Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics; Public Meeting; Request for Comments, 22499-22501 [2014-09123]
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22499
Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
we expect that about 5% of participants
taking the pre-choice survey will not
return to participate in the experiment
one week later, the number of
respondents initially required is 5%
higher (1,575) than the full sample of
1,500 required for the experiment. We
estimate based on our previous
experience with the SelectMD 1.0
experiment that participants will
require about 10 minutes to review the
information on the Web site and select
their preferred physician from the set of
doctors available. The average time
required to complete the post-choice
survey is estimated to be 20 minutes.
Consequently, respondents will average
about 40 minutes completing all three
phases of the study.
Exhibit 2 shows the respondents’ cost
burden for their time to participate in
this experiment. The total cost burden is
estimated to be $22,297.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Pre-Choice Survey ...........................................................................................
Time on Website (Choosing MD) ....................................................................
Post-Choice Survey .........................................................................................
Total Hours ...............................................................................................
Number of
responses per
respondent
1575
1500
1500
4,575
1
1
1
na
Hour per
response
(min/60)
10/60
10/60
20/60
na
Total burden
hours
263
250
500
1,013
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Form name
Number of
respondents
Total burden
hours
Average
hourly wage
rate *
Pre-Choice Survey ...........................................................................................
Time on Website (Choosing MD) ....................................................................
Post-Choice Survey .........................................................................................
Total Cost .................................................................................................
1575
1500
1500
........................
263
250
500
........................
$22.01
22.01
22.01
........................
Total cost
burden
$5,789
5,503
11,005
22,297
* Based upon the national mean hourly wage for all occupations from the ‘‘May 2012 Occupational Employment and Wage Estimates’’, U.S.
Department of Labor, Bureau of Labor Statistics.
tkelley on DSK3SPTVN1PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: April 9, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–09168 Filed 4–21–14; 8:45 am]
BILLING CODE 4160–90–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0374]
Postmarketing Requirements for the
Class-Wide Extended-Release/LongActing Opioid Analgesics; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting to obtain stakeholder
input on the design and conduct of the
postmarketing requirements (PMRs) for
the class-wide extended-release/longacting (ER/LA) opioid analgesic drug
products to further assess the serious
risks of misuse, abuse, hyperalgesia,
addiction, overdose, and death
associated with their long-term use.
FDA is seeking input on these issues
from stakeholders, including patients,
academia, researchers, State and other
Federal regulators, health care
organizations, health care providers, the
pharmaceutical industry, and others
from the general public.
DATES: The public meeting will be held
on May 19 and 20, 2014, from 8 a.m. to
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
5 p.m. Individuals who wish to present
at the meeting must register by May 9,
2014. See section III under the
SUPPLEMENTARY INFORMATION section for
information on how to register to speak
at the meeting.
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 20993–0002.
Participants must enter through
Building 1 and undergo security
screening. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit either electronic or written
comments by June 19, 2014. 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. Identify all
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Janelle Derbis, Center for Drug
Evaluation and Research, Food and
Drug Administration, 20 North
Michigan Ave., Suite 510, Chicago, IL
60602, 312–596–6516, FAX: 312–886–
E:\FR\FM\22APN1.SGM
22APN1
22500
Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
1682, email: ERLAOpioidPMRMeeting@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
tkelley on DSK3SPTVN1PROD with NOTICES
I. Background
FDA is committed to improving the
safe and appropriate use of ER/LA
opioid analgesics and preserving
appropriate access for those patients
who rely on these medications to
manage their pain. In May 2012, FDA
hosted a scientific workshop to discuss
the assessment of analgesic treatment of
chronic pain, during which presenters
raised concerns about the safe and
appropriate use of opioid analgesics.1
Over the past 2 years, FDA has reviewed
numerous submissions to Agency
dockets, including citizen petitions and
comments to petitions, and relevant
literature about the benefits and risks
associated with opioid drug products,
including the serious risks of misuse,
abuse, hyperalgesia, addiction,
overdose, and death associated with the
long-term use of ER/LA opioid
analgesics. FDA has concluded that
more data are needed regarding these
serious risks.
FDA described these data
requirements in its September 10, 2013,
letter to all new drug application (NDA)
applicants for ER/LA opioid analgesics.
Data are needed to address the following
issues:
• The incidence of and risk factors for
misuse, abuse, addiction, overdose, and
death associated with long-term use of
opioids for chronic pain.
