Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

ICR 201101-0910-003

OMB: 0910-0553

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-12-23
ICR Details
0910-0553 201101-0910-003
Historical Active 200712-0910-006
HHS/FDA
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
Extension without change of a currently approved collection   No
Regular
Approved without change 03/21/2011
Retrieve Notice of Action (NOA) 01/11/2011
  Inventory as of this Action Requested Previously Approved
03/31/2014 36 Months From Approved 03/31/2011
689 0 227
2,756 0 4,540
0 0 0

The purpose of this guidance is to allow the use of selected symbols in place of text. This guidance helps IVD manufacturers to create uniform labels and labeling for the United States and European Union (and any other countries that may permit use of symbols from these international standards)instead of needing designated labels for each market place.

US Code: 21 USC 352 Name of Law: null
   US Code: 42 USC 262 Name of Law: null
  
None

Not associated with rulemaking

  75 FR 61494 10/05/2010
76 FR 1169 01/07/2011
No

1
IC Title Form No. Form Name
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

  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 689 227 0 0 462 0
Annual Time Burden (Hours) 2,756 4,540 0 0 -1,784 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$51,342,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  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.
01/11/2011


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