83_FR_19651 83 FR 19565 - Meeting of the Pain Management Best Practices Inter-Agency Task Force

83 FR 19565 - Meeting of the Pain Management Best Practices Inter-Agency Task Force

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 86 (May 3, 2018)

Page Range19565-19566
FR Document2018-09379

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Pain Management Best Practices Inter-Agency Task Force (Task Force). The meeting will be open to the public; public comment sessions will be held during the meeting.

Federal Register, Volume 83 Issue 86 (Thursday, May 3, 2018) 
[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Notices]
[Pages 19565-19566]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Pain Management Best Practices Inter-Agency Task 
Force

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: As stipulated by the Federal Advisory Committee Act, the 
Department of Health and Human Services (HHS) is hereby giving notice 
that a meeting is scheduled to be held for the Pain Management Best 
Practices Inter-Agency Task Force (Task Force). The meeting will be 
open to the public; public comment sessions will be held during the 
meeting.

DATES: The inaugural meeting will be held on Wednesday, May 30, 2018, 
from 9:30 a.m. to 5:00 p.m. Eastern Time and Thursday, May 31, 2018, 
from 9:00 a.m. to 3:30 p.m. Eastern Time The agenda will be posted on 
the Task Force website at https://www.hhs.gov/ash/advisory-committees/pain/index.html.

ADDRESSES: U.S. Department of Health and Human Services, Hubert H. 
Humphrey Building, Great Hall, 200 Independence Avenue SW, Washington, 
DC 20201.

FOR FURTHER INFORMATION CONTACT: Alicia Richmond Scott, Designated 
Federal Officer, Pain Management Best Practices Inter-Agency Task 
Force, U.S. Department of Health and Human Services, Office of the 
Assistant Secretary for Health, 200 Independence Avenue SW, Room 736E, 
Washington, DC 20201. Email: [email protected].

SUPPLEMENTARY INFORMATION: Section 101 of the Comprehensive Addiction 
and Recovery Act of 2016 (CARA) authorizes the Secretary of Health and 
Human Services, in cooperation with

[[Page 19566]]

the Secretaries of Defense and Veterans Affairs, to convene the Task 
Force no later than two years after the date of the enactment of CARA 
(by July 22, 2018) and develop a report to Congress with updates on 
best practices and recommendations on addressing gaps or 
inconsistencies for pain management, including chronic and acute pain. 
The Task Force is governed by the provisions of the Federal Advisory 
Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. App), 
which sets forth standards for the formation and use of advisory 
committees.
    The Task Force will identify, review, and determine whether there 
are gaps or inconsistencies between best practices for pain management, 
including chronic and acute pain, developed or adopted by federal 
agencies; propose updates to best practices and recommendations on 
addressing identified gaps or inconsistencies; provide the public with 
an opportunity to comment on any proposed updates and recommendations; 
and develop a strategy for disseminating such proposed updates and 
recommendations to relevant federal agencies and the general public.
    This inaugural meeting of the Task Force will consist of an 
overview of various topics surrounding pain management, and the 
establishment of the Task Force subcommittee structure. Federal, state, 
local, and professional medical and health organization representatives 
will provide their current perspectives on pain management. The Task 
Force will discuss clinical best practices, gaps and inconsistencies 
focused on prevention and treatment; mental health and addiction; 
special populations; education; providers; payors; service and 
delivery; and research and innovation. Personal testimonials of people 
living in pain will be given. The Task Force will deliberate and vote 
on establishing subcommittees for developing the report to Congress. 
Information about the final meeting agenda will be posted prior to the 
meeting on the Task Force website: https://www.hhs.gov/ash/advisory-committees/pain/index.html.
    Members of the public are invited to participate in person or by 
webcast. To join the meeting, individuals must pre-register at the Task 
Force website at https://www.hhs.gov/ash/advisory-committees/pain/index.html. Seating will be provided first to those who have pre-
registered. Anyone who has not pre-registered will be accommodated on a 
first come, first served basis if additional seats are available 10 
minutes before the meeting starts. Individuals who need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should indicate the special accommodation when 
registering online or by notifying the Office of the Assistant 
Secretary for Health via email at [email protected] by May 22, 
2018. The subject line of the email should read, ``Task Force Meeting 
Accommodations.'' Non-U.S. citizens who plan to attend in person are 
required to provide additional information and must notify the Task 
Force staff via email at [email protected] 10 business days before 
the meeting, May 16, 2018. For those unable to attend in person, a live 
webcast will be available. More information on registration and 
accessing the webcast can be found at https://www.hhs.gov/ash/advisory-committees/pain/index.html.
    Members of the public can provide comments at the Task Force 
meeting during the following designated dates and times: May 30, 2018 
from 11:40 a.m. to 12:10 p.m. Eastern Time and May 31, 2018 from 1:50 
p.m. to 2:20 p.m. Eastern Time. Public comments made during the meeting 
will be limited to three minutes per person to ensure time is allotted 
for all those wishing to speak. Individuals are also welcome to submit 
their written comments. Written comments should not exceed three pages 
in length. Individuals submitting written comments should submit their 
comments through the Federal eRulemaking Portal at http://www.regulations.gov by May 25, 2018.

