The Clinical Laboratory Improvement
Amendments of 1988 (CLIA) requires that clinical laboratories
obtain a certificate from the Secretary of Health and Human
Services before accepting materials derived from the human body for
laboratory tests. Laboratories that perform only tests that are "so
simple and accurate as to render the likelihood of erroneous
results negligible" may obtain a certificate of waiver. The
Secretary delegated to FDA the authority to determine under CLIA
whether particular tests (waived tests) are "simple" and have "an
insignificant risk of an erroneous result". Device manufacturers
will submit to FDA an application for determination that a cleared
or approved device meets this CLIA standard (CLIA waiver
application).
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.