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View Information Collection (IC) List
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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:
201005-0910-011
Status:
Historical Active
Previous ICR Reference No:
200703-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Reporting and Recordkeeping for Electronic Products - General Requirements
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/11/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/24/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2013
36 Months From Approved
10/31/2010
Responses
40,449
0
47,355
Time Burden (Hours)
324,112
0
342,889
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.
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:
75 FR 8963
02/26/2010
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 26964
05/13/2010
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Recordkeeping for Electronic Products - General Requirements
2767, 2579, 3147, 2877, 3626, 3627, 3628, 3629, 3630, 3631, 3632, 3633, 3637, 3635, 3636, 3638, 3640, 3634, 3639, 3641, 3642, 3643, 3644, 3645, 3646, 3647, 3649, 3659, 3660, 3661, 3662, 3663, 3801
Sample Electronic Product
,
Report of Assembly of a Diagnostic XRay System
,
Laser Light Show Variance Request Form
,
Importation of Electronic Product
,
Diagnostic X-Ray Systems and Components Product Report
,
Diagnostic X-Ray CT Products Product Report
,
General Annual Report
,
Abbreviated Report
,
Sunlamp Product Report
,
Sunlamp Products Annual Report
,
Lasers and Products Containing Lasers Product Report
,
General Variance Request
,
Laser Original Equipment Manufacturer Product Report
,
Laser Light Show Notification
,
Lasers and Laser Light Show Annual Reports
,
X-Ray Components and Systems Annual Report
,
Laser Light Show Product Report
,
Television Products Annual Report.
,
Cabinet X-Ray Products Product Report
,
Cabinet X-Ray Products Annual Report
,
General Correspondence
,
Microwave Oven Products Annual Report
,
Ultrasound Therapy Products Product Report
,
Ultrasound Therapy Products Annual Report
,
Mercury Vapor Lamp Product Report
,
Mercury Vapor Lamp Annual Report
,
Accidental Radiation Occurrence
,
Television Products Product Report
,
Microwave Oven Product Report
,
Abbreviated Report for X-Ray Tables, etc.
,
Abbreviated Report for Cephalometric Devices
,
Abbreviated Report for Microwave Products
,
Medical UV lamps Product report
Reporting for Electronic Products - General Requirements
2767, 2579, 3147, 2877, 3626, 3627, 3628, 3629, 3630, 3631, 3632, 3633, 3637, 3636, 3638, 3640, 3634, 3639, 3641, 3642, 3643, 3644, 3645, 3646, 3647, 3649, 3659, 3660, 3661, 3662, 3663, 3801, 3635
Sample Electronic Product
,
Report of Assembly of a Diagnostic XRay System
,
Laser Light Show Variance Request Form
,
Importation of Electronic Product
,
Diagnostic X-Ray Systems and Components Product Report
,
Diagnostic X-Ray CT Products Product Report
,
General Annual Report
,
Abbreviated Report
,
Sunlamp Product Report
,
Sunlamp Products Annual Report
,
Lasers and Products Containing Lasers Product Report
,
General Variance Request
,
Laser Original Equipment Manufacturer Product Report
,
Laser Light Show Notification
,
Lasers and Laser Light Show Annual Reports
,
X-Ray Components and Systems Annual Report
,
Laser Light Show Product Report
,
Television Products Annual Report.
,
Cabinet X-Ray Products Product Report
,
Cabinet X-Ray Products Annual Report
,
General Correspondence
,
Microwave Oven Products Annual Report
,
Ultrasound Therapy Products Product Report
,
Ultrasound Therapy Products Annual Report
,
Mercury Vapor Lamp Product Report
,
Mercury Vapor Lamp Annual Report
,
Accidental Radiation Occurrence
,
Television Products Product Report
,
Microwave Oven Product Report
,
Abbreviated Report for X-Ray Tables, etc.
,
Abbreviated Report for Cephalometric Devices
,
Abbreviated Report for Microwave Products
,
Medical UV lamps Product report
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
40,449
47,355
0
0
-6,906
0
Annual Time Burden (Hours)
324,112
342,889
0
0
-18,777
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:
Annual Cost to Federal Government:
$2,586,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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:
Daniel Gitteson 3017965156 daniel.gitteson@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:
05/24/2010
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