Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

ICR 201211-0910-007

OMB: 0910-0734

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-11-21
ICR Details
0910-0734 201211-0910-007
Historical Active
HHS/FDA
Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 03/20/2013
Retrieve Notice of Action (NOA) 11/26/2012
  Inventory as of this Action Requested Previously Approved
03/31/2016 36 Months From Approved
203 0 0
824 0 0
0 0 0

The guidance provides information on the implementation of the new statutory provisions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation; how the Food and Drug Administration plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changed.

US Code: 21 USC 355(o)(4)(B) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  76 FR 20686 04/13/2011
77 FR 68787 11/16/2012
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 203 0 0 203 0 0
Annual Time Burden (Hours) 824 0 0 824 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$212,090,000
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.
11/26/2012


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