83_FR_40460 83 FR 40303 - Meeting of the Pain Management Best Practices Inter-Agency Task Force

83 FR 40303 - Meeting of the Pain Management Best Practices Inter-Agency Task Force

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 157 (August 14, 2018)

Page Range40303-40304
FR Document2018-17446

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 157 (Tuesday, August 14, 2018)
[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Pages 40303-40304]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17446]


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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.

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

[[Page 40304]]

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 Task Force meeting will be held on Tuesday, September 25, 
2018, from 8:30 a.m. to 4:30 p.m. Eastern Time (ET) and Wednesday, 
September 26, 2018, from 9:00 a.m. to 12:00 p.m. ET. 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. Phone: 240-453-2816. Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Section 101 of the Comprehensive Addiction 
and Recovery Act of 2016 (CARA) requires the Secretary of Health and 
Human Services, in cooperation with 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 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 review clinical guidelines and identify gaps 
and/or inconsistencies for best practices for pain management, 
including chronic and acute pain, developed or adopted by federal 
agencies; propose updates to best practices and recommendations for 
identified gaps or inconsistencies; provide a 90 day the public comment 
period 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.
    The Task Force will convene its second public meeting, on September 
25 and 26, 2018, to discuss updates to existing best practices and 
recommendations based on gaps and inconsistencies for pain management, 
including chronic and acute pain. The Task Force will receive 
presentations from three Task Force subcommittees established at the 
inaugural Task Force meeting. The Task Force subcommittees will discuss 
recommendations for updates to best practices and recommendations for 
chronic and acute pain management and prescribing pain medication based 
on the components outlined in Section 101 of the CARA statute. The Task 
Force will deliberate and vote on the draft Task Force recommendations. 
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/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 September 
21, 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, September 11, 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 oral comments at the Task Force 
meeting on September 25, 2018, at 9:20 a.m.-9:50 a.m. ET. Please 
indicate your willingness to provide oral comments on the registration 
form which can be found at https://www.hhs.gov/ash/advisory-committees/pain/index.html. Individuals who pre-register will be given priority to 
provide oral public comment within the order they are received. The 
public comment period will not be extended beyond the allotted time on 
the agenda. 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. Please note that the public comment period may end 
before the time indicated, following the last call for comments. 
Individuals who are not able to provide oral comments are encouraged to 
submit their written comments. Written comments should not exceed one 
page in length. Individuals submitting written comments should submit 
their comments through the Federal eRulemaking Portal at http://www.regulations.gov, docket number HHS-OS-2018-0016.

    Dated: August 9, 2018.
Vanila M. Singh,
Chief Medical Officer, Chair, Pain Management Task Force, Office of the 
Assistant Secretary for Health.
[FR Doc. 2018-17446 Filed 8-13-18; 8:45 am]
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                                                                           Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices                                                 40303

