Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments, 75177-75179 [2012-30516]
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Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
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2012, Drug Safety and Risk Management
Advisory Committee meeting are
currently available at https://
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CommitteesMeetingMaterials/Drugs/
DrugSafety
andRiskManagementAdvisory
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intends to make background material
available to the public no later than 2
business days before the January 24 and
25, 2013, Drug Safety and Risk
Management Advisory Committee
meeting at: https://www.fda.gov/
VerDate Mar<15>2010
16:35 Dec 18, 2012
Jkt 229001
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Safety and Risk Management Advisory
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individuals who requested time to speak
at the originally scheduled October 29–
30, 2012, Drug Safety and Risk
Management Advisory Committee
meeting, will need to follow the above
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the January 24–25, 2013, Drug Safety
and Risk Management Advisory
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scheduled meeting do not convey to this
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and Risk Management Advisory
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each presentation may be limited. If the
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speak is greater than can be reasonably
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hearing session. The contact person will
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public at its advisory committee
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75177
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Kristina
Toliver at least 7 days in advance of the
meeting.
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AdvisoryCommittees/About
AdvisoryCommittees/ucm111462.htm
for procedures on public conduct during
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30517 Filed 12–18–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1172]
Impact of Approved Drug Labeling on
Chronic Opioid Therapy; Public
Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public hearing to obtain information,
particularly scientific evidence, such as
study data or peer-reviewed analyses,
on issues pertaining to the use of opioid
drugs in the treatment of chronic pain.
DATES: The public hearing will be held
on February 7 and 8, 2013, from 9 a.m.
to 4 p.m. Submit electronic or written
requests to make oral presentations and
comments by January 18, 2013.
Electronic or written comments will be
accepted after the hearing until April 8,
2013.
ADDRESSES: The public hearing will be
held at the Bethesda Marriott, 5151
Pooks Hill Rd., Bethesda, MD 20814,
301–897–9400, Fax 1–301–897–0192.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with
the docket number found in brackets in
the heading of this document.
Transcripts of the hearing will be
available for review at the Division of
SUMMARY:
E:\FR\FM\19DEN1.SGM
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75178
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
Dockets Management and on the
Internet at https://www.regulations.gov
within 30 days of the meeting.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Silver Spring, MD
20903, 301–796–3416, FAX: 301–847–
8752, Elizabeth.Giaquinto@fda.hhs.gov;
or Mary Gross, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Silver Spring, MD
20903, 301–796–3519, FAX: 301–847–
8752, Mary.Gross@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Over the past several years, the role of
opioid drugs in treating chronic pain
has been an increasingly common
subject of public discussion. FDA and
other policymakers have been at the
forefront of these debates, striving to
find a balance between minimizing
opioid drug abuse and misuse, while
simultaneously enabling appropriate
access to pain-relieving drugs. The July
9, 2012, approval of the Risk Evaluation
Management Strategy for extendedrelease (ER) and long-acting (LA) opioid
analgesics is a recent example of FDA’s
ongoing commitment to ensuring that
the benefits of these types of opioid
drugs continue to outweigh their risks.
While ER/LA opioid issues have been
a particular focus of public health
concern, discussions continue about the
proper use of opioid drugs in general.
Over the past several years, the Agency
has received comments, petitions, and
informal inquiries concerning the extent
to which opioid drugs should be used
in the treatment of pain. In particular,
members of the public and the regulated
community have debated the presence
or absence of evidence showing the
safety and efficacy of these drugs as
pain relievers in the various populations
for whom they are prescribed. Many
have raised issues specific to particular
opioids, such as those pertaining to drug
product composition, specific abusedeterrence properties, and biological
action. Some have raised broader issues
that impact the entire class of opioid
drugs or a large subcategory thereof
(e.g., ER/LA opioids), such as the
propriety of controls on drug dosage and
duration of administration or changes in
indication and prescribing practices.
sroberts on DSK5SPTVN1PROD with
II. Purpose and Scope of the Public
Hearing
16:35 Dec 18, 2012
Jkt 229001
A. Diagnosis and Understanding of
Patient Pain
1. What methods do professionals use
to accurately distinguish between
different types of pain (e.g., cancer vs.
non-cancer) and their respective
etiologies?