    Dated: April 26, 2018.
Vanila M. Singh,
Chief Medical Officer, Office of the Assistant Secretary for Health.
[FR Doc. 2018-09379 Filed 5-2-18; 8:45 am]
BILLING CODE 4150-28-P

Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Notices 19565 Submissions,’’ publicly viewable at one self-addressed adhesive label to II. Electronic Access https://www.regulations.gov or at the assist the office in processing your Persons with access to the internet Dockets Management Staff between 9 requests. See the SUPPLEMENTARY may obtain the guidance at either a.m. and 4 p.m., Monday through INFORMATION section for electronic https://www.fda.gov/Drugs/Guidance Friday. access to the guidance document. ComplianceRegulatoryInformation/ • Confidential Submissions—To FOR FURTHER INFORMATION CONTACT: Guidances/default.htm, https:// submit a comment with confidential Peter Chen, Center for Drug Evaluation www.fda.gov/BiologicsBloodVaccines/ information that you do not wish to be and Research, Food and Drug GuidanceComplianceRegulatory made publicly available, submit your Administration, 10001 New Hampshire Information/Guidances/default.htm, or comments only as a written/paper Ave., Hillandale Building, Rm. 2112, submission. You should submit two https://www.regulations.gov. Silver Spring, MD 20993, 240–402– copies total. One copy will include the Dated: April 24, 2018. 8605, Peter.Chen@fda.hhs.gov; or information you claim to be confidential Stephen Ripley, Center for Biologics Leslie Kux, with a heading or cover note that states Evaluation and Research, Food and Associate Commissioner for Policy. ‘‘THIS DOCUMENT CONTAINS Drug Administration, 10903 New [FR Doc. 2018–09366 Filed 5–2–18; 8:45 am] CONFIDENTIAL INFORMATION.’’ The Hampshire Ave, Bldg. 71, Rm. 7301, BILLING CODE 4164–01–P Agency will review this copy, including Silver Spring, MD 20993–0002, 240– the claimed confidential information, in 402–7911. its consideration of comments. The DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: second copy, which will have the HUMAN SERVICES claimed confidential information I. Background redacted/blacked out, will be available Meeting of the Pain Management Best FDA is announcing the availability of for public viewing and posted on Practices Inter-Agency Task Force a guidance for industry entitled https://www.regulations.gov. Submit ‘‘Assessing User Fees Under the AGENCY: Office of the Assistant both copies to the Dockets Management Staff. If you do not wish your name and Prescription Drug User Fee Secretary for Health, Office of the contact information to be made publicly Amendments of 2017.’’ This guidance Secretary, Department of Health and available, you can provide this concerns the implementation of the Human Services. information on the cover sheet and not PDUFA VI and certain changes in ACTION: Notice. in the body of your comments and you policies and procedures surrounding its must identify this information as application. Because PDUFA VI created SUMMARY: As stipulated by the Federal ‘‘confidential.’’ Any information marked significant changes to the user fee Advisory Committee Act, the as ‘‘confidential’’ will not be disclosed program, this guidance serves to provide Department of Health and Human except in accordance with 21 CFR 10.20 an explanation about the new fee Services (HHS) is hereby giving notice and other applicable disclosure law. For structure and types of fees for which that a meeting is scheduled to be held more information about FDA’s posting applicants are responsible. for the Pain Management Best Practices of comments to public dockets, see 80 PDUFA VI provides two different fee Inter-Agency Task Force (Task Force). FR 56469, September 18, 2015, or access types that applicants pay: Application The meeting will be open to the public; the information at: https://www.gpo.gov/ and program fees. This guidance public comment sessions will be held fdsys/pkg/FR-2015-09-18/pdf/2015- describes when these fees are incurred during the meeting. 