Food and Drug Administration/Xavier University Global Outsourcing Conference, 41416-41417 [2012-17077]
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41416
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
FOR FURTHER INFORMATION CONTACT:
Astrid Lopez-Goldberg, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5368,
Silver Spring, MD 20993–0002,
301–796–3485, astrid.lopezgoldberg@
fda.hhs.gov.
In FR Doc.
2012–16475, appearing on page 40069
in the Federal Register of Friday, July
06, 2012, the following correction is
made:
1. On page 40070, in the first column,
in the last paragraph, the Web link
‘‘https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
EnforcementActivitiesbyFDA/Selected
EnforcementActionsonUnapproved
Drugs/ucm238675.htm’’ is corrected to
read ‘‘https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/EnforcementActivitiesby
FDA/SelectedEnforcementActionson
UnapprovedDrugs/ucm238675.htm#
narcotics’’.
SUPPLEMENTARY INFORMATION:
Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17089 Filed 7–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Food and Drug Administration/Xavier
University Global Outsourcing
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Cincinnati
District, in cosponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University Global Outsourcing
Conference.’’ This public conference for
the pharmaceutical industry is in direct
alignment with the ‘‘FDA Strategic
Priorities 2011–2015,’’ and includes
presentations from key FDA officials,
global regulators, and industry experts.
This conference drives collaboration on
the topic of global outsourcing
compliance by bringing pharmaceutical/
biotechnology companies and contract
partners to the same event to address
the issues that reside on both sides of
the contract. Expert presentations
address the ‘‘how to’’ aspects of
improving outsourced product quality
through topics such as FDA
International Initiatives, FDA Inspection
Trends, Supply Chain Development,
Quality Agreements, Supplier
Qualification, and many more. The
SUMMARY:
experience level of our audience has
fostered engaged dialogue that has led to
innovative initiatives.
Dates and Times: The public
conference will be held on September
24, 2012, from 8:30 a.m. to 5 p.m.;
September 25, 2012, from 8:30 a.m. to
5:30 p.m.; and September 26, 2012, from
8:30 a.m. to 12:45 p.m.
Location: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207, 513–745–3073 or
513–745–3396.
Contact Persons:
For information regarding this notice:
Steven Eastham, Food and Drug
Administration, Cincinnati South
Office, 36 East Seventh Street,
Cincinnati, OH 45202, 513–246–4134,
email: steven.eastham@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH 45207,
513–745–3073, email:
phillipsm4@xavier.edu.
Registration: There is a registration
fee. The conference registration fees
cover the cost of the presentations,
training materials, receptions,
breakfasts, lunches, and dinners for the
2 1⁄2 days of the conference. Early
registration ends August 5, 2012.
Standard registration ends September 2,
2012. Late registration occurs September
3 to September 23, 2012. There will also
be onsite registration. The cost of
registration is as follows:
TABLE 1—REGISTRATION FEES 1
Fee on or before
August 5th
Attendee
Industry ........................................................................................
Small Business (<100 employees) ..............................................
Consultants ..................................................................................
Startup Manufacturers/Academic ................................................
Media/Government ......................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
1 The
Fee August
6th–September 2nd
$995
800
500
200
Free
Fee September
3rd–September 23rd
$1,295
900
600
250
Free
$1,495
1,000
700
300
Free
fourth registration from the same company is free.
The following forms of payment will
be accepted: American Express, Visa,
Mastercard, and company checks.
To register online for the public
conference, please visit the ‘‘Register
Now’’ link on the conference Web site
at https://www.XavierGOC.com. FDA has
verified the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, email, and
payment information for the fee to
Xavier University, Attention: Sue
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
Bensman, 3800 Victory Pkwy.,
Cincinnati, OH 45207. An email will be
sent confirming your registration.
Attendees are responsible for their
own accommodations. The conference
headquarters hotel is the Downtown
Cincinnati Hilton Netherlands Plaza, 35
West Fifth St., Cincinnati, OH 45202,
513–421–9100. To make reservations
online, please visit the ‘‘Venue &
Logistics’’ link at https://
www.XavierGOC.com to make
reservations. The hotel is expected to
sell out during this timeframe, so early
reservation in the conference roomblock is encouraged.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
If you need special accommodations
due to a disability, please contact Marla
Phillips (see Contact Persons) at least 7
days in advance of the conference.
