Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain, 77351-77352 [2015-31375]
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77351
Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Mine Worker ......................................
50
1
12/60
10
......................................
......................................
......................................
......................................
Informed consent form (Longitudinal
boot outsole study).
Preliminary survey ............................
On-going survey ...............................
Final Survey .....................................
Talent and consent waiver ...............
150
50
50
150
1
52
1
1
15/60
12/60
6/60
6/60
38
520
5
15
Total ...........................................
...........................................................
........................
........................
........................
643
Mine
Mine
Mine
Mine
Worker
Worker
Worker
Worker
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–31344 Filed 12–11–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0112]
Proposed 2016 Guideline for
Prescribing Opioids for Chronic Pain
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the opening
of a docket to obtain public comment on
the draft CDC Guideline for Prescribing
Opioids for Chronic Pain (Guideline).
The Guideline provides
recommendations regarding initiation or
continuation of opioids for chronic
pain; opioid selection, dosage, duration,
follow-up, and discontinuation; and
assessment of risk and addressing harms
of opioid use. The Guideline is intended
to be used by primary care providers
(e.g., family physicians or internists)
who are treating patients with chronic
pain (i.e., pain lasting longer than 3
months or past the time of normal tissue
healing) in outpatient settings. The draft
Guideline is intended to apply to
patients aged 18 years of age or older
with chronic pain outside of palliative
and end-of-life care. The Guideline is
not intended to apply to patients in
treatment for active cancer. The
Guideline is not a federal regulation;
adherence to the Guideline will be
voluntary.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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Written comments must be
received on or before January 13, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0112 by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Center for Injury
Prevention and Control, Centers for
Disease Control and Prevention, 4770
Buford Highway NE., Mailstop F–63,
Atlanta, GA 30341, Attn: Docket CDC–
2015–0112.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Arlene I. Greenspan, National Center for
Injury Prevention and Control, Centers
for Disease Control and Prevention,
4770 Buford Highway NE., Mailstop F–
63, Atlanta, GA 30341; Telephone: 770–
488–4696.
SUPPLEMENTARY INFORMATION:
DATES:
Background
CDC developed the draft Guideline to
provide recommendations about opioid
prescribing for primary care providers
who are treating adult patients with
chronic pain in outpatient settings,
outside of active cancer treatment,
palliative care, and end-of-life care. The
draft Guideline summarizes scientific
knowledge about the effectiveness and
risks of long-term opioid therapy, and
provides recommendations for when to
initiate or continue opioids for chronic
pain; opioid selection, dosage, duration,
follow-up, and discontinuation; and
assessing risk and addressing harms of
opioid use. The draft Guideline
identifies important gaps in the
literature where further research is
needed.
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To develop the recommendations,
CDC conducted a systematic review on
benefits and harms of opioids and
developed the draft Guideline using the
Grading of Recommendations
Assessment, Development, and
Evaluation (GRADE) framework. CDC
drafted recommendations and consulted
with experts on the evidence to inform
the recommendations. CDC hosted
webinars in September 2015 and also
provided opportunities for stakeholder
and peer review of the draft Guideline.
The Guideline is not a federal
regulation; adherence to the Guideline
will be voluntary. For additional
information on prescription drug
overdose, please visit https://www.cdc.
gov/drugoverdose/prescribing/
guideline.html.
Supporting and Related Material in the
Docket
The docket contains the following
supporting and related materials to help
inform public comment: The Guideline;
the Clinical Evidence Review Appendix;
the Contextual Evidence Review
Appendix; and three documents that
comprise the Comment Summaries and
CDC Responses (Constituent Comment
Summary, Peer Review Summary, and
Stakeholder Review Group Summary).
The Clinical Evidence Review
Appendix and the Contextual Evidence
Review Appendix include primary
evidence, studies, and data tables that
were used by CDC to develop the
recommendations in the Guideline. The
Constituent Comment Summary reflects
input obtained in response to webinars
hosted on September 16 and September
17, 2015, during which CDC shared an
overview of the development process
and draft recommendation statements.
The Stakeholder Review Group
Summary also reflects input obtained
from stakeholders (comprised of
professional and community
organizations) following their review of
a prior draft of the Guideline. Finally,
the Peer Review Summary reflects input
obtained from three scientific peer
E:\FR\FM\14DEN1.SGM
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77352
Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Notices
reviewers following their review of a
draft of the full Guideline, along with a
summary of comments received and
CDC responses.
Dated: December 9, 2015.
Veronica Kennedy,
Acting Executive Secretary, Centers for
Disease Control and Prevention.
[FR Doc. 2015–31375 Filed 12–11–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSK4VPTVN1PROD with NOTICES
Board of Scientific Counselors,
National Center for Injury Prevention
and Control, (BSC, NCIPC)
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces, the following meeting of the
aforementioned committee:
Time and Date: 9:00 a.m.–1:00 p.m.,
January 7, 2016 (OPEN).
Place: Teleconference Dial-In
Number: 1–888–395–7561, Participant
Code: 3954121.
Status: The meeting as designated
above will be open to the public.
Purpose: The Board will: (1) Conduct,
encourage, cooperate with, and assist
other appropriate public health
authorities, scientific institutions, and
scientists in the conduct of research,
investigations, experiments,
demonstrations, and studies relating to
the causes, diagnosis, treatment, control,
and prevention of physical and mental
diseases, and other impairments; (2)
assist States and their political
subdivisions in preventing and
suppressing communicable and noncommunicable diseases and other
preventable conditions and in
promoting health and well-being; and
(3) conduct and assist in research and
control activities related to injury.
