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:
3084-0150
ICR Reference No:
201601-3084-001
Status:
Historical Active
Previous ICR Reference No:
201208-3084-004
Agency/Subagency:
FTC
Agency Tracking No:
Title:
Health Breach Notification Rule
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:
03/07/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/03/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2019
36 Months From Approved
03/31/2016
Responses
2
0
2
Time Burden (Hours)
3,267
0
200
Cost Burden (Dollars)
49,960
0
7,918
Abstract:
The Health Breach Notification Rule ("Rule"), 16 C.F.R. Part 318, requires vendors of personal health records and PHR related entities to provide: (1) notice to consumers whose unsecured personally identifiable health information has been breached; and (2) notice to the Commission. The Rule only applies to electronic health records and does not include recordkeeping requirements. The Rule requires third party service providers (i.e., those companies that provide services such as billing or data storage) to notify vendors of personal health records and PHR related entities following the discovery of a breach; those entities in turn must provide notification to consumers and the Commission. To notify the FTC of a breach, the Commission developed a form for entities subject to the Rule to complete and return to the agency.
Authorizing Statute(s):
PL:
Pub.L. 111 - 5 13407
Name of Law: American Recovery and Reinvestment Act of 2009
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 5 13407 Name of Law: American Recovery and Reinvestment Act of 2009
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:
80 FR 6530
10/16/2015
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 5750
02/03/2016
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
Identifying breach, affected customers, notifying customers, etc.
Not Applicable
Notice of Breach of Health Information
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
2
2
0
0
0
0
Annual Time Burden (Hours)
3,267
200
0
0
3,067
0
Annual Cost Burden (Dollars)
49,960
7,918
0
0
42,042
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:
The annual time and cost burden have been adjusted upward because the FTC anticipates more consumers will receive breach notifications. Since the Rule has now been in effect for over five years, staff has more information relating to the actual notifications received from covered entities. This includes the number of consumers that the covered entities notified. In 2012, the FTC estimated that an average of 2,500 consumers per year received notifications over the years 2010 and 2011. In 2015-2016, the FTC estimates approximately 20,000 consumers will receive notices per year.
Annual Cost to Federal Government:
$75,000
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)?
Yes
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Cora Han 2023262441 chan@ftc.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:
02/03/2016
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