The
public conference helps fulfill the
Department of Health and Human
Services and FDA’s important mission
to protect the public health. The
conference will provide those engaged
in FDA-regulated outsourcing with
information on the following topics:
SUPPLEMENTARY INFORMATION:
• FDA International Initiatives
• European Union Regulator
Perspective
E:\FR\FM\13JYN1.SGM
13JYN1
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
• United States Pharmacopeia Chapter
Development Impact
• Total Cost of Quality
• FDA New Inspectional Approach and
Trends
• Supplier Selection and Due Diligence
• How to Operate in Different Regions
of the World
• Establishing a Meaningful Supplier
Qualification Program
• Supply Chain Development
• Finished Product Distribution
Channel
• Enterprise Resource Planning
• Self Inspections & Corporate Audits
• Quality Agreements
• Business Process Management
• Global Standards Association Near
Term Solutions
The conference includes:
• Deep Dive Lunch Sessions
• Live Polling Used by Speakers
• Case Studies
• Small Group Discussions
• Networking Lunch by Topic
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105–
115), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121)
by providing outreach activities by
Government Agencies to small
businesses.
Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17077 Filed 7–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0622]
srobinson on DSK4SPTVN1PROD with NOTICES
Regulatory Science Considerations for
Medical Countermeasure Radiation
Biodosimetry Devices
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing the following
public meeting entitled ‘‘Regulatory
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
Science Considerations for Medical
Countermeasure (MCM) Radiation
Biodosimetry Devices.’’ The purpose of
the public meeting is to obtain input
from academia, Government, industry,
and other stakeholders on the clinical
application and scientific and
technological challenges for
performance validation of radiation
biodosimetry devices.
Date and Time: The public meeting
will be held on September 27 and 28,
2012, from 8 a.m. to 5 p.m.
Location: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Bldg. 1 where routine security
check procedures will be performed. For
parking and security information, please
visit the following Web site: https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. The public meeting
will also be webcast.
Contact: Jennifer S. Dickey, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4254,
Silver Spring, MD 20993–0002, 301–
796–5028, Fax: 301–847–8512, email:
Jennifer.Dickey@fda.hhs.gov.
Registration: Registration is free and
will be on a first-come, first-served
basis. Persons interested in attending
this public meeting must register online
by 4 p.m., September 13, 2012. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permits, onsite registration on the
day of the public meeting will be
provided beginning at 7 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4321, Silver Spring,
MD 20993–0002, 301–796–5661, email:
Susan.Monahan@fda.hhs.gov at least 7
days in advance of the meeting.
To register for the public meeting,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public meeting
from the posted events list.) Please
provide complete contact information
for each attendee, including name, title,
affiliation, email, and telephone
number. Those without Internet access
PO 00000
Frm 00068
Fmt 4703
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41417
should contact Susan Monahan to
register (see previous paragraph).
Registrants will receive confirmation
after they have been accepted. You will
be notified if you are on a waiting list.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. Persons interested in
viewing the webcast must register
online by 4 p.m., September 13, 2012.
Early registration is recommended
because webcast connections are
limited. Organizations are requested to
register all participants, but to view
using one connection per location.
Webcast participants will be sent
technical system requirements after
registration and will be sent connection
access information after September 20,
2012. If you have never attended a
Connect Pro meeting before, test your
connection at: https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit: https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Requests for Oral Presentations: This
public meeting includes public
comment sessions. During online
registration you may indicate if you
wish to present during a public
comment session or participate in a
specific session, and which topics you
wish to address. FDA has included
general topics in this document. FDA
will do its best to accommodate requests
to make public comment. Individuals
and organizations with common
interests are urged to consolidate or
coordinate their presentations, and
request time for a joint presentation.
