Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

ICR 201206-0910-002

OMB: 0910-0636

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-06-05
Supporting Statement A
2012-06-05
IC Document Collections
ICR Details
0910-0636 201206-0910-002
Historical Active 200810-0910-002
HHS/FDA
Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Extension without change of a currently approved collection   No
Regular
Approved without change 08/15/2012
Retrieve Notice of Action (NOA) 06/08/2012
  Inventory as of this Action Requested Previously Approved
08/31/2015 36 Months From Approved 08/31/2012
32,500 0 32,500
125,000 0 125,000
0 0 0

This guidance provides information on: (1) the meaning of "domestic Address" for purposes of the labeling requirements of section 502(x) of the act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x)of the act.

US Code: 21 USC 379aa Name of Law: ffdca
  
None

Not associated with rulemaking

  76 FR 80945 12/27/2011
77 FR 31024 05/24/2012
No

2
IC Title Form No. Form Name
Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c))
Recordkeeping - (21 U.S.C. 379aa(e)(1))

  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 32,500 32,500 0 0 0 0
Annual Time Burden (Hours) 125,000 125,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$23,000,000
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@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.
06/08/2012


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