[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: 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 
[email protected].
     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: 
[email protected].

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