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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:
199909-0910-001
Status:
Historical Active
Previous ICR Reference No:
199806-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
MedWatch: The FDA Medical Products Reporting Program
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/15/1999
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/07/1999
Terms of Clearance:
This collection is approved through 8/00 consistent with the previous terms of clearance. Specifically, FDA will (1) continue to redesign the data ocllected 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 prior to the resubmission to OMB; (3) make appropriate revisions and subject the redesigned forms to public comment prior to the OMB submission. As agreed to previously, 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 any changes in the resubmission any comments received. This collection has been previously extended numerous times for this purpose. It will not be extended in the future until these conditions are met in full.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2000
08/31/2000
11/30/1999
Responses
328,361
0
298,570
Time Burden (Hours)
320,081
0
289,005
Cost Burden (Dollars)
0
0
6,427,000
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 medical products' safety information is communicated rapidly to the health professional 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: The FDA Medical Products Reporting Program
FDA-3500, FDA-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
328,361
298,570
0
29,791
0
0
Annual Time Burden (Hours)
320,081
289,005
0
31,076
0
0
Annual Cost Burden (Dollars)
0
6,427,000
0
0
-6,427,000
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:
09/07/1999
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