Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001

ICR 200709-0938-005

OMB: 0938-0581

Federal Form Document

Forms and Documents
ICR Details
0938-0581 200709-0938-005
Historical Active 200408-0938-001
HHS/CMS
Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001
Revision of a currently approved collection   No
Regular
Approved without change 12/27/2007
Retrieve Notice of Action (NOA) 09/25/2007
  Inventory as of this Action Requested Previously Approved
12/31/2010 36 Months From Approved 12/31/2007
17,960 0 16,000
22,450 0 20,000
0 0 0

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

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

Not associated with rulemaking

  72 FR 31839 06/08/2007
72 FR 46085 08/16/2007
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 17,960 16,000 0 0 1,960 0
Annual Time Burden (Hours) 22,450 20,000 0 0 2,450 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Melissa Musotto 4107866962

  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.
09/25/2007


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