[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Notices]
[Pages 15439-15440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6865]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Food and Drug Administration/Xavier University Global Medical
Device Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
co-sponsorship with Xavier University, is announcing a public
conference entitled ``FDA/Xavier University Global Medical Device
Conference.'' This 3-day public conference includes presentations from
key FDA officials, global regulators, and industry experts. The public
conference has three separate tracks of interest for quality,
regulatory affairs, and clinical research professionals, and is
intended for companies of all sizes and employees at all levels.
Dates and Times: The public conference will be held on May 5, 2010,
from 8 a.m. to 5 p.m.; May 6, 2010, from 8 a.m. to 5 p.m.; and May 7,
2010, from 8 a.m. to 1 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: Gina Brackett, Food and Drug
Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700,
ext 167, FAX: 513-679-272, e-mail: [email protected].
For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, e-mail: [email protected].
Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, lunches, dinners, and dinner
speakers for the 3 days of the conference. Early registration ends
April 5, 2010. Standard registration ends May 4, 2010. There will be
onsite registration. The cost of registration is as follows:
Table 1.--Registration Fees\1\
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Attendee Fee by April 5th Fee by May 4th
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Industry $995 $1,200
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Small Business (<100 $800 $1,000
employees)
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Academic $600 $700
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Student $200 $250
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FDA Employee Fee Waived Fee Waived
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\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
``Registration'' link on the conference Web site at http://www.XavierMedCon.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, e-mail, and payment information for
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory
Parkway, Cincinnati, OH 45207. An e-mail will be sent confirming your
registration.
Attendees are responsible for their own accommodations. The
conference headquarter hotel is the Downtown
[[Page 15440]]
Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, Cincinnati,
OH, 45202, 513-421-9100. To make reservations online, please visit the
``Venue/Logistics'' link at http://www.XavierMedCon.com to make
reservations.
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 medical devices (for humans) with information on the
following topics:
Global compliance,
Global approval process,
Global harmonization,
Recalls and corrections and removals,
Common 483 observations,
What happens after an inspection,
Medical device reports,
Regulatory impact of design and process changes,
Integrating internal and external resources for clinical
trials,
New ways of doing biostatistics,
Innovative clinical study design,
Challenges in conducting global clinical trials,
Comparison of design history file and dechnical dossier,
Integrating risk management in device/combination
products,
Design controls: Human factors,
Labeling and promotion,
Corrective and preventive actions,
International filing requirements,
Promotion of device prior to approval,
Combination product filings--tips for successful
application,
The role of information technology in clinical trials and
post-approval process,
Bioresearch monitoring early intervention initiatives for
electronic records, and
Handling images and other non-traditional electronic data.
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 (21 U.S.C. 393), 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 (Public Law
104-121) by providing outreach activities by Government agencies to
small businesses.
Dated: March 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6865 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S