Confidentiality of Alcohol and Drug Abuse Patient Records - 42 CFR Part 2

Forms and Documents

Document Name	Status
Substance Use Disorder Patient Records Supporting Statement A_06102020.docx Supporting Statement A	2020-07-16

IC Document Collections

IC ID	Document Title	Status
7502	42 CFR 2.22 Notice to Patients of Federal Confidentiality Requirements	Unchanged
242314	42 CFR 2.36 Disclosures to Prescriptions Drug Monitoring Programs	Unchanged
242313	42 CFR 2.31; 2.52; 2.53	Unchanged
181480	42 CFR 2.51 Medical Emergencies	Unchanged

ICR Details

OMB Control No: 0930-0092	ICR Reference No: 202007-0930-001
Status: Active	Previous ICR Reference No: 202006-0930-003
Agency/Subagency: HHS/SAMHSA	Agency Tracking No: 19858
Title: Confidentiality of Alcohol and Drug Abuse Patient Records - 42 CFR Part 2
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/21/2020
	Date Received in OIRA: 07/16/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved	12/31/2022
Responses	4,594,583	0	1,943,535
Time Burden (Hours)	579,524	0	388,103
Cost Burden (Dollars)	27,347,415	0	95,999

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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.) § 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). The regulations serve to protect the confidentiality of patient records created by federally funded programs for the treatment of substance use disorder.

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Authorizing Statute(s): PL: Pub.L. 93 - 282 122 Name of Law: The Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act 1970
   PL: Pub.L. 103 - 321 131 Name of Law: Alcohol, Drug Abuse and Mental Health Administration Reorganization Act 1992
   US Code: 42 USC 290 dd-2 Name of Law: Confidentiality of Records
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0930-ZA07	Final or interim final rulemaking	85 FR 42986	07/15/2020

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 44568	08/26/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
42 CFR 2.31; 2.52; 2.53
42 CFR 2.36 Disclosures to Prescriptions Drug Monitoring Programs
42 CFR 2.22 Notice to Patients of Federal Confidentiality Requirements
42 CFR 2.51 Medical Emergencies

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	4,594,583	1,943,535	0	2,651,048	0	0
Annual Time Burden (Hours)	579,524	388,103	0	191,421	0	0
Annual Cost Burden (Dollars)	27,347,415	95,999	0	27,251,416	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: Cutting Redundancy

Short Statement: The changes resulting in an increase in burden are the result of an increase in the estimated number of disclosures that will be made by part 2 programs as a result of the proposals finalized in the CY 2020 final rule, offset slightly by a decrease in the number of estimated patient admissions for treatment. An additional increase in burden costs is due to an adjustment to correctly estimate wage rates which account for benefits and overhead costs; this modification to wage rates was not performed previously.

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Annual Cost to Federal Government: $33,205

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

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Common Form ICR:  No

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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: 07/16/2020

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