Prior to
publication of the final rule, the agency should provide to OMB a
summary of all comments received on the proposed information
collection and identify any changes made in response to these
comments.
Inventory as of this Action
Requested
Previously Approved
07/31/2020
36 Months From Approved
08/31/2020
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 3663, FDA 3628, FDA 3634, FDA 3638, FDA 3641, FDA 3636, FDA
3631, FDA 2579, FDA 2767, FDA 2877, FDA 3649, FDA 3649, 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 3644, FDA 3659, FDA 3660, FDA
3801, FDA 3629, FDA 3661, FDA 3147, FDA 3642, FDA 3645, FDA 3645,
FDA 3646, FDA 3647, FDA 3647, FDA 3636, FDA 3639, FDA 3633, FDA
3643, FDA 3635, FDA 3637, FDA 3147, FDA 3644
The number of
respondents/responses per respondent for each IC has been adjusted
as appropriate to reflect the proposed amendments to 21 CFR parts
1000 through 1050. As a result of these amendments, the total
estimated burden for this ICR has decreased by 67,392 hours
(previously 471,994 hours; now 404,602 hours).
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 3662 (Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements
0025--Supporting Statement--Proposed Rule_2019.doc
(Burden Change Due to Rulemaking) Reporting for Electronic Products: General Requirements