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

ICR 201008-0910-007

OMB: 0910-0607

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2010-07-29
Supporting Statement A
2010-08-03
ICR Details
0910-0607 201008-0910-007
Historical Active 200706-0910-001
HHS/FDA
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 10/18/2010
Retrieve Notice of Action (NOA) 08/23/2010
  Inventory as of this Action Requested Previously Approved
10/31/2013 36 Months From Approved 10/31/2010
900 0 900
900 0 900
46,800 0 0

A draft guidance titled Guidance for Administrative Procedures for CLIA Categorization was released for coment August 14,2000. The document describes procedures FDA will use to assign the complexity category to a device and includes information that manufacturers should send to FDA in cases where the complexity categorization is determined separate from the premarket submission.

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

Not associated with rulemaking

  75 FR 23781 05/04/2010
75 FR 47601 08/06/2010
No

1
IC Title Form No. Form Name
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1998 Categorization ( 42 CFR 493.17)

  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 0 0 0 46,800 0
No
No

$341,400
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [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.
08/23/2010


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