2. What are the definitions of the
terms ‘‘mild,’’ ‘‘moderate,’’ and ‘‘severe’’
when those terms are used to describe
symptomatic conditions such as pain?
3. How do professionals accurately
categorize a patient’s pain as mild,
moderate, or severe? For example, what
tests or assessments do they use?
4. What methods should and do
professionals use to accurately
distinguish between short-term pain and
chronic pain?
a. What are and should be the time
periods that characterize short-term
pain versus chronic pain?
b. What are and should be considered
the clinical differences between shortterm pain versus chronic pain?
c. What types of pain, if any, are
presumed chronic versus presumed
short term?
B. Understanding and Adhering to the
Labels of Pain-Treating Products
1. How are the words ‘‘indicated for
the treatment of moderate to severe
pain’’ interpreted and used by
practitioners when deciding what types
of treatments (including opioids) are
appropriate for treating patients with
pain?
2. If the indication for opioid drugs
were restricted to the treatment of
severe pain only, how would such a
change impact:
a. Prescribing practices?
b. Patient access to pain medication
and patient pain control?
c. Abuse and misuse of opioid
medicines?
3. If the pain threshold described in
the indication (e.g., moderate, moderate
to severe, severe pain) differed based on
the pain’s etiology, how would such an
approach impact:
a. Prescribing practices?
b. Patient access to pain medication
and patient pain control?
c. Abuse and misuse of opioid
medicines?
C. Limiting Opioid Prescription and Use
In light of the ongoing interest in
issues related to opioid use, FDA has
decided to hold a public hearing to
obtain information—particularly
scientific evidence, such as study data
VerDate Mar<15>2010
or peer-reviewed analyses—from expert
members of the public on the following
questions:
1. Limits on exposure to opioid drugs.
a. What data, if any, exist that would
support or oppose the establishment of
a maximum daily dose for opioid drugs?
FDA is interested in drug safety or
efficacy data in particular.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
b. What data, if any, exist that would
support or oppose a difference in
maximum daily dose for opioid drugs
based on pain etiology (e.g., cancer vs.
non-cancer pain)? FDA is interested in
drug safety or efficacy data in particular.
c. What method(s), if any, should be
used to establish a maximum daily dose
of opioid drugs?
d. What effect(s), if any, would a
maximum daily dose for opioid drugs
have on the following:
i. Prescribing practices?
ii. Patient access to pain medication
and patient pain control?
iii. Abuse and misuse of opioid
medicines?
2. Limits on duration of use of opioid
drugs.
a. What data, if any, exist that would
support or oppose the establishment of
a maximum duration of continuous
treatment with opioid drugs? FDA is
interested in drug safety or efficacy data
in particular.
b. What data, if any, exist that would
support or oppose a difference in
maximum duration of continuous
treatment with opioid drugs based on
pain etiology (e.g., cancer vs. non-cancer
pain)? FDA is interested in drug safety
or efficacy data in particular.
c. What method(s), if any, should be
used to establish a maximum duration
of continuous treatment with opioid
drugs?
d. What effect(s), if any, would a
maximum duration of continuous
treatment with opioid drugs have on the
following:
i. Prescribing practices?
ii. Patient access to pain medication
and patient pain control?
iii. Abuse and misuse of opioid
medicines?
III. Attendance at and/or Participation
in the Public Hearing
If you wish to attend the hearing or
make an oral presentation during the
hearing, you must register by submitting
either an electronic request (see the Web
address listed at the end of this
paragraph) or written request (see FOR
FURTHER INFORMATION CONTACT) by close
of business on January 18, 2013. You
must provide your name, title, business
affiliation (if applicable), address, and
type of organization you represent (e.g.,
industry, consumer organization), and a
brief summary of your presentation, if
applicable (including the discussion
topic(s) that will be addressed), to
https://www.surveymonkey.com/s/
2R5QWZP by January 18, 2013.
