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
10/30/2018
table that charts list comparision
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.
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
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.
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.
Reporting for Electronic Products: General Requirements