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: 0945-0010	ICR Reference No: 202401-0945-001
Status: Active	Previous ICR Reference No: 202211-0945-002
Agency/Subagency: HHS/OCR	Agency Tracking No:
Title: Confidentiality of Substance Use Disorder Patient Records
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: 03/08/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/16/2024
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	03/31/2027	36 Months From Approved
Responses	15,178,340	0	0
Time Burden (Hours)	672,667	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to New Statute	Change Due to Agency Discretion
Annual Number of Responses	15,178,340	6,404,406	8,773,934
Annual Time Burden (Hours)	672,667	477,929	194,738
Annual Cost Burden (Dollars)	0	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: Yes

Burden Reduction Due to: Using Information Technology

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. 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