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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:
0910-0359
ICR Reference No:
201404-0910-006
Status:
Historical Active
Previous ICR Reference No:
201103-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Medical Devices; Reports of Corrections and Removals
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
07/03/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/08/2014
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2017
36 Months From Approved
07/31/2014
Responses
1,033
0
756
Time Burden (Hours)
14,408
0
7,560
Cost Burden (Dollars)
30,660
0
0
Abstract:
The information collection requirements in 21 CFR Part 806 require each device manufacturer or importer to submit a written report to FDA of any action to correct or remove a device which may present a risk to health within 10-working days of initiating such correction or removal. The Information Collection also requires that each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA, shall keep a record of such correction or removal.
Authorizing Statute(s):
US Code:
21 USC 360i(g)
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:
78 FR 38992
06/28/2013
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 17549
03/28/2014
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Medical Devices; Reports of Corrections and Removals
806
Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products
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
1,033
756
0
0
277
0
Annual Time Burden (Hours)
14,408
7,560
0
5,918
930
0
Annual Cost Burden (Dollars)
30,660
0
0
30,660
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:
Adjustments: The average annual number of reporting respondents has increased since the last approval from 666 to 1,033. This adjustment resulted in an increase of 3,670 hours to the reporting burden. The average annual number of recordkeeping respondents has increased since the last approval from 90 to 93. This adjustment resulted in an increase of 30 hours to the recordkeeping burden. Revision: Additionally, FDA is revising this ICR making available an electronic Web-based process for submitting reports of corrections and removals. We have therefore added a line-item to the reporting burden table for set-up of the electronic process. This resulted in an additional increase of 5,918 hours. We have also accounted for the purchase of a 1 to 3 year digital verification certificate for respondents who use the new electronic process. This has resulted in an increase of $30,660 in the operating and maintenance cost.
Annual Cost to Federal Government:
$1,467,424
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:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
04/08/2014
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