80 FR 18426 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration Federal Register Volume 80, Issue 65 (April 6, 2015)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 80, Issue 65 (April 6, 2015)
| Page Range | 18426-18427 | |
| FR Document | 2015-07727 |
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)] [Notices] [Pages 18426-18427] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07727] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed 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 [[Page 18427]] 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 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 (hour) (hours) ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 2-1057, One Choke Cherry Road, Rockville, MD 20857 or email her a copy at [email protected]. Written comments should be received by June 5, 2015. Summer King, Statistician. [FR Doc. 2015-07727 Filed 4-3-15; 8:45 am] BILLING CODE 4162-20-P
![18426 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices
their child and community. Policies that —representatives from the private Proposed Project: Notification of Intent
do not do this should be strengthened. sector, including those from health To Use Schedule III, IV, or V Opioid
4.1.1 Increased efforts should be insurance organizations. Drugs for the Maintenance and
made to educate the public and state Detoxification Treatment of Opiate
legislatures on the safety and value of When responding, please self-identify Addiction Under 21 U.S.C. 823(g)(2)
vaccines, the importance of with any of the above or other categories (OMB No. 0930–0234)—Extension
recommended vaccinations and the (include all that apply) and your name.
Anonymous submissions will not be The Drug Addiction Treatment Act of
ACIP schedule, and the risks posed by 2000 (‘‘DATA,’’ Pub. L. 106–310)
low or under-vaccination in considered. Written submissions should
not exceed three to five (3–5) pages. amended the Controlled Substances Act
communities and schools. (21 U.S.C. 823(g)(2)) to permit
4.2 NVAC recommends information Please do not send proprietary,
practitioners (physicians) to seek and
on vaccination rates, vaccination commercial, financial, business,
obtain waivers to prescribe certain
exemptions, and other preventative confidential, trade secret, or personal
approved narcotic treatment drugs for
health measures (e.g., whether a school information. the treatment of opiate addiction. The
has a school nurse, etc.) for an
Dated: March 31, 2015. legislation sets eligibility requirements
educational institution be made
Bruce Gellin, and certification requirements as well as
available to parents.
4.2.1 Encourage educational Deputy Assistant Secretary for Health, an interagency notification review
institutions and childcare facilities to Director, National Vaccine Program Office, process for physicians who seek
report vaccination rates publicly (e.g., Executive Secretary, National Vaccine waivers. The legislation was amended
via a school health grade or report). Advisory Committee. in 2005 to eliminate the patient limit for
4.3 NVAC recommends ‘‘on-time [FR Doc. 2015–07778 Filed 4–3–15; 8:45 am] physicians in group practices, and in
vaccination’’ should be included as a BILLING CODE 4150–44–P
2006, to permit certain physicians to
Quality Measure for all health plans, treat up to 100 patients.
public and private, as a first line To implement these provisions,
indicator of vaccine confidence. NVAC DEPARTMENT OF HEALTH AND SAMHSA developed a notification form
acknowledges that other issues, such as HUMAN SERVICES (SMA–167) that facilitates the
access, can also effect on time submission and review of notifications.
vaccination. Substance Abuse and Mental Health The form provides the information
Services Administration necessary to determine whether
Final Recommendation practitioners (i.e., independent
5.1 The NVAC recommends that the Agency Information Collection physicians) meet the qualifications for
National Vaccine Program Office Activities: Proposed Collection; waivers set forth under the new law.
(NVPO) should work with federal and Comment Request Use of this form will enable physicians
non-federal partners to develop an to know they have provided all
implementation plan to address vaccine In compliance with section information needed to determine
confidence, including metrics, and 3506(c)(2)(A) of the Paperwork whether practitioners are eligible for a
report back to NVAC on progress, Reduction Act of 1995 concerning waiver.
annually. opportunity for public comment on However, there is no prohibition on
proposed collections of information, the use of other means to provide requisite
II. Request for Comment information. The Secretary will convey
Substance Abuse and Mental Health
NVPO, on behalf of the NVAC notification information and
Services Administration (SAMHSA)
Vaccine Confidence Working Group, determinations to the Drug Enforcement
will publish periodic summaries of
requests input on the draft report and Administration (DEA), which will
proposed projects. To request more assign an identification number to
draft recommendations. Please limit
information on the proposed projects or qualifying practitioners; this number
your comments to three (3) pages.
to obtain a copy of the information will be included in the practitioner’s
III. Potential Responders collection plans, call the SAMHSA registration under 21 U.S.C. 823(f).
HHS invites input from a broad range Reports Clearance Officer on (240) 276– Practitioners may use the form for
of stakeholders including individuals 1243. three types of notification: (a) New, (b)
and organizations that have interests in Comments are invited on: (a) Whether immediate, and (c) to notify of their
immunization efforts and the role of the proposed collections of information intent to treat up to 100 patients. Under
HHS in advancing those efforts. are necessary for the proper ‘‘new’’ notifications, practitioners may
Examples of potential responders performance of the functions of the make their initial waiver requests to
include, but are not limited to, the agency, including whether the SAMHSA. ‘‘Immediate’’ notifications
following: information shall have practical utility; inform SAMHSA and the Attorney
—General public; (b) the accuracy of the agency’s estimate General of a practitioner’s intent to
—advocacy groups, non-profit of the burden of the proposed collection prescribe immediately to facilitate the
organizations, and public interest treatment of an individual (one) patient
of information; (c) ways to enhance the
organizations; under 21 U.S.C. 823(g)(2)(E)(ii). Finally,
quality, utility, and clarity of the
—academics, professional societies, and the form may be used by physicians
information to be collected; and (d) with waivers to certify their need and
healthcare organizations;
ways to minimize the burden of the
tkelley on DSK4VPTVN1PROD with NOTICES
—public health officials and intent to treat up to 100 patients.
