CLIA Waiver Applications

ICR 201304-0910-004

OMB: 0910-0598

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement A
ICR Details
0910-0598 201304-0910-004
Historical Active 201002-0910-003
HHS/FDA 19288
CLIA Waiver Applications
Extension without change of a currently approved collection   No
Approved without change 07/02/2013
Retrieve Notice of Action (NOA) 04/23/2013
  Inventory as of this Action Requested Previously Approved
07/31/2016 36 Months From Approved 07/31/2013
40 0 40
160,000 0 143,200
350,000 0 0

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).


Not associated with rulemaking

  77 FR 56846 09/14/2012
78 FR 23568 04/19/2013

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 40 40 0 0 0 0
Annual Time Burden (Hours) 160,000 143,200 0 0 16,800 0
Annual Cost Burden (Dollars) 350,000 0 0 0 350,000 0
FDA revised the title of the information collection for clarity. Based on information received from industry in comments on the 60-day Federal Register notice, we have adjusted the average burden per response for CLIA waiver applications, as well as the estimated operating and maintenance costs. As a result, the total estimated reporting burden has increased by 16,800 hours and the operating and maintenance costs have increased by $238,800 from $66,200 to $350,000. FDA did not originally report the $66,200 in ICRAS (however, it was in the last Supporting Statement), so the whole $350,000 will show up as new.

Daniel Gitteson 3017965156 [email protected]


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.

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