82 FR 18909 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		18909-18910
FR Document		2017-08189

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

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

[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18909-18910]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Gastroenterology and Urology 
Devices Panel of the Medical Devices Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public.

DATES: The meeting will be held on May 17, 2017, from 8 a.m. to 6 p.m.

ADDRESSES: Hilton Washington, DC/North, Salons A, B, C, and D, 620 
Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 
301-977-8900. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio G. Garcia, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993-0002, 
[email protected], 301-796-6875, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On May 17, 2017, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval application (PMA) for the TRANSMEDICS ORGAN CARE SYSTEM 
(OCS)--Lung System, by TransMedics, Inc. The proposed Indication for 
Use, as stated in the PMA, is as follows: The TRANSMEDICS ORGAN CARE 
SYSTEM (OCS) Lung System is a portable organ perfusion, ventilation, 
and monitoring medical device intended to preserve donor lungs in a 
near physiologic, ventilated, and perfused state for transplantation.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
8, 2017. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Those individuals interested in making 
formal oral presentations should notify the contact person and submit a 
brief statement of the general nature of the evidence or arguments they 
wish to present, the names and addresses of proposed participants, and 
an indication of the approximate time requested to make their 
presentation on or before April 28, 2017. Time allotted for each 
presentation may be limited. If the number of registrants requesting to 
speak is greater than can be reasonably accommodated during the 
scheduled open public hearing session, FDA may conduct a lottery to 
determine the speakers for the scheduled open public hearing session. 
The contact person will notify interested persons regarding their 
request to speak by May 1, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Artair Mallett at [email protected] or 301-796-9638 at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/

[[Page 18910]]

ucm111462.htm for procedures on public conduct during advisory 
committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2017-08189 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

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

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.
Dates		The meeting will be held on May 17, 2017, from 8 a.m. to 6 p.m.
Contact		Patricio G. Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993-0002, [email protected], 301-796-6875, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FR Citation		82 FR 18909

82 FR 18909 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

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