HCFA Forms 108
and 109 are cleared for use through 4/94. OMB acted in less than 60
days in the interest of satisfying the July 1991 statutory deadline
for implementing CLIA '88. OMB notes, however, that the Department
submitted these forms for PRA review prior to issuance of final
rules establishing the laboratory standards and user fees required
by CLIA '88.
Inventory as of this Action
Requested
Previously Approved
04/30/1994
04/30/1994
320,000
0
0
826,667
0
0
0
0
0
CLIA REQUIRES EVERY LABORATORY TO BE
CERTIFIED BY THE HEALTH CARE FINANCING ADMINISTRATION AND TO HOLD A
FEDERAL CERTIFICATE. UNITL 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.