FDA will notify registered presenters
of their scheduled presentation times.
Persons registered to make an oral
presentation should check in before the
E:\FR\FM\19DEN1.SGM
19DEN1
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
sroberts on DSK5SPTVN1PROD with
hearing and are encouraged to arrive
early to ensure the designated order of
presentation times. We will try to
accommodate all persons who wish to
present; however, the duration of each
speaker’s testimony may be limited by
time constraints. An agenda of the
meeting and other background material
will be made available 5 days before the
meeting at https://www.fda.gov/Drugs/
NewsEvents/ucm326450.htm.
Questions about the meeting may also
be also submitted to
IssuesWithOpioids@fda.hhs.gov prior to
the February 7 and February 8, 2013,
meeting dates.
The hearing is free and seating will be
on a first-come, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
numbers of participants from individual
organizations as well as total number of
attendees based on space limitations.
Registrants will receive confirmation
once they have been accepted to attend
the hearing. For those who cannot
attend in person, information regarding
viewing a live Web cast of the public
hearing will be located at: https://
www.fda.gov/Drugs/NewsEvents/
ucm326450.htm.
If you need special accommodations
due to a disability, contact Elizabeth
Giaquinto or Mary Gross (see FOR
FURTHER INFORMATION CONTACT).
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). The hearing will be
conducted by a presiding officer, who
will be accompanied by FDA senior
management from the Center for Drug
Evaluation and Research.
Under § 15.30(f), the hearing is
informal and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation. Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (part 10 (21 CFR part 10),
subpart C). Under § 10.205,
representatives of the electronic media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants.
The hearing will be transcribed as
stipulated in § 15.30(b). A transcript
will be available for review at the
Division of Dockets Management (see
VerDate Mar<15>2010
16:35 Dec 18, 2012
Jkt 229001
ADDRESSES) and on the Internet at
https://www.regulations.gov within 30
days of the meeting. A transcript will
also be available in either hard copy or
on CD–ROM after submission of a
Freedom of Information request. Submit
written requests to the Division of
Freedom of Information (ELEM–1029),
Office of Management Programs, Food
and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857.
To the extent that the conditions for
the hearing, as described in this notice,
conflict with any provisions set out in
part 15, this notice acts as a waiver of
those provisions as specified in
§ 15.30(h).
V. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments for consideration by April 8,
2013. Persons who wish to provide
additional materials for consideration
should file these materials with the
Division of Dockets Management. You
should annotate and organize your
comments so that they identify the
specific questions to which they refer. It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30516 Filed 12–18–12; 8:45 am]
BILLING CODE 4160–01–P
75179
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
N43DA13–4417: Video Gaming Targeting
Relapse Prevention in Youth with Substance
Use Disorders.
Date: January 9, 2013.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Nadine Rogers, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4229, MSC 9550, Bethesda, MD
20892–9550, 301–402–2105,
rogersn2@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Profile
Screening and Predictive Toxicology (8909).
Date: February 12, 2013.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: December 13, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–30453 Filed 12–18–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute on Drug Abuse;
Notice of Closed Meetings
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 USC,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the contract
National Institute on Drug Abuse
Notice of Closed Meetings
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
E:\FR\FM\19DEN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75177-75179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1172]
Impact of Approved Drug Labeling on Chronic Opioid Therapy;
Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing to obtain information, particularly scientific evidence, such
as study data or peer-reviewed analyses, on issues pertaining to the
use of opioid drugs in the treatment of chronic pain.
DATES: The public hearing will be held on February 7 and 8, 2013, from
9 a.m. to 4 p.m. Submit electronic or written requests to make oral
presentations and comments by January 18, 2013. Electronic or written
comments will be accepted after the hearing until April 8, 2013.
ADDRESSES: The public hearing will be held at the Bethesda Marriott,
5151 Pooks Hill Rd., Bethesda, MD 20814, 301-897-9400, Fax 1-301-897-
0192.
