View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0945-0003	ICR Reference No: 202509-0945-001
Status: Active	Previous ICR Reference No: 202401-0945-002
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/15/2026
	Date Received in OIRA: 11/13/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	07/31/2027	07/31/2027
Responses	1,154,350,069	0	1,154,350,069
Time Burden (Hours)	953,982,239	0	953,982,239
Cost Burden (Dollars)	163,499,411	0	163,499,411

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	1,154,350,069	1,154,350,069
Annual Time Burden (Hours)	953,982,239	953,982,239
Annual Cost Burden (Dollars)	163,499,411	163,499,411

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: Burdens increased due to updated estimates for the number of covered entities, costs of postage, wage rates, number of breaches, and number of individuals requesting access to copies of their protected health information. Burdens increased for the one-time activities of updating policies and procedures, updating employee training, revising business associate agreements, and revising the NPP, and the recurring activity of obtaining an attestation for certain requests for copies of protected health information. Hourly burdens decreased for providing individual breach notification due to a drop in the number of affected individuals per breach in the most recent published reports.

Annual Cost to Federal Government: $216,000

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)? No

Is this ICR related to the Pandemic Response? No

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

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