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 Name	Status
Form Qualifying Other P Qualifying Other Practitioner Form and Instruction	Modified
Form Practitioner Repor Practitioner Reporting Form - 8.635 Form and Instruction	Modified
Form Waiver Form 275 pa Notice to Treat up to 275 Patients Form and Instruction	Modified
Form Waiver Form 100 pa Notice to Treat up to 100 Patients Form and Instruction	Modified
Attachment A Final NOI Physicians 30 and 100 Waiver- 01.24.2020.docx Supplementary Document	2020-01-29
OMB No. 0930-0234 Supporting Statement for NOIs 11.26.19.doc Supporting Statement A	2019-11-26
Attachment D - Notice of Intent.pdf Supplementary Document	2016-09-26
Attachment A - DATA 2000.pdf Supplementary Document	2016-07-12

IC Document Collections

IC ID	Document Title	Status
7645	Notification of Intent Instruction	Modified
223711	Qualifying Other Practitioner Form and Instruction	Modified
222817	Request for a Temporary Patient Increase Patient Increase for an Emergency - 8.655 Instruction	Modified
222816	Practitioner Reporting Form - 8.635 Form and Instruction	Modified
222815	Renewal Request for a Patient Limit Increase - 8.64 Instruction	Modified
222813	Request for Patient Limit - 8.620 Instruction	Modified
222812	Notice to Treat up to 275 Patients Form and Instruction	Modified
222811	Notice to Treat up to 100 Patients Form and Instruction	Modified
222810	Notification to Prescribe Immediately Instruction	Modified

ICR Details

OMB Control No: 0930-0234	ICR Reference No: 201911-0930-001
Status: Active	Previous ICR Reference No: 201609-0930-001
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: 01/29/2020
	Date Received in OIRA: 12/04/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	01/31/2020
Responses	8,163	0	4,446
Time Burden (Hours)	4,893	0	4,751
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. Under the SUPPORT Act, this data collection will include other practitioners who meet the statutory requirements: nurse practitioners, physician assistants, nurse specialist, nurse-midwives, and registered nurse anesthetists. SAMHSA will adding three additional forms from OMB No. 0930-0369.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 52521	10/02/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 66211	12/03/2019
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	Waiver Form 100 patients	Waiver Form 100 patients
Notice to Treat up to 275 Patients	Waiver Form 275 patients	Waiver Form 275 patients
Renewal Request for a Patient Limit Increase - 8.64
Practitioner Reporting Form - 8.635	Practitioner Reporting Form	Practitioner Reporting Form
Notification of Intent
Notification to Prescribe Immediately
Request for Patient Limit - 8.620
Request for a Temporary Patient Increase Patient Increase for an Emergency - 8.655
Qualifying Other Practitioner	Qualifying Other Pratitioner	Qualifying Other Pratitioner

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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	8,163	4,446	0	3,717	0	0
Annual Time Burden (Hours)	4,893	4,751	0	142	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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Currently there are 4,751 burden hours in the OMB inventory. SAMHSA is requesting 5,519 hours. The increase of 768 hours are due to a program change of the following: 1) the 117 hours are for the addition of three nurse specialty occupations and 2) the 651 hours are because of the expansion of the patient limit to 275 for all practitioners.

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Annual Cost to Federal Government: $821,237

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 12/04/2019

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