Meeting of the Pain Management Best Practices Inter-Agency Task Force, 19565-19566 [2018-09379]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Notices Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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FOR FURTHER INFORMATION CONTACT: Peter Chen, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, Rm. 2112, Silver Spring, MD 20993, 240–402– 8605, Peter.Chen@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.’’ This guidance concerns the implementation of the PDUFA VI and certain changes in policies and procedures surrounding its application. Because PDUFA VI created significant changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which applicants are responsible. PDUFA VI provides two different fee types that applicants pay: Application and program fees. This guidance describes when these fees are incurred and the process by which applicants can submit payments. The guidance also provides information on consequences of failing to pay PDUFA VI fees as well as the process for submitting a reconsideration and appeals request. In the Federal Register of October 13, 2017 (82 FR 47748), FDA announced the availability of a draft version of this guidance and provided interested parties an opportunity to submit comments. We have reviewed the comments submitted to the docket and determined that they did not raise any relevant issues. This guidance does not include any substantive changes from the draft guidance. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on assessing user fees under PDUFA VI. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 19565 II. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: April 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–09366 Filed 5–2–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Pain Management Best Practices Inter-Agency Task Force Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: 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/. 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: paintaskforce@ hhs.gov. SUMMARY: Section 101 of the Comprehensive Addiction and Recovery Act of 2016 (CARA) authorizes the Secretary of Health and Human Services, in cooperation with SUPPLEMENTARY INFORMATION: E:\FR\FM\03MYN1.SGM 03MYN1 sradovich on DSK3GMQ082PROD with NOTICES 19566 Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Notices 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/advisorycommittees/pain/. Members of the public are invited to participate in person or by webcast. To join the meeting, individuals must preregister at the Task Force website at https://www.hhs.gov/ash/advisorycommittees/pain/. Seating will be provided first to those who have pre-registered. Anyone who has not preregistered will be accommodated on a first come, first served basis if additional seats are available 10 minutes before the meeting starts. Individuals VerDate Sep<11>2014 17:29 May 02, 2018 Jkt 244001 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 paintaskforce@ hhs.gov by May 22, 2018. The subject line of the email should read, ‘‘Task Force Meeting Accommodations.’’ NonU.S. citizens who plan to attend in person are required to provide additional information and must notify the Task Force staff via email at paintaskforce@hhs.gov 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/advisorycommittees/pain/. 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 https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Stakeholder Listening Session in Preparation for the 71st World Health Assembly; Meeting Subject: Office of Global Affairs: Stakeholder Listening Session in preparation for the 71st World Health Assembly Time and date: Friday, May 11th, 2018, 3:00 p.m.–4:30 p.m. EST Place: Hubert H. Humphrey Building, Auditorium, 200 Independence Ave, SW, Washington, District of Columbia 20201. Status: Open, but requiring RSVP to OGA.RSVP@hhs.gov by Monday, May 7, 2018. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Purpose: The U.S. Department of Health and Human Services (HHS)— charged with leading the U.S. delegation to the 71st World Health Assembly— will hold an informal Stakeholder Listening Session on Friday, May 11 from 3:00 p.m. to 4:30 p.m., in the Hubert H. Humphrey Building Auditorium, 200 Independence Ave. SW, Washington, DC 20201. The Stakeholder Listening Session will help the HHS Office of Global Affairs prepare the U.S. delegation for the World Health Assembly by taking full advantage of the knowledge, ideas, feedback, and suggestions from all individuals interested in and affected by agenda items to be discussed at the 71st World Health Assembly. Participants will be limited to 3 minute statements per agenda item. Your input will contribute to informing U.S. positions as we negotiate with our international colleagues at the World Health Assembly on these important health topics. The listening session will be organized by agenda item, and participation is welcome from all individuals, including individuals familiar with the following topics and groups: • Public health and advocacy activities; • State, local, and Tribal issues; • Private industry; • Minority health organizations; and • Academic and scientific organizations. All agenda items to be discussed at the 71st World Health Assembly can be found at this website: https:// apps.who.int/gb/ebwha/pdf_files/ WHA71/A71_1-en.pdf RSVP: Due to security restrictions for entry into the HHS Hubert H. Humphrey Building, RSVPs are required for this event. Please send your full name and organization to OGA.RSVP@hhs.gov . Please RSVP no later than Monday, May 7, 2018. If you are not a U.S. citizen and do not have a U.S. government issued form of identification, please note this in the subject line of your RSVP, and our office will contact you to gain additional biographical information required for your clearance. Photo identification for all attendees is required for building access without exception. Written comments are welcome and encouraged, even if you are planning on attending in person. Please send your written comments to OGA.RSVP@ hhs.gov. We look forward to hearing your comments related to the 71st World Health Assembly agenda items. E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Notices]
[Pages 19565-19566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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/.

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/.
    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/. 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/.
    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 https://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


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