This ICR collects information from
manufacturers, importers, and distributors of medical devices to
disclose to health professionals and consumers specific information
about themselves or their devices on the label or labeling of their
devices. The primary users of the information disclosed on the
label or in the labeling of devices are the health professionals
who use or prescribe the device or the lay consumers who use the
device. The labeling should contain sufficient information for
these persons to use the device safely and effectively. FDA may use
the information to determine whether there is reasonable assurance
of the safety and effectiveness of the device for its intended
use.
The estimated annual hourly
burden, formerly estimated as 10,678,247 hours (2,240,929
recordkeeping and 8,437,318 third-party disclosure) has increased
by 1,610,359 hours (1,022,621 recordkeeping and 587,738 third-party
disclosure) to a total estimated annual hourly burden of 12,288,606
hours (3,263,550 recordkeeping and 9,025,056 third-party
disclosure. The increase is due to adjustments reflecting updated
data. We note that ROCIS database is inconsistent with the number
of burden hours in the previous Supporting Statement (approved
9/22/2015, supporting statement states 10,678,247 hours, ROCIS
states 10,690,449 hours). Upon submitting this Supporting
Statement, we will correct the error in ROCIS.
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.
0485_Supporting Statement_2018.doc
Processing, labeling, or repacking agreement--801.150(a)(2)