OMB notes that this submission corrects errors in the prior approval.
Inventory as of this Action
Requested
Previously Approved
01/31/2017
36 Months From Approved
04/30/2014
2,846,697
0
40,449
516,974
0
324,112
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.
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
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.
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.
Form FDA 3626 Reporting for Electronic Products: General Requirements
0025 final ss 10-31-13.doc
Reporting for Electronic Products: General Requirements