80_FR_34563 80 FR 34448 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

80 FR 34448 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 80, Issue 115 (June 16, 2015)

Page Range34448-34449
FR Document2015-14727

Federal Register, Volume 80 Issue 115 (Tuesday, June 16, 2015) 
[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Notices]
[Pages 34448-34449]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14727]


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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) 276-1243.

Project: 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 No. 0930-0234)--Extension

    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. The legislation was 
amended in 2005 to eliminate the patient limit for physicians in group 
practices, and in 2006, to permit certain physicians to treat up to 100 
patients.
    To implement these provisions, SAMHSA developed a notification form 
(SMA-167) that facilitates the submission and review of notifications. 
The form provides the information necessary to determine whether 
practitioners (i.e., independent physicians) 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 may use the form for three types of notification: (a) 
New, (b) immediate, and (c) to notify of their intent to treat up to 
100 patients. Under ``new'' notifications, practitioners may make their 
initial waiver requests to SAMHSA. ``Immediate'' notifications 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). Finally, the form may be used by 
physicians with waivers to certify their need and intent to treat up to 
100 patients.
    The form collects data on the following items: Practitioner name; 
state medical license number and DEA registration number; address of 
primary location, telephone and fax numbers; email 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 also notifies practitioners 
of Privacy Act considerations, and permits practitioners to expressly 
consent to disclose limited information to the

[[Page 34449]]

SAMHSA Buprenorphine Physician Locator.
    Since July 2002, SAMHSA has received over 25,000 notifications and 
has certified almost 27,000 physicians. Fifty-none percent of the 
notifications were submitted by mail or by facsimile, with 
approximately forty-one percent submitted through the Web based online 
system. Approximately 60 percent of the certified physicians have 
consented to disclosure on the

SAMHSA Buprenorphine Physician Locator.

    Respondents may submit the form electronically, through a dedicated 
Web page that SAMHSA will establish for the purpose, as well as via 
U.S. mail.
    There are no changes to the forms and burden hours.
    The following table summarizes the estimated annual burden for the 
use of this form.

----------------------------------------------------------------------------------------------------------------
                                                                                    Burden per
              Purpose of submission                  Number of     Responses per     response      Total burden
                                                    respondents     respondent         (hr.)           (hrs)
----------------------------------------------------------------------------------------------------------------
Initial Application for Waiver..................           1,500               1            .083             125
Notification to Prescribe Immediately...........              50               1            .083               4
Notice to Treat up to 100 patients..............             500               1            .040              20
                                                 ---------------------------------------------------------------
      Total.....................................           2,050  ..............  ..............             149
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by July 16, 2015 to the SAMHSA 
Desk Officer at the Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB). To ensure timely receipt of 
comments, and to avoid potential delays in OMB's receipt and processing 
of mail sent through the U.S. Postal Service, commenters are encouraged 
to submit their comments to OMB via email to: 
OIRA_Submission@omb.eop.gov. Although commenters are encouraged to send 
their comments via email, commenters may also fax their comments to: 
202-395-7285. Commenters may also mail them to: Office of Management 
and Budget, Office of Information and Regulatory Affairs, New Executive 
Office Building, Room 10102, Washington, DC 20503.

Summer King,
Statistician.
[FR Doc. 2015-14727 Filed 6-15-15; 8:45 am]
 BILLING CODE 4162-20-P

