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

Forms and Documents

Document Name	Status
Form SMA-162 Reporting - Opioid Treatment Programs Form and Instruction	Modified
Form SMA-163 Reporting - Accreditation Bodies Form and Instruction	Modified
Opioid regs OMB_0206-SS_OAS approved_5.15.19_8.8.19.doc Supporting Statement A	2019-08-12

IC Document Collections

IC ID	Document Title	Status
37857	Reporting - Opioid Treatment Programs Form and Instruction	Modified
191852	Reporting - Accreditation Bodies Form and Instruction	Modified

ICR Details

OMB Control No: 0930-0206	ICR Reference No: 201908-0930-004
Status: Active	Previous ICR Reference No: 201606-0930-002
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/13/2019
	Date Received in OIRA: 08/13/2019
Terms of Clearance: SAMHSA will consult with the Internal Revenue Service regarding the requirements in this collection and submit with the next extension or revision request a plan for clarifying requirements about proof of nonprofit status for applicants to become an accreditation body, including rulemaking, if appropriate. In addition, information collected from 10 or more persons under the authority at 42 CFR 8.3(b)(11) shall be submitted to OMB for review and approval under 5 CFR 1320.5.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	12/31/2019
Responses	36,534	0	36,534
Time Burden (Hours)	3,296	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:
	84 FR 27144	06/11/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 40075	08/13/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Reporting - Opioid Treatment Programs	SMA-168, SMA-162	SMA-162 ,   SMA168
Reporting - Accreditation Bodies	SMA-163	SMA163

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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	36,534	36,534	0	0	0	0
Annual Time Burden (Hours)	3,296	3,296	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $176,321

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? Uncollected

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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: 08/13/2019

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