81 FR 53493 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration Federal Register Volume 81, Issue 156 (August 12, 2016)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 81, Issue 156 (August 12, 2016)
| Page Range | 53493-53494 | |
| FR Document | 2016-19187 |
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)] [Notices] [Pages 53493-53494] From the Federal Register Online [www.thefederalregister.org] [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: http://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: http://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 http://www.regulations.gov, including any personal information provided. For access to the report or comments received, go to http://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
![Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices 53493
confidential trade secrets or commercial the guidance of the federal steering agency name and Docket Number. All
property such as patentable material, committee (FSC). It explains the RAND relevant comments received will be
and personal information concerning Corporation (RAND)/University of posted without change to http://
individuals associated with the grant California Los Angeles (UCLA) www.regulations.gov, including any
applications, the disclosure of which Appropriateness Method (RAM), personal information provided. For
would constitute a clearly unwarranted justifies its adoption, and reports the access to the report or comments
invasion of personal privacy. outcomes of its application that will received, go to http://
Name of Committee: National Human form the basis for the development of www.regulations.gov.
Genome Research Institute Special Emphasis clinical guidance. This report will serve FOR FURTHER INFORMATION CONTACT:
Panel; Gabriella Miller Kids First Review. as the foundation for the development Melinda Campopiano, MD, Medical
Date: September 8–9, 2016. of clinical guidance to be used by Officer, Substance Abuse and Mental
Time: 7:00 a.m. to 3:30 p.m. providers caring for women with opioid Health Services Administration, Center
Agenda: To review and evaluate grant use disorder and their infants.
applications.
for Substance Abuse Treatment,
Place: Embassy Suites at the Chevy Chase DATES: Comment Close Date: To be Division of Pharmacologic Therapies,
Pavilion, Room Chevy Chase 1, 4300 Military assured consideration, comments must 5600 Fishers Lane, 13E24, Rockville,
Road NW., Washington, DC 20015. be received at one of the addresses MD 20852, Email: samhsa.ppdaoram@
Contact Person: Barbara J. Thomas, Ph.D., provided below, no later than 5 p.m. no samhsa.hhs.gov.
Scientific Review Officer, Scientific Review later than 30 days after date of SUPPLEMENTARY INFORMATION: Inspection
Branch, National Human Genome Research publication in the Federal Register.
Institute, National Institutes of Health, 5635
of Public Comments: All comments
ADDRESSES: You may submit comments received before the close of the
Fishers Lane, Ste. 4076, MSC 9306, Bethesda,
MD 20892–9306, 301–402–0838, identified by Docket No. [SAMHSA– comment period are available for
barbara.thomas@nih.gov. 2016–0002] by any of the following viewing by the public, including any
(Catalogue of Federal Domestic Assistance methods: personally identifiable or confidential
Program Nos. 93.172, Human Genome • Federal eRulemaking Portal: http:// business information that is included in
Research, National Institutes of Health, HHS) www.regulations.gov. Follow the a comment. Comments received by the
instructions for submitting comments. deadline will be available for public
Dated: August 5, 2016.
• Electronically: You may submit inspection at the Substance Abuse and
Sylvia L. Neal, electronic comments to Mental Health Services Administration,
Program Analyst, Office of Federal Advisory samhsa.ppdaoram@samhsa.hhs.gov. Division of Pharmacologic Therapies,
Committee Policy. • By regular mail: You may mail 5600 Fishers Lane, 13E24, Rockville,
[FR Doc. 2016–19193 Filed 8–11–16; 8:45 am] written comments to the following MD 20852, Monday through Friday of
BILLING CODE 4140–01–P address ONLY: Substance Abuse and each week from 8:30 a.m. to 4:00 p.m.
Mental Health Services Administration, To schedule an appointment to view
Center for Substance Abuse Treatment, public comments, phone (240) 276–
DEPARTMENT OF HEALTH AND Division of Pharmacologic Therapies, 2700.
