Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling

ICR 201304-0910-005

OMB: 0910-0740

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-04-19
IC Document Collections
IC ID
Document
Title
Status
206686
New
ICR Details
0910-0740 201304-0910-005
Historical Inactive
HHS/FDA 19293
Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 05/28/2013
Retrieve Notice of Action (NOA) 04/25/2013
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

FDA is proposing to revise medical device and biological product labeling regulations to explicitly allow for the use in medical device labeling of certain stand-alone symbols contained in a standard that FDA recognizes under its authority under section 514(c) of the FD&C Act. In particular, FDA will allow the inclusion of certain stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized SDO and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices, provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. As such the requirement to submit to FDA and disclose to third-parties a symbols glossary, which means "a compiled listing of (i) each symbol used in the labeling of the device, and (ii) the meaning of or explanatory text for the symbol," is subject to the PRA.

US Code: 21 USC 352 Name of Law: FD&C Act
  
None

0910-AG74 Proposed rulemaking 78 FR 23508 04/19/2013

No

1
IC Title Form No. Form Name
Symbols Glossary

Yes
Miscellaneous Actions
No
This is a new proposed rule.

$0
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.
04/25/2013


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