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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
Authorizing Statute(s):
US Code:
21 USC 360
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Recordkeeping for Electronic Products: General Requirements
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)
,
TV (esubmitter)
,
Microwave oven (esubmitter)
,
UV lamps
,
General abbreviated 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)
,
MIcrowave oven annual report
,
Laser annual report (esubmitter)
,
Sunlamp annual report (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
,
Cephalometric Report
,
Microwave products (non-oven)
Third party disclosure for Electronic Products: General Requirements
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.
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
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:
(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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