FDA Adverse Event Reports; Electronic Submissions

ICR 201602-0910-009

OMB: 0910-0645

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-02-29
ICR Details
0910-0645 201602-0910-009
Historical Active 201409-0910-012
HHS/FDA AGENCY WIDE
FDA Adverse Event Reports; Electronic Submissions
Revision of a currently approved collection   No
Regular
Approved without change 05/04/2016
Retrieve Notice of Action (NOA) 02/29/2016
  Inventory as of this Action Requested Previously Approved
05/31/2019 36 Months From Approved 05/31/2016
1,867,657 0 1,494,577
1,120,849 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

  80 FR 72071 11/18/2015
81 FR 10252 02/29/2016
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 1,867,657 1,494,577 0 273 372,807 0
Annual Time Burden (Hours) 1,120,849 897,001 0 164 223,684 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Burden changes reflect fluctuations in adverse event reporting and new electronic reporting features. These changes are discussed more fully in the agency's supporting statement.

$35,485,483
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.
02/29/2016


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