CLIA REQUIRES EVERY LABORATORY TO BE
CERTIFIED BY THE HEALTH CARE FINANCING ADMINISTRATION ADN TO HOLD A
FEDERAL CERTIFICATE. UNTIL FIN RULES ARE DEVELOPED AND CLIA IS
FULLY IMPLEMENTED, THE HCFA IS REQUIRI ALL LABORATORIES TO APPLY
FOR A PROVISIONAL CERTIFICATE. THIS PROCESS WILL ENABLE
LABORATORIES TO CONTINUE TESTING UNTIL HCFA HAS DETERMINED
COMPLIANCE OR THE LAB HAS ACHIEVED ACCREDITATION.
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.