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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:
0910-0291
ICR Reference No:
201505-0910-002
Status:
Historical Active
Previous ICR Reference No:
201206-0910-012
Agency/Subagency:
HHS/FDA
Agency Tracking No:
OC
Title:
MedWatch: The FDA Medical Products Reporting Program
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/30/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/11/2015
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2018
36 Months From Approved
09/30/2015
Responses
769,995
0
786,773
Time Burden (Hours)
909,395
0
853,585
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection covers the reporting associated with the MedWatch program.
Authorizing Statute(s):
US Code:
21 USC 301
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:
79 FR 73591
12/11/2014
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 31042
06/01/2015
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
All Centers - Form 3500B (Consumer Reporting)
FDA 3500B
MedWatch Consumer Reporting
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY report
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities)
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Center for Devices and Radiological Health - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting)
FDA 3500A
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors
FDA 3500
MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
MedWatch 3500B Consumer reporting
FDA 3500b
MedWatch Consumer Reporting
MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting
FDA 3500a
MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
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
769,995
786,773
0
-16,778
0
0
Annual Time Burden (Hours)
909,395
853,585
0
55,810
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
FDA is requesting a renewal with adjustments to the existing Forms FDA 3500, 3500A and 3500B.
Annual Cost to Federal Government:
$12,267,000
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:
Amber Sanford 301 796-8867 amber.sanford@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:
06/11/2015
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