Extension without change of a currently approved collection
No
Regular
Approved without change
10/15/2018
09/13/2018
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
10/31/2021
36 Months From Approved
10/31/2018
81,908,682
0
60,871,112
12,289,240
0
10,690,449
0
0
0
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)