CLIA Waiver Applications

ICR 201606-0910-007

OMB: 0910-0598

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-06-23
ICR Details
0910-0598 201606-0910-007
Historical Active 201304-0910-004
HHS/FDA CDRH
CLIA Waiver Applications
Extension without change of a currently approved collection   No
Regular
Approved without change 09/21/2016
Retrieve Notice of Action (NOA) 07/20/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 36 Months From Approved 09/30/2016
40 0 40
160,000 0 160,000
350,000 0 350,000

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).

None
None

Not associated with rulemaking

  81 FR 18858 04/01/2016
81 FR 46693 07/18/2016
No

  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) 160,000 160,000 0 0 0 0
Annual Cost Burden (Dollars) 350,000 350,000 0 0 0 0
No
No

$1,700,922
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  No

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.
07/20/2016


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