• Validated measures of misuse,
abuse, addiction, overdose, and death.
• Validated coded medical
terminologies used to identify misuse,
abuse, addiction, overdose, and death.
• Validated definitions of ‘‘doctor/
pharmacy shopping’’ as outcomes
suggestive of misuse, abuse, and
addiction.
• The serious risk of developing
hyperalgesia following use of ER/LA
opioid analgesics for at least 1 year to
treat chronic pain.
In the September 10, 2013, letter, FDA
informed the ER/LA opioid analgesic
NDA application holders of the
requirement to conduct postapproval
studies (also referred to as
postmarketing requirements or PMRs)
and established milestone dates for
completion of those studies, which
include observational studies and a
clinical trial (see section II for more
1 Assessment of Analgesic Treatment of Chronic
Pain: A Scientific Workshop (see https://
www.fda.gov/Drugs/NewsEvents/ucm283979.htm).
Information and comments from that workshop are
available at www.regulations.gov, Docket No. FDA–
2012–N–0067.
VerDate Mar<15>2010
16:26 Apr 21, 2014
Jkt 232001
details). The deadline for the applicants’
final protocol submissions is August
2014.
II. Purpose and Scope of Meeting
The purpose of this public meeting is
to obtain stakeholder input on the
design and conduct of the PMRs
(described in the following paragraph)
for the ER/LA opioid analgesic drug
products to assess the serious risks of
misuse, abuse, hyperalgesia, addiction,
overdose, and death associated with
their long-term use. FDA and NDA
applicants will consider stakeholder
input when preparing final protocols to
be submitted by August 2014.
The PMRs described in FDA’s
September 10, 2013, letter to NDA
applicants of ER/LA opioid analgesics
are as follows:
(1) PMR # 2065–1: Conduct one or
more studies to provide quantitative
estimates of the serious risks of misuse,
abuse, addiction, overdose, and death
associated with long-term use of opioid
analgesics for management of chronic
pain among patients prescribed ER/LA
opioid products. Include an assessment
of risk relative to efficacy.
These studies should address at a
minimum the following specific aims:
a. Estimate the incidence of misuse,
abuse, addiction, overdose, and death
associated with long-term use of opioids
for chronic pain. Stratify misuse and
overdose by intentionality wherever
possible. Examine the effect of product/
formulation, dose and duration of
opioid use, prescriber specialty,
indication, and other clinical factors
(e.g., concomitant psychotropic
medications, personal or family history
of substance abuse, and history of
psychiatric illness) on the risk of
misuse, abuse, addiction, overdose, and
death.
b. Evaluate and quantify other risk
factors for misuse, abuse, addiction,
overdose, and death associated with
long-term use of opioids for chronic
pain, including, but not limited to, the
following: Demographic factors,
psychosocial/behavioral factors,
medical factors, and genetic factors.
Identify confounders and effect
modifiers of individual risk factor/
outcome relationships. Stratify misuse
and overdose by intentionality wherever
possible.
(2) PMR # 2065–2: Develop and
validate measures of the following
opioid-related adverse events: Misuse,
abuse, addiction, overdose, and death
(based on the Department of Health and
Human Services’ definition, or any
agreed upon definition), which will be
used to inform the design and analysis
for PMR # 2065–1 and any future
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
postmarketing safety studies and
clinical trials to assess these risks. This
can be achieved by conducting an
instrument development study or a
validation study of an algorithm based
on secondary data sources.
(3) PMR # 2065–3: Conduct a study to
validate coded medical terminologies
(e.g., ICD9, ICD10, and SNOMED) used
to identify the following opioid-related
adverse events: Misuse, abuse,
addiction, overdose, and death in any
existing postmarketing databases to be
employed in the studies. Stratify misuse
and overdose by intentionality wherever
possible. These validated codes will be
used to inform the design and analysis
for PMR # 2065–1.
(4) PMR # 2065–4: Conduct a study to
define and validate ‘‘doctor/pharmacy
shopping’’ as outcomes suggestive of
misuse, abuse, and addiction. These
validated codes will be used to inform
the design and analysis for PMR # 2065–
1.
(5) PMR # 2065–5: Conduct a clinical
trial to estimate the serious risk for the
development of hyperalgesia following
use of ER/LA opioid analgesics for at
least 1 year to treat chronic pain. We
strongly encourage you to use the same
trial to assess the development of
tolerance following use of ER/LA opioid
analgesics. Include an assessment of risk
relative to efficacy.
