Document ID: FDA-2010-N-0001-0031
Agency: fda
Document Type: Notice
Title: Food and Drug Administration/Xavier University Global Medical Device Conference
Posted Date: 2010-03-29T04:00Z

[Federal Register: March 29, 2010 (Volume 75, Number 59)]
[Notices]               
[Page 15439-15440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr10-68]                         

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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: gina.brackett@fda.hhs.gov.
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 
513-745-3073, e-mail: phillipsm4@xavier.edu.
    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\
------------------------------------------------------------------------
          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
------------------------------------------------------------------------
Student                       $200                  $250
------------------------------------------------------------------------
FDA Employee                  Fee Waived            Fee Waived
------------------------------------------------------------------------
\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