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

Forms and Documents

Document	Type	Status	Availability
Form SMA-168 Reporting - Opioid Treatment Programs	Form and Instruction	Modified	Repair queued
Form SMA-163 Reporting - Accreditation Bodies	Form and Instruction	Modified	Repair queued
0206-SS-05-23-13.doc	Supporting Statement A	Uploaded 2013-05-23	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
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: 201303-0930-002
Status: Historical Active	Previous ICR Reference No: 201001-0930-001
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 with change	Conclusion Date: 06/28/2013
	Date Received in OIRA: 03/29/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2016	36 Months From Approved	06/30/2013
Responses	26,001	0	31,982
Time Burden (Hours)	2,263	0	2,718
Cost Burden (Dollars)	0	0	450,000

---

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.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 3013	01/15/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 16516	03/15/2013
Did the Agency receive public comments on this ICR? No

---

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

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

---

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	26,001	31,982	0	-5,981	0	0
Annual Time Burden (Hours)	2,263	2,718	0	-455	0	0
Annual Cost Burden (Dollars)	0	450,000	0	0	-450,000	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 2,718 total approved burden hours. The program is requesting 2,263.15. The decrease of 454 hours is due to the 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. Importantly, this modest increase in the number of regulated entities responding has been offset by the online function. Also with the approval of the new regulation on buprenorphine there have been fewer patient exceptions necessary therefore reducing burden hours. The response number and total hours requested for accreditation organizations has increased slightly. This is due to the emphasis on patient (and other) complaint monitoring and accreditation organization follows up. The estimated burden in the tables accompanying this submission has been adjusted accordingly and indicates a decrease in the estimated information collection burden since the last submission. The net result of these re-estimations is an adjustment decrease of 454 hours from the previously approved level of 2,718 hours.

---

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]? 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

---

Common Form ICR:  No

---

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: 03/29/2013

---