Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal

ICR 201310-0910-003

OMB: 0910-0645

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2013-10-24
ICR Details
0910-0645 201310-0910-003
Historical Active 201306-0910-005
HHS/FDA 20766
Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 11/22/2013
Retrieve Notice of Action (NOA) 10/28/2013
In accordance with the terms of 5 CFR 1320, the non-substantive change request is approved for the addition of an electronic version of the form only. FDA does not have approval to alter or amend the existing collection. Should FDA wish to make alterations or amendments, it must request a revision to an approved collection under the PRA.
  Inventory as of this Action Requested Previously Approved
04/30/2016 04/30/2016 04/30/2016
1,494,577 0 1,494,577
897,001 0 897,001
0 0 0

This ICR collects both mandatory and voluntary information regarding adverse events associated with FDA-regulated products that are submitted electronically using agency data-collection applications. Because the agency continues to move from a paper/manual submissions process for reporting adverse events to an electronic systems process, the scope of the ICR is limited to those product areas for which an electronic portal has been developed. Respondents include both manufacturers and distributers of FDA products, as well as individual consumers. The information collected enables FDA to identify potential public health threats and implement mitigation strategies as appropriate.

US Code: 21 USC 355 Name of Law: FFDCA
   US Code: 21 USC 357 Name of Law: FFDCA
   US Code: 21 USC 360 Name of Law: FFDCA
   US Code: 21 USC 393 Name of Law: FFDCA
   US Code: 21 USC 301 Name of Law: FFDCA
   PL: Pub.L. 109 - 462 120 Name of Law: DSNDCPA
   PL: Pub.L. 110 - 85 1005 Name of Law: FDAAA
  
None

Not associated with rulemaking

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 1,494,577 1,494,577 0 0 0 0
Annual Time Burden (Hours) 897,001 897,001 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$28,401,010
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
10/28/2013


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