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View ICR - OIRA Conclusion

OMB Control No: 0945-0003	ICR Reference No: 201909-0945-001
Status: Historical Active	Previous ICR Reference No: 201710-0945-002
Agency/Subagency: HHS/OCR	Agency Tracking No: 20296
Title: Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164
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 with change	Conclusion Date: 01/21/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/30/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	01/31/2020
Responses	1,097,206,223	0	1,015,548,443
Time Burden (Hours)	921,158,940	0	921,813,708
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,097,206,223	1,015,548,443	12,672,468	68,985,312
Annual Time Burden (Hours)	921,158,940	921,813,708	-654,768	0
Annual Cost Burden (Dollars)	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: We have adjusted the estimated annual burdens of compliance to (1) lower the estimated number of individuals who call an entity’s toll-free number for information after being affected by a breach requiring substitute notice to reflect a more realistic estimate about the proportion of individuals who choose to call; (2) correct an error in the 2016 ICR that underestimated the average number of individuals affected per breach incident because it relied on older breach data, and thus have increased the estimate from 353 individuals to 1,941 individuals per breach; (3) recognize for the first time the burdens resulting from the pre-existing, ongoing requirement for business associates to report breaches of PHI to their covered entities; and (4) reflect increases in average wages using 2018 BLS data for the applicable labor categories.

Annual Cost to Federal Government: $35,600

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)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Sherri Morgan 202 774-3042 sherri.morgan@hhs.gov