                                                    Print Format in Direct-to-Consumer                  Dated: August 8, 2018.                              disease, respiratory protection may be
                                                    Prescription Drug Advertisements on               Leslie Kux,                                           the only countermeasure available to
                                                    Risk Knowledge and Preference.’’ Drug             Associate Commissioner for Policy.                    protect health care workers and the
                                                    Information Journal, vol. 36(3), pp. 693–
                                                                                                      [FR Doc. 2018–17360 Filed 8–13–18; 8:45 am]           general public.
                                                    705, 2002.
                                              7. Brief Summary and Adequate Directions                BILLING CODE 4164–01–P                                   Janssen Research & Development, LLC
                                                    for Use: Disclosing Risk Information in                                                                 will partner with JLABS, which exists to
                                                    Consumer-Directed Print Advertisements                                                                  foster innovation in health care
                                                    and Promotional Labeling for                      DEPARTMENT OF HEALTH AND                              products and executes QuickFire
                                                    Prescription Drugs. Revised Draft                 HUMAN SERVICES                                        Challenges for health care innovation.
                                                    Guidance. Available at https://                                                                         There is no direct equivalent of the
                                                    www.fda.gov/downloads/Drugs/                      The Biomedical Advanced Research                      QuickFire Challenge services for
                                                    GuidanceComplianceRegulatory                      and Development Authority (BARDA)
                                                    Information/Guidances/UCM069984.pdf.                                                                    innovation specific to health care as is
                                              8. ‘‘Content of Risk Information in the Major           AGENCY: Assistant Secretary for                       provided by JLABS. Its unique service
                                                    Statement in Prescription Drug Direct-to-         Preparedness and Response, HHS.                       will directly benefit BARDA’s mission
                                                    Consumer Broadcast Advertisements;                ACTION: Notice.
                                                                                                                                                            to make available medical
                                                    Establishment of a Public Docket;                                                                       countermeasures to address health
                                                    Request for Information and Comments.’’           SUMMARY:   The Biomedical Advanced                    security threats. Supporting innovation
                                                    August 21, 2017, 82 FR 39598.                     Research and Development Authority                    is an authority provided to BARDA
                                              9. Betts, Kevin R., et al., ‘‘Serious and
                                                                                                      (BARDA), Office of the Assistant                      under the Public Health Service Act and
                                                    Actionable Risks, Plus Disclosure:
                                                    Investigating an Alternative Approach             Secretary for Preparedness and                        partnering with a company providing a
                                                    for Presenting Risk Information in                Response (ASPR), in the Department of                 diverse array of products and leveraging
                                                    Prescription Drug Television                      Health and Human Services intends to                  its expertise and infrastructure has the
                                                    Advertisements.’’ Research in Social and          provide a Single Source Cooperative                   potential to provide solutions to the
                                                    Administrative Pharmacy, 2017.                    Agreement to Janssen Research &                       challenges in developing new
                                              10. Bhutada, N.S., B.L. Rollins, and M. Perri           Development, LLC. The Cooperative                     respiratory devices.
                                                    III, ‘‘Impact of Animated Spokes-                 Agreement will support QuickFire                         Reimagined, innovative respiratory
                                                    Characters in Print Direct-to-Consumer            Challenges to spur innovation in                      protection would contribute directly to
                                                    Prescription Drug Advertising: An
                                                    Elaboration Likelihood Model
                                                                                                      respiratory protection. The total                     ASPR’s mission to save lives and protect
                                                    Approach.’’ Health Communication, vol.            proposed cost of the Single Source                    Americans against 21st Century health
                                                    32, pp. 391–400, 2017.                            Cooperative Agreement is not to exceed                security threats. Respiratory protection
                                              11. Zaichkowsky, J.L., ‘‘The Personal                   $100,000 for a total of 12 months.                    is often the first line of defense, and a
                                                    Involvement inventory: Reduction,                 DATES:                                                radically improved approach to protect
                                                    Revision, and Application to                        Project Period: The period of                       both health care workers and the general
                                                    Advertising.’’ Journal of Advertising, vol.       performance is from July 30, 2018 to                  public, including children, would truly
                                                    23, pp. 59–70, 1994.                              June 30, 2019.                                        improve our ability to respond to public
                                              12. Mackert, M., S.E. Champlin, K.E. Pasch,               Award amount: Estimate $100,000.                    health emergencies. By generating
                                                    and B.D. Weiss, ‘‘Understanding Health
                                                    Literacy Measurement Through Eye                  FOR FURTHER INFORMATION CONTACT:                      interest and focusing innovation efforts
                                                    Tracking.’’ Journal of Health                     Sherrette.Funn@hhs.gov, 202–795–7714,                 on reimagining respiratory protection,
                                                    Communication, vol. 18, pp. 185–196,              Julie.Schafer@hhs.gov, 202–205–1435.                  BARDA’s goal for the QuickFire
                                                    2013.                                             SUPPLEMENTARY INFORMATION: The                        Challenge is for the resulting innovative
                                              13. Chiang, K.P. and A. Jackson, ‘‘The Impact           Biomedical Advanced Research and                      approaches to be eligible for continued
                                                    of Health Literacy on Involvement and             Development Authority (BARDA) is the                  testing and development and eventual
                                                    Attitude Toward Pharmaceutical Print              program office for this Cooperative                   regulatory approval, so that these
                                                    Ads.’’ International Journal of                                                                         revolutionary products can be widely
                                                    Healthcare Management, vol. 9(1), pp.
                                                                                                      Agreement:
                                                                                                        Single Source Justification: Janssen                available and used.
                                                    47–57, 2016.
                                              14. An, S. and N. Muturi, ‘‘Subjective Health           Research & Development, LLC creates                      Please submit an inquiry via the
                                                    Literacy and Older Adults’ Assessment             global challenges to spur innovation in               ASPR–BARDA Program Contact: Dr.
                                                    of Direct-to Consumer Prescription Drug           health care in partnership with JLABS,                Julie Schafer, Julie.Schafer@hhs.gov,
                                                    Ads.’’ Journal of Health Communication,           a global network of open innovation                   202–205–1435.
                                                    vol. 16(3), pp. 242–255, 2011.                    ecosystems designed to support
                                              15. Ball, J.G., D. Manika, and P. Stout,                                                                      Robert P. Kadlec,
                                                                                                      innovators and entrepreneurs in
                                                    ‘‘Consumers Young and Old: Segmenting             creating and accelerating innovative                  Assistant Secretary for Preparedness and
                                                    the Target Markets for Direct-to-                                                                       Response.
                                                                                                      health care solutions.
                                                    Consumer Prescription Drug                                                                              [FR Doc. 2018–17381 Filed 8–13–18; 8:45 am]
                                                                                                        Janssen Research & Development, LLC
                                                    Advertising.’’ Health Marketing
                                                    Quarterly, vol. 28(4), pp. 337–353, 2011.         and BARDA will collaborate on a global                BILLING CODE 4150–28–P

