Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction

Forms and Documents

Document	Type	Status	Availability
Form Practitioner Repor Practitioner Reporting Form	Form and Instruction	New	Repair queued
Form Patient Notice Patient Notice	Form and Instruction	Modified	Available
Form Request for Patien Request for patient Limit Increase	Form and Instruction	Modified	Repair queued
Supporting Statment for Bup Rule 9.27.16.doc	Supporting Statement A	Uploaded 2016-09-27	Repair queued
Attachment D - Notice of Intent.pdf	Supplementary Document	Uploaded 2016-09-26	Available
Attachment A - DATA 2000.pdf	Supplementary Document	Uploaded 2016-07-12	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
7645	Notification of Intent	Instruction	Unchanged
223711	Practitioner Reporting Form	Form and Instruction	New
222817	Request for a Temporary Patient Increase Patient Increase for an Emergency	Instruction	Unchanged
222816	Patient Notice	Form and Instruction	Modified
222815	Renewal Request for a Patient Limit Increase	Instruction	Unchanged
222813	Diversion Control Plan	Instruction	Unchanged
222812	Request for patient Limit Increase	Form and Instruction	Modified
222811	Notice to Treat up to 100 Patients	Instruction	Unchanged
222810	Notification to Prescribe Immediately	Instruction	Unchanged

ICR Details

OMB Control No: 0930-0234	ICR Reference No: 201609-0930-001
Status: Historical Active	Previous ICR Reference No: 201607-0930-001
Agency/Subagency: HHS/SAMHSA	Agency Tracking No:
Title: Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction
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: 01/11/2017
	Date Received in OIRA: 09/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	08/31/2019
Responses	4,446	0	3,147
Time Burden (Hours)	4,751	0	701
Cost Burden (Dollars)	0	0	0

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Abstract: The Drug Addiction Treatment Act of 2000 establishes conditions for physicians to obtain waivers to permit them to prescribe certain approved narcotic treatment medications for the maintenance or detoxification treatment of opioid addiction.

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Authorizing Statute(s): US Code: 21 USC 823 Name of Law: Drug Addiction Treatment Act of 2000
  

Citations for New Statutory Requirements: US Code: 21 USC 823 Name of Law: Drug Addiction Treatment Act of 2000

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0930-AA22	Final or interim final rulemaking	81 FR 12345	09/26/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 44576	07/08/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 66191	09/27/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Notice to Treat up to 100 Patients
Request for patient Limit Increase	Request for Patient Limit Increase	Request for Patient Limit Increase
Renewal Request for a Patient Limit Increase
Patient Notice	Patient Notice	Patient Notice
Notification of Intent
Notification to Prescribe Immediately
Diversion Control Plan
Request for a Temporary Patient Increase Patient Increase for an Emergency
Practitioner Reporting Form	Practitioner Reporting Form	Practitioner Reporting Form

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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	4,446	3,147	0	1,299	0	0
Annual Time Burden (Hours)	4,751	701	0	4,050	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Currently there are 701 total burden hours in the OMB inventory. SAMHSA is requesting 4,751 total burden hours. The increase of 4,050 burden hours is due to a program change of the reporting requirements form (1,350 respondents and 4,050 hours).

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Annual Cost to Federal Government: $1,054,500

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: 09/27/2016

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