OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Reporting and Recordkeeping for Electronic Products - General Requirements

ICR 202006-0910-013 · OMB 0910-0025 · Historical Inactive

Forms and Documents
Document
Name
Status
Form and Instruction
 Modified
Supporting Statement A
2020-07-02
IC Document Collections
IC ID
Document
Title
Status
5678 Modified
209387
Modified
193017
Modified
ICR Details
0910-0025 202006-0910-013
Historical Inactive 201810-0910-013
HHS/FDA CDRH
Reporting and Recordkeeping for Electronic Products - General Requirements
Revision of a currently approved collection   No
Regular
Improperly submitted and continue 07/07/2020
Retrieve Notice of Action (NOA) 07/06/2020
Given that no updates have been made to the package, please resubmit as an extension without change.
  Inventory as of this Action Requested Previously Approved
07/31/2020 36 Months From Approved 08/31/2020
22,995 0 22,995
471,994 0 471,994
0 0 0
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.
US Code: 21 USC 360 Name of Law: FFDCA
  
None
Not associated with rulemaking
  85 FR 3925 01/23/2020
85 FR 28958 05/14/2020
No
3
IC Title Form No. Form Name
Reporting for Electronic Products FDA 3659, FDA 3645, FDA 3646, FDA 3631, FDA 3647, FDA 3649, FDA 2767, FDA 2877, FDA 3633, FDA 3635, FDA 3637, FDA 3642, FDA 2579, FDA 3644, FDA 3640, FDA 3630, FDA 3626, FDA 3627, FDA 3639, FDA 3632, FDA 3660, FDA 3629, FDA 3661, FDA 3801, FDA 3662, FDA 3663, FDA 3628, FDA 3634, FDA 3638, FDA 3641, FDA 3643, FDA 3636 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) ,   Guide for Filing Annual Reports for X-Ray Components and Systems ,   LLS Notification ,   Report of Assembly of a Diagnostic X-Ray System ,   Laser OEM Component Report ,   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 ,   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 ,   Guide for Filing Annual Reports for X-Ray Components and Systems ,   Declaration for Imported Electronic Products Subject to Radiation Control Standards ,   General Variance Application ,   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 ,   TV Annual Report ,   Mercury Vapor Lamp Products Radiation Safety Report ,   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
Recordkeeping for Electronic Products
Third party disclosure for Electronic Products
No
No
$3,209,160
No
    No
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/06/2020