Confidentiality of Substance
Use Disorder Patient Records
No
material or nonsubstantive change to a currently approved
collection
No
Regular
12/29/2025
Requested
Previously Approved
03/31/2027
03/31/2027
15,178,340
15,178,340
672,667
672,667
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.
US Code:
42
USC 290dd-2 Name of Law: Confidentiality of Records
PL: Pub.L. 116 - 136 3221 Name of Law:
Coronavirus Aid, Relief, and Economic Security (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.
$2,214,100
No
No
Yes
No
No
No
No
Sherri Morgan 202 774-3042
sherri.morgan@hhs.gov
No
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.
Justification Statement for Non-substantive Change - Part 2 Forms.pdf
3_1_2024 Part 2 Supporting Statement FINAL.docx
Programs Receiving a Complaint