Request for Comment on Report Entitled: Advancing the Care of Pregnant and Parenting Women With Opioid Use Disorder and Their Infants: A Foundation for Clinical Guidance, 53493-53494 [2016-19187]
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Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Human
Genome Research Institute Special Emphasis
Panel; Gabriella Miller Kids First Review.
Date: September 8–9, 2016.
Time: 7:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, Room Chevy Chase 1, 4300 Military
Road NW., Washington, DC 20015.
Contact Person: Barbara J. Thomas, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, National Institutes of Health, 5635
Fishers Lane, Ste. 4076, MSC 9306, Bethesda,
MD 20892–9306, 301–402–0838,
barbara.thomas@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: August 5, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–19193 Filed 8–11–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
[Docket No. SAMHSA–2016–0002]
Request for Comment on Report
Entitled: Advancing the Care of
Pregnant and Parenting Women With
Opioid Use Disorder and Their Infants:
A Foundation for Clinical Guidance
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Department of Health and
Human Services (HHS).
ACTION: Request for comment.
AGENCY:
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Substance Abuse
Treatment, in the Department of Health
and Human Services (HHS) announces
the opening of a docket to obtain public
comment on a report entitled:
Advancing the Care of Pregnant and
Parenting Women with Opioid Use
Disorder and their Infants: A
Foundation for Clinical Guidance. The
report is available at: https://
www.regulations.gov/
docket?D=SAMHSA-2016-0002.
This report describes the formal
process agreed on and followed under
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:42 Aug 11, 2016
Jkt 238001
the guidance of the federal steering
committee (FSC). It explains the RAND
Corporation (RAND)/University of
California Los Angeles (UCLA)
Appropriateness Method (RAM),
justifies its adoption, and reports the
outcomes of its application that will
form the basis for the development of
clinical guidance. This report will serve
as the foundation for the development
of clinical guidance to be used by
providers caring for women with opioid
use disorder and their infants.
DATES: Comment Close Date: To be
assured consideration, comments must
be received at one of the addresses
provided below, no later than 5 p.m. no
later than 30 days after date of
publication in the Federal Register.
ADDRESSES: You may submit comments
identified by Docket No. [SAMHSA–
2016–0002] by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Electronically: You may submit
electronic comments to
samhsa.ppdaoram@samhsa.hhs.gov.
• By regular mail: You may mail
written comments to the following
address ONLY: Substance Abuse and
Mental Health Services Administration,
Center for Substance Abuse Treatment,
Division of Pharmacologic Therapies,
5600 Fishers Lane, 13E24, Rockville,
MD 20852 Attn: Docket No. [SAMHSA–
2016–0002]. Please allow sufficient time
for mailed comments to be received
before the close of the comment period.
• By express or overnight mail: You
may send written comments to the
following address ONLY: Substance
Abuse and Mental Health Services
Administration, Attention: DPT Federal
Register Representative, Division of
Pharmacologic Therapies, 5600 Fishers
Lane, 13E24, Rockville, MD 20852 Attn:
Docket No. [SAMHSA–2016–0002].
• By hand or courier: Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following address prior to the close of
the comment period: For delivery in
Rockville, MD: Substance Abuse and
Mental Health Services Administration,
Attention: DPT Federal Register
Representative, Division of
Pharmacologic Therapies, 5600 Fishers
Lane, 13E24, Rockville, MD 20852. To
deliver your comments to the Rockville
address, call telephone number (240)
276–2700 in advance to schedule your
delivery with one of our staff members.
Instructions: To avoid duplication,
please submit only one copy of your
comments by only one method. All
submissions received must include the
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53493
agency name and Docket Number. All
relevant comments received will be
posted without change to https://
www.regulations.gov, including any
personal information provided. For
access to the report or comments
received, go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Melinda Campopiano, MD, Medical
Officer, Substance Abuse and Mental
Health Services Administration, Center
for Substance Abuse Treatment,
Division of Pharmacologic Therapies,
5600 Fishers Lane, 13E24, Rockville,
MD 20852, Email: samhsa.ppdaoram@
samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. Comments received by the
deadline will be available for public
inspection at the Substance Abuse and
Mental Health Services Administration,
Division of Pharmacologic Therapies,
5600 Fishers Lane, 13E24, Rockville,
MD 20852, Monday through Friday of
each week from 8:30 a.m. to 4:00 p.m.
