Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization

ICR 201910-0910-003

OMB: 0910-0607

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0607 201910-0910-003
Active 201608-0910-015
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
Extension without change of a currently approved collection   No
Approved without change 11/26/2019
Retrieve Notice of Action (NOA) 10/29/2019
  Inventory as of this Action Requested Previously Approved
11/30/2022 36 Months From Approved 12/31/2019
400 0 900
400 0 900
2,000 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

Not associated with rulemaking

  84 FR 30127 06/26/2019
84 FR 57443 10/25/2019

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 400 900 0 0 -500 0
Annual Time Burden (Hours) 400 900 0 0 -500 0
Annual Cost Burden (Dollars) 2,000 46,800 0 0 -44,800 0
Our estimated burden for the information collection reflects an overall decrease of 500 hours. We attribute this adjustment to a decrease in the number of submissions we received over the last few years. Also, upon review of this information collection, we believe the previous estimate may have included requests for categorization associated with a premarket submission, the burden estimate of which is included under the OMB approval for the applicable premarket submission. We have therefore revised the number of respondents/responses to include only those that are separate from a product application, consistent with the scope of this information collection.

Amber Sanford 301 796-8867 [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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