View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0945-0014	ICR Reference No: 202511-0945-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/OCR	Agency Tracking No:
Title: 42 CFR Part 2 HHS Complaint Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/13/2026
	Date Received in OIRA: 01/13/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2029	36 Months From Approved
Responses	1,864	0	0
Time Burden (Hours)	1,398	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	1,864	1,864
Annual Time Burden (Hours)	1,398	1,398
Annual Cost Burden (Dollars)	0	0

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: A final rule for Confidentiality of Substance Use Disorder (SUD) Patient Records, published on February 16, 2024, created a right for patients to file a complaint for violations of 42 CFR part 2 with the HHS Secretary. The burden reported here is for individuals to complete and file such complaints.

Annual Cost to Federal Government: $0

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. Yes

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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