To schedule an appointment to view
public comments, phone (240) 276–
2700.
Background: SAMHSA led a federal
steering committee in overseeing the
application of the RAND/UCLA
Appropriateness Method (RAM) to the
available evidence concerning the
optimal management of opioid use
disorder for women who are pregnant or
parenting and the management of their
infants. After completion of the
literature review, generation of the
indications, and the expert panel RAM
rating process—all described in this
report—this report was generated for the
purpose of producing a clinical guide
that will be written to facilitate optimal
management of pregnant and parenting
women with opioid use disorder and
their infants across disciplines and
treatment settings. The guide will have
a dual purpose: first, to serve as a tool
that will increase provider willingness
and confidence to manage pregnant and
parenting women with opioid use
disorder and their infants; and second to
help assure the care provided this
population optimizes the outcomes for
both mother and infant.
The purpose of this effort is to
produce a patient-centered guide to be
used in a range of clinical settings.
SAMHSA plans to organize the results
described in this report around clinical
scenarios and interventions consistent
E:\FR\FM\12AUN1.SGM
12AUN1
53494
Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices
with the range of ways that women with
opioid use disorder may access
substance use treatment or maternity
care. The guide will provide options for
clinical interventions that recognize the
complexities of patients’ lives. The
guide will also include discussion of
any conflicting evidence and clinician,
treatment or patient characteristics that
directly influence the appropriateness
or effectiveness of a given clinical
intervention. The paucity of the
evidence to support specific
interventions will be addressed in the
guide. As such, the guide will present
options based on current clinical
practice, paired with the risks and
benefits of each option as currently
understood.
Public comment is sought in two
general areas: The outcomes of the RAM
process and the strategy to translate
these findings into a clinical guide.
Relevant public comment will inform
the development and final appearance
of the guide. Members of the expert
panel, FSC, and a variety of professional
societies will be asked to provide input
into the guide outline and drafting of
the guide which will then be subject to
a formal federal clearance process
including scientific review.
Supporting and Related Material in
the Docket: The report contains the
materials to help inform public
comment. The appendices include
listings of participants, more detailed
information about the literature search,
citations of primary references and data
tables that were used by SAMHSA to
develop the findings in the report. The
information provided includes:
(1) The REPORT
(2) Supporting appendices: Appendix
A: RAM Process Participants; Appendix
B: Literature Review Methods;
Appendix C: RAM Reference List and
Appendices D–E7: Rated Indications
Charles LoDico,
Chemist, SAMHSA/CSAP.
[FR Doc. 2016–19187 Filed 8–11–16; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK3G9T082PROD with NOTICES
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
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18:42 Aug 11, 2016
Jkt 238001
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 at 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: SAMHSA Disaster
Technical Assistance Center Disaster
Behavioral Health Needs Assessment
and Customer Satisfaction Surveys
(OMB No. 0930–0325)—Revision
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is requesting approval for a
revision to the data collection associated
with the SAMHSA Disaster Technical
Assistance Center (DTAC) Disaster
Behavioral Health Needs Assessment
and Customer Satisfaction Surveys
(OMB No. 0930–0325), which expire on
May 31, 2017. Specifically, SAMHSA
DTAC plans to consolidate the Needs
Assessment Survey and Customer
Satisfaction Surveys into a single
instrument. The new revised
instrument, entitled SAMHSA DTAC
Customer Feedback Survey (CFS), under
this effort will also include a change in
administration to make it appropriate
for a single, streamlined survey.
The proposed data collection effort
will provide feedback on the overall
effectiveness of SAMHSA DTAC’s
services, ongoing needs at the national
level, and areas that require enhanced
technical assistance (TA) services.