                                              16. Christensen, T.P., F.J. Ascione, and R.P.           challenge for reimagined, transformative
                                                    Bagozzi, ‘‘Understanding How Elderly              respiratory protection. Traditional
                                                    Patients Process Drug Information: A              respiratory protective devices used to                DEPARTMENT OF HEALTH AND
                                                    Test of a Theory of Information                   protect against inhalation of harmful                 HUMAN SERVICES
                                                    Processing.’’ Pharmaceutical Research,            infectious agents were designed for use
                                                    vol. 14, pp. 1589–1596, 1997.                                                                           Meeting of the Pain Management Best
                                                                                                      in occupational settings, to guard
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                                              17. Mehta, A. and S.C. Purvis, ‘‘Consumer                                                                     Practices Inter-Agency Task Force
                                                                                                      against inhalation of dangerous
                                                    Response to Print Prescription Drug
                                                                                                      particulates. Disposable versions, such               AGENCY:  Office of the Assistant
                                                    Advertising.’’ Journal of Advertising
                                                    Research, vol. 43(2), pp. 194–206, 2003.          as N95 respirators, are only available for            Secretary for Health, Office of the
                                              18. Paulhus, D.L. and S. Vazire, ‘‘The Self-            adults, must be fit-tested to ensure                  Secretary, Department of Health and
                                                    Report Method.’’ Handbook of Research             proper functioning, and can be                        Human Services.
                                                    Methods in Personality Psychology, vol.           uncomfortable to wear. In an outbreak of
                                                                                                                                                            ACTION: Notice.
                                                    1, pp. 224–239, 2007.                             a novel or newly emerging respiratory


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                                              40304                        Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices

