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

Forms and Documents

Document Name	Status
Form SMA-162 Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8 Form and Instruction	Modified
SAMHSA Response.doc Supplementary Document	2007-01-09
0206-06-SS-7-24-2006.doc Supporting Statement A	2006-09-14

IC Document Collections

IC ID	Document Title	Status
37857	Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8 Form and Instruction	Modified

ICR Details

OMB Control No: 0930-0206	ICR Reference No: 200609-0930-003
Status: Historical Active	Previous ICR Reference No: 200312-0930-005
Agency/Subagency: HHS/SAMHSA	Agency Tracking No:
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 with change	Conclusion Date: 01/10/2007
	Date Received in OIRA: 09/15/2006
Terms of Clearance: Approved consistent with SAMHSA memo submitted to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	2,657	0	9,677
Time Burden (Hours)	2,657	0	2,035
Cost Burden (Dollars)	692,999	0	2,524,000

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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. The must also communicate to opioid programs the outcomes of accreditation.....

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Authorizing Statute(s): None

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:
	71 FR 19738	04/17/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 50933	08/28/2006
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction - 42 CFR Part 8	SMA-162, SMA-163, SMA-168	Application for Certification to Use Opioid Drugs in a Treatment Program Under 42 CFR 8.11 ,   Application for Approval as Accreditation Body Under 42 CFR 8.3(b) ,   Exception Request and Record of Justification Under 42 CFR 8.11(h)

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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	2,657	9,677	0	-7,020	0	0
Annual Time Burden (Hours)	2,657	2,035	0	-374	996	0
Annual Cost Burden (Dollars)	692,999	2,524,000	0	-1,831,001	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Currently there are 2,035 total burden hours. The program is requesting 3,031. Based on SAMHSA's five-year experience with administering the regulation, some estimates of the information collection burden have been changed since the last request for information collection submitted in September 2003. For example, SAMHSA's count of the number of OTPs has increased from 1,110 to approximately 1,150. In addition, the estimated number of exemptions expected was estimated at 7,700 per year in the previous submission. Currently, the annualized estimate of the number of individual patient exemptions has increased from 7,700 to 34,480 based on a sample of the actual submission rate. On the other hand, the estimated burden for submission of form SMA-162 requesting transitional certification has declined to zero, while the number of requests for certification renewal has increased to 383 per year. The estimated burden in the tables accompanying this submission has been adjusted accordingly and indicates an increase in the estimated information collection burden since the last submission. The net result of these re-estimations is an adjustment increase of 996 hours from the previously approved level of 2,035 to 3,031 hours.

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Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/14/2006

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