Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems To Address the Misuse and Abuse of Opioid Analgesics; Request for Comments; Establishment of a Public Docket, 19619-19620 [2014-07909]
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Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2014–N–0233]
[Docket No. FDA–2013–N–1064]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Application for Participation in the
Medical Device Fellowship Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Food and Drug Administration,
HHS.
Notice.
Notification; establishment of
docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Application for Participation in the
Medical Device Fellowship Program;
Form FDA 3608’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On
January 24, 2014, the Agency submitted
a proposed collection of information
entitled ‘‘Application for Participation
in the Medical Device Fellowship
Program; Form FDA 3608’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0551. The approval expires on
March 31, 2017. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07916 Filed 4–8–14; 8:45 am]
BILLING CODE 4160–01–P
TKELLEY on DSK3SPTVN1PROD with NOTICES
Center for Drug Evaluation and
Research; Use of Innovative
Packaging, Storage, and/or Disposal
Systems To Address the Misuse and
Abuse of Opioid Analgesics; Request
for Comments; Establishment of a
Public Docket
VerDate Mar<15>2010
17:54 Apr 08, 2014
Jkt 232001
The Food and Drug
Administration (FDA) is announcing the
establishment of a docket to receive
suggestions, recommendations, and
comments on innovative packaging,
storage, and disposal systems,
technologies or designs (‘‘designs’’) that
could be used to prevent or deter misuse
and abuse of opioid analgesics by
patients and others. FDA is interested in
receiving comments on new designs as
well as enhancements to existing
designs, and is particularly interested in
comments from academic institutions,
regulated industry, technology
companies (e.g., those producing
technologies for medication adherence,
disposal, or tracking), healthcare
professionals, patient representatives,
clinical trial service providers, and
other interested organizations.
Comments submitted in response to this
notice will help the Agency determine
whether innovative designs for opioid
analgesic packaging, storage, and/or
disposal systems could help prevent or
deter misuse and abuse without
diminishing access for patients with
legitimate prescriptions.
DATES: Submit either electronic or
written comments by June 9, 2014.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–301), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Colleen Brennan, Center for Drug
Evaluation and Research, Office of
Surveillance and Epidemiology, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4410,
Silver Spring, MD 20993–0002, 301–
796–2316, email: Colleen.Brennan@
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
19619
fda.hhs.gov, with the subject line
identified as ‘‘Packaging Abuse
Deterrence Strategies.’’
SUPPLEMENTARY INFORMATION:
I. Background
Prescription opioid analgesics are
important medications that are widely
prescribed for the treatment of both noncancer and cancer-related pain. When
used properly for their approved
indications, opioid drugs provide
significant benefits for patients.
However, they also carry a risk of
misuse, abuse, addiction, overdose, and
death. According to an analysis from the
Centers for Disease Control and
Prevention, in 2010, prescription opioid
drugs were involved in 16,651 overdose
deaths, which represented a 313 percent
increase over the past decade (Ref. 1).
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) reports that for each
overdose death, there were an
additional 11 treatment admissions (Ref.
2), 33 emergency department visits (Ref.
3), and 880 non-medical users of these
drugs (Ref. 4).
Although inappropriate or illicit use,
such as sharing the drug with family
and friends or using drugs stolen from
home medicine cabinets account for
some of the problems with prescription
opioids, legitimate use of opioids for
pain may also lead to adverse events,
addiction, and death. FDA plays a
central role in the development, review,
and approval of opioid drug products
and must strike a balance between their
benefit in the legitimate treatment of
patients with pain and the risks to those
patients and others associated with
misuse, abuse, and addiction.
Combating opioid misuse, abuse, and
addiction has long been both a public
health priority and a priority for the
Agency. FDA has taken many steps to
address these problems; however, we
recognize that more can be done and
have established a task force that has
embarked on a multi-pronged approach,
building upon existing initiatives and
developing new initiatives (https://
www.fda.gov/Drugs/DrugSafety/
InformationbyDrugClass/
ucm337852.htm). Exploring innovative
designs for drug packaging, storage,
and/or disposal is one of the many
initiatives targeted by the task force.