III. Attendance and Registration
Attendance is free and will be on a
first-come, first-served basis.
Individuals who wish to present at the
public meeting must register on or
before May 9, 2014, at https://
erlaopioidpmrmeeting.eventbrite.com.
In section II, FDA has listed the PMRs.
You should identify which PMR(s) you
wish to address in your presentation, or
whether your comments apply to all
PMRs, so FDA can consider that in
organizing the presentations. FDA will
do its best to accommodate requests to
speak and will determine the amount of
time allotted to each presenter and the
approximate time that each oral
presentation is scheduled to begin. An
agenda and additional meeting
background material will be available
approximately 2 weeks before the
meeting at https://www.fda.gov/Drugs/
NewsEvents/ucm384489.htm.
Individuals who wish to attend the
meeting but do not wish to make a
presentation should register by May 12,
2014. Onsite registration on the day of
the meeting will be based on space
availability.
If you need special accommodations
due to a disability, please contact
Janelle Derbis (see FOR FURTHER
E:\FR\FM\22APN1.SGM
22APN1
Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
INFORMATION CONTACT) at least 7 days in
advance.
A live Web cast of this meeting will
be viewable at https://
collaboration.fda.gov/opmr/ on the day
of the meeting. A video record of the
meeting will be available at the same
Web address for 1 year.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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. To ensure
consideration, submit comments by
June 19, 2014. Received comments may
be seen in the 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.
V. Transcripts
As soon as possible after a transcript
of the public meeting is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09123 Filed 4–21–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0398]
Eli Lilly and Company, et al.;
Withdrawal of Approval of 3 New Drug
Applications and 41 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
SUMMARY:
22501
approval of 3 new drug applications and
41 abbreviated new drug applications
(ANDAs) from multiple applicants. The
holders of the applications notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES:
Effective May 22, 2014.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in
table 1 in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
TABLE 1—REQUESTS TO WITHDRAW APPROVAL OF APPLICATIONS
Application No.
Drug
Applicant
NDA 050440 ......
Keflet (cephalexin) Tablets ......................................................
NDA 050614 ......
NDA 050673 ......
ANDA 075457 ....
Keftab (cephalexin hydrochloride) Tablets ..............................
Ceclor CD (cefaclor) Tablets ...................................................
Famotidine Tablets USP, 20 milligrams (mg) and 40 mg .......
ANDA 075559 ....
Butorphanol Tartrate Injection USP, 1 mg/milliliter (mL) and 2
mg/mL.
Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg ..........
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Do.
Do.
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O.
Box 4310, Morgantown, WV 26505–4310.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
ANDA 075572 ....
ANDA 075594 ....
ANDA 075609 ....
ANDA 075613 ....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
075627
075730
075793
075847
075905
075943
....
....
....
....
....
....
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 075950 ....
ANDA 076018 ....
ANDA 076042 ....
ANDA 076044 ....
Pamidronate Disodium for Injection, 30 mg/vial and 90 mg/
vial.
Doxazosin Mesylate Tablets, 1 mg, 2 mg, 4 mg, and 8 mg ...
Bupropion HCl Tablets, 75 mg and 100 mg ............................
Acyclovir Injection, 50 mg/mL ..................................................
Thiotepa for Injection USP, 15 mg/vial and 30 mg/vial ...........
Famotidine Tablets USP, 20 mg and 40 mg ...........................
Oxaprozin Tablets USP, 600 mg .............................................
Famotidine Injection, 10 mg/mL ...............................................
Etodolac Extended-Release Tablets, 400 mg, 500 mg, and
600 mg.
Fluvoxamine Maleate Tablets, 50 mg and 100 mg .................
Amiodarone HCl Injection, 50 mg/mL ......................................
ANDA 076088 ....
ANDA 076193 ....
ANDA 076259 ....
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg ..
Potassium Chloride Extended-Release Tablets USP, 20 milliequivalents.
Amiodarone HCl Injection, 50 mg/mL ......................................
Propafenone HCl Tablets, 150 mg, 225 mg, and 300 mg ......
Milrinone Lacate in 5% Dextrose Injection ..............................
ANDA 076299 ....
Amiodarone HCl Injection, 50 mg/mL ......................................
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16:26 Apr 21, 2014
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Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock
Rd., Bridgeton, MO 63044.
Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA
92618.
Nesher Pharmacueticals (USA) LLC.
Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038–
0446.
Teva Parenteral Medicines, Inc.
Do.
Sandoz Inc.
Mylan Pharmaceuticals, Inc.
Hospira, Inc.
Sandoz Inc.
Mylan Pharmaceuticals, Inc.
Bedford Laboratories, 300 Northfield Rd., Bedford, OH
44146.
Mylan Pharmaceuticals, Inc.
Nesher Pharmaceuticals (USA) LLC.
Bedford Laboratories.
Nesher Pharmaceuticals (USA) LLC.
Baxter Healthcare Corp., 25212 W. Illinois Route 120, Round
Lake, IL 60073.
Bedford Laboratories.
E:\FR\FM\22APN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22499-22501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09123]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0374]
Postmarketing Requirements for the Class-Wide Extended-Release/
Long-Acting Opioid Analgesics; 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) is announcing a public
meeting to obtain stakeholder input on the design and conduct of the
postmarketing requirements (PMRs) for the class-wide extended-release/
long-acting (ER/LA) opioid analgesic drug products to further assess
the serious risks of misuse, abuse, hyperalgesia, addiction, overdose,
and death associated with their long-term use.
FDA is seeking input on these issues from stakeholders, including
patients, academia, researchers, State and other Federal regulators,
health care organizations, health care providers, the pharmaceutical
industry, and others from the general public.
DATES: The public meeting will be held on May 19 and 20, 2014, from 8
a.m. to 5 p.m. Individuals who wish to present at the meeting must
register by May 9, 2014. See section III under the SUPPLEMENTARY
INFORMATION section for information on how to register to speak at the
meeting.
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 20993-0002. Participants must enter
through Building 1 and undergo security screening. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit either electronic or written comments by June 19, 2014.
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. Identify all comments with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug
Evaluation and Research, Food and Drug Administration, 20 North
Michigan Ave., Suite 510, Chicago, IL 60602, 312-596-6516, FAX: 312-
886-
[[Page 22500]]
1682, email: ERLAOpioidPMRMeeting@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is committed to improving the safe and appropriate use of ER/LA
opioid analgesics and preserving appropriate access for those patients
who rely on these medications to manage their pain. In May 2012, FDA
hosted a scientific workshop to discuss the assessment of analgesic
treatment of chronic pain, during which presenters raised concerns
about the safe and appropriate use of opioid analgesics.\1\ Over the
past 2 years, FDA has reviewed numerous submissions to Agency dockets,
including citizen petitions and comments to petitions, and relevant
literature about the benefits and risks associated with opioid drug
products, including the serious risks of misuse, abuse, hyperalgesia,
addiction, overdose, and death associated with the long-term use of ER/
LA opioid analgesics. FDA has concluded that more data are needed
regarding these serious risks.
---------------------------------------------------------------------------
\1\ Assessment of Analgesic Treatment of Chronic Pain: A
Scientific Workshop (see https://www.fda.gov/Drugs/NewsEvents/ucm283979.htm). Information and comments from that workshop are
available at www.regulations.gov, Docket No. FDA-2012-N-0067.
---------------------------------------------------------------------------
FDA described these data requirements in its September 10, 2013,
letter to all new drug application (NDA) applicants for ER/LA opioid
analgesics. Data are needed to address the following issues:
The incidence of and risk factors for misuse, abuse,
addiction, overdose, and death associated with long-term use of opioids
for chronic pain.
Validated measures of misuse, abuse, addiction, overdose,
and death.
Validated coded medical terminologies used to identify
misuse, abuse, addiction, overdose, and death.
Validated definitions of ``doctor/pharmacy shopping'' as
outcomes suggestive of misuse, abuse, and addiction.
The serious risk of developing hyperalgesia following use
of ER/LA opioid analgesics for at least 1 year to treat chronic pain.
In the September 10, 2013, letter, FDA informed the ER/LA opioid
analgesic NDA application holders of the requirement to conduct
postapproval studies (also referred to as postmarketing requirements or
PMRs) and established milestone dates for completion of those studies,
which include observational studies and a clinical trial (see section
II for more details). The deadline for the applicants' final protocol
submissions is August 2014.
II. Purpose and Scope of Meeting
The purpose of this public meeting is to obtain stakeholder input
on the design and conduct of the PMRs (described in the following
paragraph) for the ER/LA opioid analgesic drug products to assess the
serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and
death associated with their long-term use. FDA and NDA applicants will
consider stakeholder input when preparing final protocols to be
submitted by August 2014.
