OMB approves
these requirements for use through 04/2001. However OMB does not
approve HCFA's requested burden adjustment at this time because of
its significant implications. Prior to the next submission for OMB
review, HCFA must present evidence of consultation with a
representative group of industry respondents to determine whether
various CLIA requirements are in fact considered "usual and
customary" by the private sector, rather than Federal
mandates.
Inventory as of this Action
Requested
Previously Approved
05/31/2001
05/31/2001
04/30/1998
631,459
0
149,700
17,888,923
0
17,888,923
0
0
0
The ICRs referenced in 42 CFR part 493
outline the requirements necessary to determine an entities
compliance with CLIA. CLIA requires laboratories that perform
testing on human beings to meet performance requirements (quality
standards) in order to be certified by HHS. HHS conducts
inspections to determine a laboratory's compliance with the CLIA
requirements. CLIA implements the certificate, laboratory
standards, and inspection requirements.
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.