SAMHSA DTAC will be responsible
for administering the data collection
instrument and analyzing the data.
SAMHSA DTAC will use data from the
instrument to inform current and future
TA activities and to ensure these
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Sfmt 4703
activities continue to align with state
and local needs.
A three-year clearance is being
requested. The SAMHSA DTAC CFS is
designed to allow the agency to collect
feedback on the overall effectiveness of
the services provided by SAMHSA
DTAC, as well as ongoing data regarding
disaster behavioral health (mental
health and substance use-related) needs
at the national level and areas that
require enhanced training and technical
assistance (TA) services. This is the
information that was previously
collected as part of the SAMHSA DTAC
Needs Assessment Survey (NAS) and
Customer Satisfaction Survey (CSS).
Data from this effort will continue to be
used to improve services to
jurisdictions, which will lead to (1)
better integration of disaster behavioral
health (DBH) needs with all-hazards
disaster preparedness and response, and
(2) improved outcomes at the state,
territory, tribal, and local levels with
less burden on participants. The new
Customer Feedback Survey integrates
and consolidates questions from the
previously utilized NAS and CSS,
which will reduce burden associated
with the number of instruments and
survey questions. SAMHSA DTAC will
continue to be responsible for survey
administration and analysis of the data
collected, which SAMHSA will use to
inform current and future training and
TA activities. Table 1 shows the
estimated burden associated with CFS
data collection activities and the
associated costs. It is anticipated that
the survey will be administered once
each year.
Participation in the Customer
Feedback Survey will be solicited from
all 50 states, the U.S. territories, and the
District of Columbia. The survey will be
administered to individuals who have
requested TA within the six months
prior to administration and those who
are subscribed to DTAC’s ecommunications, SAMHSA DTAC
Bulletin, or The Dialogue, at the time of
administration. Internet-based
technology will be used to collect data
via web-based survey for data entry and
management.
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Notices]
[Pages 53493-53494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19187]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
[Docket No. SAMHSA-2016-0002]
Request for Comment on Report Entitled: Advancing the Care of
Pregnant and Parenting Women With Opioid Use Disorder and Their
Infants: A Foundation for Clinical Guidance
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (HHS).
ACTION: Request for comment.
-----------------------------------------------------------------------
SUMMARY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Center for Substance Abuse Treatment, in the Department of
Health and Human Services (HHS) announces the opening of a docket to
obtain public comment on a report entitled: Advancing the Care of
Pregnant and Parenting Women with Opioid Use Disorder and their
Infants: A Foundation for Clinical Guidance. The report is available
at: https://www.regulations.gov/docket?D=SAMHSA-2016-0002.
This report describes the formal process agreed on and followed
under the guidance of the federal steering committee (FSC). It explains
the RAND Corporation (RAND)/University of California Los Angeles (UCLA)
Appropriateness Method (RAM), justifies its adoption, and reports the
outcomes of its application that will form the basis for the
development of clinical guidance. This report will serve as the
foundation for the development of clinical guidance to be used by
providers caring for women with opioid use disorder and their infants.
DATES: Comment Close Date: To be assured consideration, comments must
be received at one of the addresses provided below, no later than 5
p.m. no later than 30 days after date of publication in the Federal
Register.
ADDRESSES: You may submit comments identified by Docket No. [SAMHSA-
2016-0002] by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Electronically: You may submit electronic comments to
samhsa.ppdaoram@samhsa.hhs.gov.
By regular mail: You may mail written comments to the
following address ONLY: Substance Abuse and Mental Health Services
Administration, Center for Substance Abuse Treatment, Division of
Pharmacologic Therapies, 5600 Fishers Lane, 13E24, Rockville, MD 20852
Attn: Docket No. [SAMHSA-2016-0002]. Please allow sufficient time for
mailed comments to be received before the close of the comment period.
