80 FR 77351 - Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 239 (December 14, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 239 (December 14, 2015)
| Page Range | 77351-77352 | |
| FR Document | 2015-31375 |
[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)] [Notices] [Pages 77351-77352] From the Federal Register Online [www.thefederalregister.org] [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: http://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 http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://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 http://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
![Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Notices 77351
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Mine Worker ...................................... Informed consent form (Longitudinal 50 1 12/60 10
boot outsole study).
Mine Worker ...................................... Preliminary survey ............................ 150 1 15/60 38
Mine Worker ...................................... On-going survey ............................... 50 52 12/60 520
Mine Worker ...................................... Final Survey ..................................... 50 1 6/60 5
Mine Worker ...................................... Talent and consent waiver ............... 150 1 6/60 15
Total ........................................... ........................................................... ........................ ........................ ........................ 643
Leroy A. Richardson, DATES: Written comments must be To develop the recommendations,
Chief, Information Collection Review Office, received on or before January 13, 2016. CDC conducted a systematic review on
Office of Scientific Integrity, Office of the ADDRESSES: You may submit comments, benefits and harms of opioids and
Associate Director for Science, Office of the developed the draft Guideline using the
Director, Centers for Disease Control and
identified by Docket No. CDC–2015–
0112 by any of the following methods: Grading of Recommendations
Prevention.
• Federal eRulemaking Portal: http:// Assessment, Development, and
[FR Doc. 2015–31344 Filed 12–11–15; 8:45 am] Evaluation (GRADE) framework. CDC
www.regulations.gov. Follow the
BILLING CODE 4163–18–P
instructions for submitting comments. drafted recommendations and consulted
• Mail: National Center for Injury with experts on the evidence to inform
Prevention and Control, Centers for the recommendations. CDC hosted
DEPARTMENT OF HEALTH AND webinars in September 2015 and also
HUMAN SERVICES Disease Control and Prevention, 4770
Buford Highway NE., Mailstop F–63, provided opportunities for stakeholder
Centers for Disease Control and Atlanta, GA 30341, Attn: Docket CDC– and peer review of the draft Guideline.
Prevention 2015–0112. The Guideline is not a federal
Instructions: All submissions received regulation; adherence to the Guideline
[Docket No. CDC–2015–0112] will be voluntary. For additional
must include the agency name and
Docket Number. All relevant comments information on prescription drug
Proposed 2016 Guideline for overdose, please visit http://www.cdc.
Prescribing Opioids for Chronic Pain received will be posted without change
to http://regulations.gov, including any gov/drugoverdose/prescribing/
AGENCY: Centers for Disease Control and personal information provided. For guideline.html.
Prevention (CDC), Department of Health access to the docket to read background Supporting and Related Material in the
and Human Services (HHS). documents or comments received, go to Docket
ACTION: Notice with comment period. http://www.regulations.gov. The docket contains the following
SUMMARY: The Centers for Disease FOR FURTHER INFORMATION CONTACT: supporting and related materials to help
Control and Prevention (CDC) in the Arlene I. Greenspan, National Center for inform public comment: The Guideline;
Department of Health and Human Injury Prevention and Control, Centers the Clinical Evidence Review Appendix;
Services (HHS) announces the opening for Disease Control and Prevention, the Contextual Evidence Review
of a docket to obtain public comment on 4770 Buford Highway NE., Mailstop F– Appendix; and three documents that
the draft CDC Guideline for Prescribing 63, Atlanta, GA 30341; Telephone: 770– comprise the Comment Summaries and
Opioids for Chronic Pain (Guideline). 488–4696. CDC Responses (Constituent Comment
The Guideline provides SUPPLEMENTARY INFORMATION: Summary, Peer Review Summary, and
recommendations regarding initiation or Stakeholder Review Group Summary).
Background The Clinical Evidence Review
continuation of opioids for chronic
pain; opioid selection, dosage, duration, CDC developed the draft Guideline to Appendix and the Contextual Evidence
follow-up, and discontinuation; and provide recommendations about opioid Review Appendix include primary
assessment of risk and addressing harms prescribing for primary care providers evidence, studies, and data tables that
of opioid use. The Guideline is intended who are treating adult patients with were used by CDC to develop the
to be used by primary care providers chronic pain in outpatient settings, recommendations in the Guideline. The
(e.g., family physicians or internists) outside of active cancer treatment, Constituent Comment Summary reflects
who are treating patients with chronic palliative care, and end-of-life care. The input obtained in response to webinars
pain (i.e., pain lasting longer than 3 draft Guideline summarizes scientific hosted on September 16 and September
months or past the time of normal tissue knowledge about the effectiveness and 17, 2015, during which CDC shared an
healing) in outpatient settings. The draft risks of long-term opioid therapy, and overview of the development process
Guideline is intended to apply to provides recommendations for when to and draft recommendation statements.
