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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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 - Accreditation Bodies
SMA-163
SMA-163
Reporting - Opioid Treatment Programs
SMA-162, SMA-168
SMA-162
,
SMA-168
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
Agency Contact:
Summer King 2402761243
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
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