FDA Adverse Event and Products Experience Reports; Electronic Submissions

ICR 202109-0910-006

OMB: 0910-0645

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-09-14
Supporting Statement A
2019-05-29
ICR Details
0910-0645 202109-0910-006
Received in OIRA 202005-0910-005
HHS/FDA CROSS CENTER
FDA Adverse Event and Products Experience Reports; Electronic Submissions
No material or nonsubstantive change to a currently approved collection   No
Regular 09/14/2021
  Requested Previously Approved
06/30/2022 06/30/2022
3,013,420 3,013,420
1,809,396 1,809,396
141,386,203 141,386,203

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 distributors 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.

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

Not associated with rulemaking

  83 FR 61653 11/30/2018
84 FR 24798 05/29/2019
Yes

  Total Request 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 3,013,420 3,013,420 0 0 0 0
Annual Time Burden (Hours) 1,809,396 1,809,396 0 0 0 0
Annual Cost Burden (Dollars) 141,386,203 141,386,203 0 0 0 0
No
No
Our estimated burden for the information collection reflects an overall increase of 688,547 hours and a corresponding increase of 1,145,763 responses. The majority of these adjustments is attributed to the shift in mandatory reports associated with medical devices (mandatory reports via the ESG), which had previously been counted under OMB Control 0910-0291.

$35,485,483
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@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.
09/14/2021


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