The Board of Scientific Counselors
makes recommendations regarding
policies, strategies, objectives, and
priorities; and reviews progress toward
injury prevention goals and provides
evidence in injury prevention-related
research and programs. The Board also
provides advice on the appropriate
balance of intramural and extramural
research, the structure, progress and
performance of intramural programs.
The Board is designed to provide
guidance on extramural scientific
program matters, including the: (1)
Review of extramural research concepts
for funding opportunity
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17:36 Dec 11, 2015
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announcements; (2) conduct of
Secondary Peer Review of extramural
research grants, cooperative agreements,
and contracts applications received in
response to the funding opportunity
announcements as it relates to the
Center’s programmatic balance and
mission; (3) submission of secondary
review recommendations to the Center
Director of applications to be considered
for funding support; (4) review of
research portfolios, and (5) review of
program proposals.
Matters for Discussion: The Board of
Scientific Counselors will discuss the
background for development of the CDC
Guideline for Prescribing Opioids for
Chronic Pain (Guideline) and the
formation of the Prescribing Opioids for
Chronic Pain Workgroup (Opioid
Guideline Workgroup). We will be
accepting public comments only related
to the formation of the Opioid Guideline
Workgroup. There will be 30 minutes
allotted for public comments at the end
of the session. All public comments will
be limited to two-minutes per speaker.
CDC is also publishing a related
notice in today’s Federal Register
announcing the opening of a public
comment period on the Guideline itself.
Individuals are given 30 days to provide
comments on the Guideline. Please see
instructions in that notice about
providing comment.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Arlene Greenspan, Dr. P.H, M.P.H., P.T.,
Associate Director for Science, NCIPC,
CDC, 4770 Buford Highway NE.,
Mailstop F–63, Atlanta, Georgia 30341,
Telephone (770) 488–4696.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–31367 Filed 12–11–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–282 and
CMS–10597]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments must be received by
February 12, 2016.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ___, Room C4–26–05,
DATES:
E:\FR\FM\14DEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)]
[Notices]
[Pages 77351-77352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31375]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0112]
Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) announces the opening of
a docket to obtain public comment on the draft CDC Guideline for
Prescribing Opioids for Chronic Pain (Guideline). The Guideline
provides recommendations regarding initiation or continuation of
opioids for chronic pain; opioid selection, dosage, duration, follow-
up, and discontinuation; and assessment of risk and addressing harms of
opioid use. The Guideline is intended to be used by primary care
providers (e.g., family physicians or internists) who are treating
patients with chronic pain (i.e., pain lasting longer than 3 months or
past the time of normal tissue healing) in outpatient settings. The
draft Guideline is intended to apply to patients aged 18 years of age
or older with chronic pain outside of palliative and end-of-life care.
The Guideline is not intended to apply to patients in treatment for
active cancer. The Guideline is not a federal regulation; adherence to
the Guideline will be voluntary.
DATES: Written comments must be received on or before January 13, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0112 by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: National Center for Injury Prevention and Control,
Centers for Disease Control and Prevention, 4770 Buford Highway NE.,
Mailstop F-63, Atlanta, GA 30341, Attn: Docket CDC-2015-0112.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to https://regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center
for Injury Prevention and Control, Centers for Disease Control and
Prevention, 4770 Buford Highway NE., Mailstop F-63, Atlanta, GA 30341;
Telephone: 770-488-4696.
SUPPLEMENTARY INFORMATION:
Background
CDC developed the draft Guideline to provide recommendations about
opioid prescribing for primary care providers who are treating adult
patients with chronic pain in outpatient settings, outside of active
cancer treatment, palliative care, and end-of-life care. The draft
Guideline summarizes scientific knowledge about the effectiveness and
risks of long-term opioid therapy, and provides recommendations for
when to initiate or continue opioids for chronic pain; opioid
selection, dosage, duration, follow-up, and discontinuation; and
assessing risk and addressing harms of opioid use. The draft Guideline
identifies important gaps in the literature where further research is
needed.
To develop the recommendations, CDC conducted a systematic review
on benefits and harms of opioids and developed the draft Guideline
using the Grading of Recommendations Assessment, Development, and
Evaluation (GRADE) framework. CDC drafted recommendations and consulted
with experts on the evidence to inform the recommendations. CDC hosted
webinars in September 2015 and also provided opportunities for
stakeholder and peer review of the draft Guideline. The Guideline is
not a federal regulation; adherence to the Guideline will be voluntary.
For additional information on prescription drug overdose, please visit
https://www.cdc.gov/drugoverdose/prescribing/guideline.html.
Supporting and Related Material in the Docket
The docket contains the following supporting and related materials
to help inform public comment: The Guideline; the Clinical Evidence
Review Appendix; the Contextual Evidence Review Appendix; and three
documents that comprise the Comment Summaries and CDC Responses
(Constituent Comment Summary, Peer Review Summary, and Stakeholder
Review Group Summary). The Clinical Evidence Review Appendix and the
Contextual Evidence Review Appendix include primary evidence, studies,
and data tables that were used by CDC to develop the recommendations in
the Guideline. The Constituent Comment Summary reflects input obtained
in response to webinars hosted on September 16 and September 17, 2015,
during which CDC shared an overview of the development process and
draft recommendation statements. The Stakeholder Review Group Summary
also reflects input obtained from stakeholders (comprised of
professional and community organizations) following their review of a
prior draft of the Guideline. Finally, the Peer Review Summary reflects
input obtained from three scientific peer
[[Page 77352]]
reviewers following their review of a draft of the full Guideline,
along with a summary of comments received and CDC responses.
Dated: December 9, 2015.
Veronica Kennedy,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2015-31375 Filed 12-11-15; 8:45 am]
BILLING CODE 4163-18-P