Designs for drug packaging, storage,
and disposal have evolved considerably
in the past decade to include many
technology-based features such as
electronic systems for monitoring,
assessing, and improving adherence to
medication regimens. For example,
these systems may include functionality
to remind patients to take a dose, track
E:\FR\FM\09APN1.SGM
09APN1
19620
Federal Register / Vol. 79, No. 68 / Wednesday, April 9, 2014 / Notices
when a dose is taken and how much is
taken, and limit further access until it is
time for the next dose. Additionally,
many of these drug-device combinations
electronically encrypt and capture the
accumulated adherence data, which can
be downloaded directly from the device
or wirelessly transmitted to the
prescriber. These technologies have not
only been used in clinical management
and monitoring of protocol compliance
in clinical trials, but have also been
applied to combat the problem of
prescription opioid misuse and abuse.
Other potentially relevant
technologies include ‘‘track and trace’’
capabilities, radio-frequency
identification-based systems,
microchips embedded within tablets,
and in-home medication deactivation
and/or disposal systems.
FDA is interested in further exploring
the role of existing and innovative
designs for drug product packaging,
storage, and/or disposal in mitigating
opioid misuse, abuse, and addiction.
For example, many of the features of
medication adherence monitoring
technologies could be used or adapted
to help prevent serious complications
(e.g., overdose, addiction) by supporting
proper dosage and administration, and
could also help prescribers monitor for
signs of abuse or medication sharing by
facilitating effective patient
management and followup.
Additionally, medication packaging
and/or storage designs that limit access
could help prevent use of the
medication by someone for whom it was
not prescribed, thereby, preventing
accidental exposure (e.g., by a child or
other household contact) or theft.
Finally, medication packaging, storage,
and/or disposal designs could be
applied or adapted to help ensure safe
disposal, including chemical
deactivation, of any unused or residual
medication.
TKELLEY on DSK3SPTVN1PROD with NOTICES
II. Establishment of a Docket
FDA is announcing the establishment
of a public docket to provide an
opportunity for interested persons to
share information, research, and ideas
on how drug product packaging, storage,
and/or disposal systems could be
designed or adapted to address
problems associated with prescription
opioid abuse and misuse. These
comments will help the Agency explore
whether existing or innovative designs
can be applied or adapted to prevent or
deter misuse and abuse, while ensuring
that patients in pain have appropriate
access to opioid analgesics.
VerDate Mar<15>2010
17:54 Apr 08, 2014
Jkt 232001
III. Suggestions for Those Submitting
Comments in Response to This Notice
Proposed packaging, storage, and/or
disposal designs should be feasible to
implement, and should not impair
access for patients who have legitimate
prescriptions. Comments about specific
system or technology designs should
include a description of the following:
(1) Design features and functionality; (2)
results of any formative or summative
human factors assessments conducted;
(3) applications to date, including
information on the effectiveness and
acceptability of those applications (with
literature references or other
documentation); (4) recommendations
for how the system/technology design
could be applied or adapted (either
alone and/or in combination with other
systems/technologies) to help prevent or
deter misuse and abuse, and any
limitations of that application; (5)
specific problems that could be
addressed (e.g., serious complications
such as addiction or overdose due to
improper dosage and/or administration,
improper disposal, accidental use by
someone for whom the medication was
not prescribed); and (6) to the extent
possible, considerations for
implementation into routine dispensing
and clinical use (e.g., how the solution
would impact the workflow in a retail
pharmacy).
To help FDA prioritize among
proposed approaches, the Agency is also
interested in receiving feedback about
methods that could be used to assess a
system or technology’s potential abusedeterrent characteristics and real-world
impact (e.g., actual ability to prevent or
deter misuse and abuse, effect on access
for appropriate patients, patient
confidentiality, burden on the
healthcare system, feasibility of
implementation, whether the design
could create unintended medication
errors). Finally, FDA is interested in
receiving feedback on methods for
encouraging further research and
development in this area, and, if
promising technologies are identified,
incentivizing the pharmaceutical
industry (e.g. via patent extensions) to
adopt such technologies.
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. Received
comments may be seen in the Division
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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. The Agency will
carefully consider all comments
submitted. FDA generally will not
respond directly to the person or
organization submitting the comment.
V. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but FDA is not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Centers for Disease Control and
Prevention. ‘‘Opioids drive continued
increase in drug overdose deaths’’ [Press
Release] (2013). https://www.cdc.gov/media/
releases/2013/p0220_drug_overdose_
deaths.html.
