82 FR 18912 - Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 77 (April 24, 2017)

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.

[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18912-18913]
From the Federal Register Online  [www.thefederalregister.org]
[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 http://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: 
[email protected].

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: http://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