[Federal Register Volume 84, Number 82 (Monday, April 29, 2019)]
[Notices]
[Pages 18053-18054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08610]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1646]


Joint Meeting of the Drug Safety and Risk Management Advisory 
Committee and the Anesthetic and Analgesic Drug Products Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Drug Safety and Risk 
Management Advisory Committee and the Anesthetic and Analgesic Drug 
Products Advisory Committee. The general function of the committees is 
to provide advice and recommendations to FDA on regulatory issues. The 
meeting will be open to the public. FDA is establishing a docket for 
public comment on this document.

DATES: The meeting will be held on June 11, 2019, from 8 a.m. to 5 p.m. 
and June 12, 2019, from 8 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2019-N-1646 . The docket will close on June 
30, 2019. Submit either electronic or written comments on this public 
meeting by June 30, 2019. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before June 30, 2019. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. Eastern Time at the 
end of June 30, 2019. Comments received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.
    Comments received on or before May 28, 2019, will be provided to 
the committees. Comments received after that date will be taken into 
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-1646 for ``Joint Meeting of the Drug Safety and Risk 
Management Advisory Committee and the Anesthetic and Analgesic Drug 
Products Advisory Committee; Notice of Meeting; Establishment of a 
Public Docket; Request for Comments.'' Received comments, those filed 
in a timely manner (see the ADDRESSES section) will be placed in the 
docket and, except for those submitted as ``Confidential 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.'' FDA 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. If you do not wish your name 
and contact information be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify the information as ``confidential.'' Any 
information marked as ``confidential'' will not be disclosed except in 
accordance with 21 CFR 10.20 and other applicable disclosure law. For 
more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September18, 2015, or access the information at https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area). A notice in the Federal Register about last 
minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the

[[Page 18054]]

FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and 
scroll down to the appropriate advisory committee meeting link, or call 
the advisory committee information line to learn about possible 
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: FDA is seeking public input on the clinical utility and 
safety concerns associated with the higher range of opioid analgesic 
dosing (both in terms of higher strength products and higher daily 
doses) in the outpatient setting. FDA is interested in better 
understanding current clinical use and situations that may warrant use 
of higher doses of opioid analgesics. We are also interested in 
discussing the magnitude and frequency of harms associated with higher 
doses of opioid analgesics relative to lower doses, as well as optimal 
strategies for managing these risks while ensuring access to 
appropriate pain management for patients.
    FDA frequently hears from patients and healthcare providers that 
higher-dose opioid analgesics continue to be a unique and necessary 
part of effective pain management for some patients. FDA is also 
cognizant of serious safety concerns associated with both higher 
strengths and higher daily doses of opioid analgesics, both in patients 
and in others who may access these drugs. Higher strength products may 
be more harmful in cases of accidental exposure and overdose and may 
also be more sought out for misuse and abuse. Along with a number of 
other factors, a higher daily opioid dose is associated with greater 
risk of overdose. Concerns have also been raised that higher dose 
opioid regimens may carry a higher risk of addiction, although robust 
evidence for a causal relationship is lacking. There is a strong 
association between higher opioid dose and duration/persistence of 
opioid analgesic therapy and assessing temporal relationships and 
independent effects of opioid dose and duration on the risks of both 
addiction and overdose is challenging. In addition, FDA acknowledges 
the complex and evolving landscape of the opioid epidemic, with myriad 
Federal, State, local, and payer efforts to encourage more judicious 
prescribing of opioid analgesics, and the growing threat of highly 
lethal illicit opioids.
    To better understand both the clinical utility and harms of higher 
dose opioid analgesics in the current environment, and to discuss the 
advantages and disadvantages of various potential risk-management 
strategies, FDA brings these issues to an advisory committee to seek 
input and advice from the clinical, patient, public health, and 
research communities.
    In particular, FDA seeks to discuss: (1) The current clinical use 
and situations that may warrant pain management with opioid analgesics 
at higher product strengths and daily doses, factors influencing 
prescribing practices, and specific patient populations for whom there 
may be utility in prescribing these medications at higher doses; (2) 
the magnitude and frequency of harms associated with opioid analgesics 
at higher product strengths and daily doses, relative to lower 
strengths and daily doses, including the role of opioid dose in adverse 
health outcomes in both patients and in others who may access the drugs 
(e.g., risk for developing addiction, fatal overdose), the relevance of 
therapy duration and physical opioid dependence, and risks in different 
subpopulations (e.g., patients with chronic non-cancer pain, young 
children, adolescents); and (3) possible FDA interventions and their 
expected impact on patients and public health more broadly, including, 
for example, potential effects on prescribing and pain management 
practices, patient experience and behaviors, and adverse outcomes such 
as addiction and overdose.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committees. 
Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 12:30 p.m. on June 12, 2019. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before May 
17, 2019. Time allotted for each presentation may be limited. If the 
number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by May 20, 2019.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Moon Hee V. Choi (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08610 Filed 4-26-19; 8:45 am]
 BILLING CODE 4164-01-P