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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form NOI Qualifying Oth NOI Qualifying Other Practitioner NP and PA 30 and 100	Form and Instruction	Modified	Available
Form NOI Qualifying Oth Qualifying Other Practitioner	Form and Instruction	Modified	Repair queued
Form All Practitioner R All Practitioner Reporting Form	Form and Instruction	Modified	Available
Form All Practitioner R Practitioner Reporting Form	Form and Instruction	Modified	Repair queued
Form NOI 275 All Practi NOI 275 All Practitioners Waiver	Form and Instruction	Modified	Available
Form NOI 275 All Practi Notice to Treat up to 275 Patients	Form and Instruction	Modified	Repair queued
Form NOI Physicians 30 NOI Physicians 30 and 100 Waiver	Form and Instruction	Modified	Available
Form NOI Physicians 30 Notice to Treat up to 100 Patients	Form and Instruction	Modified	Repair queued
Supporting Statement for NOIs_OMB No. 0930-0234 _ 11-7-2022.docx	Supporting Statement A	Uploaded 2022-11-07	Repair queued
NOI Qualifying Other Practitioner NP and PA 30 and 100_30E_Revised OIRA Questions and Edits_CLEAN.docx	Supplementary Document	Uploaded 2021-05-26	Repair queued
0930-0234 NOI _ No Material or Nonsubstantive Change_5-26-2021_CLEAN.docx	Supplementary Document	Uploaded 2021-05-26	Repair queued
0930-0234 NOI _ No Material or Nonsubstantive Change_5-26-2021_CLEAN.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-05-26	Repair queued
Attachment A Final NOI Physicians 30 and 100 Waiver- 01.24.2020.docx	Supplementary Document	Uploaded 2020-01-29	Repair queued
Attachment D - Notice of Intent.pdf	Supplementary Document	Uploaded 2016-09-26	Repair queued
Attachment A - DATA 2000.pdf	Supplementary Document	Uploaded 2016-07-12	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
7645	Notification of Intent	Instruction	Modified
223711	Qualifying Other Practitioner	Form and Instruction	Modified	NOI Qualifying Other Practitioner NP and PA 30 and 100
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	Form and Instruction	Modified	All Practitioner Reporting Form
222816	Practitioner Reporting Form	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	NOI 275 All Practitioners Waiver
222812	Notice to Treat up to 275 Patients	Form and Instruction	Modified
222811	Notice to Treat up to 100 Patients	Form and Instruction	Modified	NOI Physicians 30 and 100 Waiver
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: 202211-0930-002
Status: Historical Active	Previous ICR Reference No: 202105-0930-001
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/14/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/08/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved	01/31/2023
Responses	11,683	0	8,163
Time Burden (Hours)	6,874	0	4,893
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:
	87 FR 53480	08/31/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 66317	11/03/2022
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Notice to Treat up to 100 Patients	NOI Physicians 30 and 100 Waiver	NOI Physicians 30 and 100 Waiver
Notice to Treat up to 275 Patients	NOI 275 All Practitioners Waiver	NOI 275 All Practitioners Waiver
Notification of Intent
Notification to Prescribe Immediately
Practitioner Reporting Form	All Practitioner Reporting Form	All Practitioner Reporting Form
Qualifying Other Practitioner	NOI Qualifying Other Practitioner NP and PA 30 and	NOI Qualifying Other Practitioner NP and PA 30 and 100
Renewal Request for a Patient Limit Increase - 8.64
Request for Patient Limit - 8.620
Request for a Temporary Patient Increase Patient Increase for an Emergency - 8.655

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ICR Summary of Burden

table that charts list 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	11,683	8,163	0	0	3,520	0
Annual Time Burden (Hours)	6,874	4,893	0	0	1,981	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: There is an increase in burden due to a 20 percent increase in submission of NOI waiver applications to the program annually. The program has made burden calculation adjustments to account for this increase in waiver applications.

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Annual Cost to Federal Government: $934,351

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? No

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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: 11/08/2022

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