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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0645
ICR Reference No:
201302-0910-006
Status:
Historical Active
Previous ICR Reference No:
201003-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
18920
Title:
Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
04/30/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/26/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2016
36 Months From Approved
04/30/2013
Responses
1,494,577
0
1,365,042
Time Burden (Hours)
897,001
0
462,318
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
77 FR 56847
09/14/2012
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 3433
01/16/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Early Warning Recall Voluntary
Early Warning Recall Voluntary View
FDA 1932a
Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Mandatory Adverse Event Reporting via ESG
Mandatory Adverse Event Reporting via the SRP
Mandatory View Using Direct Gateway-to Gateway Transmission
Mandatory View Using MedWatch Plus Rational Questionnaire
Reportable Food (human and animal) Mandatory View
FDA 1932
Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
Reportable Food (human and animal) Mandatory View
FDA 1932
Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
Reportable Food (human and animal) Voluntary View
FDA 1932a
Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Reportable Food (human and animal) Voluntary View
FDA 1932a
Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Voluntary Adverse Event Reporting via the SRP
Voluntary View
ICR Summary of Burden
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
1,365,042
0
293,354
-163,819
0
Annual Time Burden (Hours)
897,001
462,318
0
584,081
-149,398
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
Program change reductions reflect the removal of duplicative IC entries; program increases are the result of electronic reporting now developed for tobacco products not previously included in electronic reporting program, and the consolidation of reporting burden from 0910-0709.
Annual Cost to Federal Government:
$28,401,010
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
02/26/2013
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