The PMRs described in FDA's September 10, 2013, letter to NDA
applicants of ER/LA opioid analgesics are as follows:
(1) PMR 2065-1: Conduct one or more studies to provide
quantitative estimates of the serious risks of misuse, abuse,
addiction, overdose, and death associated with long-term use of opioid
analgesics for management of chronic pain among patients prescribed ER/
LA opioid products. Include an assessment of risk relative to efficacy.
These studies should address at a minimum the following specific
aims:
a. Estimate the incidence of misuse, abuse, addiction, overdose,
and death associated with long-term use of opioids for chronic pain.
Stratify misuse and overdose by intentionality wherever possible.
Examine the effect of product/formulation, dose and duration of opioid
use, prescriber specialty, indication, and other clinical factors
(e.g., concomitant psychotropic medications, personal or family history
of substance abuse, and history of psychiatric illness) on the risk of
misuse, abuse, addiction, overdose, and death.
b. Evaluate and quantify other risk factors for misuse, abuse,
addiction, overdose, and death associated with long-term use of opioids
for chronic pain, including, but not limited to, the following:
Demographic factors, psychosocial/behavioral factors, medical factors,
and genetic factors. Identify confounders and effect modifiers of
individual risk factor/outcome relationships. Stratify misuse and
overdose by intentionality wherever possible.
(2) PMR 2065-2: Develop and validate measures of the
following opioid-related adverse events: Misuse, abuse, addiction,
overdose, and death (based on the Department of Health and Human
Services' definition, or any agreed upon definition), which will be
used to inform the design and analysis for PMR 2065-1 and any
future postmarketing safety studies and clinical trials to assess these
risks. This can be achieved by conducting an instrument development
study or a validation study of an algorithm based on secondary data
sources.
(3) PMR 2065-3: Conduct a study to validate coded medical
terminologies (e.g., ICD9, ICD10, and SNOMED) used to identify the
following opioid-related adverse events: Misuse, abuse, addiction,
overdose, and death in any existing postmarketing databases to be
employed in the studies. Stratify misuse and overdose by intentionality
wherever possible. These validated codes will be used to inform the
design and analysis for PMR 2065-1.
(4) PMR 2065-4: Conduct a study to define and validate
``doctor/pharmacy shopping'' as outcomes suggestive of misuse, abuse,
and addiction. These validated codes will be used to inform the design
and analysis for PMR 2065-1.
(5) PMR 2065-5: Conduct a clinical trial to estimate the
serious risk for the development of hyperalgesia following use of ER/LA
opioid analgesics for at least 1 year to treat chronic pain. We
strongly encourage you to use the same trial to assess the development
of tolerance following use of ER/LA opioid analgesics. Include an
assessment of risk relative to efficacy.
III. Attendance and Registration
Attendance is free and will be on a first-come, first-served basis.
Individuals who wish to present at the public meeting must register on
or before May 9, 2014, at https://erlaopioidpmrmeeting.eventbrite.com.
In section II, FDA has listed the PMRs. You should identify which
PMR(s) you wish to address in your presentation, or whether your
comments apply to all PMRs, so FDA can consider that in organizing the
presentations. FDA will do its best to accommodate requests to speak
and will determine the amount of time allotted to each presenter and
the approximate time that each oral presentation is scheduled to begin.
An agenda and additional meeting background material will be available
approximately 2 weeks before the meeting at https://www.fda.gov/Drugs/NewsEvents/ucm384489.htm.
Individuals who wish to attend the meeting but do not wish to make
a presentation should register by May 12, 2014. Onsite registration on
the day of the meeting will be based on space availability.
If you need special accommodations due to a disability, please
contact Janelle Derbis (see FOR FURTHER
[[Page 22501]]
INFORMATION CONTACT) at least 7 days in advance.
A live Web cast of this meeting will be viewable at https://collaboration.fda.gov/opmr/ on the day of the meeting. A video record
of the meeting will be available at the same Web address for 1 year.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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. To ensure
consideration, submit comments by June 19, 2014. Received comments may
be seen in the 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.
V. Transcripts
As soon as possible after a transcript of the public meeting is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09123 Filed 4-21-14; 8:45 am]
BILLING CODE 4160-01-P
