Extension without change of a currently approved collection
No
Regular
02/19/2021
Requested
Previously Approved
36 Months From Approved
03/31/2021
615,380
613,736
615,380
615,380
0
0
This ICR collects information from
device manufactures and distributors who are subject to the
requirements for device tracking, tracking systems, and distributor
reporting. Manufacturers must track a class II or class III device
if its failure would be reasonable likely to have serious adverse
health consequences, or it is intended to be implanted in the human
body for more than one year, or it is life-sustaining or
life-supporting and used outside a device user facility, or when
FDA determines that tracking would be appropriate in order to
protect the general public in the event of a device
recall.
This information collection is
being submitted with no changes or adjustments. The ICs in ROCIS
have been consolidated from 11 to 3 to make it easier for review in
the system.
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.