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
0206-SS_6.21.16.doc Supporting Statement A	2016-06-21

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: 201606-0930-002
Status: Historical Active	Previous ICR Reference No: 201303-0930-002
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/21/2016
	Date Received in OIRA: 06/21/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	09/30/2016
Responses	36,534	0	26,001
Time Burden (Hours)	3,296	0	2,263
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:
	81 FR 22999	04/19/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 40335	06/21/2016
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-162, SMA-168	SMA-162 ,   SMA-168
Reporting - Accreditation Bodies	SMA-163	SMA-163

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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	26,001	0	10,533	0	0
Annual Time Burden (Hours)	3,296	2,263	0	1,033	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: Currently there are 2,263.15 total approved burden hours. The program is requesting 2,902.40. This modest increase of 28% is due to an increase since the last OMB approval process in both the number of OTP facilities and the quantity of SMA-168s submitted by the facilities annually since the program has made improvements and enhancements to the web-based online reporting system for forms SMA-162 and SMA-168. The forms available online include a unique online feature for both the SMA-162 and SMA-168 that pre-populates certain information within the form. This in turn reduces the program’s time spent filling out the forms as well as the staff time spent on processing it. However the increase in number of facilities reporting and the quantity of reports supplied result in increased burden hours.

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Annual Cost to Federal Government: $171,246

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 06/21/2016

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