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document. Transcripts of the hearing
will be available for review at the Division of
[[Page 75178]]
Dockets Management and on the Internet at https://www.regulations.gov
within 30 days of the meeting.
FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD
20903, 301-796-3416, FAX: 301-847-8752,
Elizabeth.Giaquinto@fda.hhs.gov; or Mary Gross, Center for Drug
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD
20903, 301-796-3519, FAX: 301-847-8752, Mary.Gross@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Over the past several years, the role of opioid drugs in treating
chronic pain has been an increasingly common subject of public
discussion. FDA and other policymakers have been at the forefront of
these debates, striving to find a balance between minimizing opioid
drug abuse and misuse, while simultaneously enabling appropriate access
to pain-relieving drugs. The July 9, 2012, approval of the Risk
Evaluation Management Strategy for extended-release (ER) and long-
acting (LA) opioid analgesics is a recent example of FDA's ongoing
commitment to ensuring that the benefits of these types of opioid drugs
continue to outweigh their risks.
While ER/LA opioid issues have been a particular focus of public
health concern, discussions continue about the proper use of opioid
drugs in general. Over the past several years, the Agency has received
comments, petitions, and informal inquiries concerning the extent to
which opioid drugs should be used in the treatment of pain. In
particular, members of the public and the regulated community have
debated the presence or absence of evidence showing the safety and
efficacy of these drugs as pain relievers in the various populations
for whom they are prescribed. Many have raised issues specific to
particular opioids, such as those pertaining to drug product
composition, specific abuse-deterrence properties, and biological
action. Some have raised broader issues that impact the entire class of
opioid drugs or a large subcategory thereof (e.g., ER/LA opioids), such
as the propriety of controls on drug dosage and duration of
administration or changes in indication and prescribing practices.
II. Purpose and Scope of the Public Hearing
In light of the ongoing interest in issues related to opioid use,
FDA has decided to hold a public hearing to obtain information--
particularly scientific evidence, such as study data or peer-reviewed
analyses--from expert members of the public on the following questions:
A. Diagnosis and Understanding of Patient Pain
1. What methods do professionals use to accurately distinguish
between different types of pain (e.g., cancer vs. non-cancer) and their
respective etiologies?
2. What are the definitions of the terms ``mild,'' ``moderate,''
and ``severe'' when those terms are used to describe symptomatic
conditions such as pain?
3. How do professionals accurately categorize a patient's pain as
mild, moderate, or severe? For example, what tests or assessments do
they use?
4. What methods should and do professionals use to accurately
distinguish between short-term pain and chronic pain?
a. What are and should be the time periods that characterize short-
term pain versus chronic pain?
b. What are and should be considered the clinical differences
between short-term pain versus chronic pain?
c. What types of pain, if any, are presumed chronic versus presumed
short term?
B. Understanding and Adhering to the Labels of Pain-Treating Products
1. How are the words ``indicated for the treatment of moderate to
severe pain'' interpreted and used by practitioners when deciding what
types of treatments (including opioids) are appropriate for treating
patients with pain?
2. If the indication for opioid drugs were restricted to the
treatment of severe pain only, how would such a change impact:
a. Prescribing practices?
b. Patient access to pain medication and patient pain control?
c. Abuse and misuse of opioid medicines?
3. If the pain threshold described in the indication (e.g.,
moderate, moderate to severe, severe pain) differed based on the pain's
etiology, how would such an approach impact:
a. Prescribing practices?
b. Patient access to pain medication and patient pain control?
c. Abuse and misuse of opioid medicines?
