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