Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop, 18912-18913 [2017-08178]
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Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
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Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08177 Filed 4–21–17; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Reducing the Risk of Preventable
Adverse Drug Events Associated With
Hypoglycemia in the Older Population;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research (CDER),
Professional Affairs and Stakeholder
Engagement Staff (PASES), is
announcing a 1-day public workshop
entitled ‘‘Reducing the Risk of
Preventable Adverse Drug Events
Associated with Hypoglycemia in the
Older Population.’’ The purpose of this
workshop is to discuss the importance
of individualized glycemic control
targets for older patients with diabetes;
to reduce the risk of serious
hypoglycemia; identify and discuss
medication safety efforts, both those that
are part of the Safe Use Initiative and
those external to FDA, that are of direct
relevance and importance to older
patients living with the disease; discuss
future areas of research which could be
explored to reduce the risk of serious
hypoglycemia in older diabetic patients;
and disseminate the results of this
discussion to inform patients, patient
advocates, and health care practitioners.
DATES: The public workshop will be
held on September 12, 2017, from 9 a.m.
to 4 p.m.
ADDRESSES: The public workshop will
be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Scott Winiecki, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 240–402–8824, email:
CDERSafeUseInitiative@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA CDER, PASES, is announcing a
1-day public workshop entitled
‘‘Reducing the Risk of Preventable
Adverse Drug Events associated with
Hypoglycemia in the Older Population.’’
The purpose of this workshop is to: (1)
Discuss the importance of
individualized glycemic control targets
for older patients with diabetes, in order
to reduce the risk of serious
hypoglycemia; (2) identify and discuss
medication safety efforts, both those that
are part of the Safe Use Initiative and
those external to FDA, that are of direct
relevance and importance to older
patients living with the disease; (3)
discuss future areas of research which
could be explored to reduce the risk of
serious hypoglycemia in older diabetic
patients; and (4) disseminate the results
of this discussion to inform patients,
patient advocates, and health care
practitioners.
II. Topics for Discussion at the Public
Workshop
The symposium will feature
presentations on the scope of
hypoglycemia-related adverse drug
events in the older population, the risks
and benefits of various degrees of
glycemic control, factors affecting
patient centered care, research into
effective diabetes management, and the
concept and translation of
individualized glycemic targets to
minimize adverse events in practice
settings. Presenters will represent
multidisciplinary backgrounds from
government, academia, patient safety
groups, health care industry, and
clinicians. There will be opportunities
for collaboration between speakers and
attendees as well as question and
answer sessions.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
Web site: https://wcms.fda.gov/FDAgov/
Drugs/NewsEvents/
ucm538666.htm?SSContributor=true.
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 August 29, 2017, midnight
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. If time and space permit,
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24APN1
Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices
onsite registration on the day of the
public workshop will be provided
beginning at 7:30 a.m.
For those without Internet access,
please contact Scott Winiecki, (see FOR
FURTHER INFORMATION CONTACT) to
register. If you need special
accommodations due to a disability,
please contact Scott Winiecki no later
than September 1, 2017.
Transcripts: A transcript of the public
workshop will be accessible at https://
www.regulations.gov approximately 30
days after the workshop. It may also be
viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08178 Filed 4–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0179]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
send proposed agendas to the Agency by
June 23, 2017.
FOR FURTHER INFORMATION CONTACT: Dan
Brum, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5480, Silver Spring,
MD 20993–0002, 301–796–0578,
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
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13:48 Apr 21, 2017
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the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the Site Tours Program will be the
responsibility of CDER; therefore,
selection will be based on the
availability of funds and resources for
each fiscal year. Selection will also be
based on firms having a favorable
facility status as determined by FDA’s
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18913
Office of Regulatory Affairs District
Offices in the firms’ respective regions.
Firms that want to learn more about this
training opportunity or that are
interested in offering a site tour should
respond by sending a proposed agenda
by email directly to Dan Brum (see
DATES and FOR FURTHER INFORMATION
CONTACT).
Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08183 Filed 4–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidance for
Naloxone Hydrochloride; New Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
new draft guidance for industry on
generic naloxone hydrochloride nasal
spray entitled ‘‘Draft Guidance on
Naloxone Hydrochloride.’’ The new
draft guidance, when finalized, will
provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs) for naloxone
hydrochloride nasal spray.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final versions of the guidance, submit
either electronic or written comments
on the draft guidances by June 23, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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\24APN1.SGM
24APN1
Agencies
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18912-18913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Reducing the Risk of Preventable Adverse Drug Events Associated
With Hypoglycemia in the Older Population; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER), Professional Affairs and Stakeholder
Engagement Staff (PASES), is announcing a 1-day public workshop
entitled ``Reducing the Risk of Preventable Adverse Drug Events
Associated with Hypoglycemia in the Older Population.'' The purpose of
this workshop is to discuss the importance of individualized glycemic
control targets for older patients with diabetes; to reduce the risk of
serious hypoglycemia; identify and discuss medication safety efforts,
both those that are part of the Safe Use Initiative and those external
to FDA, that are of direct relevance and importance to older patients
living with the disease; discuss future areas of research which could
be explored to reduce the risk of serious hypoglycemia in older
diabetic patients; and disseminate the results of this discussion to
inform patients, patient advocates, and health care practitioners.
DATES: The public workshop will be held on September 12, 2017, from 9
a.m. to 4 p.m.
ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Scott Winiecki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-8824, email:
CDERSafeUseInitiative@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA CDER, PASES, is announcing a 1-day public workshop entitled
``Reducing the Risk of Preventable Adverse Drug Events associated with
Hypoglycemia in the Older Population.'' The purpose of this workshop is
to: (1) Discuss the importance of individualized glycemic control
targets for older patients with diabetes, in order to reduce the risk
of serious hypoglycemia; (2) identify and discuss medication safety
efforts, both those that are part of the Safe Use Initiative and those
external to FDA, that are of direct relevance and importance to older
patients living with the disease; (3) discuss future areas of research
which could be explored to reduce the risk of serious hypoglycemia in
older diabetic patients; and (4) disseminate the results of this
discussion to inform patients, patient advocates, and health care
practitioners.
II. Topics for Discussion at the Public Workshop
The symposium will feature presentations on the scope of
hypoglycemia-related adverse drug events in the older population, the
risks and benefits of various degrees of glycemic control, factors
affecting patient centered care, research into effective diabetes
management, and the concept and translation of individualized glycemic
targets to minimize adverse events in practice settings. Presenters
will represent multidisciplinary backgrounds from government, academia,
patient safety groups, health care industry, and clinicians. There will
be opportunities for collaboration between speakers and attendees as
well as question and answer sessions.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following Web site: https://wcms.fda.gov/FDAgov/Drugs/NewsEvents/ucm538666.htm?SSContributor=true. 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 August 29, 2017, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization. If time
and space permit,
[[Page 18913]]
onsite registration on the day of the public workshop will be provided
beginning at 7:30 a.m.
For those without Internet access, please contact Scott Winiecki,
(see FOR FURTHER INFORMATION CONTACT) to register. If you need special
accommodations due to a disability, please contact Scott Winiecki no
later than September 1, 2017.
Transcripts: A transcript of the public workshop will be accessible
at https://www.regulations.gov approximately 30 days after the
workshop. It may also be viewed at the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08178 Filed 4-21-17; 8:45 am]
BILLING CODE 4164-01-P