Confidentiality of Substance Use Disorder Patient Records
New collection (Request for a new OMB Control Number)
No
Regular
Approved with change
03/08/2024
02/16/2024
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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
03/31/2027
36 Months From Approved
15,178,340
0
0
672,667
0
0
0
0
0
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.
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.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Part_2_ICR_Supporting_Statement 2_7_2024.docx
Programs Receiving a Complaint