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OMB Control No: 3084-0150	ICR Reference No: 201905-3084-001
Status: Historical Active	Previous ICR Reference No: 201601-3084-001
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: 06/10/2019
	Date Received in OIRA: 05/02/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	36 Months From Approved	06/30/2019
Responses	25,001	0	2
Time Burden (Hours)	4,779	0	3,267
Cost Burden (Dollars)	29,952	0	49,960

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:
	84 FR 2868	02/08/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 18845	05/02/2019
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
Major Breaches	Not Applicable
Single-person Breaches	Not Applicable

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	25,001	2	24,999
Annual Time Burden (Hours)	4,779	3,267	1,512
Annual Cost Burden (Dollars)	29,952	49,960	-20,008

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 from 3,267 annual hours in 2016 to 4,779 annual hours in 2019 and from $111,724 in annual labor and non-labor costs in 2016 to $126,608 annual labor and non-labor costs in 2019. For 2016, the FTC estimated two major breach incidents per year that, together, require the notification of approximately 40,000 consumers. There were no available estimates at that time for single breach responses. For 2019, the FTC has more comprehensive data on enforcing this rule which has been in effect since 2010. The FTC now estimates two primary categories of breaches reported: (1) single-person breaches, incidents in which a single individual’s information is potentially compromised; and (2) what are hereafter described as major breaches, in which multiple—and typically, many—individuals are affected. On average, staff now estimates 25,000 single-person breaches per year and that covered firms will require approximately 20 seconds of employee labor per single-person breach. Staff also estimates that 0.4 major breaches occur per year and the annual average hourly burden for major breaches is 4,640 hours. Taking the requirements relating to responding to single-person and major breaches, the reporting and third-party disclosure estimates have been adjusted upward since the most recent PRA submission.

Annual Cost to Federal Government: $75,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. 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

View ICR - OIRA Conclusion