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)
Food and Drug Administration
Federal Register Volume 83, Issue 94 (May 15, 2018)
| Page Range | 22491-22493 | |
| FR Document | 2018-10284 |
[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] ----------------------------------------------------------------------- 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.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
![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22491
Unaccompanied Alien Children, members of their household, and adult Complying with the normal clearance
renamed to Sponsorship Review care givers identified in a sponsor care procedures would delay or disrupt
Procedures for Approval of plan, where applicable. ORR in turn ORR’s ability to expand the background
Unaccompanied Alien Children. The shares the information collected with checks in order to more
information collection will allow ACF other federal departments to conduct comprehensively evaluate the suitability
to conduct suitability assessments to vet background checks. ORR intends the of potential sponsors of unaccompanied
potential sponsors of unaccompanied instruments used in this submission to alien children, and to ensure safe and
alien children in accordance with a be available for use by mid-May 2018. appropriate placement of children. The
Memorandum of Agreement (MOA) ACF cannot reasonably comply with information collection is essential to the
between ORR and the Department of the normal clearance procedures mission of the agency.
Homeland Security. Specifically, the because the use of normal clearance Respondents: Sponsors, adult
information collection allows ORR to procedures is reasonably likely to household members, parents or legal
obtain biometric and biographical prevent the collection of needed guardians of unaccompanied alien
information from sponsors, adult information in a timely manner. children.
Number of Average
Number of Total
Instrument responses per burden hours
respondents burden hours
respondent per response
Family reunification application ....................................................................... 50,000 1 0.5 25,000
Authorization for Release of Information ......................................................... 90,000 1 0.25 22,500
Fingerprint Instructions .................................................................................... 90,000 1 1 90,000
Letter of Designation ....................................................................................... 25,000 1 0.25 6,250
Estimated Total Annual Burden per collection of information on experience chronic pain that is managed
Respondent: 143,750. respondents, including through the use with analgesic medications such as
Additional Information: of automated collection techniques or opioids, acetaminophen, nonsteroidal
ACF is requesting that OMB grant other forms of information technology. anti-inflammatory drugs (NSAIDs),
approval for this information collection Consideration will be given to antidepressants; other medications; and
under procedures for emergency comments and suggestions submitted non-pharmacologic interventions or
processing through October 31, 2018, within 60 days of this publication. therapies.
the expiration date for the already Dated: May 11, 2018. DATES: The public meeting will be held
approved information collection. ACF Naomi Goldstein, on July 9, 2018, from 10 a.m. to 4 p.m.
requests approval of the expanded Submit either electronic or written
Deputy Assistant Secretary for Planning,
information collection by May 11, 2018. Research, and Evaluation. comments on this public workshop by
Although ACF is seeking immediate September 10, 2018. See the
[FR Doc. 2018–10452 Filed 5–11–18; 4:15 pm]
approval of the specific aspects of the SUPPLEMENTARY INFORMATION section for
BILLING CODE 4184–01–P
information collection described above, registration date and information.
ACF is also soliciting public comment ADDRESSES: The public meeting will be
on these aspects of the information held at FDA’s White Oak Campus,
DEPARTMENT OF HEALTH AND
collection and on the information 10903 New Hampshire Ave., Bldg. 31
HUMAN SERVICES
collection more generally. Conference Center, the Great Room (Rm.
Copies of the proposed collection of Food and Drug Administration 1503), Silver Spring, MD 20993.
information for emergency processing Entrance for the public meeting
and public comment can be obtained at [Docket No. FDA–2018–N–1621]
participants (non-FDA employees) is
reginfo.gov by searching for OMB through Building 1 where routine
Patient-Focused Drug Development on
Control No. 0970–0278. Comments may security check procedures will be
Chronic Pain; Public Meeting; Request
be forwarded by writing to the performed. For parking and security
for Comments
Administration for Children and information, please refer to https://
Families, Office of Planning, Research AGENCY: Food and Drug Administration, www.fda.gov/AboutFDA/
and Evaluation, 330 C Street SW, HHS. WorkingatFDA/BuildingsandFacilities/
Washington DC 20201. Attn: ACF ACTION: Notice of public meeting; WhiteOakCampusInformation/
Reports Clearance Officer. Email request for comments. ucm241740.htm.