                                              SUMMARY:   As stipulated by the Federal                 to relevant federal agencies and the                  Individuals who pre-register will be
                                              Advisory Committee Act, the                             general public.                                       given priority to provide oral public
                                              Department of Health and Human                             The Task Force will convene its                    comment within the order they are
                                              Services (HHS) is hereby giving notice                  second public meeting, on September 25                received. The public comment period
                                              that a meeting is scheduled to be held                  and 26, 2018, to discuss updates to                   will not be extended beyond the allotted
                                              for the Pain Management Best Practices                  existing best practices and                           time on the agenda. Public comments
                                              Inter-Agency Task Force (Task Force).                   recommendations based on gaps and                     made during the meeting will be limited
                                              The meeting will be open to the public;                 inconsistencies for pain management,                  to three minutes per person to ensure
                                              public comment sessions will be held                    including chronic and acute pain. The                 time is allotted for all those wishing to
                                              during the meeting.                                     Task Force will receive presentations                 speak. Please note that the public
                                              DATES: The Task Force meeting will be
                                                                                                      from three Task Force subcommittees                   comment period may end before the
                                              held on Tuesday, September 25, 2018,                    established at the inaugural Task Force               time indicated, following the last call
                                              from 8:30 a.m. to 4:30 p.m. Eastern Time                meeting. The Task Force subcommittees                 for comments. Individuals who are not
                                              (ET) and Wednesday, September 26,                       will discuss recommendations for                      able to provide oral comments are
                                                                                                      updates to best practices and                         encouraged to submit their written
                                              2018, from 9:00 a.m. to 12:00 p.m. ET.
                                                                                                      recommendations for chronic and acute                 comments. Written comments should
                                              The agenda will be posted on the Task
                                                                                                      pain management and prescribing pain                  not exceed one page in length.
                                              Force website at https://www.hhs.gov/
                                                                                                      medication based on the components                    Individuals submitting written
                                              ash/advisory-committees/pain/
                                                                                                      outlined in Section 101 of the CARA                   comments should submit their
                                              index.html.
                                                                                                      statute. The Task Force will deliberate               comments through the Federal
                                              ADDRESSES:   U.S. Department of Health                  and vote on the draft Task Force                      eRulemaking Portal at http://
                                              and Human Services, Hubert H.                           recommendations. Information about                    www.regulations.gov, docket number
                                              Humphrey Building, Great Hall, 200                      the final meeting agenda will be posted               HHS–OS–2018–0016.
                                              Independence Avenue SW, Washington,                     prior to the meeting on the Task Force
                                              DC 20201.                                               website: https://www.hhs.gov/ash/                       Dated: August 9, 2018.
                                                                                                      advisorycommittees/pain/index.html.                   Vanila M. Singh,
                                              FOR FURTHER INFORMATION CONTACT:
                                                                                                         Members of the public are invited to               Chief Medical Officer, Chair, Pain
                                              Alicia Richmond Scott, Designated
                                                                                                      participate in person or by webcast. To               Management Task Force, Office of the
                                              Federal Officer, Pain Management Best                                                                         Assistant Secretary for Health.
                                              Practices Inter-Agency Task Force, U.S.                 join the meeting, individuals must pre-
                                                                                                      register at the Task Force website at                 [FR Doc. 2018–17446 Filed 8–13–18; 8:45 am]
                                              Department of Health and Human
                                              Services, Office of the Assistant                       https://www.hhs.gov/ash/advisory-                     BILLING CODE 4150–28–P

