Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed To Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments, 27271-27273 [2017-12299]
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Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
27271
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity 1
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 2
Pretest .......................................................................
Eye-Tracking Screener .............................................
Eye-Tracking Study ..................................................
Main Study Screener ................................................
Main Study ................................................................
500
80
20
2,206
1,500
1
1
1
1
1
500
80
20
2,206
1,500
0.33 (20 min.) ...........
.08 (5 min.) ...............
1 ................................
.03 (2 min.) ...............
0.33 (20 min.) ...........
165
7
20
67
495
Total ...................................................................
........................
........................
........................
...................................
1,563
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the next full hour.
2 Rounded
mstockstill on DSK30JT082PROD with NOTICES
References
1. Dodge, T. and A. Kaufman. ‘‘What Makes
Consumers Think Dietary Supplements
Are Safe and Effective? The Role of
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‘‘Influence of the Dietary Supplement
Health and Education Act on Consumer
Beliefs About the Safety and
Effectiveness of Dietary Supplements.’’
Journal of Health Communication:
International Perspectives. 16(3), 230–
244. (2011).
3. Mason, M.J., D.L. Scammon, and X. Feng.
‘‘The Impact of Warnings, Disclaimers
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4. France, K.R. and P.F. Bone. ‘‘Policy
Makers’ Paradigms and Evidence from
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https://www.ftc.gov/news-events/blogs/
business-blog/2014/09/full-disclosure
(September 23, 2014).
6. Higgins, E., M. Leinenger, and K. Rayner.
‘‘Eye Movements When Viewing
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8. Thomsen, S. and K. Fulton. ‘‘Adolescents’
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et al. ‘‘The Impact of Salient
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10. Wedel, M. and R. Pieters. ‘‘A Review of
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(pp. 123–147), N.K. Malhotra (Ed.).
Armonk, New York: M.E. Sharpe. (2008).
VerDate Sep<11>2014
17:36 Jun 13, 2017
Jkt 241001
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12329 Filed 6–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2903]
Data and Methods for Evaluating the
Impact of Opioid Formulations With
Properties Designed To Deter Abuse in
the Postmarket Setting: A Scientific
Discussion of Present and Future
Capabilities; Public Workshop; Issues
Paper; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop
entitled ‘‘Data and Methods for
Evaluating the Impact of Opioid
Formulations with Properties Designed
to Deter Abuse in the Postmarket
Setting: A Scientific Discussion of
Present and Future Capabilities.’’ The
purpose of the public workshop is to
host a scientific discussion with expert
panel members and interested
stakeholders about the challenges in
using the currently available data and
methods for assessing the impact of
opioid formulations with properties
designed to deter abuse on opioid
misuse, abuse, addiction, overdose, and
death in the postmarket setting. The
goal of this meeting is to discuss ways
to improve the analysis and
interpretation of existing data, as well as
to discuss opportunities and challenges
for collecting and/or linking additional
data to improve national surveillance
and research capabilities in this area. To
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
assist in the workshop discussion, FDA
is making available an issues paper that
provides a brief overview of the
currently available data resources used
for evaluating the impact of opioid
formulations with properties designed
to deter abuse; summarizes some of the
key methodological issues in this area;
and outlines the issues that we would
like to discuss during the upcoming
workshop, including enhancing existing
resources, applying new methodology,
and creating new resources.
DATES: The public workshop will be
held on July 10 and 11, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic
or written comments on this public
workshop by September 11, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 11,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 11, 2017.
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. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
MD 20910. The hotel’s phone number is
301–589–0800.
You may submit comments as
follows:
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
E:\FR\FM\14JNN1.SGM
14JNN1
27272
Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
mstockstill on DSK30JT082PROD with NOTICES
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2017–N–2093 for ‘‘Data and Methods for
Evaluating the Impact of Opioid
Formulations with Properties Designed
to Deter Abuse Properties in the
Postmarket Setting: A Scientific
Discussion of Present and Future
Capabilities; Public Workshop; Issues
Paper; Request for Comments.’’