2. SAMHSA, Center for Behavioral Health
Statistics and Quality. Treatment Episode
Data Set (TEDS): 2001–2011. National
Admissions to Substance Abuse Treatment
Services. BHSIS Series S–65, HHS
Publication No. (SMA) 13–4772. Rockville,
MD: Substance Abuse and Mental Health
Services Administration, 2013.
3. SAMHSA, Center for Behavioral Health
Statistics and Quality, ‘‘Drug Abuse Warning
Network,’’ 2011. https://samhsa.gov/data/
dawn/nations/Nation_2011_AllMA.xls.
4. Substance Abuse and Mental Health
Services Administration, Results from the
2012 National Survey on Drug Use and
Health, detailed table 1.1A, NSDUH Series
H–46, HHS Publication No. (SMA) 13–4795.
Rockville, MD: Substance Abuse and Mental
Health Services Administration, 2013.
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07909 Filed 4–8–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–P–0207]
Draft Guidance for Industry: Proper
Labeling of Honey and Honey
Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Guidance for Industry: Proper Labeling
SUMMARY:
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19619-19620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07909]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0233]
Center for Drug Evaluation and Research; Use of Innovative
Packaging, Storage, and/or Disposal Systems To Address the Misuse and
Abuse of Opioid Analgesics; Request for Comments; Establishment of a
Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; establishment of docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a docket to receive suggestions, recommendations, and
comments on innovative packaging, storage, and disposal systems,
technologies or designs (``designs'') that could be used to prevent or
deter misuse and abuse of opioid analgesics by patients and others. FDA
is interested in receiving comments on new designs as well as
enhancements to existing designs, and is particularly interested in
comments from academic institutions, regulated industry, technology
companies (e.g., those producing technologies for medication adherence,
disposal, or tracking), healthcare professionals, patient
representatives, clinical trial service providers, and other interested
organizations. Comments submitted in response to this notice will help
the Agency determine whether innovative designs for opioid analgesic
packaging, storage, and/or disposal systems could help prevent or deter
misuse and abuse without diminishing access for patients with
legitimate prescriptions.
DATES: Submit either electronic or written comments by June 9, 2014.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
301), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Colleen Brennan, Center for Drug
Evaluation and Research, Office of Surveillance and Epidemiology, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4410,
Silver Spring, MD 20993-0002, 301-796-2316, email:
Colleen.Brennan@fda.hhs.gov, with the subject line identified as
``Packaging Abuse Deterrence Strategies.''
SUPPLEMENTARY INFORMATION:
I. Background
Prescription opioid analgesics are important medications that are
widely prescribed for the treatment of both non-cancer and cancer-
related pain. When used properly for their approved indications, opioid
drugs provide significant benefits for patients. However, they also
carry a risk of misuse, abuse, addiction, overdose, and death.
According to an analysis from the Centers for Disease Control and
Prevention, in 2010, prescription opioid drugs were involved in 16,651
overdose deaths, which represented a 313 percent increase over the past
decade (Ref. 1). The Substance Abuse and Mental Health Services
Administration (SAMHSA) reports that for each overdose death, there
were an additional 11 treatment admissions (Ref. 2), 33 emergency
department visits (Ref. 3), and 880 non-medical users of these drugs
(Ref. 4).
Although inappropriate or illicit use, such as sharing the drug
with family and friends or using drugs stolen from home medicine
cabinets account for some of the problems with prescription opioids,
legitimate use of opioids for pain may also lead to adverse events,
addiction, and death. FDA plays a central role in the development,
review, and approval of opioid drug products and must strike a balance
between their benefit in the legitimate treatment of patients with pain
and the risks to those patients and others associated with misuse,
abuse, and addiction.
Combating opioid misuse, abuse, and addiction has long been both a
public health priority and a priority for the Agency. FDA has taken
many steps to address these problems; however, we recognize that more
can be done and have established a task force that has embarked on a
multi-pronged approach, building upon existing initiatives and
developing new initiatives (https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337852.htm). Exploring innovative designs for
drug packaging, storage, and/or disposal is one of the many initiatives
targeted by the task force.
Designs for drug packaging, storage, and disposal have evolved
considerably in the past decade to include many technology-based
features such as electronic systems for monitoring, assessing, and
improving adherence to medication regimens. For example, these systems
may include functionality to remind patients to take a dose, track
[[Page 19620]]
when a dose is taken and how much is taken, and limit further access
until it is time for the next dose. Additionally, many of these drug-
device combinations electronically encrypt and capture the accumulated
adherence data, which can be downloaded directly from the device or
wirelessly transmitted to the prescriber. These technologies have not
only been used in clinical management and monitoring of protocol
compliance in clinical trials, but have also been applied to combat the
problem of prescription opioid misuse and abuse.