immunization program managers; collection of information on The form collects data on the
—pediatric provider groups including respondents, including through the use following items: Practitioner name; state
all physician and non-physician of automated collection techniques or medical license number and DEA
providers that administer healthcare other forms of information technology. registration number; address of primary
services to children, including location, telephone and fax numbers;
pharmacists; and email address; name and address of
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![Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18427
group practice; group practice employer the criteria in the law. The form also system. Approximately 60 percent of the
identification number; names and DEA notifies practitioners of Privacy Act certified physicians have consented to
registration numbers of group considerations, and permits disclosure on the SAMHSA
practitioners; purpose of notification practitioners to expressly consent to Buprenorphine Physician Locator.
new, immediate, or renewal; disclose limited information to the Respondents may submit the form
certification of qualifying criteria for SAMHSA Buprenorphine Physician electronically, through a dedicated Web
treatment and management of opiate Locator. page that SAMHSA will establish for the
dependent patients; certification of Since July 2002, SAMHSA has purpose, as well as via U.S. mail.
received over 25,000 notifications and
capacity to refer patients for appropriate There are no changes to the forms and
has certified almost 27,000 physicians.
counseling and other appropriate burden hours.
Fifty-none percent of the notifications
ancillary services; certification of were submitted by mail or by facsimile, The following table summarizes the
maximum patient load, certification to with approximately forty-one percent estimated annual burden for the use of
use only those drug products that meet submitted through the Web based online this form.
Responses Burden per
Number of Total burden
Purpose of submission per response
respondents (hours)
respondent (hour)
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
Send comments to Summer King, Radiographs of Pneumoconiosis (ILO Instructions: All information received
SAMHSA Reports Clearance Officer, Classification). The current ILO in response to this notice must include
Room 2–1057, One Choke Cherry Road, Classification depends on 22 standard the agency name and docket number
Rockville, MD 20857 or email her a reference radiographs that are used to (CDC–2015–0008; NIOSH–282). All
copy at summer.king@samhsa.hhs.gov. formally identify and characterize relevant comments received will be
Written comments should be received pneumoconiosis and related pulmonary posted without change to
by June 5, 2015. abnormalities arising from occupational www.regulations.gov, including any
exposure. The original standards were personal information provided. All
Summer King,
based on film radiography, but the electronic comments should be
Statistician. advent of digital radiography has led to formatted as Microsoft Word. For access
[FR Doc. 2015–07727 Filed 4–3–15; 8:45 am] the need for reference standards based to the docket to read background
BILLING CODE 4162–20–P on digitally-acquired images. NIOSH is documents or comments received, go to
assisting the ILO in the process of www.regulations.gov. All information
identifying such digital images. received in response to this notice will
DEPARTMENT OF HEALTH AND also be available for public examination
HUMAN SERVICES For this purpose, NIOSH is requesting
trained users of the ILO Classification and copying at the NIOSH Docket
Centers for Disease Control and (e.g., NIOSH B-Readers [1] and other Office, 1150 Tusculum Avenue, Room
Prevention such experts) to submit comments 155, Cincinnati, OH 45226.
regarding any of the current standard FOR FURTHER INFORMATION CONTACT:
[Docket Number CDC–2015–0008; NIOSH– reference images that are felt to be Michael Attfield, 1095 Willowdale
282] deficient and for which improvements Road, Morgantown, WV 26505–2888,
could be made. The current structure telephone (304) 285–5737 (this is not a
International Labour Office (ILO) and format of the ILO Classification is toll free number).
Reference Radiographs to remain unchanged at the present SUPPLEMENTARY INFORMATION:
AGENCY: National Institute for time. NIOSH is not soliciting comments
on the ILO Classification itself. Table of Contents
Occupational Safety and Health
(NIOSH) of the Centers for Disease Comments received on the ILO • Background
Control and Prevention (CDC), Classification will be considered • Information Needs
Department of Health and Human irrelevant to the purpose of this docket. • References
Services (HHS). DATES:Electronic or written comments Background: Chest radiographs (X-
ACTION: Request for information and must be received by June 5, 2015. Rays) provide critical medical
comment. information for the assessment of the
ADDRESSES: You may submit comments, pneumoconioses and related disorders
SUMMARY: The National Institute for identified by CDC–2015–0008 and in individuals, for example, those
Occupational Safety and Health docket number NIOSH–282, by any of caused by inhaling coal, silica, and
(NIOSH) of the Centers for Disease and the following methods: asbestos dusts [2]. Prior to 1950, the
• Federal eRulemaking Portal: http://
tkelley on DSK4VPTVN1PROD with NOTICES
Prevention is collaborating with the information evident on a radiograph
Labour Inspection, Labour www.regulations.gov. Follow the could only be interpreted qualitatively.
Administration and Occupational Safety instructions for submitting comments. However in 1950, the International
and Health Branch of the International • Mail: National Institute for Labour Office (ILO) established a more
Labour Office (ILO) in developing a set Occupational Safety and Health, NIOSH quantitative system whereby the various
of digital reference radiographs for the Docket Office, 1090 Tusculum Avenue, parenchymal and pleural changes could
ILO International Classification of MS C–34, Cincinnati, OH 45226–1998. be formally recognized and categorized.
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Document Created: 2015-12-18 11:17:58
Document Modified: 2015-12-18 11:17:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 18426 |
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