C. Limiting Opioid Prescription and Use
1. Limits on exposure to opioid drugs.
a. What data, if any, exist that would support or oppose the
establishment of a maximum daily dose for opioid drugs? FDA is
interested in drug safety or efficacy data in particular.
b. What data, if any, exist that would support or oppose a
difference in maximum daily dose for opioid drugs based on pain
etiology (e.g., cancer vs. non-cancer pain)? FDA is interested in drug
safety or efficacy data in particular.
c. What method(s), if any, should be used to establish a maximum
daily dose of opioid drugs?
d. What effect(s), if any, would a maximum daily dose for opioid
drugs have on the following:
i. Prescribing practices?
ii. Patient access to pain medication and patient pain control?
iii. Abuse and misuse of opioid medicines?
2. Limits on duration of use of opioid drugs.
a. What data, if any, exist that would support or oppose the
establishment of a maximum duration of continuous treatment with opioid
drugs? FDA is interested in drug safety or efficacy data in particular.
b. What data, if any, exist that would support or oppose a
difference in maximum duration of continuous treatment with opioid
drugs based on pain etiology (e.g., cancer vs. non-cancer pain)? FDA is
interested in drug safety or efficacy data in particular.
c. What method(s), if any, should be used to establish a maximum
duration of continuous treatment with opioid drugs?
d. What effect(s), if any, would a maximum duration of continuous
treatment with opioid drugs have on the following:
i. Prescribing practices?
ii. Patient access to pain medication and patient pain control?
iii. Abuse and misuse of opioid medicines?
III. Attendance at and/or Participation in the Public Hearing
If you wish to attend the hearing or make an oral presentation
during the hearing, you must register by submitting either an
electronic request (see the Web address listed at the end of this
paragraph) or written request (see FOR FURTHER INFORMATION CONTACT) by
close of business on January 18, 2013. You must provide your name,
title, business affiliation (if applicable), address, and type of
organization you represent (e.g., industry, consumer organization), and
a brief summary of your presentation, if applicable (including the
discussion topic(s) that will be addressed), to https://www.surveymonkey.com/s/2R5QWZP by January 18, 2013.
FDA will notify registered presenters of their scheduled
presentation times. Persons registered to make an oral presentation
should check in before the
[[Page 75179]]
hearing and are encouraged to arrive early to ensure the designated
order of presentation times. We will try to accommodate all persons who
wish to present; however, the duration of each speaker's testimony may
be limited by time constraints. An agenda of the meeting and other
background material will be made available 5 days before the meeting at
https://www.fda.gov/Drugs/NewsEvents/ucm326450.htm.
Questions about the meeting may also be also submitted to
IssuesWithOpioids@fda.hhs.gov prior to the February 7 and February 8,
2013, meeting dates.
The hearing is free and seating will be on a first-come, first-
served basis. Early registration is recommended because seating is
limited. FDA may limit the numbers of participants from individual
organizations as well as total number of attendees based on space
limitations. Registrants will receive confirmation once they have been
accepted to attend the hearing. For those who cannot attend in person,
information regarding viewing a live Web cast of the public hearing
will be located at: https://www.fda.gov/Drugs/NewsEvents/ucm326450.htm.
If you need special accommodations due to a disability, contact
Elizabeth Giaquinto or Mary Gross (see FOR FURTHER INFORMATION
CONTACT).
IV. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Center for Drug
Evaluation and Research.
Under Sec. 15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10), subpart C). Under Sec. 10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants.
The hearing will be transcribed as stipulated in Sec. 15.30(b). A
transcript will be available for review at the Division of Dockets
Management (see ADDRESSES) and on the Internet at https://www.regulations.gov within 30 days of the meeting. A transcript will
also be available in either hard copy or on CD-ROM after submission of
a Freedom of Information request. Submit written requests to the
Division of Freedom of Information (ELEM-1029), Office of Management
Programs, Food and Drug Administration, 12420 Parklawn Dr., Element
Bldg., Rockville, MD 20857.
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of those provisions as specified in Sec.
15.30(h).
V. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments for consideration
by April 8, 2013. Persons who wish to provide additional materials for
consideration should file these materials with the Division of Dockets
Management. You should annotate and organize your comments so that they
identify the specific questions to which they refer. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in Division of Dockets Management between
9 a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at https://www.regulations.gov.
Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30516 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P
