View Information Collection Request (ICR) Package
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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:
202211-0945-002
Status:
Historical Inactive
Previous ICR Reference No:
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:
Comment filed on proposed rule
Conclusion Date:
01/05/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/02/2022
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments. In addition, OMB acknowledges that at the final rule stage the agency plans to request a revision to existing OMB control number 0930-0092 rather than seeking a new control number, as described in Supporting Statement A.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
0
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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.) ยง 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 proposed regulatory changes to implement the CARES Act.
Authorizing Statute(s):
US Code:
42 USC 290dd-2
Name of Law: Confidentiality of Records
Citations for New Statutory Requirements:
PL: Pub.L. 116 - 136 3221 Name of Law: Coronavirus Aid, Relief, and Economic Security (CARES) Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0945-AA16
Proposed rulemaking
87 FR 74216
12/02/2022
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
34
IC Title
Form No.
Form Name
500 or More Affected Individuals (investigating and documenting breach)
Accounting of Disclosures - Training
Accounting of Disclosures of Part 2 Records
Breach Notification - Training
Complaint Procedures & Nonretaliation- Training
Disclosures for Audit & Evaluation - Electronic
Disclosures for Audit & Evaluation - Paper
Disclosures for Research - Electronic
Disclosures for Research - Paper
Documenting Emergency Treatment Disclosures
Individual Breach Notice-Substitute Notice (posting or publishing)
Individual Breach Notice-Written and E-mail Notice (drafting)
Individual Breach Notice-Written and E-mail Notice (preparing and documenting)
Individual Breach Notice-Written and E-mail Notice (processing and sending)
Individual Notice-Substitute Notice (individuals' voluntary burden to call toll-free number for information)
Individual Notice-Substitute Notice (staffing toll-free number)
Less than 500 Affected Individuals (investigating and documenting breach) -- affecting 10-499
Less than 500 Affected Individuals (investigating and documenting breach) -- affecting <10
Media Notice - Breach
Notice to Accompany Disclosure - Updating
Notice to Secretary (notice for breaches affecting 500 or more individuals)
Notice to Secretary (notice for breaches affecting fewer than 500 individuals)
Obtaining Consent - Training
Obtaining Consent for TPO
PDMP Reporting
Patient Notice - Providing to Patient
Patient Notice - Updating
Patient Notice and Right to Discuss - Training
Reports to the Secretary
Requests for Restrictions - Training
Right to Discuss Patient Notice
Right to Request Restrictions
Training Program Development
Updating Consent Form
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:
Changing Regulations
Short Statement:
Burden reduction was achieved due to regulatory proposals required by statute that would reduce the number of written consents needed before disclosing and redisclosing patient records. Nonrecurring burdens increased due the need to update the consent form, patient confidentiality notice, and notice to accompany disclosures consistent with statutory changes--and train staff on new requirements. Recurring burdens increased due to new breach notification requirements imposed by statute. Total burdens increased due to updates to hourly wages and an increase in the estimated number of programs subject to the regulation.
Annual Cost to Federal Government:
$1,794,543
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
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/02/2022
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