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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:
201003-0910-004
Status:
Historical Active
Previous ICR Reference No:
200906-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 and Part 803
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
04/28/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/29/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2012
09/30/2012
09/30/2012
Responses
1,365,042
0
682,521
Time Burden (Hours)
462,318
0
1,444
Cost Burden (Dollars)
0
0
0
Abstract:
FDA is implementing electronic data collection to improve adverse event reporting across the agency. FDA's current processes and systems for adverse event reporting vary across its centers and are not optimal for the efficient collection of voluntary and mandatory adverse event reports, product problems/consumer complaints, or errors associated with the use of FDA-regulated products. Current FDA reporting forms (Forms FDA 3500, 3500A, 1932, and 1932a) are an outgrowth of a paper process era and frequently result in the submission of inconsistent and poor quality information. In addition, the agency is limited in its ability to modify its paper forms to keep pace with changes in the types of regulated products and the information necessary to meet evolving standards to ensure post market safety. Further, the existing supporting business processes are not able to efficiently manage the information being provided on the paper forms.
Authorizing Statute(s):
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
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
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:
73 FR 63153
10/23/2008
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 23721
05/20/2009
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
12
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 View Using Direct Gateway-to Gateway Transmission
Mandatory View Using Direct Gateway-to-Gateway Transmission
Mandatory View Using MedWatch Plus Rational Questionnaire
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 View
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
1,365,042
682,521
0
682,521
0
0
Annual Time Burden (Hours)
462,318
1,444
0
460,874
0
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:
No
Burden Reduction Due to:
Short Statement:
FDA is implementing this new information collection in order to receive electronic data to improve adverse event reporting across the agency.
Annual Cost to Federal Government:
$12,967,899
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
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:
Jonnalynn Capezzuto 3018274659
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:
03/29/2010
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