Clinical Laboratory
Improvement Amendments Application Form 42 CFR 493.1-.2001
(CMS-116)
Revision of a currently approved collection
No
Regular
09/12/2025
Requested
Previously Approved
36 Months From Approved
03/31/2027
50,236
64,598
50,236
64,598
0
0
Clincal Laboratory Certification - The
application must be completed by entities performing laboratory's
testing specimens for diagnostic or treatment purposes. This
information is vital to the certification process.
US Code:
42
USC 493 Name of Law: Laboratory Requirement
PL:
Pub.L. 100 - 578 353 Name of Law: Clinical Laboratory
Amendments of 1988
The burden decrease is due to a
decrease in the number of new laboratories participating in the
CLIA program (from 24,400 to 17,900) and a decrease in the number
of laboratories reporting changes (from 31,575 to 23,687). The
number of laboratories using the form and burden hours has
decreased from 64,598 to 50,236.
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.