(CMS-116) Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001

ICR 201908-0938-006

OMB: 0938-0581

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2019-08-26
Supporting Statement A
2018-03-21
ICR Details
0938-0581 201908-0938-006
Active 201708-0938-023
HHS/CMS 21532
(CMS-116) Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/04/2020
Retrieve Notice of Action (NOA) 08/27/2019
  Inventory as of this Action Requested Previously Approved
03/31/2021 03/31/2021 03/31/2021
51,000 0 51,000
51,000 0 51,000
0 0 0

Clincal Laboratory Certification - The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process.

PL: Pub.L. 100 - 578 353 Name of Law: Clinical Laboratory Amendments of 1988
   US Code: 42 USC 493 Name of Law: Laboratory Requirement
  
None

Not associated with rulemaking

  82 FR 28488 06/22/2017
82 FR 40584 08/25/2017
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 51,000 51,000 0 0 0 0
Annual Time Burden (Hours) 51,000 51,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$484,655
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.
08/27/2019


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