
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Page 18910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Safe Use Symposium: A Focus on Reducing Preventable Harm From 
Drugs in the Outpatient Setting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public symposium.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research, Professional Affairs and Stakeholder 
Engagement Staff (PASES), is hosting a 1-day public symposium entitled 
``Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs 
in the Outpatient Setting.'' The purpose of this symposium is to 
discuss sources of preventable harm from drugs in the outpatient 
setting and to stimulate the exchange of ideas among thought leaders on 
interventions to reduce preventable harms and how these interventions 
can be studied.

DATES: The public symposium will be held on June 15, 2017, from 8 a.m. 
to 4 p.m.

ADDRESSES: The public symposium will be held at FDA's White Oak campus, 
10903 New Hampshire Ave, Bldg. 31 (The Great Room C), Silver Spring, MD 
20903. Entrance for the public symposium participants (non-FDA 
employees) is through Bldg. 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: Christine Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-4228, email: 
CDERSafeUseInitiative@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration's (FDA) 
Center for Drug Evaluation and Research, Professional Affairs and 
Stakeholder Engagement Staff (PASES), is hosting a 1-day public 
symposium entitled ``Safe Use Symposium: A Focus on Reducing 
Preventable Harm From Drugs in the Outpatient Setting.'' The purpose of 
this symposium is to discuss sources of preventable harm from drugs in 
the outpatient setting, such as the use of inappropriate medications in 
particular age groups, drug-drug interactions, unintended exposures, 
and misuse; and to stimulate the exchange of ideas among thought 
leaders on interventions to reduce preventable harms and how these 
interventions can be studied. This information may assist FDA in 
identifying significant and unexplored areas of preventable harm from 
drugs for the purpose of funding future research through the Safe Use 
Initiative. The symposium will feature presentations on sources of 
outpatient preventable harms, possible interventions, and future 
research topics. Areas to be discussed include identifying drugs and 
populations associated with a higher risk of preventable harm, as well 
as events which may be amenable to interventions. Methods to measure 
the effect of interventions and how to apply these to the outpatient 
setting will also be an important focus of discussion.
    Presenters will represent multidisciplinary backgrounds from 
government, academia, patient safety groups, health care industry, and 
clinicians. There will be opportunities for interaction between 
speakers and attendees as well as question and answer sessions.
    Registration: There is no registration fee to attend the public 
symposium. Early registration is recommended because seating is 
limited, and registration will be on a first-come, first-served basis. 
There will be no onsite registration. Persons interested in attending 
this symposium must register online at http://wcms.fda.gov/FDAgov/Drugs/NewsEvents/ucm538670.htm?SSContributor=true. For those without 
Internet access, please contact Christine Lee (see FOR FURTHER 
INFORMATION CONTACT) to register. If you need special accommodations 
due to a disability, please contact Christine Lee at least 7 days in 
advance.
    Transcripts: A transcript of the symposium will be available for 
review at the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
on the Internet at https://www.regulations.gov approximately 30 days 
after the symposium. Transcripts will also be available in either hard 
copy or on CD-ROM, after submission of a Freedom of Information 
request. The Freedom of Information office address is available on the 
Agency's Web site at https://www.fda.gov.

    Dated: April 17, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08182 Filed 4-21-17; 8:45 am]
 BILLING CODE 4164-01-P


