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, 51205-51206 [2016-18324]
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Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
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and customary business practice. The
recordkeeping requirements of
§ 801.150(a)(2) consist of making copies
and maintaining the records required
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2016 (81 FR 23309), FDA published a
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received.
FDA estimates the burden of this
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TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
recordkeepers
21 CFR section
Record retention, 801.150(a)(2) ..........................................
Number of
records per
recordkeeper
90
Total annual
records
20
Average
burden per
recordkeeping
(hours)
1,800
Total hours
.5
900
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
respondents
Activity/21 CFR section
Agreement and labeling requirements, 801.150(e) .............
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Office of the Secretary
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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1,800
Total hours
4
7,200
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 28, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institute of Allergy and
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HUMAN SERVICES
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20
Average
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National Institutes of Health
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[FR Doc. 2016–18417 Filed 8–2–16; 8:45 am]
90
Total annual
disclosures
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–18299 Filed 8–2–16; 8:45 am]
Dated: July 27, 2016.
Sylvia M. Burwell,
Secretary.
Number of
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per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
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as amended. The grant applications and
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Name of Committee: National Institute of
Allergy and Infectious Diseases Special
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Clinical Trial Implementation (U44).
Date: August 30, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
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Contact Person: Lynn Rust, Ph.D.,
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[FR Doc. 2016–18391 Filed 8–2–16; 8:45 am]
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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:
SAMHSA, Center for
Substance Abuse Treatment (CSAT), in
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.
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)
SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
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: SAMHSA, CSAT,
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: SAMHSA,
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: SAMHSA, 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.
VerDate Sep<11>2014
18:21 Aug 02, 2016
Jkt 238001
FOR FURTHER INFORMATION CONTACT:
Melinda Campopiano, MD, Medical
Officer, SAMHSA, CSAT, 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 SAMHSA, 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
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
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Frm 00033
Fmt 4703
Sfmt 4703
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/DWP.
[FR Doc. 2016–18324 Filed 8–2–16; 8:45 am]
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Federal Emergency Management
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[Docket ID FEMA–2016–0002; Internal
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Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This notice lists communities
where the addition or modification of
Base Flood Elevations (BFEs), base flood
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where applicable, in the supporting
Flood Insurance Study (FIS) reports,
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51205-51206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18324]
-----------------------------------------------------------------------
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: SAMHSA, Center for Substance Abuse Treatment (CSAT), in 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.
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)
[[Page 51206]]
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: SAMHSA, CSAT, 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: SAMHSA, 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: SAMHSA, 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, SAMHSA, CSAT, 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 SAMHSA,
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 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/DWP.
[FR Doc. 2016-18324 Filed 8-2-16; 8:45 am]
BILLING CODE 4162-20-P
