Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule

ICR 201312-0910-001

OMB: 0910-0757

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-11-26
ICR Details
0910-0757 201312-0910-001
Historical Inactive
HHS/FDA 20992
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 01/27/2014
Retrieve Notice of Action (NOA) 12/06/2013
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

The proposed rule would allow abbreviated new drug application (ANDA) holders to update product labeling to reflect certain types of newly-acquired safety information using the same process now available to new drug application (NDA) holders when they submit a CBE-O labeling supplement. At the time of submission of the CBE-0 labeling supplement to FDA, an ANDA holder must send notice of the labeling change proposed in the Supplement, including a copy of the information supporting the change, to the NDA holder for the reference listed drug RLD), unless approval of the NDA for the RLD has been withdrawn. ANDA holders, NDA holders, and BLA holders would be required to verify that the correct information regarding the labeling changes proposed in their CBE-0 supplement appears on the proposed FDA Web page and, if the information is incorrect, they must contact the appropriate FDA review division within 2 business days of posting on the FDA Web page.

US Code: 21 USC 314.70 Name of Law: FD&C Act
  
None

0910-AG94 Proposed rulemaking 78 FR 67985 11/13/2013

No

Yes
Miscellaneous Actions
No
This is a new approval request.

$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@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.
12/06/2013


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