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

Forms and Documents

Document Name	Status
Form Forms Reporting - Opioid Treatment Programs Form and Instruction	Modified
Form Forms Reporting - Accreditation Bodies Form and Instruction	New
sma-168.pdf Supplementary Document	2010-03-03
SMA163.pdf Supplementary Document	2010-03-03
sma162.pdf Supplementary Document	2010-03-03
Other.zip Supplementary Document	2009-12-16
Other.zip Supplementary Document	2009-12-16
0206-SS-12-1-2009.doc Supporting Statement A	2010-01-12

IC Document Collections

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

ICR Details

OMB Control No: 0930-0206	ICR Reference No: 201001-0930-001
Status: Historical Active	Previous ICR Reference No: 200609-0930-003
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: 03/07/2010
	Date Received in OIRA: 01/25/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2013	36 Months From Approved	03/31/2010
Responses	31,982	0	2,657
Time Burden (Hours)	2,718	0	2,657
Cost Burden (Dollars)	450,000	0	692,999

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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: 5 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:
	74 FR 29487	06/22/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 66362	12/15/2009
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	Forms	Forms
Reporting - Accreditation Bodies	Forms	Forms

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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	31,982	2,657	0	0	29,325	0
Annual Time Burden (Hours)	2,718	2,657	0	0	61	0
Annual Cost Burden (Dollars)	450,000	692,999	0	0	-242,999	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: $450,000

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)? 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: 01/25/2010

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