This survey form is an instrument used
by the State agency to record data collected in order to determine
compliance with CLIA. This information is needed for laboratory
certification and recertification.
Changes in burden are the
result of an increase in the numbers of respondents in the CLIA
program (i.e., 132 additional laboratory facilities that have a
CLIA certificate of compliance). The respondents increased from
19,051 to 19,183. The burden hours increased from 4,763 to 4796.
There are no program changes.
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.