                                              Secretary for Health, 200 Independence                  committees/pain/index.html. Seating
                                              Avenue SW, Room 736E, Washington,                       will be provided first to those who have
                                              DC 20201. Phone: 240–453–2816. Email:                   pre-registered. Anyone who has not pre-               DEPARTMENT OF HOMELAND
                                              paintaskforce@hhs.gov.                                  registered will be accommodated on a                  SECURITY
                                                                                                      first come, first served basis if
                                              SUPPLEMENTARY INFORMATION: Section                      additional seats are available 10 minutes             Coast Guard
                                              101 of the Comprehensive Addiction                      before the meeting starts. Individuals
                                              and Recovery Act of 2016 (CARA)                                                                               [Docket No. USCG–2018–0280]
                                                                                                      who need special assistance, such as
                                              requires the Secretary of Health and                    sign language interpretation or other                 Collection of Information Under
                                              Human Services, in cooperation with                     reasonable accommodations, should                     Review by Office of Management and
                                              the Secretaries of Defense and Veterans                 indicate the special accommodation                    Budget; OMB Control Number: 1625–
                                              Affairs, to convene the Task Force no                   when registering online or by notifying               0045
                                              later than two years after the date of the              the Office of the Assistant Secretary for
                                              enactment of CARA and develop a                         Health via email at paintaskforce@                    AGENCY:Coast Guard, DHS.
                                              report to Congress with updates on best                 hhs.gov by September 21, 2018. The                          Thirty-day notice requesting
                                                                                                                                                            ACTION:
                                              practices and recommendations on                        subject line of the email should read,                comments.
                                              addressing gaps or inconsistencies for                  ‘‘Task Force Meeting
                                              pain management, including chronic                      Accommodations.’’ Non-U.S. citizens                   SUMMARY:   In compliance with the
                                              and acute pain. The Task Force is                       who plan to attend in person are                      Paperwork Reduction Act of 1995 the
                                              governed by the provisions of the                       required to provide additional                        U.S. Coast Guard is forwarding an
                                              Federal Advisory Committee Act                          information and must notify the Task                  Information Collection Request (ICR),
                                              (FACA), Public Law 92–463, as                           Force staff via email at paintaskforce@               abstracted below, to the Office of
                                              amended (5 U.S.C. App), which sets                      hhs.gov 10 business days before the                   Management and Budget (OMB), Office
                                              forth standards for the formation and                   meeting, September 11, 2018. For those                of Information and Regulatory Affairs
                                              use of advisory committees.                             unable to attend in person, a live                    (OIRA), requesting an extension of its
                                                 The Task Force will review clinical                  webcast will be available. More                       approval for the following collection of
                                              guidelines and identify gaps and/or                     information on registration and                       information: 1625–0045, Adequacy
                                              inconsistencies for best practices for                  accessing the webcast can be found at                 Certification for Reception Facilities and
                                              pain management, including chronic                      https://www.hhs.gov/ash/advisory-                     Advance Notice—33 CFR part 158,
                                              and acute pain, developed or adopted                    committees/pain/index.html.                           without change. Our ICR describes the
                                              by federal agencies; propose updates to                    Members of the public can provide                  information we seek to collect from the
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                                              best practices and recommendations for                  oral comments at the Task Force                       public. Review and comments by OIRA
                                              identified gaps or inconsistencies;                     meeting on September 25, 2018, at 9:20                ensure we only impose paperwork
                                              provide a 90 day the public comment                     a.m.–9:50 a.m. ET. Please indicate your               burdens commensurate with our
                                              period on any proposed updates and                      willingness to provide oral comments                  performance of duties.
                                              recommendations; and develop a                          on the registration form which can be                 DATES: Comments must reach the Coast
                                              strategy for disseminating such                         found at https://www.hhs.gov/ash/                     Guard and OIRA on or before September
                                              proposed updates and recommendations                    advisory-committees/pain/index.html.                  13, 2018.


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Document Created: 2018-08-14 02:19:57
Document Modified: 2018-08-14 02:19:57
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 Task Force meeting will be held on Tuesday, September 25, 2018, from 8:30 a.m. to 4:30 p.m. Eastern Time (ET) and Wednesday, September 26, 2018, from 9:00 a.m. to 12:00 p.m. ET. 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. Phone: 240-453-2816. Email: [email protected]
FR Citation83 FR 40303 

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