83 FR 22491 - Patient-Focused Drug Development on Chronic Pain; Public Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 94 (May 15, 2018)

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on ``Patient-Focused Drug Development for Chronic Pain.'' The public meeting will provide patients (including adult and pediatric patients) with an opportunity to present to FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.

[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22491-22493]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1621]


Patient-Focused Drug Development on Chronic Pain; Public Meeting; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a public meeting and an opportunity for public comment on 
``Patient-Focused Drug Development for Chronic Pain.'' The public 
meeting will provide patients (including adult and pediatric patients) 
with an opportunity to present to FDA their perspectives on the impacts 
of chronic pain, views on treatment approaches for chronic pain, and 
challenges or barriers to accessing treatments. FDA is particularly 
interested in hearing from patients who experience chronic pain that is 
managed with analgesic medications such as opioids, acetaminophen, 
nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other 
medications; and non-pharmacologic interventions or therapies.

DATES: The public meeting will be held on July 9, 2018, from 10 a.m. to 
4 p.m. Submit either electronic or written comments on this public 
workshop by September 10, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before September 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 10, 2018. 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.

[[Page 22492]]

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-2018-N-1621 for ``Patient-Focused Drug Development on Chronic Pain; 
Public Meeting; Request for Comments.'' Received comments, those filed 
in a timely manner (see ADDRESSES), 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.'' 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. If you do not wish 
your name and contact information to 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 this 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, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/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: Meghana Chalasani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    This meeting will provide FDA the opportunity to better understand 
patients' perspectives on the impacts of chronic pain, patient views on 
treatment approaches for chronic pain, and challenges or barriers to 
accessing treatments. Chronic pain is defined as either pain that 
persists for more than 3 months or pain that lasts more than 1 month 
beyond the normal healing time. Chronic pain is diverse and can include 
primary pain, cancer pain, postsurgical and posttraumatic pain, 
neuropathic pain, headache and orofacial pain, visceral pain, and 
musculoskeletal pain. There are a number of therapeutic approaches for 
the treatment of chronic pain, including prescription and non-
prescription medications, invasive and non-invasive medical devices, 
and behavioral and physical therapies. FDA is particularly interested 
in patients' (including adult and pediatric patients) perspectives on 
types of chronic pain that are managed with analgesic medications such 
as opioids, acetaminophen, NSAIDs, antidepressants; other medications; 
and non-pharmacologic interventions or therapies.
    At the meeting, patients and patient representatives will provide 
patient perspectives on the symptoms and daily impacts of chronic pain 
and on treatment approaches for chronic pain. The questions that will 
be asked of patients and patient representatives at the meeting are 
listed in the following section and organized by topic. For each topic, 
a brief initial patient panel discussion will begin the dialogue. This 
will be followed by a facilitated discussion inviting comments from 
other patient and patient representative participants. In addition to 
input generated through this public meeting, FDA is interested in 
receiving patient and patient representative input addressing these 
questions through written comments, which can be submitted to the 
public docket (see ADDRESSES). When submitting comments, if you are 
commenting on behalf of a patient, please indicate that you are doing 
so and answer the following questions as much as possible from the 
patient's perspective.
    FDA will post the agenda and other meeting materials approximately 
5 days before the meeting at: https://www.fda.gov/Drugs/NewsEvents/ucm603093.htm.

II. Topics for Discussion at the Public Meeting

Topic 1: Symptoms and Daily Impacts of Chronic Pain That Matter Most to 
Patients

    1. How would you describe your chronic pain? (Characteristics could 
include location, radiation, intensity, duration, constancy or 
intermittency, triggers etc.)
    2. What are the most significant symptoms that you experience 
resulting from your condition? (Examples may include restricted range 
of motion, muscle spasms, changes in sensation, etc.)
    3. Are there specific activities that are important to you but that 
you cannot do at all or as fully as you would like because of your 
chronic pain? (Examples of activities may include work or school 
activities, sleeping

[[Page 22493]]

through the night, daily hygiene, participation in sports or social 
activities, intimacy with a spouse or partner, etc.)
    4. How has your chronic pain changed over time? (Considerations 
include severity and frequency of your chronic pain and the effects of 
chronic pain on your daily activities.)

Topic 2: Patients' Perspectives on Current Approaches to Treatment of 
Chronic Pain

    1. What are you currently doing to help treat your chronic pain? 
(Examples may include prescription medicines, over-the-counter 
products, and non-drug therapies.)
    a. How has your treatment regimen changed over time, and why? 
(Examples may include change in your condition, change in dose, or 
treatment side effects.)
    b. What factors do you take into account when making decisions 
about selecting a course of treatment?
    2. How well does your current treatment regimen manage your chronic 
pain? (Considerations include severity and frequency of your chronic 
pain and the effects of chronic pain on your daily activities.)
    3. What are the most significant downsides to your current 
treatments, and how do they affect your daily life?
    4. What challenges or barriers to accessing or using medical 
treatments for chronic pain have you or do you encounter?
    5. What specific things would you look for in an ideal treatment 
for your chronic pain?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, visit https://chronicpain-pfdd.eventbrite.com. Please register by July 2, 2018. 
Persons without access to the internet can call 240-402-6525 to 
register. If you are unable to attend the meeting in person, you can 
register to view a live webcast of the meeting. You will be asked to 
indicate in your registration if you plan to attend in person or via 
the webcast.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by July 2, 2018. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Registrants will receive 
confirmation once they have been accepted. If time and space permit, 
onsite registration on the day of the public meeting will be provided 
beginning at 9 a.m. If you need special accommodations because of a 
disability, please contact Meghana Chalasani (see FOR FURTHER 
INFORMATION CONTACT) no later than July 2, 2018.
    Panelist Selection: Patients or patient representatives who are 
interested in presenting comments as part of the initial panel 
discussions will be asked to indicate in their registration which 
topic(s) they wish to address. These patients or patient 
representatives also will be asked to send [email protected] a 
brief summary of responses to the topic questions by June 25, 2018. 
Panelists will be notified of their selection approximately 7 days 
before the public meeting. We will try to accommodate all patients and 
patient stakeholders who wish to speak, either through the panel 
discussion or audience participation; however, the duration of comments 
may be limited by time constraints.
    Open Public Comment: There will be time allotted during the meeting 
for open public comment. Signup for this session will be on a first-
come, first-serve basis on the day of the workshop. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate and request time for a joint presentation. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public workshop.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please register for the webcast by visiting https://chronicpain-pfdd.eventbrite.com.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/Drugs/NewsEvents/ucm603093.htm.

    Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10284 Filed 5-14-18; 8:45 am]
 BILLING CODE 4164-01-P