Laboratory Personnel Report
(CLIA) and Supporting Regulations (CMS-209)
Revision of a currently approved collection
No
Regular
06/22/2021
Requested
Previously Approved
36 Months From Approved
09/30/2021
9,582
9,593
4,791
4,796
0
0
This form is used by the State agency
to determine a laboratory's compliance with personnel
qualifications under CLIA. This information is needed for a
laboratory's CLIA certification and recertification.
There was a decrease in the
responses from 9,593 to 9,582. The burden hours decreased slightly
from 4,796 to 4,791. The changes in burden are the result of an
increase in the hourly wage of laboratory staff completing the
CMS-209 form to $52.68 from $35.92. There are no program changes.
The wage burden increased from $86,136.16 to $252,390.
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.