Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization ( 42 CFR 493.17)

ICR 201309-0910-010

OMB: 0910-0607

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2010-07-29
Supporting Statement A
2013-09-12
IC Document Collections
IC ID
Document
Title
Status
180758
Modified
ICR Details
0910-0607 201309-0910-010
Historical Active 201008-0910-007
HHS/FDA 20474
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization ( 42 CFR 493.17)
Extension without change of a currently approved collection   No
Regular
Approved without change 10/23/2013
Retrieve Notice of Action (NOA) 09/19/2013
  Inventory as of this Action Requested Previously Approved
10/31/2016 36 Months From Approved 10/31/2013
900 0 900
900 0 900
46,800 0 46,800

This ICR describes the burden to manufacturers when they request Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic (IVD) tests when a premarket review is not needed (for example, devices exempt from premarket notification). In these cases, FDA recommends that manufacturers submit to FDA a brief description of why CLIA categorization is requested (e.g., exempt from 510(k), name change for a previously cleared device), the name of the device, the package insert (instructions for use), the product code, and regulation number. FDA will use the information collected to determine device complexity. There are three categories of test complexity: waived tests, moderate complexity tests, and high complexity tests. Laboratories performing only waived tests are subject to minimal regulation. Laboratories performing moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections.

US Code: 42 USC 263a (353) Name of Law: Certification of laboratories
  
None

Not associated with rulemaking

  78 FR 30312 05/22/2013
78 FR 56899 09/16/2013
No

1
IC Title Form No. Form Name
Request for CLIA categorization

  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 900 900 0 0 0 0
Annual Time Burden (Hours) 900 900 0 0 0 0
Annual Cost Burden (Dollars) 46,800 46,800 0 0 0 0
No
No

$628,896
No
No
No
No
No
Uncollected
JonnaLynn Capezzuto 301 827-4659 [email protected]

  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.
09/19/2013


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