The Fifth Annual Food and Drug Administration-International Society for Pharmaceutical Engineering Quality Conference, 13376 [2016-05627]
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Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
https://www.fda.gov. Send faxed requests
to 301–827–9267.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05621 Filed 3–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
The Fifth Annual Food and Drug
Administration-International Society
for Pharmaceutical Engineering
Quality Conference
AGENCY:
The meeting will be held at
the Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Rd.,
Bethesda, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Susan Krys, ISPE, 7200 Wisconsin Ave.,
Suite 305, Bethesda, MD 20814, 301–
364–9202, FAX: 240–204–6024, email:
skrys@ispe.org, or Sau (Larry) Lee, 301–
796–2905, email: Sau.Lee@fda.hhs.gov.
ADDRESSES:
Food and Drug Administration,
HHS.
ACTION:
Evaluation and Research, in cosponsorship with the International
Society for Pharmaceutical Engineering
(ISPE), is announcing a meeting entitled
‘‘Fifth Annual FDA–ISPE Quality
Conference.’’ The purpose of the
meeting is to discuss manufacturing,
compliance, and management practices
that create, implement, and sustain a
culture of high quality and result in
reliable pharmaceutical and biologic
products that support patient health.
DATES: The meeting will be held on June
6, 7, and 8, 2016, from 8:30 a.m. to 4
p.m.
Notice of meeting.
The Food and Drug
Administration’s (FDA) Center for Drug
SUMMARY:
ISPE is an
association of engineers, scientists,
manufacturing, quality, and industrial
professionals involved in the
development, manufacture, quality
control, and regulation of
pharmaceuticals and related products.
This co-sponsored meeting facilitates
discussion and problem solving around
technical, quality, compliance, and
other manufacturing issues.
Registration: There is a registration fee
to attend this meeting. The registration
fee is charged to help defray the costs
of programming and facilities. Seats are
limited, and registration will be on a
first-come, first-served basis.
To register, please complete
registration online at https://
www.ispe.org/events. FDA has verified
the Web address, but FDA is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register. The
costs of registration for the different
categories of attendees are as follows:
SUPPLEMENTARY INFORMATION:
Category
Cost
jstallworth on DSK7TPTVN1PROD with NOTICES
Industry Representatives:
ISPE Members ........................................................................................................................................
Non-members ..........................................................................................................................................
Academic ........................................................................................................................................................
Government ....................................................................................................................................................
Accommodations: Attendees are
responsible for their own hotel
accommodations. Attendees making
reservations at the Bethesda North
Marriott Hotel & Conference Center in
Bethesda, MD are eligible for a reduced
rate of $209 USD, not including
applicable taxes. To receive the reduced
rate, contact the Bethesda North
Marriott Hotel (1–301–822–9200 or 1–
800–859–8003) and identify yourself as
an attendee of the meeting. If you need
special accommodations due to a
disability, please contact Susan Krys at
least 7 days in advance.
Transcripts: We expect that
transcripts will be available
approximately 30 days after the
meeting. A transcript will 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. Send faxed requests to
301–827–9267.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05627 Filed 3–11–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:20 Mar 11, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Peripheral and
Central Nervous System Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 25, 2016, from 8 a.m. to
5:30 p.m. This meeting is a reschedule
of a postponed meeting announced in
the Federal Register of December 18,
2015 (80 FR 79047), originally
scheduled for January 22, 2016.
PO 00000
Frm 00067
Fmt 4703
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$1,895 (early-bird); $2,095 (onsite).
$2,275 (early-bird); $2,475 (onsite).
$1,425 (early-bird); $1,575 (onsite).
$700 (early-bird); $700 (onsite).
Location: College Park Marriott Hotel
and Conference Center, Chesapeake
Ballroom, 3501 University Blvd. East,
Hyattsville, MD 20783. The conference
center’s telephone number is 301–985–
7300.
Contact Person: Moon Hee V. Choi,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: PCNS@
fda.hhs.gov, 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 https://
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.
Agenda: The committee will discuss
new drug application (NDA) 206488,
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Page 13376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05627]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
The Fifth Annual Food and Drug Administration-International
Society for Pharmaceutical Engineering Quality Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research, in co-sponsorship with the International
Society for Pharmaceutical Engineering (ISPE), is announcing a meeting
entitled ``Fifth Annual FDA-ISPE Quality Conference.'' The purpose of
the meeting is to discuss manufacturing, compliance, and management
practices that create, implement, and sustain a culture of high quality
and result in reliable pharmaceutical and biologic products that
support patient health.
DATES: The meeting will be held on June 6, 7, and 8, 2016, from 8:30
a.m. to 4 p.m.
ADDRESSES: The meeting will be held at the Bethesda North Marriott
Hotel & Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852.
FOR FURTHER INFORMATION CONTACT: Susan Krys, ISPE, 7200 Wisconsin Ave.,
Suite 305, Bethesda, MD 20814, 301-364-9202, FAX: 240-204-6024, email:
skrys@ispe.org, or Sau (Larry) Lee, 301-796-2905, email:
Sau.Lee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: ISPE is an association of engineers,
scientists, manufacturing, quality, and industrial professionals
involved in the development, manufacture, quality control, and
regulation of pharmaceuticals and related products. This co-sponsored
meeting facilitates discussion and problem solving around technical,
quality, compliance, and other manufacturing issues.
Registration: There is a registration fee to attend this meeting.
The registration fee is charged to help defray the costs of programming
and facilities. Seats are limited, and registration will be on a first-
come, first-served basis.
To register, please complete registration online at https://www.ispe.org/events. FDA has verified the Web address, but FDA is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register. The costs of registration for the
different categories of attendees are as follows:
----------------------------------------------------------------------------------------------------------------
Category Cost
----------------------------------------------------------------------------------------------------------------
Industry Representatives:
ISPE Members............................... $1,895 (early-bird); $2,095 (onsite).
Non-members................................ $2,275 (early-bird); $2,475 (onsite).
Academic....................................... $1,425 (early-bird); $1,575 (onsite).
Government..................................... $700 (early-bird); $700 (onsite).
----------------------------------------------------------------------------------------------------------------
Accommodations: Attendees are responsible for their own hotel
accommodations. Attendees making reservations at the Bethesda North
Marriott Hotel & Conference Center in Bethesda, MD are eligible for a
reduced rate of $209 USD, not including applicable taxes. To receive
the reduced rate, contact the Bethesda North Marriott Hotel (1-301-822-
9200 or 1-800-859-8003) and identify yourself as an attendee of the
meeting. If you need special accommodations due to a disability, please
contact Susan Krys at least 7 days in advance.
Transcripts: We expect that transcripts will be available
approximately 30 days after the meeting. A transcript will 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. Send faxed
requests to 301-827-9267.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05627 Filed 3-11-16; 8:45 am]
BILLING CODE 4164-01-P
