Laboratory Personnel Report (CLIA) and Supporting Regulations (CMS-209)

ICR 201803-0938-006

OMB: 0938-0151

Federal Form Document

ICR Details
0938-0151 201803-0938-006
Active 201502-0938-006
HHS/CMS
Laboratory Personnel Report (CLIA) and Supporting Regulations (CMS-209)
Revision of a currently approved collection   No
Regular
Approved with change 09/10/2018
Retrieve Notice of Action (NOA) 03/27/2018
  Inventory as of this Action Requested Previously Approved
09/30/2021 36 Months From Approved 09/30/2018
9,593 0 9,526
4,796 0 4,763
0 0 0

This form is used by the State agency to determine a laboratory's compliance with personnel qualifications under CLIA. This information is needed for a laboratory's CLIA certification and recertification.

PL: Pub.L. 100 - 578 353 Name of Law: Certification of Laboratories
  
None

Not associated with rulemaking

  83 FR 1037 01/09/2018
83 FR 11753 03/16/2018
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 9,593 9,526 0 0 67 0
Annual Time Burden (Hours) 4,796 4,763 0 0 33 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The changes in burden are the result of an increase in the numbers of respondents in the CLIA program (i.e. 132 additional laboratory facilities that have a CLIA certificate of compliance). The respondents increased from 19,051 to 19,183. The burden hours increased from 4,763 to 4796.

$3,000
No
    No
    No
No
No
No
Uncollected
Denise King 410 786-1013 [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.
03/27/2018


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