Other potentially relevant technologies include ``track and trace''
capabilities, radio-frequency identification-based systems, microchips
embedded within tablets, and in-home medication deactivation and/or
disposal systems.
FDA is interested in further exploring the role of existing and
innovative designs for drug product packaging, storage, and/or disposal
in mitigating opioid misuse, abuse, and addiction. For example, many of
the features of medication adherence monitoring technologies could be
used or adapted to help prevent serious complications (e.g., overdose,
addiction) by supporting proper dosage and administration, and could
also help prescribers monitor for signs of abuse or medication sharing
by facilitating effective patient management and followup.
Additionally, medication packaging and/or storage designs that limit
access could help prevent use of the medication by someone for whom it
was not prescribed, thereby, preventing accidental exposure (e.g., by a
child or other household contact) or theft. Finally, medication
packaging, storage, and/or disposal designs could be applied or adapted
to help ensure safe disposal, including chemical deactivation, of any
unused or residual medication.
II. Establishment of a Docket
FDA is announcing the establishment of a public docket to provide
an opportunity for interested persons to share information, research,
and ideas on how drug product packaging, storage, and/or disposal
systems could be designed or adapted to address problems associated
with prescription opioid abuse and misuse. These comments will help the
Agency explore whether existing or innovative designs can be applied or
adapted to prevent or deter misuse and abuse, while ensuring that
patients in pain have appropriate access to opioid analgesics.
III. Suggestions for Those Submitting Comments in Response to This
Notice
Proposed packaging, storage, and/or disposal designs should be
feasible to implement, and should not impair access for patients who
have legitimate prescriptions. Comments about specific system or
technology designs should include a description of the following: (1)
Design features and functionality; (2) results of any formative or
summative human factors assessments conducted; (3) applications to
date, including information on the effectiveness and acceptability of
those applications (with literature references or other documentation);
(4) recommendations for how the system/technology design could be
applied or adapted (either alone and/or in combination with other
systems/technologies) to help prevent or deter misuse and abuse, and
any limitations of that application; (5) specific problems that could
be addressed (e.g., serious complications such as addiction or overdose
due to improper dosage and/or administration, improper disposal,
accidental use by someone for whom the medication was not prescribed);
and (6) to the extent possible, considerations for implementation into
routine dispensing and clinical use (e.g., how the solution would
impact the workflow in a retail pharmacy).
To help FDA prioritize among proposed approaches, the Agency is
also interested in receiving feedback about methods that could be used
to assess a system or technology's potential abuse-deterrent
characteristics and real-world impact (e.g., actual ability to prevent
or deter misuse and abuse, effect on access for appropriate patients,
patient confidentiality, burden on the healthcare system, feasibility
of implementation, whether the design could create unintended
medication errors). Finally, FDA is interested in receiving feedback on
methods for encouraging further research and development in this area,
and, if promising technologies are identified, incentivizing the
pharmaceutical industry (e.g. via patent extensions) to adopt such
technologies.
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. 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. The Agency will carefully consider all comments
submitted. FDA generally will not respond directly to the person or
organization submitting the comment.
V. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. Centers for Disease Control and Prevention. ``Opioids drive
continued increase in drug overdose deaths'' [Press Release] (2013).
https://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html.
2. SAMHSA, Center for Behavioral Health Statistics and Quality.
Treatment Episode Data Set (TEDS): 2001-2011. National Admissions to
Substance Abuse Treatment Services. BHSIS Series S-65, HHS
Publication No. (SMA) 13-4772. Rockville, MD: Substance Abuse and
Mental Health Services Administration, 2013.
3. SAMHSA, Center for Behavioral Health Statistics and Quality,
``Drug Abuse Warning Network,'' 2011. https://samhsa.gov/data/dawn/nations/Nation_2011_AllMA.xls.
4. Substance Abuse and Mental Health Services Administration,
Results from the 2012 National Survey on Drug Use and Health,
detailed table 1.1A, NSDUH Series H-46, HHS Publication No. (SMA)
13-4795. Rockville, MD: Substance Abuse and Mental Health Services
Administration, 2013.
Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07909 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P
