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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:
201311-0910-008
Status:
Historical Active
Previous ICR Reference No:
201005-0910-011
Agency/Subagency:
HHS/FDA
Agency Tracking No:
20693
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:
01/03/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/20/2013
Terms of Clearance:
OMB notes that this submission corrects errors in the prior approval.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2017
36 Months From Approved
04/30/2014
Responses
2,846,697
0
40,449
Time Burden (Hours)
516,974
0
324,112
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:
78 FR 35279
06/12/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 65329
10/31/2013
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 3626, FDA 3626, FDA 3627, FDA 3627, FDA 3639, FDA 3632, FDA 3632, FDA 3640, FDA 3640, FDA 3630, FDA 3630, FDAS 3646, FDA 3644, FDA 3659, FDA 3660, FDA 3801, FDA 3629, FDA 3661, FDA 3662, FDA 3663, FDA 3628, FDA 3634, FDA 3638, FDA 3641, FDA 3643, FDA 3636, FDA 3631
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 (esubmitter)
,
General abbreviated report (esubmitter)
,
X-ray tables, etc (esubmitter)
,
Cephalometric device (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)
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
2,846,697
40,449
0
0
2,806,248
0
Annual Time Burden (Hours)
516,974
324,112
0
0
192,862
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:
o The estimated annual reporting burden, formerly estimated as 88,435 hours, now includes reporting burden and third-party disclosure burden, as discussed above, with a combined estimated burden of 192,599 hours (81,460 reporting; 111,139 third-party disclosure). The increase of 104,165 (rounded) estimated burden hours was caused by the changes listed above and by adjustments in the estimated number of respondents and responses per respondent. The estimated annual recordkeeping burden, formally estimated as 235,767 hours, has increased by 88,608 hours to the current estimate, 324,375 hours. A detailed explanation of changes appear in the #A15 of the supporting statement.
Annual Cost to Federal Government:
$3,144,480
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:
JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@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:
11/20/2013
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