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

ICR 201506-0910-032

OMB: 0910-0636

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2015-07-01
Supporting Statement A
2015-06-29
IC Document Collections
IC ID
Document
Title
Status
186861
Modified
186860
Modified
ICR Details
0910-0636 201506-0910-032
Historical Active 201206-0910-002
HHS/FDA CDER
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 12/09/2015
Retrieve Notice of Action (NOA) 07/02/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 12/31/2015
32,500 0 32,500
235,000 0 125,000
0 0 0

The guidance document discusses what should be included in a serious adverse drug event report submitted under section 760(b)(1) (21 U.S.C. 379aa(b)(1)) of the FD&C Act, including follow-up reports under 760(c)(2) (21 U.S.C. 379aa(c)(2)) of the FD&C Act, and how to submit these reports.

US Code: 21 USC 379aa Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 3608 01/23/2015
80 FR 36543 06/25/2015
Yes

2
IC Title Form No. Form Name
Reports of Serious Adverse Drug Events
Recordkeeping

  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) 235,000 125,000 0 0 110,000 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$500,000
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.
07/02/2015


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