View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0945-0010	ICR Reference No: 202511-0945-002
Status: Active	Previous ICR Reference No: 202401-0945-001
Agency/Subagency: HHS/OCR	Agency Tracking No:
Title: Confidentiality of Substance Use Disorder Patient Records
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: 12/29/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2027	03/31/2027	03/31/2027
Responses	15,178,340	0	15,178,340
Time Burden (Hours)	672,667	0	672,667
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	15,178,340	15,178,340
Annual Time Burden (Hours)	672,667	672,667
Annual Cost Burden (Dollars)	0	0

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: Burden reductions occurred due to a statutory change that will reduce the number of written patient consents that programs and lawful holders of part 2 records are required to obtain. Burden increases occurred due to a statutory change that requires programs experiencing a breach of part 2 records to provide breach notification to affected patients, HHS, and at times, the media. Non-recurring burdens increased for one-time changes to update policies and procedures, implement workforce training, and revise the patient confidentiality notice. Please see the Supporting Statement for a full description of all changes to burdens and the justification for each change.

Annual Cost to Federal Government: $2,214,100

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. Yes

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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