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: 0945-0003	ICR Reference No: 202401-0945-002
Status: Active	Previous ICR Reference No: 202304-0945-001
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: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/09/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/30/2024
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	03/31/2026
Responses	1,154,350,069	0	1,097,206,223
Time Burden (Hours)	953,982,239	0	921,158,940
Cost Burden (Dollars)	163,499,411	0	121,283,939

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	1,154,350,069	1,097,206,223	57,143,846
Annual Time Burden (Hours)	953,982,239	921,158,940	32,823,299
Annual Cost Burden (Dollars)	163,499,411	121,283,939	42,215,472

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: Yes

Burden Reduction Due to: Miscellaneous Actions

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