Patient-Focused Drug Development on Chronic Pain; Public Meeting; Request for Comments, 22491-22493 [2018-10284]

Download as PDF 22491 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices Unaccompanied Alien Children, renamed to Sponsorship Review Procedures for Approval of Unaccompanied Alien Children. The information collection will allow ACF to conduct suitability assessments to vet potential sponsors of unaccompanied alien children in accordance with a Memorandum of Agreement (MOA) between ORR and the Department of Homeland Security. Specifically, the information collection allows ORR to obtain biometric and biographical information from sponsors, adult members of their household, and adult care givers identified in a sponsor care plan, where applicable. ORR in turn shares the information collected with other federal departments to conduct background checks. ORR intends the instruments used in this submission to be available for use by mid-May 2018. ACF cannot reasonably comply with the normal clearance procedures because the use of normal clearance procedures is reasonably likely to prevent the collection of needed information in a timely manner. Number of respondents Instrument daltland on DSKBBV9HB2PROD with NOTICES Family reunification application ....................................................................... Authorization for Release of Information ......................................................... Fingerprint Instructions .................................................................................... Letter of Designation ....................................................................................... Estimated Total Annual Burden per Respondent: 143,750. Additional Information: ACF is requesting that OMB grant approval for this information collection under procedures for emergency processing through October 31, 2018, the expiration date for the already approved information collection. ACF requests approval of the expanded information collection by May 11, 2018. Although ACF is seeking immediate approval of the specific aspects of the information collection described above, ACF is also soliciting public comment on these aspects of the information collection and on the information collection more generally. Copies of the proposed collection of information for emergency processing and public comment can be obtained at reginfo.gov by searching for OMB Control No. 0970–0278. Comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the VerDate Sep<11>2014 20:27 May 14, 2018 Jkt 244001 Dated: May 11, 2018. Naomi Goldstein, Deputy Assistant Secretary for Planning, Research, and Evaluation. [FR Doc. 2018–10452 Filed 5–11–18; 4:15 pm] BILLING CODE 4184–01–P 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 Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: 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 SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Number of responses per respondent 50,000 90,000 90,000 25,000 collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. AGENCY: Complying with the normal clearance procedures would delay or disrupt ORR’s ability to expand the background checks in order to more comprehensively evaluate the suitability of potential sponsors of unaccompanied alien children, and to ensure safe and appropriate placement of children. The information collection is essential to the mission of the agency. Respondents: Sponsors, adult household members, parents or legal guardians of unaccompanied alien children. 1 1 1 1 Average burden hours per response 0.5 0.25 1 0.25 Total burden hours 25,000 22,500 90,000 6,250 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. E:\FR\FM\15MYN1.SGM 15MYN1 22492 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 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’’). daltland on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 20:27 May 14, 2018 Jkt 244001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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, Meghana.Chalasani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: pain, including prescription and nonprescription 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 I. Background Topic 1: Symptoms and Daily Impacts of Chronic Pain That Matter Most to Patients 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 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\15MYN1.SGM 15MYN1 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 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.) daltland on DSKBBV9HB2PROD with NOTICES 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 nondrug 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://chronicpainpfdd.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 VerDate Sep<11>2014 20:27 May 14, 2018 Jkt 244001 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 PatientFocused@ fda.hhs.gov 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, firstserve 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://chronicpainpfdd.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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 22493 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1837] Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on electronic user fee payment request forms. DATES: Submit either electronic or written comments on the collection of information by July 16, 2018. ADDRESSES: 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 July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 16, 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. SUMMARY: 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 E:\FR\FM\15MYN1.SGM 15MYN1

Agencies

[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22491-22493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10284]


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

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.

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

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.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: 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