Following the close of registration, FDA
will determine the amount of time
allotted to each presenter and the
approximate time that each oral
presentation is to begin, and will select
and notify participants by September
18, 2012. All requests to make oral
presentations must be received by the
close of registration on September 13,
2012 by 4 p.m. If selected for
presentation, any presentation materials
must be emailed to Jennifer Dickey (see
Contact) no later than September 24,
2012. No commercial or promotional
material will be permitted to be
presented or distributed at the meeting.
Comments: FDA is holding this public
meeting to obtain information on the
clinical application and scientific and
technological challenges for
performance validation of radiation
biodosimetry devices. In order to permit
E:\FR\FM\13JYN1.SGM
13JYN1
]]>Agencies
[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41416-41417]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17077]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Food and Drug Administration/Xavier University Global Outsourcing
Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
cosponsorship with Xavier University, is announcing a public conference
entitled ``FDA/Xavier University Global Outsourcing Conference.'' This
public conference for the pharmaceutical industry is in direct
alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes
presentations from key FDA officials, global regulators, and industry
experts. This conference drives collaboration on the topic of global
outsourcing compliance by bringing pharmaceutical/biotechnology
companies and contract partners to the same event to address the issues
that reside on both sides of the contract. Expert presentations address
the ``how to'' aspects of improving outsourced product quality through
topics such as FDA International Initiatives, FDA Inspection Trends,
Supply Chain Development, Quality Agreements, Supplier Qualification,
and many more. The experience level of our audience has fostered
engaged dialogue that has led to innovative initiatives.
Dates and Times: The public conference will be held on September
24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m.
to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m.
Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or 513-745-3396.
Contact Persons:
For information regarding this notice: Steven Eastham, Food and
Drug Administration, Cincinnati South Office, 36 East Seventh Street,
Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov.
For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, email: phillipsm4@xavier.edu.
Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, lunches, and dinners for the 2 \1/2\
days of the conference. Early registration ends August 5, 2012.
Standard registration ends September 2, 2012. Late registration occurs
September 3 to September 23, 2012. There will also be onsite
registration. The cost of registration is as follows:
Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
Fee on or before Fee August 6th- Fee September 3rd-
Attendee August 5th September 2nd September 23rd
----------------------------------------------------------------------------------------------------------------
Industry............................. $995 $1,295 $1,495
Small Business (<100 employees)...... 800 900 1,000
Consultants.......................... 500 600 700
Startup Manufacturers/Academic....... 200 250 300
Media/Government..................... Free Free Free
----------------------------------------------------------------------------------------------------------------
\1\ The fourth registration from the same company is free.
The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.
To register online for the public conference, please visit the
``Register Now'' link on the conference Web site at https://www.XavierGOC.com. FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this document
publishes in the Federal Register.
To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, email, and payment information for
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory
Pkwy., Cincinnati, OH 45207. An email will be sent confirming your
registration.
Attendees are responsible for their own accommodations. The
conference headquarters hotel is the Downtown Cincinnati Hilton
Netherlands Plaza, 35 West Fifth St., Cincinnati, OH 45202, 513-421-
9100. To make reservations online, please visit the ``Venue &
Logistics'' link at https://www.XavierGOC.com to make reservations. The
hotel is expected to sell out during this timeframe, so early
reservation in the conference room-block is encouraged.
If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.
SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated outsourcing with information on the following topics:
FDA International Initiatives
European Union Regulator Perspective
[[Page 41417]]
United States Pharmacopeia Chapter Development Impact
Total Cost of Quality
FDA New Inspectional Approach and Trends
Supplier Selection and Due Diligence
How to Operate in Different Regions of the World
Establishing a Meaningful Supplier Qualification Program
Supply Chain Development
Finished Product Distribution Channel
Enterprise Resource Planning
Self Inspections & Corporate Audits
Quality Agreements
Business Process Management
Global Standards Association Near Term Solutions
The conference includes:
Deep Dive Lunch Sessions
Live Polling Used by Speakers
Case Studies
Small Group Discussions
Networking Lunch by Topic
FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The conference helps to achieve objectives set forth
in section 406 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115), which includes working closely with
stakeholders and maximizing the availability and clarity of information
to stakeholders and the public. The conference also is consistent with
the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121) by providing outreach activities by Government Agencies to
small businesses.
Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17077 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P