address: infocollection@acf.hhs.gov. All You may submit comments as
requests should be identified by the title SUMMARY: The Food and Drug follows. Please note that late, untimely
of the information collection. Administration (FDA, the Agency, or filed comments will not be considered.
The Department specifically requests we) is announcing a public meeting and Electronic comments must be submitted
comments on: (a) Whether the proposed an opportunity for public comment on on or before September 10, 2018. The
collection of information is necessary ‘‘Patient-Focused Drug Development for https://www.regulations.gov electronic
for the proper performance of the Chronic Pain.’’ The public meeting will filing system will accept comments
functions of the agency, including provide patients (including adult and until midnight Eastern Time at the end
daltland on DSKBBV9HB2PROD with NOTICES
whether the information shall have pediatric patients) with an opportunity of September 10, 2018. Comments
practical utility; (b) the accuracy of the to present to FDA their perspectives on received by mail/hand delivery/courier
agency’s estimate of the burden of the the impacts of chronic pain, views on (for written/paper submissions) will be
proposed collection of information; (c) treatment approaches for chronic pain, considered timely if they are
the quality, utility, and clarity of the and challenges or barriers to accessing postmarked or the delivery service
information to be collected; and (d) treatments. FDA is particularly acceptance receipt is on or before that
ways to minimize the burden of the interested in hearing from patients who date.
VerDate Sep<11>2014 20:27 May 14, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\15MYN1.SGM 15MYN1](https://thefederalregister.org/doc/83_FR_22585/page/1.svg)
![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22493
through the night, daily hygiene, accommodations because of a disability, DEPARTMENT OF HEALTH AND
participation in sports or social please contact Meghana Chalasani (see HUMAN SERVICES
activities, intimacy with a spouse or FOR FURTHER INFORMATION CONTACT) no
partner, etc.) later than July 2, 2018. Food and Drug Administration
4. How has your chronic pain Panelist Selection: Patients or patient [Docket No. FDA–2015–N–1837]
changed over time? (Considerations
representatives who are interested in
include severity and frequency of your Agency Information Collection
presenting comments as part of the
chronic pain and the effects of chronic Activities; Proposed Collection;
initial panel discussions will be asked
pain on your daily activities.) Comment Request; Electronic User
to indicate in their registration which
Topic 2: Patients’ Perspectives on topic(s) they wish to address. These Fee Payment Request Forms
Current Approaches to Treatment of patients or patient representatives also AGENCY: Food and Drug Administration,
Chronic Pain will be asked to send PatientFocused@ HHS.
1. What are you currently doing to fda.hhs.gov a brief summary of ACTION: Notice.
help treat your chronic pain? (Examples responses to the topic questions by June
25, 2018. Panelists will be notified of SUMMARY: The Food and Drug
may include prescription medicines,
their selection approximately 7 days Administration (FDA or Agency) is
over-the-counter products, and non-
before the public meeting. We will try announcing an opportunity for public
drug therapies.)
a. How has your treatment regimen to accommodate all patients and patient comment on the proposed collection of
changed over time, and why? (Examples stakeholders who wish to speak, either certain information by the Agency.
may include change in your condition, through the panel discussion or Under the Paperwork Reduction Act of
audience participation; however, the 1995 (PRA), Federal Agencies are
change in dose, or treatment side
duration of comments may be limited by required to publish notice in the
effects.)