23389.pdf. and the process by which applicants can DATES: The inaugural meeting will be Docket: For access to the docket to submit payments. The guidance also held on Wednesday, May 30, 2018, from read background documents or the provides information on consequences 9:30 a.m. to 5:00 p.m. Eastern Time and electronic and written/paper comments of failing to pay PDUFA VI fees as well Thursday, May 31, 2018, from 9:00 a.m. received, go to https:// as the process for submitting a to 3:30 p.m. Eastern Time The agenda www.regulations.gov and insert the reconsideration and appeals request. will be posted on the Task Force docket number, found in brackets in the In the Federal Register of October 13, website at https://www.hhs.gov/ash/ heading of this document, into the 2017 (82 FR 47748), FDA announced the advisory-committees/pain/index.html. ‘‘Search’’ box and follow the prompts availability of a draft version of this ADDRESSES: U.S. Department of Health and/or go to the Dockets Management guidance and provided interested and Human Services, Hubert H. Staff, 5630 Fishers Lane, Rm. 1061, parties an opportunity to submit Humphrey Building, Great Hall, 200 Rockville, MD 20852. comments. We have reviewed the Independence Avenue SW, Washington, You may submit comments on any comments submitted to the docket and DC 20201. guidance at any time (see 21 CFR determined that they did not raise any FOR FURTHER INFORMATION CONTACT: 10.115(g)(5)). relevant issues. This guidance does not Submit written requests for single include any substantive changes from Alicia Richmond Scott, Designated copies of the guidance to the Division of the draft guidance. Federal Officer, Pain Management Best Drug Information, Center for Drug This guidance is being issued Practices Inter-Agency Task Force, U.S. Evaluation and Research, Food and consistent with FDA’s good guidance Department of Health and Human Drug Administration, 10001 New practices regulation (21 CFR 10.115). Services, Office of the Assistant Hampshire Ave., Hillandale Building, The guidance represents the current Secretary for Health, 200 Independence 4th Floor, Silver Spring, MD 20993– thinking of FDA on assessing user fees Avenue SW, Room 736E, Washington, sradovich on DSK3GMQ082PROD with NOTICES 0002; or to the Office of under PDUFA VI. It does not establish DC 20201. Email: paintaskforce@ Communication, Outreach and any rights for any person and is not hhs.gov. Development, Center for Biologics binding on FDA or the public. You can SUPPLEMENTARY INFORMATION: Section Evaluation and Research, Food and use an alternative approach if it satisfies 101 of the Comprehensive Addiction Drug Administration, 10903 New the requirements of the applicable and Recovery Act of 2016 (CARA) Hampshire Ave., Bldg. 71, Rm. 3128, statutes and regulations. This guidance authorizes the Secretary of Health and Silver Spring, MD 20993–0002. Send is not subject to Executive Order 12866. Human Services, in cooperation with VerDate Sep<11>2014 17:29 May 02, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\03MYN1.SGM 03MYN1