HUMAN SERVICES 5600 Fishers Lane, 13E24, Rockville, Background: SAMHSA led a federal
MD 20852 Attn: Docket No. [SAMHSA– steering committee in overseeing the
Substance Abuse and Mental Health
2016–0002]. Please allow sufficient time application of the RAND/UCLA
Services Administration
for mailed comments to be received Appropriateness Method (RAM) to the
[Docket No. SAMHSA–2016–0002] before the close of the comment period. available evidence concerning the
• By express or overnight mail: You optimal management of opioid use
Request for Comment on Report may send written comments to the disorder for women who are pregnant or
Entitled: Advancing the Care of following address ONLY: Substance parenting and the management of their
Pregnant and Parenting Women With Abuse and Mental Health Services infants. After completion of the
Opioid Use Disorder and Their Infants: Administration, Attention: DPT Federal literature review, generation of the
A Foundation for Clinical Guidance Register Representative, Division of indications, and the expert panel RAM
AGENCY: Substance Abuse and Mental Pharmacologic Therapies, 5600 Fishers rating process—all described in this
Health Services Administration Lane, 13E24, Rockville, MD 20852 Attn: report—this report was generated for the
(SAMHSA), Department of Health and Docket No. [SAMHSA–2016–0002]. purpose of producing a clinical guide
Human Services (HHS). • By hand or courier: Alternatively, that will be written to facilitate optimal
ACTION: Request for comment.
you may deliver (by hand or courier) management of pregnant and parenting
your written comments ONLY to the women with opioid use disorder and
SUMMARY: Substance Abuse and Mental following address prior to the close of their infants across disciplines and
Health Services Administration the comment period: For delivery in treatment settings. The guide will have
(SAMHSA), Center for Substance Abuse Rockville, MD: Substance Abuse and a dual purpose: first, to serve as a tool
Treatment, in the Department of Health Mental Health Services Administration, that will increase provider willingness
and Human Services (HHS) announces Attention: DPT Federal Register and confidence to manage pregnant and
the opening of a docket to obtain public Representative, Division of parenting women with opioid use
comment on a report entitled: Pharmacologic Therapies, 5600 Fishers disorder and their infants; and second to
Advancing the Care of Pregnant and Lane, 13E24, Rockville, MD 20852. To help assure the care provided this
Parenting Women with Opioid Use deliver your comments to the Rockville population optimizes the outcomes for
mstockstill on DSK3G9T082PROD with NOTICES
Disorder and their Infants: A address, call telephone number (240) both mother and infant.
Foundation for Clinical Guidance. The 276–2700 in advance to schedule your The purpose of this effort is to
report is available at: http:// delivery with one of our staff members. produce a patient-centered guide to be
www.regulations.gov/ Instructions: To avoid duplication, used in a range of clinical settings.
docket?D=SAMHSA-2016-0002. please submit only one copy of your SAMHSA plans to organize the results
This report describes the formal comments by only one method. All described in this report around clinical
process agreed on and followed under submissions received must include the scenarios and interventions consistent
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![53494 Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices
with the range of ways that women with Reduction Act of 1995 concerning activities continue to align with state
opioid use disorder may access opportunity for public comment on and local needs.
substance use treatment or maternity proposed collections of information, the A three-year clearance is being
care. The guide will provide options for Substance Abuse and Mental Health requested. The SAMHSA DTAC CFS is
clinical interventions that recognize the Services Administration (SAMHSA) designed to allow the agency to collect
complexities of patients’ lives. The will publish periodic summaries of
feedback on the overall effectiveness of
guide will also include discussion of proposed projects. To request more
any conflicting evidence and clinician, the services provided by SAMHSA
information on the proposed projects or
treatment or patient characteristics that to obtain a copy of the information DTAC, as well as ongoing data regarding
directly influence the appropriateness collection plans, call the SAMHSA disaster behavioral health (mental
or effectiveness of a given clinical Reports Clearance Officer at 240–276– health and substance use-related) needs
intervention. The paucity of the 1243. at the national level and areas that
evidence to support specific require enhanced training and technical
Comments are invited on: (a) Whether
interventions will be addressed in the assistance (TA) services. This is the
the proposed collections of information
guide. As such, the guide will present are necessary for the proper information that was previously
options based on current clinical performance of the functions of the collected as part of the SAMHSA DTAC
practice, paired with the risks and agency, including whether the Needs Assessment Survey (NAS) and
benefits of each option as currently information shall have practical utility; Customer Satisfaction Survey (CSS).