mstockstill on DSK4VPTVN1PROD with NOTICES
patients aged 18 years of age or older initiate or continue opioids for chronic The Stakeholder Review Group
with chronic pain outside of palliative pain; opioid selection, dosage, duration, Summary also reflects input obtained
and end-of-life care. The Guideline is follow-up, and discontinuation; and from stakeholders (comprised of
not intended to apply to patients in assessing risk and addressing harms of professional and community
treatment for active cancer. The opioid use. The draft Guideline organizations) following their review of
Guideline is not a federal regulation; identifies important gaps in the a prior draft of the Guideline. Finally,
adherence to the Guideline will be literature where further research is the Peer Review Summary reflects input
voluntary. needed. obtained from three scientific peer
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![77352 Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Notices
reviewers following their review of a announcements; (2) conduct of DEPARTMENT OF HEALTH AND
draft of the full Guideline, along with a Secondary Peer Review of extramural HUMAN SERVICES
summary of comments received and research grants, cooperative agreements,
CDC responses. and contracts applications received in Centers for Medicare & Medicaid
Dated: December 9, 2015. response to the funding opportunity Services
Veronica Kennedy, announcements as it relates to the [Document Identifiers: CMS–R–282 and
Acting Executive Secretary, Centers for Center’s programmatic balance and CMS–10597]
Disease Control and Prevention. mission; (3) submission of secondary
[FR Doc. 2015–31375 Filed 12–11–15; 8:45 am] review recommendations to the Center Agency Information Collection
Director of applications to be considered Activities: Proposed Collection;
BILLING CODE 4163–18–P
for funding support; (4) review of Comment Request
research portfolios, and (5) review of AGENCY: Centers for Medicare &
DEPARTMENT OF HEALTH AND program proposals. Medicaid Services, HHS.
HUMAN SERVICES Matters for Discussion: The Board of ACTION: Notice.
Centers for Disease Control and Scientific Counselors will discuss the
background for development of the CDC SUMMARY: The Centers for Medicare &
Prevention Medicaid Services (CMS) is announcing
Guideline for Prescribing Opioids for
Board of Scientific Counselors, Chronic Pain (Guideline) and the an opportunity for the public to
National Center for Injury Prevention formation of the Prescribing Opioids for comment on CMS’ intention to collect
and Control, (BSC, NCIPC) Chronic Pain Workgroup (Opioid information from the public. Under the
Paperwork Reduction Act of 1995 (the
Guideline Workgroup). We will be
In accordance with Section 10(a)(2) of PRA), federal agencies are required to
the Federal Advisory Committee Act accepting public comments only related
publish notice in the Federal Register
(Pub. L. 92–463), the Centers for Disease to the formation of the Opioid Guideline concerning each proposed collection of
Control and Prevention (CDC) Workgroup. There will be 30 minutes information (including each proposed
announces, the following meeting of the allotted for public comments at the end extension or reinstatement of an existing
aforementioned committee: of the session. All public comments will collection of information) and to allow
Time and Date: 9:00 a.m.–1:00 p.m., be limited to two-minutes per speaker. 60 days for public comment on the
January 7, 2016 (OPEN). CDC is also publishing a related proposed action. Interested persons are
Place: Teleconference Dial-In notice in today’s Federal Register invited to send comments regarding our
Number: 1–888–395–7561, Participant announcing the opening of a public burden estimates or any other aspect of
Code: 3954121. comment period on the Guideline itself. this collection of information, including
Status: The meeting as designated any of the following subjects: (1) The
Individuals are given 30 days to provide
above will be open to the public. necessity and utility of the proposed
Purpose: The Board will: (1) Conduct, comments on the Guideline. Please see
instructions in that notice about information collection for the proper
encourage, cooperate with, and assist performance of the agency’s functions;
other appropriate public health providing comment.
(2) the accuracy of the estimated
authorities, scientific institutions, and Agenda items are subject to change as burden; (3) ways to enhance the quality,
scientists in the conduct of research, priorities dictate. utility, and clarity of the information to
investigations, experiments, Contact Person for More Information: be collected; and (4) the use of
demonstrations, and studies relating to Arlene Greenspan, Dr. P.H, M.P.H., P.T., automated collection techniques or
the causes, diagnosis, treatment, control, Associate Director for Science, NCIPC, other forms of information technology to
and prevention of physical and mental minimize the information collection
CDC, 4770 Buford Highway NE.,
diseases, and other impairments; (2) burden.
Mailstop F–63, Atlanta, Georgia 30341,
assist States and their political
Telephone (770) 488–4696. DATES: Comments must be received by
subdivisions in preventing and
suppressing communicable and non- The Director, Management Analysis February 12, 2016.
communicable diseases and other and Services Office, has been delegated ADDRESSES: When commenting, please
preventable conditions and in the authority to sign Federal Register reference the document identifier or
promoting health and well-being; and notices pertaining to announcements of OMB control number. To be assured
(3) conduct and assist in research and meetings and other committee consideration, comments and
control activities related to injury. management activities, for both the recommendations must be submitted in
The Board of Scientific Counselors Centers for Disease Control and any one of the following ways:
makes recommendations regarding Prevention and the Agency for Toxic 1. Electronically. You may send your
policies, strategies, objectives, and Substances and Disease Registry. comments electronically to http://
priorities; and reviews progress toward www.regulations.gov. Follow the
injury prevention goals and provides Elaine L. Baker, instructions for ‘‘Comment or
evidence in injury prevention-related Director, Management Analysis and Services Submission’’ or ‘‘More Search Options’’
research and programs. The Board also Office, Centers for Disease Control and to find the information collection
provides advice on the appropriate Prevention. document(s) that are accepting
mstockstill on DSK4VPTVN1PROD with NOTICES
balance of intramural and extramural [FR Doc. 2015–31367 Filed 12–11–15; 8:45 am] comments.
research, the structure, progress and BILLING CODE 4163–18–P 2. By regular mail. You may mail
performance of intramural programs. written comments to the following
The Board is designed to provide address: CMS, Office of Strategic
guidance on extramural scientific Operations and Regulatory Affairs,
program matters, including the: (1) Division of Regulations Development,
Review of extramural research concepts Attention: Document Identifier/OMB
for funding opportunity Control Number ___, Room C4–26–05,
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Document Created: 2015-12-14 13:47:02
Document Modified: 2015-12-14 13:47:02
| 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 | Notice with comment period. | |
| Dates | Written comments must be received on or before January 13, 2016. | |
| 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. | |
| FR Citation | 80 FR 77351 |
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