Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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:
199806-0910-001
Status:
Historical Active
Previous ICR Reference No:
199509-0910-018
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
MedWatch: FDA's Medical Product Reporting Program
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/29/1998
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/03/1998
Terms of Clearance:
This collection is approved through 1/99 on the following conditions: (1) FDA work actively over the next 6 months to redesign the data collected under the current Medical Device Reporting (MDR) program including the 3500A, the Baseline Report, and the Medical Device Registration and Listing Process; (2) present the redesign to OMB and the regulated community by 10/98 (3) make appropriate revisions and subject the redesigned forms to public comment prior to the OMB submission. FDA shall take particular care to work closely with interested parties who will be affected by any changes to the form and will address in detail in the resubmission any comments received. This collection has been in violation of the Paperwork Reduction Act and will be reported to Congress as part of OMB's annual reporting of such violations.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/1999
01/31/1999
Responses
298,570
0
0
Time Burden (Hours)
289,005
0
0
Cost Burden (Dollars)
6,427,000
0
0
Abstract:
Reporting of adverse events and product problems by health professionals to the FDA either directly or via the manufacturer is critical to an effective national postmarketing surveillance system. The overall MedWatch program is a national educational/promotional initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and/or the manufacturer and to ensure that new safety information is communicated rapidly to the medical community thereby improving patient care.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
MedWatch: FDA's Medical Product Reporting Program
3500, 3500A
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
298,570
0
0
298,570
0
0
Annual Time Burden (Hours)
289,005
0
0
289,005
0
0
Annual Cost Burden (Dollars)
6,427,000
0
0
6,427,000
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$0
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)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
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:
06/03/1998
An official website of the United States government
The .gov means it's official.
The site is secure.
