View Information Collection Request (ICR) Package

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: 202403-3084-001
Status: Active	Previous ICR Reference No: 202305-3084-001
Agency/Subagency: FTC	Agency Tracking No:
Title: Health Breach Notification Rule
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/27/2024
	Date Received in OIRA: 05/30/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	07/31/2025
Responses	2,583	0	2,501
Time Burden (Hours)	16,954	0	4,654
Cost Burden (Dollars)	92,016,002	0	31,632

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	2,583	2,501	82
Annual Time Burden (Hours)	16,954	4,654	12,300
Annual Cost Burden (Dollars)	92,016,002	31,632	91,984,370

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The Federal Trade Commission (“FTC” or “Commission”) is finalizing amendments to the Health Breach Notification Rule (“Rule”), 16 C.F.R. Part 318. The Rule currently requires vendors of personal health records (“PHR”) and PHR related entities that are not covered by the Health Insurance Portability and Accountability Act (“HIPAA”) to comply with certain notice requirements in the event of a breach of unsecured personally identifiable health information. Among others, the amendments pertain to (1) the scope of the Rule, (2) the methods of notice, and (3) the content of notice.

Annual Cost to Federal Government: $150,000

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? No

Agency Contact: Ryan Mehm 202 326-2918 rmehm@ftc.gov

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.