CLIA Waiver Applications

Forms and Documents

Document Name	Status
CLIA Guidance.pdf Supplementary Document	2013-04-19
0598- CLIA Waiver Applications - SS Final.doc Supporting Statement A	2013-04-19

IC Document Collections

IC ID	Document Title	Status
46257	Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications	Modified

ICR Details

OMB Control No: 0910-0598	ICR Reference No: 201304-0910-004
Status: Historical Active	Previous ICR Reference No: 201002-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 19288
Title: CLIA Waiver Applications
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/02/2013
	Date Received in OIRA: 04/23/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved	07/31/2013
Responses	40	0	40
Time Burden (Hours)	160,000	0	143,200
Cost Burden (Dollars)	350,000	0	0

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Abstract: 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).

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 56846	09/14/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 23568	04/19/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $1,257,792

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/23/2013

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