87 FR 212 pgs. 66317-66318 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
Type: NOTICEVolume: 87Number: 212Pages: 66317 - 66318
Pages: 66317, 66318FR document: [FR Doc. 2022-23953 Filed 11-2-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Substance Abuse and Mental Health Services Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-0361.
Project: Notification of Intent To Use Schedule III, IV, or V Controlled Medications for the Treatment of Opioid Use Disorder Under 21 U.S.C. 823(g)(2) (OMB No. 0930-0234 and OMB No. 0930-0369)-Revision
The Drug Addiction Treatment Act of 2000 ("DATA," Pub. L. 106-310) amended the Controlled Substances Act (21 U.S.C. 823(g)(2)) to permit qualifying practitioners to seek and obtain waivers to prescribe certain approved controlled medications for the treatment of opioid use disorder. The legislation set eligibility and certification requirements as well as an interagency notification review process for practitioners who seek waivers. To implement these provisions, SAMHSA developed Notification of Intent Forms that facilitate the submission and review of notifications. The forms provide the information necessary to determine whether practitioners meet the qualifications for waivers set forth under the law at the 30-, 100-, and 275-patient limits. This includes the annual reporting requirements for practitioners with waivers for a 275-patient limit. On October 24, 2018, the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act (Pub. L. 115-71) was signed into law. Sections 3201-3202 of the SUPPORT Act made several amendments to the Controlled Substances Act regarding office-based opioid use disorder treatment that affords practitioners greater flexibility in the provision of Medications for Opioid Use Disorder (MOUD).
The SUPPORT Act expands the definition of "qualifying other practitioner" enabling Clinical Nurse Specialists, Certified Registered Nurse Anesthetists, and Certified Nurse Midwives (CNSs, CRNAs, and CNMs) to apply for a Drug Addiction Treatment Act of 2000 (DATA) waiver until October 1, 2023. It also allows qualified practitioners ( i.e., MDs, DOs, NPs, PAs, CNSs, CRNAs, and CNMs) who are board certified in addiction medicine or addiction psychiatry, -or- practitioners who provide MOUD in a qualified practice setting, to start treating up to 100 patients in the first year of practice (as defined in 42 CFR 8.2) with a waiver. Further, the SUPPORT Act extends the ability to treat up to 275 patients to "qualifying other practitioners" ( i.e., NPs, PAs, CNSs, CRNAs, and CNMs) if they have a waiver to treat up 100 patients for at least one year and provide treatment of Opioid Use Disorder with covered medications (as such terms are defined under 42 CFR 8.2) in a qualified practice setting as described under 42 CFR 8.615. Finally, the SUPPORT Act also expands how physicians could qualify for a waiver. Under the statute now, physicians can qualify for a waiver if they have received at least 8 hours of training on treating and managing patients with opioid use disorder, as listed in the statute if the physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits a Notice of Intent to SAMHSA. In order to expedite the new provisions of the SUPPORT Act, SAMHSA sought and received a Public Health Emergency Paperwork Reduction Act Waiver.
On April 28, 2021 the Department of Health and Human Services (HHS) issued the new Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (86 FR 22439) in an expedited manner. The Practice Guidelines allow practitioners who wish to obtain a 30-patient waiver to forego the 8-hour training requirement for physicians and 24-hour training for other qualifying practitioners. Practitioners utilizing this training exemption are limited to treating no more than 30-patients at a time and time spent practicing under this exemption will not qualify the practitioner to qualify for a higher patient level. In addition, the new Practice Guidelines removed the requirement to provide counseling and other ancillary services ( i.e., psychosocial services).
[top] The collection of information within the application is essential to the implementation of SAMHSA's mission to reduce the impact of substance use disorders on America's communities. Practitioners may use these forms for various types of notifications: (a) New
| 42 CFR citation | Purpose of submission | Estimated number of respondents | Responses/ respondent | Burden/ response (hr.) | Total burden (hrs.) |
|---|---|---|---|---|---|
| Notification of Intent | 1,800 | 1 | 0.083 | 149 | |
| Notification to Prescribe Immediately | 60 | 1 | 0.083 | 5 | |
| Notice to Treat up to 100 patients | 600 | 1 | 0.04 | 24 | |
| Notice to Treat up to 275 patients | 960 | 1 | 0.081 | 78 | |
| Subtotal | 3,420 | 256 | |||
| Burden Associated With the Final Rule That Increased the Patient Limit | |||||
| 8.620 (a)-(c) | Request for Patient Limit Increase?* | 620 | 1 | 0.5 | 310 |
| Request for Patient Limit Increase?* | 620 | 1 | 0.5 | 310 | |
| Request for Patient Limit Increase?* | 620 | 1 | 0.5 | 310 | |
| 8.64 | Renewal Request for a Patient Limit Increase?* | 312 | 1 | 0.5 | 156 |
| Renewal Request for a Patient Limit Increase?* | 312 | 1 | 0.5 | 156 | |
| Renewal Request for a Patient Limit Increase?* | 312 | 1 | 0.5 | 156 | |
| 8.655 | Request for a Temporary Patient Increase for an Emergency?* | 12 | 1 | 3 | 36 |
| Request for a Temporary Patient Increase for an Emergency?* | 12 | 1 | 3 | 36 | |
| Request for a Temporary Patient Increase for an Emergency?* | 12 | 1 | 3 | 36 | |
| Subtotal | 2,497 | 1,279 | |||
| Burden Associated With the Final Rule That Outlined the Reporting Requirements | |||||
| 8.635 | Practitioner Reporting Form?* | 1,620 | 3 | 4860 | |
| "Qualifying Other Practitioner" under 21 USC §?823(g)(2)-Nurse Practitioners | 979 | 1 | 0.066 | 65 | |
| "Qualifying Other Practitioner" under 21 USC §?823(g)(2)-Physician Assistants | 708 | 1 | 0.066 | 47 | |
| "Qualifying Other Practitioner" under 21 USC §?823(g)(2)-Certified Nurse Specialists | 708 | 1 | 0.066 | 47 | |
| "Qualifying Other Practitioner" under 21 USC §?823(g)(2)-Certified Nurse Mid-Wives | 708 | 1 | 0.066 | 47 | |
| "Qualifying Other Practitioner" under 21 USC §?823(g)(2)-Certified Registered Nurse Anesthetists | 708 | 1 | 0.066 | 47 | |
| Sub Total | 5,431 | 1 | 5112 | ||
| Total Burden | 6,561 | 6,647 | |||
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under 30-day Review-Open for Public Comments" or by using the search function.
Alicia Broadus,
Public Health Advisor.
[FR Doc. 2022-23953 Filed 11-2-22; 8:45 am]
BILLING CODE 4162-20-P