understood. (b) the accuracy of the agency’s estimate Data from this effort will continue to be
Public comment is sought in two used to improve services to
of the burden of the proposed collection
general areas: The outcomes of the RAM jurisdictions, which will lead to (1)
of information; (c) ways to enhance the
process and the strategy to translate better integration of disaster behavioral
quality, utility, and clarity of the
these findings into a clinical guide. health (DBH) needs with all-hazards
information to be collected; and (d)
Relevant public comment will inform disaster preparedness and response, and
ways to minimize the burden of the
the development and final appearance
collection of information on (2) improved outcomes at the state,
of the guide. Members of the expert
respondents, including through the use territory, tribal, and local levels with
panel, FSC, and a variety of professional
of automated collection techniques or less burden on participants. The new
societies will be asked to provide input
into the guide outline and drafting of other forms of information technology. Customer Feedback Survey integrates
the guide which will then be subject to Proposed Project: SAMHSA Disaster and consolidates questions from the
a formal federal clearance process Technical Assistance Center Disaster previously utilized NAS and CSS,
including scientific review. Behavioral Health Needs Assessment which will reduce burden associated
Supporting and Related Material in and Customer Satisfaction Surveys with the number of instruments and
the Docket: The report contains the (OMB No. 0930–0325)—Revision survey questions. SAMHSA DTAC will
materials to help inform public continue to be responsible for survey
comment. The appendices include The Substance Abuse and Mental administration and analysis of the data
listings of participants, more detailed Health Services Administration collected, which SAMHSA will use to
information about the literature search, (SAMHSA) is requesting approval for a inform current and future training and
citations of primary references and data revision to the data collection associated TA activities. Table 1 shows the
tables that were used by SAMHSA to with the SAMHSA Disaster Technical estimated burden associated with CFS
develop the findings in the report. The Assistance Center (DTAC) Disaster
data collection activities and the
information provided includes: Behavioral Health Needs Assessment
associated costs. It is anticipated that
(1) The REPORT and Customer Satisfaction Surveys
(2) Supporting appendices: Appendix the survey will be administered once
(OMB No. 0930–0325), which expire on
A: RAM Process Participants; Appendix May 31, 2017. Specifically, SAMHSA each year.
B: Literature Review Methods; DTAC plans to consolidate the Needs Participation in the Customer
Appendix C: RAM Reference List and Assessment Survey and Customer Feedback Survey will be solicited from
Appendices D–E7: Rated Indications Satisfaction Surveys into a single all 50 states, the U.S. territories, and the
instrument. The new revised District of Columbia. The survey will be
Charles LoDico, instrument, entitled SAMHSA DTAC administered to individuals who have
Chemist, SAMHSA/CSAP. Customer Feedback Survey (CFS), under requested TA within the six months
this effort will also include a change in prior to administration and those who
[FR Doc. 2016–19187 Filed 8–11–16; 8:45 am]
administration to make it appropriate are subscribed to DTAC’s e-
BILLING CODE 4162–20–P
for a single, streamlined survey. communications, SAMHSA DTAC
The proposed data collection effort Bulletin, or The Dialogue, at the time of
DEPARTMENT OF HEALTH AND will provide feedback on the overall administration. Internet-based
HUMAN SERVICES effectiveness of SAMHSA DTAC’s technology will be used to collect data
services, ongoing needs at the national via web-based survey for data entry and
Substance Abuse and Mental Health level, and areas that require enhanced management.
Services Administration technical assistance (TA) services.
SAMHSA DTAC will be responsible
Agency Information Collection
mstockstill on DSK3G9T082PROD with NOTICES
for administering the data collection
Activities: Proposed Collection;
instrument and analyzing the data.
Comment Request
SAMHSA DTAC will use data from the
In compliance with Section instrument to inform current and future
3506(c)(2)(A) of the Paperwork TA activities and to ensure these
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Document Created: 2018-02-09 11:33:30
Document Modified: 2018-02-09 11:33:30
| 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 | |
| Action | Request for comment. | |
| Dates | Comment Close Date: To be assured consideration, comments must | |
| 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: [email protected] | |
| FR Citation | 81 FR 53493 |
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