By express or overnight mail: You may send written
comments to the following address ONLY: Substance Abuse and Mental
Health Services Administration, Attention: DPT Federal Register
Representative, Division of Pharmacologic Therapies, 5600 Fishers Lane,
13E24, Rockville, MD 20852 Attn: Docket No. [SAMHSA-2016-0002].
By hand or courier: Alternatively, you may deliver (by
hand or courier) your written comments ONLY to the following address
prior to the close of the comment period: For delivery in Rockville,
MD: Substance Abuse and Mental Health Services Administration,
Attention: DPT Federal Register Representative, Division of
Pharmacologic Therapies, 5600 Fishers Lane, 13E24, Rockville, MD 20852.
To deliver your comments to the Rockville address, call telephone
number (240) 276-2700 in advance to schedule your delivery with one of
our staff members.
Instructions: To avoid duplication, please submit only one copy of
your comments by only one method. All submissions received must include
the agency name and Docket Number. All relevant comments received will
be posted without change to https://www.regulations.gov, including any
personal information provided. For access to the report or comments
received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Melinda Campopiano, MD, Medical
Officer, Substance Abuse and Mental Health Services Administration,
Center for Substance Abuse Treatment, Division of Pharmacologic
Therapies, 5600 Fishers Lane, 13E24, Rockville, MD 20852, Email:
samhsa.ppdaoram@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment.
Comments received by the deadline will be available for public
inspection at the Substance Abuse and Mental Health Services
Administration, Division of Pharmacologic Therapies, 5600 Fishers Lane,
13E24, Rockville, MD 20852, Monday through Friday of each week from
8:30 a.m. to 4:00 p.m. To schedule an appointment to view public
comments, phone (240) 276-2700.
Background: SAMHSA led a federal steering committee in overseeing
the application of the RAND/UCLA Appropriateness Method (RAM) to the
available evidence concerning the optimal management of opioid use
disorder for women who are pregnant or parenting and the management of
their infants. After completion of the literature review, generation of
the indications, and the expert panel RAM rating process--all described
in this report--this report was generated for the purpose of producing
a clinical guide that will be written to facilitate optimal management
of pregnant and parenting women with opioid use disorder and their
infants across disciplines and treatment settings. The guide will have
a dual purpose: first, to serve as a tool that will increase provider
willingness and confidence to manage pregnant and parenting women with
opioid use disorder and their infants; and second to help assure the
care provided this population optimizes the outcomes for both mother
and infant.
The purpose of this effort is to produce a patient-centered guide
to be used in a range of clinical settings. SAMHSA plans to organize
the results described in this report around clinical scenarios and
interventions consistent
[[Page 53494]]
with the range of ways that women with opioid use disorder may access
substance use treatment or maternity care. The guide will provide
options for clinical interventions that recognize the complexities of
patients' lives. The guide will also include discussion of any
conflicting evidence and clinician, treatment or patient
characteristics that directly influence the appropriateness or
effectiveness of a given clinical intervention. The paucity of the
evidence to support specific interventions will be addressed in the
guide. As such, the guide will present options based on current
clinical practice, paired with the risks and benefits of each option as
currently understood.
Public comment is sought in two general areas: The outcomes of the
RAM process and the strategy to translate these findings into a
clinical guide. Relevant public comment will inform the development and
final appearance of the guide. Members of the expert panel, FSC, and a
variety of professional societies will be asked to provide input into
the guide outline and drafting of the guide which will then be subject
to a formal federal clearance process including scientific review.
Supporting and Related Material in the Docket: The report contains
the materials to help inform public comment. The appendices include
listings of participants, more detailed information about the
literature search, citations of primary references and data tables that
were used by SAMHSA to develop the findings in the report. The
information provided includes:
(1) The REPORT
(2) Supporting appendices: Appendix A: RAM Process Participants;
Appendix B: Literature Review Methods; Appendix C: RAM Reference List
and Appendices D-E7: Rated Indications
Charles LoDico,
Chemist, SAMHSA/CSAP.
[FR Doc. 2016-19187 Filed 8-11-16; 8:45 am]
BILLING CODE 4162-20-P
