CLIA Waiver Applications

Forms and Documents

Document Name	Status
0598_Supporting Statement_2019.doc Supporting Statement A	2019-08-16

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: 201908-0910-008
Status: Active	Previous ICR Reference No: 201606-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
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: 09/10/2019
	Date Received in OIRA: 08/16/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved	09/30/2019
Responses	13	0	40
Time Burden (Hours)	52,000	0	160,000
Cost Burden (Dollars)	113,750	0	350,000

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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:
	84 FR 11307	03/26/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 35871	07/25/2019
Did the Agency receive public comments on this ICR? No

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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	13	40	0	0	-27	0
Annual Time Burden (Hours)	52,000	160,000	0	0	-108,000	0
Annual Cost Burden (Dollars)	113,750	350,000	0	0	-236,250	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: Our estimated burden for the information collection reflects a decrease of 27 responses and 27 records, and a corresponding overall decrease of 108,000 hours. We attribute this adjustment to a decrease in the average number of submissions we received over the last few years.

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Annual Cost to Federal Government: $1,621,830

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 08/16/2019

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