Received comments, those filed in a
timely manner (see DATES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
VerDate Sep<11>2014
17:36 Jun 13, 2017
Jkt 241001
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 Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Cynthia Kornegay, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2456, Silver Spring,
MD, 20993–0002, 301–796–0187,
Cynthia.Kornegay@fda.hhs.gov; or
Cherice Holloway, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4466, Silver Spring,
MD, 20993–0002, 301–796–4909,
Cherice.Holloway@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In this 2-day public workshop, FDA
plans to host a scientific discussion
with expert panel members and
interested stakeholders about the
challenges in using the currently
available data and methods for assessing
the impact of opioid formulations with
properties designed to deter abuse on
opioid misuse, abuse, addiction,
overdose, and death in the postmarket
setting. The goal of this meeting is to
discuss ways to improve the analysis
and interpretation of existing data, as
well as to discuss opportunities and
challenges for collecting and/or linking
additional data to improve national
surveillance and research capabilities in
this area.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
II. Topics for Discussion at the Public
Workshop
FDA has developed an issues paper
entitled ‘‘Data and Methods for
Evaluating the Impact of Opioid
Formulations with Properties Designed
to Deter Abuse in the Postmarket
Setting.’’ This issues paper (1) provides
a brief overview of the currently
available data resources used for
evaluating opioid formulations with
properties designed to deter abuse; (2)
summarizes some of the key
methodological issues in this area; and
(3) outlines the issues we would like to
discuss during the upcoming workshop,
including modifying existing resources,
applying new methodology, and
creating new resources. The issues
paper can be found on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm540845.htm.
III. Participating in the Public
Workshop
Registration: To register to attend the
public workshop, ‘‘Data and Methods
for Evaluating the Impact of Opioid
Formulations with Properties Designed
to Deter Abuse in the Postmarket
Setting: A Scientific Discussion of
Present and Future Capabilities,’’ in
person or virtually via Webcast, please
contact Cherice Holloway at
cherice.holloway@fda.hhs.gov by June
26, 2017. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by June 26, 2017. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation when they have
been accepted. If time and space permit,
onsite registration on the day of the
public meeting/public workshop will be
provided beginning at 7:30 a.m.
If you need special accommodations
due to a disability, please contact
Cherice Holloway at cherice.holloway@
fda.hhs.gov no later than Friday, June
30, 2017.
Public Participation in Scientific
Workshop: Time will be provided
during the discussion of each agenda
topic for audience participants to
provide comments if desired. Comments
should be specific to the discussion
topic, and the time provided will be at
the discretion of the session chair.
Streaming Webcast of the Public
Workshop: This public workshop will
E:\FR\FM\14JNN1.SGM
14JNN1
Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12299 Filed 6–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
mstockstill on DSK30JT082PROD with NOTICES
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 material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Career Development Program to Promote
Diversity in Health Research.
Date: July 6, 2017.
Time: 8:30 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Lindsay Marie Garvin,
Ph.D., Scientific Review Officer, National
Heart, Lung, and Blood Institute, 6701
Rockledge Drive, Suite 7189, Bethesda, MD
20892, 301–827–7911, lindsay.garvin@
nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Biorepository: Scientific
Opportunities for Exploratory Research
(R21).
Date: July 7, 2017.
17:36 Jun 13, 2017
Jkt 241001
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crystal City Marriott, 1999 Jefferson
Davis Highway, Arlington, VA 22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–827–
7938, johnsonwj@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Short-Term Research Education to Increase
Diversity.
Date: July 7, 2017.
Time: 8:30 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Lindsay Marie Garvin,
Ph.D., Scientific Review Officer, National
Heart, Lung, and Blood Institute, 6701
Rockledge Drive, Suite 7189, Bethesda, MD
20892, 301–827–7911, lindsay.garvin@
nih.gov.
Date: June 29–30, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Kan Ma, Ph.D., Scientific
Review Officer, Scientific Review Branch,
National Institute of Arthritis,
Musculoskeletal and Skin Diseases, NIH,
6701 Democracy Boulevard, Suite 814,
Bethesda, MD 20892, 301–451–4838, mak2@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
also be Webcast. Additional information
about accessing the Webcast will be
made available at least 2 days prior to
the public workshop at: https://
www.fda.gov/Drugs/NewsEvents/
ucm540845.htm.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A link to the transcript
will also be available on the Internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm540845.htm.
VerDate Sep<11>2014
27273
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 8, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–12239 Filed 6–13–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
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 meeting.
The meeting 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 material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; P30 Core
Centers for Clinical Research.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Dated: June 8, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–12240 Filed 6–13–17; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
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 meeting.
The meeting 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 material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Arthritis and Musculoskeletal and Skin
Diseases Special Emphasis Panel; Training
Grants Review.
Date: June 20, 2017.
