82 FR 18910 - Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		18910-18910
FR Document		2017-08182

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.

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

[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Page 18910]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08182]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected].

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

18910 Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices

ucm111462.htm for procedures on SUPPLEMENTARY INFORMATION: The Food symposium. Transcripts will also be
public conduct during advisory and Drug Administration’s (FDA) Center available in either hard copy or on CD–
committee meetings. for Drug Evaluation and Research, ROM, after submission of a Freedom of
Notice of this meeting is given under Professional Affairs and Stakeholder Information request. The Freedom of
the Federal Advisory Committee Act (5 Engagement Staff (PASES), is hosting a Information office address is available
U.S.C. app. 2). 1-day public symposium entitled ‘‘Safe on the Agency’s Web site at https://
Dated: April 18, 2017. Use Symposium: A Focus on Reducing www.fda.gov.
Anna K. Abram, Preventable Harm From Drugs in the Dated: April 17, 2017.
Outpatient Setting.’’ The purpose of this Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation and Analysis. symposium is to discuss sources of
Deputy Commissioner for Policy, Planning,
preventable harm from drugs in the Legislation, and Analysis.
[FR Doc. 2017–08189 Filed 4–21–17; 8:45 am]
outpatient setting, such as the use of
BILLING CODE 4164–01–P [FR Doc. 2017–08182 Filed 4–21–17; 8:45 am]
inappropriate medications in particular
BILLING CODE 4164–01–P
age groups, drug-drug interactions,
DEPARTMENT OF HEALTH AND unintended exposures, and misuse; and
to stimulate the exchange of ideas
HUMAN SERVICES DEPARTMENT OF HEALTH AND
among thought leaders on interventions
HUMAN SERVICES
Food and Drug Administration to reduce preventable harms and how
these interventions can be studied. This Food and Drug Administration
[Docket No. FDA–2017–N–0001] information may assist FDA in
identifying significant and unexplored [Docket No. FDA–2017–N–0001]
Safe Use Symposium: A Focus on areas of preventable harm from drugs for
Reducing Preventable Harm From the purpose of funding future research Vaccines and Related Biological
Drugs in the Outpatient Setting through the Safe Use Initiative. The Products Advisory Committee; Notice
symposium will feature presentations of Meeting
AGENCY: Food and Drug Administration,
HHS. on sources of outpatient preventable AGENCY: Food and Drug Administration,
ACTION: Notice of public symposium. harms, possible interventions, and HHS.
future research topics. Areas to be ACTION: Notice.
SUMMARY: The Food and Drug discussed include identifying drugs and
Administration’s (FDA or Agency) populations associated with a higher SUMMARY: The Food and Drug
Center for Drug Evaluation and risk of preventable harm, as well as Administration (FDA) announces a
Research, Professional Affairs and events which may be amenable to forthcoming public advisory committee
Stakeholder Engagement Staff (PASES), interventions. Methods to measure the meeting of the Vaccines and Related
is hosting a 1-day public symposium effect of interventions and how to apply Biological Products Advisory
entitled ‘‘Safe Use Symposium: A Focus these to the outpatient setting will also Committee (VRBPAC). The general
on Reducing Preventable Harm From be an important focus of discussion. function of the committee is to provide
Drugs in the Outpatient Setting.’’ The Presenters will represent advice and recommendations to the
purpose of this symposium is to discuss multidisciplinary backgrounds from Agency on FDA’s regulatory issues. The
sources of preventable harm from drugs government, academia, patient safety meeting will be open to the public.
in the outpatient setting and to groups, health care industry, and DATES: The meeting will be held on May
stimulate the exchange of ideas among clinicians. There will be opportunities 17, 2017, from 8:30 a.m. to 4:45 p.m.
thought leaders on interventions to for interaction between speakers and ADDRESSES: FDA White Oak Campus,
reduce preventable harms and how attendees as well as question and 10903 New Hampshire Ave., Building
these interventions can be studied. answer sessions. 31 Conference Center, the Great Room
DATES: The public symposium will be Registration: There is no registration
(rm. 1503), Silver Spring, MD 20993–
held on June 15, 2017, from 8 a.m. to 4 fee to attend the public symposium.
0002. For those unable to attend in
p.m. Early registration is recommended
person, the meeting will also be Web
because seating is limited, and
ADDRESSES: The public symposium will Cast and will be available at the
registration will be on a first-come, first-
be held at FDA’s White Oak campus, following link: https://
served basis. There will be no onsite
10903 New Hampshire Ave, Bldg. 31 collaboration.fda.gov/rsvvaccine0517.
registration. Persons interested in
(The Great Room C), Silver Spring, MD Answers to commonly asked questions
attending this symposium must register
20903. Entrance for the public including information regarding special
online at http://wcms.fda.gov/FDAgov/
symposium participants (non-FDA accommodations due to a disability,
Drugs/NewsEvents/
employees) is through Bldg. 1 where ucm538670.htm?SSContributor=true. visitor parking, and transportation may
routine security check procedures will For those without Internet access, please be accessed at: http://www.fda.gov/
be performed. For parking and security contact Christine Lee (see FOR FURTHER AdvisoryCommittees/
information, please refer to https:// INFORMATION CONTACT) to register. If you
AboutAdvisoryCommittees/
www.fda.gov/AboutFDA/ need special accommodations due to a ucm408555.htm.
WorkingatFDA/BuildingsandFacilities/ disability, please contact Christine Lee FOR FURTHER INFORMATION CONTACT:
WhiteOakCampusInformation/ at least 7 days in advance. CAPT Serina Hunter-Thomas or
ucm241740.htm. Transcripts: A transcript of the Rosanna Harvey, Center for Biologics
jstallworth on DSK7TPTVN1PROD with NOTICES

FOR FURTHER INFORMATION CONTACT: symposium will be available for review Evaluation and Research, Food and
Christine Lee, Center for Drug at the Division of Dockets Management Drug Administration, 10903 New
Evaluation and Research, Food and (HFA–305), Food and Drug Hampshire Ave., Bldg. 71, Rm. 6307C,
Drug Administration, 10903 New Administration, 5630 Fishers Lane, Rm. Silver Spring, MD 20993–0002, at 240–
Hampshire Ave., Silver Spring, MD 1061, Rockville, MD 20852, and on the 402–5771 serina.hunter-thomas@
20993–0002, 240–402–4228, email: Internet at https://www.regulations.gov fda.hhs.gov and 240–402–8072,
CDERSafeUseInitiative@fda.hhs.gov. approximately 30 days after the rosanna.harvey@fda.hhs.gov, or FDA

VerDate Sep<11>2014 13:48 Apr 21, 2017 Jkt 241001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1

Document Created: 2017-04-22 00:11:37
Document Modified: 2017-04-22 00:11:37

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public symposium.
Dates		The public symposium will be held on June 15, 2017, from 8 a.m. to 4 p.m.
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: [email protected]
FR Citation		82 FR 18910

82 FR 18910 - Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration