02-9799. Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget

The Substance Abuse and Mental Health Services Administration (SAMHSA) has submitted the following request (see below) for emergency OMB review under the Paperwork Reduction Act (44 U.S.C. chapter 35). OMB approval has been requested by May 1. A copy of the information collection plans may be obtained by calling the SAMHSA Reports Clearance Officer on [phone].

Title: Notification of Intent to Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction Under 21 U.S.C. 823(g)(2)

OMB Number: 0930-New.

Frequency: On-occasion.

Affected public: Business or other for-profit.

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 practitioners (physicians) to seek and obtain waivers to prescribe certain approved narcotic treatment drugs for the treatment of opiate addiction. The legislation sets eligibility requirements and certification requirements as well as an interagency notification review process for physicians who seek waivers.

To implement these new provisions, SAMHSA has developed a notification form (SMA 167) that will facilitate the submission and review of notifications. The form will provide the information necessary to determine whether practitioners (i.e., independent physicians and physicians in group practices (as defined under section 1877(h)(4) of the Social Security Act)) meet the qualifications for waivers set forth under the new law. Use of this form will enable physicians to know they have provided all information needed to determine whether practitioners are eligible for a waiver. However, there is no prohibition on use of other means to provide requisite information. The Secretary will convey notification information and determinations to the Drug Enforcement Administration (DEA), which will assign an identification number to qualifying practitioners; this number will be included in the practitioner's registration under 21 U.S.C. 823(f). Practitioners will also use this notification form to renew their waivers at the time they renew their DEA practitioner registration-every three years.

Practitioners will use the form for three types of notification: (a) New, (b) immediate, and (c) renewal. Under “new” notifications, practitioners will make their initial waiver requests to SAMHSA. “Immediate” notifications will inform SAMHSA and the Attorney General of a practitioner's intent to prescribe immediately to facilitate the treatment of an individual (one) patient under 21 U.S.C. 823(g)(2)(E)(ii). “Renewal” notifications will be submitted to HHS to initiate review of an existing waiver.

The form will collect data on the following items: Pactitioner name; state medical license number and DEA registration number; address of primary location, telephone and fax numbers; e-mail address; name and address of group practice; group practice employer identification number; names and DEA registration numbers of group practitioners; purpose of notification new, immediate, or renewal); certification of qualifying criteria for treatment and management of opiate-dependent patients; certification of capacity to refer patients for appropriate counseling and other appropriate ancillary services; certification of maximum patient load, certification to use only those drug products that meet the criteria in the law. The form will also notify practitioners of Privacy Act considerations, and permit practitioners to expressly consent to disclose limited information to the SAMHSA Substance Abuse Treatment Facility Locator.

At present, there are no narcotic drugs or combinations for use under notifications; however, SAMHSA believes that it is appropriate to develop a notification system to implement DATA in anticipation of narcotic treatment medications becoming available in the very near future. Therefore, SAMHSA is requesting emergency OMB approval of form SMA 167 so that physicians will have it available to use if they wish to be assured that all required information is provided on their waiver submission and so that the review of submissions may be facilitated by use of a standard format for provision of the required information. Respondents will be able to submit the form electronically, through a dedicated Web page that SAMHSA will establish for the purpose, as well as via U.S. mail.

The following table summarizes the estimated annual burden for the use of this form.

Purpose of Submission	Number of respondents	Responses per respondent	Burden per response (Hr.)	Total burden (Hrs.)
Initial Application for Waiver	1,200	1	.083	100
Notification to Prescribe Immediately	33	1	.083	3
Application for Renewal	1,200	1	.083	100
Total	1,200			203

Written comments and recommendations concerning the proposed information collection should be sent by April 30, 2002 to: Lauren Wittenberg, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503.

Dated: April 4, 2002.

Richard Kopanda,

Executive Officer, SAMHSA.