Time: 2:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Arthritis and
Musculoskeletal and Skin Diseases, 6701
Democracy Blvd., Suite 824, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Yin Liu, Ph.D., MD,
Scientific Review Officer, Scientific Review
Branch, National Institute of Health/NIAMS,
6701 Democracy Blvd., Suite 824, Bethesda,
MD 20892, 301–594–4952, liuy@
exchange.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
E:\FR\FM\14JNN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)]
[Notices]
[Pages 27271-27273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12299]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2903]
Data and Methods for Evaluating the Impact of Opioid Formulations
With Properties Designed To Deter Abuse in the Postmarket Setting: A
Scientific Discussion of Present and Future Capabilities; Public
Workshop; Issues Paper; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public workshop entitled ``Data and Methods for Evaluating
the Impact of Opioid Formulations with Properties Designed to Deter
Abuse in the Postmarket Setting: A Scientific Discussion of Present and
Future Capabilities.'' The purpose of the public workshop is to host a
scientific discussion with expert panel members and interested
stakeholders about the challenges in using the currently available data
and methods for assessing the impact of opioid formulations with
properties designed to deter abuse on opioid misuse, abuse, addiction,
overdose, and death in the postmarket setting. The goal of this meeting
is to discuss ways to improve the analysis and interpretation of
existing data, as well as to discuss opportunities and challenges for
collecting and/or linking additional data to improve national
surveillance and research capabilities in this area. To assist in the
workshop discussion, FDA is making available an issues paper that
provides a brief overview of the currently available data resources
used for evaluating the impact of opioid formulations with properties
designed to deter abuse; summarizes some of the key methodological
issues in this area; and outlines the issues that we would like to
discuss during the upcoming workshop, including enhancing existing
resources, applying new methodology, and creating new resources.
DATES: The public workshop will be held on July 10 and 11, 2017, from
8:30 a.m. to 5 p.m. Submit either electronic or written comments on
this public workshop by September 11, 2017. Late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before September 11, 2017. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of September 11, 2017. 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. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public workshop will be held at the Sheraton Silver
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's
phone number is 301-589-0800.
You may submit comments as follows:
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
[[Page 27272]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2017-N-2093 for ``Data and Methods for Evaluating the Impact of
Opioid Formulations with Properties Designed to Deter Abuse Properties
in the Postmarket Setting: A Scientific Discussion of Present and
Future Capabilities; Public Workshop; Issues Paper; Request for
Comments.'' Received comments, those filed in a timely manner (see
DATES), will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Cynthia Kornegay, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2456, Silver
Spring, MD, 20993-0002, 301-796-0187, Cynthia.Kornegay@fda.hhs.gov; or
Cherice Holloway, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4466, Silver Spring, MD, 20993-0002, 301-796-4909,
Cherice.Holloway@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In this 2-day public workshop, FDA plans to host a scientific
discussion with expert panel members and interested stakeholders about
the challenges in using the currently available data and methods for
assessing the impact of opioid formulations with properties designed to
deter abuse on opioid misuse, abuse, addiction, overdose, and death in
the postmarket setting. The goal of this meeting is to discuss ways to
improve the analysis and interpretation of existing data, as well as to
discuss opportunities and challenges for collecting and/or linking
additional data to improve national surveillance and research
capabilities in this area.
II. Topics for Discussion at the Public Workshop
FDA has developed an issues paper entitled ``Data and Methods for
Evaluating the Impact of Opioid Formulations with Properties Designed
to Deter Abuse in the Postmarket Setting.'' This issues paper (1)
provides a brief overview of the currently available data resources
used for evaluating opioid formulations with properties designed to
deter abuse; (2) summarizes some of the key methodological issues in
this area; and (3) outlines the issues we would like to discuss during
the upcoming workshop, including modifying existing resources, applying
new methodology, and creating new resources. The issues paper can be
found on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.
III. Participating in the Public Workshop
Registration: To register to attend the public workshop, ``Data and
Methods for Evaluating the Impact of Opioid Formulations with
Properties Designed to Deter Abuse in the Postmarket Setting: A
Scientific Discussion of Present and Future Capabilities,'' in person
or virtually via Webcast, please contact Cherice Holloway at
cherice.holloway@fda.hhs.gov by June 26, 2017. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by June 26, 2017. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting/public workshop
will be provided beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Cherice Holloway at cherice.holloway@fda.hhs.gov no later than
Friday, June 30, 2017.
Public Participation in Scientific Workshop: Time will be provided
during the discussion of each agenda topic for audience participants to
provide comments if desired. Comments should be specific to the
discussion topic, and the time provided will be at the discretion of
the session chair.
Streaming Webcast of the Public Workshop: This public workshop will
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also be Webcast. Additional information about accessing the Webcast
will be made available at least 2 days prior to the public workshop at:
https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm540845.htm.
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12299 Filed 6-13-17; 8:45 am]
BILLING CODE 4164-01-P
