Reporting and Recordkeeping for Electronic Products - General Requirements

ICR 201810-0910-013

OMB: 0910-0025

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2018-10-26
Supporting Statement A
2017-06-12
ICR Details
0910-0025 201810-0910-013
Historical Active 201706-0910-005
HHS/FDA CDRH
Reporting and Recordkeeping for Electronic Products - General Requirements
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/30/2018
Retrieve Notice of Action (NOA) 10/30/2018
  Inventory as of this Action Requested Previously Approved
07/31/2020 07/31/2020 07/31/2020
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: null
  
None

Not associated with rulemaking

  81 FR 79030 11/10/2016
82 FR 26937 06/12/2017
No

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

  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
No
No
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.

$3,209,160
No
    No
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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.
10/30/2018


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