Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form SMA-168 SMA-168	Form and Instruction	Modified	Available
Form SMA-162 SMA-162	Form and Instruction	Modified	Available
Form SMA-162 Reporting - Opioid Treatment Programs	Form and Instruction	Modified	Repair queued
Form SMA-163 SMA-163	Form and Instruction	Modified	Available
Form SMA-163 Reporting - Accreditation Bodies	Form and Instruction	Modified	Repair queued
Opioid regs OMB_0206-SSA.docx	Supporting Statement A	Uploaded 2024-08-07	Available
Opioid regs OMB_0206-SSA.docx	Supporting Statement A	Uploaded 2024-08-07	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
37857	Reporting - Opioid Treatment Programs	Form and Instruction	Modified	SMA-168
37857	Reporting - Opioid Treatment Programs	Form and Instruction	Modified	SMA-162
37857	Reporting - Opioid Treatment Programs	Form and Instruction	Modified
191852	Reporting - Accreditation Bodies	Form and Instruction	Modified	SMA-163
191852	Reporting - Accreditation Bodies	Form and Instruction	Modified

ICR Details

OMB Control No: 0930-0206	ICR Reference No: 202408-0930-004
Status: Active	Previous ICR Reference No: 202110-0930-001
Agency/Subagency: HHS/SAMHSA	Agency Tracking No: 19136
Title: Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8
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: 09/11/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/09/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	11/30/2024
Responses	38,332	0	36,534
Time Burden (Hours)	3,348	0	3,296
Cost Burden (Dollars)	0	0	0

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Abstract: These regulations specify requirements for opioid treatment programs, which must apply for certification and adhere to recordkeeping, disclosure and reporting specifications. In addition, entities that wish to become accreditation bodies under the regulations must apply to and obtain approval from SAMHSA. Such bodies must develop and submit accreditation elements for SAMHSA acceptance. Upon designation as an accreditation body, entities must keep certain records of accreditation surveys and submit them to SAMHSA.

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Authorizing Statute(s): US Code: 42 USC 501 Name of Law: SAMHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 47973	06/04/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 64942	08/08/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Reporting - Accreditation Bodies	SMA-163	SMA-163
Reporting - Opioid Treatment Programs	SMA-168, SMA-162	SMA-162 ,   SMA-168

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ICR Summary of Burden

table that charts list 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	38,332	36,534	0	1,798	0	0
Annual Time Burden (Hours)	3,348	3,296	0	52	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The number of respondents has increased as the universe of OTPs and staff have increased since the last renewal of the forms.

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Annual Cost to Federal Government: $137,392

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: 08/09/2024

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