Form and Instruction	Modified
Form FDA 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components Form and Instruction	Modified
0025 Electronic Products RIN AH65 SSA 2023.docx Supporting Statement A	2023-01-19

IC Document Collections

IC ID	Document Title	Status
5678	Reporting for Electronic Products Form	Modified	Mercury Vapor Lamp Products Radiation Safety Report
5678	Reporting for Electronic Products Form	Modified	REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM
5678	Reporting for Electronic Products Form and Instruction	Modified	Laser OEM Component Report
5678	Reporting for Electronic Products Form and Instruction	Modified	LLS Notification
5678	Reporting for Electronic Products Form and Instruction	Modified	General Variance Application
5678	Reporting for Electronic Products Form and Instruction	Modified	Declaration for Imported Electronic Products Subject to Radiation Control Standards
5678	Reporting for Electronic Products Form and Instruction	Modified	Notice of Availability of Sample Electronic Product
5678	Reporting for Electronic Products Form and Instruction	Modified	General Correspondence
5678	Reporting for Electronic Products Form and Instruction	Modified	Accidental Radiation Occurrence Report
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Annual Reports for Ultrasonic Therapy Products
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products
5678	Reporting for Electronic Products Form and Instruction	Modified	Microwave Oven Products Annual Report
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Filing Annual Reports for X-Ray Components and Systems
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Filing Annual Reports for X-Ray Components and Systems
5678	Reporting for Electronic Products Form and Instruction	Modified	TV Annual Report
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)
5678	Reporting for Electronic Products Form and Instruction	Modified	Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens)
5678	Reporting for Electronic Products Form and Instruction	Modified	A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use
5678	Reporting for Electronic Products Form and Instruction	Modified	A Guide for the Submission of an Abbreviated Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use
5678	Reporting for Electronic Products Form and Instruction	Modified	General Abbreviated Report
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps
5678	Reporting for Electronic Products Form and Instruction	Modified	Guidance for Preparing Reports on Radiation Safety of Microwave Ovens
5678	Reporting for Electronic Products Form and Instruction	Modified	TV Product Report
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Product Reports for Ultrasonic Therapy Products
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Product Reports on Sunlamps and Sunlamp Products
5678	Reporting for Electronic Products Form and Instruction	Modified	Reporting Guide for Laser Light Shows and Displays
5678	Reporting for Electronic Products Form and Instruction	Modified	Guide for Preparing Product Reports for Lasers and Products Containing Lasers
5678	Reporting for Electronic Products Form and Instruction	Modified	Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40
5678	Reporting for Electronic Products Form and Instruction	Modified	A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems
5678	Reporting for Electronic Products Form and Instruction	Modified	A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components
5678	Reporting for Electronic Products Form	Modified
209387	Third party disclosure for Electronic Products	Modified
193017	Recordkeeping for Electronic Products	Modified

ICR Details

OMB Control No: 0910-0025	ICR Reference No: 202301-0910-010
Status: Historical Active	Previous ICR Reference No: 202007-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Electronic Products Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/06/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/19/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2026	36 Months From Approved	08/31/2023
Responses	2,550,391	0	22,995
Time Burden (Hours)	404,602	0	471,994
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request supports agency rulemaking. FDA is amending its regulations for requirements for certain reporting and records of electronic products by removing specific reporting, as well as repealing outdated recommendations for radiation protection and performance standards, and removing submission requirements for copies of certain applications and forms to alleviate regulatory burden to both FDA and industry.

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH65	Final or interim final rulemaking	88 FR 3638	01/20/2023

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Recordkeeping for Electronic Products
Reporting for Electronic Products	FDA 3637, FDA 3660, FDA 3629, FDA 3661, FDA 3801, FDA 3662, FDA 3663, FDA 3628, FDA 3634, FDA 3638, FDA 3641, FDA 3643, FDA 3636, FDA 3631, FDA 3647, FDA 3649, FDA 2767, FDA 2877, FDA 3633, FDA 3635, FDA 3642, FDA 2579, 3646, FDA 3645, FDA 3659, FDA 3644, FDA 3640, FDA 3630, FDA 3626, FDA 3627, FDA 3639, FDA 3632	A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components ,   A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems ,   Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 ,   Guide for Preparing Product Reports for Lasers and Products Containing Lasers ,   Reporting Guide for Laser Light Shows and Displays ,   Guide for Preparing Product Reports on Sunlamps and Sunlamp Products ,   Guide for Preparing Product Reports for Ultrasonic Therapy Products ,   TV Product Report ,   Guidance for Preparing Reports on Radiation Safety of Microwave Ovens ,   Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps ,   General Abbreviated Report ,   A Guide for the Submission of an Abbreviated Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use ,   A Guide for the Submission of an Abbreviated Radiation Safety Report on Cephalometric Devices Intended for Diagnostic Use ,   Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) ,   Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) ,   TV Annual Report ,   Guide for Filing Annual Reports for X-Ray Components and Systems ,   Guide for Filing Annual Reports for X-Ray Components and Systems ,   Microwave Oven Products Annual Report ,   Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products ,   Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamp Products ,   Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps ,   Guide for Preparing Annual Reports for Ultrasonic Therapy Products ,   Accidental Radiation Occurrence Report ,   General Correspondence ,   Notice of Availability of Sample Electronic Product ,   Declaration for Imported Electronic Products Subject to Radiation Control Standards ,   General Variance Application ,   LLS Notification ,   Laser OEM Component Report ,   REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM ,   Mercury Vapor Lamp Products Radiation Safety Report
Third party disclosure for Electronic Products

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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	2,550,391	22,995	0	0	2,527,396	0
Annual Time Burden (Hours)	404,602	471,994	0	0	-67,392	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: We have revised the number of respondents to reflect the current number of entities we believe are subject to the requirements in 21 CFR parts 1000 through 1050. This figures corresponds with updated data presented in the analysis of impacts associated with the final rule (FRIA). As a result of these changes and adjustments, the information collection reflects an increase of 2,527,396 responses and a decrease of by 67,392 hours, annually.

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Annual Cost to Federal Government: $4,381,146

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? No

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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: 01/19/2023

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