b. What factors do you take into time constraints. Federal Register concerning each
account when making decisions about proposed collection of information,
Open Public Comment: There will be including each proposed extension of an
selecting a course of treatment? time allotted during the meeting for
2. How well does your current existing collection of information, and
open public comment. Signup for this to allow 60 days for public comment in
treatment regimen manage your chronic session will be on a first-come, first-
pain? (Considerations include severity response to the notice. This notice
serve basis on the day of the workshop. solicits comments on electronic user fee
and frequency of your chronic pain and Individuals and organizations with
the effects of chronic pain on your daily payment request forms.
common interests are urged to DATES: Submit either electronic or
activities.) consolidate or coordinate and request
3. What are the most significant written comments on the collection of
time for a joint presentation. No information by July 16, 2018.
downsides to your current treatments, commercial or promotional material
and how do they affect your daily life? ADDRESSES: You may submit comments
will be permitted to be presented or
4. What challenges or barriers to as follows. Please note that late,
distributed at the public workshop.
accessing or using medical treatments untimely filed comments will not be
for chronic pain have you or do you Streaming Webcast of the Public considered. Electronic comments must
encounter? Meeting: This public meeting will also be submitted on or before July 16, 2018.
5. What specific things would you be webcast. Please register for the The https://www.regulations.gov
look for in an ideal treatment for your webcast by visiting https://chronicpain- electronic filing system will accept
chronic pain? pfdd.eventbrite.com. comments until midnight Eastern Time
III. Participating in the Public Meeting If you have never attended a Connect at the end of July 16, 2018. Comments
Pro event before, test your connection at received by mail/hand delivery/courier
Registration: To register for the public https://collaboration.fda.gov/common/ (for written/paper submissions) will be
meeting, visit https://chronicpain- help/en/support/meeting_test.htm. To considered timely if they are
pfdd.eventbrite.com. Please register by postmarked or the delivery service
get a quick overview of the Connect Pro
July 2, 2018. Persons without access to acceptance receipt is on or before that
program, visit https://www.adobe.com/
the internet can call 240–402–6525 to date.
go/connectpro_overview. FDA has
register. If you are unable to attend the
verified the website addresses in this Electronic Submissions
meeting in person, you can register to
document, as of the date this document
view a live webcast of the meeting. You Submit electronic comments in the
publishes in the Federal Register, but
will be asked to indicate in your following way:
websites are subject to change over time. • Federal eRulemaking Portal:
registration if you plan to attend in
person or via the webcast. Transcripts: Please be advised that as https://www.regulations.gov. Follow the
Registration is free and based on soon as a transcript of the public instructions for submitting comments.
space availability, with priority given to meeting is available, it will be accessible Comments submitted electronically,
early registrants. Persons interested in at https://www.regulations.gov. It may including attachments, to https://
attending this public meeting must be viewed at the Dockets Management www.regulations.gov will be posted to
register by July 2, 2018. Early Staff (see ADDRESSES). A link to the the docket unchanged. Because your
registration is recommended because transcript will also be available on the comment will be made public, you are
seating is limited; therefore, FDA may internet at https://www.fda.gov/Drugs/ solely responsible for ensuring that your
daltland on DSKBBV9HB2PROD with NOTICES
limit the number of participants from NewsEvents/ucm603093.htm. comment does not include any
each organization. Registrants will Dated: May 10, 2018. confidential information that you or a
receive confirmation once they have third party may not wish to be posted,
Leslie Kux,
been accepted. If time and space permit, such as medical information, your or
onsite registration on the day of the Associate Commissioner for Policy. anyone else’s Social Security number, or
public meeting will be provided [FR Doc. 2018–10284 Filed 5–14–18; 8:45 am] confidential business information, such
beginning at 9 a.m. If you need special BILLING CODE 4164–01–P as a manufacturing process. Please note
VerDate Sep<11>2014 20:27 May 14, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\15MYN1.SGM 15MYN1](https://thefederalregister.org/doc/83_FR_22585/page/3.svg)
Document Created: 2018-05-15 00:34:30
Document Modified: 2018-05-15 00:34:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 22491 |
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