19566 Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Notices the Secretaries of Defense and Veterans who need special assistance, such as Purpose: The U.S. Department of Affairs, to convene the Task Force no sign language interpretation or other Health and Human Services (HHS)— later than two years after the date of the reasonable accommodations, should charged with leading the U.S. delegation enactment of CARA (by July 22, 2018) indicate the special accommodation to the 71st World Health Assembly— and develop a report to Congress with when registering online or by notifying will hold an informal Stakeholder updates on best practices and the Office of the Assistant Secretary for Listening Session on Friday, May 11 recommendations on addressing gaps or Health via email at paintaskforce@ from 3:00 p.m. to 4:30 p.m., in the inconsistencies for pain management, hhs.gov by May 22, 2018. The subject Hubert H. Humphrey Building including chronic and acute pain. The line of the email should read, ‘‘Task Auditorium, 200 Independence Ave. Task Force is governed by the Force Meeting Accommodations.’’ Non- SW, Washington, DC 20201. provisions of the Federal Advisory U.S. citizens who plan to attend in The Stakeholder Listening Session Committee Act (FACA), Public Law 92– person are required to provide will help the HHS Office of Global 463, as amended (5 U.S.C. App), which additional information and must notify Affairs prepare the U.S. delegation for sets forth standards for the formation the Task Force staff via email at the World Health Assembly by taking and use of advisory committees. paintaskforce@hhs.gov 10 business days full advantage of the knowledge, ideas, The Task Force will identify, review, before the meeting, May 16, 2018. For feedback, and suggestions from all and determine whether there are gaps or those unable to attend in person, a live individuals interested in and affected by inconsistencies between best practices webcast will be available. More agenda items to be discussed at the 71st for pain management, including chronic information on registration and World Health Assembly. Participants and acute pain, developed or adopted accessing the webcast can be found at will be limited to 3 minute statements by federal agencies; propose updates to https://www.hhs.gov/ash/advisory- per agenda item. Your input will best practices and recommendations on committees/pain/index.html. contribute to informing U.S. positions as addressing identified gaps or Members of the public can provide we negotiate with our international inconsistencies; provide the public with comments at the Task Force meeting colleagues at the World Health an opportunity to comment on any during the following designated dates Assembly on these important health proposed updates and and times: May 30, 2018 from 11:40 a.m. topics. recommendations; and develop a to 12:10 p.m. Eastern Time and May 31, The listening session will be strategy for disseminating such 2018 from 1:50 p.m. to 2:20 p.m. Eastern organized by agenda item, and proposed updates and recommendations Time. Public comments made during participation is welcome from all to relevant federal agencies and the the meeting will be limited to three individuals, including individuals general public. minutes per person to ensure time is familiar with the following topics and This inaugural meeting of the Task allotted for all those wishing to speak. groups: Force will consist of an overview of Individuals are also welcome to submit • Public health and advocacy various topics surrounding pain their written comments. Written activities; management, and the establishment of the Task Force subcommittee structure. comments should not exceed three • State, local, and Tribal issues; Federal, state, local, and professional pages in length. Individuals submitting • Private industry; medical and health organization written comments should submit their • Minority health organizations; and representatives will provide their comments through the Federal • Academic and scientific current perspectives on pain eRulemaking Portal at http:// organizations. management. The Task Force will www.regulations.gov by May 25, 2018. All agenda items to be discussed at discuss clinical best practices, gaps and Dated: April 26, 2018. the 71st World Health Assembly can be inconsistencies focused on prevention Vanila M. Singh, found at this website: http:// and treatment; mental health and Chief Medical Officer, Office of the Assistant apps.who.int/gb/ebwha/pdf_files/ addiction; special populations; Secretary for Health. WHA71/A71_1-en.pdf education; providers; payors; service [FR Doc. 2018–09379 Filed 5–2–18; 8:45 am] RSVP: Due to security restrictions for and delivery; and research and entry into the HHS Hubert H. Humphrey BILLING CODE 4150–28–P innovation. Personal testimonials of Building, RSVPs are required for this people living in pain will be given. The event. Please send your full name and Task Force will deliberate and vote on DEPARTMENT OF HEALTH AND organization to OGA.RSVP@hhs.gov . establishing subcommittees for HUMAN SERVICES Please RSVP no later than Monday, May developing the report to Congress. 7, 2018. Information about the final meeting Stakeholder Listening Session in If you are not a U.S. citizen and do agenda will be posted prior to the Preparation for the 71st World Health not have a U.S. government issued form meeting on the Task Force website: Assembly; Meeting of identification, please note this in the https://www.hhs.gov/ash/advisory- subject line of your RSVP, and our office committees/pain/index.html. Subject: Office of Global Affairs: will contact you to gain additional Members of the public are invited to Stakeholder Listening Session in biographical information required for participate in person or by webcast. To preparation for the 71st World Health your clearance. Photo identification for join the meeting, individuals must pre- Assembly all attendees is required for building register at the Task Force website at Time and date: Friday, May 11th, access without exception. https://www.hhs.gov/ash/advisory- 2018, 3:00 p.m.–4:30 p.m. EST Written comments are welcome and sradovich on DSK3GMQ082PROD with NOTICES committees/pain/index.html. Seating Place: Hubert H. Humphrey Building, encouraged, even if you are planning on will be provided first to those who have Auditorium, 200 Independence Ave, attending in person. Please send your pre-registered. Anyone who has not pre- SW, Washington, District of Columbia written comments to OGA.RSVP@ registered will be accommodated on a 20201. hhs.gov. first come, first served basis if Status: Open, but requiring RSVP to We look forward to hearing your additional seats are available 10 minutes OGA.RSVP@hhs.gov by Monday, May 7, comments related to the 71st World before the meeting starts. Individuals 2018. Health Assembly agenda items. VerDate Sep<11>2014 17:29 May 02, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\03MYN1.SGM 03MYN1


Document Created: 2018-05-02 23:48:37
Document Modified: 2018-05-02 23:48:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe inaugural meeting will be held on Wednesday, May 30, 2018, from 9:30 a.m. to 5:00 p.m. Eastern Time and Thursday, May 31, 2018, from 9:00 a.m. to 3:30 p.m. Eastern Time The agenda will be posted on the Task Force website at https://www.hhs.gov/ash/advisory-committees/ pain/index.html.
ContactAlicia Richmond Scott, Designated Federal Officer, Pain Management Best Practices Inter-Agency Task Force, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, 200 Independence Avenue SW, Room 736E, Washington, DC 20201. Email: [email protected]
FR Citation83 FR 19565 
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