OMB control number

Confidentiality of Substance Use Disorder Patient Records

OMB 0945-0010 · HHS/OCR.

OMB 0945-0010

The Confidentiality of Substance Use Disorder Patient Records regulations (42 CFR part 2) implement section 543 of the Public Health Service Act, 42 United States Code (U.S.C.) § 290dd-2, as amended by section 131 of the Alcohol, Drug Abuse and Mental Health Administration Reorganization Act (ADAMHA Reorganization Act), Pub. L., 102-321 (July 10, 1992) and section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law 116-136 (March 27, 2020). The regulations serve to protect the confidentiality of patient records created by federally funded programs for the treatment of substance use disorder. The Department of Health and Human Services has published regulatory changes to implement the CARES Act.

The latest form for Confidentiality of Substance Use Disorder Patient Records expires 2027-03-31 and is listed under ICR 202511-0945-002.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Justification Statement for Non-substantive Change - Part 2 Forms.pdf	Justification for No Material/Nonsubstantive Change
Supplemental Document Part 2 Investigative Agency Report Form.pdf	Supplementary Document
Supplemental Document Part 2 Investigative Agency Report Form.pdf	Supplementary Document
Supplemental Document Part2_Breach_Portal_Questions.pdf	Supplementary Document
Supplemental Document Part2_Breach_Portal_Questions.pdf	Supplementary Document
3_1_2024 Part 2 Supporting Statement FINAL.docx	Supporting Statement A
Programs Receiving a Complaint	Information collection
Attach consent form with each disclosure (paper records)	Information collection
Attach consent form with each disclosure (electronic records)	Information collection
Reports to the Secretary	Information collection
Right to Request Restrictions	Information collection
Accounting of Disclosures of Part 2 Records	Information collection
Right to Discuss Patient Notice	Information collection
Less than 500 Affected Individuals (investigating and documenting breach) -- affecting <10	Information collection
Less than 500 Affected Individuals (investigating and documenting breach) -- affecting 10-499	Information collection
500 or More Affected Individuals (investigating and documenting breach)	Information collection
Notice to Secretary (notice for breaches affecting fewer than 500 individuals)	Information collection
Notice to Secretary (notice for breaches affecting 500 or more individuals)	Information collection
Media Notice - Breach	Information collection
Individual Notice-Substitute Notice (individuals' voluntary burden to call toll-free number for information)	Information collection
Individual Notice-Substitute Notice (staffing toll-free number)	Information collection
Individual Breach Notice-Substitute Notice (posting or publishing)	Information collection
Individual Breach Notice-Written and E-mail Notice (processing and sending)	Information collection
Individual Breach Notice-Written and E-mail Notice (preparing and documenting)	Information collection
Individual Breach Notice-Written and E-mail Notice (drafting)	Information collection
Disclosures for Audit & Evaluation - Paper	Information collection
Disclosures for Audit & Evaluation - Electronic	Information collection
Disclosures for Research - Paper	Information collection
Disclosures for Research - Electronic	Information collection
Documenting Emergency Treatment Disclosures	Information collection
PDMP Reporting	Information collection
Obtaining Consent for TPO	Information collection
Patient Notice - Providing to Patient	Information collection
Breach Notification - Training	Information collection
Training Program Development	Information collection
Notice to Accompany Disclosure - Updating	Information collection
Updating Consent Form	Information collection
Obtaining Consent - Training	Information collection
Requests for Restrictions - Training	Information collection
Accounting of Disclosures - Training	Information collection
Patient Notice - Updating	Information collection
Patient Notice and Right to Discuss - Training	Information collection
Complaint Procedures & Nonretaliation- Training	Information collection

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202511-0945-002	No material or nonsubstantive change to a currently approved collection	2025-12-29	Approved without change
202401-0945-001	New collection (Request for a new OMB Control Number)	2024-02-16	Approved with change
202211-0945-002	New collection (Request for a new OMB Control Number)	2022-12-02	Comment filed on proposed rule

OMB Details

Complaint Procedures & Nonretaliation- Training

Federal Enterprise Architecture: Health - Health Care Services