View Information Collection Request (ICR) Package
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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:
0910-0449
ICR Reference No:
201608-0910-014
Status:
Historical Active
Previous ICR Reference No:
201309-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Postmarket Surveillance of Medical Devices
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:
12/06/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/09/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2019
36 Months From Approved
12/31/2016
Responses
1,160
0
1,160
Time Burden (Hours)
37,945
0
37,945
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information from manufacturers who are required to conduct postmarket surveillance of a medical device that meets the criteria set forth in the statute. The postmarket surveillance submission includes the postmarket plan, information about the person designated to conduct the surveillance, and organizational/administrative information. The information collection also includes the submission of changes to the plan, requests for a waiver of any requirement of the regulation, requests for exemption from the requirement to conduct postmarket surveillance, and submission of periodic reports as specified in the postmarket surveillance plan. Additionally, manufacturers and investigators must maintain records to ensure that the postmarket surveillance is conducted in accordance with the approved plan. The information collected and maintained enables FDA to ensure that the postmarket surveillance will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health.
Authorizing Statute(s):
US Code:
21 USC 522
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:
81 FR 25409
04/28/2016
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 62142
09/08/2016
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports
Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records
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
1,160
1,160
0
0
0
0
Annual Time Burden (Hours)
37,945
37,945
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
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:
$850,461
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:
09/09/2016
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