34448 Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Notices based on experience with the previous each site. In addition to the data staff will spend completing data CAM program. There are two sources of extraction, FTDC staff will complete 2 collection is $15,952 per year (total data collection burden for the administrations (intake and discharge) number of staff hours, 720.5 hours, performance system. First, FTDC staff of the NCFAS for each family multiplied by $22.14, the estimated extracts data from secondary sources for (approximately 267 families per year average hourly wages for social work the child, parent/caregiver and family based on estimates extrapolated from professionals as published by the functioning data elements for biannual the CAM program). The NCFAS takes Bureau of Labor Statistics, 2013). See data uploads. The total number of approximately .75 hours to complete per Table 1. responses is two per year; with each family per administration. The upload taking approximately 16 hours at estimated total cost of the time FTDC TABLE 1—ANNUALIZED HOUR BURDEN Number of Responses Total Hours per Total hour Form/instrument records per record responses response burden FTDC Form—Biannual extraction of extant data × 10 grantees ............................................................................ 10 2 20 16 320 NCFAS—Administered twice for each family ...................... 267 2 534 .75 400.5 Total .............................................................................. 277 ........................ 554 ........................ 720.5 Note: The estimated response burden includes the extractions and uploads to the FTDC Form and administration the North Carolina Family Assessment Form. Written comments and Chapter 35). To request a copy of these determinations to the Drug Enforcement recommendations concerning the documents, call the SAMHSA Reports Administration (DEA), which will proposed information collection should Clearance Officer on (240) 276–1243. assign an identification number to be sent by July 16, 2015 to the SAMHSA qualifying practitioners; this number Project: Notification of Intent To Use Desk Officer at the Office of Information will be included in the practitioner’s Schedule III, IV, or V Opioid Drugs for and Regulatory Affairs, Office of registration under 21 U.S.C. 823(f). the Maintenance and Detoxification Practitioners may use the form for Management and Budget (OMB). To Treatment of Opiate Addiction Under three types of notification: (a) New, (b) ensure timely receipt of comments, and 21 U.S.C. 823(g)(2) (OMB No. 0930– immediate, and (c) to notify of their to avoid potential delays in OMB’s 0234)—Extension intent to treat up to 100 patients. Under receipt and processing of mail sent through the U.S. Postal Service, The Drug Addiction Treatment Act of ‘‘new’’ notifications, practitioners may commenters are encouraged to submit 2000 (‘‘DATA,’’ Pub. L. 106–310) make their initial waiver requests to their comments to OMB via email to: amended the Controlled Substances Act SAMHSA. ‘‘Immediate’’ notifications OIRA_Submission@omb.eop.gov. (21 U.S.C. 823(g)(2)) to permit inform SAMHSA and the Attorney Although commenters are encouraged to practitioners (physicians) to seek and General of a practitioner’s intent to send their comments via email, obtain waivers to prescribe certain prescribe immediately to facilitate the commenters may also fax their approved narcotic treatment drugs for treatment of an individual (one) patient comments to: 202–395–7285. the treatment of opiate addiction. The under 21 U.S.C. 823(g)(2)(E)(ii). Finally, Commenters may also mail them to: legislation sets eligibility requirements the form may be used by physicians Office of Management and Budget, and certification requirements as well as with waivers to certify their need and Office of Information and Regulatory an interagency notification review intent to treat up to 100 patients. Affairs, New Executive Office Building, process for physicians who seek The form collects data on the Room 10102, Washington, DC 20503. waivers. The legislation was amended following items: Practitioner name; state in 2005 to eliminate the patient limit for medical license number and DEA Summer King, physicians in group practices, and in registration number; address of primary Statistician. 2006, to permit certain physicians to location, telephone and fax numbers; [FR Doc. 2015–14733 Filed 6–15–15; 8:45 am] treat up to 100 patients. email address; name and address of BILLING CODE 4162–20–P To implement these provisions, group practice; group practice employer SAMHSA developed a notification form identification number; names and DEA (SMA–167) that facilitates the registration numbers of group DEPARTMENT OF HEALTH AND submission and review of notifications. practitioners; purpose of notification HUMAN SERVICES The form provides the information new, immediate, or renewal; necessary to determine whether certification of qualifying criteria for Substance Abuse and Mental Health practitioners (i.e., independent treatment and management of opiate Services Administration physicians) meet the qualifications for dependent patients; certification of Agency Information Collection waivers set forth under the new law. capacity to refer patients for appropriate Use of this form will enable physicians counseling and other appropriate asabaliauskas on DSK5VPTVN1PROD with NOTICES Activities: Submission for OMB Review; Comment Request to know they have provided all ancillary services; certification of information needed to determine maximum patient load, certification to Periodically, the Substance Abuse and whether practitioners are eligible for a use only those drug products that meet Mental Health Services Administration waiver. the criteria in the law. The form also (SAMHSA) will publish a summary of However, there is no prohibition on notifies practitioners of Privacy Act information collection requests under use of other means to provide requisite considerations, and permits OMB review, in compliance with the information. The Secretary will convey practitioners to expressly consent to Paperwork Reduction Act (44 U.S.C. notification information and disclose limited information to the VerDate Sep<11>2014 17:18 Jun 15, 2015 Jkt 235001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1

Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Notices 34449 SAMHSA Buprenorphine Physician submitted through the Web based online page that SAMHSA will establish for the Locator. system. Approximately 60 percent of the purpose, as well as via U.S. mail. Since July 2002, SAMHSA has certified physicians have consented to There are no changes to the forms and received over 25,000 notifications and disclosure on the burden hours. has certified almost 27,000 physicians. SAMHSA Buprenorphine Physician The following table summarizes the Fifty-none percent of the notifications Locator. estimated annual burden for the use of were submitted by mail or by facsimile, Respondents may submit the form this form. with approximately forty-one percent electronically, through a dedicated Web Responses Burden per Number of Total burden Purpose of submission per response respondents (hrs) respondent (hr.) Initial Application for Waiver ............................................................................ 1,500 1 .083 125 Notification to Prescribe Immediately .............................................................. 50 1 .083 4 Notice to Treat up to 100 patients ................................................................... 500 1 .040 20 Total ...................................................................................................... 2,050 ........................ ........................ 149 Written comments and to obtain a copy of the information Prevention and Reduction of Underage recommendations concerning the collection plans, call the SAMHSA Drinking (‘‘Report to Congress’’). proposed information collection should Reports Clearance Officer at (240) 276– The STOP Act also requires the be sent by July 16, 2015 to the SAMHSA 1243. Secretary to develop ‘‘a set of measures Desk Officer at the Office of Information Comments are invited on: (a) Whether to be used in preparing the report on and Regulatory Affairs, Office of best practices’’ and to consider the proposed collections of information Management and Budget (OMB). To categories including but not limited to are necessary for the proper ensure timely receipt of comments, and the following: to avoid potential delays in OMB’s performance of the functions of the Category #1: Sixteen 2 specific receipt and processing of mail sent agency, including whether the underage drinking laws/regulations through the U.S. Postal Service, information shall have practical utility; enacted at the state level (e.g., laws commenters are encouraged to submit (b) the accuracy of the agency’s estimate prohibiting sales to minors; laws related their comments to OMB via email to: of the burden of the proposed collection to minors in possession of alcohol); OIRA_Submission@omb.eop.gov. of information; (c) ways to enhance the Category #2: Enforcement and Although commenters are encouraged to quality, utility, and clarity of the educational programs to promote send their comments via email, information to be collected; and (d) compliance with these laws/regulations; commenters may also fax their ways to minimize the burden of the Category #3: Programs targeted to comments to: 202–395–7285. collection of information on youths, parents, and caregivers to deter Commenters may also mail them to: respondents, including through the use underage drinking and the number of Office of Management and Budget, of automated collection techniques or individuals served by these programs; Office of Information and Regulatory other forms of information technology. Category #4: The amount that each Affairs, New Executive Office Building, state invests, per youth capita, on the Room 10102, Washington, DC 20503. Proposed Project: Survey of State prevention of underage drinking broken Underage Drinking Prevention Policies Summer King, into five categories: (a) Compliance and Practices—(OMB No. 0930–0316)— Statistician. check programs in retail outlets; (b) Revision [FR Doc. 2015–14727 Filed 6–15–15; 8:45 am] Checkpoints and saturation patrols that The Sober Truth on Preventing include the goal of reducing and BILLING CODE 4162–20–P Underage Drinking Act (the ‘‘STOP deterring underage drinking; (c) Act’’) 1 states that the ‘‘Secretary [of Community-based, school-based, and DEPARTMENT OF HEALTH AND Health and Human Services] shall . . . higher-education-based programs to HUMAN SERVICES annually issue a report on each state’s prevent underage drinking; (d) performance in enacting, enforcing, and Underage drinking prevention programs Substance Abuse and Mental Health creating laws, regulations, and programs that target youth within the juvenile Services Administration to prevent or reduce underage justice and child welfare systems; and drinking.’’ The Secretary has delegated (e) Any other state efforts or programs Agency Information Collection that target underage drinking. Activities: Proposed Collection; responsibility for this report to Congress’ purpose in mandating the Comment Request SAMHSA. Therefore, SAMHSA has collection of data on state policies and developed a Survey of State Underage In compliance with Section programs through the State Survey is to Drinking Prevention Policies and 3506(c)(2)(A) of the Paperwork provide policymakers and the public asabaliauskas on DSK5VPTVN1PROD with NOTICES Practices (the ‘‘State Survey’’) to provide Reduction Act of 1995 concerning with currently unavailable but much input for the state-by-state report on opportunity for public comment on needed information regarding state prevention and enforcement activities underage drinking prevention policies proposed collections of information, the related to underage drinking component Substance Abuse and Mental Health and programs. SAMHSA and other of the Annual Report to Congress on the Services Administration (SAMHSA) 2 Nine additional policies have been added to the will publish periodic summaries of 1 Public Law 109–422. It is assumed Congress Report to Congress pursuant to Congressional proposed projects. To request more intended to include the District of Columbia as part appropriations language or the Secretary’s authority information on the proposed projects or of the Report to Congress. granted by the STOP Act. VerDate Sep<11>2014 17:18 Jun 15, 2015 Jkt 235001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\16JNN1.SGM 16JNN1


Document Created: 2018-02-22 10:22:54
Document Modified: 2018-02-22 10:22:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 34448 
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